Existing law, the Pharmacy Law, requires the California State Board of Pharmacy within the Department of Consumer Affairs to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies. Under existing law, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription unless they are licensed, as specified. A violation of that law is a crime.

Existing law also requires the compounding of drug preparations by a pharmacy for furnishing, distribution, or use to be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. Existing law authorizes advertisements for prescription drugs, if the advertisement conforms with certain requirements, including not containing a false, fraudulent, misleading, or deceptive statement. A violation of the Pharmacy Law is a crime.

This bill would also make it unlawful for any person to advertise or otherwise promote certain compounded medications used for obesity or weight management, as provided, unless the advertisement is truthful and not misleading, including not containing an unsubstantiated claim with respect to the product. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. This bill would provide that its provisions do not apply to physicians and surgeons, as specified.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Pharmacy Law, requires the California State Board of Pharmacy within the Department of Consumer Affairs to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies. Under existing law, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription unless they are licensed, as specified. A violation of that law is a crime.

Existing law also requires the compounding of drug preparations by a pharmacy for furnishing, distribution, or use to be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. Existing law authorizes advertisements for prescription drugs, if the advertisement conforms with certain requirements, including not containing a false, fraudulent, misleading, or deceptive statement.

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 bill would also make it unlawful for any person to advertise or otherwise promote compounded medications used for obesity or weight management, as provided, unless the advertisement is truthful and not misleading, including not containing an unsubstantiated claim with respect to the product. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. This bill would provide that its provisions do not apply to physicians and surgeons, as specified.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Pharmacy Law, requires the California State Board of Pharmacy within the Department of Consumer Affairs to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies. Under existing law, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription unless they are licensed, as specified. A violation of that law is a crime.

Existing law also requires the compounding of drug preparations by a pharmacy for furnishing, distribution, or use to be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. Existing law authorizes advertisements for prescription drugs, if the advertisement conforms with certain requirements, including not containing a false, fraudulent, misleading, or deceptive statement.

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 glucagon-like peptide-1 receptor agonist used for obesity or weight management or a drug substance that is a component of a similar drug 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 compounding 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 bill would also make it unlawful for any person to advertise or otherwise promote compounded medications used for obesity or weight management, as provided, unless the advertisement is truthful and not misleading, including not containing an unsubstantiated claim with respect to the product. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. This bill would provide that its provisions do not apply to physicians and surgeons, as specified.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the protection of business good will, trademarks, trade names and designations, and other business rights, and regulates their use in solicitations for financial services.

This bill would make a nonsubstantive change to these provisions.

SENATE COMMITTEE ON

Senator Sabrina Cervantes, Chair

2025 - 2026 Regular Session

AB 1990 (Gipson) - Pharmacy Law: advertising certain compounded medications used for obesity or weight management

Bill Summary:

AB 1990 prohibits the advertising or promotion of a compounded medication for weight loss or obesity management unless the advertisement is truthful, substantiated by scientific evidence, and includes explicit disclosures regarding the drug's risks, side effects, relevant risk summaries approved by the U.S. Food and Drug Administration (FDA), and a clear statement that the product is not FDA-approved.

Fiscal Impact:

• Unknown court cost pressures ranging from minor to significant (General Fund and special funds) to the extent the Attorney General (AG) brings civil actions against any person who violates the advertising and promotion prohibitions. Actual costs will depend on the number of actions filed and the time required to adjudicate each case. The Department of Justice (DOJ) reports that it does not anticipate a significant fiscal impact; this assessment suggests the department may not actively pursue enforcement using the authority prescribed in the bill.
• Unknown, potentially significant court cost pressures (Trial Court Trust Fund and General Fund) as the False Advertising Law (FAL) and Unfair Competition Law (UCL) provide a private right of action for consumers. Although trial courts are not funded based on workload, increased pressure on the Trial Court Trust Fund may create a demand for additional court resources. For context, the proposed 2026-27 Governor’s Budget would provide $70 million General Fund support to the Trial Court Trust Fund.
• The Board of Pharmacy (BOP) estimates workload to provide education of new advertising and promotion prohibitions for specific weight loss and obesity management medications to be absorbable (Pharmacy Board Contingent Fund).

Background:

California law establishes significant protections against false, misleading, and deceptive advertising through the Business and Professions Code (BPC). The BPC broadly prohibits untrue or misleading statements regarding the sale or disposition of goods or services. Public prosecutors enforce these provisions, which can result in civil penalties, injunctive relief, and other remedies under the state’s UCL and FAL (BPC §§ 17200 et seq.; 17500 et seq.). Additionally, pharmacists and pharmacies are subject to the regulatory authority of BOP, which pursues disciplinary action for unprofessional conduct, including violations of pharmacy practice and consumer protection laws (BPC §§ 4300 et seq.).

Furthermore, current law mandates extensive patient disclosure requirements for prescription medications. Under existing prescription labeling standards, drug containers must display the patient’s name, drug name and strength, directions for use, the prescriber’s name, and other critical safety information (BPC § 4076). Pharmacists are also legally required to offer patient consultations detailing drug usage, storage, precautions, and potential side effects (BPC § 4052.5; 16 California Code of Regulations (CCR) § 1707.2). Finally, compounded drug products remain subject to their own distinct, specific labeling requirements under established pharmacy law (BPC §§ 4127.7, 4127.8).

Proposed Law:

• Makes it unlawful for any person to advertise or otherwise promote a compounded medication unless the advertisement is truthful and not misleading. Provides that an advertisement is misleading and not truthful if it includes any unsubstantiated claim regarding product.
• Provides the following definitions:
  • “Compounded medication” means a compounded drug that is a glucose-dependent insulinotropic polypeptide (GIP) receptor or glucagon-like peptide-1 (GLP-1) receptor agonist or other amino acid polymer intended to be used by humans for obesity or weight management.
  • “Person” means any individual, partnership, firm, corporation, or other legal entity.
  • “Unsubstantiated claim” means any statement, representation, or assertion concerning the safety, efficacy, or other attributes of a drug that is not supported by competent and reliable scientific evidence.
• Provides that an advertisement of compounded medication is misleading unless it contains all of the following disclosures:
  • A disclosure of the potential side effects, adverse reactions, contraindications, precautions, and warnings associated with the active ingredients in the medication. This includes the risk disclosures found in the labeling of any FDA-approved drug containing the same active ingredients, unless the advertiser can demonstrate that a particular disclosure is not relevant to the compounded drug.
  • A summary of the specified risk information from the labeling of the FDA-approved drug, when the compounded drug contains an active ingredient shared with an FDA-approved drug.
  • A clear and conspicuous statement indicating that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or efficacy.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Dr. Aisha Wahab, Chair

2025 - 2026 Regular

Bill No: Hearing Date: June 29, 2026

Subject:

SUMMARY:

Prohibits any person from advertising or otherwise promoting a compounded medication containing an active ingredient used for weight loss or the treatment of obesity unless the advertisement is truthful and not misleading, and specifies that an advertisement is misleading if it contains an unsubstantiated claim regarding the safety, efficacy, or other attributes of the compounded medication. Requires advertisements for those compounded medications to include specified disclosures, including information regarding potential side effects, adverse reactions, contraindications, precautions, and warnings associated with the active ingredients, a summary of specified FDA-approved labeling information when applicable, and a clear and conspicuous statement that the product is a compounded medication that has not been approved or evaluated by the FDA for safety or efficacy.

NOTE: This bill is double-referred to the Senate Committee on Judiciary, second.

Existing law:

1. Prohibits any person, firm, corporation, or association from making or disseminating any statement concerning real or personal property or services that is untrue or misleading, or that is known, or by the exercise of reasonable care should be known, to be untrue or misleading, for the purpose of inducing the public to enter into any obligation relating thereto. (Business and Professions Code (Business and Professions Code (BPC)) § 17500)
2. Establishes the Unfair Competition Law (UCL), which prohibits any unlawful, unfair, or fraudulent business act or practice and authorizes civil enforcement actions by the Attorney General and other public prosecutors. (BPC §§ 17200 et seq.)
3. Defines the practice of pharmacy to include compounding and authorizes a pharmacist to furnish a reasonable quantity of compounded drug product to a prescriber for office use, as specified. (BPC § 4052)
4. Requires a pharmacist, upon the oral or written request of a patient or the patient’s agent, to provide consultation regarding a prescription drug, and requires pharmacies to maintain a procedure for offering consultation to patients or their agents for all new prescriptions and, where appropriate, refill prescriptions. Requires the consultation, when provided, to include information the pharmacist determines is appropriate, such as the name and description of the medication, dosage and directions for use, route of administration, storage requirements, precautions and relevant warnings, common severe side effects or adverse effects or interactions, techniques for self-monitoring therapy, proper use of drug delivery devices, and actions to take in the event of a missed dose. Requires pharmacies to provide patients with written information regarding their rights to consultation and maintain policies and procedures to ensure consultation is offered for new prescriptions. (BPC § 4052.5; 16 CCR § 1707.2)
5. Authorizes a licensed physician and surgeon, and certain other authorized prescribers, to dispense dangerous drugs or dangerous devices directly to their own patients, provided specified conditions are met, including offering the patient a written prescription that may be filled at the pharmacy of the patient's choice, providing written notice of that option, and complying with applicable dispensing, packaging, labeling, and recordkeeping requirements. (BPC § 4170)
6. Requires prescription medication dispensed to a patient to bear a label containing specified information, including, among other things, the patient’s name, the prescriber’s name, the directions for use, the date of issue, the name and strength of the drug, and other information intended to promote the safe use of the medication. (BPC § 4076)
7. Authorizes the California State Board of Pharmacy (Board) to administer and enforce the Pharmacy Law and to investigate violations and take disciplinary action against licensees for unprofessional conduct or violations of the Pharmacy Law. (BPC § 4000 et seq.)
8. Provides that the compounding of drug preparations by a pharmacy for furnishing, distribution, or use in California shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary (USP), including relevant testing and quality assurance; authorizes the BOP to adopt regulations to impose additional standards for compounding drug preparations. (BPC § 4126.8)
9. Authorizes a pharmacy to distribute compounded human drug preparations interstate if specified conditions are met. (BPC § 4126.10)
10. Requires a pharmacy that compounds sterile drug products to possess a sterile compounding pharmacy license. (BPC § 4127)
11. Prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the BOP. (BPC § 4127.1)
12. Prohibits a nonresident pharmacy from compounding sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the BOP. (BPC § 4127.2)
13. Provides that whenever the Board has a reasonable belief, based on information obtained during an inspection or investigation by the Board, that a pharmacy compounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the Board may issue an order to the pharmacy to immediately cease and desist from compounding sterile drug products. (BPC § 4127.3)

This bill:

1. Makes it unlawful in the Pharmacy Law for any person to advertise or otherwise promote a compounded drug that is a glucose-dependent insulinotropic polypeptide (GIP) receptor or glucagon-like peptide-1 receptor (GLP-1) agonist or other amino acid polymer intended to be used by humans for obesity or weight management unless the advertisement is truthful and not misleading. Provides that an advertisement is not truthful and is misleading if it includes any unsubstantiated claim with respect to the product.
2. States that an advertisement of a compounded GIP or GLP-1 is misleading unless it contains all of the following:
3. A disclosure of the potential side effects, adverse reactions, contraindications, precautions, and warnings associated with active ingredients in the medication, including the potential side effects, adverse reactions, contraindications, precautions, and warnings in the labeling of any FDA-approved drug containing the active ingredients named in the compounded drug, unless the advertiser can demonstrate that a particular disclosure is not relevant to the compounded drug.
4. A summary of the specified risk information in the labeling of the FDA-approved drug, when a compounded drug contains an active ingredient that is named as an active ingredient in an FDA-approved drug.
5. A clear, conspicuous statement that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or efficacy.

FISCAL EFFECT:

Unknown. This bill is keyed fiscal by Legislative Counsel but the current version of the bill has not been evaluated by a fiscal committee of the Legislature.

COMMENTS:

1. Purpose. The Author is the Sponsor of this bill. According to the Author, “AB 1990 protects patients by ensuring compounded GLP-1 agonist and similar drugs for weight loss are safe, high quality, and honestly marketed. As these medications—such as semaglutide and tirzepatide—have grown in popularity for weight management, demand has surged across the country. During initial supply shortages, many patients turned to compounded versions of these medications when FDA-approved products were difficult to access. These products are not reviewed or approved by the FDA and are not subject to the same rigorous standards for safety, quality, and consistency as approved medications. In some cases, compounded GLP-1 products are produced from raw active pharmaceutical ingredients imported from Chinese manufacturers that are not FDA-inspected or monitored and distributed to patients.”

The Author states that “Patients seeking out GLP-1s from telehealth providers may erroneously believe they are purchasing an FDA-approved and regulated treatment. AB 1990 seeks to increase transparency and establish safeguards, so patients are appropriately informed of the unapproved status of the drugs they are purchasing and make sure they understand the differences between unapproved, compounded drugs and FDA-approved therapies. This will further protect consumers from the potential dangers of unapproved drugs made with substandard, inauthentic, or illicit ingredients.”

1. Background.

Pharmacy Labeling and Advertising. California law already provides significant protections against false, misleading, and deceptive advertising, including by pharmacies and pharmacists. The BPC broadly prohibits untrue or misleading statements made in connection with the sale or disposition of goods or services. Violations may be enforced by public prosecutors and may result in civil penalties, injunctive relief, and other remedies under California’s unfair competition and false advertising laws. (BPC §§ 17200 et seq.; 17500 et seq.)

In addition, pharmacists and pharmacies are subject to regulation and discipline by the Board, which may take action against licensees for unprofessional conduct, including violations of laws governing pharmacy practice and consumer protection. (BPC §§ 4300 et seq.)

California law also already requires pharmacists to provide extensive information to patients regarding prescription medications. Existing pharmacy labeling requirements mandate that prescription containers include, among other things, the name of the patient, the name and strength of the drug, directions for use, the name of the prescriber, and other information necessary for safe use. (BPC § 4076) Pharmacists are further required to offer consultation to patients and provide information regarding drug usage, storage, precautions, and potential side effects. (BPC § 4052.5; 16 CCR § 1707.2.) Compounded drug products are also subject to specific labeling requirements under existing pharmacy law. (BPC §§ 4127.7, 4127.8.)

California Regulation of Drug Compounding. The Board is the state agency responsible for licensing and regulating pharmacists, pharmacies, wholesalers, and other entities involved in the distribution and dispensing of prescription drugs. Among its responsibilities, the Board oversees the practice of drug compounding, which generally refers to the preparation of a medication by combining, mixing, or altering ingredients to create a drug tailored to the needs of an individual patient. Compounding may be used when a commercially available drug is not available in the required dosage form or strength, or when a patient cannot use an FDA-approved product because of an allergy or other clinical need.

Compounded drugs are not approved by the federal FDA for safety, effectiveness, or quality prior to being dispensed. Instead, compounding is regulated through a combination of federal and state law. Under Section 503A of the federal Food, Drug, and Cosmetic Act, licensed pharmacies may compound patient-specific medications under specified conditions and are exempt from certain federal drug approval and manufacturing requirements. Federal law also recognizes standards developed by the United States Pharmacopeia (USP), which establishes quality standards for drug ingredients, preparation, testing, storage, and handling. Compounding has traditionally existed for situations such as different dosage strengths, alternative dosage forms, removal of allergens or preservatives, or customized formulations for individual patients.

California law requires compounding to be performed consistent with applicable USP standards. Following a multistate fungal meningitis outbreak linked to contaminated compounded medications, California strengthened oversight of compounding activities and directed the Board to align state requirements with evolving national standards. Most recently, the Board completed a comprehensive update of its compounding regulations governing nonsterile compounding, sterile compounding, hazardous drugs, and radiopharmaceuticals. Those regulations became effective on October 1, 2025, and establish detailed requirements relating to facilities, personnel qualifications, ingredient sourcing, quality assurance, environmental controls, testing, recordkeeping, and compliance with USP standards. The Board's revised regulations in 16 CCR §§ 1735, 1735.1 et seq., 1736, 1737, and 1738 already regulate many of the core quality and safety issues associated with compounding, including:

• Use of appropriate ingredients and components.
• Quality assurance programs.
• Documentation and record retention.
• Beyond-use dating.
• Environmental controls and sterility requirements.
• Personnel training and competency.
• Testing requirements for compounded products.
• Inspection authority by the Board.
• Compliance with USP standards and federal compounding requirements.

As a result, California already maintains a comprehensive regulatory framework governing the sourcing, preparation, testing, documentation, and inspection of compounded medications.

GLP-1 and Related Weight-Management Medications. Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of medications originally developed to treat Type 2 diabetes that are now widely prescribed for chronic weight management. These medications work by mimicking naturally occurring hormones involved in blood sugar regulation, appetite control, and digestion. More recently, newer therapies, including glucose-dependent insulinotropic polypeptide (GIP) receptor agonists and combination products that act on multiple incretin pathways, have entered the market and are commonly used for obesity treatment.

The active ingredient in a compounded product may be the same active ingredient found in an FDA-approved drug. For example:

• Semaglutide is the active ingredient in Ozempic and Wegovy.
• Tirzepatide is the active ingredient in Mounjaro and Zepbound.

A compounding pharmacy may obtain semaglutide or tirzepatide active pharmaceutical ingredient (API) and prepare a compounded product containing that same active ingredient. However, the compounded product is not FDA-approved and may differ from the FDA-approved product with respect to formulation, concentration, inactive ingredients, packaging, delivery device, stability data, or manufacturing controls.

Federal law has long allowed compounding when FDA-approved products are unavailable due to shortages. When Wegovy, Ozempic, Mounjaro, and Zepbound experienced prolonged shortages, compounding pharmacies began preparing semaglutide and tirzepatide products for patients who could not obtain the branded products. Although several of the most prominent GLP-1 medications have since been removed from the FDA's shortage list, demand for compounded versions of these products remains substantial.

A patient generally does not walk into a pharmacy and ask for something similar to a name-brand GLP-1. A licensed prescriber evaluates the patient. The prescriber writes a prescription. The pharmacy compounds a preparation consistent with that prescription and applicable state and federal law. The patient receives the compounded medication. Not all compounding activity occurs in licensed pharmacies. Physicians may also prepare and furnish medications in connection with the treatment of their patients, subject to applicable state and federal requirements.

In the GLP-1 context, the compounded product frequently contains semaglutide or tirzepatide itself, rather than a completely different ingredient designed to have a similar effect.

Recent Federal Enforcement Activity. Federal regulators have increasingly focused on the compounding, marketing, and distribution of GLP-1 and related weight-management medications. The FDA has issued warning letters regarding compounded products that allegedly do not comply with federal requirements and has raised concerns regarding the sourcing and quality of certain active pharmaceutical ingredients used in compounding. Federal regulators have also expressed concern regarding marketing practices that may imply compounded products are equivalent to FDA-approved medications.

In addition, the Federal Trade Commission has taken enforcement action against entities marketing weight-loss programs involving GLP-1 medications, alleging deceptive advertising and billing practices. These actions have focused on claims regarding product effectiveness, representations concerning FDA approval status, and other marketing statements directed toward consumers.

Efforts to Regulate Compounded GLP-1 Medications. In 2025, H.R. 6509, the SAFE Drugs Act of 2025, was introduced in the United States House of Representatives to increase oversight and regulation of compounding pharmacies and outsourcing facilities that compound what that bill would define as “essentially a copy” of an FDA‑approved product. The legislation proposes to cap the number of drug copies that can be made each month without patient‑specific justification, require reporting when pharmacists or facilities compound and ship high volumes of drugs across state lines, mandate more frequent inspections of large outsourcing facilities, and allow the federal government to adjust user fees to support enhanced oversight. A companion bill was introduced in the United States Senate in 2026, but to date, no significant federal legislation has been signed.

Legislation has been proposed in several states to crack down on the compounding of alleged “copycat” GLP-1 medications. For example, HB 2613 was introduced in the State of Washington to prohibit entities from selling, transferring, or distributing compounded drugs that use bulk drug substances unless the compounder complies with certain quality assurance requirements. Similar legislation has been introduced in Arizona, Colorado, Florida, Kentucky, Mississippi, and Virginia. The Indiana General Assembly enacted SB 282 in 2026, which both restricted the compounding of GLP-1 medications and increased state oversight of medical spas.

Federal regulation of prescription drug advertising. According to the FDA, prescription drug advertising is subject to a comprehensive federal regulatory framework administered by the FDA's Office of Prescription Drug Promotion (OPDP). The FDA explains that prescription drug advertisements must be truthful, balanced, and accurately communicate both a drug's benefits and risks. Advertisements for FDA-approved prescription drugs must present a "fair balance" between efficacy and risk information, be consistent with the drug's FDA-approved prescribing information (labeling), and may not be false or misleading or omit material facts. The FDA reviews promotional materials and may take enforcement action when advertisements fail to comply with these requirements. (21 C.F.R. § 202.1; FDA, The Office of Prescription Drug Promotion (OPDP); FDA, Drug Promotion; FDA, Bad Ad Program.) These federal advertising requirements are tied to the FDA approval process. FDA-approved prescription drugs are supported by agency-reviewed prescribing information that includes approved indications, contraindications, warnings, precautions, adverse reactions, and other labeling that forms the basis for the required fair balance in advertising.

Compounded GIP and GLP-1 medications are not FDA-approved products. Many of the advertising disclosures proposed by AB 1990, including summaries of contraindications, warnings, adverse reactions, and FDA-approved labeling, are concepts drawn from the federal regulatory framework applicable to FDA-approved prescription drugs. The bill requires every advertisement for certain compounded obesity and weight-management drugs containing GIP receptor agonists, GLP-1 receptor agonists, and other specified amino acid polymers to include affirmative disclosures that do not currently appear in California's general false advertising laws, including: a summary of FDA-approved labeling; side effects; contraindications; precautions; warnings; and a statement that the compounded medication has not been approved or evaluated by the FDA for safety or efficacy.

1. Arguments in Support for the April 23 version of the bill. Biocom writes, for the former version of AB 1990, that “Misleading claims about compounded weight-loss medications have driven patient confusion and unsafe use. Requiring disclosure of side effects, contraindications, and warnings consistent with FDA-approved labeling — along with clear notice that a product is not FDA-approved — directly addresses that harm.”

According to the National Hispanic Health Foundation on the prior version of the measure, this bill “strengthens requirements for transparency, ensures that patients are clearly informed when a drug is compounded and not FDA-approved, and limits misleading or deceptive marketing practices that blur the line between approved medications and compounded alternatives.”

The Diabetes Patient Advocacy Coalition, writing about the prior version of this bill, says that “Compounded drugs inherently pose a greater risk for consumers especially for those who believe they are receiving an FDA approved, safe and effective medication. Federal law requires bulk drug substances to be accompanied by a certificate of analysis and produced by an FDA registered manufacturer. There is growing concern that the remaining imports of bulk GLP-1 active ingredients post shortage are coming from unregistered and uncontrolled facilities in countries like China and India. A reasonable level of reporting and accountability is warranted to ensure patient safety.”

National Consumers League, on the prior version of this bill, writes “Because deceptive advertising hinders the ability of consumers to be aware of these risks, thousands of Americans have experienced serious health problems related to dosing errors and reactions to harmful ingredients in compounded GLP-1 products. As of September 9, 2025 , FDA had received 1,424 reports of adverse events associated with compounded GLP-1 drugs, including reports of 329 hospitalizations, and 23 deaths.4 Moreover, poison control centers have seen a nearly 1,500 percent increase in calls since 2019 related to overdose or side effects of injectable weight loss drugs and have managed 3,633 GLP-1 agonist related exposure cases as of April 30, 2025.”

The California Dermatology Advocacy Network says, for the prior version, the “bill promotes transparency in the marketing of compounded medications by requiring advertisements to clearly disclose that a compounded product has not been approved or evaluated by the [FDA] for safety or efficacy. These disclosures will help patients make informed decisions and better understand the differences between FDA-approved medications and compounded products.”

1. Arguments in Opposition for the current version of this bill. The Alliance for Pharmacy Compounding writes that “The most recent amendments substantially reduce the scope of AB 1990 to certain compounded medications used for obesity and weight management and include a clear disclosure that compounded medications are not approved by the [FDA]. APC supports these disclosures and appreciates their inclusion.” The group notes that it submitted amendments in April related to the advertising provisions and is particularly concerned with language that requires advertisements for compounded medications to include risk information and summaries drawn from the labeling of FDA-approved drugs containing the same active ingredient, noting “Although pharmacies may appropriately reference FDA-approved labeling as one source of clinical and safety information, requiring pharmacies to adopt FDA-approved product labeling as the default advertising standard creates a false equivalency between approved and compounded products.” AB 1990’s current advertising language goes beyond consumer protection and risks creating confusion, unnecessary liability, and barriers to patient access.

Midi Health writes that this bill “will not lead to truthful advertising and will put advertisers in a catch-22.” According to the company, “Requiring compounded drugs to carry safety disclosures derived from an FDA-approved drug's labeling is scientifically misleading. Compounded drugs are not identical to their branded counterparts and have not been evaluated in the same clinical trials. Applying a branded drug's risk profile to a compounded preparation misstates the actual risk information for that product.” They write that “Federal law prohibits compounders from incorporating or relying on FDA-approved drug labeling. Doing so creates a false impression that the compounded drug has been approved by the FDA — which is precisely the opposite of what the bill intends. The bill's advertising requirements would therefore put pharmacies in an impossible position: comply with state law and violate federal law or comply with federal law and violate state law.” They also add that “The clinical trial data underlying FDA-approved labeling belongs to the drug's sponsor. Compounders have no legal right to reuse that data, making compliance with the disclosure requirement legally untenable on its face.”

The company urges “adoption of the APC proposed amendment: it is unlawful for any person to advertise or otherwise promote compounded medications in a manner that is false or misleading. This aligns with the existing federal standard under FDA and FTC and avoids the preemption problem…” They also believe the labeling requirement should be simplified to say “This is a compounded medication prepared for an individual patient, as authorized in the Food, Drug, and Cosmetic Act. It has not been approved by the FDA.”

1. Stakeholder Comments for the April 23 version of the bill. The American Pharmacists Association notes, for the prior version of the bill, that it “supports truthful and non-misleading medication advertising and agrees that inappropriate marketing of medications, including marketing directed at minors, should be addressed. However, AB 1990 is not narrowly tailored to address social media marketing to minors or the unlicensed and noncompliant entities responsible for misleading promotion…”

Similarly, the California Pharmacists Association notes, for the prior version of the bill, that “We agree that marketing prescription medications to minors or facilitating inappropriate access to prescription drugs is unacceptable and should be addressed. However, despite proponents making youth access and teen use a primary justification for this legislation, AB 1990 does not meaningfully address those concerns. Instead, the bill imposes sweeping new requirements on licensed, regulated pharmacies that already operate under rigorous state and federal standards, while doing little to target the actors responsible for the practices cited by supporters.”

1. Policy Comments. AB 1990 creates a pharmacy-specific advertising standard that may duplicate existing prohibitions under BPC § 17500, which already makes it unlawful to disseminate advertising that is known, or through the exercise of reasonable care should be known, to be untrue or misleading. The bill’s requirements regarding side effects, warnings, and risk disclosures may likewise overlap with existing federal prescription drug labeling requirements, pharmacist consultation obligations, and state prescription labeling laws that are already intended to ensure patients receive material safety information before using a medication.

At the same time, California permits physicians to furnish compounded medications directly to their own patients under BPC § 4170 and permits pharmacists to furnish compounded medications to prescribers for office use under Section 4052. To the extent AB 1990 seeks to ensure patients receive information regarding risks and regulatory status, the bill establishes a new compounded-drug-specific advertising regime that goes beyond existing false advertising protections and may create requirements that differ from the disclosure framework applicable when compounded medications are furnished directly by prescribers rather than dispensed by pharmacies.

This bill requires every advertisement for only one type of compounded medication to include a summary of FDA-approved drug labeling, side effects, contraindications, and warnings is more stringent than California's general false advertising standard, establishing a mandated disclosure regime, rather than enhancing false advertising provisions. Congress and the FDA have developed a comprehensive federal regulatory framework governing advertising of FDA-approved prescription drugs because those drugs have undergone FDA review and have FDA-approved prescribing information upon which those advertising requirements are based. Compounded drugs, by contrast, are not FDA-approved products and do not have FDA-approved labeling, which is why applying that same framework raises practical and legal questions.

SUPPORT AND OPPOSITION:

Support:

None received for the current version of the bill

Opposition:

Alliance for Pharmacy Compounding

Midi Health

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Dr. Aisha Wahab, Chair

2025 - 2026 Regular

Bill No: Hearing Date: June 22, 2026

Subject:

SUMMARY:

Establishes additional requirements governing the compounding, distribution, and advertising of certain compounded obesity and weight-management drugs, including compounded GIP and GLP-1 receptor agonists, and prohibits false or misleading advertising of compounded medications.

NOTE: This bill is double-referred to the Senate Committee on Judiciary, second.

Existing law:

1. Establishes the Pharmacy Law. (Business and Professions Code (BPC) §§ 4000 et seq.)
2. Establishes the California State Board of Pharmacy (Board) to administer and enforce the Pharmacy Law. (BPC § 4001)
3. Defines “outsourcing facility” as a facility that is engaged in the compounding of sterile drugs and nonsterile drugs in California and is both registered with the Food and Drug Administration (FDA) and licensed by the Board. (BPC § 4034)
4. Requires a pharmacy to obtain a license from the Board and establishes information to be provided by pharmacies to the Board as a condition of license renewal, including a notification to the Board regarding compounding practices, including compounded human drug preparations distributed outside of the state. (BPC § 4110)
5. Requires every pharmacy to establish a quality assurance program that documents medication errors attributable to the pharmacy or its personnel. (BPC § 4125)
6. Provides that the compounding of drug preparations by a pharmacy for furnishing, distribution, or use in California shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary (USP), including relevant testing and quality assurance; authorizes the BOP to adopt regulations to impose additional standards for compounding drug preparations. (BPC § 4126.8)
7. Requires a pharmacy that issues a recall notice regarding a nonsterile compounded drug product to contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice under specified circumstances. (BPC § 4126.9)
8. Authorizes a pharmacy to distribute compounded human drug preparations interstate if specified conditions are met. (BPC § 4126.10)
9. Requires a pharmacy that compounds sterile drug products to possess a sterile compounding pharmacy license. (BPC § 4127)
10. Prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the BOP. (BPC § 4127.1)
11. Prohibits a nonresident pharmacy from compounding sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the BOP. (BPC § 4217.2)
12. Provides that whenever the Board has a reasonable belief, based on information obtained during an inspection or investigation by the Board, that a pharmacy compounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the Board may issue an order to the pharmacy to immediately cease and desist from compounding sterile drug products. (BPC § 4127.3)
13. Authorizes the Board to issue a temporary license to compound sterile drug products upon the conditions and for any periods of time as the Board determines to be in the public interest. (BPC § 4127.7)
14. Requires a pharmacy that issues a recall notice regarding a sterile compounded drug to contact the recipient pharmacy, prescriber, or patient of the recalled drug as well as the Board as soon as possible within 12 hours of the recall notice if use of or exposure to the recalled drug may cause serious adverse health consequences or death. (BPC § 4127.8)

This bill:

1. Defines “bulk drug substance,” also known as an active pharmaceutical ingredient (API), as any substance intended for incorporation into a finished drug product and 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; excludes intermediates used in the synthesis of the substance.
2. Makes it unlawful to sell, transfer, or distribute a drug compounded under Section 503A of the federal Food, Drug, and Cosmetic Act using a drug substance that is a glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, glucagon-like peptide-1 (GLP-1) receptor agonist, or other amino acid polymer intended for human obesity or weight management use, or a drug substance that is a component of a generic equivalent approved by the federal Food and Drug Administration (FDA) for obesity or weight management, unless the compounder does all of the following:
3. Uses bulk drug substances that comply with the following, as applicable:
   • 1. The standards of an applicable United States Pharmacopeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding.
     2. If no such monograph exists, the bulk drug substances are drug substances that are components of drugs approved by the FDA.
     3. If no such monograph exists and the drug substance is not a component of an FDA-approved drug, the bulk drug substance appears on the list developed by the FDA pursuant to the federal Food, Drug, and Cosmetic Act.
4. Confirms that the bulk drug substance was manufactured according to the process specified in the FDA approval for the drug, if applicable.
5. Ensures that the bulk drug substance is a pharmaceutical-grade produc
6. Verifies that the bulk drug substance is accompanied by a valid certificate of analysis.
7. Conducts and documents quality control testing of any bulk drug substance before its use in a compounded drug to confirm its identity and content and the name and quantity of each impurity present in an amount exceeding 0.1%.
8. Conducts and documents quality control testing of finished drug product compounded in batches before release and at expiration for any impurities derived from the use of a bulk drug substance, including the chemical name and quantity of each impurity.
9. Obtains proof that the manufacture of the bulk drug substance took place in an establishment that:
   • 1. Is registered with the FDA under the federal Food, Drug, and Cosmetic Act.
     2. Has undergone an FDA inspection as a human drug establishment within the preceding two years.
     3. Is not subject to an FDA import alert.
     4. Complies with the federal Food, Drug, and Cosmetic Act, including Section 503A.
10. Makes it unlawful for a manufacturer or wholesaler to sell, transfer, or distribute a bulk drug substance for use in compounding without providing written verification to the purchaser that the substance is pharmaceutical grade, satisfies the bill’s sourcing and quality requirements, and is accompanied by a valid certificate of analysis.
11. Subjects violators to a civil penalty of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed and revocation of the applicable pharmacy or business license.
12. Requires any person or entity engaged in the sale, transfer, or distribution of compounded GIP receptor agonists, GLP-1 receptor agonists, or other amino acid polymer drugs intended for obesity or weight management to maintain records relating to the acquisition, examination, and testing of the bulk drug substance for at least two years after the expiration date of the last lot containing that substance and, upon request, furnish those records to the Board of Pharmacy (BOP) within one business day or within another reasonable period determined by the BOP.
13. Authorizes the BOP, its duly authorized agent, or a duly authorized agent of a third party approved by the BOP to inspect any person or entity engaged in compounding drugs, or any domestic supplier, wholesaler, repackager, or other provider of bulk drug substances used in compounding, for compliance with the bill.
14. Provides that refusal to permit an inspection by the BOP, its agent, or an approved third-party inspector constitutes a violation subject to enforcement under the bill.
15. Defines an “unsubstantiated claim” as any statement, representation, or assertion concerning the safety, efficacy, or other attributes of a drug that is not supported by competent and reliable scientific evidence.
16. Makes it unlawful to advertise or otherwise promote compounded medications unless the advertisement is truthful and not misleading. Provides that an advertisement is misleading if it contains an unsubstantiated claim regarding the product.
17. Provides that an advertisement is misleading unless it contains all of the following:
18. A disclosure of the potential side effects, adverse reactions, contraindications, precautions, and warnings identified in the labeling of any FDA-approved drug containing the active ingredients named in the compounded drug, unless the advertiser can demonstrate that a particular disclosure is not relevant to the compounded drug.
19. A summary of the specified risk information contained in the labeling of an FDA-approved drug when the compounded drug contains an active ingredient that is also an active ingredient in an FDA-approved drug.
20. A clear and conspicuous statement that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or efficacy.
21. Exempts physicians and surgeons licensed under the Medical Practice Act from the provisions of the bill, while preserving their obligations under other applicable state and federal laws.
22. Authorizes the BOP to adopt regulations necessary to implement the bill.
23. Makes legislative findings and declarations that patient safety is threatened by the use of illicit, substandard, contaminated, or otherwise noncompliant active pharmaceutical ingredients (APIs) in compounded weight-loss medications, particularly where foreign manufacturers may circumvent FDA regulatory requirements.
24. Finds that federal enforcement alone has been insufficient to prevent potentially unsafe APIs from entering the compounding supply chain and that Californians may remain at risk of receiving compounded medications containing ingredients from manufacturers that failed to comply with federal manufacturing standards.
25. States Legislative intent to establish additional state safety and regulatory requirements to ensure that APIs used in compounded weight-loss medications are sourced from registered, inspected, and reputable establishments and meet pharmaceutical-grade quality standards.

FISCAL EFFECT:

This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations, the bill will result in “Costs of an unknown but potentially significant amount to the [Board]. The Board anticipates this bill will result in longer and more complex inspections and investigations, potentially increasing operational costs; however, the net cost is uncertain because the bill also establishes automatic fines that could offset some expenses. The Board also notes that additional costs may arise from due process requirements for license revocations and potential legal challenges, but is unable to project the extent of these costs. The Department of Consumer Affairs, Office of Information Services estimates costs of $800 to add new enforcement codes.

COMMENTS:

1. Purpose. The Author is the sponsor of this bill. According to the Author, “AB 1990 protects patients by ensuring compounded GLP-1 agonist and similar drugs for weight loss are safe, high quality, and honestly marketed. As these medications-such as semaglutide and tirzepatide-have grown in popularity for weight management, demand has surged across the country. During initial supply shortages, many patients turned to compounded versions of these medications when FDA-approved products were difficult to access. These products are not reviewed or approved by the FDA and are not subject to the same rigorous standards for safety, quality, and consistency as approved medications. In some cases, compounded GLP-1 products are produced from raw active pharmaceutical ingredients imported from Chinese manufacturers that are not FDA-inspected or monitored and distributed to patients.

Patients seeking out GLP-1s from telehealth providers may erroneously believe they are purchasing an FDA-approved and regulated treatment. AB 1990 seeks to increase transparency and establish safeguards, so patients are appropriately informed of the unapproved status of the drugs they are purchasing and make sure they understand the differences between unapproved, compounded drugs and FDA-approved therapies. This will further protect consumers from the potential dangers of unapproved drugs made with substandard, inauthentic, or illicit ingredients.”

The Author states that “Evidence shows that consumers do not understand that compounded drugs are not evaluated by FDA for safety, efficacy and quality before they are marketed. Furthermore, compounded variations of approved drugs expose patients to untested formulations that are sold at high volumes under the guise of “personalization.” For example, the combination of a GLP-1 with other vitamins (such as b12) has never been tested as a combination. There has never been a clinical trial or study to ensure that combining GLP-1s with other drugs or vitamins is safe and efficacious. Californians have become members without consent of an unregulated clinical trial – one with no outcomes tracking or adverse events reporting.”

1. Background.

California Regulation of Drug Compounding. The Board is the state agency responsible for licensing and regulating pharmacists, pharmacies, wholesalers, and other entities involved in the distribution and dispensing of prescription drugs. Among its responsibilities, the Board oversees the practice of drug compounding, which generally refers to the preparation of a medication by combining, mixing, or altering ingredients to create a drug tailored to the needs of an individual patient. Compounding may be used when a commercially available drug is not available in the required dosage form or strength, or when a patient cannot use an FDA-approved product because of an allergy or other clinical need.

Compounded drugs are not approved by the federal FDA for safety, effectiveness, or quality prior to being dispensed. Instead, compounding is regulated through a combination of federal and state law. Under Section 503A of the federal Food, Drug, and Cosmetic Act, licensed pharmacies may compound patient-specific medications under specified conditions and are exempt from certain federal drug approval and manufacturing requirements. Federal law also recognizes standards developed by the United States Pharmacopeia (USP), which establishes quality standards for drug ingredients, preparation, testing, storage, and handling. Compounding has traditionally existed for situations such as different dosage strengths, alternative dosage forms, removal of allergens or preservatives, or customized formulations for individual patients.

California law requires compounding to be performed consistent with applicable USP standards. Following a multistate fungal meningitis outbreak linked to contaminated compounded medications, California strengthened oversight of compounding activities and directed the Board to align state requirements with evolving national standards. Most recently, the Board completed a comprehensive update of its compounding regulations governing nonsterile compounding, sterile compounding, hazardous drugs, and radiopharmaceuticals. Those regulations became effective on October 1, 2025, and establish detailed requirements relating to facilities, personnel qualifications, ingredient sourcing, quality assurance, environmental controls, testing, recordkeeping, and compliance with USP standards. The Board's revised regulations in 16 CCR §§ 1735, 1735.1 et seq., 1736, 1737, and 1738 already regulate many of the core quality and safety issues associated with compounding, including:

• Use of appropriate ingredients and components.
• Quality assurance programs.
• Documentation and record retention.
• Beyond-use dating.
• Environmental controls and sterility requirements.
• Personnel training and competency.
• Testing requirements for compounded products.
• Inspection authority by the Board.
• Compliance with USP standards and federal compounding requirements.

As a result, California already maintains a comprehensive regulatory framework governing the sourcing, preparation, testing, documentation, and inspection of compounded medications.

GLP-1 and Related Weight-Management Medications. Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of medications originally developed to treat Type 2 diabetes that are now widely prescribed for chronic weight management. These medications work by mimicking naturally occurring hormones involved in blood sugar regulation, appetite control, and digestion. More recently, newer therapies, including glucose-dependent insulinotropic polypeptide (GIP) receptor agonists and combination products that act on multiple incretin pathways, have entered the market and are commonly used for obesity treatment.

The active ingredient in a compounded product may be the same active ingredient found in an FDA-approved drug. For example:

• Semaglutide is the active ingredient in Ozempic and Wegovy.
• Tirzepatide is the active ingredient in Mounjaro and Zepbound.

A compounding pharmacy may obtain semaglutide or tirzepatide active pharmaceutical ingredient (API) and prepare a compounded product containing that same active ingredient. However, the compounded product is not FDA-approved and may differ from the FDA-approved product with respect to formulation, concentration, inactive ingredients, packaging, delivery device, stability data, or manufacturing controls.

Federal law has long allowed compounding when FDA-approved products are unavailable due to shortages. When Wegovy, Ozempic, Mounjaro, and Zepbound experienced prolonged shortages, compounding pharmacies began preparing semaglutide and tirzepatide products for patients who could not obtain the branded products. Although several of the most prominent GLP-1 medications have since been removed from the FDA's shortage list, demand for compounded versions of these products remains substantial.

A patient generally does not walk into a pharmacy and ask for something similar to a name-brand GLP-1. A licensed prescriber evaluates the patient. The prescriber writes a prescription. The pharmacy compounds a preparation consistent with that prescription and applicable state and federal law. The patient receives the compounded medication. Not all compounding activity occurs in licensed pharmacies. Physicians may also prepare and furnish medications in connection with the treatment of their patients, subject to applicable state and federal requirements.

In the GLP-1 context, the compounded product frequently contains semaglutide or tirzepatide itself, rather than a completely different ingredient designed to have a similar effect.

Recent Federal Enforcement Activity. Federal regulators have increasingly focused on the compounding, marketing, and distribution of GLP-1 and related weight-management medications. The FDA has issued warning letters regarding compounded products that allegedly do not comply with federal requirements and has raised concerns regarding the sourcing and quality of certain active pharmaceutical ingredients used in compounding. Federal regulators have also expressed concern regarding marketing practices that may imply compounded products are equivalent to FDA-approved medications.

In addition, the Federal Trade Commission has taken enforcement action against entities marketing weight-loss programs involving GLP-1 medications, alleging deceptive advertising and billing practices. These actions have focused on claims regarding product effectiveness, representations concerning FDA approval status, and other marketing statements directed toward consumers.

Efforts to Regulate Compounded GLP-1 Medications. In 2025, H.R. 6509, the SAFE Drugs Act of 2025, was introduced in the United States House of Representatives to increase oversight and regulation of compounding pharmacies and outsourcing facilities that compound what that bill would define as “essentially a copy” of an FDA‑approved product. The legislation proposes to cap the number of drug copies that can be made each month without patient‑specific justification, require reporting when pharmacists or facilities compound and ship high volumes of drugs across state lines, mandate more frequent inspections of large outsourcing facilities, and allow the federal government to adjust user fees to support enhanced oversight. A companion bill was introduced in the United States Senate in 2026, but to date, no significant federal legislation has been signed.

Legislation has been proposed in several states to crack down on the compounding of alleged “copycat” GLP-1 medications. For example, HB 2613 was introduced in the State of Washington to prohibit entities from selling, transferring, or distributing compounded drugs that use bulk drug substances unless the compounder complies with certain quality assurance requirements. Similar legislation has been introduced in Arizona, Colorado, Florida, Kentucky, Mississippi, and Virginia. The Indiana General Assembly enacted SB 282 in 2026, which both restricted the compounding of GLP-1 medications and increased state oversight of medical spas.AB 1990 would establish additional statutory requirements specific to certain compounded obesity and weight-management drugs containing GIP receptor agonists, GLP-1 receptor agonists, and other specified amino acid polymers. Among other provisions, the bill would impose additional sourcing, testing, documentation, inspection, supply-chain verification, and advertising requirements applicable to compounders, manufacturers, wholesalers, and other entities involved in the distribution of these products.

AB 1990 would establish additional statutory sourcing, testing, documentation, inspection, and advertising requirements applicable to certain compounded obesity and weight-management medications. Because the Board's updated compounding regulations became effective on October 1, 2025, the bill raises the question of whether additional statutory requirements specific to GLP-1, GIP, and related products are necessary beyond California's existing compounding framework.

The bill also expressly exempts physicians and surgeons licensed under the Medical Practice Act from its provisions.

1. Arguments in Support. Biocom writes that “Federal law already restricts compounding of FDA-approved versions of these drugs, but enforcement against non-compliant compounders has been limited. AB 1990 closes that gap by aligning California's standards with federal law and adding meaningful state-level enforcement. It establishes pharmaceutical-grade ingredient requirements, chain-of-custody documentation, and Board of Pharmacy inspection authority over compounders, suppliers, wholesalers, and repackagers. Per-dose penalties paired with license revocation give regulators the tools needed to deter substandard conduct, and upstream verification requirements ensure bulk drug substances meet quality standards before transfer. The bill's advertising provisions are equally sensible. Misleading claims about compounded weight-loss medications have driven patient confusion and unsafe use. Requiring disclosure of side effects, contraindications, and warnings consistent with FDA-approved labeling — along with clear notice that a product is not FDA-approved — directly addresses that harm.”

According to the California Dermatology Advocacy Network, the bill “addresses increasing concerns regarding the sourcing and quality of active pharmaceutical ingredients used in compounded medications. Recent reports have highlighted the risk that substandard or contaminated ingredients may enter the supply chain, particularly in high-demand therapeutic categories such as weight-loss medications. AB 1990 helps safeguard patients by requiring pharmaceutical-grade ingredients, certificates of analysis, quality control testing, and verification that manufacturers meet federal regulatory standards.”

The National Hispanic Health Foundation states that “This bill is not about restricting legitimate medical compounding. Compounding plays an essential role in patient care when medications must be tailored to meet individual needs. Rather, AB 1990 is about addressing a marketplace that has expanded far beyond traditional compounding into mass production, telehealth-driven distribution, and aggressive digital marketing.”

1. Arguments in Opposition. According to the American Pharmacists Association, “Many California patients rely on compounded medications because commercially available products may not meet their clinical needs. Patients may require individualized dosage strengths, alternative dosage forms, specific formulations, or accommodations for allergies, sensitivities, or other patient-specific factors. AB 1990 would make it more difficult for pharmacists acting in compliance with applicable compounding standards and state and federal laws to meet legitimate patient needs and force compounders to only purchase bulk drug substances from large pharmaceutical companies. APhA is also concerned that AB 1990’s penalty structure, including per-dose penalties and mandatory license revocation, could create disproportionate liability exposure for licensed pharmacies and pharmacists operating in good faith to meet California patients’ needs for these prescribed medications. Policies intended to address unsafe or unlawful conduct should be carefully tailored and preserve pharmacists' ability to exercise their professional judgment in the best interests of patients.

The Alliance for Pharmacy Compounding writes that “the bill effectively bans compounded GLP-1's by requiring that all compounded GLP-1 API be manufactured in the same process as FDA approved product bulk drug substances, even though FDA does not make such a distinction. Moreover, compounders do not have access to GLP-1 API that is produced using the same process as the FDA-approved product. It also requires an FDA-registered manufacturing facility to be inspected every two years to lawfully manufacture bulk drug substances despite the requirement that the FDA conduct risk-based inspections that do not occur on a regular cadence. This may seem like good policy, but it directly conflicts with purpose of compounding therapies and with long established national policies set in the federal Food, Drug and Cosmetic Act. California should not make it harder for patients to obtain medications through licensed, regulated healthcare providers while failing to address many of the entities responsible for the conduct that prompted legislative concern. Stakeholder amendments previously submitted to the author would correct these shortcomings. Those amendments would directly address misleading advertising, establish enforceable standards that apply to the appropriate actors, prohibit inappropriate marketing practices, and preserve access to medically necessary compounded therapies. The Committee faces a straightforward choice: amend the bill so it addresses the actual problem, or advance legislation that burdens regulated pharmacies while leaving significant gaps in enforcement.”

The California Pharmacists Association states that “Throughout the discussion surrounding AB 1990, proponents have repeatedly suggested that compounded medications are inherently unsafe or insufficiently regulated. Such assertions are inaccurate and risk creating unwarranted fear among patients who rely on compounded medications every day. Compounding is a well-established and highly regulated area of pharmacy practice that serves an essential role within the healthcare system. Licensed pharmacists compound medications pursuant to state and federal law, professional standards, and regulatory oversight designed to protect patient safety. Compounded medications are often the only way to meet a patient's specific medical needs. Pharmacists routinely compound medications for patients with allergies to ingredients contained in commercially manufactured products, for patients who require individualized dosages that are not otherwise available, and for patients who cannot use standard dosage forms. Compounding also plays a critical role in oncology care, where individualized chemotherapy preparations are routinely compounded to meet the unique needs of cancer patients. Suggesting that pharmacy compounding is inherently unsafe risks undermining public confidence in these essential patient care services and could discourage patients from seeking therapies that are both appropriate and necessary. The bill's restrictions are particularly troubling given the vital role compounding pharmacists play in responding to drug shortages and ensuring continuity of care when commercially available products are unavailable. During recent shortages of GLP-1 medications and other critical therapies, compounding pharmacies helped fill gaps in access for patients under the supervision of licensed healthcare professionals. Restricting access to regulated compounding services may ultimately drive patients toward unregulated or illicit sources, undermining the very consumer protection goals the bill seeks to achieve.”

Midi Health writes that “While the vast majority of our prescriptions are for mass-marketed pharmaceutical drugs, we believe that clinicians, not rigid legislative mandates, are best suited to judge when a patient’s individual biological needs warrant a compounded solution.”

According to the California Society for Health System Pharmacists, “By making compounding operationally and legally untenable, AB 1990 will eliminate access for these patients and shut them out of needed therapies used not only for weight management, but also for diabetes, sleep apnea, and complex metabolic disorders.

Additionally, although AB 1990 currently targets obesity‑related therapies, it establishes a precedent that could readily expand to other therapeutic categories, further eroding access to individualized care.”

1. Policy Concerns. While compounded drugs are not FDA-approved, the absence of FDA approval does not mean that compounding is inherently unsafe or outside the law. Federal law expressly recognizes compounding under Section 503A of the federal Food, Drug, and Cosmetic Act, and FDA acknowledges that compounded drugs can serve an important medical need for patients when an approved drug cannot meet the patient’s clinical needs.

Existing federal and state law already place meaningful limits on compounding. Section 503A restricts compounding drugs that are “essentially copies” of commercially available drugs, while FDA guidance recognizes that certain amounts may still be permissible if compounding is not done “regularly or in inordinate amounts.” FDA also states that a drug on the FDA shortage list is not considered commercially available for purposes of that restriction. The Board’s updated compounding regulations align state rules with current USP standards, include testing and quality-assurance requirements, and impose additional standards above the national USP minimums.

Compounded GLP-1 medications are already subject to extensive federal and state regulation. The bill’s drug-specific statutory requirements may not be necessary on top of the state’s newly updated compounding framework, particularly where those regulations already address ingredient sourcing, compounding records, quality assurance, testing, sterile preparation standards, environmental controls, and Board enforcement authority.

The compliance framework outlined in the bill coupled with steep penalties has the potential to reduce the number of pharmacies willing or able to provide these medications, which could affect patient access and cost, especially for patients who cannot obtain or afford FDA-approved branded products. The market for FDA-approved GLP-1 and related weight-management drugs is dominated by a small number of branded products. While supporters argue that additional oversight is necessary to ensure the quality and integrity of active pharmaceutical ingredients used in compounded weight-management medications, compounded GLP-1 products have also served as a lower-cost alternative for some patients, particularly during periods of drug shortages and for patients without insurance coverage for FDA-approved products.

Recent litigation has highlighted the extent to which disputes over compounded GLP-1 medications involve issues of competition and access in addition to patient safety. In January 2026, a compounding pharmacy filed a federal antitrust lawsuit alleging that Eli Lilly and Novo Nordisk used their market positions to restrict access to lawful compounded alternatives and suppress competition; the manufacturers deny those allegations. More broadly, ongoing litigation and regulatory actions involving manufacturers, telehealth companies, and compounders reflect competing views regarding patient safety, market competition, and consumer access to lower-cost treatment options. To the extent the bill increases compliance costs or limits the availability of compounded products, it is important to consider whether the resulting impact on access and affordability is justified by any demonstrated gap in California’s existing compounding framework. The bill may have the practical effect of limiting lawful lower-cost alternatives in a market where affordability and access are already significant concerns.

The bill also does not apply uniformly to every setting where medication preparation may occur. The bill expressly exempts physicians and surgeons licensed under the Medical Practice Act, even though physician practices may prepare or furnish medications in connection with patient care subject to other applicable laws. If the bill is intended to address risks associated with compounded weight-management medications, it is unclear why its requirements would apply to pharmacies and supply-chain entities that are already subject to extensive regulation, but not to physician office settings where patients may also receive prepared medications.

SUPPORT AND OPPOSITION:

Support:

American Diabetes Association
Biocom
California Dermatology Advocacy Network
California Life Sciences Association
Diabetes Patient Advocacy Coalition
National Association for the Advancement of Orthotics and Prosthetics

National Consumers League
National Hispanic Health Foundation
Partnership for Safe Medicines

Opposition:

Alliance for Pharmacy Compounding

American Pharmacists Association
California Pharmacists Association
California Society of Health-system Pharmacists
Chamber of Progress
Midi Health
Netchoice

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 1990

Author:(Gipson)

As Amended Ver:April 23, 2026

Majority vote

SUMMARY

Establishes additional requirements for the compounding of drugs containing glucagon-like-peptide-1 (GLP-1) receptor agonists or similar drug substances used for obesity or weight management and provides that it is unlawful for any person to advertise compounded medications unless the advertisement is truthful and not misleading, as specifically defined.

Major Provisions

1. Define "bulk drug substance," also known as "active pharmaceutical ingredient (API)," as 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; exempts intermediates used in the synthesis of the substance from this definition.
2. Make it unlawful to sell, transfer, or distribute a drug compounded under Section 503A of the federal Food, Drug, and Cosmetic Act using a drug substance that is a glucose-dependent insulinotropic polypeptide receptor or GLP-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 (FDA) unless the compounder of the drug does all of the following:
   1. Uses bulk drug substances that comply with the following, as applicable:
      1. The standards of an applicable United States Pharmacopeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding.
      2. If such a monograph does not exist, the bulk drug substances are drug substances that are components of drugs approved by the FDA.
      3. 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 the federal Food, Drug, and Cosmetic Act.
   2. Confirms that the bulk drug substance was manufactured according to the process specified in the FDA's approval of the drug label, if applicable.
   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 its identity and content and the name and quantity of each impurity present in the bulk drug substance in an amount that exceeds 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:
      1. Is duly registered with the FDA under the federal Food, Drug, and Cosmetic Act.
      2. Has undergone an inspection by the FDA as a human drug establishment within the last two years.
      3. Is not subject to an import alert by the FDA.
   8. Complies with the federal Food, Drug, and Cosmetic Act, including Section 503A.
3. Provide that it is unlawful for any manufacturer or wholesaler to sell, transfer, or distribute a bulk drug substance for use in compounding without providing to the purchaser written verification that the bulk drug substance is pharmaceutical grade, meets the bill's sourcing and quality control requirements, and is accompanied by a valid certificate of analysis.
4. Subject violators of the bill's requirements to both a fine of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed and revocation of the person or entity's pharmacy or business license, as applicable.
5. Authorize the California State Board of Pharmacy (BOP) or its duly authorized agent, or a duly authorized agent of a third party approved by the BOP, 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 of the bill.
6. Provide that it is unlawful for any person to advertise or otherwise promote compounded medications unless the advertisement is truthful and not misleading. An advertisement is not truthful and is misleading if it includes any unsubstantiated claim with respect to the product.
7. Expressly provide that an advertisement is misleading unless it contains all of the following:
   1. A disclosure of the potential side effects, adverse reactions, contraindications, precautions, and warnings associated with active ingredients in the medication, including the potential side effects, adverse reactions, contraindications, precautions, and warnings in the labeling of any FDA-approved drug containing the active ingredients named in the compounding drug, unless the advertiser can demonstrate that a particular disclosure is not relevant to the compounded drug.
   2. A summary of the specified risk information in the labeling of the FDA-approved drug, when a compounded drug contains an active ingredient that is named as an active ingredient in an FDA-approved drug.
   3. A clear, conspicuous statement that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or efficacy.

COMMENTS

Requirements for Drug Compounding. According to the FDA, drug compounding is generally described as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Combining two or more drugs is a form of compounding, as is the reconstitution of a drug into another ingestible form. Compounded drugs are not approved by the FDA for safety or effectiveness. Federal law establishes the authority for specified individuals to compound human drug products under provisions specified in section 503A of the federal Food, Drug, and Cosmetic Act. Drug products compounded under these provisions are exempt from some of the requirements for drug manufacturing and the drug approval process.

The USP is a combination of two compendia published by two longstanding nonprofits: the United States Pharmacopeia, published by the United States Pharmacopeial Convention; and the National Formulary, published by the American Pharmaceutical Association. As the FDA's officially designated compendium, the USP sets numerous standards for drug ingredients and manufacturing processes, including testing and quality assurance. Generally speaking, drug products and ingredients sold in the United States must conform to the USP to be considered unadulterated and of minimum quality.

Pharmacy professionals who engage in the practice of drug compounding in California are required to obtain a license from the BOP. However, prior to 2020, there were no state laws that outlined specific requirements for the compounding of prescription medication. Partially in response to a significant multistate outbreak of fungal meningitis for which the unsafe compounding of a preservative-free steroid injection resulted in numerous deaths, the BOP sponsored legislation in 2019 to require that compounding in California must be performed consistent with standards established in the pharmacy compounding chapters of the current version of the USP. The USP develops and publishes standards for drug substances, drug products, excipients, and dietary supplements. These standards are recognized in the federal Food, Drug, and Cosmetic Act.

The BOP recently completed rulemaking to clarify requirements for drug compounding by licensees in response to changes enacted to the USP. These efforts began when changes to the USP were initially proposed in 2019, at which time the BOP held a series of public meetings to discuss proposed language with stakeholders; however, these discussions were paused following delays in the USP's process. Following the finalization of the USP Chapters, the BOP resumed efforts to revise its compounding regulations and held another series of meetings to receive further comments from stakeholders. The changes proposed by the BOP included restructuring its regulations to align with the USP Chapters, eliminating and clarifying requirements, and adding new requirements.

The BOP approved proposed regulation text in April 2023 to amend the BOP's regulations regarding compounded drug preparations to implement, clarify, or make more specific requirements related to the USP-National Formulary for nonsterile compounding, sterile compounding, the handling of hazardous drugs, and the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals. The new USP Chapters became effective on November 1, 2023; because the BOP's proposed regulations were not yet effective, the BOP released an updated Policy Statement in September 2023 providing stakeholders with additional guidance.

On April 19, 2024, the BOP formally distributed its proposed regulation text to interested parties. Through the public rulemaking process, stakeholders submitted comments to the BOP expressing concerns that the provisions relating to sterile compounding exceeded the requirements of the USP and national standards and would result in fewer pharmacies providing compounding services in California. Stakeholders further criticized the BOP for what was characterized as excessive enforcement activity against licensees for minor infractions. In its sunset report to the Committees, the BOP argued that it believed there had been significant misinformation in the public domain misrepresenting the requirements of federal law. The BOP's final updated regulations governing nonsterile compounding, sterile compounding, hazardous drugs, and radiopharmaceuticals took effect on October 1, 2025.

Additional issues relating to compounding were raised during the BOP's sunset review in 2025. As reported by the BOP, in recent years, the FDA has released warnings about instances of drug products being compounded under insanitary conditions. Many of these warnings stem from compounding occurring in sites that are not regulated by the BOP or other regulatory agencies, including medical spas and IV hydration clinics. Following an incident in California where a patient was hospitalized and treated for suspected septic shock with multi-organ failure after receiving an IV vitamin infusion in her home, the FDA reported that it was aware of sterile compounding activities, such as adding vitamins to IV infusion bags, being performed by hydration clinics where it is unknown and undocumented if the drug products are prepared, packed, or held under insanitary conditions. Additionally, it is unknown whether a licensed practitioner is on-site to evaluate patients and write prescriptions for the drug products being administered.

GLP-1 Medications. GLP-1 medications are a class of prescription drugs originally developed to treat type-2 diabetes and are now widely used for chronic weight management. These medications mimic the action of a naturally occurring gut hormone, GLP-1, which helps regulate blood sugar, appetite, and digestion. GLP-1 drugs work by stimulating insulin release in response to food, suppressing glucagon (a hormone that raises blood sugar), slowing gastric emptying to prolong fullness, and acting on brain appetite centers to reduce hunger and food cravings. Well-known examples include semaglutide (marketed as Ozempic or Wegovy) and liraglutide (Saxenda), while related or newer agents such as tirzepatide (Zepbound) act on similar incretin pathways and are often grouped with GLP-1–based therapies. These drugs are part of a broader class of "incretin mimetics," and ongoing research has produced additional variants that expand on the same biological mechanisms. Most FDA-approved GLP-1 medications are delivered via injection pens or, more recently, oral tablets.

Section 503A of the federal Food, Drug, and Cosmetic Act allows for GLP-1 medication to be compounded under specific, limited circumstances. Compounding pharmacies operating under sections 503A (traditional pharmacies) and 503B (outsourcing facilities) are allowed to prepare customized versions of drugs only when there is a legitimate medical need that cannot be met by an FDA-approved product. For example, if a patient requires a different dosage form, strength, or ingredient due to an allergy, a patient-specific version of the medication may be compounded. Additionally, an FDA-approved drug may be compounded when the FDA has officially declared a shortage of that drug. GLP-1 medications, such as semaglutide, were previously included on the FDA drug shortage list due to high demand following an increase in public awareness of the potential to use the drug for weight loss; however, as of February 2025, they are no longer on the official shortage list, and cannot be compounded under that exception.

In December 2025, the Federal Trade Commission (FTC) approved a final order against NextMed, a telehealth company, for deceptive advertising of weight-loss programs and deceptive and unfair billing and cancellation practices related to GLP-1 weight-loss programs. The FTC alleged that NextMed took advantage of the explosion in demand for GLP-1 medications by selling weight-loss programs with undisclosed costs and unsubstantiated claims about the weight loss achieved by their clients. The FTC ordered NextMed to cease its misconduct and pay $150,000, which is expected to be used to provide refunds to consumers.

In March 2026, the FDA sent 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. In a press release announcing the issuance of the letters, FDA Commissioner Marty Makary stated: "We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action. Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA's approval process." The warning letters included specific alleged violations, including unlawful claims to consumers that compounded drugs are the same as FDA-approved products.

Efforts to Regulate Compounded GLP-1 Medications. In 2025, H.R. 6509, the SAFE Drugs Act of 2025, was introduced in the United States House of Representatives to increase oversight and regulation of compounding pharmacies and outsourcing facilities that compound what that bill would define as "essentially a copy" of an FDA‑approved product. The legislation proposes to cap the number of drug copies that can be made each month without patient‑specific justification, require reporting when pharmacists or facilities compound and ship high volumes of drugs across state lines, mandate more frequent inspections of large outsourcing facilities, and allow the federal government to adjust user fees to support enhanced oversight. A companion bill was introduced in the United States Senate in 2026, but to date, no significant federal legislation has been signed.

Legislation has been proposed in several states to crack down on the compounding of alleged "copycat" GLP-1 medications. For example, HB 2613 was introduced in the State of Washington to prohibit entities from selling, transferring, or distributing compounded drugs that use bulk drug substances unless the compounder complies with certain quality assurance requirements. Similar legislation has been introduced in Arizona, Colorado, Florida, Kentucky, Mississippi, and Virginia. The Indiana General Assembly enacted SB 282 in 2026, which both restricted the compounding of GLP-1 medications and increased state oversight of medical spas.

This bill would similarly establish additional requirements and restrictions on compounding pharmacies that produce GLP-1 medications. The bill would require all bulk substances used in compounded drugs containing GLP-1 drug substances to be pharmaceutical-grade, comply with USP and FDA standards and requirements, undergo quality control testing, be accompanied by a valid certificate of analysis, and sourced from FDA-registered and recently inspected facilities. The bill would require records of those bulk drug substances to be maintained and made available for inspection by the BOP.

Additionally, this bill specifically makes it unlawful for any person to advertise or otherwise promote compounded medications unless the advertisement is truthful and not misleading. The bill provides that an advertisement is not truthful and is misleading if it includes any unsubstantiated claim with respect to the product, or if it fails to include specified disclosures. These disclosures would include information about the potential side effects, adverse reactions, contraindications, precautions, and warnings associated with active ingredients in the medication, including the potential side effects, adverse reactions, contraindications, precautions, and warnings in the labeling of any FDA-approved drug containing the active ingredients named in the compounding drug, unless the advertiser can demonstrate that a particular disclosure is not relevant to the compounded drug.

According to the Author

"AB 1990 protects patients by ensuring compounded GLP-1 agonist and similar drugs for weight loss are safe, high quality, and honestly marketed. As these medications—such as semaglutide and tirzepatide—have grown in popularity for weight management, demand has surged across the country. During initial supply shortages, many patients turned to compounded versions of these medications when FDA-approved products were difficult to access. These products are not reviewed or approved by the FDA and are not subject to the same rigorous standards for safety, quality, and consistency as approved medications. In some cases, compounded GLP-1 products are produced from raw active pharmaceutical ingredients imported from Chinese manufacturers that are not FDA-inspected or monitored and distributed to patients. Patients seeking out GLP-1s from telehealth providers may erroneously believe they are purchasing an FDA-approved and regulated treatment. AB 1990 seeks to increase transparency and establish safeguards so patients are appropriately informed of the unapproved status of the drugs they are purchasing and make sure they understand the differences between unapproved, compounded drugs and FDA-approved therapies. This will further protect consumers from the potential dangers of unapproved drugs made with substandard, inauthentic, or illicit ingredients."

Arguments in Support

The California Life Sciences Association supports this bill, writing: "Over the past several years, the market for compounded weight loss medications has grown at an unprecedented pace. Unlike FDA-approved drugs, which undergo years of rigorous research, clinical trials, and ongoing safety monitoring, compounded drugs are not subject to FDA premarket review for safety, quality, or efficacy. This regulatory gap has created an opening for bad actors to introduce illicit, inauthentic, or substandard materials into the supply chain – many sourced from facilities in China that have never been inspected by the FDA. The consequences for patients are serious, impurities, contaminants, and inconsistent dosages have led to measurable patient harm, and widespread deceptive advertising has left consumers misinformed about the products they are using."

Arguments in Opposition

The Alliance for Pharmacy Compounding opposes this bill, writing: "Compounding plays a critical role not only when commercially available products are not clinically appropriate, but also during FDA-recognized drug shortages, when patients may have no access to the FDA-approved drug at all. GLP-1s have experienced ongoing supply challenges and are often needed in customized dosages or formulations for patients with obesity or diabetes. This bill would apply even in shortage scenarios, potentially cutting off access at the very moment patients need alternatives most."

FISCAL COMMENTS

According to the Assembly Committee on Appropriations, costs of an unknown but potentially significant amount to the BOP, which anticipates this bill will result in longer and more complex inspections and investigations, potentially increasing operational costs; however, the net cost is uncertain because the bill also establishes automatic fines that could offset some expenses. The BOP also notes that additional costs may arise from due‑process requirements for license revocations and potential legal challenges, but is unable to project the extent of these costs. Additional one-time costs of $800 to the DCA.

VOTES

ASM BUSINESS AND PROFESSIONS: 17-1-1

YES: Berman, Johnson, Addis, Ahrens, Bains, Bauer-Kahan, Caloza, Chen, Elhawary, Haney, Hart, Irwin, Jackson, Lowenthal, Macedo, Nguyen, Pellerin

NO: Hadwick

ABS, ABST OR NV: Alanis

ASM PRIVACY AND CONSUMER PROTECTION: 15-0-0

YES: Bauer-Kahan, Macedo, Bryan, DeMaio, Hoover, Irwin, Lowenthal, McKinnor, Ortega, Patterson, Pellerin, Petrie-Norris, Ward, Wicks, Wilson

ASM APPROPRIATIONS: 13-0-2

YES: Wicks, Hoover, Aguiar-Curry, Calderon, Caloza, Fong, Mark González, Krell, Pacheco, Pellerin, Sharp-Collins, Solache, Tangipa

ABS, ABST OR NV: Dixon, Ta

UPDATED

VERSION: April 23, 2026

CONSULTANT: Robert Sumner / B. & P. / (916) 319-3301 FN: 0002772

Date of Hearing: May 13, 2026

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Buffy Wicks, Chair

ABPCA Bill Id:AB 1990

Author:(Gipson) – As Amended Ver:April 23, 2026

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill prohibits the sale, transfer, or distribution of a compounded drug using a glucagon-like peptide-1 receptor agonist (GLP-1) or glucose-dependent insulinotropic polypeptide receptor drug used for obesity or weight management or a component of a generic equivalent unless the compounder follows specified standards and requirements, including quality control testing. The bill also provides that it is unlawful for any person to advertise compounded medications unless the advertisement is truthful and not misleading, as defined.

FISCAL EFFECT:

Costs of an unknown but potentially significant amount to the Board of Pharmacy (Board). The Board anticipates this bill will result in longer and more complex inspections and investigations, potentially increasing operational costs; however, the net cost is uncertain because the bill also establishes automatic fines that could offset some expenses. The Board also notes that additional costs may arise from due‑process requirements for license revocations and potential legal challenges, but is unable to project the extent of these costs (Pharmacy Board Contingent Fund).

The Department of Consumer Affairs, Office of Information Services estimates costs of $800 to add new enforcement codes (Consumer Affairs Fund).

COMMENTS:

1. Purpose. According to the author:

[This bill] protects patients by ensuring compounded GLP-1 agonist and similar drugs for weight loss are safe, high quality, and honestly marketed. As these medications—such as semaglutide and tirzepatide—have grown in popularity for weight management, demand has surged across the country. During initial supply shortages, many patients turned to compounded versions of these medications when FDA-approved products were difficult to access. These products are not reviewed or approved by the FDA and are not subject to the same rigorous standards for safety, quality, and consistency as approved medications.

Patients seeking out GLP-1s from telehealth providers may erroneously believe they are purchasing an FDA-approved and regulated treatment. [This bill] seeks to increase transparency and establish safeguards so patients are appropriately informed of the unapproved status of the drugs they are purchasing and make sure they understand the differences between unapproved, compounded drugs and FDA-approved therapies.

1. Background. GLP-1 medications are a class of prescription drugs originally intended to manage type-2 diabetes. By mimicking the action of a naturally occurring gut hormone, these medications help stimulate insulin release in response to food and suppress glucagon (a hormone that raises blood sugar). GLP-1 medications also slow digestion to prolong fullness, and act on brain appetite centers to reduce hunger and food cravings, making them effective for weight management.
   
   Ozempic, a GLP-1 drug created by Novo Nordisk, held FDA-approval as a treatment for diabetes for several years leading up to 2021, when the same drug at a different dosage, Wegovy, was approved for weight loss. The resulting exponential growth in demand for Ozempic led to nationwide shortages and steep prices. In 2022, FDA placed Wegovy and Ozempic on the FDA’s drug shortage list, as thousands of pharmacists struggled with backorders and had to turn away patients looking to refill medications. To cope with demand, the FDA temporarily allowed pharmacists to sell compounded versions of the medication. Compounded medications do not undergo the rigorous testing and quality assurance that FDA-approved medicines do. By November 2024, the FDA had received over 600 reports of adverse events related to compounded semaglutide and tirzepatide, the active ingredients in GLP-1 weight loss medications.

The FDA announced the end of the GLP-1 shortage on February 21, 2025. Without the FDA exemptions allowed because of the shortage, compounders were no longer allowed to produce and sell large quantities of GLP-1 medications. Since then, the Federal Trade Commission and FDA have taken action against telehealth companies and pharmaceutical companies for making unlawful claims to consumers about weight loss achieved by consumers and that compounded drugs are the same as FDA-approved products.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: April 21, 2026

Fiscal:

ASSEMBLY COMMITTEE ON PRIVACY AND CONSUMER PROTECTION

Rebecca Bauer-Kahan, Chair

ABPCA Bill Id:AB 1990 (

Author:Gipson) – As Amended Ver:April 15, 2026

PROPOSED AMENDMENTS

SUBJECT: Pharmacy Law: compounded medications: consumer protection

SYNOPSIS

Glucagon-like peptide-1 receptor agonists (GLP-1s) are weight loss medications that have skyrocketed in popularity in recent years due in part to celebrity and influencer endorsements. Typically thought of by a common name brand, Ozempic, GLP-1 medications experienced a shortage in 2022 due to widespread consumption. With the shortage, compounding pharmacists – pharmacists that are not Food and Drug Administration (FDA) approved and therefore are not verified as safe and efficacious by the FDA – were able to produce and sell GLP-1s. In 2025, however, the shortage ended and compounding pharmacists were no longer allowed to participate in the lucrative weight loss market, causing concerns that bad actors would continue to try and sell compounded medications. Additionally, misleading and deceptive advertisements about compounded medications have created administrative burden for the FDA as it attempts to “crack-down” on unlawful GLP-1 advertisements.

This bill aims to place guardrails around compounding pharmacies that produce GLP-1 medications by requiring all bulk drug substances used in the compounding of GLP-1 drugs to be pharmaceutical-grade and compliant with current federal standards and requirements. This bill requires bulk drug substances used in compounded GLP-1 medications to undergo quality control testing and receive a certificate of analysis. Additionally, this bill would require that compounding pharmacies maintain records of bulk drug substances to be made available upon inspection by the Board of Pharmacists (BOP). Finally, this bill makes it unlawful for any person to promote a compounded medication unless the advertisement is truthful and not misleading – the only part of the bill that is squarely in this Committee’s jurisdiction.

This author-sponsored bill has support from California Life Sciences Association, American Diabetes Association, Biocom California, and The Partnership of Safe Medicines. This bill has opposition from the Alliance for Pharmacy Compounding, the California Pharmacists Association, and Chamber of Progress.

Committee amendments, described in Comment #7, aim to address opposition’s concerns about advertisement disclosure policies infringing on intellectual property.

This bill was heard previously in Business and Professions Committee, where it passed on a 17-1 vote.

EXISTING LAW:

1. Establishes the Pharmacy Law. (Bus. & Prof. Code §§ 4000 et seq.)
2. Establishes the California State Board of Pharmacy (BOP) to administer and enforce the Pharmacy Law. (Bus. & Prof. Code § 4001.)
3. Provides that protection of the public shall be the highest priority for the BOP in exercising its licensing, regulatory, and disciplinary functions. (Bus. and Prof. Code § 4001.1.)
4. Authorizes the BOP to adopt rules and regulations as may be necessary for the protection of the public. (Bus. & Prof. Code § 4005.)
5. Defines “outsourcing facility” as a facility that is engaged in the compounding of sterile drugs and nonsterile drugs in California and is both registered with the FDA and licensed by the BOP. (Bus. & Prof. Code § 4034.)
6. Defines “pharmacy” as an area, place, or premises licensed by the BOP in which the profession of pharmacist is practiced and where prescriptions are compounded. (Bus. & Prof. Code § 4037.)
7. Requires a pharmacy to obtain a license from the BOP and establishes information to be provided by pharmacies to the BOP as a condition of license renewal, including a notification to the BOP regarding compounding practices, including compounded human drug preparations distributed outside of the state. (Bus. & Prof. Code § 4110.)
8. Requires each pharmacy to designate a pharmacist-in-charge, subject to approval by the BOP, who is responsible for a pharmacy’s compliance with all state and federal laws and regulations pertaining to the practice of pharmacy. (Bus. & Prof. Code § 4113.)
9. Requires pharmacies that contract to compound a drug for parenteral therapy to report that contractual arrangement to the BOP within 30 days of commencing the compounding. (Bus. & Prof. Code § 4123.)
10. Requires every pharmacy to establish a quality assurance program that documents medication errors attributable to the pharmacy or its personnel. (Bus. & Prof. Code § 4125.)
11. Provides that the compounding of drug preparations by a pharmacy for furnishing, distribution, or use in California shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance; authorizes the BOP to adopt regulations to impose additional standards for compounding drug preparations. (Bus. & Prof. Code § 4126.8.)
12. Requires a pharmacy that issues a recall notice regarding a nonsterile compounded drug product to contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice under specified circumstances. (Bus. & Prof. Code § 4126.9.)
13. Authorizes a pharmacy to distribute compounded human drug preparations interstate if specified conditions are met. (Bus. & Prof. Code § 4126.10.)
14. Requires a pharmacy that compounds sterile drug products to possess a sterile compounding pharmacy license. (Bus. & Prof. Code § 4127.)
15. Prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the BOP. (Bus. & Prof. Code § 4127.1.)
16. Prohibits a nonresident pharmacy from compounding sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the BOP. (Bus. & Prof. Code § 4217.2.)
17. Provides that whenever the BOP has a reasonable belief, based on information obtained during an inspection or investigation by the BOP, that a pharmacy compounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the BOP may issue an order to the pharmacy to immediately cease and desist from compounding sterile drug products. (Bus. & Prof. Code § 4127.3.)
18. Authorizes the BOP to issue a temporary license to compound sterile drug products upon the conditions and for any periods of time as the BOP determines to be in the public interest. (Bus. and Prof. Code § 4127.7.)
19. Requires a pharmacy that issues a recall notice regarding a sterile compounded drug to contact the recipient pharmacy, prescriber, or patient of the recalled drug as well as the BOP as soon as possible within 12 hours of the recall notice if use of or exposure to the recalled drug may cause serious adverse health consequences or death. (Bus. & Prof. Code § 4127.8.)
20. Requires clinics to retain a consulting pharmacist to approve policies and procedures and to certify in writing quarterly that the clinic is, or is not, operating in compliance with the requirements of the Pharmacy Law. (Bus. & Prof. Code § 4192.)
21. Provides that the BOP shall take action against any licensee who is guilty of unprofessional conduct, with various specific examples provided. (Bus. & Prof. Code § 4301.)

THIS BILL:

1. Makes findings and declarations regarding the recent proliferation of inferior or contaminated active pharmaceutical ingredients, especially for use in weight loss medications. States that the intent of the Legislature is to establish safety and regulatory requirements for compounded medications.
2. Defines “bulk drug substance” also referred to as “active pharmaceutical ingredient (API)” as 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.
3. Makes it unlawful to sell, transfer, or distribute a drug compounded under Section 503A of the federal Food, Drug, and Cosmetic Act using a drug substance that is a glucose-dependent insulinotropic polypeptide receptor or GLP-1 receptor agonist used for obesity or weight management or a drug substance that is a component of a similar drug approved by the federal FDA unless the compounder of the drug does all of the following:
   1. Uses bulk drug substances that comply with the following, as applicable:
      1. 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.
      2. If such a monograph does not exist, the bulk drug substances are drug substances that are components of drugs approved by the FDA.
      3. 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 the federal Food, Drug, and Cosmetic Act.
   2. Confirms that the bulk drug substance was manufactured according to the process specified in the FDA’s approval of the drug label, if applicable.
   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 its identity and content and the name and quantity of each impurity present in the bulk drug substance in an amount that exceeds 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:
      1. Is duly registered with the FDA under the federal Food, Drug, and Cosmetic Act.
      2. Has undergone an inspection by the FDA as a human drug establishment within the last two years.
      3. Is not subject to an import alert by the FDA.
   8. Complies with the federal Food, Drug, and Cosmetic Act, including Section 503A.
4. Provides that it is unlawful for any manufacturer or wholesaler to sell, transfer, or distribute a bulk drug substance for use in a compounded drug without providing to the purchaser written verification that the bulk drug substance is pharmaceutical grade, meets the bill’s sourcing and quality control requirements, and is accompanied by a valid certificate of analysis.
5. Subjects violators of the bill’s requirements to both a fine of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed and revocation of the person or entity’s pharmacy or business license, as applicable.
6. Requires any person or entity engaging in the sale, transfer, or distribution of compounded GLP-1 drugs to 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 BOP, furnish those records within one business day of receiving the request, or within a reasonable time as determined by the BOP based on the circumstances of the request.
7. Authorizes the BOP or its duly authorized agent, or a duly authorized agent of a third party approved by the BOP, 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 of the bill.
8. Provides that refusal to permit the BOP or its duly authorized agent or third-party access to conduct an inspection constitutes a violation subject to enforcement under the bill.
9. Defines “unsubstantiated claim” as any statement, representation, or assertion concerning the safety, efficacy, or other attributes of a drug that is not supported by competent and reliable scientific evidence.
10. Provides that it is unlawful for any person to advertise or otherwise promote compounded medications unless the advertisement is truthful and not misleading. States that an advertisement is not truthful and is misleading if it includes any unsubstantiated claim with respect to the product.
11. Expressly provides that an advertisement is misleading unless it contains all of the following:
12. A disclosure of the potential side effects, adverse reactions, contraindications, precautions, and warnings associated with active ingredients in the medication, including any noted from clinical trials, research, and other appropriate information sources.
13. A summary of the specified risk information in the labeling of the FDA-approved drug, when a compounded drug contains an active ingredient that is named as an active ingredient in an FDA-approved drug.
14. A clear, conspicuous statement that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or efficacy.
15. Authorizes the BOP to adopt necessary rules and regulations to implement the bill.
16. Exempts physicians and surgeons licensed, as specified, from the provisions of the bill.

COMMENTS:

1) Author’s statement. According to the author:

AB 1990 protects patients by ensuring compounded GLP-1 agonist and similar drugs for weight loss are safe, high quality, and honestly marketed. As these medications—such as semaglutide and tirzepatide—have grown in popularity for weight management, demand has surged across the country. During initial supply shortages, many patients turned to compounded versions of these medications when FDA-approved products were difficult to access. These products are not reviewed or approved by the FDA and are not subject to the same rigorous standards for safety, quality, and consistency as approved medications. In some cases, compounded GLP-1 products are produced from raw active pharmaceutical ingredients imported from Chinese manufacturers that are not FDA-inspected or monitored and distributed to patients.

Patients seeking out GLP-1s from telehealth providers may erroneously believe they are purchasing an FDA-approved and regulated treatment. AB 1990 seeks to increase transparency and establish safeguards so patients are appropriately informed of the unapproved status of the drugs they are purchasing and make sure they understand the differences between unapproved, compounded drugs and FDA-approved therapies. This will further protect consumers from the potential dangers of unapproved drugs made with substandard, inauthentic, or illicit ingredients.

2) GLP-1 Medications. GLP-1 medications are a class of prescription drugs originally intended to manage type-2 diabetes. By mimicking the action of a naturally occurring gut hormone, GLP-1, these medications help stimulate insulin release in response to food and suppress glucagon (a hormone that raises blood sugar). However, GLP-1 medications also slow digestion to prolong fullness, and act on brain appetite centers to reduce hunger and food cravings, making them effective for weight management.^[1] Most FDA-approved GLP-1 medications are delivered via injection or, more recently, oral tablets.^[2]

For many, GLP-1 medications are synonymous with Ozempic. Created by Novo Nordisk, a Danish Pharmaceutical company, the drug held FDA-approval as a treatment for diabetes for several years leading up to 2021 when the same drug at a different dosage, Wegovy, was approved for weight loss.^[3] Weight loss is a multi-billion dollar market, valued at approximately $135 billion in 2022 and growing exponentially.^[4] Production difficulties with Wegovy, however, led to public discussions of using Ozempic for the same purpose.^[5] As the pandemic raged on, celebrities and influencers began posting about their weight loss journeys with Ozempic, leading to waves of interest from the general public. Views for TikTok videos tagged #Ozempic went from two million in 2021 to 1.2 billion in 2023.^[6] Undoubtedly due to the widespread advertising, Ozempic would be the third best-selling drug in 2023.^[7]

3) Compounding pharmacies and GLP-1 medications. The exponential growth of Ozempic led to nationwide shortages, and incredibly steep prices, of these medications. In 2022, Wegovy and Ozempic were both placed on the FDA’s drug shortage list, as thousands of pharmacists struggled with backorders and had to turn away patients looking to refill medications.^[8] In an attempt to cope with demand, the FDA temporarily allowed pharmacists to sell compounded versions of the medication. Compounded medications are not FDA-approved and therefore do not undergo the rigorous testing and quality assurance that FDA-approved medicines do. Compounding pharmacists make custom medications for people who, for whatever reason, cannot take the FDA-approved drug (e.g., people who are allergic to an ingredient in the FDA-approved medicine, people needing a specific dose, or people who need a medication that is unavailable due to shortage).^[9] There are two general categories of compounding pharmacies: 503A compounding pharmacists that can compound medications based on a prescription provided by healthcare professionals and 503B compounding pharmacists that can both compound medications based on prescriptions but can also compound and sell medications in large quantities.^[10]

4) Attempts to rein in GLP-1 compounders. In the years of the GLP-1 shortage, compounding pharmacists sold millions of near-identical copies of the medicines, often for cheaper than brand-names. However, the lack of quality assurance and testing also came with downsides. By November 2024, the FDA had received over 600 reports of adverse events related to compounded semaglutide and tirzepatide, the active ingredients in GLP-1 weight loss medications.^[11]

The FDA announced the end of the GLP-1 shortage on February 21, 2025, effectively ending the reign of compounding pharmacists.^[12] Without the exemptions offered by the shortage, compounders were no longer allowed to produce and sell large quantities of GLP-1 medications, and the FDA announced that it would begin taking action against compounding pharmacists that make alternatives to brand-name drugs 60 to 90 days after the shortage ended.^[13]

Unsurprisingly, compounding pharmacists were hesitant to walk away from the gold-mine of GLP-1 medications, forcing the FDA to act. As stated in the Business and Professions Committee analysis:

In December 2025, the Federal Trade Commission (FTC) approved a final order against NextMed, a telehealth company, for deceptive advertising of weight-loss programs and deceptive and unfair billing and cancellation practices related to GLP-1 weight-loss programs. The FTC alleged that NextMed took advantage of the explosion in demand for GLP-1 medications by selling weight-loss programs with undisclosed costs and unsubstantiated claims about the weight loss achieved by their clients. The FTC ordered NextMed to cease its misconduct and pay $150,000, which is expected to be used to provide refunds to consumers.^[14]

In March 2026, the FDA sent 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. In a press release announcing the issuance of the letters, FDA Commissioner Marty Makary stated: “We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action. Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”^[15] The warning letters included specific alleged violations, including unlawful claims to consumers that compounded drugs are the same as FDA-approved products.

Similar attempts to rein in compounding pharmacists have been made in Congress with the introduction of H.R. 6509, the SAFE Drugs Act. Aimed at strengthening production standards and guardrails, and encouraging oversight of compounding pharmacists, H.R. 6509 would require compounding pharmacies to report high volume drug shipments across state to the Legislature, mandate more frequent inspections of large outsourcing facilities, and authorize the FDA to adjust outsourcing facility user fees.^[16] A companion bill, S. 3794, was introduced in 2026, though neither has moved beyond the house of origin.^[17]

In the states, several bills have been introduced to address compounding GLP-1 medications, including HB 2613 in Washington, SB 2544 in Mississippi, SB 860 in Florida, and HB 4036 in Arizona.^[18] These bills attempt to control the quality of compounded medications by requiring that the active pharmaceutical ingredients meet quality and safety standards and obtain a certificate of analysis, as well as conduct quality control inspections. In Indiana, a similar bill passed due to a focus on medical spas, businesses that market cosmetic, wellness, or lifestyle treatments while also administering prescription drugs like Botox injects and GLP-1 medications.^[19]

5) What this bill would do. This bill mimics similar legislation introduced across the nation attempting to establish guardrails on compounding pharmacists. Specifically, this bill requires all bulk substances used in compounded drugs containing GLP-1 drug substances to be pharmaceutical grade and comply with United States Pharmacopoeia and FDA standards. Additionally, this bill requires all GLP-1 compounded medications to undergo quality control testing and receive valid certificates of analysis. Any person or entity engaging in the sale, transfer, or distribution of compounded drugs is required to maintain all records of the bulk drug substance testing for at least two years to be made available to the BOP upon request. This bill establishes that it is misleading to advertise a compounded medication unless the advertisement includes a disclosure regarding potential side effects and warnings associated with the active ingredients in the medication; a summary of the risk information in the labeling of the FDA-approved drug if the compounded medication has the same active ingredient that is named in an FDA-approved drug; and a clear and conspicuous statement that the drug is a compounded medication that has not been approved by the FDA for safety or efficacy. Physicians and surgeons are exempt. Violations of the bill will result in fines of $1,000 per dose of an illegally compounded drug that is sold, transferred, or distributed.

6) Misleading advertisements for GLP-1 medications. As the Business and Professions Committee’s analysis has already evaluated the feasibility of this bill from the pharmacists’ perspective, this analysis will focus on the bill’s consumer protection aspects within this Committee’s jurisdiction. As outlined above, the bill establishes requirements for advertisements of GLP-1 compounded medications to be considered truthful and not misleading, including providing risk information of compounded drugs made with the same active ingredient of FDA-approved drugs and providing a clear statement that the drug is not FDA-approved and not tested for safety or efficacy.

The FDA is tasked with ensuring that direct-to-consumer (DTC) drug advertising provides information that is truthful, balanced, and accurately described. Under the Federal Food, Drug, and Cosmetics Act, drug manufacturers must submit evidence of a new drug’s safety and efficacy to the FDA before marketing and public distribution.^[20] Unless a drug is approved to treat a specific condition, that drug cannot be promoted as safe and effective for treating that condition, including drugs that are compounded.

Despite FDA requirements for drug advertising, bad actors continue to make false or misleading claims in drug advertisements, including compounding pharmacists. The Partnership for Safe Medicines, supporters of the bill, argue:

Businesses selling compounded medicine have omitted disclosures of dangerous side effects, and promoted doses and forms of weight loss drugs that have no scientific track record. They have also characterized products as “generics,” even though compounded medicines haven’t undergone the rigorous testing and approval process for actual generic products. All of these practices misrepresent products in ways that can have grave consequences for California residents.

A Presidential memorandum published September 9, 2025, directed the FDA to take action to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions, and ensure truthful and non-misleading information in DTC prescription drug advertisements.^[21] As is highlighted by supporters of the bill, the National Hispanic Health Foundation, this memorandum led the National Consumers League to petition:

Federal regulators to investigate what it described as “pervasive, deceptive and misleading advertising practices” by telehealth platforms promoting compounded GLP-1 drugs. That letter documented misleading claims, blurred lines between FDA-approved products and compounded versions, and inadequate risk disclosures.^[22] We are concerned that without clear standards, these practices will continue to proliferate in California.

Indeed, as outlined in Comment #5, GLP-1 medication manufacturers have recently come under scrutiny for making false or misleading claims. A 2026 lawsuit filed by Novo Nordisk argues that the telehealth company Hims made false and misleading statements about their GLP-1 medications.^[23] NextMed faced significant fines for deceptive advertisements of GLP-1 medications, including making unfound claims about the weight loss achieved by clients, using fake testimonials, and unfairly distorting customer reviews.^[24] A 2025 analysis of online marketing for compounded GLP-1 medications found that:

Of the 79 pharmacies found, 13.9 percent did not disclose the medications for sale were compounded, and 36.7 percent claimed or implied the drugs were FDA approved. Nearly half the sites did not report harmful effects, warnings, precautions, or contraindications, and 40.5 percent claimed efficacy for something not in the label of the FDA-approved branded drugs.^[25]

Despite growing evidence of deceptive advertising practices for compounded weight loss medications, the Alliance of Pharmacy Compounding, opponents of the bill, argue that:

AB 1990 would require compounded drugs that are based on FDA-approved products to include safety disclosures derived from the approved drug’s labeling. This presents several fundamental problems:

• Scientific mismatch: Compounded drugs are not identical to FDA-approved products and have not been evaluated in the same clinical trials. Applying the branded drug’s risk disclosures to a compounded preparation is not scientifically accurate and risks misleading patients.
• Legal inconsistency: Federal law does not permit compounders to rely on or incorporate branded drug labeling in this way. In fact, doing so may create the false impression that the compounded drug has been reviewed or endorsed by FDA.
• Intellectual property and data concerns: The clinical trial data underlying FDA-approved labeling belongs to the drug sponsor and is not available for reuse by compounders.

While compounded drug manufacturers are required to state that they are not FDA-approved, accurate disclosures of information (including potential side effects linked with any active ingredients found in FDA-approved medications) are also required. Therefore, clear disclosures outlining that the compounded drug is not identical to the FDA-approved product would prevent concerns of scientific mismatch whilst also abiding by current federal law. Proposed amendments outlined below intend to address the opposition’s concerns regarding intellectual property and data.

7) Amendments. In order to ensure that disclosure requirements do not infringe upon the intellectual property of data collected during FDA-approved clinical trials, the author has agreed to the following amendment:

4157.4 (c)(1) A disclosure of the potential side effects, adverse reactions, contraindications, precautions, and warnings associated with active ingredients in the medication, including the potential side effects, adverse reactions, contraindications, precautions, and warnings in the labeling of any FDA-approved drug containing the active ingredients named in the compounding drug, unless the advertiser can demonstrate that a particular disclosure is not relevant to the compounded drug. any noted from clinical trials, research, and other appropriate information sources.

ARGUMENTS IN SUPPORT: The California Life Sciences Association writes in support:

Over the past several years, the market for compounded weight loss medications has grown at an unprecedented pace. Unlike FDA-approved drugs, which undergo years of rigorous research, clinical trials, and ongoing safety monitoring, compounded drugs are not subject to FDA premarket review for safety, quality, or efficacy. This regulatory gap has created an opening for bad actors to introduce illicit, inauthentic, or substandard materials into the supply chain – many sourced from facilities in China that have never been inspected by the FDA. The consequences for patients are serious, impurities, contaminants, and inconsistent dosages have led to measurable patient harm, and widespread deceptive advertising has left consumers misinformed about the products they are using.

AB 1990 addresses these risks directly by mandating that compounders verify all bulk drug substances originate from FDA-registered and FDA-inspected facilities. By requiring documented proof of sourcing and compliance with federal manufacturing standards, the bill prevents substandard or contaminated materials from reaching California patients. The legislation also empowers the California State Board of Pharmacy to inspect compounders and their ingredient suppliers and to obtain records providing regulators with the tools they need to identify and act against bad actors before patient harm occurs.

[…]

The bill also addresses the proliferation of misleading advertising for compounded weight loss medications, which has too often exploited patients’ health goals while omitting critical safety information. AB 1990 requires all advertisements for compounded medications to be truthful, to disclose potential side effects and contraindications, and to include a clear, conspicuous statement that the product has not been approved by the FDA and has not been evaluated for safety or efficacy.

It is important to note what AB 1990 does not do. The bill does not restrict access to legitimately compounded medications for patients who need them. It does not apply to compounded drugs made from FDA-approved drugs commonly used in hospital and clinical settings, does not apply to outsourcing facilities, and preserves the ability of prescribers to determine when a compounded drug is clinically necessary. What it does is ensure that when patients in California receive a compounded medication, it is made from ingredients that are authentic, properly tested, sourced from inspected facilities, and that the advertising they encounter is honest.

By enacting AB 1990, California has the opportunity to establish a national model for compounding oversight that protects patients, upholds supply chain integrity, and promotes honest communication between providers, compounders, and consumers.

ARGUMENTS IN OPPOSITION: In opposition to the bill, California Pharmacists Association argues:

California already requires pharmacies to comply with United States Pharmacopeia (USP) standards, including USP <795>, <797>, and <800>, which provide a comprehensive, risk-based framework for safe compounding. Compounding pharmacies adhere to these standards and operate with a strong commitment to patient safety. Licensed pharmacies operate under these standards alongside oversight from the California State Board of Pharmacy.

AB 1990 departs from this framework by imposing requirements that more closely resemble those applied to pharmaceutical manufacturers. These include mandatory impurity profiling of bulk drug substances, batch and expiration testing of finished compounded products, and extensive supply chain verification obligations. These requirements exceed USP standards and are not reflective of pharmacy practice. This could effectively force many compliant compounding pharmacies out of the market, reducing patient access to necessary medications.

Additionally, the bill imposes severe penalties, including fines of $1,000 per dose and potential license revocation, for violations, even in cases where pharmacists are acting in good faith. This punitive framework creates significant liability risk and uncertainty, discouraging pharmacists from providing compounded therapies, even when clinically appropriate and necessary for patients. As a result, the bill risks reducing access to compounded medications that are essential for patients with unique clinical needs.

The bill’s restrictions are particularly concerning, given the important role compounding pharmacists play in addressing drug shortages and meeting individualized patient needs when commercially available products are not suitable. Limiting pharmacists’ ability to compound medications, especially in high-demand therapeutic areas, may drive patients toward unregulated or unsafe alternatives, undermining the very consumer protections the bill seeks to advance.

[…]

If the Legislature seeks to address unsafe compounding practices, a more targeted approach focused on enforcement against noncompliant or unlicensed entities would be more effective than imposing broad requirements on already regulated pharmacies.

The Association of Compounding Pharmacists write in opposition:

Risk of Increased Consumer Confusion

Ironically, the advertising provisions in AB 1990 may undermine, rather than enhance, consumer protection:

• Patients could reasonably interpret the inclusion of FDA-derived safety language as an indication that the compounded drug has been evaluated by FDA.
• Conflicting or inapplicable disclosures may obscure, rather than clarify, important information about how a compounded medication differs from an FDA-approved product.
• Pharmacies attempting to comply with both federal and state requirements may be forced into inconsistent or overly complex messaging that is difficult for patients to understand.

REGISTERED SUPPORT / OPPOSITION:

Support

American Diabetes Association
Biocom California
California Life Sciences Association
National Hispanic Health Foundation
Partnership for Safe Medicines

Opposition

Alliance for Pharmacy Compounding
California Pharmacists Association
Chamber of Progress

Analysis Prepared by: Kate Davis / P. & C.P. / (916) 319-2200

1. Radwan Darwish, G. Abu-Sharia, A. E. Butler, “History of glucagon-like peptide-1 receptor agonists,” Pharmacological Research, Vol. 222, (Dec. 2025), https://www.sciencedirect.com/science/article/pii/S1043661825004700. ↑

2. Drucker, Daniel J. “Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1.” Cell Metabolism, vol. 27, no. 4, 2018. https://www.cell.com/cell-metabolism/fulltext/S1550-4131(18)30179-7?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1550413118301797%3Fshowall%3Dtrue. ↑

3. Gavin Scheldrup, “The Ozempic Era,” Medical University of South Caroline, (Aug. 29, 2024), https://www.musc.edu/content-hub/news/2024/08/29/the-ozempic-era. ↑

4. Custom Market Insights, “U.S. Weight Loss Market Size/Share Worth USD 305.30 Billion by 2030 at a 9.7% CAGR: Custom Market Insights (Analysis, Outlook, Leaders, Report, Trends, Forecast, Segmentation, Growth, Growth Rate, Value),” yahoo!finance, (May 9, 2023), https://finance.yahoo.com/news/latest-u-weight-loss-market-170000586.html. ↑

5. Scheldrup, “The Ozempic Era.” ↑

6. Id. ↑

7. Id. ↑

8. Emma Court, “TikTok trend wipes out Ozempic supply, leaving people with diabetes dizzy, scared,” Los Angeles Times, (Dec. 23, 2022), https://www.latimes.com/business/story/2022-12-23/tiktok-trend-sold-out-ozempic-diabetes-drug. ↑

9. Joshua Murdock, “What Are Compounding Pharmacies,” GoodRx, (Nov. 22, 2021), https://www.goodrx.com/drugs/medication-basics/what-is-compounding-pharmacy?srsltid=AfmBOoqwuh3Gaf0zSiYLQpkJk8Q8mHyPr0KX8ffBosUoNyT4anSCjkuP. ↑

10. Id. ↑

11. Nikhil Sood, R. Garg, “Global Rise of Compounded Weight-Loss Medicines: A Worrisome Trend,” Journal of the Endocrine Society, vol. 9, is. 8, (June 7, 2025), https://pmc.ncbi.nlm.nih.gov/articles/PMC12164287/. ↑

12. Robert Fischer, “Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy),” U.S. Food & Drug Administration, (Feb. 21, 2025), https://www.fda.gov/media/185526/download. ↑

13. Id. ↑

14. “FTC Approves Final Order against Telehealth Provider NextMed over Charges It Used Deceptive Advertising Claims to Sell GLP‑1 Weight‑Loss Programs.” Federal Trade Commission, December 2025. ↑

15. U.S. Food and Drug Administration. “FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP‑1s.” FDA, March 2026. ↑

16. H.R. 6509, 119^th Cong., 1^st Sess. (2025), congress.gov, https://www.congress.gov/bill/119th-congress/house-bill/6509/text. ↑

17. S.3794, 119^th Cong., 2nd Sess. (2026), congress.gov, https://www.congress.gov/bill/119th-congress/senate-bill/3794. ↑

18. H.B. 2613, Washington Legislature (2026), https://www.billtrack50.com/billdetail/1942704.; S.B. 2544, Mississippi Legislature, (2026), https://billstatus.ls.state.ms.us/documents/2026/html/SB/2500-2599/SB2544IN.htm.; S.B 680, Florida Legislature (2026), https://www.flsenate.gov/Session/Bill/2026/860.; H.B. 4036, Arizona Legislature, (2026), https://legiscan.com/AZ/text/HB4036/id/3350491. ↑

19. Casey Smith, “Medical spas, compounded drugs in focus as Indiana lawmakers hear warnings – and pushback,” Indiana Capital Chronicle, (Feb. 18, 2026), https://indianacapitalchronicle.com/2026/02/18/medical-spas-compounded-drugs-in-focus-as-indiana-lawmakers-hear-warnings-and-pushback/. ↑

20. Clinton Lam and P. Patel, “Food, Drug, and Cosmetic Act,” StatPearls, (July 31, 2023), https://www.ncbi.nlm.nih.gov/books/NBK585046/. ↑

21. The White House. “Memorandum for the Secretary of Health and Human Services the Commissioner of the Food and Drugs” The White House, Sept. 9, 2025, https://www.whitehouse.gov/presidential-actions/2025/09/memorandum-for-the-secretary-of-health-and-human-services-the-commissioner-of-food-and-drugs/. ↑

22. National Consumers League September 2025 letter to Andrew Ferguson, Chairman, Federal Trade Commission, https://nclnet.org/wp-content/uploads/2025/09/NCL-Petition-to-the-FTC-on-Deceptive-FTC-Adverising-of-Compounded-GLP-1-Drugs-09.22.2025.pdf. ↑

23. “NYSE: Hims. Hims & Hers Health, Inc.,” The Rosen Law Firm, https://rosenlegal.com/case/hims-hers-health-inc/#:~:text=Details%20of%20the%20case:,Wegovy%20alongside%20compounded%20semaglutide%20products.. ↑

24. “FTC Approves Final Order against Telehealth Provider NextMed.” ↑

25. Jessica M. Scully, “New Study Finds Online Advertising for Compounding Diabetes and Weight-Loss Drugs May Mislead Consumers,” Yale School of Medicine, (Feb. 19, 2025), https://medicine.yale.edu/news-article/new-study-finds-online-advertising-for-compounded-diabetes-and-weight-loss-drugs-may-mislead-consumers/. ↑

Date of Hearing:

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Marc Berman, Chair

ABPCA Bill Id:AB 1990

Author:(Gipson) – As Amended Ver:March 9, 2026

NOTE: This bill is double referred and if passed by this Committee will be re-referred to the Assembly Committee on Privacy and Consumer Protection.

SUBJECT: Pharmacy Law: compounded medications: consumer protection.

SUMMARY: Establishes additional requirements for the compounding of drugs containing glucagon-like-peptide-1 (GLP-1) receptor agonists or similar drug substances used for obesity or weight management and provides that it is unlawful for any person to advertise compounded medications unless the advertisement is truthful and not misleading, as specifically defined.

EXISTING LAW:

1. Establishes the Pharmacy Law. (Business and Professions Code (BPC) §§ 4000 et seq.)
2. Establishes the California State Board of Pharmacy (BOP) to administer and enforce the Pharmacy Law. (BPC § 4001)
3. Provides that protection of the public shall be the highest priority for the BOP in exercising its licensing, regulatory, and disciplinary functions. (BPC § 4001.1)
4. Authorizes the BOP to adopt rules and regulations as may be necessary for the protection of the public. (BPC § 4005)
5. Defines “outsourcing facility” as a facility that is engaged in the compounding of sterile drugs and nonsterile drugs in California and is both registered with the Food and Drug Administration (FDA) and licensed by the BOP. (BPC § 4034)
6. Defines “pharmacy” as an area, place, or premises licensed by the BOP in which the profession of pharmacist is practiced and where prescriptions are compounded. (BPC § 4037)
7. Requires a pharmacy to obtain a license from the BOP and establishes information to be provided by pharmacies to the BOP as a condition of license renewal, including a notification to the BOP regarding compounding practices, including compounded human drug preparations distributed outside of the state. (BPC § 4110)
8. Requires each pharmacy to designate a pharmacist-in-charge, subject to approval by the BOP, who is responsible for a pharmacy’s compliance with all state and federal laws and regulations pertaining to the practice of pharmacy. (BPC § 4113)
9. Requires pharmacies that contract to compound a drug for parenteral therapy to report that contractual arrangement to the BOP within 30 days of commencing the compounding. (BPC § 4123)
10. Requires every pharmacy to establish a quality assurance program that documents medication errors attributable to the pharmacy or its personnel. (BPC § 4125)
11. Provides that the compounding of drug preparations by a pharmacy for furnishing, distribution, or use in California shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary (USP), including relevant testing and quality assurance; authorizes the BOP to adopt regulations to impose additional standards for compounding drug preparations. (BPC § 4126.8)
12. Requires a pharmacy that issues a recall notice regarding a nonsterile compounded drug product to contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice under specified circumstances. (BPC § 4126.9)
13. Authorizes a pharmacy to distribute compounded human drug preparations interstate if specified conditions are met. (BPC § 4126.10)
14. Requires a pharmacy that compounds sterile drug products to possess a sterile compounding pharmacy license. (BPC § 4127)
15. Prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the BOP. (BPC § 4127.1)
16. Prohibits a nonresident pharmacy from compounding sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the BOP. (BPC § 4217.2)
17. Provides that whenever the BOP has a reasonable belief, based on information obtained during an inspection or investigation by the BOP, that a pharmacy compounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the BOP may issue an order to the pharmacy to immediately cease and desist from compounding sterile drug products. (BPC § 4127.3)
18. Authorizes the BOP to issue a temporary license to compound sterile drug products upon the conditions and for any periods of time as the BOP determines to be in the public interest. (BPC § 4127.7)
19. Requires a pharmacy that issues a recall notice regarding a sterile compounded drug to contact the recipient pharmacy, prescriber, or patient of the recalled drug as well as the BOP as soon as possible within 12 hours of the recall notice if use of or exposure to the recalled drug may cause serious adverse health consequences or death. (BPC § 4127.8)
20. Requires clinics to retain a consulting pharmacist to approve policies and procedures and to certify in writing quarterly that the clinic is, or is not, operating in compliance with the requirements of the Pharmacy Law. (BPC § 4192)
21. Provides that the BOP shall take action against any licensee who is guilty of unprofessional conduct, with various specific examples provided. (BPC § 4301)

THIS BILL:

1. Defines “bulk drug substance,” also known as “active pharmaceutical ingredient (API),” as 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; exempts intermediates used in the synthesis of the substance from this definition.
2. Makes it unlawful to sell, transfer, or distribute a drug compounded under Section 503A of the federal Food, Drug, and Cosmetic Act using a drug substance that is a glucose-dependent insulinotropic polypeptide receptor or GLP-1 receptor agonist used for obesity or weight management or a drug substance that is a component of a similar drug approved by the federal FDA unless the compounder of the drug does all of the following:
   1. Uses bulk drug substances that comply with the following, as applicable:
      1. The standards of an applicable USP or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding.
      2. If such a monograph does not exist, the bulk drug substances are drug substances that are components of drugs approved by the FDA.
      3. 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 the federal Food, Drug, and Cosmetic Act.
   2. Confirms that the bulk drug substance was manufactured according to the process specified in the FDA’s approval of the drug label, if applicable.
   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 its identity and content and the name and quantity of each impurity present in the bulk drug substance in an amount that exceeds 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:
      1. Is duly registered with the FDA under the federal Food, Drug, and Cosmetic Act.
      2. Has undergone an inspection by the FDA as a human drug establishment within the last two years.
      3. Is not subject to an import alert by the FDA.
   8. Complies with the federal Food, Drug, and Cosmetic Act, including Section 503A.
3. Provides that it is unlawful for any manufacturer or wholesaler to sell, transfer, or distribute a bulk drug substance for use in compounding without providing to the purchaser written verification that the bulk drug substance is pharmaceutical grade, meets the bill’s sourcing and quality control requirements, and is accompanied by a valid certificate of analysis.
4. Subjects violators of the bill’s requirements to both a fine of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed and revocation of the person or entity’s pharmacy or business license, as applicable.
5. Requires any person or entity engaging in the sale, transfer, or distribution of compounded GLP-1 drugs to 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 BOP, furnish those records within one business day of receiving the request, or within a reasonable time as determined by the BOP based on the circumstances of the request.
6. Authorizes the BOP or its duly authorized agent, or a duly authorized agent of a third party approved by the BOP, 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 of the bill.
7. Provides that refusal to permit the BOP or its duly authorized agent or third-party access to conduct an inspection constitutes a violation subject to enforcement under the bill.
8. Defines “unsubstantiated claim” as any statement, representation, or assertion concerning the safety, efficacy, or other attributes of a drug that is not supported by competent and reliable scientific evidence.
9. Provides that it is unlawful for any person to advertise or otherwise promote compounded medications unless the advertisement is truthful and not misleading. An advertisement is not truthful and is misleading if it includes any unsubstantiated claim with respect to the product.
10. Expressly provides that an advertisement is misleading unless it contains all of the following:
    1. A disclosure of the potential side effects, adverse reactions, contraindications, precautions, and warnings associated with active ingredients in the medication, including any noted from clinical trials, research, and other appropriate information sources.
    2. A summary of the specified risk information in the labeling of the FDA-approved drug, when a compounded drug contains an active ingredient that is named as an active ingredient in an FDA-approved drug.
    3. A clear, conspicuous statement that the product is a compounded medication, has not been approved by the FDA, and has not been evaluated by the FDA for safety or efficacy.
11. Authorizes the BOP to adopt necessary rules and regulations to implement the bill.

FISCAL EFFECT: Unknown; this bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

Purpose. This bill is sponsored by the author. According to the author:

AB 1990 protects patients by ensuring compounded GLP-1 agonist and similar drugs for weight loss are safe, high quality, and honestly marketed. As these medications—such as semaglutide and tirzepatide—have grown in popularity for weight management, demand has surged across the country. During initial supply shortages, many patients turned to compounded versions of these medications when FDA-approved products were difficult to access. These products are not reviewed or approved by the FDA and are not subject to the same rigorous standards for safety, quality, and consistency as approved medications. In some cases, compounded GLP-1 products are produced from raw active pharmaceutical ingredients imported from Chinese manufacturers that are not FDA-inspected or monitored and distributed to patients. Patients seeking out GLP-1s from telehealth providers may erroneously believe they are purchasing an FDA-approved and regulated treatment. AB 1990 seeks to increase transparency and establish safeguards so patients are appropriately informed of the unapproved status of the drugs they are purchasing and make sure they understand the differences between unapproved, compounded drugs and FDA-approved therapies. This will further protect consumers from the potential dangers of unapproved drugs made with substandard, inauthentic, or illicit ingredients.

Background.

California State Board of Pharmacy. The BOP is the regulatory body within the Department of Consumer Affairs responsible for overseeing pharmacies and pharmacist practice in California. The BOP is currently estimated to regulate over 50,700 pharmacists, 1,300 advanced practice pharmacists, 4,400 intern pharmacists, and 65,700 pharmacy technicians across 32 licensing programs. In addition to regulating professionals, the BOP licenses and oversees pharmacies, clinics, wholesalers, third-party logistic providers, and automated drug delivery systems.

The BOP has its own enforcement staff, which includes field inspectors responsible for conducting investigations and inspections of pharmacies as well as sterile compounding and outsourcing facilities. The BOP’s enforcement program is its largest budget expenditure, historically comprising about 64 percent of its total operating expenses. The BOP regularly engages in investigations that may result in disciplinary action. The BOP’s Enforcement and Compounding Committee provides oversight of all drug distribution and dispensing activities, including drug compounding, and is responsible for ensuring compliance with state and federal pharmacy laws.

During the BOP’s sunset review in 2020, the Committees considered whether the Pharmacy Law’s requirements for the appointment of pharmacists representing specific practice settings were sufficient to provide the BOP with expert perspectives on matters relating to compounding. The sunset background paper recognized that the practice of compounding had recently drawn national attention for both its importance and complexity, and that the BOP had recently put forth a number of regulations regarding pharmacy compounding. At the time, there had not been a compounding pharmacist specifically represented on the BOP. In response, the BOP’s sunset bill was amended in 2021 to include a member from a compounding pharmacy specializing in human drug preparations.

Requirements for Drug Compounding. According to the FDA, drug compounding is generally described as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Combining two or more drugs is a form of compounding, as is the reconstitution of a drug into another ingestible form. Compounded drugs are not approved by the FDA for safety or effectiveness. Federal law establishes the authority for specified individuals to compound human drug products under provisions specified in section 503A of the federal Food, Drug, and Cosmetic Act. Drug products compounded under these provisions are exempt from some of the requirements for drug manufacturing and the drug approval process.

The USP is a combination of two compendia published by two longstanding nonprofits: the United States Pharmacopeia, published by the United States Pharmacopeial Convention; and the National Formulary, published by the American Pharmaceutical Association. As the FDA’s officially designated compendium, the USP sets numerous standards for drug ingredients and manufacturing processes, including testing and quality assurance. Generally speaking, drug products and ingredients sold in the United States must conform to the USP to be considered unadulterated and of minimum quality.

Pharmacy professionals who engage in the practice of drug compounding in California are required to obtain a license from the BOP. However, prior to 2020, there were no state laws that outlined specific requirements for the compounding of prescription medication. Partially in response to a significant multistate outbreak of fungal meningitis for which the unsafe compounding of a preservative-free steroid injection resulted in numerous deaths, the BOP sponsored legislation in 2019 to require that compounding in California must be performed consistent with standards established in the pharmacy compounding chapters of the current version of the USP. The USP develops and publishes standards for drug substances, drug products, excipients, and dietary supplements. These standards are recognized in the federal Food, Drug, and Cosmetic Act.

The BOP recently completed rulemaking to clarify requirements for drug compounding by licensees in response to changes enacted to the USP. These efforts began when changes to the USP were initially proposed in 2019, at which time the BOP held a series of public meetings to discuss proposed language with stakeholders; however, these discussions were paused following delays in the USP’s process. Following the finalization of the USP Chapters, the BOP resumed efforts to revise its compounding regulations and held another series of meetings to receive further comments from stakeholders. The changes proposed by the BOP included restructuring its regulations to align with the USP Chapters, eliminating and clarifying requirements, and adding new requirements.

The BOP approved proposed regulation text in April 2023 to amend the BOP’s regulations regarding compounded drug preparations to implement, clarify, or make more specific requirements related to the USP-National Formulary for nonsterile compounding, sterile compounding, the handling of hazardous drugs, and the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals. The new USP Chapters became effective on November 1, 2023; because the BOP’s proposed regulations were not yet effective, the BOP released an updated Policy Statement in September 2023 providing stakeholders with additional guidance.

On April 19, 2024, the BOP formally distributed its proposed regulation text to interested parties for a 45-day comment period, which ended on June 3, 2024. An additional regulation hearing was held on June 18, 2024. Through this process and throughout these public meetings, stakeholders submitted numerous comments to the BOP expressing concerns about the proposed regulations. Representatives of compounding pharmacies specifically raised concern that the provisions relating to sterile compounding exceeded the requirements of the USP and national standards and would result in fewer pharmacies providing compounding services in California. Stakeholders further criticized the BOP for what was characterized as excessive enforcement activity against licensees for minor infractions.

In the months following the conclusion of the formal comment period, the BOP approved multiple sets of changes to its proposed text in response to the concerns it had received. During its November 2024 meeting, the BOP voted to approve a modified regulation text for a 30-day comment period, which ended on December 9, 2024. An additional 15-day comment period was then initiated following further modifications by the BOP during its January 2025 meeting, and yet another 15-day comment period was initiated following changes made during the BOP’s February 2025 meeting. The BOP’s final updated regulations governing nonsterile compounding, sterile compounding, hazardous drugs, and radiopharmaceuticals took effect on October 1, 2025.

Throughout the rulemaking process, organizations opposed to the BOP’s proposed regulations organized a robust public campaign, specifically citing concerns that the regulations would limit patient access to compounded products such as glutathione, methylcobalamin, and NAD+ infusions. Representatives of the veterinary medical profession also raised additional issues specific to animal patients. In its sunset report to the Committees, the BOP argued that it had provided a fair and transparent rulemaking process, providing numerous opportunities for interested stakeholders to participate. The BOP believed there had been significant misinformation in the public domain misrepresenting the requirements of federal law.

Additional issues relating to compounding were raised during the BOP’s sunset review in 2025. As reported by the BOP, in recent years, the FDA has released warnings about instances of drug products being compounded under insanitary conditions. Many of these warnings stem from compounding occurring in sites that are not regulated by the BOP or other regulatory agencies, including medical spas and IV hydration clinics. Following an incident in California where a patient was hospitalized and treated for suspected septic shock with multi-organ failure after receiving an IV vitamin infusion in her home, the FDA reported that it was aware of sterile compounding activities, such as adding vitamins to IV infusion bags, being performed by hydration clinics where it is unknown and undocumented if the drug products are prepared, packed, or held under insanitary conditions. Additionally, it is unknown whether a licensed practitioner is on-site to evaluate patients and write prescriptions for the drug products being administered.

In light of the patient safety concerns associated with compounding taking place in unregulated clinics, the BOP submitted a proposal to require hydration clinics to obtain a license from the BOP prior to compounding or administering sterile injectable products, subject to inspection by the Board. Clinics would also be required to designate a licensed prescriber as the professional director responsible for the safe, orderly, and lawful provisions of compounding and administration of the sterile injectable products. Ultimately, however, this proposal was not included in the BOP’s sunset bill.

GLP-1 Medications. GLP-1 medications are a class of prescription drugs originally developed to treat type-2 diabetes and are now widely used for chronic weight management. These medications mimic the action of a naturally occurring gut hormone, GLP-1, which helps regulate blood sugar, appetite, and digestion. GLP-1 drugs work by stimulating insulin release in response to food, suppressing glucagon (a hormone that raises blood sugar), slowing gastric emptying to prolong fullness, and acting on brain appetite centers to reduce hunger and food cravings. Well-known examples include semaglutide (marketed as Ozempic or Wegovy) and liraglutide (Saxenda), while related or newer agents such as tirzepatide (Zepbound) act on similar incretin pathways and are often grouped with GLP-1–based therapies. These drugs are part of a broader class of “incretin mimetics,” and ongoing research has produced additional variants that expand on the same biological mechanisms. Most FDA-approved GLP-1 medications are delivered via injection pens or, more recently, oral tablets.^[1]

Section 503A of the federal Food, Drug, and Cosmetic Act allows for GLP-1 medication to be compounded under specific, limited circumstances. Compounding pharmacies operating under sections 503A (traditional pharmacies) and 503B (outsourcing facilities) are allowed to prepare customized versions of drugs only when there is a legitimate medical need that cannot be met by an FDA-approved product. For example, if a patient requires a different dosage form, strength, or ingredient due to an allergy, a patient-specific version of the medication may be compounded. Additionally, an FDA-approved drug may be compounded when the FDA has officially declared a shortage of that drug. GLP-1 medications, such as semaglutide, were previously included on the FDA drug shortage list due to high demand following an increase in public awareness of the potential to use the drug for weight loss; however, as of February 2025, they are no longer on the official shortage list, and cannot be compounded under that exception.

In December 2025, the Federal Trade Commission (FTC) approved a final order against NextMed, a telehealth company, for deceptive advertising of weight-loss programs and deceptive and unfair billing and cancellation practices related to GLP-1 weight-loss programs. The FTC alleged that NextMed took advantage of the explosion in demand for GLP-1 medications by selling weight-loss programs with undisclosed costs and unsubstantiated claims about the weight loss achieved by their clients. The FTC ordered NextMed to cease its misconduct and pay $150,000, which is expected to be used to provide refunds to consumers.^[2]

In March 2026, the FDA sent 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. In a press release announcing the issuance of the letters, FDA Commissioner Marty Makary stated: “We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action. Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”^[3] The warning letters included specific alleged violations, including unlawful claims to consumers that compounded drugs are the same as FDA-approved products.

Efforts to Regulate Compounded GLP-1 Medications. In 2025, H.R. 6509, the SAFE Drugs Act of 2025, was introduced in the United States House of Representatives to increase oversight and regulation of compounding pharmacies and outsourcing facilities that compound what that bill would define as “essentially a copy” of an FDA‑approved product. The legislation proposes to cap the number of drug copies that can be made each month without patient‑specific justification, require reporting when pharmacists or facilities compound and ship high volumes of drugs across state lines, mandate more frequent inspections of large outsourcing facilities, and allow the federal government to adjust user fees to support enhanced oversight. A companion bill was introduced in the United States Senate in 2026, but to date, no significant federal legislation has been signed.

Legislation has been proposed in several states to crack down on the compounding of alleged “copycat” GLP-1 medications. For example, HB 2613 was introduced in the State of Washington to prohibit entities from selling, transferring, or distributing compounded drugs that use bulk drug substances unless the compounder complies with certain quality assurance requirements. Similar legislation has been introduced in Arizona, Colorado, Florida, Kentucky, Mississippi, and Virginia. The Indiana General Assembly enacted SB 282 in 2026, which both restricted the compounding of GLP-1 medications and increased state oversight of medical spas.

This bill would similarly establish additional requirements and restrictions on compounding pharmacies that produce GLP-1 medications. The bill would require all bulk substances used in compounded drugs containing GLP-1 drug substances to be pharmaceutical-grade, comply with USP and FDA standards and requirements, undergo quality control testing, be accompanied by a valid certificate of analysis, and sourced from FDA-registered and recently inspected facilities. The bill would require records of those bulk drug substances to be maintained and made available for inspection by the BOP.

Additionally, this bill specifically makes it unlawful for any person to advertise or otherwise promote compounded medications unless the advertisement is truthful and not misleading. The bill provides that an advertisement is not truthful and is misleading if it includes any unsubstantiated claim with respect to the product, or if it fails to include specified disclosures. These provisions are within the jurisdiction of the Assembly Committee on Privacy and Consumer Protection, which has also been referred this bill.

Current Related Legislation. AB 2141 (Patterson) would authorize the BOP to resolve a potential cause for discipline by a licensee through a stipulated settlement agreement prior to the filing of a formal accusation. This bill is pending in the Assembly Committee on Judiciary.

Prior Related Legislation. AB 1503 (Berman), Chapter 196, Statutes of 2025 extended the sunset date for the BOP and made additional changes to the Pharmacy Law.

AB 3063 (McKinnor) of 2024 would have exempted the addition of flavoring agents to a drug from the state’s requirement that such actions comply with pharmacy compounding standards set under the USP. This bill was vetoed by the Governor.

AB 782 (McKinnor) of 2023 was substantially similar to AB 3063. This bill was vetoed by the Governor.

AB 973 (Irwin), Chapter 184, Statutes of 2020, requires compounding to comply with the USP.

ARGUMENTS IN SUPPORT:

The California Life Sciences Association supports this bill, writing:

Over the past several years, the market for compounded weight loss medications has grown at an unprecedented pace. Unlike FDA-approved drugs, which undergo years of rigorous research, clinical trials, and ongoing safety monitoring, compounded drugs are not subject to FDA premarket review for safety, quality, or efficacy. This regulatory gap has created an opening for bad actors to introduce illicit, inauthentic, or substandard materials into the supply chain – many sourced from facilities in China that have never been inspected by the FDA. The consequences for patients are serious, impurities, contaminants, and inconsistent dosages have led to measurable patient harm, and widespread deceptive advertising has left consumers misinformed about the products they are using.

AB 1990 addresses these risks directly by mandating that compounders verify all bulk drug substances originate from FDA-registered and FDA-inspected facilities. By requiring documented proof of sourcing and compliance with federal manufacturing standards, the bill prevents substandard or contaminated materials from reaching California patients. The legislation also empowers the California State Board of Pharmacy to inspect compounders and their ingredient suppliers and to obtain records providing regulators with the tools they need to identify and act against bad actors before patient harm occurs.

ARGUMENTS IN OPPOSITION:

The Alliance for Pharmacy Compounding (APC) opposes this bill, writing:

Compounding plays a critical role not only when commercially available products are not clinically appropriate, but also during FDA-recognized drug shortages, when patients may have no access to the FDA-approved drug at all. GLP-1s have experienced ongoing supply challenges and are often needed in customized dosages or formulations for patients with obesity or diabetes. This bill would apply even in shortage scenarios, potentially cutting off access at the very moment patients need alternatives most.

APC further argues that the bill would impose overly restrictive API sourcing requirements; duplicative testing, documentation, and verification mandates; excessive penalties and enforcement provisions; and advertising and labeling requirements that are not aligned with compounding practice.

POLICY ISSUE(S) FOR CONSIDERATION:

Potentially Overbroad Application. This bill’s requirements would apply to compounded medicines containing drug substances that are glucose-dependent insulinotropic polypeptide receptor or GLP-1 receptor agonists used for obesity or weight management, or a drug substance that is a component of a similar drug approved by the FDA for obesity or weight management. The term “similar drug” may inadvertently capture more medications than intended by the bill. Additionally, language in the bill placing new requirements on bulk drug substances used in compounding and prohibiting certain advertisements do not specifically refer back to GLP-1 drug substances, implying broader applicability. The author may wish to substitute the term “generic equivalent” for “similar drug” and insert additional clarifying language regarding the scope of this bill.

Unclear Enforcement Jurisdiction. This bill would establish specific enforcement mechanisms for violations of its requirements and prohibitions. The BOP would be authorized to engage in inspections to confirm compliance and to adopt regulations to implement the bill. However, not all licensed professionals who would potentially be covered by the bill are within the BOP’s jurisdiction. For example, concerns have been raised that physicians and surgeons, who are licensed and overseen by either the Medical Board of California or the Osteopathic Medical Board of California, could be inadvertently subject to enforcement by the BOP under this bill, despite not being the intended target of the legislation. The author may wish to add language exempting physicians and surgeons from the bill, while ensuring that existing requirements for those licensees remain in place.

AMENDMENTS:

1. To confirm that the scope of the bill applies only to GLP-1 medications or other drugs intended to be captured:

• Add the following subdivision to the proposed Section 4157:

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.

• Amend subdivision (a) of the proposed Section 4157.1 to replace the term “similar drug” with “generic equivalent.”
• Insert additional cross-references to subdivision (a) of the proposed Section 4157.1 to confirm what types of compounded medications are subject to requirements and prohibitions in the bill.

1. To clarify that the bill’s requirements and prohibitions do not apply to licensed physicians and surgeons or subject those licensees to enforcement by the BOP, add the following subdivision to the proposed Section 4157.5:

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.

REGISTERED SUPPORT:

American Diabetes Association
Biocom California
California Life Sciences Association
National Consumers League
National Hispanic Health Foundation
Partnership for Safe Medicines

REGISTERED OPPOSITION:

Alliance for Pharmacy Compounding
California Pharmacists Association
Chamber of Progress

Analysis Prepared by: Robert Sumner / B. & P. / (916) 319-3301

1. Drucker, Daniel J. “Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1.” Cell Metabolism, vol. 27, no. 4, 2018. ↑

2. “FTC Approves Final Order against Telehealth Provider NextMed over Charges It Used Deceptive Advertising Claims to Sell GLP‑1 Weight‑Loss Programs.” Federal Trade Commission, December 2025. ↑

3. U.S. Food and Drug Administration. “FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP‑1s.” FDA, March 2026. ↑