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Current Status Bill Number:View additional legislative information at the LPITS web site.471 Type of Legislation:General Bill GB Introducing Body:Senate Introduced Date:20010320 Primary Sponsor:Giese All Sponsors:Giese Drafted Document Number:l:\council\bills\nbd\11197ac01.doc Residing Body:Senate Current Committee:Medical Affairs Committee 13 SMA Subject:Pharmacists, certified pharmacy technician, practitioners; permits and renewal of; generic drugs, labels; Pharmacies History Body Date Action Description Com Leg Involved ______ ________ ______________________________________ _______ ____________ Senate 20010320 Introduced, read first time, 13 SMA referred to Committee Versions of This Bill
TO AMEND SECTION 39-24-40, CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO SUBSTITUTING GENERIC DRUGS FOR NAME BRAND DRUGS, SO AS TO REQUIRE A PHARMACIST TO PLACE THE NAME BRAND OR MANUFACTURER OF A GENERIC DRUG ON THE FILE COPY OF A PRESCRIPTION OR TO STORE IT ELECTRONICALLY, OR BOTH, AND TO FURTHER CLARIFY THE LABELING PROCEDURES WHEN SUBSTITUTIONS OF GENERIC DRUGS OCCUR; TO AMEND SECTION 40-43-30, AS AMENDED, RELATING TO DEFINITIONS IN THE PHARMACY PRACTICE ACT, SO AS TO DEFINE "CERTIFIED PHARMACY TECHNICIAN"; TO AMEND SECTION 40-43-60, AS AMENDED, RELATING TO, AMONG OTHER THINGS, THE DUTIES OF THE CHIEF DRUG INSPECTOR, PROCEDURES CONCERNING ADULTERATED OR MISBRANDED DRUGS, AND THE AUTHORITY OF VARIOUS PRACTITIONERS TO PRESCRIBE AND DISPENSE DRUGS, SO AS TO PROVIDE THAT THE PHARMACY PRACTICE ACT DOES NOT PREVENT A PRACTITIONER FROM DISPENSING COMPLIMENTARY TRIAL DRUGS OWNED BY A CORPORATE ENTITY; TO AMEND SECTION 40-43-82, AS AMENDED, RELATING TO REGISTRATION REQUIREMENTS FOR PHARMACY TECHNICIANS, SO AS TO FURTHER SPECIFY REGISTRATION RENEWAL PROCEDURES, TO ESTABLISH CRITERIA TO BECOME A CERTIFIED PHARMACY TECHNICIAN, AND TO PROVIDE DUTIES THAT MAY BE ASSIGNED TO A CERTIFIED TECHNICIAN; TO AMEND SECTION 40-43-86, AS AMENDED, RELATING, AMONG OTHER THINGS, TO FACILITY REQUIREMENTS FOR PHARMACIES, DUTIES OF A PHARMACIST-IN-CHARGE, DUTIES OF CONSULTANT PHARMACISTS, CONTENT REQUIREMENTS FOR PRESCRIPTION DRUG ORDERS, AND TRANSFER OF PRESCRIPTIONS, SO AS TO EXEMPT EMERGENCY MEDICAL SERVICES FROM PERMIT FEES AND THE REQUIREMENT OF HAVING A PHARMACIST-IN-CHARGE, TO EXEMPT FACILITIES SUPPLYING DURABLE MEDICAL EQUIPMENT FROM THE REQUIREMENT OF HAVING A PHARMACIST-IN-CHARGE, TO CONFORM PRESCRIPTION LABEL REQUIREMENTS TO OTHER PROVISIONS OF THIS ACT; TO AMEND SECTION 40-43-89, RELATING, AMONG OTHER THING, TO WHOLESALE DISTRIBUTOR PERMITS AND RENEWALS, DRUG STORAGE AND DISTRIBUTION FACILITY REQUIREMENTS, AND RECORDKEEPING REQUIREMENTS FOR WHOLESALE DRUG DISTRIBUTORS, SO AS TO DELETE PROVISIONS REGARDING APPLICATION AND RENEWAL PROCEDURES FOR PHARMACY PERMITS AND TO CORRECT A CROSS REFERENCE; TO AMEND SECTION 40-43-90, AS AMENDED, RELATING TO PHARMACY PERMIT AND RENEWAL REQUIREMENTS, SO AS TO REINSTATE THESE REQUIREMENTS DELETED FROM SECTION 40-43-89, TO AUTHORIZE THE BOARD TO CHARGE AN ADDITIONAL PENALTY FOR LAPSED PERMITS, AND TO PROVIDE THAT A PERMIT BECOMES VOID WHEN THERE IS A CHANGE IN OWNERSHIP, NAME, OR LOCATION OF A PHARMACY; TO AMEND SECTION 40-43-91, RELATING TO THE REQUIREMENT TO REPORT TO THE BOARD WHEN VARIOUS CHANGES AND EVENTS OCCUR, SO AS TO REQUIRE A PERMIT HOLDER TO REPORT AN EMPLOYEE'S ALLEGED VIOLATION, RATHER THAN A CONVICTION, OF A STATE OR FEDERAL DRUG LAW AND TO REPORT AN EMPLOYEE TERMINATION FOR UNPROFESSIONAL CONDUCT; TO AMEND SECTION 40-43-110, AS AMENDED, RELATING TO PERMIT AND LICENSE RENEWAL PROCEDURES AND PENALTIES AND REQUIREMENTS FOR INACTIVE AND LAPSED LICENSES, SO AS TO CLARIFY THESE LICENSE PROVISIONS, TO PROVIDE THAT CURRENTLY LICENSED ASSISTANT PHARMACISTS HAVE ALL THE RIGHTS AND PRIVILEGES OF A LICENSED PHARMACIST, AND TO PROVIDE THAT NO TEMPORARY LICENSE MAY BE ISSUED; AND TO AMEND SECTION 40-43-130, RELATING TO CONTINUING EDUCATION REQUIREMENTS, SO AS TO ESTABLISH CONTINUING EDUCATION REQUIREMENTS FOR PHARMACY TECHNICIANS.
Be it enacted by the General Assembly of the State of South Carolina:
SECTION 1. The last paragraph of Section 39-24-40 of the 1976 Code, as added by Act 416 of 1994, is amended to read:
"When dispensing a prescribed medication, if a pharmacist substitutes a generic drug for a name brand prescribed drug, the generic drug name must be listed on the prescription label first followed by the words 'substituted for' and the name brand prescribed drug or this information must be affixed to the container on an auxiliary label. The pharmacist shall note the brand name or the manufacturer of the substituted drug dispensed on the file copy of a written or oral prescription or record this information electronically, or both. If substitution occurs, the brand name and the generic name of the drug and its manufacturer with an explanation of 'generic for', or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label."
SECTION 2. Section 40-43-30(4) of the 1976 Code, as amended by Act 366 of 1998, is further amended to read:
"(4) 'Brand name' means the proprietary or trade name placed upon a drug, or its container, label, or wrapping at the time of packaging.
(4A) 'Certified pharmacy technician' means an individual who is a registered pharmacy technician and who has completed the requirements provided for in Section 40-43-82(C)."
SECTION 3. 40-43-60(I) of the 1976 Code, as last amended by Act 340 of 2000, is further amended to read:
"(I) This chapter does not require a permit of or prevent a licensed practitioner as defined under in Section 40-43-30(45) from dispensing drugs or devices that are the lawful property of the practitioner or a partnership or corporate entity which is fully owned by licensed practitioners or from dispensing a complimentary trial supply of drugs owned by an eligible institutional facility to eligible patients as defined in Section 340(B) of the Public Health Service Act. Drugs or medicine dispensed must comply with the labeling requirements of state and federal laws and regulations."
SECTION 4. Section 40-43-82 of the 1976 Code, as amended by Act 297 of 2000, is further amended to read:
"Section 40-43-82. (A) The Board of Pharmacy shall register pharmacy technicians who are performing pharmacy functions under the supervision of a pharmacist. Registrations are valid for one year or more and renewable on dates prescribed by the department with the consent of the board. Registrations must be renewed by June first of the designated renewal year. Applications for renewal must be on a form provided by the department and must be accompanied by an annual fee in an amount established in accordance with Section 40-1-50. Applications received after June first are subject to an additional late fee of ten dollars. Registrations expire at midnight on June thirtieth of the designated renewal year. A pharmacy technician who has failed to properly renew a registration by June thirtieth must immediately cease practice and refrain from performing any duties as a pharmacy technician. Reinstatement of a registration may be granted upon evidence satisfactory to the board of good and sufficient grounds for the failure to renew the registration within the prescribed period and payment of the renewal fee and a penalty of five dollars.
(B) A person who is a registered technician and who is employed in a pharmacy or drug outlet within this State shall display his annual renewal certificate in a conspicuous place in the primary pharmacy or drug outlet in which he is employed, so that the annual renewal certificate is easily and readily observable by the public. Registered technicians who are working in a pharmacy or drug outlet where their renewal certificate is not posted must have their wallet card as proof of registration.
(C) A pharmacy technician is deemed certified upon compliance with the following requirements:
(1) working for one thousand hours under the supervision of a licensed pharmacist as a registered technician or the completion of a Board of Pharmacy approved pharmacy technician course as provided for in subsection (F);
(2) have a high school diploma or equivalent;
(3) pass the National Pharmacy Technician Certification Board exam, or a Board of Pharmacy approved exam and maintain current certification; and
(4) fulfill continuing education requirements as required in Section 40-43-130(G).
(D) Compliance must be certified by the pharmacist-in-charge and be maintained at the pharmacy in a readily retrievable manner for inspection.
(E) Notwithstanding other provisions of this chapter, additional duties for a certified pharmacy technician which may be granted by the supervising pharmacist may include:
(1) receiving and initiating verbal telephone orders;
(2) one-time prescription transfers;
(3) checking technician's work if going to another health care provider in an institutional setting for refill of medications;
(4) checking technician's work for repackaging from bulk to unit dose in an institutional setting.
(B) (F) Formal academic pharmacy technician training programs that lead to a certificate, diploma, or higher degree may be approved by the board if they include at a minimum:
(1) introduction to pharmacy and health care systems;
(2) pharmacy law and ethics;
(3) pharmacy calculations;
(4) pharmacology;
(a) anatomy and physiology;
(b) therapeutic agents;
(c) prescription drugs;
(d) nonprescription drugs;
(5) pharmacy operations;
(a) drug distribution systems;
(b) records management and inventory control;
(c) ambulatory and institutional practice;
(6) compounding;
(a) aseptic technique;
(b) nonsterile compounding;
(7) general education;
(a) medical terminology;
(b) interpersonal relations;
(c) communications;
(d) computers/keyboarding;
(8) problem solving/critical thinking;
(9) experiential training (practical experience).
(C)(G) NoA pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes is not eligible to be registered as a pharmacy technician.
(D)(H) Notwithstanding the requirements of this section or any other provision of law or regulation, an individual who works as an unpaid volunteer under the personal supervision of a licensed pharmacist or who handles legend drugs in a pharmacy department of a free medical clinic staffed by a licensed pharmacist may be registered as a pharmacy technician and perform pharmacy functions as a pharmacy technician without payment of a registration fee or filing with the board; provided, that a register is maintained in the pharmacy department of the free medical clinic bearing the name of every such volunteer performing pharmacy functions as a pharmacy technician and documenting each volunteer's period of service. This special registration shall be valid only in the free medical clinic. The register must be kept for a period of three years. For the purposes of this section, 'free medical clinic' means a permitted facility that provides medical services, including the dispensing of legend drugs and other medications, free of any charge to members of the public."
SECTION 5. Section 40-43-86(C) of the 1976 Code, as amended by Act 76 of 1999, is further amended by adding at the end:
"(4) Emergency medical services licensed by the Department of Health and Environmental Control are exempt from permit fees and the requirement of this section that a consultant pharmacist be responsible for the duties as stated in this chapter at the permit holder's location, so as to allow either the medical director or a consultant pharmacist to be responsible and accountable for the duties of the consultant pharmacist as provided in this chapter.
(5) Facilities supplying durable medical equipment are exempt from the requirement of this section that a consultant pharmacist be responsible for the duties as stated in this chapter at the permit holder's location, so as to allow a medical director, respiratory care therapist, registered nurse, or consultant pharmacist to be responsible and accountable for the duties of the consultant pharmacist as provided in this chapter."
SECTION 6. Section 40-43-86(H)(5) of the 1976 Code, as added by Act 366 of 1998, is amended to read:
"(5) The pharmacist shall note the brand name or the manufacturer of the substituted drug dispensed on the file copy of a written or oral prescription or record this information electronically, or both. If substitution occurs, the prescription label shall contain brand name and the generic name of the drug and its manufacturer listed first, followed by the words 'substituted for', and the brand name prescribed drug in this information must with an explanation of 'generic for' or similar language to indicate substitution has occurred must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label."
SECTION 7. 40-43-89(N)(5) and (6) of the 1976 Code, as added by Act 366 of 1998, are amended to read:
"(5) An application for a pharmacy permit under the provisions of this section must be made on a form furnished by the board, signed by a responsible person who has been designated as the permit holder, and accompanied by the required fee. The board may require information from the facility reasonably necessary to carry out the purposes of this section. Each facility shall apply individually and obtain a separate permit for each location. The permit is not transferable and expires annually. A renewal application must be mailed to the board postmarked no later than June second or the existing permit lapses on the date of its expiration, and no renewal permit may be granted except:
(a) upon evidence satisfactory to the board of good and sufficient grounds for the failure to file the application within the prescribed period;
(b) upon payment of the renewal fee and a penalty of fifty dollars. Reserved
(6) The board may deny, revoke, suspend, or otherwise take action against a facility permit issued under the provisions of this section for:
(a) failure to comply with the requirements of:
(i) this section;
(ii) subsection (C), provisions in this chapter dealing with prescription drug orders, drug product selection, labeling, patient records, drug review, drug dispensing, patient counseling, emergency refills, and advertisements;
(iii) subchapter 1, Chapter 13, Title 21 (Federal Controlled Substance Act);
(iv) Chapter 2, Title 21 of the Code of Federal Regulations (Federal Controlled Substance Regulation);
(b) conduct which causes serious bodily or serious psychological injury to a resident of this State if the board has referred the matter to the regulatory or licensing agency under which the pharmacy operates in the state in which it is located and that agency fails to initiate an investigation within forty-five days of the referral. The board shall maintain a record of referrals pursuant to this item and action taken on them."
SECTION 8. Section 40-43-90 of the 1976 Code, as last amended by Act 366 of 1998, is further amended to read:
"Section 40-43-90. (A) To obtain a permit, an applicant shall:
(1) submit a written application in the form prescribed by the Board of Pharmacy at least forty-five days before the opening date of the facility;
(2) pass an inspection conducted by inspectors of the Board of Pharmacy; and
(3) pay all appropriate required fees.
(B) Applicants for permits to distribute, manufacture, sell, purchase, or produce drugs or devices within this State shall file with the Board of Pharmacy a verified application containing such information as the board requires of the applicant relative to the qualifications for a permit holder Each facility shall apply individually and obtain a separate permit for each location.
(C) Permits issued by the board pursuant to this chapter are not transferable or assignable and expire annually on June thirtieth.
(D) A permit renewal application, including the required fee, must be mailed to the board postmarked no later than June first. If not postmarked by June first, a penalty of fifty dollars is imposed. for permits not renewed by the expiration date, the board may charge an additional ten dollars a day until reinstatement of the permit. A permit which has not been renewed before July first is considered a lapsed permit. A permit holder who allows a site to operate with a lapsed permit is considered to be in violation of Section 40-43-83.
(E) Upon the occurrence of any of the flowing, an existing, permit is void and a new permit must be applied for:
(1) change of ownership, including:
(a) any change of ownership in the case of a sole proprietorship;
(b) a gain or loss of a partner in the case of a partnership; or
(c) a change of ownership of fifty percent or more of stock in the case of a corporation.
(2) change of name; or
(3) change of location from on city to another."
SECTION 9. Section 40-43-91(A)(2) of the 1976 Code, as added by Act 366 of 1998, is amended to read:
"(2) conviction of any employee of any state or federal drug laws. an alleged violation by an employee of any state or federal drug laws or suspension or involuntary termination of an employee due to unprofessional conduct as defined in Section 40-43-86(DD) and Section 40-1-110."
SECTION 10. Section 40-43-110 of the 1976 Code, as last amended by Act 366 of 1998, is further amended to read:
"Section 40-43-110. (A) For permits not renewed by the expiration date specified on the permit, the board may charge late penalties as follows:
(1) ten dollars a day if renewed during the first thirty days following expiration;
(2) failure to renew by the end of thirty days following expiration shall result in automatic cancellation of the permit and application for a new permit is required.
(B) Upon the occurrence of any of the following, an existing permit is void and a new permit must be applied for:
(1) change of ownership:
(a) any change of ownership in the case of a sole proprietorship;
(b) a gain or loss of a partner in the case of a partnership;
(c) a change of ownership of fifty percent or more of stock in the case of a corporation.
(2) change of name; or
(3) change of location.
A change in location of a permit within the same city requires an inspection and the payment of a relocation fee.
(C) The board may, upon application and payment of the applicable renewal fee, issue an inactive status license to a licensed pharmacist who is not actively engaged in the practice of pharmacy in this State, pursuant to this chapter. The pharmacist's license renewal certificate must be prominently marked as an inactive license, and the holder may not practice pharmacy under any conditions in this State. If the pharmacist wishes to reactivate the license, he shall complete the required continuing education for license renewal, plus an additional fifteen hours which must have been obtained during the calendar year immediately preceding the reactivation.
(D)(1) After May first, a license which has not been renewed is considered a lapsed license. A person who practices pharmacy with a license that has lapsed is considered practicing without a license. Reinstatement of a lapsed license may be granted upon evidence satisfactory to the board of good and sufficient grounds for the failure to renew the license within the prescribed period and payment of the renewal fee and a penalty of fifty dollars.
(2) A pharmacist whose license has lapsed for less than three years may reactivate his license by applying to the board, submitting proof of completion of 1.5 CEU's for each year the license has lapsed, and paying the reactivation fee.
(3) A pharmacist whose license has lapsed for three years but less than five years may reactivate his license by applying to the board, demonstrating to the board evidence of no less than one thousand hours of practice under the on-site supervision of a pharmacist licensed in this State, and paying the reactivation fee.
(4) A pharmacist whose license has lapsed for ten years or more may reactivate his license by applying to the board, demonstrating to the board evidence of no less than one thousand hours of practice under the on-site supervision of a pharmacist licensed in this State, successfully passing an examination administered or approved by the board, and paying the reactivation fee.
(5)(a) A pharmacist whose license has lapsed for less than three years and who has active status outside of South Carolina may reinstate his license by submitting proof of completion of 1.5 CEU's for each year the license has lapsed, official verification of a current license, and paying the reactivation fee.
(b) A pharmacist whose license has lapsed for three years or more and who has active status outside of South Carolina may reinstate his license by submitting evidence of no less than one thousand hours of out-of-state employment within the last five years, official verification of a current license, and paying the reactivation fee.
(E)(1) Each licensed pharmacist shall apply for renewal of his license annually no later than April first. A licensed pharmacist who desires to continue in the practice of pharmacy in this State shall file with the board an application in such form and containing data as the board requires for renewal of the license. If the board finds that the applicant has been licensed, and that the license has not been revoked or suspended or otherwise disciplined, that the applicant has paid the renewal fee and has completed all pharmacy education requirements for continuing education in accordance with this chapter, the board shall issue a license to the applicant.
(2) If a pharmacist fails to make application to the Board of Pharmacy for renewal of his license within a period of three years from the expiration of his license, he must pass the Pharmacy Law Examination for license renewal; except that a person who has been licensed under the laws of this State and after the expiration of his license has continually practiced pharmacy in another state under a license issued by the authority of such state, may renew his license upon payment of the designated fee and proof of completion of thirty hours of continuing education on a form approved by the board.
(3) Those assistant pharmacists currently licensed have all the rights and privileges of a licensed pharmacist.
(F) No temporary license may be issued.
(A) A license issued by the board pursuant to this chapter expires annually on April thirtieth.
(B) A pharmacist who wishes to renew his license in an active status must mail a renewal application to the board postmarked no later than April first, including all required fees, data, and certification of acceptable continuing education. If not postmarked by April first, a penalty of fifty dollars is imposed.
(C) Any pharmacist who wishes to renew his license in an inactive status must mail a renewal application to the board postmarked no later than April first, including all required fees and data; however no continuing education is required. If not postmarked by April first, a penalty of fifty dollars is imposed. The license renewal certificate must be prominently marked as an inactive license, and the holder may not practice pharmacy under any conditions in this or any state based on the South Carolina license. If the pharmacist wishes to reactivate the license, he shall complete the required continuing education for license renewal, plus an additional fifteen hours which must have been obtained during the calendar year immediately preceding the date of the reactivation application.
(D) A license which has not been renewed before May first is considered a lapsed license. A person who practices pharmacy with a license that has lapsed is considered practicing without a license. Reinstatement of a lapsed license may be granted upon evidence satisfactory to the board of good and sufficient grounds for the failure to renew the license within the prescribed period and payment of the renewal fee and a penalty of fifty dollars and any other required penalty.
(E) A pharmacist whose license has lapsed for three years or less may reinstate his license by applying to the board, submitting proof of completion of fifteen hours of acceptable continuing education for each year the license has been lapsed, and paying the renewal fee and any applicable penalty.
(F) A pharmacist whose license has lapsed for more than three years and who has been actively practicing pharmacy in another state may reinstate his license by applying to the board, submitting evidence of no less than one thousand hours of out-of-state employment in the practice of pharmacy within the last three years, official verification of a current license in another state, proof of completion of sixty hours of acceptable continuing education, and paying the renewal fee and any applicable penalty.
(G) A pharmacist whose license has lapsed for more than three years and who has not been actively practicing pharmacy in another state may reinstate his license by applying to the board, demonstrating to the board evidence of no less than one thousand hours of practice under the on-site supervision of a pharmacist licensed in this State, successfully passing the Multistate Pharmacy Jurisprudence Examination, submitting proof of completion of sixty hours of acceptable continuing education, and paying the renewal fee and any applicable penalty.
(H) Those assistant pharmacists currently licensed have all the rights and privileges of a licensed pharmacist.
(I) No temporary license may be issued."
SECTION 11. Section 40-43-130 of the 1976 Code, as amended by Act 340 of 2000, is further amended by adding at the end:
"(G) A registered pharmacy technician must comply with the following continuing education requirements for renewal:
(1) A registered pharmacy technician shall complete ten hours (1.0 CEU's) of American Council on Pharmaceutical Education approved continuing education each year, beginning July 1, 2002 for the next renewal period. A minimum of four hours of the total number must be obtained through attendance at lectures, seminars, or workshops.
(2) Topics and formats of study for continuing education must include subject matter designed to maintain the professional competence of pharmacy technicians registered with the board and to improve their professional skills in order to protect the public health and safety.
(3) Certification of completion of the required continuing education must be made on the annual registration renewal application and no renewal may be made without this certification. The board shall conduct an audit of continuing education credits of ten percent, randomly selected, of the total number of pharmacy technicians renewing.
(4) All hours completed in any registration year in excess of the requirements may be carried forward for credit in the next registration year but may not be carried forward for more than one registration year.
(5) Pharmacy technicians are exempt from continuing education requirements for the first renewal period."
SECTION 12. This act takes effect July 1, 2001.
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