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 to
pharmacists and pharmacies, so as to provide for the compounding of certain active
pharmaceutical ingredients; to provide for definitions; to prohibit the sale, transfer, or
distribution of certain compounded drugs under certain conditions; to require manufacturers
and wholesalers to provide certain documentation; to provide for record maintenance; to
provide for the timely furnishing of records to the State Board of Pharmacy; to authorize
inspections by the State Board of Pharmacy; to provide for penalties and enforcement; to
provide for rules and regulations; to provide for related matters; to repeal conflicting laws;
and for other purposes.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION 1.
Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists and
pharmacies, is amended in Article 5, relating to prescription drugs, by adding a new Code
section to read as follows:
<ins>"26-4-91.
(a) As used in this Code section, the term:
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<ins>(1) 'Active pharmaceutical ingredient' means any substance that is intended for
incorporation into a finished drug product and is intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention
of disease, or to affect the structure or any function of the body. Such term shall include
bulk drug substances, but shall not include inactive ingredients, such as flavoring agents,
or intermediates used in the synthesis of the substance.
(2) 'Human drug establishment' means a place of business that manufactures, prepares,
propagates, compounds, or processes drugs intended for human use and subject to
inspections under 21 U.S.C. Section 374. Such term shall not include a wholesaler,
relabeler, repacker, or similar entity.
(3) 'Pharmaceutical grade product' means any active or inactive drug, biologic, or reagent
that is manufactured under good manufacturing practices and approved by the federal
Food and Drug Administration for use in humans and for which a chemical purity
standard has been written or established by a recognized compendia. Such term shall not
include chemical grade, research grade, animal grade, or food grade substances.
(b) It shall be unlawful for any person or entity to engage in the sale, transfer, or
distribution of a drug compounded under Section 503A of the federal act using an active
pharmaceutical ingredient that is a glucose-dependent insulinotropic polypeptide receptor
or a glucagon-like peptide-1 receptor agonist used for obesity or weight management or
that is a component of a similar drug approved by the federal Food and Drug
Administration for obesity or weight management unless the compounder of the drug:
(1) Uses active pharmaceutical ingredients that:
(A) Comply with the standards of an applicable United States Pharmacopeia or
National Formulary monograph, if a monograph exists, and the United States
Pharmacopeia chapter on pharmacy compounding;
(B) If such a monograph does not exist, are pharmaceutical ingredients that are
components of drugs approved by the federal Food and Drug Administration; or
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<ins>(C) If such a monograph does not exist and the drug substance is not a component of
a drug approved by the federal Food and Drug Administration, appear on the list
developed by the federal Food and Drug Administration pursuant to Section
503A(b)(1)(A)(i)(III) of the federal act;
(2) Confirms that any active pharmaceutical ingredient used under subparagraph (B) of
paragraph (1) of this subsection was reviewed as part of a new drug application approved
by the federal Food and Drug Administration under Section 505 of the federal act;
(3) Ensures that the active pharmaceutical ingredient is a pharmaceutical grade product;
(4) Verifies that the active pharmaceutical ingredient is accompanied by a valid
certificate of analysis;
(5) Conducts and documents quality control testing of any active pharmaceutical
ingredient prior to its use in a compounded drug to confirm:
(A) The identity and content of the active pharmaceutical ingredient; and
(B) The name and quantity of each impurity present in the active pharmaceutical
ingredient;
(6) Conducts and documents quality control testing of the finished compounded drug
product in batches before release and at expiry for any impurities derived from the use
of an active pharmaceutical ingredient, including identifying the chemical name and
quantifies of any such impurities;
(7) Obtains proof that the manufacture of the active pharmaceutical ingredient took place
in an establishment that:
(A) Is duly registered with the federal Food and Drug Administration under Section
510 of the federal act;
(B) Has undergone an inspection by the federal Food and Drug Administration as a
human drug establishment; and
(C) Is not subject to an import alert by the federal Food and Drug Administration; and
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<ins>(8) Complies with the provisions of the federal act, including, but not limited to, the
provisions in Section 503A.
(c) It shall be unlawful for any manufacturer or wholesaler to sell, transfer, or distribute
any active pharmaceutical ingredient in this state for use in compounding without
providing to the purchaser written documentation that such ingredient is a pharmaceutical
grade product, a valid certificate of analysis of such ingredient, any quality control testing
of such ingredient, and the sourcing requirements for such ingredient as provided for under
paragraphs (3) through (7) of subsection (b) of this Code section.
(d) Any person or entity engaging in the sale, transfer, or distribution of compounded
drugs shall maintain all records related to the acquisition, examination, and testing of the
active pharmaceutical ingredient for not less than two years after the expiration date of the
last lot of drug containing the active pharmaceutical ingredient and, upon a request by the
board of pharmacy, shall furnish such records within one business day of receiving the
request, or within a reasonable time as determined by the board based on the circumstances
of the request.
(e) The board of pharmacy, its duly authorized agent, or a duly authorized agent of a third
party approved by the board shall have the authority to inspect any person or entity that
engages in compounding drugs, as well as any domestic supplier, wholesaler, repackager,
or other provider of the active pharmaceutical ingredient for compounding, for compliance
with the requirements in subsection (b) of this Code section. Refusal to permit the board
or its duly authorized agent or third party access to conduct an inspection shall constitute
a violation of this Code section.
(f) A violation of this Code section shall result in:
(1) A fine of $1,000.00 per dose of the illegally compounded drug sold, transferred, or
distributed; and
(2) Revocation of the pharmacy or business license, as applicable.
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<ins>(g) The board is authorized to promulgate rules and regulations as necessary to implement
the provisions of this Code section."
</ins> SECTION 2.
All laws and parts of laws in conflict with this Act are repealed.