HB382: HB382 Controlled substances; Schedule I; psilocybin; revise a provision

26 LC 46 1487S/AP House Bill 382 (AS PASSED HOUSE AND SENATE) By: Representatives Stephens of the 164th and Newton of the 127th A BILL TO BE ENTITLED AN ACT To amend Code Section 16-13-25 of the Official Code of Georgia Annotated, relating to1 Schedule I controlled substances, so as to revise a provision relating to certain substances;2 to amend Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to3 pharmacists and pharmacies, so as to modify the supervisory responsibilities of pharmacists;4 to allow pharmacy technicians to perform certain technical functions from a remote location;5 to provide for certain supervisory ratios; to provide for pharm acy interns and externs; to6 provide for definitions; to provide for the removal of the requirement that the State Board of7 Pharmacy may only require wholesale drug distributors to accept the return of drugs essential8 to healthcare treatment if such drugs have an expiration date that is less than one year from9 the date such drug is manufactured; to provide for a short title; to provide for construction;10 to provide for effectiveness contingencies; to provide for related matters; to repeal conflicting11 laws; and for other purposes.12 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:13 SECTION 1.14 This Act shall be known and may be cited as the "Prescription Drug Security, Supervision,15 and Return Act."16 H. B. 382 - 1 - 26 LC 46 1487S/AP SECTION 2. 17 Code Section 16-13-25 of the Official Code of Georgia Annotated , relating to Schedule I18 controlled substances, is amended by revising subparagraph (I) of paragraph (3) as follows:19 "(I) Lysergic acid diethylamide. Such term does not include a drug containing20 lysergide tartrate that is approved by the federal Food and Drug Administration under21 Section 505 of the federal Food, Drug, and Cosmetic Act, scheduled in accordance with22 its scheduling by the United States Drug Enforcement Administration, and listed in the23 federal Controlled Substances Act, 21 U.S.C. Section 812;"24 SECTION 3.25 Said Code section is further amended by revising subparagraph ( N) of paragraph (3) as26 follows:27 "(N) Psilocybin. Such term does not include a drug containing crystalline polymorph28 psilocybin that is approved by the federal Food and Drug Administration under Section29 505 of the federal Food, Drug, and Cosmetic Act, scheduled in a ccordance with its30 scheduling by the United States Drug Enforcement Administration , and listed in the31 federal Controlled Substances Act, 21 U.S.C. Section 812; or"32 SECTION 4.33 Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists and34 pharmacies, is amended in Article 1, relating to general provis ions, by revising35 paragraph (32) of subsection (a) of Code Section 26-4-5, relating to definitions, as follows: 36 "(32) 'Pharmacy technician' means those support persons utilized in pharmacies in the37 practice of pharmacy whose responsibilities are to provide nonjudgmental technical38 services concerned with the preparation for dispensing of drugs under the direct39 supervision and responsibility of a pharmacist."40 H. B. 382 - 2 - 26 LC 46 1487S/AP SECTION 5.41 Said chapter is further amended in Article 5, relating to prescription drugs, by revising Code42 Section 26-4-82, relating to duties requiring professional judg ment and responsibilities of43 licensed pharmacist, as follows:44 "26-4-82.45 (a) In dispensing drugs, no individual other than a licensed p harmacist shall perform or46 conduct those duties or functions which require professional ju dgment. It shall be the47 responsibility of the supervisi ng pharmacist to ensure that no other employee of the48 pharmacy, including pharmacy technicians, performs or conducts those duties or functions49 which require professional judgment.50 (b) For all prescriptions, it shall be the responsibility of the pharmacist on duty at a facility51 to ensure that only a pharmacist or a pharmacy intern under the direct supervision of a52 pharmacist provides professional consultation and counseling wi th patients or other53 licensed health care professionals, and that only a pharmacist or a pharmacy intern under54 the direct supervision of a pharmacist accepts initial telephoned prescription drug orders55 or provides information in any manner relative to prescriptions or prescription drugs.56 (c) In the dispensing of all prescription drug orders:57 (1) The pharmacist shall be responsible for all activities of the pharmacy technician in58 the preparation of the drug for delivery to the patient;59 (2) The pharmacist shall be physically present and personally supervising the activities60 of the any pharmacy technician in the licensed area of a pharmacy at all times;61 (3) When electronic systems are employed within the by a pharmacy, pharmacy62 technicians may enter information into the system and prepare labels; provided, however,63 that it shall be the responsibility of the pharmacist to verify the accuracy of the64 information entered and the label produced in conjunction with the prescription drug65 order;66 H. B. 382 - 3 - 26 LC 46 1487S/AP (4) When a prescription drug order is presented for refilling, it shall be the responsibility67 of the pharmacist to review all appropriate information and make the determination as to68 whether to refill the prescription drug order; and69 (5) Pharmacy technicians in the dispensing area licensed area of a pharmacy shall be70 easily identifiable.71 (d)(1) As used in this subsection, the term 'closed-door pharmacy' means a pharmacy that72 provides specialized services and is not open to the general public.73 (2) The board of pharmacy shall promulgate rules and regulations regarding the activities74 and utilization of pharmacy technicians in by pharmacies, including the establishment of75 a registry as required in paragraph (7) of subsection (a) of Co de Section 26-4-28;76 provided, however, that the pharmacist to pharmacy technician ratio shall not exceed one77 pharmacist providing direct supervision of four pharmacy techni cians located in the78 licensed area of the pharmacy. Any pharmacy technician perform ing pharmacy79 technician functions from a remote location outside a pharmacy shall not be counted80 toward the pharmacist to pharmacy technician supervisory ratio. The board may consider81 and approve an application to increase the ratio in a pharmacy located in a licensed82 hospital or in a closed-door pharmacy. Such application must shall be made in writing83 and must shall be submitted to the board by the pharmacist in charge of a specific hospital84 pharmacy in this state or a specific closed-door pharmacy. At any time during which the85 pharmacist directly supervises four or more pharmacy technician s , t w o o f s u c h86 technicians must be certified. At any time during which the ph armacist directly87 supervises three pharmacy technicians, one of such technicians must be certified. No88 certification is required for pharmacy technicians in pharmacies at any time during which89 the pharmacist directly supervises one or two pharmacy technicians.90 (e) In order to be certified, pharmacy technicians must shall:91 (1) Have successfully passed a certification program approved by the board of pharmacy;92 H. B. 382 - 4 - 26 LC 46 1487S/AP (2) Have successfully passed an employer's training and assessment program which has93 been approved by the board of pharmacy; or94 (3) Have been certified by either the Pharmacy Technician Cert ification Board or any95 other nationally recognized certifying body approved by the board of pharmacy.96 As used in this subsection, the term 'closed-door pharmacy' mea ns a pharmacy that97 provides specialized services and is not open to the general public.98 (e)(f) In addition to the utilization of pharmacy technicians, a pharmacist may be assisted99 by and directly supervise one pharmacy intern and one pharmacy extern pharmacy interns100 and pharmacy externs; provided, however, that the total number of such persons under the101 direct supervision of one pharmacist shall not exceed six perso ns, in any combination102 thereof."103 SECTION 6. 104 Said chapter is further amended in Article 6, relating to pharmacies, by revising subsection105 (c) of Code Section 26-4-115, relating to wholesale drug distri buters, registration, fees,106 reports of excessive purchases, penalty for violations, and transfers of drugs, as follows:107 "(c) The board shall be authorized to promulgate rules and regu lations to facilitate108 compliance with this Code section. Such rules and regulations shall include a requirement109 that all wholesale drug distributors required to register pursuant to this Code section shall110 make adequate provision for the return of outdated drugs, both full and partial containers,111 for up to six months after the labeled expiration date for prompt full credit or replacement;112 provided, however, that such rules and regulations may also inc lude a list of drugs113 exempted from the requirements of such provision that have been determined by the board114 as essential to health care healthcare treatment and having an expiration date of less than115 one year from the date such drug is manufactured."116 H. B. 382 - 5 - 26 LC 46 1487S/AP SECTION 7.117 Nothing in this Act shall be construed so as to affect or limit any authority of the State Board118 of Pharmacy provided by law, including any emergency power. Nothing in this Act shall be119 construed to affect the scheduling of any drug which is, by rul e o f t h e S t a t e B o a r d o f120 Pharmacy or by law, already listed as a controlled substance in Schedule II, III, IV, or V of121 Chapter 13 of Title 16 of the Official Code of Georgia Annotated.122 SECTION 8.123 (a) Section 2 of this Act shall become effective only if a drug containing lysergide tartrate124 is approved by the federal Food and Drug Administration under Section 505 of the federal125 Food, Drug, and Cosmetic Act, scheduled in accordance with its scheduling by the United126 States Drug Enforcement Administration, and listed in the federal Controlled Substances Act,127 21 U.S.C. Section 812.128 (b) Section 3 of this Act shall become effective only if a dru g containing crystalline129 polymorph psilocybin is approved by the federal Food and Drug A dministration under130 Section 505 of the federal Food, Drug, and Cosmetic Act, scheduled in accordance with its131 scheduling by the United States Drug Enforcement Administration, and listed in the federal132 Controlled Substances Act, 21 U.S.C. Section 812.133 SECTION 9.134 All laws and parts of laws in conflict with this Act are repealed.135 H. B. 382 - 6 -