Bill Text: CA AB1990 | 2025-2026 | Regular Session | Amended
Bill Title: Pharmacy Law: advertising certain compounded medications used for obesity or weight management.
Sponsorship: Partisan Bill (Democrat 1)
Status: (Engrossed) 2026-08-03 - In committee: Referred to APPR. suspense file. [AB1990 Detail]
Download: California-2025-AB1990-Amended.html
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Amended
IN
Senate
June 24, 2026 |
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Amended
IN
Assembly
April 23, 2026 |
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Amended
IN
Assembly
April 15, 2026 |
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Amended
IN
Assembly
March 09, 2026 |
| Introduced by Assembly Member Gipson |
February 17, 2026 |
LEGISLATIVE COUNSEL'S DIGEST
This bill would make it unlawful for a person or entity to engage in the sale, transfer, or distribution of a compounded drug using a drug substance that is a glucose-dependent insulinotropic polypeptide receptor or glucagon-like peptide-1 receptor agonist used for obesity or weight management or a drug substance that is a component of a generic equivalent approved by the federal Food and Drug Administration for obesity or weight management unless the compounder of the drug takes specified actions. These acts would include ensuring that the bulk drug substance, as defined, is a pharmaceutical grade product and is accompanied by a valid certificate of analysis. The bill would
also make it unlawful for a manufacturer or wholesaler to sell, transfer, or distribute a bulk drug substance for use in a compounded drug used for obesity or weight management, as provided, without providing to the purchaser written verification that the bulk drug substance meets specified conditions, including being pharmaceutical grade. The bill would make a violation of these provisions punishable by a fine of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed and license revocation.
The bill would require any person or entity 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 not less than 2 years after the expiration date of the last lot of drug containing the bulk drug substance and, upon request, to furnish that information to the board. The bill would authorize
the board or its duly authorized agent to inspect any person or entity that engages in compounding drugs, as prescribed.
The
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YESBill Text
The people of the State of California do enact as follows:
(a)The Legislature finds and declares all of the following:
(1)The safety and integrity of compounded medications are paramount for the health and well-being of residents of California.
(2)The United States Food and Drug Administration (FDA) sets internationally recognized standards for drug approval and regulatory oversight; however, there have been increasing attempts by unscrupulous actors to circumvent these regulations, undermining public trust and patient safety.
(3)Foreign entities, including
those from countries such as China, have exploited regulatory gaps to introduce inferior or contaminated active pharmaceutical ingredients (API) into the supply chain for medications intended for compounding.
(4)Recent cases, such as those involving medications for weight loss, have demonstrated that high demand can lead to the proliferation of the use of illicit, substandard, and potentially harmful API, jeopardizing patient health and safety.
(5)While the FDA bears responsibility for enforcing federal laws to protect citizens from misbranded and adulterated pharmaceutical ingredients, enforcement has proven insufficient to curtail the influx of these substances.
(6)Even after the FDA took some action to curb imports
of API for weight loss medications from entities that are not compliant with current good manufacturing practice requirements, patients in our state remain at risk of receiving compounded medications containing API produced by entities that the FDA found to not be compliant with those requirements, including API imported into the United States before the FDA took action.
(7)Therefore, it is necessary for the state to take action to protect its residents by ensuring that all API used in compounding is sourced from reputable, registered, and inspected establishments, and that only pharmaceutical-grade, safe, and pure ingredients are utilized in medications for weight loss.
(b)It is the intent of the Legislature, in enacting this bill, to establish safety and regulatory
requirements for compounded medications.
SEC. 2.SECTION 1.
Article 10.5 (commencing with Section 4157) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:
Article
10.5. Consumer Protection Compounding Act Advertising Compounded Medications
(a)This article applies solely to compounded drugs that are glucose-dependent insulinotropic polypeptide receptor or glucagon-like peptide-1 receptor agonists or other amino acid polymers intended to be used by humans for obesity or weight management. This article does not relieve, exempt, or otherwise limit the applicability of any state or federal law to compounded drugs that do not fall within the scope of this article.
(b)For purposes of this article, “bulk drug substance,” also known as “active pharmaceutical ingredient (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. “Bulk drug substance” does not include intermediates used in the synthesis of the substance.
(a)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 U.S.C. Sec. 353a) using a drug substance that is a glucose-dependent insulinotropic polypeptide receptor or glucagon-like peptide-1 receptor agonist used for obesity or weight management or a drug substance that is a component of a generic equivalent approved by the federal Food and Drug Administration for obesity or weight management unless the compounder of the drug does all of the following:
(1)Uses bulk drug substances that comply with the following, as applicable:
(A)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.
(B)If such a monograph does not exist, the bulk drug substances are drug substances that are components of drugs approved by the United States Food and Drug Administration (FDA).
(C)If such a monograph does not exist and the drug substance is not a component of a drug approved by the FDA, the bulk drug substances appear on the list developed by the FDA pursuant to Section 503A(c)(2) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353a(c)(2)).
(2)If the labeling of a drug approved by the federal Food and Drug Administration specifies a process for manufacturing the drug substance, confirms that any bulk drug substance used under 21 U.S.C. Sec. 353a(b)(1)(A)(i)(II) was manufactured according to that process.
(3)Ensures that the bulk drug substance is a pharmaceutical grade product.
(4)Verifies that the bulk drug substance is accompanied by a valid certificate of analysis.
(5)Conducts and documents quality control testing of any bulk drug substance prior to its use in a compounded drug to confirm the identity and content of the bulk drug substance and the name and quantity of each impurity present in the bulk drug substance in an amount that exceeds one-tenth of one percent (0.1%).
(6)Conducts and documents quality control testing of finished drug product compounded in batches before release and at expiry for any impurities derived from the use of a bulk drug substance, including the chemical name and quantities of any impurities.
(7)Obtains proof that the manufacture of the bulk drug substance took place in an establishment that meets all of the following:
(A)Is duly registered with the FDA under Section 510 of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360).
(B)Has undergone an inspection by the FDA as a human drug establishment within the last two years.
(C)Is not subject to an import alert by the FDA.
(8)Complies with the federal Food, Drug, and Cosmetic Act, including the provisions in Section 503A (21 U.S.C. Sec. 353a).
(b)It is unlawful for any manufacturer or wholesaler to sell, transfer, or distribute a bulk drug substance in this state for use in
a compounded drug specified in subdivision (a) without providing to the purchaser written verification that the bulk drug substance meets all of the following:
(1)Is pharmaceutical grade, as required under paragraph (3) of subdivision (a).
(2)Meets the sourcing requirements under paragraph (7) of subdivision (a).
(3)Meets the quality control testing requirements under paragraph (5) of subdivision (a)
(4)Is accompanied by a valid certificate of analysis, as required under paragraph (4) of subdivision (a).
A violation of this article shall result in both of the following:
(a)A fine of one thousand dollars ($1,000) per dose of the illegally compounded drug sold, transferred, or distributed.
(b)Revocation of the person or entity’s pharmacy or business license, as applicable.
(a)Any person or entity engaging in the sale, transfer, or distribution of compounded drugs under subdivision (a) of Section 4157.1 shall maintain all records related to the acquisition, examination, and testing of the bulk drug substance for not less than two years after the expiration date of the last lot of drug containing the bulk drug substance and, upon a request by the board, shall furnish those 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.
(b)The board or its duly authorized agent, or a duly authorized agent of a third party approved by the board, has
the authority to inspect any person or entity that engages in compounding drugs, or any domestic supplier, wholesaler, repackager, or other provider of the bulk drug substance for compounding, for compliance with the requirements in Section 4157.1. Refusal to permit the board or its duly authorized agent or third-party access to conduct an inspection constitutes a violation of this article.
4157.4.4157.
(a) For purposes of this section:(a)The board may adopt necessary rules and regulations to implement this article.
(b)This article does not apply to physicians and surgeons licensed pursuant to Chapter 5 (commencing with Section 2000). This subdivision does not alter the obligation of a physician and surgeon to comply with any other applicable law.
(c)The provisions of this article are severable. If any provision of this article or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
