HB1361: HB1361 Pharmacies; compounding of certain active pharmaceutical ingredients; provisions

26 LC 52 1029 House Bill 1361 By: Representatives Kelley of the 16th, Hawkins of the 27th, and Dempsey of the 13th A BILL TO BE ENTITLED AN ACT To amend Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to1 pharmacists and pharmacies, so as to provide for the compoundin g of certain active2 pharmaceutical ingredients; to provide for definitions; to proh ibit the sale, transfer, or3 distribution of certain compounded drugs under certain conditions; to require manufacturers4 and wholesalers to provide certain documentation; to provide fo r record maintenance; to5 provide for the timely furnishing of records to the State Board of Pharmacy; to authorize6 inspections by the State Board of Pharmacy; to provide for pena lties and enforcement; to7 provide for rules and regulations; to provide for related matters; to repeal conflicting laws;8 and for other purposes.9 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:10 SECTION 1.11 Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists and12 pharmacies, is amended in Article 5, relating to prescription drugs, by adding a new Code13 section to read as follows:14 "26-4-91.15 (a) As used in this Code section, the term:16 H. B. 1361 - 1 - 26 LC 52 1029 (1) 'Active pharmaceutical ingredient' means any substance tha t is intended for17 incorporation into a finished drug product and is intended to f urnish pharmacological18 activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention19 of disease, or to affect the structure or any function of the body. Such term shall include20 bulk drug substances, but shall not include inactive ingredients, such as flavoring agents,21 or intermediates used in the synthesis of the substance.22 (2) 'Human drug establishment' means a place of business that manufactures, prepares,23 propagates, compounds, or processes drugs intended for human us e and subject to24 inspections under 21 U.S.C. Section 374. Such term shall not in clude a wholesaler,25 relabeler, repacker, or similar entity.26 (3) 'Pharmaceutical grade product' means any active or inactive drug, biologic, or reagent27 that is manufactured under good manufacturing practices and app roved by the federal28 Food and Drug Administration for use in humans and for which a chemical purity29 standard has been written or established by a recognized compendia. Such term shall not30 include chemical grade, research grade, animal grade, or food grade substances.31 (b) It shall be unlawful for any person or entity to engage in t h e s a l e , t r a n s f e r , o r32 distribution of a drug compounded under Section 503A of the federal act using an active33 pharmaceutical ingredient that is a glucose-dependent insulinotropic polypeptide receptor34 or a glucagon-like peptide-1 receptor agonist used for obesity or weight management or35 that is a component of a similar drug approved by the federal F ood and Drug36 Administration for obesity or weight management unless the compounder of the drug:37 (1) Uses active pharmaceutical ingredients that:38 (A) Comply with the standards of an applicable United States P harmacopeia or39 National Formulary monograph, if a monograph exists, and the Un ited States40 Pharmacopeia chapter on pharmacy compounding;41 (B) If such a monograph does not exist, are pharmaceutical ing redients that are42 components of drugs approved by the federal Food and Drug Administration; or43 H. B. 1361 - 2 - 26 LC 52 1029 (C) If such a monograph does not exist and the drug substance is not a component of44 a drug approved by the federal Food and Drug Administration, ap pear on the list45 developed by the federal Food and Drug Administration pursuant to Section46 503A(b)(1)(A)(i)(III) of the federal act;47 (2) Confirms that any active pharmaceutical ingredient used under subparagraph (B) of48 paragraph (1) of this subsection was reviewed as part of a new drug application approved49 by the federal Food and Drug Administration under Section 505 of the federal act;50 (3) Ensures that the active pharmaceutical ingredient is a pharmaceutical grade product;51 (4) Verifies that the active pharmaceutical ingredient is acco mpanied by a valid52 certificate of analysis;53 (5) Conducts and documents quality control testing of any acti ve pharmaceutical54 ingredient prior to its use in a compounded drug to confirm:55 (A) The identity and content of the active pharmaceutical ingredient; and56 (B) The name and quantity of eac h impurity present in the acti ve pharmaceutical57 ingredient;58 (6) Conducts and documents quality control testing of the fini shed compounded drug59 product in batches before release and at expiry for any impurit ies derived from the use60 of an active pharmaceutical ingredient, including identifying t he chemical name and61 quantifies of any such impurities;62 (7) Obtains proof that the manufacture of the active pharmaceutical ingredient took place63 in an establishment that:64 (A) Is duly registered with the federal Food and Drug Administ ration under Section65 510 of the federal act;66 (B) Has undergone an inspection by the federal Food and Drug A dministration as a67 human drug establishment; and68 (C) Is not subject to an import alert by the federal Food and Drug Administration; and69 H. B. 1361 - 3 - 26 LC 52 1029 (8) Complies with the provisions of the federal act, including , but not limited to, the70 provisions in Section 503A.71 (c) It shall be unlawful for any manufacturer or wholesaler to sell, transfer, or distribute72 any active pharmaceutical ingredient in this state for use in c ompounding without73 providing to the purchaser written documentation that such ingredient is a pharmaceutical74 grade product, a valid certificate of analysis of such ingredient, any quality control testing75 of such ingredient, and the sourcing requirements for such ingredient as provided for under76 paragraphs (3) through (7) of subsection (b) of this Code section.77 (d) Any person or entity engaging in the sale, transfer, or di stribution of compounded78 drugs shall maintain all records related to the acquisition, examination, and testing of the79 active pharmaceutical ingredient for not less than two years after the expiration date of the80 last lot of drug containing the active pharmaceutical ingredient and, upon a request by the81 board of pharmacy, shall furnish such records within one busine ss day of receiving the82 request, or within a reasonable time as determined by the board based on the circumstances83 of the request.84 (e) The board of pharmacy, its duly authorized agent, or a duly authorized agent of a third85 party approved by the board shall have the authority to inspect any person or entity that86 engages in compounding drugs, as well as any domestic supplier, wholesaler, repackager,87 or other provider of the active pharmaceutical ingredient for compounding, for compliance88 with the requirements in subsection (b) of this Code section. Refusal to permit the board89 or its duly authorized agent or third party access to conduct an inspection shall constitute90 a violation of this Code section.91 (f) A violation of this Code section shall result in:92 (1) A fine of $1,000.00 per dose of the illegally compounded drug sold, transferred, or93 distributed; and94 (2) Revocation of the pharmacy or business license, as applicable.95 H. B. 1361 - 4 - 26 LC 52 1029 (g) The board is authorized to promulgate rules and regulations as necessary to implement96 the provisions of this Code section."97 SECTION 2.98 All laws and parts of laws in conflict with this Act are repealed.99 H. B. 1361 - 5 -