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(Statutory Authority: 1976 Code Sections 1-23-10, 1-23-110, 1-23-120(I), 6-19-40, 13-7-10, 13-7-40, 13-7-45 et seq., 13-7-110 et seq., 20-1-350, 20-3-230, 38-25-20, 39-23-40, 40-25-30(9), 44-1-20, 44-1-140, 44-5-120, 44-7-130, 44-7-250, 44-7-260(A), 44-7-430, 44-7-500 through 44-7-590, 44-29-40, 44-41-70(b), 44-53-280(a), 44-53-950, 44-55-10 to 44-55-60, 44-56-30, 44-61-30, 44-63-20, 44-69-10 et seq., 44-87-10, 44-96-80, 44-96-290, 44-96-300, 44-96-320, 44-96-340, 44-96-360, 44-96-380, 44-96-400, 44-96-450, 44-96-460, 48-1-10 et seq., 48-1-30 through 48-1-60 et seq., 48-2-10, 59-111-580)

61-1. Medical and Dental Scholarship Fund.

1. Public Notice: As soon as the initial appropriation to the Fund is approved by the Governor, and at appropriate intervals (at least annually) thereafter, the Office of Communications of the Department of Health and Environmental Control shall send a news release to all news media in South Carolina and nearby communities describing the availability of scholarship funds, the persons eligible, the contractual obligations to be assumed by successful applicants, and the address for application forms and information.

2. Assignment of Responsibility in Department: The Commissioner shall designate an office in the Department to be responsible for distribution of application forms approved by the Board, for collection of completed forms, and for performing other staff functions related to the operation of the Fund.

3. Deadline for Receipt of Applications: The Board may set from time to time appropriate dates after which no more applications will be accepted for a particular granting period. In order that all applicants be given equal consideration, such deadlines will allow adequate time for processing the applications prior to final selection of successful applicants by the Board.

4. Legal Residency in South Carolina: South Carolina residency shall be established in accordance with the principles of Section 59-101-70, S.C. Code, as amended, which currently provides in part as follows: "Persons who have been domiciled in South Carolina for a period no less than twelve months with an intention of making a permanent home therein, including persons in their majority, emancipated minors and unemancipated minors whose parents have been domiciled in this State for no less than twelve months with an intention of making a permanent home herein may be considered South Carolina residents, provided that where the parents of an unemancipated minor are living apart or are separated, divorced, or deceased, the residency of the child shall be determined by the place of domicile of the parent or legal guardian with whom the child normally resides. Students making application for residency status shall have the burden of proving that these requirements are met."

5. Investigation of Fitness of Applicants: The office designated in paragraph 2 shall make a careful and full investigation of the ability, character and qualifications of each applicant to determine his fitness. The office shall submit a written summary of its findings on each applicant to the Board through the Commissioner. This investigation shall include a sharing of information pertaining to the applicant with the medical or dental school(s) which has accepted him for enrollment and a visit to his home community contacting his family, his church, his school, his credit references, law enforcement authorities, and other knowledgeable persons. Each applicant shall be required to sign a release form authorizing any person or agency having information about his ability, character and qualifications to release such information to the Board or its agents.

6. Appearance before Board: The Board may examine each applicant to assist in determining if he is qualified.

7. Duration of Loan or Scholarship: Each loan or scholarship shall be for a period of one year. However, recipients of a loan or scholarship who successfully complete the related year of study shall have first priority on unobligated funds for renewal of the loan or scholarship for the succeeding year.

8. Amount of Loan or Scholarship: Each loan or scholarship shall consist of two parts: (1) Payment of tuition and other school related expenses up to a total of $5000 per year, and (2) an allowance of $100 per month for living expenses.

9. Practice Selection: Each loan or scholarship shall be based upon the condition that on or before six months from the date the applicant completes one year of internship he engage in the general practice of medicine or dentistry in a county within the State which has a doctor ratio of not more than one doctor for each two thousand people or a dentist ratio of not more than one dentist for each four thousand people. The Department shall keep a list of the counties having such ratios and the applicant may choose which of these counties he desires to practice in.

10. Determination of Doctor and Dentist Ratios: The number of doctors and dentists practicing in counties shall be primarily based on the latest data from the State Board of Medical Examiners and the State Board of Dentistry pertaining to practitioners licensed and registered by these Boards. The Board of Health and Environmental Control may also take into consideration the Federal physicians assigned in the counties inasmuch as the people they serve are included in the population of the counties. The population used in calculating the ratios shall be the estimate of the Research and Statistical Services Division of the Budget and Control Board closest to the time of assembly of the information from which the number of professionals is derived.

11. Repayment of Loan or Scholarship: For each year during which an applicant benefits from a loan or scholarship he shall be required to engage in practice as defined in paragraph 9 for one year. Such work shall in addition constitute a repayment of the loan or scholarship. Applicants who receive a scholarship or loan for four years shall only be required to practice in such a county for three years, at the end of which time the loan shall be considered paid in full. Where the Board is convinced that there is justifiable cause which the applicant could not have foreseen, the Board may allow him to repay the loan or scholarship by paying in cash the full amount of the loan or scholarship, plus 7% interest per year compounded semiannually.

12. Contracts with Applicants: Before being granted a loan or scholarship, each applicant shall enter into a contract with the Board, agreeing to the terms and conditions upon which the loan or scholarship shall be granted to him. The contract shall include terms and provisions to carry out the purpose and intent of paragraphs 7 through 10 and 14 of these regulations. It shall be signed by the chairman of the Board, countersigned by the executive secretary of the Board, and signed by the applicant.

13. Contracts with Professional Schools: The Board may make arrangements and execute contracts with approved medical or dental schools for the admission of students granted loans or scholarships by the Board. Such contracts may provide for the payment of tuition and other school related expenses directly to the schools. The Board, upon proper notice, may cancel any contract made with such institutions.

14. Failure of Recipient to Fulfill Contract: If the recipient of a scholarship fails without justifiable cause to practice medicine or dentistry in accordance with the terms of his contract, three times the entire amount of the scholarship benefits received, plus 7% interest per year compounded semiannually shall become due and payable. However, if the Board determines there is justifiable cause for the failure to practice pursuant to the terms of the contract, it may relieve the recipient of the obligation to practice according to the terms of the contract, and shall provide for repayment of the amount received, plus 7% interest per year on any terms it may deem proper. Upon recommendation and request of the Board, the Attorney General shall institute proceedings for the purpose of recovering any amount due the State upon breach of the contract.

15. Receipts and Expenditures: Funds appropriated and all sums received in repayment of loans and scholarships shall be placed in the State Treasury to the credit of the South Carolina Medical and Dental Scholarship Fund. Loan and scholarship payments shall be paid out of this fund upon a voucher to the State Comptroller General signed by the chairman and the executive secretary of the Board.

61-2. Repealed by State Register Volume 20, Issue 5, eff May 24, 1996.

61-3. The Practice of Selling and Fitting Hearing Aids.

(Statutory Authority: Section 40-25-30 et seq of 1976 Code, as amended.)

Definitions and Interpretations

I. Definitions:

For the purpose of these rules and regulations, the following definitions shall apply:

(a) The Act: The "Fitting and Selling of Hearing Aids Act" enacted June 25, 1971. [1976 Code Sections 40-25-10 et seq.]

(b) The Department: The South Carolina Department of Health and Environmental Control.

(c) The Commission: The State Commission for Hearing Aid Dealers and Fitters.

(d) License: A license issued by the Department under this Act to a hearing aid dealer and fitter.

(e) Temporary Permit: A permit issued by the Department under this Act while the applicant is in training to become a licensed hearing aid dealer and fitter.

(f) Hearing Aid: Any acceptable wearable instrument or device designated for or offered for the purpose of aiding or compensating for impaired human hearing and any parts, attachments or accessories, including earmold, but excluding batteries and cords.

(g) Practice of Fitting and Dealing in Hearing Aids: The measurement of human hearing by means of an audiometer or by any other established means for the purpose of making selections, adaptations or sale of hearing aids. The term also includes the making of impressions for earmolds. Counseling and instruction relative to the above.

(h) Sale of Hearing Aids: Any transfer of title or of the right to use by lease, bailment, or any other contract, excluding wholesale transactions with distributors or representatives.

(i) Otolaryngologist: A licensed physician specializing in diseases of the ear, nose and throat.

(j) Audiologist: An individual completing satisfactory graduate work and holding a Certificate of Clinical Competence and who is actually engaged in audiological practice.

(k) Licensee: The individual authorized to engage in the practice of fitting and selling hearing aids and on whom rests the responsibility for complying with the provisions of the Act and these Rules and Regulations promulgated thereunder.

(l) Application: Application means a form which shall contain all of the prescribed information established by the Department as set forth in the Act.

(m) Examination: Examination means the testing of knowledge and proficiency of an applicant required for fitting and selling hearing aids.

(n) Registrant: Registrant shall be synonymous with licensee, holder of a certificate of registration, trainee and temporary permit holder.

II. Interpretations:

(a) License: A license is issued by the Department pursuant to the provisions of the Act and these Rules and Regulations promulgated thereunder. This license shall be posted in a conspicuous place in his office or place of business at all times in full view at the address specified on the license. A license is not assignable or transferable and is subject to revocation or suspension for a fixed period by the Department for cause as defined within Section 13(2) of the Act [Section 40-25-160(2)].

(b) Term of License:

(1) Each person licensed to fit and sell hearing aids shall annually, on or before January 30, pay to the Department a fee of fifty dollars ($50.00) for issuance or renewal of license.

(2) A thirty (30) day grace period shall be allowed after January 30, during which time licenses may be renewed on payment of a fee of sixty dollars ($60.00) to the Department. After expiration of the grace period, the Department may renew such license upon payment of a fee of seventy-five dollars ($75.00) to the Department. No person who applies for renewal, whose license has expired, shall be required to submit to any examination as a condition to renewal, provided such renewal application is made within a period of two (2) years from the date of such expiration.

(3) A license shall be effective for a twelve (12) month period, beginning January 31 and ending January 30 of the succeeding year.

(c) Temporary Permit: A temporary permit shall be issued to an applicant who fulfills the requirements of the Act but does not meet the experience qualifications and shall entitle applicant to engage in the fitting and selling of hearing aids for a period of one (1) year under the supervision of a licensed hearing aid dealer and fitter.

PART I

CHAPTER I--Management

Section 101. Application

(a) No person shall fit, or offer for sale, hearing aids in this State unless such person has complied with the requirements hereof as to registration and licensing.

(b) An individual, in making his first registration hereunder, shall write or cause to be written upon the application blank, so furnished by the Department, his full name, business address, residence address and such other facts for identification of the applicant as may be deemed necessary and shall execute and verify the same before a notary public and shall file the same with the Department.

(c) The Department on or before December 1 of each year, after the first registration, shall mail to each licensee or registrant a blank form of application for registration addressed to the last known business of such person.

(d) The Department shall, in accordance with the Act, issue to any individual who has submitted his application for registration complete with the information as may be deemed applicable by the Department, a license or temporary permit under the seal of the Department for the ensuing year.

(1) Any licensee or temporary permit holder must maintain a progressing level of professional competence by participation during each calendar year in educational programs designed to keep such licensee informed of changes, current practices, and developments pertaining to the fitting of hearing aids and rehabilitation as appropriate to hearing aid use.

(2) The licensee shall annually submit to the Commission proof of having participated in a minimum of eight hours of continuing education during the calendar year. A licensee who is granted a license during a calendar year shall not be required to complete such requirements during that year and such requirement shall begin the second full licensing year. The requirement may be fulfilled by attending and participating in training activities approved by the Commission.

(3) Failure to complete the minimum educational requirements shall result in a license suspension until the requirements are met. The Commission, upon sufficient cause shown by the licensee, may allow the licensee to make up the necessary hours during the next calendar year. The make-up allowance shall not waive the full annual requirements for continued education.

(e) Application for Examination Fee: An application for examination shall be accompanied by a check or money order made payable to the South Carolina Department of Health and Environmental Control in the amount of fifty dollars ($50.00). It shall be understood by the applicant that the examination fee shall in no instance be refunded, applied as payment for temporary permit, or transferred to the license fee.

(f) Failure to complete all forms and provide all information required by law may be just cause for the application to be rejected by the Department.

(g) Any person furnishing false information or omitting pertinent information in such application shall be denied the right to the examination, or if the applicant has already been licensed before the falseness of such information has been made known to the Department, such license shall be subject to suspension or revocation.

Section 102. License

A license under this Act shall confer upon the holder the right to select, fit and sell hearing aids.

(a) Licenses or temporary permits shall not by any manner or means be duplicated by the licensee or other persons.

(b) Any change in status of licensee or temporary permit, such as address or name, shall make the license null and void and shall be returned to the Department for proper disposition.

(c) Persons who hold a license or temporary permit shall notify the Department in writing of his regular address, business address, office address or the place where he engages or intends to engage in the fitting or the sale of hearing aids. Notification of any change of status must be made to the Department within fifteen (15) days subsequent to such change.

Section 103. Temporary Permit

An applicant who fulfills the requirements of the Act, and who has not previously applied to take the examination delineated in Section 202 of these Rules and Regulations, may apply to the Department for a temporary permit.

(a) Prior experience or a waiting period shall not be required provided he shall be reasonably supervised and trained for a period of one year by a currently licensed hearing aid dealer.

(b) Annual reports of progress must be maintained on each person with a temporary permit by a licensed dealer verifying adequate personal contact supervision, and training and all such reports shall be kept on file at the Department. The phased training reports shall be submitted quarterly to complete the annual reports of progress.

(c) If any person who holds a temporary permit has not successfully passed the licensing examination within one year from the date of issuance, the temporary permit may, at the discretion of the Department, be renewed or he shall be required to reapply at a date specified by the Department.

Section 104. Display of License/Temporary Permit

The license or temporary permit shall be prominently displayed in his office or place of business in full view of any customer or client. The wallet sized identification shall be in the possession of licensed hearing aid dealers and temporary permit holders at all times and shall be displayed upon request by any customer, client, or agent of the Department, or peace officer.

Where there is more than one office or place of business, duplicate licenses shall be issued by the Department.

Section 105. Fees

(a) All fees shall be made payable to the South Carolina Department of Health and Environmental Control and are not transferable.

(b) Licensing fee or renewal fee established in the Act is fifty dollars ($50.00) and duplicate licenses will be issued where more than one office or place of business is in operation.

(c) Temporary permit fee has been established at twenty-five dollars ($25.00).

(d) Examination fee is set in the amount of fifty dollars ($50.00) and is not refundable.

Section 106. Conduct/Ethics

1. It shall be the responsibility of the licensee or the temporary permit holder, under the Act, to be familiar with and to avoid commission of any acts regarded as unethical conduct including, but not limited to, the following:

(a) The obtaining of any fee or making any sale by fraud or misrepresentation.

(b) Employing directly or indirectly any suspended or unregistered person to perform any work covered by the Act.

(c) Engaging in falsification of name or using an alias with fraudulent intent for the purposes of fitting and selling hearing aids.

(d) Gross incompetence, or negligence shall be considered, in dispensing or selling a hearing aid to a customer, client or person without that person having been given the opportunity of tests utilizing appropriate established procedures and instrumentation to determine the extent or type of hearing impairment: except in cases of selling replacement hearing aids, in which case retesting hearing within 18 months of original purchase except in extenuating circumstances as determined by the Department.

(e) Using or causing or promoting the use of any advertising matter, promotional literature, testimonial, guarantee, warranty, label, brand, insignia, or any other representation, however disseminated or published, which is misleading, deceiving, or untruthful.

(f) Advertising or offering for sale a particular model, type or kind of hearing aid when the offer is not a bonafide effort to sell the product so offered as advertised and at the advertised price. In determining whether there has been a violation of this rule, consideration will be given to actions or practices indicating that the offer was not made in good faith for the purpose of selling the advertised product, but was made for the purpose of contacting prospective purchasers and selling them a product offered.

(g) Violation of any of the provisions of the Act.

2. Actions or procedures which shall be considered for the purpose of determining misrepresentation shall be the following:

(a) The creation, by virtue of the initial offer or advertisement, of a false impression of the product offered in any material respect.

(b) A refusal to show, demonstrate or sell the product offered in accordance with the terms of offer.

(c) To vilify by actions or words, the product offered, credit terms, availability of service, repairs or parts in connection with the offer or advertisement.

(d) To delay, in the event of sale, the delivery of such product or the service of such product offered within a reasonable time thereafter.

(e) Representing, advertising or implying that the hearing aid or repair is guaranteed without complete disclosure of the nature and extent of the guarantee and any conditions or limitations thereof.

3. Representing that the professional services or advice of a physician will be used or made available in the selling or fitting, adjustment, maintenance or repair of hearing aids when that is not true, or using the words "doctor", "clinic", "audiologist", or any similar words, abbreviations, or symbols which tend to connote the audiological or medical profession when such is not the case.

4. Permitting another the use of license or temporary permit.

5. The indulgence in excessive consumption of beverages or drugs for purposes of intoxication shall constitute habitual intemperance.

6. Offering for sale, rent, or lease, by advertisement, a manufacturer's product or using a manufacturer's name or trademark which implies a relationship with the manufacturer(s) that does not exist.

7. Directly or indirectly giving or offering to give, permitting or causing the exchange of anything of value, whether it be money or otherwise, to any person who advises another as an inducement to influence him or others to purchase or contract for purchase products sold or offered for sale by a hearing aid dealer or fitter.

8. Making any statement or implying that the use of any hearing aid will restore or preserve hearing, prevent or regress hearing impairment.

9. To conduct business during any affliction thereby causing to be spread any contagious or infectious disease which may constitute a hazard to the well-being of any client.

10. Committing or contributing to any of the above actions or deeds shall be construed a violation of the Act.

Section 107. Corporation or Like Organizations

Nothing in this Law shall prohibit a corporation, partnership, trust, association or other like organizations from engaging in the business of fitting and selling or offering for sale hearing aids at retail without a license, if it employs licensed persons in the direct sale and fitting of such products. Such corporations, partnerships, trusts, associations, or other like organizations shall also file annually with the Department and Commission a list of all licensed hearing aid dealers, fitters, and holders of temporary permits directly or indirectly employed by it. Corporate officers or agents of such organizations shall file with the Department by affixing their signature(s) to the application and thereby submit themselves to the Rules and Regulations and the provisions of this Act which the Department may deem applicable.

PART II

CHAPTER II--Procedures

Section 201. Procedures/Equipment

1. The following procedure shall be used in the fitting and selling of hearing aids where applicable:

(a) Pure tone audiometric testing by air and bone conduction to determine the level of hearing impairment.

(b) Speech reception threshold, speech discrimination, sound pressure measurement of the speech frequency range for the purpose of determining the best ear(s) for maximal hearing aid benefit and comfort. Selection of the best instrument to compensate for degree of loss.

(c) Only when the above procedures are clearly impractical, then the selection of the best instrument to compensate the loss may be made by trial of several instruments.

The following minimal equipment shall be used in the fitting and selling of hearing aids:

(a) Pure tone audiometer which shall meet with the latest specification standards as determined by the Department.

(b) Speech audiometer or a master hearing aid in order to determine the most comfortable listening level and speech discrimination.

(c) Ear light or an otoscope, for revealing any obstruction of the auditory canal, shall be free of cerumen and maintained in an aseptic manner at all times.

(d) Audiometers shall be checked for proper calibration as often as deemed necessary but not less than once each year. Evidence of calibration shall be furnished with the license renewal application and a copy maintained on file in the office.

1. Calibration shall be conducted by person, or an institution of higher learning equipped with proper instruments for calibrating as determined by the Department.

(e) Maintain or have access to facilities for making ear molds.

(f) A hearing aid office or place of business must have available or access to a selection of hearing aids and supplies and offer services complete enough to accommodate within reasonable limits the various needs of the clientele.

(g) The testing room shall be sufficient in dimensions to accommodate all equipment necessary for the proper testing and evaluation of the client.

(h) Every person who fits and sells hearing aids shall transmit to each person supplied with a hearing aid a receipt which shall contain the licensee's signature, show his business address and the license or temporary permit number together with the make, model and serial number of the hearing aid furnished and full terms of the sale clearly stated thereon. In the event of a used or rebuilt, reconditioned hearing aid, it shall be so specified on said receipt and shall indicate the length of time of the guarantee and by whom guaranteed.

1. The licensee shall advise the purchaser prior to any sale, testing or evaluation by the hearing aid dealer that any examination or representation is not to be construed as a diagnosis, a medical opinion or that such examination imparts to the purchaser a prescription by a person licensed to practice medicine in this State.

2. Any person engaging in the fitting and sale of hearing aids will, when dealing with a child twelve years of age or under, ascertain whether the child has been examined by an otolaryngologist for his recommendation within ninety days prior to the fitting. If such not be the case, a recommendation to do so must be made and this fact noted on the receipt.

Section 202. Examination

1. An applicant for license, or holder of a temporary permit who meets all the requirements of the Act, shall appear at a time, place, and before such persons as prescribed by the Department to be examined by written and practical testing. The examination shall be such that it will establish knowledge and proficiency in each of the following categories:

(a) Basic physics of sound.

(b) Anatomy and physiology of the ear.

(c) Basic structure and functions of hearing aids.

(d) Pure tone audiometry, air and bone conduction.

(e) Live voice or recorded speech, speech audiometry including speech reception threshold testing and speech discrimination testing.

(f) Masking (when indicated).

(g) Recording and evaluation of audiograms.

(h) Speech audiometry.

(i) Taking earmold impressions.

2. Examination and Fee:

(a) A fee of fifty dollars ($50.00) has been established for the examination and is not transferable or refundable.

(b) Receipt shall be transmitted to applicant.

(c) Application for examination shall be kept on file by the Department.

(d) Applicant shall be notified within a reasonable time of the results of the prescribed tests.

(e) Examinations for applicants shall be given not less than once each year.

3. The examination shall not constitute criteria or standards nor be conducted in a manner requiring college training in order to pass, or imply that the applicant possess a degree of competence normally expected of physicians or audiologists.

Section 203. Inspections

Inspection(s) shall be conducted periodically by the Department; such inspection(s) shall include but not be limited to the following:

1. Calibration check of audiometric equipment: evidence of calibration check shall be furnished upon request or shall be affixed to audiometer and shall have date and name of person(s) calibrating such equipment.

(a) Calibration shall be conducted on each audiometer as often as deemed necessary but not less than once each year.

(b) Calibration shall be accomplished by the manufacturer or properly trained person or an institution of higher learning equipped with proper instruments for calibrating audiometer as determined by the Department.

(c) Calibration of audiometers and earphones shall be in accordance with the American National Standards and Specification of Audiometers recent edition.

2. Records or receipt applicable to the sale of hearing aid:

(a) Such records or receipts shall contain the signature or initials of licensee, the business address, make, model and serial number of the hearing aid offered.

(b) Full disclosure of the terms of the sale.

(c) The warranty or guarantee and by whom.

(d) Any person engaging in the fitting and sale of hearing aids will, when dealing with a child twelve years of age or under, ascertain whether the child has been examined by an otolaryngologist for his recommendations within ninety days prior to the fitting. If such not be the case, a recommendation to do so must be made and this fact noted on the receipt.

(e) These records and receipts shall be retained, by the licensee or dealer, for a period of time not less than ten (10) years in keeping with good practice.

(f) Suggest all employees be required to check in to the owner of the business all pertinent records on termination of association with said owner of business.

3. The facility and individuals who work with, or handle, the equipment shall be clean at all times and all necessary precautions shall be taken to prevent the spread of any communicable disease.

4. Audiograms shall be recorded when applicable, and shall transmit the following information:

(a) Date of evaluation.

(b) Name of customer or client.

(c) Address of customer or client.

(d) Sex.

(e) Age.

(f) Signature of individual conducting test.

(g) Audiogram shall be filed by the dealer, licensee or permit holder at his place of business for a period of ten (10) years or until such time as good practice may dictate.

5. An otoscope or ear light shall be operational and maintained in a clean manner and free of any debris or cerumen at all times.

Section 204. General

Conditions arising which have not been covered in these regulations shall be handled in accordance with the best practices as interpreted by the South Carolina Department of Health and Environmental Control.

Section 205. Continuing Education Programs-Approval

Any person or organization desiring to conduct continuing education training programs must submit such programs to the Commission for approval.

a. Courses which have been approved by the National Institute of Hearing Instruments Studies (NIHIS) of the National Hearing Aid Society will be approved by the Commission under the following conditions:

(1) The organization offering the program furnishes to the Department, not later than thirty days prior to its presentation, an outline which identifies the course content and NIHIS approved hours;

(2) The course is publicized and available to all South Carolina licensed hearing aid dealers; and

(3) The organization offering the courses furnishes the Department the names of such dealers who attended the program and the courses and hours creditable to each one.

b. Courses which do not meet the requirements outlined in "a", above, may be approved by the Commission under the following conditions:

(1) The organization offering the program furnishes to the Department, not later than sixty days prior to its presentation, an outline which includes:

(a) date and location;

(b) a description of each course;

(c) hours of each course; and

(d) biographical data of the instructors.

(2) The course is publicized and available to all South Carolina licensed hearing aid dealers; and

(3) The organization offering the courses furnishes the Department the names of such dealers who attended the program and the courses and hours creditable to each one.

c. The Department will secure Commission approval as appropriate and notify the training organization of the hours approved.

61-4. CONTROLLED SUBSTANCES.

(Statutory Authority: S.C. Code Section 44-53-280(a))

Table of Contents

Part 1 Section 101-114 Definitions, Information, Payment of Fees, Certain

Exemptions, Separate Registrations, Out-of-State

Dispensing of Prescriptions

Section 115-121 Application for Registration

Section 122-139 Action on Applications for Registrations: Revocation or

Suspension of Registration

Section 140-147 Security Requirements

Part 2 Section 201-206 Labeling and Packaging Requirements for Controlled

Substances

Part 3 Section 301-322 Records and Reports of Registrants

Part 4 Section 401-403 Order Forms

Part 5 Section 501-518 Prescriptions

Part 6 Section 601-609 Miscellaneous

Part 7 Section 701-799 Schedules of Controlled Substances

Part 8 Section 801-818 Hearings and Other Administrative Matters

Part 9 Section 901-923 Handling and Administering Controlled Substances in

Hospitals

PART 1 Definitions, Information, Payment of Fees, Certain Exemptions, Separate Registrations, Out-of-State Dispensing of Prescriptions

101. Definitions.

As used in this regulation, the following terms shall have the meaning specified:

(a) Act. Article 3 of Chapter 53 of Title 44 of the 1976 SC Code of Laws, including all amendments thereto;

(b) Administration and the abbreviation DEA. Refer to Drug Enforcement Administration, United States Department of Justice, the successor agency to the Bureau of Narcotics and Dangerous Drugs as defined in the Act;

(c) Commercial container. Any bottle, jar, tube, ampoule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and, in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term "commercial container" does not include any package liner, package insert, or other material kept with or within a commercial container, nor any carton, crate, box, or other package in which commercial containers are stored or are used for shipment of controlled substances;

(d) Commissioner. Unless otherwise specified, the Commissioner of the Department of Health and Environmental Control;

(e) Commissioner of Narcotics. The Commissioner of Narcotics and Controlled Substances as defined in the Act; or his or her statutory successor;

(f) Controlled premises:

(1) Places where original or other records or documents required under the Act are required to be kept, and

(2) Places, including factories, warehouses, or other establishments, and conveyances, where persons registered under the Act or exempted from registration under the Act may lawfully hold, manufacture, dispense, distribute, administer, or otherwise dispose of controlled substances;

(g) DHEC. The South Carolina Department of Health and Environmental Control;

(h) Director. The Director of the Bureau of Drug Control, DHEC;

(i) Dispenser. An individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance;

(j) Hearing. Any hearing held pursuant to the provisions of the Act or of this regulation, including, but not limited to, hearings for the granting, denial, revocation, or suspension of a registration pursuant to the Act;

(k) Individual practitioner. A physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted by the United States or the State of South Carolina, or by other jurisdiction, or otherwise permitted by the United States or the State of South Carolina, or by any other jurisdiction in which he practices to dispense a controlled substance in the regular course of professional practice, but does not include a pharmacist, a pharmacy, or any institutional practitioner;

(l) Inspector or drug inspector. An officer or employee of the Bureau of Drug Control authorized by the Director to make inspections under the Act, and to conduct audit procedures in relation to controlled substances, and includes the Director of the Bureau of Drug Control;

(m) Institutional practitioner. A hospital or other person (other than an individual) licensed, registered, or otherwise permitted by the United States, the State of South Carolina, or other jurisdiction in which it practices, to dispense a controlled substance in the regular course of professional practice, but does not include a pharmacy;

(n) Interested person. Any person adversely affected or aggrieved by any rule or proposed rule issued or issuable pursuant to the Act;

(o) Name. The official name, common or usual name, chemical name, or brand name of a substance;

(p) Person. Includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity;

(q) Pharmacist. Any pharmacist licensed by a State to dispense controlled substances, and shall include any person (e.g., pharmacy intern) authorized by the State to dispense controlled substances under the supervision of a pharmacist licensed by the State;

(r) Prescription. An order for medication which is dispensed to or for an ultimate user, but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription);

(s) Proceeding. All actions taken for the issuance, amendment, or repeal of any rules and regulations issued pursuant to the Act, commencing with the publication by the Director of the proposed rule, amended rule, or appeal.

(t) Readily retrievable. Certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined, or in some other manner visually identifiable apart from other items appearing on the records; when the term is not applicable to data processing systems, the term also means that a registrant is able to produce controlled substances records in a timely manner (usually within one hour) and that such records are segregated, sorted, or filed in such a manner that the controlled substances information may be derived from the material within a reasonable time (usually with a few hours) by an inspector.

(u) Register and registration. Refer only to registration required and permitted by the Act;

(v) Registrant. Any person who is registered pursuant to the Act.

(w) Emergency situation. For the purposes of authorizing an oral prescription of a controlled substance listed in Schedule II of the Act, the term "emergency situation" means those situations in which the prescribing practitioner determines:

(1) That immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user; and

(2) That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and

(3) That it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing.

(x) Any term not defined in this section shall have the definition set forth in the Act, or amendments thereto.

(y) Long Term Care Facility (LTCF). Nursing home, intermediate care, mental care, or other facility or institution which provides extended health care to resident patients and is licensed as such by DHEC or other appropriate State agency, which may further define the term for licensing and certification purposes.

(z) Compounder. Any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages, or changes the dosage forms of a narcotic drug listed in Schedules II, III, IV, or V for use in maintenance or detoxification treatment by another narcotic treatment program. The term "compounder" as the content requires, includes any lawfully authorized person who changes the dosage forms, mixes, or prepares any controlled substance for use by the ultimate user pursuant to the legitimate and lawful order of a practitioner acting in the regular course of professional practice or by the practitioner personally, if authorized by law to compound and dispense controlled substances.

(aa) Detoxification treatment. The dispensing for a period not in excess of twenty-one days, of a narcotic or narcotics drugs in decreasing dosages to an individual in order to alleviate adverse physiological or psychological effects incidental to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. SEE ALSO Sections 507 through 507.5 inclusive.

(ab) Code. The Code of Laws of South Carolina, 1976, including all amendments thereto.

(ac) Home infusion pharmacy. A pharmacy which compounds solutions for direct administration to a patient in a private residence, Long Term Care Facility or hospice setting by means of parenteral, intravenous, intra-muscular, subcutaneous or intra-spinal infusion.

102. Information; special instructions.

Information regarding procedures under these rules and special instructions supplementing these rules will be furnished upon request by writing to the Bureau of Drug Control DHEC, 2600 Bull Street, Columbia, SC 29201.

103. Fee amounts.

(a) For each registration or re-registration to possess and dispense controlled substances as a pharmacy or health clinic, the registrant shall pay a fee of $125.00.

(b) For each registration or re-registration to possess, dispense and administer controlled substances as a hospital or other institutional practitioner, the registrant shall pay a fee of $325.00.

(c) For each registration or re-registration to possess, dispense, and administer controlled substances as an individual practitioner other than a pharmacy or hospital [i.e., physician (medical or osteopathic), dentist, veterinarian, podiatrist, optometrist, physician assistant or nurse practitioner], the registrant shall pay a fee of $125.00.

(d) For each registration or re-registration to conduct research or instructional activities with controlled substances listed in schedule II through V inclusive, the registrant shall pay a fee of $125.00.

(e) For each registration or re-registration to conduct research or instructional activities with controlled substances listed in Schedule I, the registrant shall pay a fee of $125.00.

(f) For each registration or re-registration to manufacture controlled substances, the registrant shall pay a fee of $650.00.

(g) For each registration or re-registration to distribute controlled substances, the registrant shall pay a fee of $550.00.

(h) For each registration or re-registration to conduct chemical analysis with controlled substances listed in any schedule, the registrant shall pay a fee of $125.00.

104. Time and method of payment; refund.

Registration and re-registration fees shall be paid at the time when the application for registration is submitted for filing. Payment shall be made in the form of a personal, certified or cashier's check or money order made payable to DHEC. Payments made in the form of stamps, foreign currency, or third party endorsed checks will not be accepted. In the event that the application is not accepted for filing or is denied, the payment shall be refunded to the applicant.

105. Registrants exempt from fee.

(a) Any federal agency, installation or official authorized by law to procure or purchase controlled substances for official use shall be exempt from payment of a fee for registration or re-registration.

(b) In order to claim exemption from the payment of fees for registration or re-registration, the registrant shall have completed the certification on the appropriate application form, wherein the applicant's superior or the agency head certifies to the status and address of the registrant and to the authority of the registrant to acquire, possess or handle controlled substances.

(c) Exemption from payment of a registration fee does not relieve the registrant of any other requirements or duties prescribed by law.

106. Persons required to register.

Every person who manufactures, distributes, prescribes or dispenses any controlled substance or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance shall obtain annually a registration unless exempted by law. Only persons actually engaged in such activities are required to obtain a registration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration.)

107. Separate registration for independent activities.

(a) The following groups of activities are deemed to be independent of each other:

(1) Manufacturing controlled substances;

(2) Distributing controlled substances;

(3) Dispensing controlled substances listed in schedules II through V;

(4) Conducting research (other than research described in paragraph (a) (6) of this section) with controlled substances listed in schedules II through V;

(5) Conducting instructional activities with controlled substances listed in schedule II through V;

(6) Conducting a narcotic treatment program using any drug listed in Schedules II through V: however, pursuant to Section 109, employees, agents or affiliated practitioners, in programs, need not register separately. Each program site located away from the principal location and at which place narcotic drugs are stored or dispensed shall be separately registered and obtain narcotic drugs by use of order forms pursuant to Sections 401 and 402;

(7) Conducting research and instructional activities with controlled substances listed in schedule I;

(8) Conducting chemical analysis with controlled substances listed in any schedules;

(9) Importing controlled substances;

(10) Exporting controlled substances listed in schedules I through IV; and

(11) A compounder as defined by Section 101(z).

(b) Every person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph. Any person, when registered to engage in the group of activities described in each subparagraph in this paragraph, shall be authorized to engage in the coincident activities described in that subparagraph without obtaining a registration to engage in such coincident activities, provided that, unless specifically exempted, he complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities:

(1) A person registered to manufacture or import any controlled substance or basic class of controlled substance shall be authorized to distribute that substance or class, but no other substance or class which he is not registered to manufacture or import;

(2) A person registered to manufacture any controlled substance listed in schedules II through V shall be authorized to conduct chemical analysis and pre-clinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture;

(3) A person registered to conduct research with a basic class of controlled substance listed in schedule I shall be authorized to manufacture or import such class if and to the extent that such manufacture and importation is set forth in the research protocol filed with the application for registration which shall conform with the provisions of 21 CFR Section 1301.33, and to distribute such class to other persons registered or authorized to conduct research with such class, or registered or authorized to conduct chemical analysis with controlled substances.

(4) A person registered to conduct chemical analysis with controlled substances shall be authorized to manufacture and import such substances for analytical or instructional purposes, to distribute such substances to other persons registered to conduct chemical analysis or instructional activities and to persons exempted from registration pursuant to Section 111, to export such substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries, and to conduct instructional activities with controlled substances;

(5) A person registered or authorized to conduct research (other than research described in paragraph (a)(6) of this section) with controlled substances listed in those schedules in which he or she is authorized to conduct research, to manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration, to import such substances for research purposes, to distribute such substances to other persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to Regulation III, and to conduct instructional activities with controlled substances, and

(6) A person registered to dispense controlled substances listed in Schedules II through V may conduct research (other than research described in paragraph (a) (6) of this section) in conformity with the provisions of S.C. Code Ann.Section 44-53-300(c) and conduct instructional activities with those substances.

(c) A single registration to engage in any group of independent activities may include one or more substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in Schedule I may conduct research with any substance listed in Schedule I for which he or she has filed and had approved a research protocol.

108. Separate registrations for separate locations.

(a) A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, or dispensed by a person.

(b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:

(1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registrants other than the registered person or to persons not required to register by the Act.

(2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances for display purposes or lawful distribution as samples only nor serves as a distribution point for filling sales orders; and

(3) An office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office and where no supplies of controlled substances are maintained.

109. Exemption of agents and employees; affiliated practitioners.

(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his or her business or employment. (For example, a pharmacist employed by a pharmacy need not be individually registered to conduct lawful business activity in preparing and dispensing of controlled substances if the pharmacy in which he or she is employed is properly registered under the Act; a manufacturer's sales representative may lawfully distribute samples of controlled substances manufactured by his or her employer, provided the manufacturer-employer is lawfully registered and the distribution is made to a registrant authorized to possess controlled substances and not to a non-registrant employee of the recipient of the sample.)

(b) An individual practitioner who is affiliated with one or more other individual practitioners in any legitimate and lawful form of business arrangement (i.e., partnership, professional association, etc.) shall be registered individually with DHEC prior to engaging in any form of controlled substances activity, pursuant to the provisions of S.C. Code Ann. Sections 44-53-290 and 44-53-370(a)(1). With the written Power of Attorney of another affiliated practitioner within the group, any other affiliate individual practitioner may administer or dispense (other than by prescribing) controlled substances within the regular course of professional practice if and to the extent the practitioner granting the power of attorney has authorized. (For example, Dr. X and Dr. Y are partners; they shall be individually registered in order to utilize controlled substances in their practice; if Dr. X desired, he or she could issue Dr. Y a power of attorney to utilize Dr. X's office stock of controlled substances to administer an injection of product CRx to Dr. Y's Patient, Mrs. A. while she is in the office. Dr. Y may not, however, sign Dr. X's name to prescriptions, nor may Dr. Y use Dr. X's registration number to obtain stocks of controlled substances for himself or herself or his or her own office stock.) Any power of attorney, once granted, may be revoked by the grantor in writing. Nothing in this Section shall be construed to relieve the grantor of any power of attorney of any responsibility for the proper storage, record keeping, handling, or legitimate use of any controlled substances acquired by the grantor; nor shall anything be construed as relieving the grantee practitioner from full and complete responsibility for his or her actions conducted pursuant to the power of attorney or for controlled substances acquired or utilized pursuant to this paragraph.

(c) Pharmacists listed with the SC Board of Pharmacy as the "pharmacist-in-charge" of a pharmacy holding a permit issued by that Board to operate as a retail pharmacy, shall be considered as a "registrant" within the meaning of the Act and this Regulation, and shall be primarily responsible for the controlled substances activity at the registered location of the pharmacy. Nothing in this paragraph shall be construed as relieving an owner, partner, corporate officer, or any other person who may be a registrant-in-fact (due to his or her position within the business entity) from any direct or vicarious liability which may be incurred due to unlawful or ultra vires activity, nor shall it be construed to relieve any employee of the business entity from direct responsibility for his or her own unlawful acts.

(d) Individual practitioners permitted under the provisions of Federal Regulation 21 CFR Section 1301.24 to dispense, administer, or prescribe controlled substances under the registration of a hospital or other institution which is registered, in lieu of personal registration, are prohibited from this practice by the provisions of S.C. Code Ann. Sections 44-53-290 and 44-53-370(a)(1). No prescriptions issued within this State shall be dispensed by any person registered with DHEC unless the individual practitioner issuing the prescription holds a valid individual practitioner registration with DEA. Nothing shall prevent the dispensing of such prescriptions if they are co-signed by an individual practitioner holding a valid individual registration with the DEA and DHEC, providing that the co-signing practitioner has established a valid practitioner-patient relationship as set forth by Sections 508.2 and 514.2 of this Regulation prior to the dispensing of the controlled substance. Nothing in this paragraph shall preclude any pharmacy or dispensary operated by the Federal government on any property or enclave not subject to State jurisdiction from any act permitted under Federal law or regulation, nor shall it preclude the dispensing of out-of-state prescriptions as permitted bySection 114 of this Regulation.

110. Exemption of certain military and other personnel.

(a) The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service or Bureau of Prisons who is authorized to prescribe, dispense or administer, but not procure or purchase controlled substances in the course of his or her official duties, provided such prescribing, dispensing, and administering of controlled substances takes place upon a military reservation or other Federal enclave. Any practitioner who issues prescriptions for controlled substances which are to be dispensed from non-governmental pharmacies or dispensaries shall register with DHEC prior to issuing such prescriptions. Public Health Service practitioners who dispense controlled substances from governmental stocks shall be exempt from registration, but if such practitioners issue prescriptions to be dispensed from non-governmental pharmacies or dispensaries, they shall register with DHEC prior to the issuance of such prescriptions.

(b) If any official exempted by this section also engages as a private individual in any activity or group of activities for which registration is required, such official shall obtain a registration for such private activities.

111. Exemption of law enforcement officials.

(a) The requirement of registration is waived for the following persons in the circumstances described in this section:

(1) Any official or employee of the DEA, U.S. Department of Justice, any officer of the U.S. Bureau of Customs, any officer or employee of the United States Food and Drug Administration, and any other federal officer who is lawfully engaged in the law enforcement of any federal law relating to controlled substances, drugs or customs, and is duly authorized to possess controlled substances in the course of his or her official duties; and

(2) Any officer or employee of any state, or any political subdivision or agency thereof, who is engaged in the enforcement of any state or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his or her official duties.

(b) Any official exempted by this section may when acting in the course of his or her official duties, possess any controlled substances and distribute any such substance to any other official who is also exempted by this section and acting in the course of his or her official duties.

(c) Any official exempted by this section may procure any controlled substance in the course of an inspection, in accordance with the Act or in the course of any criminal investigation involving the person from whom the substance was procured.

(d) In order to enable law enforcement agency laboratories to obtain and transfer controlled substances for use in chemical analysis, such laboratories shall obtain annually a registration to conduct chemical analysis. Such laboratories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described. For purposes of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this section.

112. Exemption of civil defense officials.

(a) The requirement of registration is waived for any official of a civil defense or disaster relief organization who, in the course of his or her official duties, is authorized to:

(1) Maintain, and distribute for such maintenance, controlled substances held for emergency use; or

(2) Procure controlled substances for the purpose of maintaining supplies for emergency use, provided that all of such procurement is from the U.S. General Services Administration and in accordance with the rules of the U.S. Office of Emergency Preparedness.

(b) The requirement of registration is waived for any official of a civil defense or relief organization during a state of emergency or disaster within his or her jurisdiction proclaimed by the President or by a concurrent resolution of the Congress, which official, in the course of his or her official duties, during such emergency or disaster, is authorized to:

(1) Dispense controlled substances; or

(2) Procure or distribute controlled substances, provided that all such procurement is on a special "Civil Defense Emergency Order Form" as prescribed in the Federal Regulations (21 CFR Section 1301.27(c)).

113. Registration regarding ocean vessels and aircrafts.

Registration of masters of ocean vessels and aircraft or the medical officers thereof shall be deemed sufficient if they are properly registered with the U.S. Department of Justice, DEA.

114. Dispensing of out-of-state prescriptions and orders.

(a) Prescriptions or orders for controlled substances from out-of-state practitioners may be filled in good faith by dispensers provided:

(1) The dispenser knows the recipient; or requires proper ID and notes such on the prescription.

(2) The dispenser makes a good faith inquiry concerning whether the order or prescription is legitimate;

(3) The prescription or order meets all of the requirements of this regulation and the Act, including whether the order or prescription is for legitimate medical purposes, and is within the regular course of practice of the practitioner.

(4) The practitioner who issued the prescription would ordinarily be entitled to issue prescriptions under SC law (i.e., physicians, dentists, veterinarians, and podiatrists are authorized to issue prescriptions; chiropractors, psychologists, etc. are not authorized to prescribe drugs);

(5) The prescribing practitioner holds a valid individual Federal [D.E.A.] controlled substance registration number in the state, district, or territory of origin of the prescription, or is exempt from such registration requirement under the provisions of Federal Regulation 21 CFR Section 1301.24.

(b) Out-of-State prescriptions which do not conform to SC law (i.e., prescriptions for amphetamines not permitted under S.C. Code Ann. Section 40-47-65, methadone other than as set forth by Sections 507 through 507.5 of these regulations, unapproved uses or excessive quantities within the meaning of S.C. Code Ann. Section 44-53-360, etc.) and which are not otherwise exempted shall not be dispensed.

Application for Registration

115. Time for application for registration; expiration date.

(a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Director to such person.

(b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his or her registration.

(c) Fees for registration for a physician shall be from October 2nd of the year until October 1st of the succeeding year. Fees for registration for any other person required to be registered shall be from April 2nd of the year until April 1st of the succeeding year. In the event any physician shall become registered subsequent to October 1st of any year, the entire registration fee shall be due and no pro-rata of fees will be allowed. In the event any other person required to be registered shall become registered subsequent to April 1st of any year, the entire registration fee shall be due and no pro-rata of fees will be allowed.

116. Application forms; content; signature.

(a) If the person is required to be registered, and is not so registered and is applying for registration;

(1) To manufacture or distribute controlled substances, he or she shall apply on DHEC Form 225/227;

(2) To dispense narcotic or non-narcotic, or to conduct instructional activities with narcotic or non-narcotic controlled substances listed in schedules II through V, he or she shall apply on DHEC form 224;

(3) To conduct research with any controlled substances listed in schedules II through V, he or she shall apply on Form 225/227;

(4) To conduct research with a controlled substance listed in schedule I, he or she shall apply on Form 225/227, with three copies of a research protocol describing the research project attached to the form;

(5) To conduct instructional activities with a controlled substance listed in schedule I, he or she shall apply as a researcher on Form 225/227, with two copies of a statement describing the nature, extent, and duration of such instructional activities attached to the form; and

(6) To conduct chemical analysis with controlled substances listed in any schedule, he or she shall apply on Form 225/227.

(b) Application forms may be obtained by writing to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201. Renewal forms will be mailed, as applicable, to each registered person approximately 60 days before the expiration date of his or her registration; if any registered person does not receive such forms within 45 days before the expiration date of his or her registration, he or she shall promptly give notice of such fact and request such forms by writing to the Bureau of Drug Control at the foregoing address.

(c) Each application for registration to handle any basic class of controlled substances listed in schedule I (except to conduct chemical analysis with such classes), and each application for registration to manufacture a basic class of controlled substance listed in schedule II, or to conduct research with any Narcotic controlled substance listed in schedule II, shall include the Controlled Substances Control Number, as set forth in Part 7 of these Regulations for each basic class or substance to be covered by such registration.

(d) Each application shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated.

(e) Each application, attachment, or other document files as part of an application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division, association, trust or other entity. Another person may be authorized to sign for the applicant, if proof of authority (e.g. general power of attorney) accompanies the application.

117. Research Protocols.

(a) Applicants for "Researcher" registration in Schedule I shall submit a research protocol containing all the information required for Federal Schedule I research protocol set forth under 21 CFR Section 1301.32.

(b) Practitioners registered with DHEC desiring to perform incidental research on or with controlled substances under the provisions of S.C. Code Ann. Section 44-53-300(c) are not required to furnish the formal protocol (except for narcotic substances as is required under Federal law), but shall instead provide a written summary of the proposed research, including the scope, the substance to be utilized, the number of research subjects (and their identity if protection from prosecution is desired), the duration of the research and the estimated usage of the controlled substance. Insofar as is practical, the dispensing of the controlled substance utilized in a valid research project shall be performed by the researcher or a particular dispenser or small group of dispensers in order to maintain adequate control. While not imperative to DHEC, notice of any participating dispensaries or pharmacies should be made to the Bureau of Drug Control in order that inadvertent and unnecessary investigations of normally unusual dispensing practices may be avoided.

(c) DHEC may require additional information or updating of protocols from time to time, but not more often than annually, unless a major change or deviation from previously submitted protocols or summaries is discovered. It is the responsibility of the person conducting the research project to notify to Department prior to any change in a protocol.

118. Filing an application; joint filings.

(a) All applications for registration shall be submitted for filing to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201. The appropriate registration fee and any required attachments shall accompany the application.

(b) Any person required to obtain more than one registration may submit all applications in one package. Each application shall be complete and should not refer to any accompanying application for required information.

119. Acceptance for filing; defective applications.

(a) Applications submitted for filing are dated upon receipt. If complete, the application will be accepted for filing. Applications failing to comply with the requirements of this part will not generally be accepted for filing. In the case of minor defects as to completeness, the Director may accept the application for filing with a request to the applicant for additional information. A defective application will be returned to the applicant within 10 days following its receipt with a statement of the reason for not accepting the application for filing. A defective application may be corrected and resubmitted for filing at any time; the Director shall accept for filing any application upon re-submission by the applicant, whether complete or not.

(b) Accepting an application for filing does not preclude any subsequent request for additional information pursuant to Section 120 and has no bearing on whether the application will be granted.

120. Additional information.

The Director may request an applicant to submit such documents or written statements of fact relevant to the application as he or she deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after having been requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Director in granting or denying the application.

121. Amendments to and withdrawal of applications.

(a) An application may be amended or withdrawn without permission of the Director at any time before the date on which the applicant receives an order to show cause pursuant to Section 129 or before the date on which a notice of hearing on the application is published pursuant to Section 124 whichever is sooner. An application may be amended or withdrawn with permission of the Director at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.

(b) After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application.

Action on Applications for Registration; Revocation or Suspension of Registration

122. Administrative review generally.

The Director may inspect, or cause to be inspected the establishment of an applicant or registrant, pursuant to the Act or this Regulation. The Director shall review the application for registration and other information gathered by the Bureau of Drug Control regarding an applicant in order to determine whether the applicable standards of the Act have been met by the applicant.

123. Applications for research in controlled Schedule I substances.

(a) In the case of an application for registration to conduct research with controlled substances, the Director shall refer such application to the Commissioner who shall determine the qualifications and competency of the applicant as well as the merits of the research protocol. The Director, in determining the merits of a research protocol, shall consider procedures to effectively safeguard against diversion of such controlled substances from legitimate medical or scientific use. If the Director finds the applicant qualified and competent and the research protocol meritorious and adequately safeguarded, he shall register the applicant unless he finds registration should be denied on a ground specified in the Act.

(b) If the Director is unable to find the applicant qualified or finds that grounds exist for the denial of the application, the Director shall issue an order to show cause pursuant to Section 129 and, if requested by the applicant, hold a hearing on the application pursuant to Section 130.

124. Application for bulk manufacture of Schedules I and II substances.

The Director shall coordinate applications for bulk manufacture of schedules I and II controlled substances with the DEA of the U.S. Department of Justice. Applications may be received by the Director for such bulk manufacture, but shall not be acted upon until tentative or conditional approval is made by the appropriate federal agency, and after such notifications, publications, and other actions required by Chapter II, Title 21, Code of Federal Regulations [21 CFR Section 1301, ff.] are effected by the applicant.

124.1. Provisional Registration.

(a) The Director, in his or her discretion, may grant provisional registration as a Researcher, Manufacturer, Distributor, Importer, or Exporter to any applicant, pending such applicant's obtaining a registration under Federal law. The duration of such provisional registration shall not exceed one year, and may not be renewed. Upon the granting of Federal registration, the provisional registration may be converted to a permanent registration by DHEC, which may renew such registration in the same manner as any other regular registration. If the Director does not find it in the public interest to grant a provisional registration, or to convert a provisional registration into a regular registration in the manner provided above, procedures set forth in S.C. Code Ann. Section 44-53-320 for denial of registration shall be followed.

(b) Provisional registration does not entitle the applicant (i.e., the provisional registrant) to conduct any controlled substances activity within this State until such time as the applicant obtains a valid Federal [DEA] registration for the identical activity at the same registered location.

125. Certificate of Registration; denial of registration.

(a) The Director shall issue a Certificate of Registration (Form 223) to an applicant if the issuance of registration or re-registration is required under the applicable provisions of the Act. In the event that the issuance of registration or re-registration is not required, the Director shall deny the application. Before denying any application, the Director shall issue an order to show cause pursuant to Section 129 and, if requested by the applicant, shall hold a hearing on the application pursuant to Section 130.

(b) The Certificate of Registration (Form 223) shall contain the name, address, and registration number of the registrant, the activity authorized by the registration, the schedules and/or Controlled Substances Code Number (as set forth in Part 7 of this chapter) of the controlled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expiration date of the registration. The registrant shall maintain the Certificate of Registration at the registered location in a readily retrievable manner and shall permit inspection of the certificate by any official, agent or employee of the DEA or of any federal, state, or local agency engaged in enforcement of laws relating to controlled substances.

126. Suspension or revocation of registration.

(a) The Director may suspend any registration pursuant to the Act for any period of time he determines.

(b) The Director may revoke any registration pursuant to the Act.

(c) Before revoking or suspending any registration, the Director shall issue an order to show cause pursuant to Section 129 and, if requested by the registrant shall hold a hearing pursuant to Section 130. Notwithstanding the requirements of this section, however, the Commissioner may suspend any registration pending a final order pursuant to Section 127.

(d) Upon service of the order of the Director suspending or revoking registration, the registrant shall immediately deliver his or her Certificate of Registration and any forms to his or her possession to the office of the Bureau of Drug Control. The suspension or revocation of a registration shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant. Also, upon service of the order of the Director suspending or revoking registration, the registrant shall:

(1) Deliver all controlled substances in his or her possession to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control; or

(2) Place all controlled substances in his or her possession under seal as described in the Act.

(e) In the event that revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required to be paid for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration and, if appropriate, any order forms in his or her possession to the office of the Bureau of Drug Control. The suspension or revocation of a registration, when limited to a particular basic class or classes of controlled substances, shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant for such class or classes. Also, upon service of the order of the Director revoking or suspending registration, the registrant shall:

(1) Deliver to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control all of the particular controlled substances or substances affected by the revocation or suspension which are in his or her possession; or

(2) Place all of such substances under seal as described in the Act.

127. Suspension of registration pending final order.

(a) The Director may suspend any registration simultaneously with or at any time subsequent to the service upon the registration of an order to show cause why such registration should not be revoked or suspended, in any case where he or she finds there is an imminent danger to the public health or safety. If the Director so suspends, he or she shall serve with the order to show cause pursuant to Section 129 an order of immediate suspension, which shall contain a statement of his or her findings regarding the danger in public health or safety.

(b) Upon service of the order of immediate suspension, the registrant shall promptly return his or her Certificate of Registration and any order forms in his or her possession to the office of the Bureau of Drug Control. The suspension of any registration under this section shall suspend any quota fixed for the registrant. Also, upon service of the order of the Director immediately suspending registration, the registrant shall, as instructed by the Director:

(1) Deliver all affected controlled substances in his or her possession to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control; or

(2) Place all of such substances under seal as described in the Act.

(c) Any suspension shall continue in effect until the conclusion of all proceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Director or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under this section may request a hearing on the revocation or suspension of his or her registration at as time earlier than specified in the order to show cause pursuant to Section 129, which request shall be granted by the Director, who shall fix a date for such hearing as early as reasonably possible.

128. Extension of registration pending final order.

In the event that an applicant for re-registration (who is doing business under a registration previously granted and not revoked or suspended) has applied for re-registration of at least 45 days before the date on which the existing registration is due to expire, and the Director has issued an order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue to effect until the date on which the Director so issues his or her order.

The Director may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for re-registration; at least 45 days before expiration of the existing registration, with or without request by the registrant, if the Director finds that such extension is not inconsistent with the public health and safety.

129. Order to show cause.

(a) If, upon examination of the application for registration from any applicant and other information gathered by the Bureau of Drug Control regarding the applicant, the Director is unable to make the determinations required by the applicable provisions of the Act to register the applicant, the Director shall serve upon the applicant an order to show cause why the registration should not be denied.

(b) If, upon information gathered by the Bureau of Drug Control regarding any registrant, the Director determines that the registration of such registrant is subject to suspension or revocation to the Act, the Director shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended.

(c) The order to show cause shall call upon the applicant or registrant to appear before a hearing officer at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.

(d) Upon receipt of an order to show cause, the applicant or registrant shall, if he or she desires a hearing, file a request for a hearing in writing. If a hearing is requested, the hearing officer shall hold a hearing at the time and place stated in the order, pursuant to Section 131.

(e) When authorized by the Director, any agent of the Bureau of Drug Control may serve the order to show cause, or service may be effected by registered or certified mail.

130. Hearing generally.

(a) In any case where the hearing officer shall hold a hearing on any registration or application therefore, the procedures for such hearing shall be governed generally by the adjudication procedures set forth by statute or by the Attorney General's Office.

(b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under the Act of any other law of this State or the United States.

131. Purpose of hearing.

If requested by a person entitled to a hearing the hearing officer shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration, and the granting of any application for registration to manufacture in bulk a basic class of controlled substances listed in schedules I or II. Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law.

132. Waiver and modification of rules.

The Commissioner or the presiding officer (with respect to matters pending before him or her) may modify or waive any rules in this part by notice in advance of the hearing, if he or she determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the record of the hearing.

133. Request for hearing or appearance; waiver.

(a) Any person entitled to a hearing pursuant to Sections 123-126 and desiring a hearing shall, within 30 days after the date of receipt of the order to show cause, file with the Commissioner a written notice for a hearing.

(b) Any person entitled to and desiring to participate in a hearing pursuant toSection 124 and desiring to do so shall, within 10 days of the date of the hearing, file with the Commissioner a written notice of his or her intention to participate in such hearing.

(c) Any person entitled to a hearing or to participate in a hearing pursuant toSections 123-126 may, within the period permitted for filing a request for a hearing or a notice of appearance, file with the Commissioner a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding his or her position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.

(d) If any person entitled to a hearing or to participate in a hearing pursuant to Sections 123-126 fails to file a request for a hearing or a notice of appearance, or if he so files and fails to appear at the hearing, he shall be deemed to have waived his or her opportunity for the hearing or to participate in the hearing, unless he show good cause for such failure.

(e) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Commissioner may cancel the hearing if scheduled, and issue his or her final order pursuant to Section 136 without a hearing.

134. Burden of proof.

(a) At any hearing on an application to manufacture any controlled substance listed in schedule I or II, the applicant shall have the burden of proving that the requirements for such registration pursuant to the Act are satisfied. Any other person participating in the hearing pursuant to Section 124 shall have the burden of proving any proposition of fact or law asserted to him or her in the hearing.

(b) At any hearing on the granting or denial of an application to be registered to conduct a narcotic treatment program or as a compounder, the applicant shall have the burden of proving that the requirements for each registration pursuant to S.C. Code Ann. Section 44-53-290(i) are satisfied.

(c) At any other hearing for the denial of a registration, DHEC shall have the burden of proving that the requirements for such registration pursuant to the Act are not satisfied.

(d) At any hearing for the revocation or suspension of a registration, DHEC shall have the burden of proving that the requirements of the Act for such suspension or revocation are satisfied.

135. Time and place of hearing.

The hearing will commence at the place and time designated in the order to show cause or notice of hearing (unless expedited pursuant to Section 127) but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing.

136. Final order.

As soon as practicable after the hearing officer has certified the record to the Commissioner, the Commissioner shall certify his or her order on the granting, denial, revocation, or suspension of registration.

137. Modification in registration.

Any registrant may apply to modify his or her registration to authorize the handling of additional controlled substances or to change his or her name or address, by submitting a letter of request to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201. The letter shall contain the registrant's name, address, and registration number as printed on the Certificate of Registration, and the substances and/or schedules to be added to his or her registration or the new name or address and shall be signed in accordance with Section 116(e). If the modification in registration is approved, the Director shall issue a new Certificate of Registration (Form 223) to the registrant, who shall maintain it with the old Certificate of Registration until expiration.

138. Termination of registration.

The registration of any person shall terminate if and when such person dies, ceases legal existence, or discontinues business or professional practice. Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Director promptly of such fact.

138.1 Termination of registration; Partnerships and Corporations; other business entities.

(a) Upon the transfer of ownership of a controlling interest in any partnership, corporation, holding company, association, or other business entity holding a registration under the Act, which is not a personal registration as an individual or a proprietorship registration involving a single individual registrant, the registration held prior to any transfer of any controlling interest or controlling ownership shall terminate upon the effective date of the transfer, and a new registration shall be obtained if the business entity is to continue controlled substances activity. DHEC may, in its discretion, permit a transferor-registrant to permit the transferee to continue operation pursuant to a written power of attorney for a period of not more than sixty days, during the pendency of obtaining a new registration for the transferee.

(b) If the control of a corporation already registered under the Act shall be acquired by another corporation not registered under the Act, the acquiring corporation need not obtain a separate registration for itself, unless merger takes place; the corporation acquired shall, however, obtain a new registration even if there is no change in corporate officers if it intends to continue controlled substances activity. In the event a merger is effected between the acquiring corporation and the acquired corporation (regardless of the surviving or ensuing name) the acquiring corporation shall obtain a new registration in its own name, or in the name of the successor or ensuing corporation (if different) prior to engaging in controlled substances activity. Successor corporations shall be deemed to be new business entities, and shall obtain new registration prior to conducting controlled substances activity.

139. Transfer of registration.

No registration or authority conferred thereby shall be assigned or otherwise transferred except upon conditions as the Director may specifically designate and then only pursuant to his or her written consent.

Security Requirements

140. Security requirements generally.

(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Director shall use the security requirements set forth in Sections 141-145 as standards for the physical security controls and operating procedures necessary to diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth inSections 141, 142, and 144 may be used in lieu of the materials and construction described in those sections.

(b) Substantial compliance with the standards set forth in Sections 141-145 may be deemed sufficient by the Director after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Director may consider any of the following factors as he may deem relevant to the need for strict compliance with security requirements:

(1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.);

(2) The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or non-usable powders);

(3) The quantity of controlled substances handled;

(4) The location of the premises and the relationship such location bears on security needs;

(5) The type of building construction comprising the facility and the general characteristics of the building or buildings;

(6) The type of vault, safe, and secure enclosures or other storage systems (e.g., automatic storage and retrieval system) used;

(7) The type of closures on vaults, safes, and secure enclosures;

(8) The adequacy of key control systems and/or combination lock control system;

(9) The adequacy of electric detection and alarm systems if any, including use of supervised transmittal lines and standby power sources;

(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any,

(11) The adequacy of supervision over employees having access to manufacturing and storage area;

(12) The procedures for handling business guests, visitors, maintenance personnel, and non-employees service personnel;

(13) The availability of local police protection or of the registrant's or applicant's security personnel; and

(14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations.

(c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different scientific schedule, or as a result of a non-controlled substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in Sections 141-145 when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations.

(d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in Sections 141-145 may submit any plans, blueprints, sketches or other materials regarding the proposed security system either to the Director or to the Compliance Investigations Division, DEA, Department of Justice, Washington, DC 20537.

(e) Physical security controls of locations registered under the Harrison Act or the Narcotics Manufacturing Act of 1960 on April 30, 1971, shall be deemed to comply substantially with the standards set forth in Sections 141, 142, and 144. Any new facilities or work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Bureau of Drug Control, shall not necessarily be deemed to comply substantially with the standards set forth in Sections 141, 142, and 144 notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved.

141. Physical security controls for non-practitioners; storage areas.

(a) Schedules I and II. Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in schedules I and II shall be stored in one of the following secure storage areas:

(1) Where small quantities permit, a safe or steel cabinet:

(i) Which safe or steel cabinet shall have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-minutes against lock manipulation, and 20 man-minutes against radiological techniques.

(ii) Which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and

(iii) Which safe or steel cabinet, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system which, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Director may approve.

(2) A vault constructed before, or under construction on, September 1, 1971, which is of substantial construction with a steel door, combination or key lock, and an alarm system and

(3) A vault constructed after September 1, 1971:

(i) The walls, floors, and ceilings of which vaults are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1/2 inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors and ceilings;

(ii) The door and frame of which vault shall conform to the following specifications or the equivalent; 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against local manipulation, and 20 man-hours against radiological techniques.

(iii) Which vault, if operations require it to remain open for frequent access, is equipped with a "day-gate" which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open;

(iv) The walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station protection company, or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant as the Bureau of Drug Control may approve and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;

(v) Which vault has one of the following: complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the Bureau of Drug Control.

(b) Schedules III, IV and V. Raw materials, bulk materials awaiting further processing and finished products which are controlled substances listed in schedules III, IV, and V shall be stored in one of the following secure storage areas:

(1) Where small quantities permit, a safe which complies with the requirements set forth in paragraph (a)(1) of this section;

(2) A vault which complies with the requirements set forth in either paragraph (a)(2) or (3) of this section; equipped with an alarm system as described in paragraph (b) (4) (v) of this section;

(3) A building used for storage of Schedules III through V controlled substances with perimeter security which limits access during working hours and provides security after working hours and meets the following specifications:

(i) Has an electronic alarm system as described in paragraph (b) (4) (v) of this section,

(ii) Is equipped with self-closing, self-locking doors constructed of substantial material commensurate with the type of building construction, provided, however, a door which is kept closed and locked at all times when not in use, and when in use is kept under direct observation of a responsible employee of the agent or registrant is permitted in lieu of a self-closing, self-locking door. Doors may be sliding or hinged. Regarding hinged doors, where hinges are mounted on the outside, such hinges shall be sealed, welded, or otherwise constructed to inhibit removal. Locking devices for such doors shall be either of the multiple-position combination or key lock type and:

(a) In the case of key locks, shall require key control which limits access to a limited number of employees, or;

(b) In the case of combination locks, the combination shall be limited to a minimum number of employees and can be changed upon termination of employment of an employee having knowledge of the combination;

(4) A cage, located within a building on the premises, meeting the following specifications:

(i) Having walls constructed of not less than No. 10 gauge steel posts, which posts are:

(a) at least one inch in diameter;

(b) set in concrete or installed with lag bolts that are pinned or brazed; and

(c) which are placed no more than 10 feet apart with horizontal one and one-half inch reinforcements every sixty inches;

(ii) Having a mesh construction with openings of not more than two and one-half inches across the square,

(iii) Having a ceiling constructed of the same material, or in the alternative, a cage shall be erected which reaches and is securely attached to the structural ceiling of the building. A lighter gauge mesh may be used for the ceilings of large enclosed areas if walls are at least 14 feet in height.

(iv) Is equipped with a door constructed of No. 10 gauge steel fabric on a metal door frame in a metal door flange, and in all other respects conforms to all of the requirements of subparagraph (b)(3)(ii) of this section, and

(v) Is equipped with an alarm system which upon unauthorized entry shall transmit a signal directly to a central station protection agency, or a local or state police agency, each having a legal duty to respond, or a 24-hour control station operated by the registrant, or to such other source of protection that the Director may approve;

(5) An enclosure of masonry or other material, approved in writing by the Director as providing security comparable to a cage;

(6) A building or enclosure within a building which has been inspected and approved by DEA or its predecessor, agency, BNDD, and continues to provide adequate security against the diversion of Schedule III through V controlled substances, of which fact written acknowledgment from DEA (BNDD) has been received for the area in which such building or enclosure is situated;

(7) Such other secure storage areas as may be approved by the Director after consulting with DEA and the factors listed in Section 140(b)(1) through (14) of this regulation;

(8)(i) Schedule III through V controlled substances may be stored with Schedules I and II controlled substances under security measures provided by paragraph (a) of this section;

(ii) Non-controlled drugs, substances, and other materials may be stored with Schedule III through V controlled substances in any of the secure storage areas required by this section, provided, that permission for such storage of non-controlled substances has been obtained in advance, in writing, from both the Director and the DEA agent in charge of the area in which such storage area is situated [See 21 CFR Section 1301.72 (b)(8)(ii)]. Any such permission shall be based upon the determination that the storage of such items does not diminish security for the controlled substances.

(c) Multiple store areas. Where several types or classes of controlled substances are handled separately by the registrant or applicant for different purposes (e.g. returned goods, or goods in process), the controlled substances may be stored separately, provided that each storage area complies with the requirements set forth in this section.

(d) Accessibility to storage areas. The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through controlled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

142. Physical security controls for non-practitioners; manufacturing areas.

All manufacturing activities (including processing, packaging, and labeling) involving controlled substances listed in any schedule and all activities of compounders shall be conducted in accordance with the following:

(a) All in-process substances shall be returned to the controlled substances storage area at The termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant.

(b) Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area. "Limited access" may be provided in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted, provided, that he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his or her knowledge.

(c) During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

143. Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs.

(a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the DEA or with the state controlled registration agency to determine that the person is registered to possess the controlled substance.

(b) The registrant shall design and operate a system to alert the registrant of suspicious orders of controlled substances. The registrant shall inform the Bureau of Drug Control of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

(c) The registrant shall notify the office of the Bureau of Drug Control of any theft or significant loss of any controlled substances upon discovery of such theft or loss. The supplier shall be responsible for reporting in-transit losses of controlled substances by the contract or common carrier pursuant to subparagraph (e) of this section, upon discovery of such theft or loss. The registrant shall also complete DEA Form 106 regarding such theft or loss. Thefts shall be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.

(d) The registrant shall not distribute any controlled substances in schedules II through V as a complimentary sample to any potential or current customer (1) without the prior written request of the customer, (2) to be used only for satisfying the legitimate medical needs of patients of the customer and (3) only in reasonable quantities. Such request shall contain the name, address, and registration number of the customer and the name and quantity of the specific controlled substances desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements of Part 4 of the Regulation shall be complied with for any distribution of a controlled substance listed in schedule II. For purposes of this paragraph, The term "customer" includes a person to whom a complimentary sample of a substance is given in order to encourage the prescribing or recommending of the substance to the person.

(e) When shipping controlled substances, a registrant is responsible for selecting common or contract carriers, which provide adequate security to guard against in-transit losses. When storing controlled substances in a public warehouse, a registrant is responsible for selecting a warehouseman which will provide adequate security to guard against storage losses; wherever possible, the registrant shall store controlled substances in a public warehouse which complies with the requirements set forth in Section 141. In addition, the registrant shall employ precautions (e.g. assuring that shipping containers do not indicate the contents are controlled substances) to guard against storage or in-transit losses.

(f) When distributing controlled substances through agents (e.g., detail men), a registrant is responsible for providing adequate security to guard against theft and diversion while the substances are being stored or handled by the agent or agents.

(g) Before the initial distribution of etorphine hydrochloride and/or diprenorphine to any person, the registrant shall verify that the person is authorized to handle the substance(s) by contacting the Bureau of Drug Control and DEA.

(h) The acceptance of delivery of narcotic substances by a narcotic treatment program shall be made only by a licensed practitioner employed at the facility or other authorized individuals designated in writing. At the time of delivery, the licensed practitioner or other authorized individual designated in writing (excluding persons currently or previously dependent on narcotic drugs), shall sign for the narcotics and place his or her specific title (if any) on any invoice. Copies of these signed invoices shall be kept by the distributor.

(i) Narcotics dispensed or administered at a narcotic treatment program will be dispensed or administered directly to the patient by either (1) the licensed practitioner, (2) a registered nurse under the direction of the licensed practitioner, (3) a licensed practical nurse (LPN) under the direction of the licensed practitioner, or (4) a pharmacist acting under a prescription or an order issued by the licensed practitioner.

(j) Persons enrolled in a narcotic treatment program will be required to wait in an area physically separated from the narcotic storage and dispensing area. This requirement will be enforced by the program physician and employees.

(k) All narcotic treatment programs shall comply with standards established by the appropriate Federal authorities [see 21 CFR Section 1301.74(k)] and the Bureau of Drug Control, and the provisions of S.C. Code Ann. Sections 44-53-710 through 44-53-760 respecting the quantities of narcotic drugs that may be provided to persons enrolled in a narcotic treatment program for unsupervised use.

(l) DEA and the Bureau of Drug Control may exercise discretion regarding the degree of security required in narcotic treatment programs based upon such factors as the location of the program, the number of patients enrolled in a program, and the number of physicians, staff members, and security guards. Similarly, such factors will be taken into consideration when evaluating existing security or requiring new security at a narcotic treatment program.

144. Physical security controls for practitioners.

(a) Controlled substances listed in schedule I shall be stored in a securely locked, substantially constructed cabinet.

(b) Controlled substances listed in schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

(c) This section shall also apply to non-practitioners authorized to conduct research or chemical analysis under another registration.

(d) Etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

145. Other security controls of practitioners.

(a) The registrant shall not knowingly employ as an agent or employee, who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration denied, or has had his or her registration revoked, at any time.

(b) The registrant shall notify the Bureau of Drug Control, DHEC, of the loss or theft of any controlled substances upon discovery of such loss or theft. The registrant shall also complete DEA Form 106 regarding such loss or theft. The Bureau of Drug Control will forward copies of DEA Form 106 to the appropriate federal authority.

(c) The registrant shall notify the Bureau of Drug Control of any theft or significant loss of any controlled substances upon discovery of such theft or loss. The supplier shall be responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to 21 CFR Section 1301.74(e), upon discovery of such theft or loss. Thefts shall be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.

(d) Whenever the registrant distributes a controlled substance (without being registered as a distributor, as permitted by Section 107(b) and/or Sections 604 through 607 of this Regulation) he or she shall comply with the requirements imposed on non-practitioners in Section 143(a), (b), and (e).

146. Significant loss by diversion due to repeated thefts.

(a) Any registrant who suffers repeated significant losses of controlled substances by theft due to break-ins, employee theft, mysterious disappearance, or other than through an armed robbery shall be deemed to be providing inadequate security for such controlled substances.

(b) Upon the first such significant diversion, the registrant shall cause such physical security measures to be instituted to prevent reoccurrence.

(c) Upon the second such significant diversion, the registrant shall be required to appear before the designated hearing officer of DHEC to provide, under oath, the security measures that the registrant has effected and plans to effect in the future to prevent further diversion by theft.

(d) Upon the third such significant diversion, the registrant shall be cited to show cause, if any he or she may have, why his or her registration under the Controlled Substances Act should not be revoked, suspended, or denied pursuant to the provisions of S.C. Code Ann. Section 44-53-310(e).

(e) For the purposes of this section, a significant diversion shall be considered the loss of two thousand dosage units, or the equivalent thereof.

147. Filing of theft reports.

Theft reports (DEA Form 106) as required by this regulation shall be filed with the Bureau of Drug Control not later than thirty days following the discovery of the theft. Failure to file theft reports within the thirty-day period shall result in the issuance of an order to show cause for revocation or suspension of registration under the Act.

148. Employee screening procedures.

It is the position of the Bureau of Drug Control that the obtaining of certain information by registrants is vital to fairly assess the likelihood of an employee committing a drug security breach. The need to know this information is a matter of business necessity, essential to overall controlled substances security. In this regard, it is believed that conviction of crimes and unauthorized use of controlled substances are activities that are proper subjects for inquiry. It is therefore assumed that the following questions will become a part of an employer's comprehensive employee screening program:

Question: Within the past five years have you been convicted of a felony or any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses, or military conviction, except by general court martial.) If the answer is yes, furnish details of the conviction, offense, location, date, and sentence.

Question: In the past three years, have you ever knowingly used any narcotic, barbiturates, or amphetamines, other than prescribed to you by a physician or other practitioner? If the answer is yes, furnish details.

Advice: An authorization, in writing, that allows inquires to be made of courts and law enforcement agencies for possible pending charges or convictions shall be executed by a person who is allowed to work in an area where access to controlled substances clearly exists. A person shall be advised that any false information or omission of information will jeopardize his or her position with respect to employment. The application for employment should inform a person that information furnished or recovered as a result of any inquiry will not necessarily preclude employment, but will be considered as part of an overall evaluation of the person's qualifications. The maintaining of fair employment practices, the protection of the person's right to privacy, and the assurance that the results of such inquires will be treated by the employer in confidence will be explained to the employee.

149. Employee responsibility to report drug diversion.

Report of drug diversion by fellow employees is not only a necessary part of an overall employee security program, but also serves the public interest at large. It is therefore the position of the Bureau of Drug Control that an employee who has knowledge of drug diversion from his or her employer by a fellow employee has an obligation to report such information to a responsible security official of the employer, or to a person in a management position with the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information. A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area, or with access to controlled substances. The employer shall inform all employees concerning this policy.

150. Illicit activities by employees.

It is the position of the Bureau of Drug Control that employees who sell, possess, use, or divert controlled substances will subject themselves not only to State and Federal criminal prosecution for any illicit activity, but shall also immediately become the subject of independent action regarding their continued employment. The employer will assess the seriousness of the employee's violation, the position of responsibility held by the employee, past record of employment, etc., in determining whether to suspend, transfer, terminate, or take other action against the employee.

PART 2 Labeling and Packaging Requirements for Controlled Substances

201. [Reserved]

202. Symbol required; exceptions.

(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Director pursuant to Section 708 of this chapter) shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container if it otherwise has no label, shall bear a label complying with the requirement of this part.

(b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him or her the symbol designating the schedule in which such controlled substance is listed.

(c) The following symbols shall designate the schedule corresponding thereto:

Schedule Symbol

Schedule I I or C-I

Schedule II II or C-II

Schedule III III or C-III

Schedule IV IV or C-IV

Schedule V V or C-V

The word "schedule" need not be used. No distinction need be made between narcotic and non-narcotic substances.

(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper.

(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.

(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies.

(g) The symbol is not required on a commercial container containing, or on labeling of, a controlled substance intended for export from the United States.

203. Location and size of symbol on label.

(a) The symbol shall be prominently located on the right upper corner of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in schedules I through V. The symbol shall be at least two times as large as the largest type otherwise printed on the label.

(b) In lieu of locating the symbol in the corner of the label, as prescribed in paragraph (a) of this section, the symbol may be overprinted on the label, in which case the symbol shall be printed at least one-half the height of the label and in a contrasting color providing clear visibility against the background color of the label.

(c) In all cases the symbol shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf.

204. Location and size of symbol on labeling.

The symbol shall be prominently located on all labeling other than labels covered by Regulation 203. In all cases the symbol shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.

(a) All labels on commercial containers of, and all labeling of, a controlled substance which is listed in any schedule on July 1, 1971, and which is packaged after December 1, 1971, shall comply with the requirements of Section 202.

(b) All labels on commercial containers of, and all labeling of, a controlled substance which either is listed in any schedule on July 1, 1971, and thereafter transferred to another schedule or is added to any schedule after July 1, 1971, and which is packaged more than 180 days following the dates on which the transfer or addition becomes effective shall comply with the requirements of Section 202.

(c) The Director may, in the case of any controlled substance, require compliance with the requirements of Section 202 within a period of time shorter than required by this section if he or she finds that public health or safety necessitates an earlier effective date.

(d) Until compliance is required under this section, the label on commercial container containing, and the labeling of, any controlled substance shall comply with any requirements under Federal or State law as to labels of such containers and as to labeling of such substances existing prior to the effective date prescribed in this section.

205. Effective dates of labeling requirements.

(a) All labels on commercial containers of, and all labeling of, a controlled substance which is listed in any schedule on July 1, 1971, and which is packaged after December 1, 1971, shall comply with the requirements of Section 202.

(b) All labels on commercial containers of, and all labeling of, a controlled substance which either is listed in any schedule on July 1, 1971, and thereafter transferred to another schedule or is added to any schedule after July 1, 1971, and which is packaged more than 180 days following the dates on which the transfer or addition becomes effective shall comply with the requirements of Section 202.

(c) The Director may, in the case of any controlled substance, require compliance with the requirements of Section 202 within a period of time shorter than required by this section if he or she finds that public health or safety necessitates an earlier effective date.

(d) Until compliance is required under this section, the label on commercial container containing, and the labeling of, any controlled substance shall comply with any requirements under Federal or State law as to labels of such containers and as to labeling of such substances existing prior to the effective date prescribed in this section.

206. Sealing of controlled substances.

(a) On each bottle, multiple dose vial, other commercial container of any controlled substance listed in schedules I and/or II, and of any narcotic controlled substance listed in schedule III or IV, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper of such container a seal to disclose upon inspection any tampering or opening of the container.

(b) Any seal accepted for use, under Federal law prior to July 1, 1971, shall be deemed acceptable for use under this section.

207. Labeling for controlled substances dispensed directly to ultimate users.

Controlled substances which are dispensed directly to an ultimate user other than by a prescription dispensed by a pharmacy or by direct administration or application of the substance into or upon the person for whom it is intended, shall bear a label or labeling containing the name and address of the dispenser, the name of the ultimate user (i.e., the "patient"), specific directions for use, and the date of the dispensing. The label or labeling shall include any necessary cautionary statement, whether customary or required by State or Federal law. A serial number may be utilized at the discretion of the dispenser. The act of dispensing controlled substances shall be performed by the registrant, and shall not be delegated to any person other than a pharmacist acting in the regular course of professional activity. Prescriptions shall be labeled pursuant to the provisions of Part 5 of this Regulation, unless specifically exempted. No practitioner shall directly dispense more than a thirty-one day supply.

PART 3 Records and Reports of Registrants

301. Scope of Part 3.

Inventory and other records and reports required under the Act shall be in accordance with, and contain the information required by, those sections and by the sections of this Part.

302. [Reserved]

303. Persons required to keep records and file reports.

(a) Each registrant shall maintain the records and inventories and shall file the reports required by this Part, except as exempted by this Section. Any registrant who is authorized to conduct other activities without being registered to conduct these activities, either pursuant to Section 107(b) or to Sections 604 through 608, shall maintain the records and inventories and shall file the reports required by this Part for persons registered to conduct such activities. The latter requirement should not be construed as requiring stocks of controlled substances being used in various activities under one registration to be stored separately, nor that separate records are required for each activity. The intent of the Bureau of Drug Control is to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled substances used in any activity. The Bureau of Drug Control does not wish to require separate stocks of the same substance to be purchased and stored for separate activities. Otherwise, there is no advantage gained by permitting several activities under one registration. Thus, when a researcher manufactures a controlled item, he or she shall keep a record of the quantity manufactured; when he or she distributes a quantity of the item, he or she shall use and keep invoices or order forms to document the transfer; when he or she imports a substance, he or she keeps as part of his or her records the documentation required to an importer; and when substances are used in chemical analysis, he or she need not keep a record of this because such a record would not be required of him or her under a registration to do chemical analysis. All of those records may be maintained in one consolidated record system. Similarly, the researcher may store all of his or her controlled items in one place, and every year take inventory of all items in hand, regardless of whether the substances were manufactured by him or her, imported by him or her, or purchased domestically by him or her, or whether the substances will be administered to subjects, distributed to other researchers, or destroyed during chemical analysis.

(b) A registered individual practitioner is not required to keep specific records with respect to controlled substances for which he or she issues prescriptions or orders for administration within an institutional practitioner setting (e.g., hospital "orders") in the lawful course of his or her professional practice; provided, that a record or memorandum of such prescription or order be maintained upon regular patient records.

(c) A registered individual practitioner is required to maintain a readily retrievable record, separate from patient charts, of all controlled substances acquired, dispensed, administered (other than by the issuance of an institutional order or a prescription) distributed, or otherwise disposed of by the practitioner, his or her employees or agents, whether the controlled substance is separately charged for, included in other charges, or is provided at no charge. Practitioners who personally administer narcotic controlled substances in an emergency need only keep a simple record of the date, kind, quantity, and strength of the controlled substance administered in such emergency, and the name of the recipient. Within 72 hours of the emergency administration, a permanent record shall be constituted and included in the readily retrievable records of dispensing required herein. Repeated or excessive emergency administrations will require the registrant to notify the Bureau of Drug Control of such happenstance.

(d) A registered person using any controlled substance in research conducted in conformity with an exemption granted under Section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) as a registered establishment which maintains records in accordance with either of those sections is not required to keep records if he notified the Bureau of Drug Control of the name, address, and registration number of the establishment maintaining such records.

(e) A registered person using any controlled substance in pre-clinical research or in teaching at a registered establishment, which maintains records with respect to such substance is not required to keep records if he notifies the Bureau of Drug Control of the name, address, and registration number of the establishment maintaining such records.

(f) Notice required by paragraphs (d) and (e) of this section shall be given at the time the person applies for registration or re-registration and shall be made in the form of an attachment to the application, which shall be filed with the application.

304. Maintenance of records and inventories.

(a) Every inventory and other record required to be kept under this Part shall be kept by the registrant and be available, for at least two years from the date of such inventory or record, for inspecting and copying by authorized employees of the Bureau of Drug Control, except that financial and shipping records (such as invoices and packing slips but not executed order forms subject to 21 CFR Section 1305.13) may be kept at a central location rather than at the registered location if the registrant has notified the Bureau of Drug Control of its intention to keep central records. Written notification shall be submitted by registered or certified mail, return receipt requested, in triplicate to the Director. Unless the registrant is informed by the Director that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of the return receipt accompanying the notification.

All notifications shall include:

(1) The nature of the records to be kept centrally and the exact location where the records will be kept;

(2) The name, address, State and DEA registration numbers, and type of registration of the registrant whose records are being maintained centrally;

(3) Whether central records will be maintained in a manual, or computer readable form.

(b) Each registered manufacturer, distributor, importer, and exporter shall maintain inventories and records of controlled substances as follows:

(1) Inventories and records of controlled substances listed in schedules I and II shall be maintained separately from all of the records of the registrants, and

(2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.

(c) Each registered individual practitioner required to keep records and each institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in paragraph (b) of this section.

(d) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

(1) Inventories and records of all controlled substances listed in schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained as a separate prescription file.

(2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy.

(3) Prescriptions for controlled substances shall be maintained in separate files from prescriptions for non-controlled substances. Prescriptions for schedule II controlled substances shall be filed separately from prescriptions for schedules III, IV, and V controlled substances. Compliance with this Section will be deemed proper if the pharmacy maintains not less than three files, those being:

File No. 1-Schedule II Controlled Substances only.

File No. 2-Schedules III, IV, and V Controlled Substances only.

File No. 3- Non-controlled Substances.

Sequential numbering systems of the files shall be at the discretion of the dispenser.

(e) All registrants that are authorized to maintain a central record keeping system shall be subject to the following conditions:

(1) The records to be maintained at the central record location shall not include executed order forms, prescriptions, and/or inventories which shall be maintained at each registered location.

(2) If the records are kept on microfilm, computer media, or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information) a key to the code shall be provided to make the records understandable.

(3) The registrant agrees to deliver all or any part of such records to the registered location within two business days upon receipt of a written request from the Bureau of Drug Control, and if the Bureau of Drug Control chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Bureau of Drug Control to inspect such records at the central location upon request by such employees without a warrant of any kind.

(4) In the event that a registrant fails to comply with these conditions, the Director may cancel such central record keeping authorization, and all other central record keeping authorization held by the registrant without a hearing or other procedures. In the event of cancellation of central record keeping authorization under this paragraph, the registrant shall, within the time specified by the Director, comply with the requirements of this section that all records be kept at the registered location.

(f) Original documents shall be maintained in addition to those which are stored in computer media for a period of two years from the date of the origination of the document, or from the last transaction contained therein or entered thereupon, whichever is the later date.

Inventory Requirements

305. General requirements for inventories.

(a) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, substances ordered by a customer but not yet invoiced, substances stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples.

(b) A separate inventory shall be made by a registrant for each registered location. In the event controlled substances in the possession or under the control of the registrant at a location for which he is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. Each inventory for a registered location shall be kept at the registered location.

(c) A separate inventory shall be made by a registrant for each independent activity for which he is registered, except as provided in Section 311.

(d) A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business and the date the inventory is taken.

(e) An inventory shall be maintained in a written, typewritten, or printed form. An inventory taken by use of an oral recording device shall be promptly transcribed.

306. Inventory upon transfer of business; change of pharmacist-in-charge.

(a) Inventory upon transfer of business.

(1) Any registrant transferring his or her business to another person who shall become registered to continue such business shall inventory all controlled substances on hand at the close of business on the day of transfer. The receiving registrant shall either (a) certify the inventory taken as being correct, or (b) shall affect his or her own inventory at the start of business on the date of transfer. Any discrepancy in the inventory shall be reported within five days to the Director.

(2) A new establishment, never before having been registered, and having no prior inventory of controlled substances, shall be deemed to have a zero inventory as of the first day of business.

(3) A registrant discontinuing business shall upon the date of discontinuance inventory all controlled substances and place said controlled substances in sealed containers under adequate protection from theft, until such time as the controlled substances are transferred to another registrant or are surrendered to the Director. A copy of this inventory shall be forwarded to the Director, a copy placed with the controlled substances, and a copy retained by the discontinuing registrant.

(b) A complete inventory of all controlled substances on hand shall be performed at the time of a change in pharmacist-in charge.

307. Annual inventory date.

Inventories shall be taken on May 1st of each year unless permission for another date is granted by the Bureau of Drug Control. In the event that a person commences business with no controlled substances on hand, he or she shall record this fact as his or her initial inventory.

308. Inventories of manufacturers.

Each registered manufacturer shall include the following information in his or her inventory:

(a) For each controlled substance in bulk form to be used in (or capable of use in) the manufacture of the same or other controlled or non-controlled substances in finished form:

(1) The name of the substance; and

(2) The total quantity of the substance to the nearest metric unit weight consistent with unit size (except that for inventories made in 1971), avoirdupois weights may be utilized where metric weights are not readily available)

(b) For each controlled substance in the process of manufacture on the inventory date:

(1) The name of the substance;

(2) The quantity of the substance in each batch and/or state of manufacture, identified by the batch number of other appropriate identifying number;

(3) The physical form which the substance is to take upon completion of the manufacturing process (e.g., granulations, tablets, capsules, or solutions), identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of volume thereof.

(c) For each controlled substance in finished form:

(1) The name of the substance;

(2) Each finished form of the substance (e.g. 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);

(3) The number of units or volume of each finished form in each commercial container (e.g. 100-tablet bottle or 3-milliliter vial); and

(4) The number of commercial containers of each such finished form (e.g., four 100-tablet bottles or six 3-milliliter vials).

(d) For each controlled substance not included in paragraphs (a), (b), or (c) of this section (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compounding):

(1) The name of the substance;

(2) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and

(3) The reason for the substance being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substance in finished form.

309. Inventories for distributors.

Each registered distributor shall include in his or her inventory the same information required of manufactures pursuant to Sections 308(c) and (d).

310. Inventories of dispensers and researchers.

Each person registered to dispense or conduct research with controlled substances and required to keep records pursuant to Section 301 shall include in his or her inventory the same information required of manufacturers pursuant to Sections 308(c) and (d). In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:

(a) If the substance is listed in schedule I or II, he or she shall make an exact count or measure of the contents; and

(b) If the substance is listed in schedule III, IV, V, he or she shall make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he or she shall make an exact count of the contents.

(c) It is the responsibility of the registrant to determine that any estimates are accurate, as audit procedures will be based upon the inventories maintained by the registrant. The Bureau of Drug Control utilizes exact counts in all audit procedures, and will allow only minor leeway for estimated inventories.

311. Inventories of importers and exporters.

Each registered importer or exporter shall include in his or her inventory the same information required of manufacturers pursuant to Sections 309(a), (c), and (d). Each registered importer or exporter who is also registered as a manufacturer or as a distributor shall include in his or her inventory as an importer or exporter only those stocks of controlled substances that are actually separated from his or her stocks as a manufacturer or as a distributor (e.g., in transit or in storage for shipment).

312. Inventories for chemical analysis.

Each analytical laboratory registered to conduct chemical analysis with controlled substances shall include in its inventory the same information required of manufacturers pursuant to Sections 309(a), (c), and (d) as to substances which have been manufactured, imported, or received by the laboratory conducting the inventory. If less than 1 kilogram of any controlled substance (other than a hallucinogenic controlled substance listed in schedule I), or less than 20 grams of a hallucinogenic substance listed in schedule I (other than lysergic acid diethylamide), or less than 0.5 grams of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory. Laboratories of the Bureau of Drug Control may possess up to 150 grams of any hallucinogenic substance in schedule I without regard to a need for an inventory of those substances.

Continuing Records

313. General requirements for continuing records.

(a) On and after June 17, 1971 every registrant required to keep records pursuant to Regulation 303 shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him or her, except that no registrant shall be required to maintain a perpetual inventory, except as provided in paragraph (e) of this section.

(b) Separate records shall be maintained by a registrant for each registered location except as provided in Section 303. In the event controlled substances are in the possession or under the control of a registrant at a location for which he or she is not registered, the substance shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.

(c) Separate records shall be maintained by a registrant for each independent activity for which he or she is registered, except as provided in Section 316.

(d) In recording dates of receipt, importation, distribution, exportation or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported or otherwise transferred shall be used as the date of receipt or distribution of any packing slips.

(e) DHEC, upon a finding that a registrant has maintained inadequate records, or upon a finding that the registrant has a history of poor or inadequate record keeping, may, in its discretion, require perpetual inventories of all or a part on the controlled substances possessed or otherwise utilized or handled by such registrant (or an applicant for new registration having a history of record keeping deficiencies) as a condition for granting or renewing controlled substances registration. DHEC, upon a finding that adequate record keeping has been maintained for two or more years, pursuant to a perpetual inventory requirement, may remove the requirement and permit the registrant to resume standard record keeping activities with or without a probationary period of registration, as DHEC deems proper.

314. Records of manufacture.

Each registered manufacturer shall maintain records with the following information.

(a) For each controlled substance in bulk form to be used, or capable of use in, or being used in, the manufacture of the same or other controlled or non-controlled substance in finished form:

(1) The name of the substance;

(2) The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured;

(3) The quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received;

(4) The quantity imported directly by the registrant (under a registration as an importer) for use in manufacture by him or her, including the date, quantity, and import permit or declaration number for each importation.

(5) The quantity used to manufacture the same substance in finished form, including:

(i) The date and batch or other identifying number of each manufacturer;

(ii) The quantity used in the manufacture;

(iii) The finished form (e.g., 10-milligram tablets or 10 milligram concentrate per fluid ounce or milliliter);

(iv) The number of units of finished form manufactured;

(v) The quantity used in quality control;

(vi) The quantity lost during manufacturing and the causes thereof, if known;

(vii) The total quantity of the substance contained in the finished form;

(viii) The theoretical and actual yields; and

(ix) Such other information as is necessary to account for all controlled substances used in the manufacturing process.

(6) The quantity used to manufacture other controlled and non-controlled substances, including the name of each substance manufactured and the information required in subparagraph (5) of this paragraph;

(7) The quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address, and registration number of each person to whom a distribution was made;

(8) The quantity exported directly the registrant (under a registration as an exporter), including the date quantity, and export permit or declaration number of each exportation;

(9) The quantity distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity distributed or disposed.

(b) For each controlled substance in finished form:

(1) The name of the substance;

(2) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(3) The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to subparagraph (5) of paragraph (a) of this section;

(4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each receipt and the name, address, and registration number of the person from whom the units were received.

(5) The number of units of finished forms and/or commercial containers imported directly by the registrant (under a registration as an importer), including the date of and the number of units and for commercial containers to each importation;

(6) The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including:

(i) The date and batch or other identifying number of each manufacturer;

(ii) The operation performed (e.g., repackaging or re-labeling);

(iii) The number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes therefore, if known; and

(iv) Such other information as is necessary to account for all controlled substances used in the manufacturing process.

(7) The number of commercial containers distributed to other persons, including the date and number of containers in each distribution, and the name, address, and registration number of the person to whom the containers were distributed.

(8) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and

(9) The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed.

315. Records for distributors.

Each registered distributor shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) Each finished form (e.g. 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);

(c) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address, and registration of the person from whom the containers were received;

(d) The number of commercial containers of each such finished form imported directly by the registrant (under a registration as an importer), including the date of and the number of containers in each importation;

(e) The number of commercial containers of each such finished form distributed to other persons, including the date of and number of containers in each distribution and the name, address and registration number of the person to whom the containers were distributed;

(f) The number of commercial containers of such finished form exported directly by the registrant (under a registration as an exporter), including the date of and the number of containers of each exportation; and

(g) The number of units or volume of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution as complimentary samples), including the date and manner of distribution or disposal, the name and address, and registration number of the person to whom distributed or disposed.

316. Records for dispensers and researchers.

Each person registered to dispense or conduct research with controlled substances required to keep records pursuant to Section 303 shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial).

(c) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address, and registration number of the person from whom the containers were received;

(d) The number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser; and

(e) The number of units or volume of such finished form and/or commercial containers disposed of in any other manner by the registrant, including the date and manner of disposal and the quantity of the substance in finished form disposed.

317. Records for importers.

Each registered importer shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) The quantity (or number of units or volume in finished form) imported, including the date, quantity (or number of units or volume), and import permit or declaration number for each importation;

(c) The quantity (or number of units or volume in finished form) distributed to other persons, including the date and quantity (or number of units or volume) of each distribution and the name, address, and registration number of each person to whom a distribution was made; and

(d) The quantity disposed of in any other manner by the registrant, except quantities used for manufacturing by an importer under a registration as a manufacturer, which quantities are to be recorded pursuant to Section 314(a)(4) or (b)(5) including the date and manner of disposal and the quantities disposed.

318. Records of exporters.

Each registered exporter shall maintain records with the following information for each controlled substance:

(a) The name of the substance;

(b) The quantity or number of units (or volume in finished form) received from other persons, including the date and quantity (or number of units or volume) of each receipt and the name, address, and registration number of each person from whom the substance was received;

(c) The quantity (or number of units or volume in finished form) exported, including the date, quantity or number of units or volume), and the export permit or declaration number for each exportation, but excluding all quantities (and numbers of units and volumes) manufactured by an exporter under a registration as a manufacturer, which quantities (and numbers of units and volumes) are to be recorded pursuant to Section 314(a)(8) or (b)(8); and

(d) The quantity disposed of in any other manner by the registrant including the date and manner of disposal and the quantity disposed.

319. Records for chemical analysis.

(a) Each person registered to conduct chemical analysis with controlled substances shall maintain records, with the following information (to the extent known and reasonably ascertainable by him or her) for each controlled substance:

(1) The name of the substance;

(2) The form or forms in which the substance is received, imported, or manufactured by the registrant (e.g., powder, granulation, tablet, capsules, or solution) and the concentration of the substance in such form (e.g., C.P., U.S.P., N.F., 10-milligram concentration per milliliter);

(3) The total number of the forms received, imported, or manufactured (e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder), including the date and quantity of each receipt, importation, or manufacture and the name, address, and registration number, if any, of the person from whom the substance was received;

(4) The quantity distributed, exported, or destroyed in any manner by the registrant (except quantities used in chemical analysis or other laboratory work), including the date and manner of distribution, exportation or destruction, and the name, address, and registration number, if any, of each person to whom the substance was distributed or exported.

(b) Order forms, import and export permits, import invoices, and export declarations, relating to controlled substances shall be maintained separately from all other records of the registrant.

(c) Records of controlled substances used in chemical analysis or other laboratory work are not required.

(d) Records relating to known or suspected controlled substances received as samples for analysis are not required under paragraph (a) of this section.

320. Reports.

Manufacturers, re-packers, re-labelers, importers, exporters, and distributors who are required to report to ARCOS systems of the DEA, U.S. Department of Justice, need not file copies of such reports with the Bureau of Drug Control, but such registrants shall make copies of the reports available to the Bureau of Drug Control upon its written or oral request. Substantial compliance with the provisions of 21 CFR Sections 1304.31 through 1304.33 shall be deemed sufficient compliance with state reporting requirements.

321. Records for maintenance treatment programs and detoxification treatment programs.

(a) Each person registered or authorized by DHEC to maintain and/or detoxify controlled substances users in a narcotic treatment program shall maintain records with the following information for each narcotic controlled substance:

(1) Name of substance;

(2) Strength of substance;

(3) Dosage form;

(4) Date dispensed;

(5) Adequate identification of the patient (consumer);

(6) Amount consumed;

(7) Amount and dosage form taken home by patient; and

(8) Dispenser's initials.

(b) The records required by paragraph (a) of this section will be maintained in a dispensing log at the narcotic treatment program site and will be maintained in compliance with Section 316 without reference to Section 303.

(c) All sites which compound a bulk narcotic solution from bulk narcotic powder to liquid for on-site use, shall keep a separate batch record of the compounding.

(d) Records of identity, diagnosis, prognosis, or treatment of any patients which are maintained in connection with the performance of a narcotic treatment program shall be confidential, except that such records may be disclosed for purposes and under the circumstances authorized by this regulation and any other State or Federal law or regulation.

322. Records for treatment programs which compound narcotics for treatment programs and other locations.

Each person registered or authorized under the provisions of Section 107 of this Regulation to compound narcotic drugs for off-site use in a narcotic treatment program shall maintain records which include the following information for each narcotic drug:

(a) For each narcotic controlled substance in bulk form to be used in, or capable of being used in, or being used in the compounding of the same or other non-controlled substances in finished form:

(1) The name of the substance;

(2) The quantity compounded in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch compounded;

(3) The quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received;

(4) The quantity imported directly by the registrant (under a registration as an importer) for use in compounding by him or her, including the date, quantity, and import permit or declaration number of each importation;

(5) The quantity used to compound the same substance in finished form, including:

(i) The date and batch or other identifying number of each compounding;

(ii) The quantity used in the compound;

(iii) The finished form (e.g., 10-milligram tablets; 10 mg/ml per fluidounce, etc.)

(iv) The number of units of finished form compounded;

(v) The quantity used in quality control;

(vi) The quantity lost through compounding and the causes therefore, if known;

(vii) The total quantity of the substance contained in the finished form;

(viii) The theoretical and actual yields;

(ix) Such other information as is necessary to account for all controlled substances used in the compounding process;

(6) The quantity used to manufacture other controlled and non-controlled substances, including the name of each substance manufactured and the information required in paragraph (a) (5) of this section;

(7) The quantity distributed in bulk form to other programs, including the date and quantity of each distribution, and the name, address, and registration number of each program to whom a distribution was made;

(8) The quantity exported directly by the registrant (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exportation; and

(9) The quantity disposed of by destruction, including the reason, date, and manner of destruction. All other destruction of narcotic controlled substances will comply with Section 609.

(b) For each narcotic controlled substance in finished form:

(1) The name of the substance;

(2) Each finished form and the number of units or volume or finished form in each commercial container (e.g., 100- tablet bottle or 3 ml. ampoule, etc.);

(3) The number of containers of each such commercial finished form compounded from bulk form by the registrant, including the information required by paragraph (a) (5) of this section;

(4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each receipt and the name, address, and registration number of the person from whom the units were received;

(5) The number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;

(6) The number of units and/or commercial containers compounded by the registrant from units in finished form received from others or imported, including:

(i) The date and batch or other identifying number of each compounding.

(ii) The operation performed (e.g., repackaging or re-labeling);

(iii) The number of units of finished form used in the compound, the number compounded, and the number lost during compounding, with the causes for such losses, if known;

(iv) Such other information as is necessary to account for all controlled substances used in the compounding process.

(7) The number of containers distributed to other programs, including the date, the number of containers in each distribution, and the name, address, and registration number of the program to whom the containers were distributed;

(8) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers, and export permit or declaration number for each exportation; and

(9) The number of units of finished forms and/or commercial containers destroyed in any manner by the registrant, including the reason, the date, and manner of destruction. All other destruction of narcotic controlled substances will comply with Section 609.

PART 4 Order Forms

401. Order forms.

DEA Form 222 as issued by the DEA, U.S. Department of Justice, as required by the Federal Controlled Substances Act (21 USC 828) when properly executed and filed will be deemed a sufficient order form as required by the Act.

402. Handling and filing.

Handling and filing of order forms shall be accomplished in the manner provided under Part 1305, 21 C.F.R. (Regulations of the DEA, United States Department of Justice.)

403. Power of attorney.

Any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his or her behalf by executing a power of attorney for each such individual. The power of attorney shall be signed by the same person who signed (or was authorized to sign) the most recent application for registration or re-registration and by the individual being authorized to obtain and execute order forms. The power of attorney shall be filed with the executed order forms of the purchaser, and shall be retained for the same period as any order form bearing the signature of the attorney. The power of attorney shall be available for inspection together with other order form records. Any power of attorney shall be available for inspection together with other order form records. Any power of attorney may be revoked at any time by executing a notice of revocation, signed by the person who signed (or was authorized to sign) the power of attorney or by a successor, whoever signed the most recent application for registration or re-registration, and filing it with the power of attorney being revoked. The forms are available from Director of the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201.

PART 5 Prescriptions

501. [Reserved]

502. [Reserved]

503. Persons entitled to issue prescriptions.

(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:

(1) Licensed by the SC State Board of Medical Examiners, State Board of Dentistry, State Board of Veterinary Medicine Examiners, State Board of Nursing, State Board of Examiners in Optometry, or the State Board of Podiatry Examiners, and is authorized to prescribe under the type of license issued by the pertinent Board to the individual practitioner; and

(2) Acting in the regular course of professional practice, e.g., a veterinarian prescribing for a human is not within the regular course of professional practice, nor is a dentist when prescribing for illnesses or disease other than those of the oral cavity and adjacent tissues, nor is a podiatrist when prescribing for treatment of disease other than those manifesting themselves in the foot; and

(3) Registered with DHEC under the provisions of the Act.

(b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. The individual practitioner may not delegate the act of prescribing (i.e., the decision-making process whether to issue a prescription, what drug or substance to prescribe, what dosage, what frequency, and whether to refill the prescription) to a person not authorized to issue a prescription in his or her own right as an individual practitioner.

Example: A nurse or other employee of a physician may transmit an oral prescription (if permissible as a Schedule III, IV, or V substance) to a pharmacist if authorized to do so by the prescribing physician; the transmitting person has no authority to make any change whatsoever in the order of the practitioner, nor to add or delete any information to be transmitted.

504. Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective shall be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Act and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs whether or not in the course of conducting an authorized clinical investigation in the development of a narcotic rehabilitation program.

505. Manner of issuance of prescription.

All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address, and registration number of the practitioner. A practitioner shall sign a prescription in the same manner as he or she would sign a check or legal document (e.g., J. H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter, or other mechanical means of printing, and shall be manually signed by the practitioner. The prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by this regulation. See also Section 503(b).

505.1. Registration number required on prescriptions.

All prescriptions for controlled substances, whether written by the practitioner or telephoned and subsequently reduced to writing, shall bear the Federal Controlled Substances Registration Number (DEA Number) of the prescribing practitioner.

506. Persons entitled to fill prescriptions.

A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his or her professional practice and either registered individually or employed in a registered pharmacy or registered institutional practitioner.

506.1. Information required for filled prescriptions.

A notation shall be placed upon any prescription for controlled substances when originally filled that shall indicate the date filled, the identity or initials of the pharmacist dispensing the prescription and, if different from the quantity prescribed, the quantity dispensed. All notations shall be performed manually and in cursive handwriting, except that a date stamp (manual or mechanical) may be utilized by the pharmacist in lieu of handwriting the date dispensed or the refill date. The purpose of the manual handwriting is to assist in positively identifying the performer of the dispensing function.

507. Dispensing of narcotic drugs for maintenance purposes.

The administering or dispensing directly (but not prescribing of) narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term "in the course of his or her professional practice or research" in the Act, provided, that approval is obtained prior to the initiation of such a program by submission of a Notice of Claimed Investigational Exemption for a New Drug to the Food and Drug Administration which will be reviewed concurrently by the Food and Drug Administration for scientific merit and by the DEA for drug control requirements, and that the clinical investigation thereafter accords with such approval.

507.1. Federal approval of maintenance programs required.

DHEC will not register any person to conduct an authorized maintenance program for drug dependent persons until approval of such program has been made by the Food and Drug Administration, U.S. Department of Health, Education, and Welfare, and the DEA, U. S. Department of Justice. Upon approval by these agencies, the applicant for such registration shall submit to the Bureau of Drug Control copies of such approvals and copies of the protocols required by Federal Regulations. The Bureau of Drug Control shall accept the application for registration as complete only after submission of the aforementioned information and other information required by this regulation.

507.2. Withdrawal of drug dependent persons by use of methadone or other narcotic controlled substances.

Practitioners desiring to withdraw, but not maintain, drug dependent persons addicted to narcotic controlled substances from such substances by the use of methadone or any other schedule II narcotic controlled substance, may do so provided that all of the following criteria are met:

(a) The drug dependent person shall be a narcotic addict.

(b) The drug dependent person shall be confined to a hospital, clinic, rest home, or other appropriate location that properly segregates the drug dependent person from contact with possible illicit suppliers.

(c) The withdrawal program shall be on a reducing dosage basis, preferably through use of oral administration of the narcotic controlled substance used for withdrawal.

(d) Withdrawal treatment shall not exceed twenty-one days in length and shall not be available to any drug dependent person more often than once every six months. If, in the opinion of the withdrawing practitioner, longer periods of withdrawal treatment are necessary, application for such longer treatment shall be made to the Commissioner stating the reasons therefore, along with pertinent medical facts including, but not limited to, the following:

(1) Medical condition of subject at onset of withdrawal treatment;

(2) Amount of drug intake and name of drug at onset of treatment;

(3) Initial withdrawal dosage of methadone (or other narcotic controlled substance);

(4) Reduction schedule of withdrawal substance;

(5) Current medical evaluation of withdrawal regimen;

(6) Statement concerning presence or absence from urine sample of drug dependent person of the drug to which he or she was addicted; and

(7) Any other pertinent facts deemed necessary by the withdrawing practitioner or by the Commissioner.

(e) Any maintenance facility shall be approved by DHEC, by the Food and Drug Administration, and the DEA.

507.3 Approved uses of methadone in hospitals. Methadone is approved for the following uses for inpatients of hospitals licensed by DHEC:

(a) analgesia;

(b) pertussis;

(c) detoxification (withdrawal) of drug dependent persons under conditions set forth in Section 507.2 of this regulation; or

(d) temporary maintenance of methadone treatment of a drug dependent person enrolled in a methadone maintenance program licensed by any State or the federal government while such person is institutionalized within a licensed hospital for medical treatment of an illness or malady medically unrelated to drug dependence.

507.4 Departmental Approval; when required.

(a) Prior approval by DHEC for methadone use as set forth in Section 507.3 of this regulation is not required.

(b) Prior approval of DHEC and registration as provided by Title 21, Section 1301.22(a)(6) of the Code of Federal Regulations and S.C. Code Ann. Section 44-53-290(i), is required of all persons desiring to operate a treatment program utilizing methadone (i.e., a "methadone maintenance program"). Concurrence with Departmental approval by the SC Department of Mental Health, licensure by that Department as provided by Section 1 of Act No. 439 of 1980, and approval by the SC Commission on Alcohol and Drug Abuse, is required before such treatment program may dispense or administer methadone to any person, unless otherwise provided by statute.

(c) Prior approval by DHEC in the manner set forth by Section 507.5 of this regulation is not required to dispense methadone to outpatients of a hospital licensed by DHEC. Prior approval of DHEC is not required for "take home" methadone preparations which are lawfully dispensed by a methadone maintenance treatment facility licensed or operated by the SC Department of Mental Health or by and the Federal government.

(d) Approvals by DHEC, as required by Sections 507.2 through 507.5 of this regulation, may be granted by the Bureau of Drug Control in its discretion. If the Bureau finds that it cannot approve a request, the request shall be submitted to the Commissioner, along with the Bureau's reasons for non-approval. The Commissioner, in his or her discretion, may then approve or deny the request, but if he or she shall deny such request, the person making the request shall be entitled to a hearing to determine the public interest, in the manner provided for "contested cases" in the South Carolina Administrative Procedures Act.

(e) DHEC may require further information from any applicant in order to obtain sufficient information to be utilized in approving or denying any request.

507.5 Treatment of outpatients with methadone.

(a) If a physician determines that methadone would be the drug of choice as an analgesic for a particular patient, the physician may issue prescriptions for methadone to the patient. Such prescriptions may be dispensed by any pharmacy that has agreed to perform such dispensing function.

(b) The treating physician shall agree to maintain adequate records to substantiate the use of methadone as an analgesic for the patient and shall make such records available to DHEC upon request.

Controlled Substances Listed in Schedule II

508. Requirement of prescription.

(a) A pharmacist may dispense directly a controlled substance listed in schedule II, which is a prescription drug as determined under the Act, only pursuant to a written prescription signed by the prescribing individual practitioner, except as provided in paragraph (d) of this section.

(b) An individual practitioner may administer or dispense directly a controlled substance listed in schedule II in the course of his or her professional practice without a prescription subject to Section 507.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.

(d) In the case of an emergency situation, a pharmacist may dispense a controlled substance listed in schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:

(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period shall be pursuant to a written prescription signed by the prescribing individual practitioner);

(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information requested in Section 505 except for the signature of the prescribing individual practitioner;

(3) If the prescribing individual practitioner is not known to the pharmacist, he or she shall make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his or her phone number as listed in the telephone directory and/or other good faith efforts to insure his or her identity; and

(4) Within 72 hours after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of Section 505, the prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it shall be postmarked within the 72-hour period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the Director if the prescribing individual practitioner fails to deliver a written prescription to him or her; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

(e) A prescription prepared in accordance with Section 505 written for a Schedule II narcotic controlled substance, to be compounded for the direct administration to a patient by parenteral, intravenous, intra-muscular, subcutaneous or intra-spinal infusion, may be transmitted by the practitioner or the practitioner's agent by facsimile to a home infusion pharmacy. The facsimile serves as the original prescription for the purposes of this paragraph (e) and it shall be maintained in accordance with Section 304(d). The written, signed prescription shall be maintained in the medical record of the patient.

(f) A prescription prepared in accordance with Section 505 written for a Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with Section 304(d). The written, signed and voided prescription shall be maintained in the medical record of the patient.

(g) A prescription prepared in accordance with Section 505 written for a Schedule II narcotic controlled substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII, or a hospice program which is licensed by DHEC may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent shall note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and shall be maintained in accordance with Section 304(d). The written, signed, and voided prescription shall be maintained in the medical record of the patient.

508.1. Limitations on prescriptions for schedule II substances.

Prescriptions for schedule II controlled substances shall not be issued for more than a thirty-one day supply of the substance. No prescription for schedule II controlled substances shall be dispensed later than sixty days from the date of issue.

508.2. Practitioner-patient relationship required.

Prior to the issuance of a prescription for, or the direct dispensing of any schedule II controlled substances, the prescribing practitioner shall have a valid practitioner-patient relationship established with the recipient of the prescription, such relationship to include, but not be limited to, a sufficient knowledge of the medical need of the patient for such schedule II controlled substance, determination of the benefit to risk ratio of the use of such substance, good faith determination of the identity and address of the patient, a determination of the physical condition of the patient, and such practitioner shall be in personal attendance of the patient at the time of issuance of the prescription. Any prescription issued by any practitioner for any person outside of the reasonable bounds of a practitioner-patient relationship shall be deemed issued other than in the course of professional practice required by the Act. A practitioner cannot usually acquire a valid patient-practitioner relationship with himself or herself, nor with a member of his or her immediate family, due to the likelihood of the loss of or the vitiation of the objectivity required in making the necessary medical decisions in order to properly prescribe or dispense controlled substances. The practitioner may not be able to acquire a sufficient practitioner-patient relationship with non-family members (i.e., fiancé or fiancee, close personal friend, paramour, etc.) if total objectivity in deciding to prescribe or dispense controlled substances cannot be maintained due to such factors as extreme compassion, ardor, extortion, etc. which would vitiate such objectivity. In the event of a bona fide emergency situation, where great detriment to the health or safety of a patient may be involved, a practitioner may administer, dispense or prescribe limited amounts of controlled substances to any person, notwithstanding the provisions of this Section, until such time as another objective practitioner can be contacted.

509. Refilling prescription.

The refilling of a prescription for a controlled substance listed in schedule II is prohibited.

510. Partial filling of prescription.

(a) The partial filling of a prescription for a controlled substance listed in schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

(b) Prescriptions for schedule II controlled substances issued for patients in Long Term Care Facilities (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be dispensed in partial quantities, to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist shall record on the prescription whether the patient is "terminally ill" or LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. For each partial dispensing, the pharmacist shall record on the back of the prescription the date of the partial dispensing, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. Prior to any subsequent partial filling the pharmacist is to determine that the additional partial filling is necessary. The total quantity of Schedule II controlled substances dispensed in all partial dispensings shall not exceed the total quantity prescribed. Schedule II prescriptions, for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 30 days from the issue date unless sooner terminated by the discontinuance of medication.

(c) Information pertaining to current Schedule II prescriptions for patients in a LTCF may be maintained in a computerized system if this system has the capability to permit:

(1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, identification of LTCF, identification of medication authorized (to include dosage form, strength and quantity), listing of partial dispensings that have been dispensed under each prescription and the information required in Section 510(b).

(2) Immediate (real time) updating of the prescription record each time a partial dispensing of the prescription is conducted.

(3) Retrieval of partially dispensed Schedule II prescription information is the same as required by Sections 514(b)(4) and (5) for Schedule III, IV, and V prescription refill information.

511. Labeling of substance.

The pharmacist filling a written or emergency oral prescription for a controlled substance listed in schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law. See also Section 920.

512. Filing of prescriptions.

All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of Section 304.

Controlled Substances listed in Schedules III, IV, and V.

513. Requirement of prescription.

(a) A pharmacist may dispense a controlled substance listed in schedule III, IV, or V which is a prescription drug as determined under the Act, only pursuant to either a written prescription signed by a prescribing individual practitioner or an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Section 505, except for the signature of the prescribing individual practitioner.

(b) An individual practitioner may administer or dispense a controlled substance listed in schedule III, IV, or V in the regular course of his or her professional practice without a prescription subject to Section 507.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule III, IV, or V pursuant to a written prescription signed by a prescribing individual practitioner, or pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in Regulation 505 except for the signature of the prescribing individual practitioner), or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user, subject to Section 507.

514. Refilling of Prescriptions.

(a) No prescription for a controlled substance listed in schedule III, IV, or V shall be filled or refilled more than six months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times. Each refilling of a prescription shall be entered on the back of the prescription and shall indicate the date of each refilling, the quantity dispensed, and the initials of the dispensing pharmacist in each refilling. If the pharmacist merely initials and dates the back of the prescription he shall be deemed to have dispensed a refill for the face amount of the prescription. Additional quantities of controlled substances listed in schedule III, IV, or V may only be authorized by a prescribing practitioner through issuance of a new prescription as provided inSection 513 which shall be a new and separate prescription.

(b) As an alternative to the procedures provided by subsection (a), an automated data processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedules III, IV, and V, subject to the following conditions:

(1) Any such proposed computerized system shall provide online retrieval (via CRT display or hard-copy printout information for those prescription orders which are currently authorized for refilling. This shall include, but is not limited to data such as the original prescription number, date of issuance of the original prescription order by the practitioner, full name and address of the patient, name, address, and DEA registration number of the practitioner, and the name, strength, dosage form, quantity of the controlled substance prescribed (and quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.

(2) Any such proposed computerized system shall also provide on-line retrieval (via CRT display or hard-copy printout) of the current refill history for Schedule III, IV, or V controlled substance prescription orders (those authorized for refill during the past six months). This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.

(3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedule III, IV, or V controlled substance is correct shall be provided by the individual pharmacist who makes use of such a system. If such a system provides a hard-copy of each day's controlled substance prescription order refill data, that print-out shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist shall verify that the data indicated is correct and then sign this document in the same manner as he or she would sign a check or legal document (e.g. J.H. Smith or John H. Smith). This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day's controlled substance prescription order refill data shall be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. It shall be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him or her and is correct as shown. Such a book or file shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized refill.

(4) Any such computerized system shall have the capability of producing a print-out of any refill data which the user pharmacy is responsible for maintaining under the Act and its implementing regulation. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both.) Such a print-out shall indicate name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist and the number of the original prescription order. In any computerized system employed by a user pharmacy the central record-keeping location shall be capable of sending the print-out to the pharmacy within 48 hours, and if a DEA Special Agent or compliance Investigator or an Inspector from DHEC requests a copy of such print-out from the user pharmacy it shall, if requested to do so by the Agent, Investigator, or Inspector verify the print-out transmittal capability of its system by documentation (e.g. postmark).

(5) In the event that a pharmacy which employs such a computerized system experiences system downtime, the pharmacy shall have an auxiliary procedure which will be used for the documentation of refills of Schedule III, IV, and V controlled substance prescription orders. This auxiliary procedure shall insure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.

(c) When filing refill information for original prescription orders for Schedule III, IV, or V controlled substances, a pharmacy may use the system described in either paragraph (a) or (b) of this section.

514.1. Limitations on prescriptions for Schedules III, IV, and V substances.

Prescriptions for controlled substances listed in Schedules III, IV, and V shall not be issued for more than a thirty-one day supply of the substance. If authorized for refill, no prescription shall be refilled sooner than 48 hours prior to the time that the prescription should be consumed if the prescribed daily dosage is divided into the total prescribed amount. (Example: 4 daily divided into 100 dosage units = 25 days.) Carry over time shall not accrue between refills. In the event that the practitioner does not specify an exact daily dosage, the dispenser shall calculate date of refill from the usual daily dosage recommended by the manufacturer of the controlled substance.

514.2. Practitioner-patient relationship required.

Prior to the issuance of a prescription for controlled substances listed in Schedule III, IV, or V the prescribing practitioner shall have a valid practitioner-patient relationship established with the recipient of the prescription, such relationship to include, but not be limited to, a sufficient knowledge of the medical need of the patient for such schedule III, IV, or V controlled substance, determination of the benefit to risk ratio of the use of such substance, good faith determination of the identity and address of the patient, a determination of the physical condition of the patient, and such practitioner shall be in personal attendance of the patient at the time of issuance of the prescription. Any prescription issued by any practitioner for any person outside of the reasonable bounds of a practitioner-patient relationship shall be deemed issued other than in the course of professional practice required by the Act. A practitioner cannot usually acquire a valid patient-practitioner relationship with himself or herself, now with a member of his or her immediate family, due to the likelihood of the loss or vitiation of the objectivity required in making the necessary medical decisions in order to properly prescribe or dispense controlled substances. The practitioner may not be able to acquire a sufficient practitioner-patient relationship with non-family members (i.e., fiancé or fiancee, close personal friend, paramour, etc.) if total objectivity in deciding to prescribe or dispense controlled substances cannot be maintained due to such factors as extreme compassion, ardor, extortion, etc. which would vitiate such objectivity. In the event of a bona fide emergency situation, where great detriment to the health or safety of a patient may be involved, a practitioner may administer, dispense or prescribe limited amounts of controlled substances to any person, notwithstanding the provisions of this Section, until such time as another objective practitioner can be contacted.

514.3 Partial Filling of Prescriptions.

The partial filling (dispensing) of a prescription for a controlled substance listed in Schedules III, IV, or V is permissible, provided that:

(a) Each partial filling is recorded in the same manner as a refilling.

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and

(c) No dispensing occurs after six months from the date on which the prescription was issued.

515. Labeling of substances.

The pharmacist filling a prescription for a controlled substance listed in schedule III, IV, or V shall affix to the package a label showing the pharmacy name and address, the serial number of the prescription and the date of the initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in such prescriptions as required by law.

516. Filing prescriptions.

All prescriptions for controlled substances listed in schedules III, IV, and V shall be kept in accordance with Section 304.

Controlled Substances Listed in Schedule V

517. Requirement of prescription

(a) A pharmacist may dispense a controlled substance listed in Schedule V pursuant to a prescription as required for controlled substances listed in Schedules III and IV in Section 513. A prescription for a controlled substance listed in Schedule V may be refilled only as expressly authorized by the prescribing individual practitioner on the prescription; if no such authorization is given, the prescription may not be refilled. A pharmacist dispensing such substance pursuant to a prescription shall label the substance in accordance with Section 515 and file the prescription in accordance with Section 516.

(b) An individual practitioner may administer or dispense a controlled substance listed in Schedule V in the course of his or her professional practice without a prescription, subject to Section 507.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule V only pursuant to a written prescription signed by the prescribing individual practitioner, or pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in Section 505 except for the signature of the prescribing individual practitioner), or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user, subject to Section 507.

517.1 Limitation on prescriptions for schedule V substances

Prescriptions for schedule V controlled substances shall not be issued for more than a thirty-one day supply of the substance. Such prescriptions shall not be refilled more than five times, or after six months from the date of issue, and shall be refilled only if authorized by the prescribing practitioner.

518. Dispensing without prescription

A controlled substance in Schedule V, and a controlled substance listed in schedule II, III, or IV which is not a prescription drug as determined under the Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:

(a) Such distribution is made only by a pharmacist and not by a non-pharmacist employee even if under the direct supervision of a pharmacist (although after the pharmacist has fulfilled his or her professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a non-pharmacist):

(b) Not more than 240 ml. (8 ounces) of any such substance containing opium, nor more than 120 ml. (4 ounces) of any other controlled substance listed in Schedule V may be distributed at retail to the same purchaser in any given 48-hour period;

(c) The purchaser is at least 18 years of age;

(d) The pharmacist requires every purchaser of a controlled substance listed in Schedule V not known to him or her to furnish suitable identification (including proof of age where appropriate);

(e) A bound record book for distributions of controlled substances listed in Schedule V (other than by prescription) is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who distributed the substance to the purchaser (the book shall be maintained in accordance with the record keeping requirement of Section 304 of this chapter); and

(f) A prescription is not required for distribution or dispensing of the substance pursuant to the Act or any other law.

(g) Repetitive sales without prescription of Schedule V controlled substances without positive determination of medical need by the pharmacist selling the non-prescription controlled substance shall be deemed dispensing for other than medical purposes, and shall be prima facie evidence of detriment to the public health and safety.

PART 6 Miscellaneous

601. Severability.

If a provision of any section of Part 1 through 10 of this regulation is held invalid, all valid provisions that are severable shall remain in effect. If a provision of any of this regulation is held invalid in one or more of its applications, the provision shall remain in effect in all its valid applications that are severable.

602. Application of other laws.

Nothing in this regulation shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under Federal laws or obligations under international treaties, conventions or protocols, or under the law of the State in which he desires to do such act nor shall compliance with such Parts be construed as compliance with other Federal or State laws unless expressly provided in such other laws.

603. Exceptions in regulations.

Any person may apply for an exception to the application of any provision of these regulations by filing a written request stating the reasons for such exception. Requests shall be filed with the Director. The Director may grant an exception in his or her discretion, but in no case shall he or she be required to grant an exception to any person which is not otherwise required by law or the regulations cited in this section.

Special Exceptions for Manufacture and Distribution of Controlled Substances

604.1 Distribution by Dispenser to another practitioner.

(a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner for the purpose of general dispensing by the practitioner to his or her patients, provided that;

(1) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance;

(2) The distribution is recorded by the distributing practitioner in accordance with Section 316(e) of this regulation and by the receiving practitioner in accordance with Section 316(c) of this regulation;

(3) If the substance is listed in Schedule I or II, an order form (DEA Form 222) is used as required by Part 4 of this regulation;

(4) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section during any 12 month period does not exceed five percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the twelve month period. Registrants in existence less than 12 months shall prorate the time period, and shall not distribute more than five percent of the dispensings for any monthly period.

(b) If, at any time during any consecutive 12 month period during which the practitioner is registered to dispense, there is reason to believe that the total number of dosage units of all controlled substance which will be distributed by him or her pursuant to this section will exceed five percent of the total number of dosage units of all controlled substances distributed and dispensed by him or her during the 12 month period, the practitioner shall obtain a registration to distribute controlled substances.

605. Manufacture and distribution of narcotic solutions and compounds by a pharmacist.

As an incident to a distribution under Section 604.1, a pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the complete solution, compound, or mixture.

606. Distribution to supplier.

Any person lawfully in possession of a controlled substance listed in any schedule may distribute (without being registered to distribute) that substance to the person from whom he or she obtained it or to the manufacturer of the substance, provided that a written record is maintained which indicates the date of the transaction, the name, form and quantity of the substance, the name, address, and registration number, if any, of the person making the distribution, and the name, address, and registration number, if know, of the supplier or manufacturer. In the case of returning a controlled substance listed in schedule I or II, an order form shall be used in the manner prescribed in Part 4 of these regulations and be maintained as the written record of the transaction.

607. Distribution upon discontinuance of transfer of business.

(a) Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (without transferring such business activities to another person) shall return for cancellation his or her certificate of registration, and any un-executed order forms in his or her possession, to the Registration Unit, DEA, Department of Justice, Post Office Box 28083, Central Station, Washington, DC 20005, or to Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201. Any controlled substances in his or her possession may be disposed of in accordance with Section 609.

(b) Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (by transferring such business activities to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Director at least 14 days in advance of the date of the proposed transfer (unless the Director waives this time limitation in individual instances), the following information:

(1) The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor);

(2) The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee);

(3) Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed);

(4) Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in schedule I or II (if so, the basic class or class of the substance should be indicated); and

(5) The date on which the transfer of controlled substances will occur.

(c) Unless the registrant-transferor is informed by the Director, before the date on which the transfer was stated to occur, that the transfer may not occur, the registrant-transferor may distribute (without being registered to distribute) controlled substances in his or her possession to the registrant-transferee in accordance with the following:

(1) On the date of transfer of the controlled substances, a complete inventory of all controlled substances being transferred shall be taken in accordance with Sections 305-312. This inventory shall serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee, and a copy of the inventory shall be included in the records of each person. It shall not be necessary to file a copy of the inventory with the Bureau of Drug Control unless requested by the Director. Transfers of any substances listed in schedules I or II shall require the use of order forms in accordance with Part 1305 of the Federal Regulations.

(2) On the date of transfer of the controlled substances, all records required to be kept by the registrant-transferor with reference to the controlled substances being transferred, under Part 3 of this Regulation, shall be transferred to the registrant-transferee. Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee.

(3) In the case of registrants required to make reports pursuant to Part 3 of this Regulation, a report marked "Final" will be prepared and submitted by the registrant-transferor showing the disposition of all the controlled substances for which a report is required; no additional report will be required from him or her, if no further transactions involving controlled substances are consummated by him or her. The initial report of the registrant-transferee shall account for transactions beginning with the day next succeeding the date of discontinuance or transfer of business by the transferor-registrant, and the substances transferred to him or her shall be reported as receipts in his or her initial report.

608. Incidental manufacture of controlled substances.

Any registered manufacturer who, incidentally but necessarily, manufactures a controlled substance or basic class of controlled substance for which he is registered and has been issued an individual manufacturing quota (if such substance or class is listed in schedule I or II) shall be exempt from the requirement of registration pursuant to Part I of this chapter and, if such incidentally manufactured substance is listed in schedule I or II, shall be exempt from the requirement of an individual manufacturing quota, if such substances are disposed of in accordance with Section 609.

Disposal of Controlled Substances

609. Procedure for disposing of controlled substances.

(a) Any person in possession of any controlled substance and desiring or required to dispose of such substance may request the Director for authority and instructions to dispose of such substance. The request should be made as follows:

(1) If the person is a registrant required to make reports pursuant to Part 3 of this chapter, he or she shall list the controlled substance, or substances which he or she desires to dispose of on the "b" subpart of the report normally filed by him or her, and submit three copies of that subpart to the Director;

(2) If the person is a registrant not required to make reports pursuant to Part 2 of this chapter, he or she shall list the controlled substance or substances which he or she desires to dispose of on DHEC Form 41 and submit three copies of that form to the Director; and

(3) If the person is not a registrant, he or she shall submit to the Director a letter stating:

(i) The name and address of the person;

(ii) The name and quantity of each controlled substance to be disposed of;

(iii) How the applicant obtained the substance, if known; and

(iv) The name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant, if known.

(b) The Director shall authorize and instruct the applicant to dispose of the controlled substance in one of the following manners:

(1) By transfer to person registered under the Act and authorized to possess the substance;

(2) By destruction in the presence of an agent of the Bureau of Drug Control or other authorized person, or

(3) By such other means as the Director may determine to assure that the substance does not become available to unauthorized persons.

(c) In the event that a registrant is required regularly to dispose of controlled substances, the Director may authorize the registrant to dispose of such substances, in accordance with paragraph (b) of this section, without prior approval of the Bureau of Drug Control in each instance, on the condition that the registrant keep records of such disposals and file periodic reports with the Director summarizing the disposals made by the registrant. In granting such authority, the Director may place such condition as he deems proper on the disposal of controlled substances, including the method of disposal and the frequency and detail of reports.

PART 7 Schedules of Controlled Substances

701. Schedule I.

Any substance declared a controlled substance in schedule I by the DEA, United States Department of Justice or its successor agency, and listed in 21 CFR Section 1308.11, shall be considered a schedule I controlled substance within the meaning of this regulation upon the effective date specified in the Federal Register announcement.

702. Schedule II.

Any substance declared a controlled substance in schedule II by the DEA, United States Department of Justice, or its successor agency, and listed in 21 CFRSection 1308.12, shall be considered a schedule II Controlled Substance within the meaning of this regulation upon the effective date specified in the Federal Register announcement.

703. Schedule III.

Any substance declared a controlled substance in schedule III by DEA, United States Department of Justice, or its successor agency, and listed in 21 CFR Section 1308.13, shall be considered a Schedule III Controlled Substance within the meaning of this regulation upon the effective date specified in the Federal Register announcement.

704. Schedule IV.

Any substance declared a controlled substance in schedule IV by the DEA, United States Department of Justice, or its successor agency, and listed in 21 CFRSection 1308.14, shall be considered a Schedule IV Controlled Substance within the meaning of this regulation upon the effective date specified in the Federal Register announcement.

705. Schedule V.

Any substance declared a controlled substance in schedule V by the DEA, United States Department of Justice, or its successor agency, and listed in 21 CFRSection 1308.15, shall be considered a Schedule V Controlled Substance within the meaning of this regulation upon the effective date specified in the Federal Register announcement.

Excluded Non-narcotic Substances

706. Application for exclusion of a non-narcotic substance.

(a) Any person seeking to have any non-narcotic substance which may, under the Federal Food, Drug and Cosmetic Act (21 USC 301, et seq.), be lawfully sold over the counter without a prescription, excluded from any schedule, pursuant to the Act, may apply to the Director, Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201. No substance, drug, or any other product which is not excluded or exempted under the Federal Controlled Substances Act (21 USC Section 801 et seq.) or regulations (21 CFR Section 1301 et seq.) may lawfully be excluded or exempted under state law pursuant to Federal preemption under the provisions of 21 USC Section 903.

(b) An application for an exclusion under this section shall be handled by the Director, in determining whether the substance shall be excluded, in the manner prescribed for petitions to classify a substance on a schedule set forth in 21 CFR Section 1301 et seq.

707. Excluded substances.

Substances excluded from Federal schedules of controlled substances by Federal regulation 21 CFR Section 1308.22 of the DEA, U.S. Department of Justice, are hereby excluded from the schedules of this regulation.

Excepted Stimulant or Depressant Compounds

708. Application for exception of a stimulant or depressant compound.

An application for an exception under this section shall be handled in the manner prescribed for petitions to classify a substance on any schedule set forth in Federal Regulation 21 CFR Section 1308.31.

709. Excepted compounds.

Substances excepted from Federal schedules of controlled substances pursuant to 21 CFR Section 1308.32 are hereby excepted from the provisions of this regulation.

710-799. [Reserved]

PART 8 Hearings and Other Administrative Matters Subpart A

801. Hearings.

Hearings shall be conducted in the manner set forth by the Office of General Counsel, DHEC.

802. [Reserved]

803. Authority to make inspections.

In carrying out his or her functions under the Act, the Director, through his or her inspectors, is authorized in accordance with the Act to enter controlled premises and conduct administrative inspections thereof, for the purpose of:

(a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under the Act and any regulations promulgated under the Act, including, but not limited to, inventory and other records required to be kept pursuant to Part 3 of this chapter, order form records required to be kept pursuant to Part 4 of this chapter, prescription and distribution records required to be kept pursuant to Part 5 of this chapter, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each storage;

(b) Inspecting within reasonable limits and in a reasonable manner all pertinent equipment, finished and unfinished controlled substances and other substances or materials, containers, and labeling found at the controlled premises relating to this Act;

(c) Making a physical inventory of all controlled substances on hand at the premises;

(d) Collecting samples of controlled substances or precursors (in the event any samples are collected during an inspection, the inspector shall issue a receipt for such samples on DEA Form 84 to the owner, operator, or agent in charge of the premises);

(e) Checking of records and information on distribution of controlled substances by the registrant as they relate to total distribution of the registrant (i.e., has the distribution in controlled substances increased markedly within the past year, and if so, why); and

(f) Except as provided in Section 804, all other things therein (including records, files, papers, processes, controls and facilities) appropriate for verification of the records, reports, documents referred to above or otherwise bearing on the provisions of the Act and the regulations thereunder.

804. Exclusion from inspection.

(a) Unless the owner, operator, or agent in charge of the controlled premises so consents, no inspection authorized by the regulations shall extend to:

(1) Financial data;

(2) Sales data other than shipping data; or

(3) Pricing data.

805. Entry.

An inspection shall be carried out by an inspector. Any such inspector, upon:

(a) Stating his or her purpose and

(b) Presenting to the owner, operator, or agent in charge of the premises to be inspected:

(1) Appropriate credentials, or

(2) Written notice of or her inspection authority under Section 803 and the Act, or

(c) Receiving informed consent under Section 808 of this Regulation or through the use of administrative warrant issued under the Act shall have the right to enter such premises and conduct inspections at reasonable times and in a reasonable manner.

806. Notice of inspection.

The notice of inspection shall contain:

(a) The name and title of the owner, operator, or agent in charge of the controlled premises;

(b) The controlled premises name;

(c) The address of the controlled premises to be inspected;

(d) The date and time of the inspection;

(e) A statement that a notice of inspection is given pursuant to the Act;

(f) A reproduction of the pertinent parts of the Act; and

(g) The signature of the inspector.

807. [Reserved]

808. Consent to inspection.

(a) An administrative inspection warrant shall not be required if informed consent is obtained from the owner, operator, or agent in charge of the controlled premises to be inspected.

(b) Wherever possible, informed consent obtained by the inspector shall consist of a written statement signed by the owner, operator or agent in charge of the premises to be inspected.

(c) After August 17, 1974, informed consent may be shown by the production of a completed registration application or certificate, which shall contain printed thereon a preamble and conditions of registration.

809. Application for administrative inspection warrant.

(a) An administrative inspection warrant application shall be submitted to any judge or any magistrate and shall contain the following information:

(1) The name and address of the controlled premises to be inspected;

(2) A statement of statutory authority for the administrative inspection warrant, and that the fact that the particular inspection in question is designed to insure compliance with the regulations promulgated under those acts;

(3) A statement relating to the nature and extent of the administrative inspection, including, where necessary, a request to seize specified items and/or to collect samples of finished or unfinished controlled substances;

(4) A statement that the establishment either:

(i) has not been previously inspected, or

(ii) was last inspected on a particular date.

(b) The application shall be submitted under oath to an appropriate judge or magistrate.

810. Administrative probable cause

If the judge or magistrate is satisfied that "administrative probable cause" exists, he shall issue an administrative warrant. Administrative probable cause shall not mean criminal probable cause as defined by Federal or State statute or case law.

811. Execution of warrants.

An administrative inspection warrant shall be executed and returned as required by, and any inventory or seizure made shall comply with the requirements of the Act. The inspection shall begin as soon as is practicable after the issuance of the administrative inspection warrant and shall be completed with reasonable promptness. The inspection shall be conducted during regular business hours and shall be completed in a reasonable manner.

812. Refusal to allow inspection with an administrative warrant.

If a registrant or any person subject to the Act refuses to permit execution of an administrative warrant or impedes the inspector in the execution of that warrant, he shall be advised that such refusal or action constitutes a violation of the Act. If he or she persists and the circumstances warrant, heshe shall be arrested and the inspection shall commence or continue.

813. [Reserved]

Subpart B

Protection of Researchers and Research Subjects

814. Confidentiality of research subjects.

(a) Any person registered to conduct a bona fide research project with controlled substances under the Act who intends to maintain the confidentiality of those persons who are the subjects of such research, shall, upon registration or within a reasonable time thereafter, submit to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201, a separate request for each research project involving controlled substances, which shall contain the following:

(1) The researcher's registration number for that project;

(2) The location of the research project;

(3) A general description of the research or a copy of the research protocol;

(4) A specific request to withhold the names and/or any other identifying characteristics of the research subjects; and

(5) The reasons supporting the request.

(b) Within 60 days from the date of receipt of the request, the Director shall issue a letter, either granting confidentiality, requesting additional information or denying confidentiality, in which case the reasons for the denial shall be included. A grant of confidentiality shall be limited solely to the specific research project indicated in the request.

(c) Within 30 days after the date of completion of the research project, the researcher shall so notify the Director.

(d) In addition to the requirements set forth in paragraphs (a), (b), and (c) of this Section, the person requesting confidentiality of research subjects shall also provide the Bureau of Drug Control with a copy of the petition to the Attorney General of the United States required pursuant to the provisions of 21 CFR Section 1316.23. In the event that the Federal petition for confidentiality is not granted, or is withdrawn by the Attorney General of the United States, the Bureau of Drug Control shall, after notice to the researcher, remove its grant of confidentiality, if previously granted.

815. Exemption from prosecution for researcher.

(a) Upon registration of a practitioner to engage in research in controlled substances under the Act, the Bureau of Drug Control, DHEC, on its own motion or upon request in writing from the Commissioner or from the practitioner, may exempt the registrant when acting within the scope of his or her registration, from prosecution under State or local laws for offenses relating to possession, distribution or dispensing of those controlled substances within the scope of his or her exemption. However, this exemption does not diminish any requirement of compliance with the Federal Food, Drug and Cosmetic Act (21 USC 301, et seq.) or with the Federal Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801, et seq.).

(b) All petitions for Grants of Exemption from Prosecution for the Researcher shall be addressed to the Director, Bureau of Drug Control, SCDHEC, 2600 Bull Street, Columbia, SC 29201, and shall contain the following:

(1) The researcher's registration number, if any, for the project;

(2) The location of the research of the research project;

(3) The qualifications of the principal investigator;

(4) A general description of the research or a copy of the research protocol;

(5) The source of funding for the research project;

(6) A statement as to the risks posed to the research subjects by the research procedures and what measures of protection will be afforded to the research subjects;

(7) A statement as to the risks posed to society in general by the research procedures and what measures will be taken to protect the interests of society;

(8) A specific request for exemption from prosecution by Federal, State, or local authorities for offenses related to the possession, distribution, and dispensing of controlled substances in accord with the procedures described in the research protocol;

(9) A statement establishing that a grant of exemption from prosecution is necessary to the successful completion of the research project;

(c) Any researcher or practitioner proposing to engage in research requesting both exemption from prosecution and confidentiality of identity of research subjects may submit a single petition incorporating the information required inSections 814 and 815.

(d) The exemption shall consist of a letter issued by the Director, which shall include:

(1) The researcher's name and address;

(2) The researcher's registration number for the research project;

(3) The location of the research project;

(4) A concise statement of the scope of the researcher's registration; and

(5) The limits of the exemption;

(6) The exemption shall apply to all acts done in the scope of the exemption while the exemption is in effect. The exemption shall remain in effect until completion of the research project or until the registration of the researcher is either revoked or suspended or his or her removal of registration is denied. However, the protection afforded by the grant of exemption from prosecution during the research period shall be perpetual.

(e) Within 30 days of the date of completion of the research project, the researcher shall so notify the Director. The Director shall issue another letter including the information required in paragraph (d) of this section and stating the date on which the period of exemption concluded; upon receipt of this letter, the researcher shall return the original letter of exemption.

Subpart C

Enforcement Proceedings

816. Authority for enforcement proceeding.

A hearing may be ordered or granted by the Director of the Bureau of Drug Control, at his or her discretion, to permit any person against whom criminal and/or civil action is contemplated under the Act an opportunity to present his or her views and his or her proposals for bringing his or her alleged violations into compliance with the law. Such hearing will also permit him or her to show cause why prosecution should not be instituted, or to present his or her views on the contemplated proceeding.

817. Notice of proceeding; time and place.

Appropriate notice designating the time and place for the hearing shall be given to the person. Upon request, timely and properly made, by the person to whom notice has been given, the time and place of the hearing, or both, may be changed if the request states reasonable grounds for such change. Such request shall be addressed to the Director who issued the notice.

818. Conduct of proceeding.

Presentation of views at a hearing under this Subpart shall be private and informal. The views presented shall be confined to matters relevant to bringing violations into compliance with the Act or to other contemplated proceedings under the Act. These views may be presented orally or in writing by the person to whom the notice was given, or by his or her authorized representative.

PART 9 Handling and Administering Controlled Substances in Hospitals

901. Hospital registration.

All hospitals (except those owned and operated by the Federal government) shall be registered with DHEC in controlled substances schedules II through V inclusive.

902. Practitioners' registration.

Physicians and other practitioners who prescribe or order controlled substances for, or administer controlled substances to, patients in a hospital, shall be registered under the provisions of Article 3 of Chapter 53 of Title 44 of the 1976 Code.

903. Interns' registration.

An intern employed by a hospital may prescribe or order the administration of controlled substances for patients within the hospital, provided, that such intern has completed his or her course of study in a recognized college of medicine and has been duly licensed by the Board of Medical Examiners of South Carolina to practice medicine within this state, and has duly registered with DHEC and the DEA under the respective Controlled Substances Acts. An intern who is not licensed to practice medicine within this state may not register.

904. Damaged controlled substances.

Damaged, deteriorated, surplus, outdated, unusable, or unsalable controlled substances shall be returned to a manufacturer or a distributor for credit, or destroyed pursuant to State and Federal regulations in the manner provided for elsewhere within this chapter, on an annual basis. All such controlled substances shall be separated from usable or active stock; the registrant or his or her agent shall maintain a current inventory (similar to a perpetual inventory) of these substances until such substances can be returned to a manufacturer or distributor or destroyed in accordance with the above provisions. Returns to manufacturers and distributors can be made at any time within the year, and may, for good reason shown, be delayed past one year upon notice to DHEC.

905. Responsibility for controlled substances.

The administrative head of the hospital as a registrant under the Controlled Substances Act is responsible for the proper safeguarding and handling of controlled substances within the hospital. Responsibility for storage, accountability, and proper dispensing of controlled substances from the pharmacy may be delegated to a pharmacist employed by the hospital. Likewise, the Director of Nursing is usually delegated the authority for proper storage at nursing stations, and use, as directed by physician orders. However, delegation of authority does not relieve the administrator of the hospital of supervisory responsibility to insure detection and correction or any diversion of mishandling. The administrator shall be certain that all possible control measures are observed, and that any suspected diversion or mishandling of controlled substances is reported immediately to the Bureau of Drug Control for investigation. The administrator is ultimately responsible that all thefts be reported to DHEC pursuant to Sections 149 through 150 of this Regulation.

906. Prescriptions not required on floor-stocked Controlled Substances.

(a) Physicians' orders for patients within the hospital shall appear on the doctor's order sheet and no prescription is required. (It is unlawful for a hospital to fill or dispense a physician's prescription on an outpatient basis unless the hospital maintains a pharmacy holding a permit for such issued by the South Carolina Board of Pharmacy, and which is under the supervision of a registered pharmacist.) The nursing station floor stock used in administering controlled substances in any schedule shall be accounted for on a controlled substances certificate or disposition form. The physician's order sheet shall be checked against the medication administration record (MAR) and the controlled substances control sheet periodically by the person in charge of the pharmacy or drug room.

(b) Due to finite limits of nursing unit controlled substances storage areas, controlled substances that are not kept as floor stock will be occasionally ordered. Proper accountability for these controlled substances not included in floor stock require that they be issued on an individual demand basis with an accompanying sign-out control sheet. Any amount of these controlled substances which are not administered to or ingested by the patient shall be returned to the pharmacy within 72 hours after the medication order is discontinued by the individual practitioner treating the patient.

(c) Controlled substances secured from or obtained by prescription from retail sources outside the hospital are to be stored securely with all other controlled substances on the nursing unit. These controlled substances are to be monitored as to their administration to the patient by a supplemental controlled substances disposition sheet. This sheet should be designated with a control number or an identifying mark in order to distinguish it from regular hospital stock. If the patient is discharged before all of these controlled substances are administered, the amount sent home with the patient (if any) shall be noted on the disposition sheet and signed and dated by a registered nurse involved in the discharge process, who shall cause the sheet to be transmitted to the hospital pharmacy. In the event there are controlled substances obtained from outside sources which are not to be sent home with the patient, or if the patient expires and there are unutilized controlled substances from these sources, the balance of the medication shall be noted on the sheet by the Registered Nurse, and the sheet and the medication shall be returned to the hospital pharmacy for disposition.

(d) All orders shall be signed by the practitioner.

(e) All controlled substances within a hospital that are not located within the hospital pharmacy shall be accompanied by a disposition sheet or a sign-out sheet upon which to record the administration of the substance, whether the substance originated as hospital stock, from a retail source outside the hospital, or was brought into the hospital by the patient with the consent of the hospital and the patient's practitioner.

907. Registry number.

The physician's full name shall appear on the physician's order sheet. The physician's registry number is not required on the sheet, but shall be recorded within the pharmacy or drug room.

908. Telephone orders.

Telephone orders for hospital patients are permissible only in absolute necessity. The nurse will write the order on the physician's order sheet, stating "Telephone Order" and sign the physician's name and the nurse's initials. The controlled substance may be administered at once. The physician shall verify his or her telephoned order by signature upon the patient's chart within 72 hours.

909. Verbal orders.

Verbal (oral) orders for hospital patients are permitted in a bona fide emergency. Such orders shall be handled in the same manner as telephone orders.

910. Controlled substances records.

All orders and records of controlled substances shall be in ink, typed, or indelible pencil. Mechanical systems may be used to collect and store this data. All data shall be kept in a readily retrievable manner as set forth inSections 301, 303, 304, 313, and 316 of this regulation. Any mechanical system shall be designed to retrieve data in such a manner as to show individual controlled substance activity per nursing unit as well as individual controlled substance volume in its entirety. This shall include, but is not limited to, control numbers, date dispensed, identity of the controlled substance, strength, quantity dispensed, and location within the hospital.

911. Procedure in case of waste, destruction, contamination, etc.

(a) Aliquot part of solutions used for drugs: The nurse shall use the proper number of tablets or ampoules from nursing unit stock. The nurse shall record the number of tablets or ampoules used and the does given in the proper columns of the controlled substances disposition sheet. The nurse shall expel into the sink that portion of the solution not used. The aliquot shall be recorded and witnessed by a second signature on the back of the disposition sheet, or on a separate waste form designated by the hospital.

(b) Prepared dose refused by patient or canceled by physician: When a dose of a controlled substance has been prepared for a patient but not used due to refusal by the patient or cancellation by the physician, or has been accidentally contaminated during the regular course of administering the drug to the patient for whom it has been ordered (e.g., blood aspirated into a syringe when beginning the administration of an intra-muscular medication) the nurse shall expel the solution into the sink, and record on the back of the disposition sheet the reason why the controlled substance was not administered.

Example: "Discarded: Refused by patient," or "Order cancelled by Dr. A. Jones." The head nurse of the unit shall sign the statement.

(c) Accidental destruction of controlled substance: When a solution, table, ampoule or substance is accidentally destroyed on a nursing unit, the person responsible shall indicate the accidental loss by writing "wasted; see waste report" on the line allowed for the record on the controlled substances disposition sheet. The person shall write on the back of the disposition sheet a complete report of the accident and sign the statement. The head nurse or charge nurse of the unit shall witness and sign the statement when complete.

(d) Contaminated or broken hypodermic tablets and contaminated controlled substance solutions: When a controlled substance hypodermic tablet is contaminated or broken or a controlled substance solution is contaminated, the person responsible or the head nurse shall place the tablets, particles, or solution in a suitable container and label. The person responsible, or the head nurse, shall indicate the contaminated controlled substance by check in the space or spaces allowed for the record on the controlled substance disposition sheet of that substance. He or she shall write on the back of the sheet a complete report and sign the statement when complete. The container with the contaminated controlled substance shall be returned to the pharmacy or drug room. The pharmacist or person in charge of the drug room will receive it and note on the controlled substances disposition sheet covering the particular substance that it has been returned. The hospital shall return the material either by itself or with similar controlled substance material at a convenient time, to the DEA or the Bureau of Drug Control, DHEC, through an Inspector. (In using the above procedure, the head nurse should sign entries as a witness.)

912. Procedures in case of loss, theft, etc.

(a) Discrepancies in controlled substances count: Those involving small amounts (such as single doses) shall be reported to a responsible supervisory official. An investigation should be made to determine the cause of the loss. A copy of the report of the investigation, signed by the responsible supervisor shall be filed with the hospital controlled substance records, and appropriate action taken to prevent recurrence.

(b) Recurring shortages: In cases of recurring shortages or loss of significant quantities of controlled substances (several doses), a thorough investigation shall be made, making every effort to determine the reason for the shortages, and the person responsible for the shortage, if possible. A complete report of the incident and findings shall be made to the administrative authority of the hospital. Appropriate action shall be taken immediately to prevent recurrence. A copy of the report, including any findings resulting from the local investigations, and a theft report, as required by Section 147, shall be forwarded to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201.

913. [Reserved]

914. Controlled substances of physician's office or bag.

It is unlawful for a physician to obtain substances for his or her office or bag use from the controlled substances stock of the hospital. A physician may obtain his or her controlled substances from a drug wholesaler by invoice; Schedule II substances shall be acquired through the use of order forms supplied by the DEA, U. S. Department of Justice (DEA Forms 222). Those hospitals maintaining permitted retail pharmacies, or otherwise licensed as a "drug outlet" by the SC Board of Pharmacy, may at their option, furnish controlled substances to practitioners pursuant to the provisions of Section 604.1 of this Regulation.

915. Dispensing to outpatients.

It is unlawful for a hospital to dispense controlled substances to outpatients on physicians' orders. Such dispensing shall be done only on the prescription of a duly licensed physician and only from the pharmacy holding a permit as a retail pharmacy of a hospital registered under Article 3 of Chapter 53 of Title 44 of the 1976 Code, and by or under the immediate supervision of a registered pharmacist. With the permission of the hospital, a practitioner may personally dispense limited quantities of controlled substances to their patients for take-home purposes, provided that such substances are properly packaged and labeled as required by provisions elsewhere within this regulation, and in compliance with statutory provisions.

916. Administering to outpatients.

Controlled substances may be administered to outpatients or emergency patients when admitted to the emergency room of the hospital when ordered by the physician in charge of the case, provided a record is kept showing the name and address of the patient, kind and quantity of controlled substance administered, date and physician's order. Under no conditions may the patient be given controlled substances to take out of the hospital except as provided in Section 915.

916.1 Emergency Rooms.

The stock of controlled substances maintained in hospital emergency rooms or outpatient facilities is kept for the use by or at the direction of physicians in the emergency room. Therefore, in order to receive such medication, a patient shall be examined by a physician in the emergency room or outpatient facility and the need for the particular controlled substance determined by such physician. It is not possible under Federal requirements for the use of controlled substances for a physician to see a patient outside of the emergency room setting, or talk to the patient over a telephone, and then call the emergency room and order the administration of a stocked controlled substance upon the patient's arrival at the emergency facility. Cf., S.C. Code Ann. Section 44-53-110, "administer" ['...in his presence...']; Sections 508.2 and 514.2 of this Regulation, requiring personal attendance, etc.

917. Storage of controlled substances.

All controlled substances shall be kept in a locked, secure place. Large reserve stocks should be kept in a strong safe, substantial enough to deter entry and heavy enough to prevent being carried away. Other valuable property may be kept in the safe provided adequate security of the controlled substances contained therein is maintained. See also Sections 140 through 145, inclusive.

(a) Nursing station controlled drug box: Responsibility: Only a very limited number of persons should possess the key to the controlled substances on the nursing station. When such person(s) are relieved from duty, the person(s) taking charge, should count and transfer the controlled substances in the presence of the person(s) being relieved, and all controlled substances should be accounted for. The responsibility rests with the person(s) assigned to possession of the key on each shift. The administrator shall be responsible for control of these keys. This responsibility may be delegated to the Director of Nursing. Written documentation of accountability of controlled substances (i.e., shift change nurses' signatures) shall be stored in a readily retrievable manner and maintained for a period of not less than two years, after which they may be destroyed.

(b) Responsibility of drug room: In those hospitals not maintaining a pharmacy under the supervision of a registered pharmacist, the drug room shall be restricted to the Director of Nurses, a designated assistant, or a designated registered nurse, not more than one of whom shall be in possession of the key to the drug room at the same time. The nurse in possession of the key to the drug room shall be responsible for all transactions in the drug room on his or her respective shift. (Observance of (a) and (b) does not relieve the Administrator of his or her responsibilities.)

918. Dispensing of controlled substances to employees of hospitals.

The dispensing of controlled substances from the stock of the hospital to employees of the hospital is prohibited. Provided, however, that in those hospitals maintaining a pharmacy holding a permit as a retail pharmacy and registered under Article 3 of Chapter 53 of Title 44 of the 1976 Code, the pharmacist may compound or dispense a properly executed prescription issued by a duly licensed physician, provided further, that an employee of the hospital may be administered a controlled substance in an emergency if the administration of such drug is properly ordered and recorded in the same manner as provided for patients in the emergency room.

919. Availability of records for inspectors.

The administrative head of the hospital shall, upon service of an inspection warrant by an inspector of the Bureau of Drug Control, DHEC, or if such administrative head chooses, voluntarily without inspection warrant, (acting pursuant to the informed consent to inspection delineated as a condition of registration upon the application for registration and the registration certificate issued to the registrant by DHEC) make available to such inspector all dispensing and administering records of controlled substances, for the purpose of audit of said controlled substances, as well as records of receipt and disposition of all controlled substances acquired by the hospital. Inspectors shall not divulge information contained on patient records that do not concern controlled substances or other drugs restricted to prescription use only.

920. Labeling of substances. (Schedule II)

The requirements of Section 511 do not apply when a controlled substance listed in schedule II is prescribed for administration to an ultimate user who is institutionalized: Provided, that:

(1) Not more than 7-day supply of the controlled substance listed in schedule II is dispensed at one time;

(2) The controlled substance listed in schedule II is not in the possession of the ultimate user prior to the administration; and

(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substances listed in schedule II; and

(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

921. Labeling of substances. (Schedules III, IV, V)

The requirements of Section 513 do not apply when a controlled substance listed in schedule III or IV is prescribed for administration to an ultimate user who is institutionalized; Provided, that:

(1) Not more than a 30-day supply or 100 dosage units, whichever is less, of the controlled substance listed in schedule III, IV or V is dispensed at one time.

(2) The controlled substance listed in schedule III, IV or V is not in the possession of the ultimate user prior to administration;

(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing and storage of the controlled substance listed in schedule III, IV or V; and

(4) The system employed by the pharmacist in dispensing a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

922. Clarification and intent.

These regulations are considered to be a general but minimal required control level in the opinion of the Bureau of Drug Control, DHEC. More stringent control for the institution in question, or special interpretations of these regulations may be approved by a special meeting with the Bureau of Drug Control, and the administrator or designated pharmacy and therapeutics committee of the respective hospital every 3 to 5 years when the need is felt for such clarification. The intent of these 900 series regulations is to insure adequate control and accountability of controlled substances utilized in health care without duly hindering or restraining the delivery of such care. Accountability and an accurate audit at periodic intervals are the crux of the adequate control system.

923. Consultation procedure.

At the request of the institution under examination and/or the Bureau of Drug Control, DHEC, the SC Society of Hospital Pharmacists may furnish a recognized local authority on Institutional Medication Delivery and Control Systems to accompany the agent/or inspector and act as a consultant to the institution in question on rectifying flaws in the system under scrutiny.

61-5. Repealed by State Register Volume 20, Issue No. 5, eff. May 24, 1996.

61-6. Capital Expenditure Reviews under Section 1122, Social Security Act.

Table of Contents

Chapter I--Administration and Organization

Chapter II--Review Criteria

Chapter III--Review and Reporting Procedures

Chapter IV--Fair Hearings

Chapter V--Reimbursement and Budget

CHAPTER I ADMINISTRATION AND ORGANIZATION

1. --Section 1122, Social Security Act

Title 42, Part 100 Federal Regulations

2. Authority--On March 4, 1974, Governor West designated the 314(a) Comprehensive Health Planning Agency, the S. C. Department of Health and Environmental Control as the body to administer Section 1122 of the Social Security Act.

The following rules and regulations implement an Act in amendment of and in addition to Sections 44-5-10 through 44-5-140 of the S. C. Code of Laws, entitled:

"STATE COMPREHENSIVE HEALTH PLANNING ACT."

3. Other State Agencies--Other state agencies will be requested to comment as the need arises, e.g., Bureau of Health Facilities and Services, Department of Health and Environmental Control, S. C. Mental Health Commission, S. C. Mental Retardation Commission.

4. Areawide Planning Agencies--

District Agency Counties

Appalachia S.C. Appalachian Health Coun- Anderson, Cherokee,

No. 1 cil, P.O. Box 6708, Green- Greenville, Oconee,

ville, S.C. 29606 Pickens, Spartanburg

Upper Savannah Upper Savannah Regional Abbeville, Edgefield

No. 2 Planning & Development Greenwood, Laurens

Council, P.O. Box 1244, McCormick, Saluda

Greenwood, S.C. 29646

Catawba Catawba Regional Planning Chester, Lancaster

No. 3 Council, P.O. Box 862, Union, York

Park Hill S.C. 29730

Central Midlands Central Midlands Regional Fairfield, Lexington

No. 4 Planning Council, Suite 155 Newberry, Richland

Dutch Plaza, 800 Dutch

Square Blvd., Columbia,

S.C. 29210

Lower Savannah Lower Savannah Regional Allendale, Aiken,

No. 5 Planning & Development Bamberg, Barnwell,

Council, P.O. Box 850, Calhoun, Orangeburg

Aiken, S.C. 29801

Wateree Santee-Wateree Regional Clarendon, Kershaw,

No. 6 Planning Council, P.O. Box Lee, Sumter

1837, Sumter, S.C. 29150

Pee Dee Pee Dee Planning & Develop- Chesterfield, Dar-

No. 7 ment Council, P.O. Box lington, Dillon,

4366 Florence, S.C. 29501 Florence, Marion,

Marlboro

Waccamaw Waccamaw Regional Planning Georgetown, Horry,

No. 8 & Development Council, P.O. Williamsburg

Drawer 419, Georgetown, S.C.

29440

Charleston Area Charleston Area CHP Council, Berkeley, Charleston,

No. 9 P.O. Box 2696, Charleston, Dorchester

S.C. 29403

Lowcountry Lowcountry Regional Planning Beaufort, Colleton.

No. 10 Council, P.O. Box 98, Hampton, Jasper

Yemassee, S.C. 29945

5. Definitions--For the purpose of these rules and regulations, the definitions listed below will apply:

A. Application--A request for a capital expenditure review.

B. Approval--Approval of the Board shall be sought by filing an application. The applicant is required to simultaneously submit the application to both the local areawide comprehensive health planning council and the Board.

C. Bed Capacity--means licensed capacity under applicable state or local law, or, if there is no such law, the number of beds in a given facility as of January 1, 1974, as determined by the designated planning agency. It includes hemodialysis stations. Bed capacity of facilities under construction and for which favorable action has been recommended will be included along with the licensed capacity.

D. Board--S. C. Department of Health and Environmental Control (see paragraph E. below).

E. Board Membership--

Consumers Providers

Lachlan L. Hyatt, Chairman J. Howard Stokes, M.D.

William M. Wilson V. Chairman Leonard W. Douglas, M.D.

I. DeQuincey Newman, Secretary

W. A. Barnett, Jr.

Caroline G. Newhall

F. Capital Expenditure--which requires review is an expenditure, including a force account expenditure (i.e., an expenditure for a construction project undertaken by a facility as its own contractor) which under generally accepted accounting principles, is not properly chargeable as an expense of operation and maintenance and which (i) exceeds $100,000, or (ii) changes the bed capacity of the facility with respect to which such expenditure is made, or (iii) substantially changes the services of the facility with respect to which such expenditure is made. If any one of these three conditions is met, review is required.

G. DPA--Designated Planning Agency, the S. C. Department of Health and Environmental Control.

H. Exceptions to Full Review Procedure--

(1) Simple licensure changes from one category of nursing care to another, where no new beds are to be constructed, shall be handled by means of a narrative report from the applicant to the appropriate areawide planning council and the Board explaining what he proposes to do and why. This type of application will be expedited by administrative review at the staff level.

(2) Where projects are essentially service oriented, a detailed narrative report using the information required for an application shall serve as the basic points to be covered with the applicant furnishing any additional information he or the Board may feel is necessary.

(3) The narrative report shall be used for nonsubstantial building projects.

(4) When any serious emergency occurs, customary review procedures may be suspended until the immediate emergency has been overcome. Subsequently, any changes effected under the emergency condition must be reviewed. The Board shall have final authority in determining an emergency situation.

I. Exemptions--

(1) Office practice of private physicians including any outpatient clinics connected with a private practice of a physician or groups of private physicians. This does not extend to Health Maintenance Organizations which seek to serve a pre-enrolled group of consumers who subscribe for service in advance of need.

(2) "Simple modernization to improve care" (as defined in these regulations).

J. Health Care Facility--includes hospital, psychiatric hospitals, tuberculosis hospitals, skilled nursing facilities, home health agencies, and providers of outpatient physical therapy services (including speech pathology services) as defined in Section 1861(e), (f), (g), (j), (o), and (p), respectively, of the Social Security Act, as amended (except that such term shall not apply with respect to outpatient physical therapy services performed by a physical therapist in his office or in a patient's home); kidney disease treatment centers, including freestanding hemodialysis units; intermediate care facilities as defined in Section 1905(c) of the Social Security Act, as amended; and organized ambulatory health care facilities such as health centers, family planning clinics, and facilities providing surgical treatment to patients not requiring hospitalization (surgicenters), which are not part of a hospital but which are organized and operated to provide medical care to outpatients.

K. Health Maintenance Organization--means a public or private organization, organized under the laws of any State which:

(1) Provides or otherwise makes available to enrolled participants health care services, including at least the following basic health care services: Usual physician services, hospitalization, laboratory, X-ray, emergency and preventive services, and out-of-area coverage; and

(2) Is compensated (except for co-payments) for the provision of the basic health care services listed in subparagraph (1) of this paragraph to enrolled participants on a predetermined periodic rate basis; and

(3) Provides physicians' services primarily (i) directly through physicians who are either employees or partners of such organization, or (ii) through arrangements with individual physicians or one or more groups of physicians (organized on a group practice or individual practice basis).

L. "Major Modernization or Modification"--This item refers to alterations, additions, or deletions of services, facilities or equipment which significantly affect the scope or volume of service provided by the institution such as, but not limited to, the addition of a new special care unit (i.e., coronary care, rehabilitation unit, self-care, intensive care), the development of new extramural patient services (i.e., home care, satellite outpatient health center, multiphasic screening center), the addition, expansion or deletion of a patient care service or a discrete diagnostic or treatment service, (i.e., cobalt therapy, inhalation therapy, dialysis unit, open heart surgery), or the closing of an existing patient care department.

M. Obligation--An obligation for a capital expenditure shall be deemed to have been incurred by or on behalf of a health care facility or health maintenance organization.

(1) When an enforceable contract is entered into by such facility or organization or by a person proposing such capital expenditure on behalf of such facility or organization for the construction, acquisition, lease or financing of a capital asset; or

(2) Upon the formal internal commitment of funds by such facility or organization for a force account expenditure which constitutes a capital expenditure; or

(3) In the case of donated property, the date on which the gift is completed in accordance with applicable State Law.

N. Person--means an individual, a trust or estate, a partnership, corporation (including associations, joint-stock companies, and insurance companies), or a State, or a political subdivision or instrumentality (including a municipal corporation) of a State.

O. Project--All approval requests shall be in terms of projects. A project is defined as a change in the facility that would either expand or reduce the scope or type of health services rendered. The Board reserves the right to exempt certain service projects from review where no generally acceptable national standards for evaluation are in existence. Projects will be classified into one of the following categories:

(1) Physical plant and equipment--new

(2) Physical plant and equipment--change in existing

(3) Equipment (installed) only--new

(4) Equipment (installed) only--change in existing

(5) Primarily service oriented projects--new or existing

A request for a project by a proponent will be subjected to one of three possible alternatives:

(1) Exempted

(2) Application

(3) Simple letter of notification

Whenever a doubt exists as to which route is the proper one for the project, the Board should be contacted for a determination.

P. Proposed capital expenditure--Common practice and common sense must govern in determining what is considered a single expenditure. A provider should not be allowed to avoid review by splitting what is really one expenditure into two (for example, renovate the third floor for $60,000 and renovate the fourth floor for $60,000). On the other hand, the DPA should not be allowed to lump projects together arbitrarily to bring them under review (for example, lumping together construction of extended care beds and renovation of an emergency room merely because they occurred in the same year).

Q. "Simple Modernization to Improve Care"--This item refers to the routine and ordinary maintenance of health facilities and to the replacement of standard equipment in both patient care areas and support departments, such as, but not limited to, replacement of bedroom furnishings, lighting and plumbing fixtures, diagnostic and treatment equipment, vehicles, dietary equipment, laundry equipment, housekeeping, machinery, business office machinery, data processing equipment, waiting areas, patient care areas, entrances, and parking areas. The installation of new equipment which adds to the efficiency or economy of services or functions already provided by the institution but which does not significantly affect the scope or volume of services, is also considered "simple modernization." "Simple modernization to improve care" as previously defined is exempted from these rules. No notification to the Board is required prior to undertaking the project. However, if it is questionable as to whether or not a project would fall under these rules, the Board should be notified and a determination will be made at that time.

R. Substantial Change of Service--means the addition of a clinically related (e.g., diagnostic, curative, or rehabilitative) service not previously provided in the facility or the termination of such a service which had previously been provided in the facility.

6. Health Facility Plans--Statewide--The DPA and the 314(b) agencies will determine the consistency of the proposed expenditure with the appropriate State Health Facility Plan, which shall include the latest revision of the following plans:

A. S. C. Hill-Burton Hospital Plan

B. S. C. Mental Health Facilities Plan

C. S. C. Comprehensive Health Plan

D. S. C. Disabilities State Plan

7. Health Facility Plans--Areawide--The Areawide Health Planning Agencies will, at their option, consider the consistency of the proposed expenditure with the Areawide Comprehensive Health Plan prepared and adopted by the agency for the area which it serves.

Health Plans will be filed with the DPA for reference.

8. Application--The application will be submitted on forms furnished by the Board which shall be mailed simultaneously to the appropriate areawide planning council and the Board. Concurrent with the submission of the application, the applicant shall cause to be published in a newspaper(s) having wide distribution in the area, a notice of intention to seek approval for the proposed project and a brief description of the project. This public notice shall appear during three consecutive weeks, although publication is required on one day of each week only. Applicants are encouraged to involve the appropriate areawide health planning council in development of proposed projects prior to the submission of an application. The application shall contain the following information regarding the project:

A. A brief description of the project setting forth the proposed change in services or facilities or change thereof, and a statement, where applicable, as to whether the bed capacity or services which the health facility is licensed to provide is to be changed or it represents the development of a new service for which no construction is required, together with the details thereof.

B. If a replacement facility is being constructed, describe plans for disposition of old facility upon completion of a new facility.

C. The proposed location of the facility or service and/or equipment.

D. The estimated cost of the project including all design fees and related expenses.

E. The proposed method of financing the costs of the project and the status of such financing.

F. A statement as to whether the applicant has applied or intends to apply for Federal grant or loan funds and the specific amount and source or sources.

G. The adequacy of the financial resources of the applicant and sources of private construction funds and future revenue.

H. A projected manpower budget detailing the personnel required for the staffing of the new proposed project and the contemplated program and plan for recruiting and training personnel.

I. The estimated date of contract award and completion date (applicable only to projects not requiring application).

J. Demonstration by the applicant of the public need for the project at the time and place under the circumstances proposed.

K. How the proposed project relates to the short-range and long-range plans of the applicant.

9. Disposition of Application--The application shall be forwarded to the Board. A copy shall be sent to the appropriate areawide planning council. Upon receipt of the application, the areawide health planning council shall review, study and evaluate the proposed project, from an 1122 standpoint, and recommend approval or disapproval of the applicant's proposed project as described in his application.

A. Project Review Period--The project review period will be ninety (90) days except as provided below. The review period will begin upon receipt of the application except that when it is determined within fifteen (15) days that the application is incomplete and the provider so notified, the review period will begin upon receipt of the complete application. Receipt of Application, will be mailed to the applicant and the 314(b) agencies. Failure of the DPA and/or 314(b) agency to reach a decision within the review period allocated will be considered as concurrence by that Agency with the proposed expenditure. Exceptions to the 90-day review will be:

If the applicant states on his application that he plans to incur the obligation prior to the 90th day (i.e., between 60 and 90 days). The review period will be sixty (60) days.

B. Extension of Review Period--The 90-day review period may be extended upon request of, and with the consent of, the applicant. The term of the extension will be the prerogative of the applicant.

C. Deadline for 314(b) Action--In view of the time limitation on the review period, the deadlines for 314(b) action shall be as stated below. The deadline date will be stated on Review and Recommendation Record.

(1) 90-day Review Period. 75 days from the start of the review period.

(2) 60-day Review Period. 45 days from the start of the review period.

(3) Extended Review Period. Action deadline to be determined based on reasons for extension of time.

D. Review and Recommendations Alternatives--The 314(b) Agency will be requested to review the Application in one of three types of review:

(1) Standard Review--According to Review Criteria set forth above and by completion of the appropriate section of Review and Recommendation Record.

(2) Nonsubstantive Review--According to Review Criteria set forth and completion of the appropriate section of Review and Recommendation Record.

(3) Elected Not to Review--Pursuant to Section 1122 requirements, the DPA is required to process every Application submitted. Agreements with areawide planning agencies will extend this requirement. During the development stages of the Section 1122 program, there may be Applications submitted of a highly complicated nature of which the review agencies feel that it is not at that time fully competent to review and make recommendations, either favorably or adversely. In such instances "No Review" action will be considered as concurrence with the Application and the proposed expenditure.

10. Supplemental Information for Application--In addition to the application, a project narrative must be included which will contain as a minimum:

A. Adequate programmatic documents in support of the various elements of the proposed project. Programmatic documents will include as a minimum:

(1) A map of sufficiently large scale to be meaningful, indicating the location of the project site and its geographical survey area;

(2) A plot plan of the project site showing existing buildings, roads, parking areas, walks, service and entrance courts, existing utilities (electricity, telephone, water, sewer, gas, etc.) and other natural land features necessary for adequate analysis of site conditions;

(3) A legal description of the project site indicating its physical characteristics and existing easements.

(4) A square foot program of spaces and/or equipment elements included in the proposed project;

(5) Any additional information pertaining to the proposed project which the Board may deem necessary.

B. As part of the Application the applicant shall give the following assurances where applicable:

(1) That the applicant has or will have a fee simple title or such other estate or interest in the site including necessary easements and rights-of-way, sufficient to assure use and possession for the purpose of the construction and operation of the facility;

(2) That he will obtain the approval of the Board of the final drawings and specifications which shall be prepared by an architect or engineer legally registered under the laws of the State of South Carolina;

(3) That he will submit to the Board for prior approval changes that substantially alter the scope of work, function, utilities, major items of equipment, safety, or cost of the facility;

(4) That he will cause the project to be completed in accordance with the application and approved plans and specifications by maintaining competent and adequate architectural and engineering supervision and inspection of the project;

(5) That the facility will be operated and maintained in accordance with the standards prescribed by law and regulation for the maintenance and operation of such facilities;

(6) That the applicant understands that the approval shall be valid for no longer than twelve months from the date of issuance unless the applicant has awarded a construction contract; or, in projects in which no construction was necessary, has either implemented the proposed change in service or has made significant progress thereto; and that the Board may extend the approval provided that no other applicant has submitted a valid request for a like project and that progress can be shown by the original applicant;

(7) That the Board or its authorized representative may, at any time during the course of construction or upon the completion of the project, make an onsite inspection of the construction and equipment to check for compliance of the construction in accordance with the terms of his prior approval;

(8) That the controlling interest in the project shall not be sold or leased without prior approval of the Board.

11. Disposition of Application--When the Board determines to issue an approval and/or disapproval, it shall send to the proponent, by registered mail, a notice setting forth the particular reasons for the determination. A disapproval shall become final thirty (30) days after the mailing of the notice, unless the proponent or licensee, within such thirty day period, shall give written notice of his desire for a hearing. If the proponent or licensee shall give such notice, he shall be given a fair hearing before the Board or his designee and may present such evidence as may be proper. On the basis of such evidence the determination involved shall be affirmed or set aside, and a copy of such decisions, setting forth the findings of facts and the particular reasons upon which it is based, shall be sent by registered mail to the applicant.

12. Penalties for Non-Compliance--The undertaking of construction or change in the scope of a service by a health facility without prior approval of the Board shall be grounds for negative recommendation regarding reimbursement for capital expenditures under titles V, XVIII, and XIX.

CHAPTER II REVIEW CRITERIA

1. Mandated Review Criteria--Pursuant to Section 100.107, Federal Regulations, the DPA and partnership agencies will review and report their findings on each application for reimbursement of capital expenditures. The minimum criteria considered shall be:

A. Community need for the proposed facility or service.

B. Ability of the applicant to adequately staff the facility.

C. Economic feasibility of the facility.

D. Cost containment.

2. Community Need for the Facility or Service--Whether the proposed facility is needed or projected as necessary to meet the needs in the community in terms of health services required. Provided that projects for highly specialized services, (such as open heart surgery, renal transplantation or radiation therapy) which will draw from patient population outside the community in which the project is situated, will receive appropriate consideration.

In addition to determining whether the proposed facility or service is consistent with the State Plans, the DPA and areawide planning agencies will specifically consider the following factors:

A. Facility service area.

B. Population characteristics and growth.

C. Current and projected utilization in area.

D. Accessibility to the public (Geographic, Economic, Emergency).

E. Conformity with local zoning and development plans.

F. Probable effect on other like facilities in the area.

G. Community reaction to the facility.

H. Existing and planned facilities offering similar programs and services.

3. Staffing--Whether the proposed facility or service can be adequately staffed and operated when completed. Factors to be considered include, but are not necessarily limited to:

A. Presentation of a staffing program in conformity with minimum licensure standards.

B. Availability of unemployed health personnel in area.

C. Probable effect on other facilities within the area.

D. Proposed health career training and educational support programs by the facility.

E. Projected number of health career graduates by local and state educational and training institutions.

F. Sufficiency or shortage of health career personnel in the area.

4. Economic Feasibility of the Project--Whether the proposed capital expenditure is economically feasible and can be accommodated in the patient charge structure of the health care facility or health maintenance organization without unreasonable increases. Specific factors to be considered include:

A. Conformity with Cost of Living Council Guidelines.

B. Budget and Utilization Data for past three years.

C. Project Budget and Utilization Data for two years following completion of the project.

D. Schedule of current and projected charges.

5. Cost Containment--Whether the project will foster cost containment through improved efficiency and productivity, including promotion of cost-effective factors such as ambulatory care, preventive health care services, home health care, and design and construction economies. In addition to these factors, consideration will also be given to the following:

A. Referral and other management agreements with other facilities.

These will include referrals both from and to other health care facilities.

B. Sharing of services.

C. Duplication of existing facilities and services.

6. Nonsubstantive Projects--With limitation of $100,000 established as the maximum capital expenditure exempt from Section 1122, many projects, especially for the larger hospitals, will be submitted which should not require definitive review procedures inasmuch as they will call for routine replacement expenditures, emergency or expenditures necessary for compliance with statutes and regulations. These expenditures will be determined "nonsubstantive" by the DPA according to criteria delineated in these rules.

A. Replacement of Equipment--Equipment purchases or leases in excess of $100,000 will receive nonsubstantive review provided such purchases replace existing equipment and/or are intended to improve an existing service. Equipment purchases or leases in excess of $100,000 which are intended to materially expand an existing service or provide a new service will be subject to the standard review.

B. Structural Alterations and Improvements--Capital expenditures in excess of $100,000 which are intended to improve quality of service but which will not delete a service, provide a new service, or which do not change the bed capacity, will be considered nonsubstantive.

C. Compliance with Statutory and Regulatory Requirements--Expenditures in excess of $100,000 which are required for compliance with State Licensure Regulations, Federal Regulations (Medicare and Medicaid), the Life Safety Code, and local building codes, and which do not delete a service, add a service, or alter the bed capacity, will be considered nonsubstantive.

D. Emergency Expenditures--Any expenditure made necessary by unforeseen events which endanger the health and safety of the patient shall be considered nonsubstantive. This definition includes emergency expenditures to maintain quality care to overcome failure of Group I (Fixed) equipment including, but not necessarily limited to, heating and air conditioning equipment, elevators, electrical transformers, and switch gear, sterilization equipment, emergency generator equipment, water supply, and other utility connections. Emergency expenditures may be incurred without prior approval by the DPA and partnership agencies. However, these agencies should be notified immediately when the emergency occurs and written justification be submitted as early as practical. In the event a provider and the DPA staff disagree as to whether or not an expenditure constitutes an "emergency" expenditure, the question will be referred to the Board. Appeals, if necessary, can be handled by a Fair Hearing.

E. Bed Capacity--Applications for projects proposing the addition or subtraction of 5 beds or 2% of the existing bed capacity, whichever is larger, will be considered nonsubstantive.

F. Fund Limitation--Maximum fund limitation for nonsubstantive projects shall be $300,000.00 or 2% of the facility's or HMO's annual operating budget, whichever is less.

G. "Nonsubstantive Project" Not Applicable to Certain Facilities--Facilities which are listed in approved Health Facility Plans as no longer required to meet community needs, and which are programmed to be phased out, shall not be extended the privilege of "nonsubstantive projects." All applications for capital expenditures except those for expenditures under $100,000, which do not substantially change a service, or change the bed capacity, will be given the standard review provided that Emergency Expenditures for these facilities will be considered nonsubstantive.

CHAPTER III REVIEW AND REPORTING PROCEDURES

1. Initial Action by Partnership Agencies--

A. Areawide Planning Agencies--It is anticipated that as the Section 1122 Program continues, more and more prospective providers will make initial contact with the Areawide Planning Agencies. These agencies are requested to immediately notify the DPA of probable applicants for project review.

B. DPA--Upon learning that a provider is planning to incur a capital expenditure which may fall within the scope of Section 1122, Social Security Act, the Department of Health and Environmental Control will disseminate the information to its applicable planning agencies.

C. Other Planning Agencies--These Agencies are requested to notify the DPA of probable applicants for project review.

2. Initial Notification to Partnership Agencies--The DPA will Initially notify Partnership Agencies using Project Notification Record. This Notification will include known pertinent information but probably will be incomplete. The Partnership Agency will not be requested to take any action nor to reply to the Notification. However, the agency is urged to take such action as it may deem appropriate to initiate the review process.

3. Initial Determinations--Based on the best information available at the initial stage of review procedures, the DPA will make an initial determination of the applicability of Section 1122 of the Social Security Act. Where there appears to be some doubt of the applicability of Section 1122, the DPA will request additional information by the most expeditious means. In some cases it may be necessary to request submittal of a completed Application to make a determination.

4. Notification to Project Owner--Upon initial determination by the DPA that the proposed capital expenditure falls within the scope of Section 1122, the DPA will notify the applicant or provider of the provisions of Section 1122 and Part 81 of Federal Regulations. The DPA will also forward the Application for Review Under Section 1122 of the Social Security Act, and Assurance of Need, hereinafter called the Application to the applicant or provider.

5. Filing Fees--Neither the DPA nor any other planning agency securing reimbursement for Section 1122 activities may require a filing fee for Section 1122 reviews.

6. Initial Submission of Application--Federal Regulations require that the complete Application must be filed with the DPA not less than sixty (60) days prior to the date of fund obligation. Capital expenditures obligated prior to 60 days following receipt of the complete application will not be eligible for reimbursement under the Social Security Act.

7. Review for Completeness of Application--Upon initial receipt of the Application, the DPA and the Areawide Planning Agency will review it for completeness. Should either Agency deem the Application to be incomplete, it will promptly notify the other. The DPA has the regulatory responsibility to notify the provider within 15 days after receipt of the Application of its completeness or of any additional information required. Should the DPA not receive communication from the Areawide Agency within 10 days, the DPA will assume that the Areawide Agency considers the Application to be complete.

A. Complete Applications--Upon determination that the Application is complete the DPA will notify the provider of receipt of the Application (Receipt of Application.) In no case will this receipt of application exceed 15 days. This Form will also advise the provider or applicant and the 314(b) Agencies of the start of the review period.

B. Incomplete Applications--Upon determination that the Application is incomplete the DPA will notify the applicant of the receipt of the Application and will advise the applicant of the additional information desired, (Request for Additional Information.) The applicant will be requested to submit the additional information.

Upon determination of completeness of the Application, notification procedures as set forth in A. above will be followed.

8. Project Review Package--Upon determination of the completeness of the Application, the DPA will forward to the Partnership Agencies, the Project Review Package which will include the completed Project Notification Record.

9. Finalization of Review Process--Upon receipt of Review and Recommendation Record from the Partnership Agencies, the DPA will take the appropriate action as set forth in this Section.

10. Projects Consistent with Approved Plans and Recommended for Approval--The DPA will review all documentation submitted by Partnership Agencies, and if the approval is found to be consistent with Criteria set forth in this Manual and with the appropriate State Plans, the following action will be taken:

A. Notification of Action Under Section 1122 of the Social Security Act will be forwarded to the Regional Health Administrator, DHEW. Copies of the Notification will be forwarded to the Applicant and Partnership Agencies.

B. In cases where other Federal Agencies (DHUD, SBA, etc.) are involved, a copy of the Notification together with the appropriate form requested by the Federal Agency will be forwarded to that Agency.

11. Projects Consistent with Approved Plans but Not Recommended by Other Agencies--In such event, the procedures set forth below will be followed:

A. DPA will attempt to resolve the problem. If differences are resolved action will be finalized. If the DPA staff and the disagreeing parties fail to reach agreement, the file will be referred to the Board for review and decision. If Board recommendations constitute a "favorable" decision, action will be finalized. Disagreeing parties will be invited to attend all Board (DPA) meetings with reference to their application.

B. In the event of disagreement concerning the applicability of Section 1122, the question can be referred to HEW for comment.

12. Notification of DPA Findings--The Applicant will be notified by Letter regarding the DPA findings and will be advised of his rights to a Fair Hearing when necessary.

13. Reconsideration of the Application Subsequent to Plan Revision--In the event the State Plan is revised the Applicant will be invited to resubmit his application which will be afforded review.

14. Determination that Section 1122 Action is Not Required--Upon determination by the DPA that the proposed expenditure does not fall within the scope of Section 1122, the DPA will notify the applicant or provider, by Letter that Section 1122 Action is Not Required.

15. The Role of The Board of DHEC (DPA)--This Board will play an essential role in the development of policy for the Section 1122 program in finalizing findings and recommendations, and in the consideration of conflicting recommendations as described above. The Board will perform its statutory role in the conduct and administration of Section 1122 of the Social Security Act.

A. The Board may appoint a Review Committee consisting of governmental representatives, providers, and consumers (51% or more consumers) to review and make recommendations. All applications in which conflicting recommendations are received and all applications for which an adverse recommendation is made, may be reviewed by this Committee. The CHP Council is to serve as the Committee.

B. The Board will serve to set policy and make final recommendations to the Secretary of HEW.

C. DPA Committees--The Board may establish such other committees as it may deem advisable to improve and facilitate administration of the Section 1122 program.

D. Summary Report--A summary and report of activities, to include a list of all findings and recommendations finalized, may be presented to the full Board at each of its meetings.

16. Consulting State Agency--The DPA may determine the role of review committees as it may deem necessary to facilitate its role in the Section 1122 Program. In the interest of efficient administration, only complex applications which may receive unfavorable recommendations are to be considered by such committees and/or the full Board.

17. The Areawide Health Planning Agency--The Areawide Health Planning Agencies are to adopt review procedures pursuant to Section 1122 Regulations. It is suggested that project applications be considered by Project Review Committee with representation from each county. It is further recommended, in the interest of facilitating the review process, that favorable action by the Review Committee be considered final. Consideration by the full Council should be limited to controversial projects and those which receive adverse recommendation by the Committee. A Review Committee must be the proportional equivalent of the full Council in terms of governmental, provider, and consumer members. The Review Committee, with decision making authority, shall meet the legal make-up criteria for the full Council.

18. Public Notice of Applications Received--Upon receipt of complete applications for review under Section 1122, DPA will promptly issue press releases to the news media throughout the State and to the news media serving the area in which the proposed project is to be located. This news release will include at least the following information:

A. Name of sponsoring organization

B. Name of local areawide health planning agency

C. Location of proposed project

D. Type of facility (hospital, nursing home, etc.)

E. Description of facility (new facility, or service, expansion, change in bed capacity, etc.)

F. Estimated cost of the facility or service

G. Proposed starting and completion dates

H. Estimate of service units (patient visits, utilization, treatments, procedures, etc.) that will be provided.

19. Public Notice of DPA Decisions--When the DPA has reached a decision concerning the Application, it will notify interested agencies and will issue a press release of its findings and recommendations. The press release will include at least the following information:

A. Name of project sponsor

B. Name and location of project

C. General description of the project

D. DPA findings and recommendations (favorable or adverse)

E. Relation to DPA findings to those of the areawide planning agencies. In the case of conflicting findings and recommendations, a brief statement explaining the conflict will be included.

20. Public Notification of Fair Hearing--Upon request from an Applicant who received an adverse decision, the DPA will, as soon as the date, time and place of the Hearing has been established notify the news media. Fair Hearings shall be open to the general public and to the news media. Upon completion of the Fair Hearing and receipt of decision by the Hearing Officer, a news release will be issued to the general news media and to the news media serving the area in which the project is located.

21. Term of the Applications and Favorable Recommendations--The application and favorable recommendations shall be valid for a period of one year from the date of issuance. The provider holding it may request an extension if it is necessary as prescribed by these Federal Regulations.

22. Application for Extension of Approved Application--Approximately one month prior to the termination date of the application, the applicant will be notified and will be invited to apply for an extension. Complete application for extension should be forwarded to reach the DPA not less than 10 days prior to termination of the current approval. Failure to submit the Application for Extension within 10 days following the termination date of the original document, the beds and/or services shall be considered available for review procedures leading to issuance of an Assurance to the original recipient thereof or a competing applicant without either party holding priority.

23. Criteria for Extension of Approval of Application and Favorable Recommendation--The DPA will review the application for extension against the criteria enumerated and described below. Unless there is a significant change in the program of service, scope of the project, or projected budget and utilization data, the Application for Extension will not be referred to the areawide planning agencies. All information as set forth on Application for Extension must be submitted by the Applicant. Criteria for extension will include:

A. Minimum Criteria--(which will not require review by areawide health planning agencies.)

(1) Site Procurement--The Applicant or Provider must have acquired fee simple title, long-term leasehold, or option to purchase or lease the facility site.

(2) Architectural Progress--The facility architect must have been employed and must have obtained approval of First State or schematic drawings.

(3) Program Narrative--Must be updated to show any change in the scope of the project. If no change, the applicant must so state.

(4) Financial Status--Applicant must present evidence that financing plan is feasible. Appropriate statement must be obtained from lending agency and attached.

B. Criteria which may necessitate review by 314(b) Agency--

(1) Program Narrative--Any significant change in bed capacity or services to be changed must be described. At the option of the DPA the significant change may be determined to be cause for a separate initial application and review.

(2) Budget and Utilization Data--In the event there is a significant change in the facility, it will be necessary to submit revised Budget and Utilization Data. Increased cost without significant change in Program will not be considered cause for a repeat of the Review Process.

(3) Cost Containment--If the Applicant does not have a Cost Containment Statement on file, he must submit one. If the statement is coupled with a significant change in the Program Narrative, a full review may be indicated.

24. Beds or Services to be Reserved Pending Decision of Extension--Beds or Services which have been the content of an Original Application shall not be considered as available for review for a competing project application until a final decision is made on an Application for Extension.

25. Duration of Extension--An approved extension shall be valid for a period of six months from the expiration date of the original Assurance.

26. Termination Date for Projects Under Construction--A favorable decision by the DPA shall be considered to be valid for an indefinite period as of the date the obligation is incurred; provided, the date of obligation occurs prior to the termination date of the application.

27. Continuing Effect of Projects Requiring a Series of Obligations--Under the so-called "Fast-Track" or similar construction procedures, it may require several obligations of expenditures over a period in excess of one year. Normally, approval would be considered valid only for the obligation incurred prior to the termination date thereof. In cases where the Provider elects the "Fast-Track" or similar method for the construction of what would otherwise be considered one distinct facility, the provider may apply for and receive an approval of sufficient duration of time, but not to exceed three (3) years provided all expenditures for the distinct and complete project must be incurred within the three (3) year period.

28. Withdrawal of Approval or Abandonment of Project--The Applicant or provider may at any time and at his discretion advise the DPA and Areawide Planning Agencies of the abandonment of the project. Upon such notification, the outstanding approval will be automatically terminated.

29. Categories of Projects Which Have Received Unfavorable Decision--There will be two categories of projects which will have received an unfavorable decision. Both categories shall have the right to a reconsideration of their Application as set forth in this Section.

A. Category I. Application Denied/Facility Not Constructed--This includes all facilities for which applications were denied for any reason and which, as a result thereof, were not constructed.

B. Category II. Application Denied/Facility Constructed--This category includes those facilities which received an unfavorable or adverse decision but which were constructed. These facilities would not receive reimbursement for capital expenditures.

30. Reconsideration Rights. Category I--Applications receiving unfavorable decisions shall be kept in an active file pending reconsideration at such time as there is a need for the facilities or services. Prior to consideration of Applications for other similar facilities or services in the same area, the DPA will notify the applicant who received the unfavorable decision that there exists a need for the facilities or services. Should the Applicant request in writing within thirty days that the Application be reconsidered, the same procedures for review and notice will apply to resubmitted proposals as to original proposals. Should the Applicant fail to reply in thirty days or advise of his intentions not to build the facility, the Application will be considered closed and no longer subject to reconsideration. Provided, however, the Applicant may, at some future date, submit another application which will be afforded the regular review procedures.

31. Reconsideration Rights. Category II--Applications receiving unfavorable or adverse decisions will be kept on file for reconsideration, upon request of the Applicant. After submission of such additional information as the DPA may require, these applications may be reconsidered.

A. Whenever there is a substantial change in existing or proposed health facilities or services, of the type proposed, in the area served by such facility, or

B. Upon a substantial change in the need for facilities or services, of the type proposed in the area served by such facility, as reflected in the standards, criteria or plans as may be current at the time of the request, or

C. At any time following the expiration of three years from the date of the adverse decision by the DPA or of the last reconsideration by the DPA pursuant to this Section, whichever is later.

32. Additional Data May be Required--As a minimum, DPA will require up-dating of supporting data and information submitted by the Applicant. Unless there is a change in proposed beds or services, this information may be limited to cost data, budget information, and cost containment statement.

33. Review Procedures--The Review Procedures as set forth in this document will apply to reconsideration of Applications.

34. Favorable Decisions--Reconsidered Applications which receive a favorable decision will be issued an approval and a copy of the Notification of Action Under Section 1122 of the Social Security Act will be forwarded to the Regional Health Administrator.

35. Adverse Decision--Reconsidered Applications which receive an adverse decision will be processed as may be appropriate. The Applicant will be given the opportunity to request a Fair Hearing as outlined in these Rules.

CHAPTER IV FAIR HEARINGS

1. Fair Hearing Procedures Required--Section 1122 of the Social Security Act and proposed Federal Regulations, Part 100, require that the Designated Planning Agency Administering Section 1122 set up a fair hearing procedure and that the opportunity for a fair hearing shall be offered to all applicants who receive a negative finding and recommendation.

2. Fair Hearing Provided--The State 314(a) Agency, the Department of Health and Environmental Control, as the official state planning agency designated by the Governor pursuant to Section 1122 of the Social Security Act, will provide an opportunity for a fair hearing before a qualified hearing officer to every applicant proposing a capital expenditure, and who receives a notice of an adverse finding or recommendation, and who is dissatisfied with such adverse notice, and who requests a fair hearing within the procedures set forth herein.

3. Substance of Fair Hearing under Section 1122--The primary purpose of the Fair Hearing process is for the hearing officer to determine whether the proposed expenditure is consistent with the standards, criteria, and plans specified in the statute. The correctness, adequacy, or appropriateness of the standards, criteria, and plans against which the proposed expenditure was measured are not matters for consideration at the hearing. The question of the DPA's adherence to its procedures, as outlined in the Regulations and the Agreement, may be considered. The applicant may also introduce evidence and argument on the issue of whether the exclusion of expenses related to the proposed expenditure would discourage the operation or expansion of the facility or organization, or would otherwise be inconsistent with the effective organization and delivery of health services or the effective administration of Titles V, XVIII, and XIX.

The question of whether a proposed expenditure is subject to review under Section 1122 will not, in light of the appeal to DHEW available to the proponent, be a question in the Fair Hearing.

The hearing officer may submit his own finding as to whether the proposed expenditure is consistent with the applicable standards, criteria, and plans, and in the case of a negative finding, his recommendation as to whether or not the Secretary should exclude from reimbursement expenses related to the proposed expenditure. The hearing officer may direct that the DPA take further action on the proposed expenditure. The hearing officer may also reach such supplementary conclusion (e.g., on the question of adherence to procedural requirements) and submit such further recommendations as he deems appropriate.

4. Fair Hearing Officer--The Hearing Officer shall be selected by the Governor and he shall be a person who has no official assignment or tie to the State Comprehensive Health Planning Agency. Areawide Health Planning Agencies (314-b), or other Agency, playing a direct role in the required review process.

5. Time for Requesting Hearing--

A. Individual notification of adverse findings and recommendations and notification of the right to a fair hearing shall be sent to the provider or applicant no more than five (5) days after the adverse finding has been made by the Designated Planning Agency.

B. The applicant or provider may request a hearing as provided in these procedures, in writing, within thirty (30) days after the applicant or provider receives notice of adverse finding and recommendations.

C. Failure to receive a written request for hearing within thirty (30) days from the date of notification of adverse finding and recommendation shall be deemed by the Designated Planning Agency as acceptance of said adverse decision by the applicant or provider.

6. Time and Place of Fair Hearing--The fair hearing will be held at a location to be determined by the Hearing Officer. The hearing shall be commenced within thirty (30) days after receipt by the DPA of the written request for hearing (or later at the option of the person requesting the hearing).

7. Notification of Hearing--The applicant or provider requesting the hearing will be notified in writing of the time and place of the hearing.

8. Open Hearing--The hearing shall be open to the public and shall be publicized through local newspapers and public information channels.

9. Right of Counsel--The appellant is entitled to be represented. The appellant, planning agencies involved in the finding and recommendation process, representatives of consumers of the proposed health services, and other interested parties are entitled to examine all evidence and to question opposing witnesses. The planning agencies involved in the review process, shall also be entitled to be represented, present evidence, question opposing witnesses, and examine evidence submitted by the applicant or provider.

10. Stenographic Record--The record of the proceedings shall be transcribed and copies of the transcription, together with copies of all documents and evidence, shall be available to the appellant, planning agencies, representatives of consumers, and the public for inspection and copying, provided that any person or agency who requests copies of such material shall bear the costs thereof.

11. Notification of Decision--As soon as practicable, but no more than 45 days after the conclusion of the hearing, the Hearing Officer shall notify the appellant, the Designated Planning Agency, the other health planning agencies who participated in the hearing, and other interested parties at the discretion of the hearing officer, of his decision and reasons therefor. Failure to provide decision and notification thereof within forty-five (45) days after the conclusion of the hearing shall have the effect of a finding that the proposal is in conformity with the standards, criteria, and plans. Such decision shall be published through local newspapers and public information channels.

12. Effect of Decision of Hearing Officer--The decision of the hearing officer, shall, to the extent that it reverses or revises the findings or recommendations of the Designated Planning Agency, supersede the findings and recommendations of that agency: provided that, where judicial review of such decision is obtained; the final decision of the reviewing court, to the extent that it modifies the findings and recommendations of the Designated Planning Agency, shall to such extent constitute the findings and recommendations of the DPA.

13. Further Action by DPA--To the extent that, the hearing officer's decision requires further action by the DPA, such action must be completed by the date specified by the hearing officer. Failure to complete the action by the date specified has the effect of a positive finding.

14. Compensation of Hearing Officer and Costs of Hearing--Compensation of the Hearing Officer and payment of costs of the hearing will be made from funds within the Budget of the DPA.

15. Fair Hearing Procedures Under--Section 1122 of the Social Security Act and Part 81, Federal Regulations require that projects recommended for reimbursement of capital expenditures must be consistent with State and Areawide Health Facility Plans. Therefore, it is anticipated that the majority of applications given an adverse recommendation will be those proposing beds and/or services in excess of the programming in the Plans. As provided elsewhere, the Applicant may request a revision of the pertinent State Plan according to procedures set forth in the Plan. Applicants who, after completion of the procedures for revision of the Plan, may request a Fair Hearing on the decision not to revise that Plan.

16. Informal Hearing--The Board will afford the Applicant an informal hearing at any of its regular monthly meetings provided the request is made not later than seven (7) days prior to the meeting date.

17. Local Agency Request for Fair--If the DPA reverses the decision of a local agency, the local agency may not receive a fair hearing under Section 1122 procedures. Hearings are, under Federal Regulations, available only to the provider or applicant. However, the participation by the local agency in the decision making process should provide the local agency with an adequate opportunity to express its views and recommendations. If further recourse is desired, the local agency will have the opportunity for an informal hearing. It should be noted that an informal hearing following the decision of the DPA would not have any bearing on the decision. Such hearings would be effective in determining future policy and guidelines.

CHAPTER V REIMBURSEMENTS AND BUDGET

1. Reimbursement to DPA--Pursuant to the basic disbursement formula delineated in Section 100.110, Federal Regulations, the Department of Health, Education and Welfare will reimburse the DPA for costs of agency review. Areawide Health Planning agencies are referred to Section 100.110, Federal Regulations and to Section IX-a, DPA Manual for the allocation formula. Funds received by DPA will be allocated to the 314(b) agencies according to criteria set forth in this chapter.

2. Information Required of 314(a) Agency--The 314(a) Agency will submit each year to DHEW, (1) their total expenditures for carrying out the provisions of Sections 314(a) and 314(b) of the Public Health Service Act, and (2) the amount of such expenditures which were expended for the purposes of cost containment. The most favorable of the two expenditures will be used for determining the basis of reimbursement to the DPA.

3. Reimbursement to Partnership Agencies--Subject to receipt of a budget, the DPA will retain 30% of funds received from DHEW and will distribute the remaining 70% to the Areawide Planning Agencies according to the percent of the State Population which it serves.

4. Percentage of Population in Each Planning Region--

July 1, 1972

District Estimated Population % of State

1-Appalachia 687,400 25.8

2-Upper Savannah 156,500 5.9

3-Catawba 196,600 7.4

4-Central Midlands 385,100 14.4

5-Lower Savannah 215,000 8.1

6-Wateree 161,800 6.1

7-Pee Dee 265,200 9.9

8-Waccamaw 146,600 5.5

9-Charleston Area 342,200 12.8

10-Lowcounty 109,300 4.1

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State Total 2,665,000

Sum of individual

counties 2,665,700 100.0

Source: Division of Research and Statistical Services, preliminary estimates--1972.

Notes: Sum of individual counties may not equal state total due to independent rounding of county estimates. Denominator for percent was sum of individual county population.

5. Records and Accounts--The DPA will maintain such fiscal, statistical and other records as the Secretary, DHEW, may direct for a period of not less than 5 years from the date of preparation of any such record. The DPA will require the 314(b) Agencies to maintain similar records and accounts. All records and accounts of the DPA and any other agency performing any function under Section 1122 shall make such records available to the Secretary as he may direct.

6. DPA Budget Required--As a prerequisite for reimbursement for activities performed under Section 1122 of the Social Security Act, the DPA will submit an annual budget to DHEW. The budget will be prepared in two parts: (1) Total budget summary for the Agency to include amounts and sources of revenue, and (2) detailed budget relating to cost containment (review and findings activities). The cost containment budget will be used as justification for reimbursement and will include the following information:

A. Functional Areas: administration, review and comment, planning, etc.

B. Personnel: Name, designation, compensation by base salary, fringe benefits, projected increases.

C. Fair Hearings: Compensation for the Hearing Officer, court recorder and transcription, and other expenses.

D. Other Expenditures: travel, contractual expenses, supplies, etc.

7. Activities Not Eligible for Reimbursement--Although administration and development of health facility plans may be considered items of cost containment, such costs will not be eligible for reimbursement. Only actual costs incurred in connection with the review and comment procedures will be eligible for reimbursement.

61-7. Emergency Medical Services.

(Statutory Authority: S.C. Code Ann. Sections 44-61-30 and 44-78-65 (1976 Code of Laws, as amended))

Table of Contents

Section 100. PURPOSE AND SCOPE

Section 101. Scope of ACT 1118 of 1974 as Amended.

Section 200. DEFINITIONS.

Section 201. Definitions as Stated in the Act.

Section 300. ENFORCING REGULATIONS.

Section 301. General.

Section 302. Inspections/Investigations.

Section 303. Enforcement Actions.

Section 304. Violation Classifications.

Section 400. LICENSING PROCEDURES.

Section 401. Application.

Section 402. Medical Control Physician. (I)

Section 403. Licensing Basic Life Support. (II)

Section 404. Licensing Intermediate Life Support. (II)

Section 405. Licensing Advanced Life Support. (II)

Section 406. Licensing Special Purpose Ambulance Providers. (II)

Section 407. Advanced Life Support Information. (II)

Section 408. Advertising Level of Care.

Section 409. Criteria for License Category - EMT First Responder. (II)

Section 500. PERMITS, AMBULANCE. (I)

Section 501. Vehicle and Equipment.

Section 600. STANDARDS FOR AMBULANCE PERMITS.

Section 601. Ambulance Design and Equipment.

Section 700. EQUIPMENT (II).

Section 701. Minimum Ambulance Medical Equipment.

Section 702. Intermediate and Advanced Equipment.

Section 703. Minimum Ambulance Rescue Equipment.

Section 704. Convalescent Transport Units.

Section 705. Special Purpose Ambulance Equipment.

Section 706. EMT First Responder Equipment.

Section 800. SANITATION STANDARDS FOR LICENSED PROVIDERS.

Section 801. Exterior Surfaces.

Section 802. Interior Surfaces - Ambulance.

Section 803. Linen.

Section 804. Oxygen Administration Apparatus. (II)

Section 805. Resuscitation Equipment. (II)

Section 806. Suction Unit.

Section 807. Splints.

Section 808. Stretchers, and Spine Boards.

Section 809. Bandages and Dressings. (II)

Section 810. Obstetrical Kits. (II)

Section 811. Oropharyngeal Appliances. (II)

Section 812. Communicable Diseases. (II)

Section 813. Miscellaneous Equipment.

Section 814. Equipment and Materials Storage Areas.

Section 815. Personnel.

Section 900. TRAINING AND CERTIFICATION

Section 901. Emergency Medical Technician Training Programs. (II)

Section 902. Certification. (I)

Section 903. Application for Certification as an Emergency Medical

Technician-Basic.

Section 904. Application for Certification as an Emergency Medical

Technician-Intermediate or Paramedic.

Section 905. Recertification as an Emergency Medical Technician-Basic.

Section 906. Recertification as an Emergency Medical

Technician-Intermediate or Paramedic.

Section 907. EMT Course Approval. (II)

Section 908. EMT Instructor Training Programs and Certification.

Section 1000. PERSONNEL REQUIREMENTS. (I)

Section 1100. REVOCATION OR SUSPENSION OF CERTIFICATES OF EMTs. (I)

Section 1200. AIR AMBULANCES.

Section 1201. Licensing. (I)

Section 1202. Basic Life Support Air Ambulance, Medical Equipment

Requirements.(II)

Section 1203. Interfacility and Special Purpose Air Ambulance. (II)

Section 1204. Advanced Life Support Air Ambulance Medical Equipment

Requirements. (II)

Section 1205. Medication and Fluids for Advanced Life Support Ambulances.

(II)

Section 1206. Rescue Exception. (II)

Section 1300. PATIENT CARE REPORTS.

Section 1301. Forms Control Officer.

Section 1302. Content.

Section 1303. Report Maintenance.

Section 1400. DO NOT RESUSCITATE ORDER.

Section 1401. Purpose and Authority of Emergency Medical Services Do Not

Resuscitate Order.

Section 1402. Definitions.

Section 1403. General Provisions.

Section 1404. Revocations of EMS DNR Order.

Section 1405. Patient's Assessment and Intervention. (II)

Section 1406. Resuscitative Measures to be Withheld or Withdrawn. (II)

Section 1407. Procedures to Provide Palliative Treatment. (II)

Section 1408. DNR Information for the Patient, the Patient's Family, the

Health Care Provider and EMS Personnel. (II)

Section 1500. SEVERABILITY.

Section 1501 General.

Section 1600. GENERAL.

Section 1601. General.

Section 100. SCOPE AND PURPOSE

Section 101. SCOPE OF ACT 1118 OF 1974 AS AMENDED.

A. Establishment of EMS program.

B. General licensing, certification, inspection and training procedures.

C. Establishment of an Emergency Medical Service Council and duties of the Council.

D. Establishment of the Department of Health and Environmental Control authority for enforcement of these rules and regulations.

Section 200. DEFINITIONS.

Section 201. Definitions as stated in the Act.

A. Advanced Life Support (ALS): Treatment of life-threatening medical emergencies through the use of techniques such as endotracheal intubation, administration of drugs or intravenous fluids, cardiac monitoring, and electrical therapy by a qualified person pursuant to these regulations.

B. Advanced Life Support Service: A service provider that in addition to basic life support minimum standard, provides at least 2 EMT's, one of which is an EMT-Intermediate or Paramedic and demonstrates the capability to provide IV therapy, advanced airway care, approved drug therapy, cardiac monitoring and electrical therapy on 80% of all emergency calls.

C. Air ambulance: Any aircraft that is intended to be used for and is maintained or operated for transportation of persons who are sick, injured or otherwise incapacitated.

D. Basic Life Support Service: A service provider that meets all criteria for basic life support minimum standard and is able to provide one EMT-Basic to 100% of all calls.

E. Condition Requiring an Emergency Response: The sudden onset of a medical condition manifest by symptoms of such sufficient severity, including severe pain, that a prudent layperson who possesses an average knowledge of health and medicine could reasonably expect without medical attention, to result in:

1. Serious illness or disability;

2. Impairment of a bodily function;

3. Dysfunction of the body; or

4. Prolonged pain, psychiatric disturbance, or symptoms of withdrawal.

F. Continuing education: An educational program designed to update the knowledge and skills of its participants by attending conventions, seminars, workshops, educational classes, labs, symposiums, etc. Points toward recertification may be awarded for successful completion of approved activities.

G. Convalescent vehicle: A vehicle that is used for making nonemergency calls such as scheduled visits to a physician's office or hospital for treatment, routine physical examinations, x-rays or laboratory tests, or is used for transporting patients upon discharge from a hospital or nursing home to a hospital or nursing home or residence, or other nonemergency calls.

H. Emergency Transport: Services and transportation provided after the sudden onset of a medical condition manifesting itself by acute symptoms of such severity, including severe pain, that the absence of medical attention could reasonably be expected to result in the following:

1. Placing the patient's health in serious jeopardy;

2. Causing serious impairment to bodily functions; or

3. Causing serious dysfunction of bodily organ or part;

4. A situation that resulted from an accident, injury, acute illness, unconsciousness, or shock, for example, required oxygen or other emergency treatment, required the patient to remain immobile because of a fracture, stroke, heart attack, or severe hemorrhage.

I. EMT: Emergency Medical Technician. An individual possessing a valid basic, intermediate, or paramedic certificate issued by the State pursuant to the provisions of these Regulations.

J. EMT First Responder Service: A licensed agency providing medical care at the EMT-Basic level or above, as a nontransporting first responder.

K. FAA: Federal Aviation Administration. The agency of the federal government that governs aircraft design, operations, and personnel requirements.

L. Fixed Wing: Any aircraft that uses fixed wings to permit it to take off and fly.

M. Flight Nurse: A licensed registered nurse who is trained in all aspects of emergency care except roadside pickups and who has been so designated by the Department.

N. Intermediate Life Support Service: A service provider that, in addition to basic life support minimum standard, provides at least 2 EMT's, one of which is an EMT-Intermediate or EMT-Paramedic and demonstrates the capability to provide IV therapy and advanced airway care on 80% of all emergency calls.

O. Medical Control: Medical Control is usually provided by a unit's physician who is responsible for the care of the patient by the provider's medical attendants. Actual medical control may be direct by two-way voice communications (on-line) or indirect by standing orders or protocols (off-line) control.

P. Moral Turpitude: Behavior that is not in conformity with and is considered deviant by societal standards.

Q. Nonemergency Transport: Services and transportation provided to a patient whose condition is considered stable. A stable patient is one whose condition reasonably can be expected to remain the same throughout the transport and for whom none of the criteria for emergency transport has been met. Prearranged transports scheduled at the convenience of the service or medical facility will be classified as a nonemergency transport.

R. Off-Line Medical Control Physician: A provider's medical control physician who actually takes responsibility for treatment of patients in the prehospital setting, by standing orders or protocols.

S. On-Line Medical Control Physician: The physician who directly communicates with EMT's regarding appropriate patient care procedures en-route. An on-line medical control physician must be available for all EMT's performing procedures designated as such by the Department.

T. Revocation: The Department has permanently voided a license, permit, or certificate and the holder no longer may perform the function associated with the license, permit, or certificate. The Department will not reissue the license, permit, or certificate for a period of two years for a license or permit and three years for a certificate. At the end of this period, the holder may petition the Department for reinstatement.

U. Rotocraft: A helicopter or other aircraft that uses a rotary blade to permit vertical and horizontal flight without the use of wings.

V. Special purpose ambulance: An ambulance equipped and designated to transport only patients in need of specialized types of care. Examples include neonatal ambulances, cardiac-care ambulances, etc.

W. Suspension: The Department has temporarily voided a license, permit, or certificate and the holder may not perform the function associated with the license, permit, or certificate until the holder has complied with the statutory requirements and other conditions imposed by the Department.

X. The Department: The administrative agency known as the South Carolina Department of Health and Environmental Control.

Section 300. ENFORCING REGULATIONS.

Section 301. General.

A. The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding an EMT, training facility, instructor, or provider in order to enforce these regulations.

B. The Department reserves the right to make exceptions to these regulations where it is determined that the health and welfare of those being served would be compromised.

Section 302. Inspections/Investigations.

A. An inspection shall be conducted prior to initial licensing of a provider and subsequent inspections conducted as deemed appropriate by the Department.

B. All providers, EMTs, training facilities, and instructors are subject to inspection or investigation at any time without prior notice by individuals authorized by the Department.

C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, equipment, and records, and have the authority to require that entity to make photocopies of those documents required in the course of inspections or investigations. Photocopies shall be used for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings.

Section 303. Enforcement Actions.

When the Department determines that an EMT, provider, instructor, or training facility is in violation of any statutory provision, rule, or regulation relating to the duties therein, the Department may, upon proper notice to that entity, impose a monetary penalty and/or deny, suspend, and/or revoke its certification, license, or authorization.

Section 304. Violation Classifications.

Violations of standards in this regulation are classified as follows:

A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of the persons being served or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods, operations, or lack thereof may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time established by the Department may be considered a subsequent violation.

B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety or well-being of those being served. The citation of a Class II violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation.

C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation.

D. The notations "(I)" or "(II)", placed within sections of this regulation, indicate that those standards are considered Class I or II violations, if they are not met, respectively. Standards not so annotated are considered Class III violations.

E. In arriving at a decision to take enforcement actions, the Department shall consider the following factors: specific conditions and their impact or potential impact on the health, safety, or well-being of those being served; efforts by the EMT, provider, training facility or instructor to correct cited violations; behavior of the entity in violation that reflects negatively on that entity's character, such as illegal or illicit activities; overall conditions; history of compliance; and any other pertinent factors that may be applicable to current statutes and regulations.

F. When a decision is made to impose monetary penalties, the following schedule shall be used as a guide to determine the dollar amount:

Frequency of violation of standard within a 36-month period:

MONETARY PENALTY RANGES

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FREQUENCY CLASS I CLASS II CLASS III

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1^st $300 - 500 $100 - 300 $50 - 100

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2^nd $500 - 1,500 $300 - 500 $100 - 300

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3^rd $1,000 - 3,000 $500 - 1,500 $300 - 800

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4^th $2,000 - 5,000 $1,000 - 3,000 $500 -1,500

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5^th $5,000 - 7,500 $2,000 - 5,000 $1,000 - 3,000

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6^th or more $10,000 $7,500 $2,000 - 5,000

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G. Any enforcement action taken by the Department may be appealed pursuant to the Administrative Procedures Act beginning with Section 1-23-310.

Section 400. LICENSING PROCEDURES.

Section 401. Application.

A. Application for license shall be made to the Department by private firms, public entities, volunteer groups or non-federal governmental agencies. The application shall be made upon forms in accordance with procedures established by the Department and shall contain the following:

1. The name and address of the owner of the licensed provider or proposed licensed provider;

2. The name under which the applicant is doing business or proposes to do business;

3. A description of each ambulance, including the make, model, year of manufacture or other distinguishing characteristics to be used to designate applicant's vehicle.

4. The location and description of the place or places from which the licensed provider is intended to operate. The Department shall be notified within five (5) working days of any expansion of the service or if the headquarters, director or any substation locations are changed.

5. Personnel roster showing EMT's name, address, certification number and expiration date.

6. Type of license applied for.

7. Name, address, and phone number of medical control physician.

8. Name, fax, e-mail, and phone number of person in charge of day-to-day operations.

9. Number of units and level of service provided from each transporting station.

10. Insurance information, to include name of insurance company, agent, phone number and type of coverage. A copy of insurance policy(s) shall be furnished to the Department upon request. The minimum limits of coverage shall be $1,000,000 liability and $500,000 malpractice per occurrence.

11. A copy of current Drug Enforcement Agency license, when applicable.

12. Such other information as the Department shall deem reasonable and necessary to a fair determination of compliance with this regulation.

B. The Department shall issue a license valid for a period of two (2) years when it is determined that all the requirements of this regulation have been met. If disapproved, the applicant may appeal in a manner pursuant to the Administrative Procedures Act beginning with Section 1-23-310.

C. Subsequent to issuance of any license, the Department shall cause to be inspected each licensed provider (ambulances, equipment, personnel, records, premises, and operational procedures) whenever that service is initially licensed. Thereafter, services will be inspected by the Department on a random basis with a percentage of permitted ambulances inspected. These random inspections will be conducted dependent upon past compliance history.

1. Pursuant to Section 44-61-70 of the Code, the following fine schedule shall be used when a permitted ambulance or licensed first responder service loses points upon reinspection:

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Point Value of Item as Delineated on Inspection Report Fine for Each Item

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2 $15.00

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3 $25.00

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6 $50.00

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9 $75.00

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12 $100.00

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D. The Department is herein authorized, pursuant to Section 44-61-70 of the Code, to suspend or revoke a license so issued at any time it determines that the holder no longer meets the requirements prescribed for operating as a licensed provider.

E. Renewal of any license issued under the provision of this Act shall require conformance with all the requirements of this Act as upon original licensing.

F. The Department shall be notified within five (5) working days when changes of ownership of a licensed provider are impending or occur so that a new license may be issued.

G. The issuance of a license shall not be construed so as to authorize any person, firm, corporation, or association to provide EMT first responder services or ambulance services or to operate any ambulance not in conformity with any ordinance or regulation enacted by any county, municipality or special purpose district or authority.

H. The Department reserves the right to make exceptions to these standards where it is determined that the health and welfare of the community requires the services of the provider. When an "exception" applies to an existing provider, it will continue to meet the standards in effect at the time it was licensed.

I. Conditions which have not been covered in these regulations shall be handled in accordance with the standard practices as interpreted by the Department.

Section 402. Medical Control Physician. (I)

Each licensed provider that provides patient care shall retain a medical control physician to maintain quality control of the care provided, whose functions include the following:

A. Quality assurance of patient care including development of protocols, standing orders, training, policies, and procedures; and approval of medications and techniques permitted for field use by direct observation, field instruction, in-service training or other means including, but not limited to:

1. Patient care report review;

2. Review of field communications tapes;

3. Post-run interviews and case conferences;

4. Investigation of complaints or incident report.

B. The medical control physician shall serve as medical authority for the licensed provider, to perform in liaison with the medical community, medical facilities, and governmental entities.

C. The medical control physician may have disciplinary authority sufficient to oversee the quality of patient care for all EMT's and retain other responsibilities as may be negotiated by agreement with the service.

D. Providers will register their medical control physician with the Department and provide a copy of their current standing orders and authorized drug list signed and dated by medical control physician.

E. The Department must be notified of any change in medical control physician, drug list or standing orders within ten (10) days.

F. The medical control physician may withdraw at his/her discretion, the authorization for personnel to perform any or all patient care procedure(s).

G. All initial Medical Control Physicians must attend a Medical Control Physician Workshop conducted by the Department within 12 months of being designated Medical Control Physician. Failure to attend the above mentioned workshop will result in immediate dismissal from that position.

Section 403. Criteria for License Category of Basic Life Support (Ambulance).(II)

(Minimum Standard):

A. Must have ambulances that are permitted or can be permitted pursuant to these regulations.

B. Shall have no less than five (5) EMT's associated with the provider.

C. Must have staffing patterns, policy and procedure, and if necessary, mutual aid agreements to assure that an ambulance is en route with at least one EMT onboard to all emergent calls within five (5) minutes or the next closest staffed ambulance must be dispatched, excluding prearranged transports. (Minimum crew shall be one driver and one EMT.) Volunteer Services (services not utilizing paid personnel) without on site personnel must have staffing patterns, policy and procedure, and if necessary, mutual aid agreements to assure that an ambulance is en route with at least one EMT onboard to all emergent calls within ten (10) minutes or have the closest staffed ambulance dispatched. (Minimum crew shall be one driver and one EMT.)

1. Non-emergent transport services shall not utilize emergency lights and sirens to a call and shall not utilize lights and sirens from a call unless patient condition deteriorates while on scene or onboard the ambulance.

2. An exception to the above provision regarding utilization of emergency lights and sirens by non-emergent transport services shall be made only when non-emergent transport services are operating under the auspices of a mutual aid agreement with the local emergency transport provider or during a disaster situation.

D. The Department will, upon request, be furnished with staffing patterns, policy and procedure, and mutual aid agreements that assures compliance with the en route times noted in Section 403.C.

E. Industries that provide ambulance service for their employees may exempt the minimum number of EMT's noted in Section 403.B, as long as they meet en route times and staffing requirements of the regulations.

F. The provider maintains records that include, but are not limited to, approved ambulance run reports, employee / member rosters, time sheets, call rosters, training records and dispatch logs that show at least time call received, type call and time unit is en route. Such records are to be available for inspection by the Department with copies furnished upon request.

Section 404. Criteria for License Category - Intermediate Life Support: (Ambulance).(II)

To be categorized as an intermediate life support provider, the provider must meet all criteria established for basic life support, minimum standard. Additionally, the provider must demonstrate sufficient equipping and staffing capability to assure that life support consisting of at least IV therapy and advanced airway care are onboard the ambulance with two EMT's, one of which must be an Intermediate or Paramedic, at least 80% of the time on emergency calls. For initial applicants seeking licensure with no prior call history, category shall be determined by the Department on a case by case basis.

Section 405. Criteria for License Category - Advanced Life Support: (Ambulance).(II)

To be categorized as an advanced life support provider, the provider must meet all criteria established for basic life support, minimum standard. Additionally, the provider must demonstrate sufficient equipping and staffing capability to assure that life support consisting of IV therapy, advanced airway care, cardiac monitoring, electrical therapy and drug therapy, approved by the Department and the unit medical control physician, are onboard the ambulance with a minimum of two EMT's, one of which must be an EMT-Paramedic at least 80% of the time on emergency calls. For initial applicants seeking licensure with no prior call history, category shall be determined by the Department on a case by case basis.

Section 406. Criteria for License Category - Special Purpose Ambulance Provider: (Ambulance).(II)

A. Have an approved vehicle that is in compliance with Section 201.V of these regulations and meets minimum equipment requirements, as delineated in Section 705.

B. Have a medical control physician as delineated in Section 402 of these regulations.

C. Provide the Department with copies of policy and procedure for the operation of the special purpose ambulance.

D. Provide a list of special purpose equipment that is carried on the special purpose ambulance and is approved by the medical control physician for review and approval by the Department.

E. Provide other license information delineated in Section 401 of these regulations.

F. Except during extenuating circumstances, special purpose ambulances shall be used for interfacility transports only.

Section 407. Advanced Life Support Information. (II)

Ambulance service providers professing to provide advanced life support level of care for a patient must at all times transport an ALS patient in an ambulance which is fully equipped as an advanced life support unit, per these regulations, with an EMT-Paramedic, physician or RN, as delineated in these regulations, in the patient compartment.

Section 408. Advertising Level of Care.

Ambulance service providers may not advertise that they provide a level of life support above the category for which they are licensed.

Section 409. Criteria for License Category - EMT First Responder. (II)

A. Personnel assigned to First Responder duty must be currently certified EMT's with no less than five (5) EMT's associated with the provider.

B. Must have staffing patterns, policy and procedure, to assure that a First Responder unit is en route with at least one EMT to all emergent calls within five (5) minutes. Volunteer units (services not utilizing paid personnel) without on site personnel must have staffing patterns, policy and procedure to assure that a First Responder unit is en route with at least one EMT to all emergent calls within ten (10) minutes.

C. The Department will, upon request, be furnished with staffing patterns, policy and procedure to assure compliance with the en route times noted in Section 409.B.

D. The provider maintains records that include, but are not limited to, approved patient care report forms, employee/member rosters, time sheets, call rosters, training records and dispatch logs that show at least time call received, type call and time unit is en route. Such records are to be available for inspection by the Department with copies furnished upon request.

Section 500. PERMITS, AMBULANCE. (I)

Section 501. Vehicle and Equipment.

A. Before a permit may be issued for a vehicle to be operated as an ambulance, its registered owner must apply to the Department for an ambulance permit. Prior to issuing an original or renewal permit for an ambulance, the Department shall determine that the vehicle for which the permit is issued meets all requirements as to design, medical equipment, supplies and sanitation as set forth in these regulations of the Department. Prior to issuance of the original permit, if the ambulance does not meet all minimum requirements and loses points during the inspection, no permit will be issued.

B. Permits will be issued for specific ambulances and will be displayed on the lower left-hand corner of the windshield of the ambulance or in the aircraft portfolio, whichever is applicable.

C. No official entry made upon a permit may be defaced, altered, removed or obliterated.

D. Permits may be issued or suspended by the Department.

E. Permits must be returned to the Department when the ambulance or chassis is sold or removed from ambulance service.

Section 600. STANDARDS FOR AMBULANCE PERMIT.

Section 601. Ambulance Design and Equipment.

The following designs are hereby established as the minimum criteria for ambulances utilized in South Carolina and are effective with the publication of these regulations. Any emergency ambulance purchased after publication of these requirements must meet the following minimum criteria.

A. Based Unit: Chassis should not be less than three quarter ton. In the case of modular or other type body units, the chassis shall be proportionate to the body unit, weight and size; power train shall be compatible and matched to meet the performance criteria listed in the most current edition of the Federal KKK Specification; maximum effective sized tires; power steering; power brakes; heavy duty cooling system; heavy duty brakes; mirrors; heavy duty front and rear shock absorbers; 70 amp battery; 100 amp alternator; front end stabilizer; driver and passenger seat belts; padded dash; collapsible steering wheel; door locks for all doors; inside mirror; inside control handles on rear and side doors. Four-wheel drive is recommended for operating in mountainous area during winter months where snow and ice is prevalent, in rough terrain and at the seashores where traction in sand is difficult.

B. Color: There shall be no restrictions concerning the painted color of the ambulance.

C. Emblems and Markings: All items in this section shall be of reflective quality and in contrasting color to the exterior painted surface of the ambulance.

1. There shall be a continuous stripe, of not less than 3"' on cab and 6"' on patient compartment, to encircle the entire ambulance with the exclusion of the hood panel.

2. Emblems and markings shall be of the type, size and location as follows:

a. Front: The word "AMBULANCE", minimum of 4"' in height, shall be in mirror image (reverse reading) for mirror identification by drivers ahead, with a "Star of Life", minimum of 3"' height, to the left and right of the word "AMBULANCE." If vehicle design permits, there shall be a "Star of Life" of no less than 12"' in height on the front section of the patient compartment.

b. Side: Each side of the patient compartment shall have the "Star of Life" not less than 12"' in height. The word "AMBULANCE", not less than 6"' in height, shall be under or beside each star. The name of the licensee as stated on their provider's license shall be of lettering not less than 3"' in height.

c. Rear: The word "AMBULANCE", not less than 6"'in height, and two "Star of Life" emblems of not less than 12"' in height.

d. Top (roof): There shall be a "Star of Life" of not less than 32"' in height as well as the individual provider's ambulance number (example: unit "23") of not less than 12"'in height.

3. Prior to private sale of ambulance vehicles to the public, all emblems and markings in Section 601.C must be removed.

D. Interior Patient Compartment Dimensions:

1. Length: The compartment length shall provide a minimum of 25"' clear space at the head and 15"' at the foot of a 76"' stretcher. Minimum inside length will be 116"'.

2. Width: Minimum inside width is 69 inches.

3. Height: Inside height of patient compartment shall be a minimum dimension of 60"' from floor to ceiling.

E. Access to Vehicle:

1. Driver Compartment.

a. Driver's seat will have an adjustment to accommodate the 5th percentile to 95^th percentile adult male.*

*Note: This means that the driver's area will accommodate the male drivers who are 90% of the smallest and largest in stature, which includes weight and size.

b. There shall be a door on each side of the vehicle in the driver's compartment.

c. Separation from the patient area is essential to afford privacy for radio communication and to protect the driver from an unruly patient. Provision for both verbal and visual communication between driver and attendant will be provided by a sliding shatterproof glass partition at upper portion of partition. The bulkhead must be strong enough to support an attendant's seat in the patient area at the top of the patient's head and to withstand deceleration forces of the attendant in case of accident.

2. Patient Compartment:

a. There shall be a door on the right side of the patient compartment near the patient's head area of the compartment. The side door must permit a technician to position himself at the patient's head and quickly remove him from the side of the vehicle should the rear door become jammed.

b. Rear doors shall swing clear of the opening to permit full access to the patient's compartment.

c. All patient compartment doors shall incorporate a holding device to prevent the door closing unintentionally from wind or vibration. When doors are open the holding device shall not protrude into the access area. Special purpose ambulances are exempt as long as access/egress is not obstructed due to wheelchair ramps or other specialized equipment.

d. Spare tire storage shall be positioned such that the tire can be removed without disturbing the patient.

F. Interior Lighting:

1. Driver Compartment: Lighting must be available for both the driver and an attendant, if riding in the driving compartment, to read maps, records, etc. There must be shielding of the driver's area from the lights in the patient compartment.

2. Patient Compartment: Illumination must be adequate throughout the compartment and provide an intensity of 40-foot candles at the level of the patient for adequate observation of vital signs, such as skin color and pupillary reflex, and for care in transit. Lights should be controllable from the entrance door, the head of the patient, and the driver's compartment. Reduced lighting level may be provided by rheostat control of the compartment lighting or by a second system of low intensity lights.

G. Illumination Devices:

1. Illumination Devices: Flood and load lights - there shall be at least one flood light mounted not less than 75"' above the ground and unobstructed by open doors located on each side of the vehicle. A minimum of one flood light, with a minimum of 150 lumens equivalent, shall be mounted above the rear doors of the vehicle.

2. Warning lights - at a minimum alternating flashing red lights must be on the corners of the ambulance so as to provide 360° conspicuity.

3. Flares: Six red reflectorized or chemically induced illumination devices may be substituted for flares. Combustible type flares are not acceptable.

4. One set battery jumper cables, minimum 04 gauge copper, 600 amp rating.

H. Seats:

1. A seat for both driver and attendant will be provided in the driver's compartment with armrests on each side of driver's compartment.

2. Technician (Patient Compartment): two fixed seats, padded, 18"' wide 18"' high; to head of patient behind the driver, the other one may be square bench type located on curb (right) side of the vehicle. Space under the seats may be designed as storage compartments.

I. Safety Factors for Patient Compartment:

1. Stretcher Fasteners: Crash-stable fasteners must be provided to secure a primary and secondary stretcher.

2. Stretcher Restraint: If the stretcher is floor supported on its own support wheels, a means shall be provided to secure it in position under all conditions. These restraints shall permit quick attachment and detachment for quick transfer of patient.

3. Patient Restraint: A restraining device shall be provided to prevent longitudinal or transverse dislodgement of the patient during transit, or to restrain an unruly patient to prevent further injury or aggravation to the existing injury.

4. Safety Belts for Drivers and Attendants:

a. Quick-release safety belts will be provided for both driver and attendants, plus all seated patients (squad bench). These safety belts will be retractable and self-adjustable.

5. Mirrors:

a. There shall be two exterior rear view mirrors, one mounted on the left side of the vehicle and one mounted on the right side. Location of mounting must be such as to provide maximum rear vision from the driver's seated position.

b. There shall be an interior rear view mirror to provide the driver with a view of occurrences in the patient compartment.

6. Windshield Wipers and Washers:

a. Vehicle is to be equipped with two electrical windshield wipers and washers in addition to defrosting and defogging systems.

7. Sun Visors:

a. There shall be a sun visor for both driver and attendant.

J. Environmental Equipment: Driver/Patient Compartment.

1. Heating: Shall be capable of heating the compartment to a temperature of 75° F. within a reasonable period while driving in an ambient temperature of 0° F. It must be designed to recirculate inside air, also be capable of introducing 20% of outside air with minimum effect on inside temperature. Fresh air intake shall be located in the most practical contaminant-free air space on the vehicle.

2. Heating Control: Heating shall be thermostatically or manually controlled. The heater blower motors must be at least a three (3) speed design. Separate switches will be installed in patient compartment.

3. Air Conditioning: Air Conditioning shall have a capacity sufficient to lower the temperature in the driver's and patient's compartment to 75° F within a reasonable period and maintain that temperature while operating in an ambient temperature of 95° F. The unit must be designed to deliver 20% of fresh outside air of 95° F. ambient temperature while holding the inside temperature specified. All parts, equipment, workmanship, etc., shall be in keeping with accepted air conditioning practices.

4. Air Conditioning Controls: The unit air delivery control may be manual or thermostatic. The reheat type system is not required in the driver's compartment unit. Switches or other controls must be within easy reach of the driver in his normal driving position. Air delivery fan motor shall be at least a three (3) speed design. Switches and other control components must exceed in capacity the amperage and resistance requirements of the motors.

5. Insulation: The entire body, side, ends, roof, floor, and patient compartment doors shall be insulated to minimize conduction of heat, cold, or external noise entering the vehicle interior. The insulation shall be vermin and mildew-proof, fireproof, non-hygroscopic, non-setting type. Plywood floor when undercoated will be considered sufficient insulation for the floor area.

K. Storage Cabinets: All cabinets must meet the criteria as stated in the most current edition of the Federal KKK Specifications as to types of surfaces, design and storage. Cabinets must be of sufficient size and configuration to store all necessary equipment. All equipment must be accessible to attendant at all times.

L. Two-Way Radio Mobile: Two way radio mobile equipment shall be included which will provide a reliable system operating range of at least a 20 mile radius from the base station antenna. The mobile installation shall provide microphones for transmitting to at least medical control and receiving agencies, at both the driver's position and in the patient's compartment. Selectable speaker outputs, singly and in combination, shall be provided at the driver's position, in the patient's compartment, and through the PA system.

1. All radio frequencies utilized by a licensed service will be provided to the Department.

2. In the event technological advancements render the above components obsolete, the Department shall make determinations as to the efficacy of proposed technology on an individual basis prior to allowing their use.

M. Siren-Public Address: Siren and public address systems shall be provided. If a combined electronic siren and public address system is provided, in siren operation, the power output shall be 100 watts. In voice operation the power output shall be 45 watts through two exterior mounted speakers. The public address amplifier shall be independent of the mobile radio unit.

N. Antenna: Rooftop mounted with coaxial cable.

O. Glass Windows: All windows, windshield and door glass must be shatterproof.

Section 700. EQUIPMENT.(II)

Section 701. Minimum Ambulance Medical Equipment.

Effective the date of these Rules and Regulations, all ambulances will be required to be equipped with, but not limited to the following:

A. Minimum of two stretchers.

1. One multilevel, elevating, wheeled stretcher with elevating back. Two patient restraining straps (chest and thigh) minimum, at least two inches wide shall be provided.

2. One secondary patient transport stretcher, with a minimum of two patient restraining straps. Minimum acceptable stretcher is vinyl covered, aluminum frame, folding stretcher.

B. Suction Devices.

1. An engine vacuum operated or electrically powered, complete suction aspiration system, shall be installed permanently on board to provide for the primary patient. It shall have wide bore tubing.

2. A portable suction device, age and weight appropriate, with wide bore tubing and at least a six ounce reservoir.

3. There must be an assortment of suction catheters (minimum of 2 each) on board. Sizes 6 fr, 8 fr, 10 fr, 16 fr, 18 fr. A rigid suction catheter (e.g. Yankaur) will also be carried. Minimum 2 each.

C. Bag Mask Ventilation Units.

1. One adult, hand-operated. Valves must operate in all weather, and unit must be equipped to be capable of delivering 90-100% oxygen to the patient.

2. One pediatric, hand-operated. Valves must operate in all weather and unit must be equipped to be capable of delivering 90-100% oxygen to the patient. Must include safety pop off mechanism with override capability.

3. One infant, hand-operated. Valves must operate in all weather and unit must be equipped to be capable of delivering 90-100% oxygen to the patient. Must include safety pop-off mechanism with override capability.

4. The following sized masks will be carried aboard all permitted ambulances to be used in conjunction with the ventilation units above, 0,1,2,3,4,5. Masks must be clear. Either the disposable or non-disposable types are acceptable.

D. Nonmetallic Oropharyngeal (Berman type)/ Nasopharyngeal Airways - adult, child and infant sizes. All airways shall be clean and individually wrapped.

1. Large adult

2. Med. adult

3. Large child

4. Child

5. Infant

E. "S" tube type airways may not be substituted for Berman type airways.

F. Oxygen Equipment.

1. Portable oxygen equipment: Minimum "D" size (360 Liter) cylinder, two required (one full spare cylinder). Liter flow gauges shall be non-gravity, dependent (Bourdon Gauge) type. Additionally, when the vehicle is in motion, all oxygen cylinders shall be readily accessible and securely stored.

2. Permanent On-Board Oxygen Equipment: The ambulance shall have a hospital type piped oxygen system, capable of storing and supplying a minimum of 2400 liters of humidified medical oxygen.

3. Single use, individually wrapped, non-rebreather masks and cannulas in adult and pediatric sizes shall be provided (3 each).

4. A "no smoking" sign will be prominently displayed in the patient compartment.

G. Bite sticks commercially made. (Clean and individually wrapped).

H. Twelve sterile dressings (minimum size 5"' x 9"').

I. Thirty-six each sterile gauze pads 4"'x 4"'.

J. Twelve each bandages, self-adhering type, minimum three inches by five yards. Bandages must be individually wrapped or in clean containers.

K. A minimum of four commercial sterile occlusive dressings, four inches by four inches.

L. Adhesive Tape, hypoallergenic, one, two and three inches wide.

M. Burn sheets, two, sterile.

N. Splints:

1. Traction type, lower extremity, overall length of splint 43 inches, with limb support slings, padded ankle hitch, traction device and heel stand. Either the Bi-polar or Uni-polar type is acceptable.

2. Padded type, two or more, three feet long, of material comparable to four-ply wood for coadaptation splinting of the lower extremities.

3. Padded wooden type, two or more, 15 inches by three inches, for fractures of the upper extremity. (By local option, commercially available arm or leg splints may be substituted for items N-2,3 above).

O. Spinal immobilization devices:

1. Short spine board, at least 16 inches by 36 inches with appropriate straps. (Commercially available vest type KED, XP1 or other equivalent is acceptable.) Additionally: Child backboard or pedi-board or any type commercially available spinal immobilization device sized for the pediatric patient.

2. Long spine board, at least 16 inches by 72 inches constructed of three-quarter inch plyboard or equivalent material and having at least three quarter inch runners on each side for lifting with appropriate straps. If not equipped with runners, board must be designed so handholds are accessible even with gloves on.

3. Cervical collars to accommodate the infant, child, medium adult and large adult sizes. Collars must be manufactured of semirigid or rigid material.

4. Three, two inches by nine foot patient restraint straps.

5. Head immobilization device, commercially available or towel/blanket rolls.

P. Five each triangular bandages.

Q. Two blankets.

R. Bandage shears, large size.

S. Obstetrical kit, sterile. The kit shall contain gloves, scissors or surgical blades, umbilical cord clamps or tapes, dressings, towels, perinatal pad, bulb syringe and a receiving blanket for delivery of infant.

T. Blood pressure manometer, cuff and stethoscope.

1. Blood pressure set, portable, both pediatric and adult (non mercurial type).

2. Stethoscopes.

U. Emesis basin or commercially available emesis container.

V. Bedpan and urinal.

W. Two dependable flashlights or electric lanterns, minimum size, two-D-cell or six volt lanterns.

X. Minimum of one fire extinguisher, CO2 or dry chemical, five pound capacity, type ABC.

Y. Working gloves, two pair with leather palms and reflective vests for each crew member.

Z. Minimum of 1000 cc of sterile water or normal saline solution for irrigation.

AA. Protective head gear and eye protection devices (minimum two each) must be carried on each ambulance. Standard fire face shield not acceptable.

BB. Personal protective equipment (gloves, masks, gowns and eyeshields).

CC. At the option of the medical control the following equipment may be added:

1. Laryngoscope handle with batteries.

2. Laryngoscope blades, adult, child and infant sizes. Infant sizes shall be 0,1,2 (straight). In addition, a #2 curved blade will be carried.

3. Six disposable endotracheal tubes, sizes to be from 2.5-9.0 with at least one of each size available. An intubation stylette sized for the neonate patient shall also be available (6 fr.).

4. Dual Lumen or LMA airways, age and weight appropriate.

5. Magill Forceps.

a. Adult.

b. Pediatric.

Section 702. Intermediate and Advanced Equipment.

Ambulances providing intermediate and advanced life support must, in addition to meeting all other requirements of Section 701 must have the following equipment:

A. Butterfly or scalp vein needles between 19 and 25 gauge, a total of four. (Medical Control Option)

B. Four each 14, 16, 18, 22 , and 24 gauge IV cannulae.

C. Two Macro drip sets.

D. Two Micro drip sets.

E. Three 21 or 23 and three 25 gauge needles, total six. (Medical Control Option)

F. Three tourniquets.

G. Laryngoscope handle with batteries.

H. Laryngoscope blades, adult, child, and infant sizes. Infant sizes shall be 0,1,2 (straight). In addition, a #2 curved blade will be carried.

I. Six disposable endotracheal tubes sizes to be from 2.5-9.0 with at least one of each size available. An intubation stylette sized for the neonate patient shall also be available (6 fr.).

J. Equipment for drawing blood samples. (Medical Control Option)

K. Syringes, two each 1 ml, 3 ml, 10 ml, 20 ml, and one 50 ml.

L. Twelve (12) alcohol and iodine preps for preparing IV injection sites.

M. One (1) roll of tape, at least 1/2 inch wide.

N. Five (5) band-aids.

O. A minimum of 4 liters of normal saline or other appropriate IV solution.

P. Intraosseous devices.

1. Pediatric - minimum of two sizes.

2. Adult - (Medical Control Option) minimum of one size.

Q. Ambulances providing advanced cardiac life support must be equipped with a battery powered (DC) portable monitor-defibrillator unit, appropriate for both adult and pediatrics with ECG printout. The monitor-defibrillator equipment utilized by the service has the capability of producing hard copy of patient's ECG.

R. Such drugs/fluids as may be approved by the Board for possession and administration by EMT's trained and certified in their use and authorized by the medical control physician, as documented to the Department.

S. Magill Forceps.

1. Adult

2. Pediatric

T. Dual Lumen or LMA airways, age and weight appropriate.

U. Portable sharps container.

V. Pediatric length/weight-based drug dose chart or tape.

Section 703. Minimum Ambulance Rescue Equipment.

The following additional items will be carried by each ambulance:

A. Hammer, one four pound with 15 inch handle.

B. One axe.

C. Wrecking Bar, minimum 24-inch (bar and two preceding items can either be separate or combined as a forcible entry tool).

D. Crowbar, minimum 48"', with pinch point.

Section 704. Convalescent Transport Units. (II)

A. Convalescent transport units must meet the requirements of Section 701, minimum ambulance medical equipment, minus items C-3, H, K, M, Y.

B. Convalescent transport units are exempted from Section 703, minimum ambulance rescue/extrication equipment.

C. Convalescent transport units are required to be equipped with a radio that meets the requirements of Section 601-N (minus the PA system) whenever transporting a patient outside of its home county.

D. Convalescent transport units may not have any emergency markings, but shall display the words "Convalescent Transport" and the name of the licensee in letters a minimum of 3"' in height, on each side of the ambulance.

Section 705. Special Purpose Ambulance Equipment.

A. All special purpose ambulances will be equipped with at least the following items from Section 701 of these regulations: A-1, B, C(appropriate size), D, F, G, T, U, V, W, X in addition to special purpose equipment that is documented to the Department as delineated in Section 406. Item A-1 can be replaced by a specialized patient transfer device so long as there is a provision to safely secure the device in the special purpose ambulance.

B. Special purpose equipment as documented to the Department as delineated in Section 406 of these regulations must be on the special purpose ambulance when it is in use and is subject to inventory and inspection by the Department as provided for in Section 406 of these regulations.

Section 706. EMT First Responder Equipment.

A. The First Responder Agency's vehicle must be properly marked as to identify the vehicle as an emergency vehicle.

B. The First Responder Agency will provide a minimum of one EMT-Basic for each response.

C. All first responder vehicles will be equipped with at least the following items from Section 701 of these regulations:B-2, B-3, C, D, F-1, F-3, G, H, I, J, K, L, M, N-2, N-3, O, P(3each), Q, R, S, T, W(1each), X, Y, Z, BB, CC.

D. The first responder agency must at all times be able to communicate with (a) on-line medical control, (b) dispatch center and (c) the local transporting service.

E. Equipment In Addition to 706-C To Be Carried By EMT-Intermediate First Responders.

1. Four each, 14, 16, 18 and 22 gauge IV cannulae.

2. Two Macro Drip sets.

3. Two Micro Drip sets.

4. One Sharps type container.

5. A minimum of 4 liters of normal saline or other appropriate IV solution.

6. Three Tourniquets.

7. Twelve each, Alcohol and Betadine Preps for preparing IV injection sites.

8. Five Bandaids.

F. Equipment In Addition To 706.C & E To Be Carried By EMT-Paramedic First Responders.

1. A battery powered Monitor-Defibrillator, appropriate for both adults and pediatrics, capable of producing hard copy of the patient's ECG.

2. Such drugs/fluids as may be approved by the Board for possession and administration by EMT's trained and certified in their use and authorized by the medical control physician, as documented to the Department.

G. All medical and patient care equipment used by a licensed first responder organization shall meet the same standards for cleanliness and communicable diseases as is required of transporting EMS units.

Section 800. SANITATION STANDARDS FOR LICENSED PROVIDERS.

Section 801. Exterior Surfaces.

A. The exterior of the vehicle shall have a reasonably clean appearance.

B. All exterior lighting should be kept clear of foreign matter (insects, road grime, etc.) to assure adequate visibility.

Section 802. Interior Surfaces Patient Compartment-Ambulance.

A. Interior surface shall be of a nonporous material to allow ease of cleaning. Carpet-type materials shall not be used on any surface of the patient compartment.

B. Floors shall be free from sand, dirt and other residue that may have been tracked into the compartment.

C. Wall, cabinet, and bench surfaces shall be kept free of dust, sand, grease, or any other accumulated surface matter.

D. Interiors of cabinets and compartments shall be kept free from dust, moisture or other accumulated foreign matter.

E. Bloodstains, vomitus, feces, urine and other similar matter must be cleaned from the unit and all equipment after each call, using an agent or hypochlorite solution described in Section 802.H.

F. Window glass and cabinet doors shall be clean and free from foreign matter.

G. A receptacle shall be provided for the deposit of trash, litter, and all used items, etc.

H. An EPA recommended germicidal/viralcidal agent or a hypochlorite solution of 99 parts water and 1 part bleach must be used to clean patient contact areas. For surfaces where such an EPA solution is not recommended, alcohol or hypochlorite solution can be used.

I. A container specifically for the deposit of contaminated needles or syringes and a second container for contaminated or infectious waste shall be provided and will be easily accessible from the patient compartment.

Section 803. Linen.

A. Storage area for clean linens shall be provided in such configuration so that linens remain dry and clean. (Ambulance)

B. Freshly laundered or disposable linens (minimum of six sets) shall be used on stretchers and pillows, and shall be changed after each patient is transported. (Ambulance)

C. Soiled linen is to be transported in a closed plastic bag or container and removed from the ambulance as soon as possible.

D. Blankets and towels shall be clean and stored in such a manner to assure cleanliness.

1. Towels shall not be used more than once between laundering.

2. Blankets shall be laundered/cleaned as they become soiled. Blankets should preferably be of a hypoallergenic material designed for easy maintenance.

Section 804. Oxygen Administration Apparatus. (II)

A. Oxygen administration devices such as masks, cannulas, and delivery tubing shall be disposable.

B. All masks and cannulas and tubing shall be individually wrapped and not opened until used on a patient.

C. Once used, the masks, cannulas and tubing is to be disposed of and not reused.

D. Oxygen humidifiers should be filled with distilled or sterile water upon use only. Reusable humidifiers must be cleaned after each use. Disposable, single use humidifiers are acceptable in lieu of multiuse types.

Section 805. Resuscitation Equipment. (II)

A. Bag mask assemblies and masks shall be stored in the original container, jump kit, or a closed compartment to promote sanitation of the unit.

B. The bag mask assembly shall be free from dust, moisture and other foreign matter.

C. Masks, valves, reservoirs and other items or attachments for bag mask assemblies shall be cleaned and sanitized after each use. A ten (10) minute sodium hypochlorite soak ninety-nine (99) parts water to one (1) part bleach, or other acceptable method shall be used.

Section 806. Suction Unit.

A. Suction hoses shall be clean and free from foreign matter. Preferably, disposable type hoses should be used.

B. Suction reservoir shall be clean and dry.

C. Suction units shall be clean and free from dust, dirt or other foreign matter.

D. Tonsil tips and suction catheters shall be of the disposable type, stored in sterile packaging until used. Tonsil tips and suction catheters shall not be reused.

E. Suction units with attachments shall be cleaned and sanitized after each use. (See Section 805.C).

Section 807. Splints.

A. Padded splints shall be neatly covered with a nonpermeable material and clean. When the outside cover of the splint becomes soiled, they should be thoroughly cleaned and replaced.

B. Pneumatic trousers, if used, shall be clean and free from dust, dirt or other foreign matter.

C. Commercial splints shall be free of dust, dirt or other foreign matter.

D. Traction splints with commercial supports shall be clean and free from accumulated material.

E. All splinting materials must be stored in such a manner as to promote/maintain cleanliness.

Section 808. Stretchers and Spine Boards.

A. Pillows, mattresses and head immobilization devices (HIDs) shall be covered with a nonpermeable material and in good repair. (Single use items exempt.)

B. Stretchers, pillows, HIDs and spine boards shall be clean and free from foreign material.

C. Canvas or neoprene covers on portable type stretchers shall be in good repair.

D. All restraint straps/devices shall be kept clean and shall be washed immediately if soiled.

E. Wooden spine boards shall be sealed with an appropriate substance to facilitate cleaning.

F. All spine boards shall be free from rough edges/areas that may cause splinters.

Section 809. Bandages and Dressings. (II)

A. Bandages need not be sterile, but they must be clean. They should be individually wrapped, or stored in a closed container or cabinet to insure cleanliness.

B. Dressings must be sterile, individually packaged and sealed, and stored in a closed container or compartment. If the seal is broken or wrap is torn, the dressing is to be discarded.

C. Dressings or burn sheets that are not commercially wrapped must be sterilized in an autoclave or gas sterilizer, with the date of sterilization shown on each item. Items with a sealed plastic dust cover may remain on the unit no longer than six months without being resterilized or rotated with other sterile equipment. Cloth covered items must be resterilized or rotated at least every thirty (30) days.

D. Triangular bandages must be washed after each use if not the disposable type.

E. All bandages or dressings that have been exposed to moisture or otherwise have become soiled must be replaced.

Section 810. Obstetrical Kits. (II)

A. All OB kits must be sterile and wrapped with cellophane or plastic. If the wrapper is torn or the kit is opened but not used, the items in the kit that are not individually wrapped must be resterilized or discarded and replaced.

B. OB kits that are not commercially wrapped must be sterilized in an autoclave or gas sterilizer with a date of sterilization shown on the item. Items with a sealed plastic cover may remain on the unit no longer than six months without being resterilized or rotated at least every thirty (30) days.

Section 811. Oropharyngeal Appliances. (II)

Instruments inserted into a patient's mouth or nose shall be single service, individually wrapped and stored properly. Oropharyngeal airways designed for multi use shall be sterilized in an autoclave or gas sterilizer, Cidex or sodium hypochlorite soak (ninety-nine (99) parts water to one (1) part bleach) and individually wrapped.

Section 812. Communicable Diseases. (II)

A. When an ambulance or transport vehicle has been utilized in the transport of a patient known to have a communicable disease, the vehicle must be taken out of service until cleaning and disinfecting is completed.

B. Linen must be removed from the stretcher and properly disposed of, or immediately placed in a plastic bag or container and sealed until properly cleaned.

C. Patient contact areas, equipment and any surface soiled during the call, must be cleaned in accordance with Section 802.H of these guidelines.

Section 813. Miscellaneous Equipment.

Miscellaneous equipment such as scissors, stethoscopes, BP cuffs and/or other items used for direct patient care should be cleansed as they become soiled. Items should be kept clean and free from foreign matter.

Section 814. Equipment and Materials Storage Areas.

Equipment not used in direct patient care shall be in storage spaces that prevent contamination/damage to direct patient care equipment or materials.

Section 815. Personnel.

A. All personnel functioning on the vehicle shall present themselves in a clean, neat appearance at all times.

B. Hands and forearms should be thoroughly washed according to Standard 1910.1030 set forth by the Occupational Safety and Health Administration (OSHA).

C. Uniforms/clothing should be neat, clean or changed if they become soiled or exposed to vomitus, blood or other foreign matter.

Section 900. TRAINING AND CERTIFICATION.

Section 901. Emergency Medical Technician Training Programs. (II)

A. Emergency Medical Technician-Basic Training Program - This program is established by the Department and is only conducted in approved local technical colleges, colleges, vocational schools, and regional EMS training offices. The curriculum for this training program is the Department of Transportation curriculum for EMT's or any other curriculum approved by the Department.

B. Emergency Medical Technician-Intermediate Training Program - This program is established by the Department to provide a level of care between the basic and Paramedic programs and is only conducted in approved local technical colleges, colleges, vocational schools, and regional EMS training offices. The curriculum for this training program is the Department of Transportation curriculum for EMT-Intermediate or any other curriculum approved by the Department.

C. The Emergency Medical Technician-Paramedic Training Program - The curriculum for this training program is the Department of Transportation curriculum for EMT-Paramedic or any other EMT-Paramedic training program as developed or established and approved by the Department and is only conducted in approved local technical colleges, colleges, vocational schools, and regional EMS training offices.

D. Candidates may complete their required refresher training program by one of the following methods:

1. Complete the state approved EMT-Basic, EMT-Intermediate, or EMT-Paramedic refresher course as appropriate to the individual certification level, including the state approved practical and written examination.

2. Complete refresher course requirements by attending state approved C.E. unit lectures and/or seminars that equate to the regular structured refresher courses, including the state approved practical and written examination.

3. Complete the state approved in-service training program that meets the requirements of the Department, including the state approved practical and written examination. In-service training program requirements include, medical control physician participation and supervision of the service's program. Participation includes development of the service's in-service training program to meet the Department requirements and the needs of the individual service.

4. EXCEPTIONS - Candidates may exempt the state written and/or practical examinations if they meet the following criteria:

a. Candidates that complete the state approved in-service program may, if otherwise qualified, exempt the practical examination if the medical control physician signs a statement indicating the individual is competent in all the skills published by the Department for the level of EMT certification the candidate is recertifying. Candidates may also exempt the written examination if the medical control physician signs a statement indicating they are knowledgeable, proficient, and capable of performing all of the duties for the level of EMT certification they are recertifying.

b. Candidates that are nationally reregistered may exempt the state written and practical examinations.

E. Criteria for Special Purpose EMT. In order to be issued a valid special purpose EMT certificate, one must meet all of the following criteria:

1. The special purpose EMT must be a registered nurse.

2. The special purpose EMT must have completed an acceptable training program for delivery of the special area or possess experience in that special care area satisfactory to the Department.

3. The special purpose EMT must be employed by the medical service which utilizes the special purpose ambulance and recommended by the director of the medical service which utilizes a special purpose ambulance.

4. The medical service by which the special purpose EMT is employed must have operational procedures and medical protocols directing the daily operations of the special purpose EMT and special purpose ambulance. These medical protocols must be in written form, approved and signed by the director of the medical service in order for the special purpose EMT to administer medical treatment required by the protocols.

F. Pilot Programs. The Department may authorize providers to initiate pilot programs which provide training in new and innovative procedures that have potential for lifesaving care. Those who wish to initiate a pilot program must provide in writing to the Department a detailed proposal of the program and any supporting materials. Under no circumstances shall pilot programs be initiated without prior approval by the Department. The EMT's who participate in these programs are allowed to perform the pilot procedures, under medical control physician supervision, during the period of the pilot program. At the conclusion of the pilot program a report must be submitted to the Department describing the outcome/results of the program. Research gained from the pilot programs will be used to revise and upgrade existing EMT programs and scope of practice.

G. Department approved Advanced Training Centers in existence prior to the effective date of these regulations shall continue to provide EMT training in accordance with the provisions of this article.

Section 902. Certification.(I)

A. No persons shall act or serve in the capacity of primary patient care attendant in an ambulance without first completing, minimally, an approved Emergency Medical Technician-Basic Training Program and holding a South Carolina certificate as an emergency medical technician-Basic. Emergency medical technician-Basic certificates are in force for three years and are subject to renewal before expiration date if the candidate continues to meet state qualification. Certified emergency medical technician-Basic may perform those functions taught in the approved EMT Basic curriculum. Emergency medical technician-Basic certificates may be issued to eligible personnel, eighteen years of age or older, upon the satisfactory completion of any of the following requirements:

1. Any person completing the Department approved "Emergency Medical Technician-Basic Course" (to include examination), or ...

2. Any person who has successfully passed the written and practical portions of the "National Registry of Emergency Medical Technician-Basic" examination and other requirements established by the Department, and is currently registered, (applies to initial State certification only) "These candidates are exempt from the state practical and written certification examinations," or ...

3. Any person who receives comparable training within three years of their application. Comparable course credit may be determined by submitting copies of course certification and content to the Department for review. Comparable course credit is normally allotted to selected individuals completing extensive emergency courses, such as RNs and United States armed forces medical personnel. These personnel must complete and pass the appropriate state approved refresher course and satisfactorily pass the State or National Registry approved practical and written emergency medical technician examinations.

4. Special Purpose EMT Qualifications. The Department may issue a valid special purpose EMT certificate to those registered nurses who are both extensively trained in a particular special area of care and approved by the Department to attend patients needing that particular care while being transported in special purposes ambulances. These special purpose EMT's may be assisted by other health professionals who are determined qualified and approved by the Department to assist in attendance of the patient during transportation in a special purpose ambulance.

B. Emergency Medical Technician-Intermediate or Paramedic - No person shall act in the capacity of an emergency medical technician-Intermediate or Paramedic without satisfactorily completing an approved emergency medical technician Intermediate or Paramedic training course and holding a South Carolina certificate. EMT-Intermediate or Paramedic certificates are in force for three years and subject to renewal if the candidate continues to meet State qualifications. Appropriate certificates will be issued to candidates who satisfactorily complete an EMT-Intermediate or Paramedic program approved by the Department.

C. Guidance for EMT's - All currently certified emergency medical technicians may only "engage in those practices for which they have been trained" in the state approved curriculum and for which the supervising physician will assume responsibility. In all cases, an EMT will perform procedures under the supervision of a physician licensed in the State of South Carolina. Means of supervision should be direct, by standing orders or by radio and telephone communications.

D. Emergency medical technicians (Intermediate and Paramedic levels only) whose certificates have expired may be reactivated by the candidate completing an appropriate EMT refresher course and submitting an application for certification prior to taking state examinations. Emergency medical technicians at the Basic level whose certificate has expired may only be reactivated by completing all necessary requirements to become Nationally Registered.

E. Emergency medical technician must notify the Department each time they have change of address and furthermore, provider associated EMT's will provide their correct address on the personnel roster required in Section 401.A.5 of these regulations each time their provider submits a license or relicensure application.

F. All initial EMT certifications (Basic, Intermediate, Paramedic) must maintain a National Registry credential to be certified and recertified in South Carolina.

G. The Department may deny certification to applicants with certain past felony convictions and to those who are under felony indictment. Applications for certification of individuals convicted of or under indictment for the following crimes will be denied in all cases*:

1. Felonies involving criminal sexual conduct;

2. Felonies involving the physical or sexual abuse of children, the elderly, or the infirm including, but not limited to, criminal sexual misconduct with a child, making or distributing child pornography or using a child in a sexual display, incest involving a child, assault on a vulnerable adult;

3. A crime in which the victim is a patient or resident of a healthcare facility, including abuse, neglect, theft from, or financial exploitation of a person entrusted to the care or protection of the applicant.

*Applications from individuals convicted of, or under indictment for, other offenses not listed above will be reviewed by the Department on a case by case basis.

Section 903. Application for Certification as an Emergency Medical Technician-Basic.

A. Applications for certification as an Emergency Medical Technician-Basic in South Carolina are to be submitted to the Department, indicating that the student has satisfactorily completed the required curriculum to include any required clinical experience. Reciprocity candidates must provide a copy of their out-of-state certificate that has at least six months remaining on it prior to its expiration date, and have met other requirements as established by the Department. Candidates holding an out of state certificate will be issued a provisional South Carolina certification that expires on the date of their out-of-state certificate, or up to but not exceeding 1 year, whichever is less. During their provisional status, the candidate must become Nationally Registered to be recertified in South Carolina. National Registry candidates requesting initial reciprocity will receive a South Carolina Certification, providing they have a certificate that has at least six months remaining on it prior to its expiration date and have met other requirements as established by the Department.

B. Upon receipt of the completed application, practical and written examinations will be given at such times as will be scheduled by the Department. An emergency medical technician-Basic certificate will be issued by the Department upon satisfactory completion of the state approved practical and written examinations, and will be effective for three years from the date of issue. A pocket ID card will be issued along with the Basic certificate and must be in the possession of the EMT-Basic at all times that patient care is rendered.

Section 904. Application for Certification as an Emergency Medical Technician-Intermediate or Paramedic.

A. Applications for certification as an EMT-Intermediate or Paramedic in South Carolina are to be submitted to the Department, using forms provided by the Department as follows:

1. Candidates completing a South Carolina approved course must provide a certificate application card that indicates satisfactory completion of the course.

2. Candidates applying for certification by reciprocity must provide a certificate application card along with a copy of their out-of-state certificate that has at least six months remaining on it prior to its expiration date and have met other requirements as established by the Department. They must also provide statements from a South Carolina licensed provider and the unit medical control physician indicating sponsorship. Candidates holding an out of state certificate will be issued a provisional South Carolina certification that expires on the date of their out-of-state certificate, or up to but not exceeding 1 year, whichever is less. During their provisional status, the candidate must become Nationally Registered to be recertified in South Carolina. National Registry EMT-Intermediate or Paramedic candidates requesting reciprocity, will receive a South Carolina certification providing they have a certificate that has at least six months remaining on it prior to its expiration date and have met other requirements as established by the Department.

B. Candidates that meet the requirements in "A." above will be permitted to take the state approved examinations. Candidates that pass the state approved examinations will then be issued an intermediate or paramedic EMT certificate as appropriate by the Department which will be effective for three years. A pocket ID card will be issued along with the EMT-Intermediate or Paramedic certificate and must be in the possession of the EMT-Intermediate or Paramedic at all times that patient care is rendered.

Section 905. Recertification as a Emergency Medical Technician-Basic.

A. Recertification as an emergency medical technician-Basic within a 12-month period prior to the expiration date of the EMT-Basic certificate, each emergency medical technician-Basic is required to submit an application for recertification, indicating completion of an approved EMT-Basic refresher course, CEUs or state approved in-service training program, to qualify for recertification. Upon receipt of this application, the Department will schedule and conduct the practical and written examination, as necessary. Upon satisfactory completion of the practical and written examinations, the Department will extend the individual's EMT-Basic certification for another three-year period of time.

B. All initial EMT certifications (Basic, Intermediate, Paramedic) must maintain a National Registry credential to be certified and recertified in South Carolina.

Section 906. Recertification as an EMT-Intermediate or Paramedic.

Each EMT-intermediate or paramedic must do the following prior to their certificate expiring in a three-year period:

A. Submit an application for recertification to the Department requesting recertification. Application to include:

1. Signed statement from licensed provider's medical control physician indicating he will sponsor and supervise the candidate.

2. Signed statement from the licensed provider's director indicating the candidate is a functioning member of the service. Provides documentation that he has the required continuing education points, refresher course completion certificate or in-service EMT training completion record as appropriate.

3. Pass the state practical and written examination. Candidates completing in-service training may with concurrence of the medical control physician, exempt the practical and/or written state examinations.

B. Upon successful completion of the above requirements, the Department will renew the applicant's EMT-intermediate or paramedic certificate, as appropriate, for another three-year period.

C. All initial EMT certifications (Basic, Intermediate, Paramedic) must maintain a National Registry credential to be certified and recertified in South Carolina.

Section 907. Emergency Medical Technician Course Approval Regulations. (II)

A. All EMT courses at all levels, conducted by EMS regional offices or local technical colleges or vocational centers, or colleges must be taught by EMT instructors certified and approved by the Department for the level they are teaching.

B. All EMS training institutions must receive prior approval from the Department prior to starting any course.

C. All licensed providers who wish to conduct approved in-service training program must receive prior approval of the Department and follow the established guidelines of the program.

Section 908. Emergency Medical Technician Instructor Training Programs and Certification.

A. The Department is responsible for the review and approval of all EMT instructor courses. Instructors that meet the requirements and satisfactorily complete the Department approved instructor's course, will be certified by the Department. Certification will coincide with the EMT certification date.

B. Emergency Medical Technician - Basic Instructor Training Program and Authorization. Requirements for authorization as an initial EMT-Basic instructor are as follows:

1. Be twenty-one years of age or older with a high school diploma or GED.

2. Must be currently certified Paramedic with 1 year of experience as an EMT-Paramedic.

3. Complete the Department approved EMS instructor course.

4. Be recommended by a teaching institution that sponsors EMT-Basic courses.

5. Provide the Department with an approved and current CPR instructor card.

6. Meet all other requirements as determined by the Department.

C. The Department is responsible for certification of EMT-Intermediate and Paramedic Instructors who must meet the following qualifications:

1. Be a registered nurse with experience and knowledge in critical care areas; OR be a current South Carolina and Nationally Registered EMT-Paramedic with 5 years experience, high school or GED, and be twenty-one years of age or older.

2. Meet all instructor requirements in areas such as Pediatrics, Trauma and Cardiology as determined by the Department.

3. Be recommended by a teaching institution that sponsors EMT-Intermediate or Paramedic courses.

4. Provide the Department with a copy of an approved and current CPR instructor card.

5. Meet all other requirements as determined by the Department.

6. Complete the Department approved EMS instructor course.

D. Instructor certificates may be renewed as follows:

1. Must provide a letter of endorsement from the teaching institution.

2. Be currently certified as a South Carolina and Nationally Registered EMT-Paramedic.

3. Provide the Department with a copy of an approved and current CPR instructor card.

4. Have met all teaching requirements as determined by the Department.

5. Participate in 12 hours of Department approved continuing education in Instructor Methodology during the 3 year certification period.

6. Meet all other requirements as determined by the Department.

E. An EMT Instructor authorization may be suspended or revoked for any of the following reasons:

1. Any act of misconduct as outlined in Section 1100 of these regulations.

2. Suspension or revocation of the holder's EMT certificate.

3. Failure to maintain required credentials necessary for instructor designation.

4. Any act of proven sexual harassment toward another instructor or candidate.

5. Use of profane, obscene or vulgar language while in the presence of candidates or the EMT program coordinator during the context of class or related functions.

6. Conducting class without the minimum required equipment available and in working condition.

7. The use of any curricula not approved by the Department.

8. Gross or repeated violations of policy pertaining to the EMT training program.

9. Multiple instructor reprimands within a given period of time as established by the Department.

10. Any other actions determined by the Department that compromises the integrity of the program. Those actions may include, but are not limited to the following:

a. An instructor who places himself/herself in a situation which will embarrass or bring unfavorable notoriety to himself/herself or the training institution.

b. Unprofessional behavior in the classroom.

c. Failure to notify the EMT program coordinator when classes must be cancelled or rescheduled.

d. Consistently starting class late or dismissing class early.

e. Conducting classes while under the influence of alcohol.

f. Conducting classes while under the influence of drugs that negatively impair your ability to instruct (prescribed, non-prescribed, or illegal).

g. Falsification of any documents pertaining to the course. (attendance logs, equipment checklists, etc.)

h. Repeated poor class results on the written and/or practical portion(s) of candidate examinations.

Section 1000. PERSONNEL REQUIREMENTS. (I)

A. During the transportation of patients, there shall be an emergency medical technician-Basic, intermediate or paramedic in the patient compartment at all times. The crew member with the highest level of certification shall determine which crew member will attend the patient during transport. If advanced life support procedures are in use, the responsible EMT-intermediate or paramedic shall attend the patient in the patient compartment during transport.

B. Exception: Transferring or receiving medical facilities registered nurses are authorized as ground ambulance attendants when assisting emergency medical technicians in the performance of their duties when all of the following requirements are met:

1. The medical care of the patient is beyond the limit of certification of the EMT.

2. When the ambulance transport is between medical facilities or from medical facility to patient's home.

3. When the responsible physician, transferring or receiving, assumes responsibility of the patient and provides appropriate orders, written preferred, to the registered nurse for patient care.

4. The registered nurse is on duty with the appropriate medical facility during the ambulance transport.

C. No person under the age of eighteen shall operate any emergency vehicle owned or operated by the licensed provider.

D. No person shall act or serve in the capacity of attending a patient while under felony indictment or with certain past felony convictions as listed in Section 902.G of these regulations.

E. All licensed providers must notify the Department immediately should they become aware of a felony indictment or conviction of any person on their roster.

Section 1100. REVOCATION OR SUSPENSION OF CERTIFICATES OF EMERGENCY MEDICAL TECHNICIANS. (I)

A. The Department shall, upon receiving a complaint of misconduct as herein defined, initiate an investigation to determine whether or not suitable cause exists to take action against the holder of an emergency medical technician certificate.

1. The initial complaint shall be in the form of a brief statement, dated and signed by the person making the complaint, which shall identify the person or service who is the subject of the complaint and contain a summary as to the nature of the complaint. The Department is also authorized to initiate an investigation based upon information acquired from other sources.

2. Information received by the Department through inspection, complaint or otherwise authorized under S.C. Code, Section 44-61-10, et.seq., shall not be disclosed publicly except in a proceeding involving the question of licensing, certification or revocation of a license or certificate.

B. "Misconduct," which constitutes grounds for a revocation or suspension or other restriction of a certificate, shall be a satisfactory showing of any of the following:

1. That a false, fraudulent, or forged statement or document has been used, or any fraudulent, deceitful, or dishonest act has been practiced by the holder of a certificate in connection with any of the certification requirements or official documents required by the Department.

2. That, while holding a certificate, the holder is convicted of a felony or any other crime involving moral turpitude, drugs, or gross immorality.

3. That the holder of a certificate is addicted to alcohol or drugs to such a degree as to render him unfit to perform as an EMT.

4. That the holder of a certificate has sustained any physical or mental disability which renders further practice by him dangerous to the public.

5. That the holder of a certificate is guilty of obtaining fees or assisting obtaining such fees under dishonorable, false or fraudulent circumstances.

6. That the holder of a certificate is guilty of disregarding an appropriate order by a physician concerning emergency treatment and transportation.

7. That the holder of a certificate has, at the scene of an accident or illness, refused to administer emergency care on the grounds of age, sex, race, religion, creed or national origin of the patient.

8. That the holder of a certificate has, after initiating care of a patient at the scene of an accident or illness, discontinued such care or abandoned the patient without the patient's consent or without providing for the further administration of care by an equal or higher medical authority.

9. That a holder of a certificate has revealed confidences entrusted to him in the course of medical attendance, unless such revelation is required by law or is necessary in order to protect the welfare of the individual or the community.

10. That the holder of a certificate has, by action or omission and without mitigating circumstance, contributed to or furthered the injury or illness of a patient under his care.

11. That the holder of a certificate is guilty of the careless, or reckless, or irresponsible operation of an emergency vehicle.

12. That the holder of a certificate is guilty of a breach of any section of the Emergency Medical Services Act of South Carolina (Act 1118 of 1974) or any subsequent amendment of the Act or any of the Rules and Regulations published pursuant to the Act.

13. That the holder of a certificate has performed skills above the level for which he was certified or performed skills that he was not trained to do.

14. That the holder of a certificate did allow sub-standard care to be administered by another individual without documenting a supervisor being notified.

15. That the holder of a certificate has, by his actions, or inactions, created a substantial possibility that death or serious physical harm could result therefrom.

16. That the holder of a certificate has not taken or completed remedial training or other courses of action as directed by the Department as a result of an investigation.

17. That the holder of a certificate is found to be guilty of the falsification of any documentation as required by the Department.

C. The suspension or revocation of the emergency medical technician certificate shall include all levels of certification.

Section 1200. AIR AMBULANCES.

Section 1201. Licensing.(I)

It shall be unlawful for any ambulance service provider, agent or broker to secure or arrange for air ambulance service originating in the State of South Carolina unless such ambulance service meets the provisions of South Carolina Emergency Medical Services Law and Regulations.

A. Air Ambulance Licensing and Insurance Requirements:

1. Air ambulance licensing procedures are contained in Section 400 of these regulations. Air ambulance permit procedures are contained in Section 500 of these regulations. A permit is required for each aircraft.

2. As part of the licensing procedure, every air ambulance operator shall carry an air ambulance insurance policy. This policy shall cover malpractice, bodily injury and property damage with solvent and responsible insurers licensed to do business in the State of South Carolina. This policy shall provide payment for any loss or damage resulting from any occurrence arising out of or caused by the medical treatment or operation or use of any of the operator's aircraft. Each aircraft shall be insured for the sum of at least $1,000,000 for injuries to or death of any one person arising out of any one incident and the sum of at least $3,000,000 for injuries to or death of more than one person in any one incident. In addition, the provider shall carry at least $500,000 malpractice insurance. Every insurance policy or contract for such insurance shall provide for the payment and satisfaction of any financial judgment entered against the operator and present insured, or any person flying the insured aircraft. All such insurance shall provide for thirty-day cancellation notice to the Department.

B. Out-of-State Air Ambulances.

1. Out-of-state air ambulances transporting patients from locations in South Carolina must be licensed in their home state, if applicable. The medical attendant must be a basic or advanced EMT or have flight nurse who is certified in the home-ported state.

2. Out-of-state air ambulances operating in a state where no license is available must obtain a license in South Carolina and meet all requirements in Section 1200.

C. Air Ambulance Categories:

1. Interfacility Transport. Air ambulance services that transport patients receiving definitive care within the medical care system are those services which provide inter hospital, medical facility to hospital, hospital to other facility, or similar transports where the patients involved are transported from a definitive care medical setting. These transports may be accomplished by fixed-wing or rotary wing aircraft, and range from the transport of a critically ill patient requiring a sophisticated aircraft equipped with special care facilities, staff and supplies to the transport of a patient who has no special medical requirements. It is the responsibility of the medical director to insure that the level of patient care required in any given transport is adequate for that patient's medical needs.

2. Prehospital Transport. Air ambulance services that transport patients in the prehospital setting will be permitted as either an advanced or basic life support service and each prehospital service shall be required to meet the requirements and be licensed accordingly. Each such service shall contract with a medical control physician.

3. Special Purpose Ambulance. Air ambulances that meet the special purpose ambulance requirements.

D. Air Ambulance Aircraft Requirements. The aircraft operator shall, in all operations, comply with all federal aviation regulations which are adopted by reference, Part 135. The aircraft shall meet the following specifications:

1. Be configured in such a way that the medical attendants have adequate access for the provision of patient care within the cabin to give cardiopulmonary resuscitation and maintain patient's life support.

2. Allow loading of a supine patient by two attendants.

3. Have appropriate communication equipment to insure both internal crew and air to ground exchange of information between individuals and agencies appropriate to the mission, including at least medical control, air traffic control, and navigational aids.

4. Be equipped with radio headsets that insure internal crew communications and transmission to appropriate agencies.

5. Have adequate interior lighting, so that patient care can be given and patient status be monitored without interfering with the pilot's vision.

6. Have hooks and/or appropriate devices for hanging intravenous fluid bags.

7. Helicopters must have an external landing light and tail-rotor illumination.

8. Design must not compromise patient stability in either loading, unloading or in-flight operations.

9. Have factory installed or FAA approved add-on air conditioning which has the capacity to lower the temperature in the patient's compartment to 75° F within a reasonable period and maintain that temperature while operating in an ambient temperature of 95° F. All parts, equipment, workmanship, etc., shall be in keeping with accepted air conditioning practices.

E. Aircraft Flight Crew Manning Requirements. The aircraft operator shall, in all operations, comply with all federal aviation regulations which are adopted by reference, Part 135.

1. Rotor craft:

a. The pilot must possess commercial rotor craft certification and a minimum of 1,000 rotor craft flight hours as pilot in command and 50 hours of pilot in command flight time in helicopters within the 12 months prior to application for permitted air ambulance certification. Of this time during which the pilot is in command (referred to as "pilot in command time"), 25 hours must be in the same make and model of aircraft to be used in the proposed air ambulance operation.

b. The pilot must have received factory training or equivalent and must have at least five hours in the specific type of aircraft, before flying as pilot in command on patient missions.

c. The pilot must have received factory training or equivalent in flying over the types of terrain and under the conditions unique to the air ambulance flight program.

d. The pilot must be readily available within a defined call-up time to insure an expeditious and timely response.

e. The helicopter mechanic is vital to mission readiness and, as such, should possess at least two years of experience and must be a certified air frame and power plant mechanic.

f. The mechanic must be properly trained and FAA certified to maintain the aircraft designed by the flight service for its aeromedical program.

2. Fixed-Wing:

a. The pilot must possess a commercial pilot airplane license with a multi-engine land rating and a minimum of 1,000 flight hours as pilot in command and 50 hours of pilot in command flight time in multi-engine airplanes within the 12 months prior to application for permitted air ambulance certification.

b. If flying IFR, the pilot must possess an aircraft instrument rating with a minimum 50 hours of instrument flying time, to include no more than 20 hours in a ground simulator acceptable to the FAA.

c. The pilot must have received factory training or equivalent and must have at least five hours in the specific type of aircraft, before flying as pilot in command on patient missions.

d. The pilot must be readily available within a defined call-up time to insure an expeditious and timely response.

e. The mechanic is vital to mission readiness and must be a certified air frame and power plant mechanic.

f. The mechanic must be properly trained and FAA certified to maintain the aircraft designated by the flight service for its aeromedical program.

F. Off-Line Medical Control Physician (Medical Director). The off-line medical control physician of air ambulance services shall be responsible for:

1. Being knowledgeable of the capabilities and limitations of the aircraft used by his service.

2. Being knowledgeable of the medical staff's capability relative to the patient's needs.

3. Being knowledgeable of the routine and special medical equipment available to the service.

4. Ensuring that each patient is evaluated prior to a flight for the purpose of determining that appropriate aircraft, flight and medical crew and equipment are provided to meet the patient's needs.

5. Ensuring that all medical crew members are adequately trained to perform in-flight duties prior to functioning in an in-flight capacity.

6. All duties and responsibilities listed in these regulations.

G. Aircraft Medical Crew Requirements:

1. Each basic life support air ambulance must be staffed with at least one currently certified EMT.

2. Each advanced life support air ambulance must be staffed with at least one currently certified EMTParamedic or flight nurse as may be required by the patient's condition.

3. Each special purpose air ambulance must be staffed with at least one special purpose EMT, EMTParamedic or RN with specialty training, as approved by the Department.

H. Orientation Program:

1. All medical flight crew members must complete flight orientation program approved by the Department and supervised by the service's medical control physician.

2. The flight orientation program shall be of sufficient duration and substance to cover all patient care procedures, including altitude physiology, and flight crew requirements.

Section 1202. Basic Life Support Air Ambulance Medical Equipment Requirements. (II)

Each prehospital basic life support air ambulance shall be equipped with the following basic life support equipment:

A. There shall be one vinyl covered folding stretcher or acceptable equivalent with at least two patient restraint straps and stretcher fasteners for each patient (spine board is not acceptable). Stretcher fasteners must be bolted directly on the air frame of the aircraft.

B. Suction Device:

1. A portable suction device, age and weight appropriate, with wide bore tubing and at least a six ounce reservoir.

2. There must be an assortment of suction catheters (minimum of two each) on board. Sizes 6 fr, 8 fr, 10 fr, and 14 fr. A rigid suction catheter (e.g. Yankaur) will also be carried. Minimum, 2 each.

C. Bag Valve Ventilation Units:

1. One adult, hand operated. Valves must operate in all weather, and unit must be equipped to be capable of delivering 90-100% oxygen to the patient.

2. One pediatric, hand operated. Valves must operate in all weather and unit must be equipped to be capable of delivering 90-100% oxygen to the patient. Must include safety pop-off mechanism with override capability.

3. One infant, hand operated. Valves must operate in all weather and unit must be equipped to be capable of delivering 90-100% oxygen to the patient. Must include safety pop-off mechanism with override capability.

4. The following sized masks will be carried aboard all permitted ambulances to be used in conjunction with the ventilation units above, 0,1,2,3,4,5. Masks must be clear. Either the disposable or nondisposable types are acceptable.

D. Nonmetallic oropharyngeal (Berman type)/Nasopharyngeal airways: adult, child, and infant sizes. All airways shall be clean and individually wrapped.

1. Large adult

2. Medium adult

3. Large child

4. Child

5. Infant

E. "S" tube type airways may not be substituted for Berman type airways.

F. Fixed and portable oxygen equipment - The portable equipment should be: Minimum "D" size (360 liter) cylinder (one required), adequate tubing and semirigid valveless, transparent, single use, individually wrapped nonrebreather masks and nasal cannulas in adult and pediatric sizes, minimum of three each. In addition, a "No Smoking" sign with minimum one inch letter shall be displayed in the patient compartment. When the vehicle is in motion, all oxygen cylinders shall be affixed to a wall or floor with crash stable, quick release fittings. Liter flow gauge shall be non- gravity dependent (Bourdon gauge) type.

G. Bite stick commercially made. (Clean and individually wrapped.)

H. Six sterile dressings (minimum size 5"'x 9"') compactly folded and packaged.

I. Thirty-six each sterile gauze pads 4"'x 4"'.

J. Four each bandages, self-adhering tape, minimum three inches by five yards. Bandages must be individually wrapped or in clean containers.

K. A minimum of four commercial sterile occlusive dressing, 4"'x 4"'.

L. Adhesive tape, hypoallergenic, one, two, and three inches wide.

M. Burn sheets, two, sterile.

N. Splints:

1. Traction type, lower extremity splint. Uni-polar or bi-polar type is acceptable (Medical Control Option).

2. Padded, wooden type splints, two each, 15"'x 3"' and 36"'x 3"', or other approved commercially available splints for arm or leg fractures.

3. Pneumatic splints not acceptable.

O. Spine Boards:

1. Long, at least 16"'x 72"'. (The use of folding backboards is acceptable as a substitute for the long spine board.) (Medical Control Option)

2. Cervical collars. Small, medium, and large. (Each cervical collar should be manufactured with rigid or semi-rigid material) (Medical Control Option)

P. Triangular bandages, four each.

Q. Nine foot straps, three required.

R. Bandage shears, large size.

S. Obstetrical kit, sterile. The kit shall contain gloves, scissors or surgical blades, umbilical cord clamps or tapes, dressing, towels, perinatal pad, bulb syringe and a receiving blanket for delivery of infant. (Medical Control Option)

T. Blood pressure manometer, cuff and stethoscope.

1. Blood pressure set, portable, both adult and pediatric (non mercurial type).

2. Stethoscopes.

U. Emesis basin.

V. Bedpan and urinal. (Medical Control Option)

W. Two dependable flashlights or electric lanterns, minimum size, two "D" cell or six volt lanterns.

X. Minimum of one fire extinguisher, clean agent type, five pound capacity.

Y. Working gloves. (Medical Control Option)

Z. Minimum of 1000 cc of sterile water or normal saline for irrigation.

AA. Dual Lumen or LMA airways, age and weight appropriate.

BB. Magill forceps.

1. Adult.

2. Pediatric.

CC. Flame retardant uniform with reflective striping to be worn by each crew member.

Section 1203. Interfacility and Special Purpose Air Ambulances. (II)

All inter facility and special purpose air ambulances must be equipped with at least the following items from Section 1202:A, B, C, D, F, G, T, U, V, W, and X.

Section 1204. Advanced Life Support Air Ambulance Medical Equipment Requirements. (II)

Air ambulances providing advanced life support in the prehospital, interfacility or special purpose category must have the following equipment and supplies on board in addition to Section 1202:

A. Battery powered (DC) portable monitor-defibrillator unit, appropriate for both adults and pediatrics, with ECG printout. The monitor-defibrillator equipment utilized by the service has the capability of producing hard copy of patient's ECG.

B. Butterfly or scalp vein needles 26 gauge, total of two.

C. Two each 14, 16, 18, and 20 gauge IV cannula.

D. Two macro drip sets.

E. Two micro drip sets.

F. Three 21 or 23 and three 25 gauge needles, total six.

G. Three tourniquets.

H. Laryngoscope handle with batteries.

I. Laryngoscope blades, adult, child, and infant sizes. Sizes must include 0,1,2 straight and #2 curved.

J. Six disposable endotracheal tubes, assorted sizes (2.5-9.0). An intubation stylet sized for the pediatric patient will also be carried (6 fr.).

K. Suitable equipment and supplies for collection and temporary storage of two blood samples (Medical Control Option).

L. Syringes, two 1 ml, 3 ml, 10 ml, 20ml, and one 50 ml.

M. Backup power supply for all patient care devices carried.

N. Twelve (12) alcohol and iodine preps for preparing IV injection sites.

O. One (1) roll of tape.

P. Five (5) Band-Aids.

Q. Intraosseous needles in sizes 14, 18 ga. (1 each).

R. Four liters of normal saline or other appropriate IV solution.

S. Dual lumen or LMA airways, age and weight appropriate.

T. Magill forceps.

1. Adult.

2. Pediatric.

U. Sharps container.

V. Pediatric length/weight-based drug dose chart or tape.

Section 1205. Medication and Fluids for Advanced Life Support Air Ambulances. (II)

Such drugs and fluids approved by the Board for possession and administration by EMT's, and specified by the medical control physician, will be carried on the air ambulance. Drugs not included on the approved drug list for paramedics may be carried on board the air ambulance so long as there is a written protocol which is signed and dated by the medical control physician, for the use of the drug and delineates administration only by a registered nurse or physician.

Section 1206. Rescue Exception. (II)

A non-permitted aircraft may be used for occasional non routine missions, such as the rescue and transportation of victim/patients, who may or may not be ill or injured, from structures, depressions, water, cliffs, swamps or isolated scenes, when in the opinion of the rescuers or EMS provider present at the scene, such is the preferred method of rescue and transportation incident thereto due to the nature of the entrapment, condition of the victim, existence of an immediate life-threatening condition, roughness of terrain, time element and other pertinent factors:

A. Provided that after the initial rescue, an EMT or higher level EMS technician accompanies the victim-patient en-route with the necessary and appropriate EMS supplies needed for the en-route care of the specific injuries or illness involved.

B. Provided the aircraft is of adequate size and configuration to effectively make the rescue and to accommodate the victim-patient, attendant(s) and equipment.

C. Provided reasonable space is available inside the aircraft for continued victim-patient comfort and care.

D. Provided a permitted aircraft is not available within a reasonable distance response time; and

E. Provided the victim-patient is transferred to a higher level of EMS ground transportation for stabilization and transport if such ground unit is available at a reasonably safe landing area.

Section 1300. PATIENT CARE REPORTS.

Section 1301. Forms Control Officer.

A. Each licensed provider that provides patient care shall appoint a forms control officer to maintain supplies, ensure safe storage, edit to ensure accuracy, and provide monthly reporting to the Department.

B. The Department must be notified of any change in forms control officer within ten (10) days.

Section 1302. Content.

A. The format/design of the patient care report must be approved by the Department, including medium to be used.

B. Patient care reports shall reflect services, treatment, and care provided directly to the patient by the provider including, but not limited to; information required to properly identify the patient, a narrative description of the call from time of first patient contact to final destination, and other information as determined by the Department.

C. All entries shall be indelibly written, authenticated by the author, and dated.

Section 1303. Report Maintenance.

A. The licensed provider shall provide accommodations, space, supplies, and equipment adequate for the protection, security, and storage of patient care reports.

B. The Department copy of the patient care report shall be maintained by the Department for a period of no less than one (1) year. Licensed providers must maintain their copy of the patient care report for no less than ten (10) years on all adult patients and thirteen (13) years for pediatric patients. Reports shall be destroyed after this time period in accordance with state and federal laws.

C. Prior to closure of business, the licensed provider must arrange for preservation of patient care reports to ensure compliance with these regulations. The provider must notify the Department, in writing, describing these arrangements within ten (10) days of closure.

D. In the event of a change of ownership, all patient care reports shall be transferred to the new owner(s).

E. The patient care report is confidential. Reports containing protected or confidential health information shall be made available only to authorized individuals in accordance with state and federal laws.

F. The Department copy of the patient care report, to include "Page 2" and supplemental forms, shall be sent to the Department on or before the fifteenth (15^th) of the month following the close of a month along with a monthly summary as specified by the Department.

G. When patient care is transferred, the receiving agency shall receive their copy of the patient care report within a reasonable amount of time, preferably at the time of transfer, to ensure continuity in quality care.

H. Pursuant to Section 44-61-160 of the S.C. Code, a person who intentionally fails to comply with reporting, confidentiality, or disclosure of requirements in this section is subject to a civil penalty of not more than one hundred dollars for a violation of the first time a person fails to comply and not more than five thousand dollars for a subsequent violation.

Section 1400. DO NOT RESUSCITATE ORDER.

Section 1401. Purpose and Authority of Emergency Medical Services Do Not Resuscitate Order.

A. Title 44, Chapter 78 of the 1976 S.C. code as amended directs the Department to promulgate regulations necessary to provide directions to emergency medical personnel in identifying and honoring the wishes of patients who have executed a Do Not Resuscitate Order for Emergency Services. The Do Not Resuscitate Order for Emergency Services is commonly referred to as the EMS DNR law.

B. The EMS DNR law is applicable only to resuscitative attempts by EMS providers in the pre-hospital setting such as the declarant's home, a long-term care facility, during transport to or from a health care facility and in other locations outside of acute care hospitals.

C. Specific statutory authority is found in Section 44-78-65.

Section 1402. Definitions.

A. The definitions contained in S.C. Code Section 44-78-15 are hereby incorporated by reference.

B. Agent or Surrogate means a person appointed by the declarant under a Health Care Power of Attorney, executed or made in accordance with the provisions of Sec. 62-5-504 and/or Sec. 44-77-10.

C. Cardiac Arrest means the cessation of a functional heartbeat.

D. Cardiopulmonary Resuscitation or CPR means the use of artificial respirations to support restoration of functional breathing combined with closed chest massage to support restoration of a functional heart beat following cardiac arrest.

E. Department means the South Carolina Department of Health & Environmental Control.

F. Respiratory Arrest (Pulmonary Arrest) means cessation of functional breathing.

G. Do Not Resuscitate Order for Emergency Medical Services marker is a bracelet or necklace that is engraved with the patient's name, the health care provider's name and telephone number and the words "Do Not Resuscitate" or the letters DNR.

Section 1403. General Provisions.

A. The EMS DNR Form. The document which is to be a "Do Not Resuscitate Order" for EMS purposes must be in substantially the following form:

NOTICE TO EMS PERSONNEL

This notice is to inform all emergency medical personnel who may be called to render assistance to

__________

(Name of patient)

that he/she has a terminal condition which has been diagnosed by me and has specifically requested that no resuscitative efforts including artificial stimulation of the cardiopulmonary system by electrical, mechanical, or manual means be made in the event of cardio-pulmonary arrest.

REVOCATION PROCEDURE

THIS FORM MAY BE REVOKED BY AN ORAL STATEMENT BY THE PATIENT TO EMS PERSONNEL, OR BY MUTILATING, OBLITERATING, OR DESTROYING THE DOCUMENT IN ANY MANNER.

Date:__________

__________

Patient's Signature (or Surrogate or Agent)

__________

Physician's Signature

__________

Physician's Address

__________

Physician's Telephone Number

B. Distribution of the EMS DNR Form. The EMS DNR form, along with instructions for execution and a patient information sheet shall be distributed by the Department to health care providers. Informational pamphlets shall be prepared by the Department and made available to other interested parties upon request.

C. Location of the Executed EMS DNR Form. The executed EMS DNR Form shall be placed in a location where the document is easily observed and recognized by EMS personnel. The form shall be displayed in such a manner that it will be visible and protected at all times.

D. EMS DNR Marker. The DNR marker shall be a bracelet or necklace as approved by the Department. The marker may be worn upon the execution of the EMS DNR Document. Wearing of the marker shall not be mandatory but is encouraged. The marker will alert EMS personnel of the probable existence of the EMS DNR document. The marker shall be of metallic construction and shall be unique and easily recognizable. The marker shall contain the patient's name, the health care provider's name and telephone number and the words "Do Not Resuscitate" or the letters DNR.

Section 1404. Revocation of EMS DNR Order.

The EMS DNR Order may be revoked at anytime by the oral expression of the patient to EMS personnel or by the mutilation, obliteration or destruction of the document in any manner. If the order is revoked, EMS personnel shall perform full resuscitation and treatment of the patient.

Section 1405. Patient's Assessment and Intervention. (II)

When EMS Personnel report to a scene, they shall do a patient assessment. If an EMS DNR bracelet or necklace is found during the assessment, EMS personnel shall make a reasonable effort to determine that a EMS DNR form exists and to assure that the EMS DNR form applies to the person on which the assessment is being made. If no DNR form is found, resuscitative measure will be initiated. If after starting resuscitative measures a EMS DNR form is later found, resuscitative measure must be stopped.

Section 1406. Resuscitative Measures to be Withheld or Withdrawn. (II)

In the event that the patient has a valid EMS DNR order, the following procedures shall be withheld or withdrawn.

A. CPR

B. Endotracheal intubation and other advanced airway management

C. Artificial ventilation

D. Defibrillation

E. Cardiac resuscitation medication

F. Cardiac diagnostic monitoring

Section 1407. Procedures to Provide Palliative Treatment. (II)

The following treatment may be provided as appropriate to patients who have executed a valid EMS DNR order.

A. Suction

B. Oxygen

C. Pain medication

D. Non-cardiac resuscitation medication

E. Assistance in the maintenance of an open airway as long as such assistance does not include intubation or advanced airway management

F. Control of bleeding

G. Comfort care

H. Support to patient and family

Section 1408. DNR Information for the Patient, the Patient's Family, the Health Care Provider and EMS Personnel. (II)

A. Responsibilities of the patient or his/her Surrogate or agent.

The patient and his/her surrogate or agent shall:

1. Make all care givers aware of the location of the EMS DNR Form and ensure that the form is displayed in such a manner that it will be visible and available to EMS personnel.

2. Be aware of the consequences of refusing resuscitative measures.

3. Be aware that if the form is altered in any manner resuscitative measures will be initiated.

4. Understand that in all cases, supportive care will be provided to the patient.

B. Responsibilities of the Health Care Provider (Physician) The patient's physician:

1. Has determined that the patient has a terminal condition.

2. Has completed the patient's EMS DNR Form.

3. Has explained to the patient and family the consequences of withholding resuscitative care; the medical procedures that will be withheld and the palliative and supportive care that will be administrated to the patient.

C. Responsibilities of EMS Personnel

EMS personnel:

1. Will confirm the presence of the EMS DNR Form and the identity of the patient.

2. Upon finding an unaltered EMS DNR Form, will withhold or withdraw resuscitative measures such as CPR, endotracheal intubation or other advanced airway management, artificial ventilation, defibrillation, cardiac resuscitation medication and related procedures.

3. Will provide palliative and supportive treatment such as suctioning the airway, administration of oxygen, control of bleeding, provision of pain and non-cardiac medications, provide comfort care and provide emotional support for the patient and the patient's family.

4. Must have in his possession either the original or a copy of the DNR Order during transport of the patient.

Section 1500. Severability.

Section 1501. General.

In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect, as if such invalid portions were not originally a part of these regulations.

Section 1600. GENERAL.

Section 1601. General.

Conditions that have not been addressed in these regulations shall be managed in accordance with best practices as interpreted by the Department.

61-8. Vaccination, Screening and Immunization Regarding Contagious Diseases.

I. REQUIREMENTS FOR SCHOOL ADMITTANCE

A. No child shall be admitted to any public, private, or parochial school, grades kindergarten through twelve (K-12), or any child development program under the control of the Department of Education without first presenting a valid South Carolina Certificate of Immunization. To be valid, the South Carolina Certificate of Immunization must be signed by an individual licensed to practice medicine, surgery, or osteopathy or his/her authorized representative. "Admitted" as the term is used in this paragraph shall apply to all students grades kindergarten through twelve. Exemptions to this requirement are authorized in Section II of this regulation.

B. A South Carolina Certificate of Immunization needs to be presented to school officials only once. School officials shall record the immunization data on the student's school health record or attach a copy of the Certificate to the health record. Students who have previously submitted a South Carolina Certificate of Immunization are not required to submit another Certificate. Students previously admitted into any public, private, or parochial school with only a Conditional Certificate of Immunization must present a South Carolina Certificate of Immunization before being readmitted.

C. The standard which must be met to obtain a South Carolina Certificate of Immunization shall be the annually published schedule of required vaccinations, screening and immunizations for school admittance determined by the Department of Health and Environmental Control to be necessary to prevent the spread of contagious diseases. Except during emergency situations, the Department shall seek advice from the appropriate medical associations and academies in development of the schedule of required vaccinations, screening and immunizations. The schedule of required vaccinations, screening and immunizations shall be applicable for any child admitted during the school year immediately following the schedule's publication date unless otherwise stipulated by the Department of Health and Environmental Control in the annually published schedule.

D. Blank forms for the South Carolina Certificate of Immunization will be provided by the Department of Health and Environmental Control.

II. EXEMPTIONS

A. Students may be exempt from the immunization requirements of this regulation for the following reasons:

1. Medical Exemption.

(a) A South Carolina Certificate of Medical Exemption, signed by an individual licensed to practice medicine, surgery, or osteopathy, may be granted to a child when the physician has determined that a particular vaccine(s) required by this regulation is not advisable for the child. When it is determined that this particular vaccine(s) is no longer contraindicated, the child will be required to have the vaccine(s).

(b) A South Carolina Certificate of Medical Exemption, signed by an individual licensed to practice medicine, surgery, or osteopathy or his/her authorized representative, may be granted to a student who meets the requirements for medical exemption as stated in the schedule of required vaccinations, screening and immunizations published annually by the Department of Health and Environmental Control.

2. Religious Exemption. A South Carolina Certificate of Religious Exemption may be granted to any student whose parents, parent, guardian, or person in loco parentis signs the appropriate section of the South Carolina Certificate of Religious Exemption stating they are members of a recognized religious denomination in which the tenets and practices of the religious denomination conflict with immunizations.

3. Special Exemptions. A South Carolina Certificate of Special Exemption, signed by the school principal or his authorized representative, may be issued to transfer students while awaiting arrival of medical records from their former area of residence or to other students who have been unable to secure immunizations or documentation of immunizations already received. A South Carolina Certificate of Special Exemption may be issued only once and shall be valid for only thirty (30) calendar days from date of enrollment. At the expiration of this special exemption, the student must present a valid South Carolina Certificate of Immunization, or a valid South Carolina Certificate of Medical Exemption, or a valid South Carolina Certificate of Religious Exemption.

B. Blank forms for the South Carolina Certificate of Medical Exemption, South Carolina Certificate of Religious Exemption and South Carolina Certificate of Special Exemption will be provided by the Department of Health and Environmental Control.

III. REPORTING REQUIREMENTS.

Forty-five (45) calendar days after the beginning of each school year, school principals must submit to the local health department, on forms provided by the Department of Health and Environmental Control, the name of each student admitted to school with a South Carolina Certificate of Medical Exemption, a South Carolina Certificate of Religious Exemption, and a South Carolina Certificate of Special Exemption as provided in Section II of this regulation.

IV. COMPLIANCE.

Representatives of the Department of Health and Environmental Control shall have the authority to audit school records to insure compliance with this regulation.

V. EFFECTIVE DATE.

This regulation shall become effective upon successful completion of review by the General Assembly.

61-9. WATER POLLUTION CONTROL PERMITS.

(Statutory Authority: Sections 48-1-10 et seq. and Sections 48-14-10 et seq.)

Table of Contents
61-9.122. The National Pollutant Discharge Elimination System.
61-9.124. Procedures for Decision Making.
61-9.125. Criteria and Standards for the National Pollutant Discharge

Elimination System.
61-9.129. Toxic Pollutant Effluent Standards.
61-9.133. Secondary Treatment Regulation.
61-9.403. General Pretreatment Regulations for Existing and New Sources of Pollution.
61-9.503. Standards for the Use or Disposal of Sewage Sludge.
61-9.504. Standards for the Use or Disposal of Industrial Sludge.
61-9.505. Land Application Permits and State Permits.

61-9.122. The National Pollutant Discharge Elimination System.

Table of Contents

Part A--Definitions and General Program Requirements

Section

122.1 Purpose and scope.

122.2 Definitions.

122.3 Exclusions.

122.4 Prohibitions.

122.5 Effect of a permit.

122.6 Continuation of expiring permits.

122.7 Confidentiality of information.

Part B--Permit Application and Special NPDES Program Requirements

122.21 Application for a permit.

122.22 Signatories to permit applications and reports.

122.23 Concentrated animal feeding operations.

122.24 Concentrated aquatic animal production facilities.

122.25 Aquaculture projects.

122.26 Storm water discharges.

122.27 Silvicultural activities.

122.28 General permits.

122.29 New sources and new dischargers.

122.30 What are the objectives of the storm water regulations for small MS4s?

122.31 Indian Tribes.

122.32 Is an operator of a small MS4 regulated under the NPDES storm water program?

122.33 How does an operator of a regulated, small MS4 apply for an NPDES permit, and when must be apply?

122.34 As an operator of a regulated, small MS4, what will my NPDES MS4 storm water permit require?

122.35 May an operator of a regulated small MS4 share the responsibility to implement the minimum control measures with other entities?

122.36 As an operator of a regulated small MS4, what happens if I don't comply with the application or permit requirements in sections 122.33 through 122.35?

Part C--Permit Conditions

122.41 Conditions applicable to all permits.

122.42 Additional conditions applicable to specified categories of NPDES permits.

122.43 Establishing permit conditions.

122.44 Establishing limitations, standards and other permit conditions.

122.45 Calculating NPDES permit conditions.

122.46 Duration of permits.

122.47 Schedules of compliance.

122.48 Requirements for recording and reporting of monitoring results.

122.49 [Reserved]

122.50 Disposal of pollutants into publicly-owned treatment works.

Part D--Transfer, Modification, Revocation and Reissuance, and Termination of Permits

122.61 Transfer of permits.

122.62 Modification or revocation and reissuance of permits.

122.63 Minor modifications of permits.

122.64 Termination of permits.

APPENDIX A--NPDES Primary Industry Categories

APPENDIX B--[Reserved]

APPENDIX C--Criteria For Determining A Concentrated Aquatic Animal Production Facility (section 122.24)

APPENDIX D--NPDES Permit Application Testing Requirements (section 122.21) (Refer to 40 CFR Part 122, Appendix D)

APPENDIX E--Rainfall Zones Of The United States (Refer to 40 CFR Part 122, Appendix E)

APPENDIX F--Incorporated Places With Populations Greater Than 250,000 According To The 1990 Decennial Census By Bureau Of Census (Refer to 40 CFR Part 122, Appendix F)

APPENDIX G--Incorporated Places With Populations Greater Than 100,000 And Less Than 250,000 According To 1990 Decennial Census By Bureau Of Census (Refer to 40 CFR Part 122, Appendix G)

APPENDIX H--Counties With Unincorporated Urbanized Areas With A Population Of 250,000 Or More According To The 1990 Decennial Census By The Bureau Of Census (Refer to 40 CFR Part 122, Appendix H)

APPENDIX I--Counties With Unincorporated Urbanized Areas Greater Than 100,000, But Less Than 250,000 According To The 1990 Decennial Census By The Bureau Of Census (Refer to 40 CFR Part 122, Appendix I)

APPENDIX J--NPDES Permit Testing Requirements For Publicly Owned Treatment Works [section 122.21(j)]

(Statutory Authority: The Clean Water Act, 33 U.S.C. 1251 et seq. and the South Carolina Pollution Control Act, S.C. Code Ann. 48-1-10 et. seq.)

PART A--Definitions and General Program Requirements

122.1. Purpose and scope.

(a) Coverage

(1) The regulatory provisions contained in R.61-9.122 and 124 implement the National Pollutant Discharge Elimination System (NPDES) Program under sections 318, 402, and 405 of the Clean Water Act (CWA) (Public Law 92-500, as amended by Pub. L. 95-217, Pub. L. 95-576, Pub. L. 96-483, Pub. L. 97-117, and Pub. L. 100-4; 33 U.S.C. 1251 et seq.) and the South Carolina Pollution Control Act, S.C. Code Ann. 48-1-10, et seq.

(2) These provisions cover basic Department permitting requirements (122) and procedures for Department processing of permit applications and appeals (124).

(3) These provisions also establish the requirements for public participation in State permit issuance and enforcement and related variance proceedings.

(4) The NPDES permit program has separate, additional provisions that are used by the Department to determine what requirements must be placed in permits, if issued. These provisions are located at S.C. R61-9.125, 129, 133, and 503, 40 CFR 136, and 40 CFR subchapter N (parts 400 through 471).

(b) Scope of the NPDES permit requirement.

(1) The NPDES program requires permits for the discharge of "pollutants" from any "point source" into "waters of the State" and into "waters of the United States." The terms "pollutant", "point source", "waters of the State", and "waters of the United States" are defined in section 122.2.

(2) The permit program established under this part also applies to owners or operators of any treatment works treating domestic sewage, whether or not the treatment works is otherwise required to obtain an NPDES permit, unless all requirements implementing section 405(d) of the CWA applicable to the treatment works treating domestic sewage are included in a permit issued under the appropriate provisions of subtitle C of the Solid Waste Disposal Act, Part C of the Safe Drinking Water Act, the Marine Protection, Research, and Sanctuaries Act of 1972, or the Clean Air Act, or under a Land Application or State permit issued by the Department under R.61-9.505, as adequate to assure compliance with section 405 of the CWA.

(3) The Department may designate any person subject to the standards for sewage sludge use and disposal as a "treatment works treating domestic sewage" as defined in section 122.2, where it finds that a permit is necessary to protect public health and the environment from the adverse effects of sewage sludge or to ensure compliance with the technical standards for sludge use and disposal developed under CWA section 405(d). Any person designated as a "treatment works treating domestic sewage" shall submit an application for a permit under section 122.21 within 180 days of being notified by the Department that a permit is required. The Department's decision to designate a person as a "treatment works treating domestic sewage" under this paragraph shall be stated in the fact sheet for the permit.

(4) The following are point sources requiring NPDES permits for discharges:

(i) Concentrated animal feeding operations as defined in section 122.23;

(ii) Concentrated aquatic animal production facilities as defined in section 122.24;

(iii) Discharges into aquaculture projects as set forth in section 122.25;

(iv) Discharges of storm water as set forth in sections 122.26 and 122.30 through 36; and,

(v) Silvicultural point sources as defined in section 122.27.

(c) The Department may incorporate the requirements (either directly or by reference), for permits for the Use and Disposal of Sewage Sludge (see R.61-9.503), or the Use and Disposal of Industrial Sludge (see R.61-9.504) into NPDES permit(s) that may be issued to the applicant. A separate Land Application permit (see R.61-9.505) may be issued by the Department for the activities covered under R.61.9-503 or R.61-9.504, unless an NPDES permit is required for the activity.

(d) Relation to other requirements.

(1) Permit application forms. Applicants for permits must submit their applications on permit application forms designated by the Department. The basic information required in the general form (Form 1) and the additional information required by NPDES applications (Forms 2 a through e) are listed in section 122.21.

(2) Technical Regulations. The NPDES permit program has separate additional regulations. These separate regulations are used by the Department to determine what requirements must be placed in permits if they are issued. These separate regulations are located at R.61-9.125, 129, 133, and 403; 40 CFR Part 136; Subchapter N (40 CFR Parts 400 through 402 and 404 through 460); R.61-9.503, R.61-9.504 and R.61-9.505.

(e) Public participation. This part of the regulation (R.61-9.122) establishes the requirements for public participation in NPDES permit issuance and enforcement and related variance proceedings.

(f) [Reserved]

(g) Authority.

(1) Section 48-1-90(a), S.C. Code of Laws (1976), provides that "it shall be unlawful for any person, directly or indirectly, to throw, drain, run, allow to seep, or otherwise discharge into the environment of the State organic or inorganic matter, including sewage, industrial wastes and other wastes, except as in compliance with a permit issued by the Department." Section 301(a) of CWA provides that "Except as in compliance with this section and sections 302, 306, 307, 318, 402, and 404 of this Act, the discharge of any pollutant by any person shall be unlawful."

(2) Section 48-1-100(a), S.C. Code of Laws (1976), provides that "if, after appropriate public comment procedures, as defined by Department regulations, the Department finds that the discharge from the proposed outlet ... will not be in contravention of provisions of Chapter 1, Title 48, S.C. Code of Laws, a permit to construct and a permit to discharge must be issued to the applicant." Section 402(a)(1) of CWA provides in part that "The [Department] may, after opportunity for public hearing, issue a permit for the discharge of any pollutant, or combination of pollutants, ... upon condition that such discharge will meet either all applicable requirements under sections 301, 302, 306, 307, 308, and 403 of this Act, or prior to the taking of necessary implementing actions relating to all such requirements, such conditions as the [Department] determines are necessary to carry out the provisions of this Act."

(3) Section 318(a) of CWA provides that "The [Department] is authorized, after public hearings, to permit the discharge of a specific pollutant or pollutants under controlled conditions associated with an approved aquaculture project under Federal or State supervision pursuant to section 402 of this Act."

(4) Section 405 of CWA provides, in part, that "Where the disposal of sewage sludge resulting from the operation of a treatment works as defined in section 212 of this Act (including the removal of in-place sewage sludge from one location and its deposit at another location) would result in any pollutant from such sewage sludge entering the [waters of the State], such disposal is prohibited except in accordance with a permit issued by the [Department] under section 402 of this Act."

(5) Section 405(d)(4) of the CWA requires the Department, prior to promulgation of standards for sewage sludge use and disposal, to "impose conditions in permits issued to publicly owned treatment works under section 402 of this Act, or take such other measures as the [Department] deems appropriate to protect public health and the environment from any adverse effects which may occur from toxic pollutants in sewage sludge."

(6) Section 405(f) of CWA provides that NPDES permits must include requirements implementing the standards for sludge use and disposal (40 CFR Part 503) "unless such requirements have been included in a permit issued under the appropriate provisions of subtitle C of the Solid Waste Disposal Act, part C of the Safe Drinking Water Act, the Marine Protection, Research, and Sanctuaries Act of 1972, or the Clean Air Act, or under State [NPDES] permit programs approved by the Administrator...." Section 405(f) also authorizes the Department to issue permits with requirements for sludge use or disposal that assure compliance with 40 CFR Part 503 to any treatment works treating domestic sewage that is not subject to NPDES (i.e., has no point source discharge) and has not been issued a permit that includes applicable 40 CFR Part 503 standards under the other permit programs listed in section 405(f)(1) of the CWA.

(7) Sections 402(b), 318(b) and (c), and 405(c) and (f) of CWA authorize EPA approval of State NPDES permit programs for discharges from point sources, discharges to aquaculture projects, and use and disposal of sewage sludge.

(8) Section 304(i) of CWA provides that the Administrator shall promulgate guidelines establishing uniform application forms and other minimum requirements for the acquisition of information from dischargers in approved States and establishing minimum procedural and other elements of approved State NPDES programs.

(9) Section 48-1-40 authorizes the Department "after public hearing as herein provided, [to] adopt standards and determine what qualities of water ... shall indicate a polluted condition and these standards shall be promulgated and made a part of the rules and regulations of the Department." Section 48-1-50(22) authorizes the Department to "[r]equire the owner or operator of any ... disposal system to establish and maintain such operational records; make reports; install, use, and maintain monitoring equipment or methods; sample and analyze ... discharges in accordance with established methods, at locations, intervals, and procedures as the Department shall prescribe; and provide such other information as the Department reasonably may require." Section 48-1-50(23) authorizes the Department to "[a]dopt ... effluent control regulations, standards and limitations that are applicable to the entire State, that are applicable only within specified areas or zones of the State, or that are applicable only when a specified class of pollutant is present." Section 501(a) of CWA provides that "The [Department] is authorized to prescribe such regulations as are necessary to carry out [its] functions under this Act."

(10) Section 48-1-100(a) requires an opportunity for public comment before issuance of permits to discharge. Section 101(e) of CWA provides that "Public participation in the development, revision, and enforcement of any regulation, standard, effluent limitation, plan, or program established by the Administrator or any State under this Act shall be provided for, encouraged, and assisted by the Administrator and the States. The Administrator, in cooperation with the States, shall develop and publish regulations specifying minimum guidelines for public participation in such processes."

122.2. Definitions.

(a) The following definitions apply to this regulation, R.61-9.124, R.61-9.125, R.61-9.129, R.61-9.133, and R.61-9.403. Terms not defined in this section have the meaning given by the Clean Water Act (CWA) or the Pollution Control Act (PCA).

(b) Definitions:

"Administrator" means the Administrator of the Environmental Protection Agency or any employee of the Agency to whom the Administrator may by order delegate the authority to carry out his functions under section 307(a) of the CWA, or any person who shall by operation of law be authorized to carry out such functions.

Note: "Animal feeding operation" is defined at section 122.23.

"Applicable standards and limitations" means all State, interstate, and federal standards and limitations to which a discharge, a sewage sludge use or disposal practice, or a related activity is subject under the CWA, including effluent limitations, water quality standards, standards of performance, toxic effluent standards or prohibitions, best management practices, pretreatment standards, and standards for sewage sludge use or disposal under section 301, 302, 303, 304, 306, 307, 308, 403 or 405 of CWA.

"Applicant" means a person applying to the Department for a State or NPDES permit to discharge wastes into the waters of the State or to operate a treatment works.

"Application" means the uniform NPDES application form, including subsequent additions, revisions, or modifications thereof promulgated by the Administrator of EPA, and adopted for use by the Board or a State permit application form.

Note: "Aquaculture project" is defined at section 122.25.

"Average monthly discharge limitation" means the highest allowable average of daily discharges over a calendar month, calculated as the sum of all daily discharges measured during a calendar month divided by the number of daily discharges measured during that month.

"Average weekly discharge limitation" means the highest allowable average of daily discharges over a calendar week, calculated as the sum of all daily discharges measured during a calendar week divided by the number of daily discharges measured during that week.

"Best management practices" (BMP) means schedules of activities, prohibitions of practices, maintenance procedures, and other management practices to prevent or reduce the pollution of waters of the State. BMPs also include treatment requirements, operating procedures and practices to control plant site runoff, spillage or leaks, sludge or waste disposal, or drainage from raw material storage.

"BMP" means best management practices.

"Board" means the Board of Health and Environmental Control for the State of South Carolina and shall be inclusive of any agent designated by the Board to perform any function.

Note: "Bypass" is defined at section 122.41(m).

"CFR" means the Code of Federal Regulations, as amended.

"Class I sludge management facility" means any POTW identified under R.61-9.403.8(a), as being required to have an approved pretreatment program and any other treatment works treating domestic sewage classified as a Class I sludge management facility by the Regional Administrator in conjunction with the Department because of the potential for its sludge use or disposal practices to adversely affect public health and the environment.

"Code" means the South Carolina Code of 1976, as amended.

"Commissioner" means the Commissioner of the S.C. Department of Health and Environmental Control, or his designated representative.

Note: "Concentrated animal feeding operation" is defined at section 122.23.

Note: "Concentrated aquatic animal feeding operation" is defined at section 122.24.

"Contiguous zone" means the entire zone established by the United States under Article 24 of the Convention on the Territorial Sea and the Contiguous Zone.

"Continuous discharge" means a discharge which occurs without interruption throughout the operating hours of the facility, except for infrequent shutdowns for maintenance, process changes, or other similar activities.

"CWA" means the Clean Water Act (formerly referred to as the Federal Water Pollution Control Act or Federal Water Pollution Control Act Amendments of 1972) Pub. L. 92-500, as amended by Pub. L. 95-217, Pub. L. 95-576, Pub. L. 96-483, and Pub. L. 97-117, 33 U.S.C. 1251 et seq. Specific references to sections within the CWA will be according to Pub. L. 92-500 notation.

"CWA and regulations" means the Clean Water Act (CWA) and applicable regulations promulgated thereunder and includes State NPDES program requirements.

"Daily discharge" means the discharge of a pollutant measured during a calendar day or any 24-hour period that reasonably represents the calendar day for purposes of sampling. For pollutants with limitations expressed in units of mass, the daily discharge is calculated as the total mass of the pollutant discharged over the day. For pollutants with limitations expressed in other units of measurement, the daily discharge is calculated as the average measurement of the pollutant over the day.

"Department" means the S.C. Department of Health and Environmental Control and shall also be inclusive of those persons within the Department authorized by the Board to administer the NPDES program or take any action in behalf of the Board.

"Direct discharge" means the discharge of a pollutant.

"Discharge" means any discharge or discharge of any sewage, industrial wastes or other wastes into any of the waters of the State, whether treated or not.

"Discharge of a pollutant"

(1) means:

(i) Any addition of any pollutant or combination of pollutants to waters of the State from any point source, or

(ii) Any addition of any pollutant or combination of pollutants to the waters of the contiguous zone or the ocean from any point source other than a vessel or other floating craft which is being used as a means of transportation.

(2) includes additions of pollutants into waters of the State from: surface runoff which is collected or channelled by man; discharges through pipes, sewers, or other conveyances owned by a State, municipality, or other person which do not lead to a treatment works; and discharges through pipes, sewers, or other conveyances, leading into privately owned treatment works. This term does not include an addition of pollutants by any indirect discharger.

"Discharge Monitoring Report" (DMR) means the EPA uniform national form, including any subsequent additions, revisions, or modifications for the reporting of self-monitoring results by permittees, and modified to substitute the State Agency name, address, logo, and other similar information, as appropriate, in place of EPA's.

"Discharger" means any person who discharges any treated or untreated sewage, industrial wastes, or other wastes into any of the waters of the State.

"DMR" means Discharge Monitoring Report.

"Draft Permit" means a document prepared by the staff of the Department, in accordance with R.61-9.124.6, prior to public notice of an application for a permit by a discharger. This document indicates the Department's tentative decision to issue or deny, modify, revoke and reissue, terminate, or reissue a permit to discharge. It contains proposed effluent standards and limitations, proposed compliance schedules and other proposed conditions or restrictions deemed necessary by the Department for a discharge. A notice of intent to terminate a permit, and a notice of intent to deny a permit, as discussed in R.61-9.124.5, are types of draft permits. A denial of a request for modification, revocation and reissuance, or termination, as discussed in R.61-9.124.5, is not a draft permit. A "proposed permit" is not a draft permit.

"Effluent limitation" means any restriction imposed by the Department on quantities, discharge rates, and concentrations of pollutants which are discharged from point sources into waters of the State, the waters of the contiguous zone, or the ocean.

"Effluent limitations guidelines" means: A regulation published by the Administrator under section 304(b) of CWA to adopt or revise effluent limitations.

"Effluent standards and limitations" means restrictions or prohibitions of chemical, physical, biological, and other constituents which are discharged from point sources into State waters, including but not limited to, effluent limitations, standards of performance, toxic effluent standards and prohibitions, pretreatment standards and schedules of compliance.

"Environmental Protection Agency" (EPA) means the United States Environmental Protection Agency.

"EPA" means the United States Environmental Protection Agency.

"Facility or activity" means any NPDES point source or any other facility or activity (including land or appurtenances thereto) that is subject to regulation under the NPDES program.

"Fact sheet" means a description of a discharge available to the public prepared by the Department staff pursuant to the guidelines, which includes, but is not limited to, information on the location of the discharge, rate of frequency of the discharge, components of the discharge, proposed requirements of the Department regarding the discharge, the location and identification of uses of the receiving waters, water quality standards and procedures for formulation of final requirements on the discharge by the Department.

"Federal Act" means the Federal Water Pollution Control Act (CWA), as amended.

"General permit" means an NPDES permit issued under section 122.28 authorizing a category of discharges or activities under the PCA and CWA within a geographical area.

"Hazardous substance" means any substance designated under 40 CFR Part 116 pursuant to section 311 of CWA.

"Indian country" means:

(1) All land within the limits of any Indian reservation under the jurisdiction of the United States Government, notwithstanding the issuance of any patent, and, including rights-of-way running through the reservation;

(2) All dependent Indian communities within the borders of the United States whether within the originally or subsequently acquired territory thereof, and whether within or without the limits of a state; and

(3) All Indian allotments, the Indian titles to which have not been extinguished, including rights-of-way running through the same.

"Indirect discharger" means a non-domestic discharge introducing pollutants to a publicly owned treatment works.

"Industry" means a private person, corporation, firm, plant or establishment which discharges sewage, industrial wastes or other wastes into the waters of the State.

"Interstate agency" means an agency of two or more States established by or under an agreement or compact approved by the Congress, or any other agency of two or more States having substantial powers or duties pertaining to the control of pollution as determined and approved by the Administrator under the CWA and regulations.

"Mailing list" means a list of persons requesting notification and information on public hearings, permits and other NPDES forms.

"Major Facility" means any NPDES facility or activity classified as such by the Regional Administrator in conjunction with the Department.

"Management agency" means an area-wide waste treatment management agency designated by the governor pursuant to Section 208(a) of the Federal Act.

"Maximum daily discharge limitation" means the highest allowable daily discharge.

"Minor discharge" means a discharge of wastewater which has a total volume of less than 50,000 gallons on every day of the year, does not closely affect the waters of another state and is not identified by the Department, the Regional Administrator or by the Administrator of EPA in regulations issued by him pursuant to Section 307(a) of the Federal Act, as a discharge which is not a minor discharge, except that in the case of a discharge of less than 50,000 gallons on any day of the year which represents 1 or 2 or more discharges from a single person which in total exceeds 50,000 gallons on any day of the year, then no discharge from the facility is a minor discharge.

Note: "Municipal separate storm sewer system" is defined at sections 122.26 (b).

"Municipality" means a city, town, borough, county, parish, district, association, or other public body created by or under State law and having jurisdiction over disposal of sewage, industrial wastes, or other wastes, or an Indian tribe or an authorized Indian tribal organization, or a designated and approved management agency under section 208 of CWA.

"National Pollutant Discharge Elimination System" means the national program for issuing, modifying, revoking and reissuing, terminating, monitoring and enforcing permits, and imposing and enforcing pretreatment requirements, under sections 307, 402, 318, and 405 of CWA.

"New discharger"

(1) means any building, structure, facility, or installation:

(i) From which there is or may be a discharge of pollutants.

(ii) That did not commence the discharge of pollutants at a particular site prior to August 13, 1979;

(iii) Which is not a new source, and

(iv) Which has never received a finally effective NPDES permit for discharges at that site.

(2) includes an indirect discharger which commences discharging into waters of the State after August 13, 1979. It also includes any existing mobile point source (other than an offshore or coastal oil and gas exploratory drilling rig or a coastal oil and gas developmental drilling rig) such as a seafood processing rig, seafood processing vessel, or aggregate plant, that begins discharging at a site for which it does not have a permit; and any offshore or coastal mobile oil and gas exploratory drilling rig or coastal mobile oil and gas developmental drilling rig that commences the discharge of pollutants after August 13, 1979, at a site under Department's permitting jurisdiction for which it is not covered by an individual or general permit and which is located in an area determined by the Department in the issuance of a final permit to be an area of biological concern. In determining whether an area is an area of biological concern, the Department shall consider the factors specified in section 122(a)(1) through (10). An offshore or coastal mobile exploratory drilling rig or coastal mobile developmental drilling rig will be considered a new discharger only for the duration of its discharge in an area of biological concern.

"New source" means any building, structure, facility, or installation from which there is or may be a discharge of pollutants, the construction of which commenced:

(1) After promulgation of standards of performance under section 306 of CWA which are applicable to such source, or

(2) After proposal of standards of performance in accordance with section 306 of CWA which are applicable to such source, but only if the standards are promulgated in accordance with section 306 within 120 days of their proposal.

"NPDES" means National Pollutant Discharge Elimination System established by the CWA.

"NPDES form" means any issued permit or any uniform national form used by the Department developed for use in the NPDES, including a NPDES application, a Refuse Act permit application and a reporting form.

"NPDES permit" means a permit issued by the Department to a discharger pursuant to regulations adopted by the Board for all point source discharges into surface waters, and shall constitute a final determination of the Board.

"Non-compliance list" means a list of dischargers, prepared by the Department pursuant to this regulation and the guidelines for transmittal to the Regional Administrator, who fail or refuse to comply with a compliance schedule in a NPDES permit issued pursuant to the State law.

"Owner or operator" means the owner or operator of any facility or activity subject to regulation under the NPDES program.

"Permit" means an authorization, license, or equivalent control document issued by the Department to implement the requirements of this regulation, 40 CFR Parts 123, and R.61-9.124. Permit includes an NPDES general permit (section 122.28). Permit does not include any permit which has not yet been the subject of final agency action, such as a draft permit or a proposed permit.

"Person" means any individual, public or private corporation, political subdivision, association, partnership, corporation, municipality, State or Federal agency, industry, copartnership, firm, trust, estate, any other legal entity whatsoever, or an agent or employee thereof.

"Point source" means any discernible, confined, and discrete conveyance, including but not limited to, any pipe, ditch, channel, tunnel, conduit, well, discrete fissure, container, rolling stock, concentrated animal feeding operation, vessel, or other floating craft from which pollutants are or may be discharged. This term does not include return flows from irrigated agriculture.

"Point source discharge" means a discharge which is released to the waters of the State by a discernible, confined and discrete conveyance, including but not limited to a pipe, ditch, channel, tunnel, conduit, well, discrete fissure, container, rolling stock, concentrated animal feeding operation, vessel, or other floating craft from which waste is or may be discharged.

"Pollutant"

(1) means dredged spoil, solid waste, incinerator residue, filter backwash, sewage, garbage, sewage sludge, munitions, chemical wastes, biological materials, radioactive materials (except those regulated under the Atomic Energy Act of 1954, as amended (42 U.S.C. 2011 et seq.)), heat, wrecked or discarded equipment, rock, sand, cellar dirt and industrial, municipal, and agricultural waste discharged into water.

(2) does not mean:

(i) Sewage from vessels; or

(ii) Water, gas, or other ma