Mississippi Active Pharmaceutical Ingredient Quality Assurance Act; enact to impose certain provisions for compounding.

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To: Public Health and
Welfare
MISSISSIPPI LEGISLATURE REGULAR SESSION 2026

By: Senator(s) Fillingane

SENATE BILL NO. 2544

AN ACT TO CREATE THE "MISSISSIPPI ACTIVE PHARMACEUTICAL 1
INGREDIENT QUALITY ASSURANCE ACT" WITHIN CHAPTER 21, TITLE 73, 2
MISSISSIPPI CODE OF 1972; TO PROVIDE THAT IT IS UNLAWFUL FOR ANY 3
PERSON OR ENTITY TO ENGAGE IN THE SALE, TRANSFER OR DISTRIBUTION 4
OF A DRUG COMPOUNDED UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, 5
AND COSMETIC ACT UNLESS THE COMPOUNDER OF THE DRUG SATISFIES 6
CERTAIN REQUIREMENTS AND STANDARDS RELATING TO BULK DRUG 7
SUBSTANCES; TO SET FORTH PENALTIES FOR VIOLATIONS OF THIS ACT; TO 8
REQUIRE PERSONS OR ENTITIES ENGAGING IN THE SALE, TRANSFER OR 9
DISTRIBUTION OF COMPOUNDED DRUGS TO MAINTAIN ALL RECORDS RELATED 10
TO THE ACQUISITION, EXAMINATION AND TESTING OF THE BULK DRUG 11
SUBSTANCE FOR AT LEAST TWO YEARS AFTER THE EXPIRATION DATE OF THE 12
LAST LOT OF DRUG CONTAINING THE BULK DRUG SUBSTANCE; TO AUTHORIZE 13
THE BOARD OF PHARMACY TO PERFORM INSPECTIONS FOR COMPLIANCE WITH 14
THIS ACT AND TO PROMULGATE RULES AND REGULATIONS NECESSARY TO 15
IMPLEMENT THIS ACT; AND FOR RELATED PURPOSES. 16
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI: 17
SECTION 1. This act shall be known and may be cited as the 18
"Mississippi Active Pharmaceutical Ingredient Quality Assurance 19
Act." 20
SECTION 2. As used in this act, "bulk drug substance," also 21
known as "active pharmaceutical ingredient" or "API," means any 22
substance that is intended for incorporation into a finished drug 23
product and is intended to furnish pharmacological activity or 24
other direct effect in the diagnosis, cure, mitigation, treatment 25
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or prevention of disease, or to affect the structure or any 26
function of the body. A bulk drug substance does not include 27
intermediates used in the synthesis of the substance. 28
SECTION 3. It is unlawful for any person or entity to engage 29
in the sale, transfer or distribution of a drug compounded under 30
Section 503A of the Federal Food, Drug, and Cosmetic Act (21 USC § 31
353a) unless the compounder of the drug: 32
(a) Uses bulk drug substances that: 33
(i) Comply with the standards of an applicable 34
United States Pharmacopoeia or National Formulary monograph, if a 35
monograph exists, and the United States Pharmacopoeia chapter on 36
pharmacy compounding; 37
(ii) If such a monograph described under 38
subparagraph (i) of this paragraph (a) does not exist, are drug 39
substances that are components of drugs approved by the United 40
States Food and Drug Administration (FDA); or 41
(iii) If such a monograph described under 42
subparagraph (i) of this paragraph (a) does not exist and the drug 43
substance is not a component of a drug approved by the FDA as 44
described under subparagraph (ii) of this paragraph (a), appears 45
on the list developed by the FDA pursuant to Section 46
503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act 47
(21 USC § 353a(b)(1)(A)(i)(III)); 48
(b) Confirms that any bulk drug substance used under 49
subsection (1)(a)(ii) of this section was reviewed as part of a 50
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new drug application approved by the FDA under Section 505 of the 51
Federal Food, Drug, and Cosmetic Act (21 USC § 355); 52
(c) Ensures that the bulk drug substance is a 53
pharmaceutical grade product; 54
(d) Verifies that the bulk drug substance is 55
accompanied by a valid certificate of analysis containing all 56
informational material regarding the safety and effectiveness of 57
the drug compounded using the bulk drug substance, including the 58
identity and content of the bulk drug substance, the country where 59
the bulk drug substance was originally manufactured, 60
identification of each impurity by chemical name and amount 61
present, and any additional element that the Board of Pharmacy may 62
by regulation require; 63
(e) Conducts and documents quality control testing of 64
the bulk drug substance prior to its use in a compounded drug to 65
confirm: 66
(i) The identity and content of the bulk drug 67
substance; and 68
(ii) That impurities present are identified, 69
characterized, quantified and justified given the product and its 70
intended use; 71
(f) Obtains proof that the manufacture of the bulk drug 72
substance took place in an establishment that: 73
(i) Is duly registered with the FDA under Section 74
510 of the Federal Food, Drug, and Cosmetic Act (21 USC § 360); 75
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(ii) Has, within the last two (2) years, undergone 76
an inspection by the FDA as a human drug establishment and such 77
inspection: 78
1. Included current good manufacturing 79
practice compliance and covered the relevant bulk drug substance; 80
and 81
2. Was classified as Voluntary Action 82
Indicated (VAI) or No Action Indicated (NAI); and 83
(g) Complies with the Federal Food, Drug, and Cosmetic 84
Act, including the provisions in Section 503A (21 USC § 353a). 85
SECTION 4. The Board of Pharmacy shall impose the following 86
penalties to a person or entity found in violation of this act: 87
(a) A fine of One Thousand Dollars ($1,000.00) per dose 88
of the illegally compounded drug sold, transferred or distributed; 89
and 90
(b) Revocation of the pharmacy or business license of 91
the person or entity, as applicable. 92
SECTION 5. (1) Any person or entity engaging in the sale, 93
transfer or distribution of compounded drugs shall maintain all 94
records related to the acquisition, examination and testing of the 95
bulk drug substance for not less than two (2) years after the 96
expiration date of the last lot of drug containing the bulk drug 97
substance and, upon a request by the Board of Pharmacy, shall 98
furnish such records within one (1) business day of receiving the 99
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ST: Mississippi Active Pharmaceutical
Ingredient Quality Assurance Act; enact to
impose certain provisions for compounding.
request, or within a reasonable time as determined by the Board of 100
Pharmacy based on the circumstances of the request. 101
(2) The Board of Pharmacy or its duly authorized agent, or a 102
duly authorized agent of a third party approved by the Board of 103
Pharmacy, shall have the authority to inspect any person or entity 104
that engages in compounding drugs, as well any domestic supplier, 105
wholesaler, repackager or other provider of the bulk drug 106
substance for compounding, for compliance with the requirements 107
under Section 3 of this act. Refusal to permit the Board of 108
Pharmacy or its duly authorized agent, or a duly authorized agent 109
of a third party approved by the Board of Pharmacy access to 110
conduct an inspection shall constitute a violation of this act. 111
(3) The Board of Pharmacy is authorized to promulgate rules 112
and regulations as necessary to implement this act. 113
SECTION 6. If any provision of this act, or its application 114
to any person or circumstance, is held invalid, such invalidity 115
shall not affect other provisions or applications of this act that 116
can be given effect without the invalid provision or application. 117
To this end, the provisions of this act are severable. 118
SECTION 7. Sections 1 through 6 of this act shall be 119
codified within Chapter 21, Title 73, Mississippi Code of 1972. 120
SECTION 8. This act shall take effect and be in force from 121
and after its passage. 122