Bill Text: MS SB2544 | 2026 | Regular Session | Introduced
Bill Title: Mississippi Active Pharmaceutical Ingredient Quality Assurance Act; enact to impose certain provisions for compounding.
Sponsorship: Partisan Bill (Republican 1)
Status: (Failed) 2026-02-03 - Died In Committee [SB2544 Detail]
Download: Mississippi-2026-SB2544-Introduced.html
2026 Regular Session
To: Public Health and Welfare
By: Senator(s) Fillingane
Senate Bill 2544
AN ACT TO CREATE THE "MISSISSIPPI ACTIVE PHARMACEUTICAL INGREDIENT QUALITY ASSURANCE ACT" WITHIN CHAPTER 21, TITLE 73, MISSISSIPPI CODE OF 1972; TO PROVIDE THAT IT IS UNLAWFUL FOR ANY PERSON OR ENTITY TO ENGAGE IN THE SALE, TRANSFER OR DISTRIBUTION OF A DRUG COMPOUNDED UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT UNLESS THE COMPOUNDER OF THE DRUG SATISFIES CERTAIN REQUIREMENTS AND STANDARDS RELATING TO BULK DRUG SUBSTANCES; TO SET FORTH PENALTIES FOR VIOLATIONS OF THIS ACT; TO REQUIRE PERSONS OR ENTITIES ENGAGING IN THE SALE, TRANSFER OR DISTRIBUTION OF COMPOUNDED DRUGS TO MAINTAIN ALL RECORDS RELATED TO THE ACQUISITION, EXAMINATION AND TESTING OF THE BULK DRUG SUBSTANCE FOR AT LEAST TWO YEARS AFTER THE EXPIRATION DATE OF THE LAST LOT OF DRUG CONTAINING THE BULK DRUG SUBSTANCE; TO AUTHORIZE THE BOARD OF PHARMACY TO PERFORM INSPECTIONS FOR COMPLIANCE WITH THIS ACT AND TO PROMULGATE RULES AND REGULATIONS NECESSARY TO IMPLEMENT THIS ACT; AND FOR RELATED PURPOSES.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
SECTION 1. This act shall be known and may be cited as the "Mississippi Active Pharmaceutical Ingredient Quality Assurance Act."
SECTION 2. As used in this act, "bulk drug substance," also known as "active pharmaceutical ingredient" or "API," 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. A bulk drug substance does not include intermediates used in the synthesis of the substance.
SECTION 3. It is unlawful for any person or entity to engage in the sale, transfer or distribution of a drug compounded under Section 503A of the Federal Food, Drug, and Cosmetic Act (21 USC � 353a) unless the compounder of the drug:
(a) Uses bulk drug substances that:
(i) Comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(ii) If such a monograph described under subparagraph (i) of this paragraph (a) does not exist, are drug substances that are components of drugs approved by the United States Food and Drug Administration (FDA); or
(iii) If such a monograph described under subparagraph (i) of this paragraph (a) does not exist and the drug substance is not a component of a drug approved by the FDA as described under subparagraph (ii) of this paragraph (a), appears on the list developed by the FDA pursuant to Section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act (21 USC � 353a(b)(1)(A)(i)(III));
(b) Confirms that any bulk drug substance used under subsection (1)(a)(ii) of this section was reviewed as part of a new drug application approved by the FDA under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 USC � 355);
(c) Ensures that the bulk drug substance is a pharmaceutical grade product;
(d) Verifies that the bulk drug substance is accompanied by a valid certificate of analysis containing all informational material regarding the safety and effectiveness of the drug compounded using the bulk drug substance, including the identity and content of the bulk drug substance, the country where the bulk drug substance was originally manufactured, identification of each impurity by chemical name and amount present, and any additional element that the Board of Pharmacy may by regulation require;
(e) Conducts and documents quality control testing of the bulk drug substance prior to its use in a compounded drug to confirm:
(i) The identity and content of the bulk drug substance; and
(ii) That impurities present are identified, characterized, quantified and justified given the product and its intended use;
(f) Obtains proof that the manufacture of the bulk drug substance took place in an establishment that:
(i) Is duly registered with the FDA under Section 510 of the Federal Food, Drug, and Cosmetic Act (21 USC � 360);
(ii) Has, within the last two (2) years, undergone an inspection by the FDA as a human drug establishment and such inspection:
1. Included current good manufacturing practice compliance and covered the relevant bulk drug substance; and
2. Was classified as Voluntary Action Indicated (VAI) or No Action Indicated (NAI); and
(g) Complies with the Federal Food, Drug, and Cosmetic Act, including the provisions in Section 503A (21 USC � 353a).
SECTION 4. The Board of Pharmacy shall impose the following penalties to a person or entity found in violation of this act:
(a) A fine of One Thousand Dollars ($1,000.00) per dose of the illegally compounded drug sold, transferred or distributed; and
(b) Revocation of the pharmacy or business license of the person or entity, as applicable.
SECTION 5. (1) 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 bulk drug substance for not less than two (2) years after the expiration date of the last lot of drug containing the bulk drug substance and, upon a request by the Board of Pharmacy, shall furnish such records within one (1) business day of receiving the request, or within a reasonable time as determined by the Board of Pharmacy based on the circumstances of the request.
(2) The Board of Pharmacy or its duly authorized agent, or a duly authorized agent of a third party approved by the Board of Pharmacy, shall have the authority to inspect any person or entity that engages in compounding drugs, as well any domestic supplier, wholesaler, repackager or other provider of the bulk drug substance for compounding, for compliance with the requirements under Section 3 of this act. Refusal to permit the Board of Pharmacy or its duly authorized agent, or a duly authorized agent of a third party approved by the Board of Pharmacy access to conduct an inspection shall constitute a violation of this act.
(3) The Board of Pharmacy is authorized to promulgate rules and regulations as necessary to implement this act.
SECTION 6. If any provision of this act, or its application to any person or circumstance, is held invalid, such invalidity shall not affect other provisions or applications of this act that can be given effect without the invalid provision or application. To this end, the provisions of this act are severable.
SECTION 7. Sections 1 through 6 of this act shall be codified within Chapter 21, Title 73, Mississippi Code of 1972.
SECTION 8. This act shall take effect and be in force from and after its passage.
