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4909Ratification Number: 413Act Number: 314Type of Legislation: General Bill GBIntroducing Body: HouseIntroduced Date: 20020314Primary Sponsor: BinghamAll Sponsors: BinghamDrafted Document Number: l:\council\bills\nbd\11370ac02.docDate Bill Passed both Bodies: 20020528Date of Last Amendment: 20020522Governor's Action: SDate of Governor's Action: 20020604Subject: Pharmacists, pharmacy technicians, and pharmacy distributors, provisions regarding; reporting of drug theft and employee drug convictions to Board of PharmacyHistory Body Date Action Description Com Leg Involved ______ ________ ______________________________________ _______ ____________ ------ 20020618 Act No. A314 ------ 20020604 Signed by Governor ------ 20020530 Ratified R413 House 20020528 Concurred in Senate amendment, enrolled for ratification Senate 20020522 Amended, read third time, returned to House with amendment Senate 20020516 Amended, read second time, notice of general amendments Senate 20020509 Committee report: Favorable with 13 SMA amendment Senate 20020409 Introduced, read first time, 13 SMA referred to Committee House 20020404 Read third time, sent to Senate ------ 20020404 Scrivener's error corrected House 20020403 Amended, read second time House 20020402 Committee report: Favorable with 27 H3M amendment House 20020314 Introduced, read first time, 27 H3M referred to Committee Versions of This Bill Revised on April 2, 2002 - Word format Revised on April 3, 2002 - Word format Revised on April 4, 2002 - Word format Revised on May 9, 2002 - Word format Revised on May 16, 2002 - Word format Revised on May 22, 2002 - Word format
(A314, R413, H4909)
AN ACT TO AMEND SECTION 39-24-40, AS AMENDED, CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO REQUIREMENTS FOR DRUG PRESCRIPTIONS AUTHORIZING SUBSTITUTION OF A GENERIC DRUG, SO AS TO AUTHORIZE A PHARMACIST TO MAINTAIN GENERIC SUBSTITUTION RECORDS ELECTRONICALLY AND TO CONFORM THESE PROVISIONS TO OTHER GENERIC SUBSTITUTION PROVISIONS; TO AMEND SECTION 40-43-30, RELATING TO DEFINITIONS OF TERMS USED 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, AUTHORIZATION OF A HEALTH CARE PRACTITIONER DISPENSING DRUGS THAT THE PRACTITIONER OWNS, SO AS TO ALSO AUTHORIZE A PRACTITIONER TO DISPENSE A COMPLIMENTARY TRIAL SUPPLY OF DRUGS OWNED BY THE PRACTITIONER OR AN INSTITUTION AUTHORIZED TO POSSESS MEDICATIONS; TO AMEND SECTION 40-43-82, AS AMENDED, RELATING TO REGISTRATION QUALIFICATIONS FOR PHARMACY TECHNICIANS, SO AS TO REVISE THESE QUALIFICATIONS AND TO FURTHER SPECIFY APPLICATION AND RENEWAL PROCEDURES; TO AMEND SECTION 40-43-86, AS AMENDED, RELATING TO VARIOUS PHARMACY FACILITY AND PRACTICE REQUIREMENTS, SO AS TO PROVIDE THAT IN PROVIDING ADEQUATE STAFFING, A PHARMACIST-IN-CHARGE IS NOT REQUIRED TO EMPLOY CERTIFIED PHARMACY TECHNICIANS, TO PROVIDE THAT EMERGENCY MEDICAL SERVICES AND DURABLE MEDICAL EQUIPMENT FACILITIES ARE NOT REQUIRED TO HAVE A CONSULTANT PHARMACIST AND TO AUTHORIZE OTHER HEALTH PROFESSIONALS WITH THESE SERVICES OR FACILITIES TO PERFORM THE DUTIES THAT WOULD HAVE BEEN PERFORMED BY A CONSULTANT PHARMACIST, AND TO AUTHORIZE A PHARMACIST TO MAINTAIN GENERIC SUBSTITUTION RECORDS ELECTRONICALLY AND TO CONFORM THOSE PROVISIONS TO OTHER GENERIC SUBSTITUTION PROVISIONS; TO AMEND SECTION 40-43-89, RELATING TO VARIOUS REQUIREMENTS RELATING TO WHOLESALE PHARMACY DISTRIBUTORS, SO AS TO CLARIFY PROVISIONS AND TO DELETE DUPLICATE STATUTORY PROVISIONS RELATING TO PERMIT APPLICATION PROCEDURES; TO AMEND SECTION 40-43-90, RELATING TO PERMIT APPLICATION PROCEDURES, SO AS TO FURTHER PROVIDE FOR PERMIT RENEWAL PROCEDURES AND FOR CHANGE OF NAME OR OWNER CIRCUMSTANCE WHICH REQUIRE A NEW PERMIT TO BE OBTAINED; TO AMEND SECTION 40-43-91, RELATING TO INFORMATION THAT MUST BE REPORTED TO THE BOARD OF PHARMACY ON DRUG THEFT AND EMPLOYEE DRUG CONVICTIONS, SO AS TO INCREASE THE TIME FOR REPORTING THESE EVENTS FROM THREE TO THIRTY DAYS; TO AMEND SECTION 40-43-110, RELATING TO PHARMACY PERMIT AND LICENSE APPLICATION AND RENEWAL PROCEDURES, SO AS TO FURTHER SPECIFY AND CLARIFY THESE PROCEDURES; AND TO AMEND SECTION 40-43-130, AS AMENDED, RELATING TO CONTINUING EDUCATION REQUIREMENTS FOR PHARMACISTS, SO AS TO ALSO PROVIDE CONTINUING EDUCATION REQUIREMENTS FOR REGISTERED PHARMACY TECHNICIANS.
Be it enacted by the General Assembly of the State of South Carolina:
Requirements for prescriptions and labels regarding generic drug substitutions
SECTION 1. Section 39-24-40 of the 1976 Code, as amended by Act 416 of 1994, is further amended to read:
"Section 39-24-40. (A) An oral or written drug prescription must provide an authorization from the practitioner as to whether or not a therapeutically equivalent generic drug may be substituted.
(B) A written prescription must have two signature lines at opposite ends on the bottom of the form. Under the line at the left side must be clearly printed the words 'DISPENSE AS WRITTEN'. Under the line at the right side shall be clearly printed the words 'SUBSTITUTION PERMITTED', unless the prescription is to be paid for with Medicaid funds. The practitioner shall communicate the instructions to the pharmacist by signing on the appropriate line. A written prescription is not valid without the signature of the practitioner on one of these lines.
(C) An oral prescription from the practitioner must instruct the pharmacist as to whether or not a therapeutically equivalent generic drug product may be substituted, unless the prescription is to be paid for with Medicaid funds. The pharmacist shall note the instructions on the file copy of the prescription and retain the prescription form for the period as prescribed by law.
(D) 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.
(E) Substitution may not occur unless the pharmacist advises the patient that the practitioner has authorized substitution and the patient consents.
(F) If a pharmacist substitutes a generic drug for a name brand prescribed drug when dispensing a prescribed medication, the brand name and the name of the generic 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 of the 1976 Code is amended by adding at the end:
"(54) '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(B)."
Free trial drugs may be dispensed
SECTION 3. Section 40-43-60(I) of the 1976 Code, as 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 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 free complimentary trial supply of drugs owned by a person or institution authorized to possess medication under state or federal law for indigent patients with guidelines equal to or equivalent to Section 340B of the Public Health Service Act. Drugs or medicine dispensed must comply with the labeling requirements of state and federal laws and regulations."
Pharmacy technician registration and certification requirements
SECTION 4. Section 40-43-82 of the 1976 Code, as last amended by Act 297 of 2000, is further amended to read:
"Section 40-43-82. (A)(1) The Board of Pharmacy shall register pharmacy technicians who are performing pharmacy functions under the supervision of a pharmacist.
(2) A registration is valid from July one through June thirtieth and is renewable on dates as prescribed by the department with the consent of the board. An application for renewal must be on a board approved form provided by the department and must be submitted and accompanied by an annual fee in an amount established in accordance with Section 40-1-50. A pharmacy technician who has failed to properly renew a registration before July first shall immediately cease practice and refrain from performing any duties as a pharmacy technician. Reinstatement of a registration must be granted upon the board receiving a renewal application and renewal and penalty fees.
(3) A pharmacy technician shall display his or her current registration in a conspicuous place in the primary pharmacy or drug outlet in which the technician is employed, so that the current registration is easily and readily observable by the public. A technician working in a pharmacy or drug outlet where the technician's registration is not posted must have his or her wallet registration card with him or her.
(B)(1) An individual may be certified by the board as a pharmacy technician if the individual has:
(a) worked for fifteen hundred hours under the supervision of a licensed pharmacist as a registered pharmacy technician or has completed a Board of Pharmacy approved pharmacy technician course as provided for in subsection (D); however, beginning July 1, 2004, to be certified as a pharmacy technician an individual must have worked for one thousand hours under the supervision of a licensed pharmacist as a technician and must have completed a Board of Pharmacy approved technician course as provided for in subsection (D);
(b) a high school diploma or equivalent; and
(c) passed the National Pharmacy Technician Certification Board exam or a Board of Pharmacy approved exam and has maintained current certification; and
(d) fulfilled continuing education requirements as provided for in Section 40-43-130(G).
(2) The pharmacist-in-charge shall verify compliance with the requirements of item (a) of subsection (B)(1) and maintained a record of this requirement in a readily retrievable manner for inspection.
(C) Notwithstanding any other provision of this chapter, a supervising pharmacist may authorize a certified pharmacy technician to:
(1) receive and initiate verbal telephone orders;
(2) conduct one time prescription transfers;
(3) check a technician's refill of medications if the medication is to be administered by a licensed health care professional in an institutional setting;
(4) check a technician's repackaging of medications from bulk to unit dose in an institutional setting.
(D) A formal academic pharmacy technician training program that leads to a certificate, diploma, or higher degree may be approved by the board if it includes at a minimum:
(1) introduction to pharmacy and health care systems;
(2) pharmacy law and ethics;
(3) pharmacy calculations;
(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;
(a) aseptic technique;
(b) nonsterile compounding;
(7) general education;
(a) medical terminology;
(b) interpersonal relations;
(8) problem solving/critical thinking;
(9) experiential training (practical experience).
(E) A pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes is not eligible to be registered as a pharmacy technician.
(F) 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 may 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 is 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."
Certified pharmacy technicians not required to be employed
SECTION 5. The first paragraph of Section 40-43-86(B)(4) of the 1976 Code is amended to read:
"The pharmacist-in-charge must be assisted by a sufficient number of licensed pharmacists and registered pharmacy technicians as may be required to competently and safely provide pharmacy services; however, this may not be construed to require a pharmacist-in-charge to employ certified pharmacy technicians."
Exemptions from fees and use of consultant pharmacist
SECTION 6. Section 40-43-86(C) of the 1976 Code is 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 provisions of this section requiring a consultant pharmacist to perform the duties set forth in this chapter at the permit holder's location, and the medical director or a consultant pharmacist may perform the duties of the consultant pharmacist pursuant to this chapter.
(5) A facility supplying durable medical equipment is exempt from the provisions of this section requiring a consultant pharmacist to perform the duties set forth in this chapter at the permit holder's location, and a medical director, respiratory therapist, registered nurse, or consultant pharmacist may perform the duties of the consultant pharmacist pursuant to this chapter."
Requirements for substituting generic drugs
SECTION 7. Section 40-43-86(H)(5) of the 1976 Code 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 a pharmacist substitutes a generic drug for a name brand prescribed drug when dispensing a prescribed medication, 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 8. Section 40-43-89(N)(5) through (8) of the 1976 Code are amended to read:
"(5) 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) portions of 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.
(6) A facility required to obtain a permit pursuant to this subsection but which has not been issued a permit, may not advertise its services in this State, and a resident of this State may not advertise the services for the facility.
(7) A permit issued pursuant to this section is not evidence that the pharmacy is doing business within this State."
SECTION 9. Section 40-43-90 of the 1976 Code is amended to read:
"Section 40-43-90. (A) To obtain a permit, an applicant shall:
(1) submit an 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 or a pharmacist designee; and
(3) pay all required fees.
(B) Each facility shall apply individually and obtain a separate permit for each location.
(C) A permit issued by the board pursuant to this chapter is not transferable or assignable and expires annually on June thirtieth.
(D) A permit renewal application, including the required fee, must be submitted to the board before June first. If not postmarked before June first, a penalty of fifty dollars must be assessed. For permits not renewed by the expiration date, the board may charge an additional ten dollars a day until the permit is reinstated. A permit which has not been renewed before July first is a lapsed permit. A permit holder who allows a site to operate with a lapsed permit is in violation of Section 40-43-83.
(E) 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 from one city to another."
Reporting time extended
SECTION 10. Section 40-43-91(A) of the 1976 Code is amended to read:
"(A) A permit holder shall report to the Board of Pharmacy within thirty working days of the discovery of the occurrence of:
(1) theft or loss of drugs or devices; or
(2) conviction of any employee of any state or federal drug law."
License renewal requirements
SECTION 11. Section 40-43-110 of the 1976 Code is amended to read:
"Section 40-43-110. (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 submit a renewal application to the board. If mailed, the board must receive the application before April first, including all required fees, data, and certification of acceptable continuing education. If not postmarked before April first, a penalty of fifty dollars must be assessed.
(C) A pharmacist who wishes to renew his license in an inactive status must submit a renewal application to the board. If mailed, the board must receive the application before April first, including all required fees and data; however, no continuing education is required. If not postmarked before April first a penalty of fifty dollars must be assessed. The license 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 a lapsed license. A person who practices pharmacy with a license that has lapsed is practicing without a license. Reinstatement of a lapsed license must be granted upon evidence satisfactory to the board, subject to disciplinary actions 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 at least 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 at least 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) An assistant pharmacist currently licensed has all the rights and privileges of a licensed pharmacist.
(I) The board may not issue temporary licenses."
Pharmacy technician continuing education requirements
SECTION 12. Section 40-43-130 of the 1976 Code, as amended by Act 340 of 2000, is further amended by adding at the end:
"(G)(1) As a condition of registration renewal, a registered pharmacy technician shall complete ten hours of American Council on Pharmaceutical Education or CME I approved continuing education each year, beginning with the next renewal period after June 30, 2003. A minimum of four hours of the total hours 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 issued 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."
SECTION 13. This act takes effect July 1, 2002.
Ratified the 30th day of May, 2002.
Approved the 4th day of June, 2002.
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