2025-19
Dangers of Compounded GLP-1 Obesity Medications
Sponsored by
Sen. Cristina Castro (IL) and Rep. Veronica Paiz (MI)
Reported to the Caucus by the
NHCSL Healthcare Task Force
Rep. Alma Hernández (AZ), Chair
Unanimously ratified by the Caucus on November 22, 2025
WHEREAS, the National Hispanic Caucus of State Legislators (NHCSL) has recognized obesity as a chronic disease requiring comprehensive, evidence-based treatment and has encouraged states to ensure coverage of Food and Drug Administration (FDA)-approved pharmaceuticals where medically appropriate;[1] and,
WHEREAS, a survey from 2019 from the Centers for Disease Control and Prevention (CDC) reported that 34.9% of Hispanic adults were obese compared to 30% of non-Hispanic white adults[2], and CDC data showed that in 2022, 11.5% of Hispanic adults were diabetic compared to 7.2% of non-Hispanic white adults;[3] and,
WHEREAS, a 2024 study found that Hispanic adults are more likely than non-Hispanic white adults to report taking GLP-1 receptor agonists and related incretin therapies (13% v. 10%);[4] and,
WHEREAS, according to the CDC, among U.S. adults with diagnosed diabetes in 2024, 31.3% of Hispanic adults used injectable GLP-1 medications, compared to 26.2% of non-Hispanic white adults;[5] and,
WHEREAS, patients rely on FDA approval for ensuring medication quality, safety, and efficacy, and this Caucus previously called on Congress to eliminate the barriers to coverage of FDA-approved anti-obesity medications in the Medicare Part-D program;[6] and,
WHEREAS, the FDA reported that as of April 30, 2025, it had received 520 reports of adverse events associated with unapproved versions of GLP-1 receptor agonists, such as Semaglutide, illustrating how unapproved versions marketed jeopardize safety, effectiveness, and quality of these medications popularly used for weight-loss;[7] and,
WHEREAS, GLP-1 receptor agonists and related incretin therapies are FDA-approved for certain indications and must meet stringent manufacturing, labeling, dosing, and pharmacovigilance requirements; be produced under rigorous current Good Manufacturing Practice (cGMP) requirements; undergo robust quality, sterility, stability, and dosing controls; and are subject to post-market safety monitoring; and,
WHEREAS, federal law strictly limits pharmacy compounding to narrow circumstances and generally does not permit it when an FDA-approved product is commercially available, because compounded drugs are not FDA-approved and do not undergo FDA premarket review for safety, effectiveness, or quality; are not required to be produced under cGMP requirements; and are not subject to post-market safety monitoring; and,
WHEREAS, federal law also distinguishes between 503A pharmacies—traditional state-licensed pharmacies that may not engage in bulk compounding and are not required to comply with cGMP—and 503B outsourcing facilities that register with FDA, can compound drugs in bulk under certain circumstances, and are required to comply with cGMP. Reselling of compounded drugs, including from 503B facilities to 503A pharmacies, circumvents the important differences between different types of compounders and allows traditional pharmacies to evade safety guardrails on compounding; and,
WHEREAS, FDA and state boards of pharmacy have noted a proliferation of illegally compounded GLP-1 products and warned of serious patient safety risks from these products, including from dosing errors (sometimes up to 20 times), contamination, impurities, incorrect concentrations, and super-potent or sub-potent products;[8] and,
WHEREAS, the safety and quality issues of compounded GLP-1 products may arise because they contain active pharmaceutical ingredients (APIs) from dangerous and illicit foreign sources, as a recent FDA report noted that API manufacturers in China and India that exclusively supply U.S. compounders are chronic concerns from a cGMP compliance perspective;[9] and,
WHEREAS, certificates of analysis (COAs) contain crucial information about the source and quality of APIs and are an essential tool for verifying APIs. While all APIs are required by law to be accompanied by a valid COA, in practice, many COAs fail to include the information needed to ensure product quality; and,
WHEREAS, the National Association of Attorneys General (NAAG) issued a letter signed by a bipartisan group of Attorneys General from 38 states and territories highlighting the quality and safety issues of compounders using API from unregulated foreign sources and urging that FDA “take decisive action against bad actors unlawfully profiting off the high demand for FDA-approved weight loss and diabetes drugs”;[10] and,
WHEREAS, certain compounders are manipulating their compounded GLP-1 products, including by adding untested ingredients, changing the dose, or altering the route of administration, and falsely claiming these changes “personalize” the compounded drugs to evade restrictions on compounding; and,
WHEREAS, according to a 2024 study, 11% of adults who report taking a GLP-1 product received it from an online provider, and 10% acquired it from medical spas or aesthetic medical centers.[11] These purchasing channels often offer unapproved compounded drugs, and communities of color, including Hispanic patients who experience disproportionate burdens of obesity and diabetes, may be especially vulnerable to deceptive marketing and sales of illegally compounded drugs when facing coverage barriers; and
WHEREAS, ensuring appropriate access to FDA-approved therapies through Medicaid and other coverage channels, as endorsed by NHCSL in Resolution 2023-16, in tandem with strong enforcement against illegal compounding, can reduce demand that drives patients toward unsafe, illegally compounded products and improve health equity; and,
WHEREAS, Hispanic patients deserve medicines they can trust, made with API from legitimate sources and in accordance with FDA’s quality standards. States—through boards of pharmacy, medicine, and nursing, attorneys general, and consumer protection agencies—must take action to protect patients from illegally compounded drugs.
THEREFORE, BE IT RESOLVED, that the NHCSL calls on states to protect patients by addressing the illegal compounding of GLP-1 receptor agonists and related incretin products as follows:
- Enforce federal and state compounding laws that prohibit compounding of GLP-1 products that are essentially copies of FDA-approved drugs when the FDA-approved product is commercially available, and that prohibit sham “personalization” used to justify the compounding of copies of available and approved GLP-1 drugs; and,
- Support additional authority and resources for state Boards of Pharmacy, Boards of Medicine, and Boards of Nursing to promote more effective oversight over illegal compounding that puts patients at risk; and,
- Prohibit the use of APIs that fail to meet basic quality standards and that are not the same as the active ingredient in an FDA-approved drug; and require APIs to have valid COAs and be obtained only from FDA-registered manufacturers with no significant unresolved deficiencies from FDA inspection; and,
- Restrict the reselling of compounded drugs as contrary to federal law and as an improper expansion of compounding that is intended to be narrowly conducted to address the unmet needs of individual patients; and,
- Enforce federal and state laws against deceptive and misleading marketing and promotion for non–FDA-approved GLP-1 products.
BE IT FINALLY RESOLVED, that NHCSL supports federal and state collaboration to swiftly identify and remove illegally compounded GLP-1 products from the market, protect patients from harm, and uphold trust in evidence-based, FDA-approved therapies.
IN ITS MEETING OF NOVEMBER 13, 2025, THE NHCSL HEALTHCARE TASK FORCE UNANIMOUSLY RECOMMENDED THIS RESOLUTION TO THE EXECUTIVE COMMITTEE FOR APPROVAL.
THE NHCSL EXECUTIVE COMMITTEE UNANIMOUSLY APPROVED THIS RESOLUTION ON NOVEMBER 14, 2025, IN A VIRTUAL MEETING.
THE NATIONAL HISPANIC CAUCUS OF STATE LEGISLATORS UNANIMOUSLY RATIFIED THIS RESOLUTION AT ITS ANNUAL MEETING OF NOVEMBER 22, 2025 IN OKLAHOMA CITY, OKLAHOMA.
[1] See NHCSL Resolution 2023-16
[2] Office of Minority Health, “Obesity and Hispanic/Latino Americans,” (last reviewed September 2025).
[3] Office of Minority Health, “Diabetes and Hispanic Americans,” (February 2025).
[4] Montero, A. et.al., “KKF Health Tracking Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs” (KKF, May 10, 2024).
[5] Vahratian, A. and Warren, A., “GLP-1 Injectable Use Among Adults With Diagnosed Diabetes: United States, 2024.” (CDC, August 2025).
[6] See NHCSL Resolution 2020-07
[7] U.S. Food and Drug Administration, (FDA). “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.” (April 30, 2025).
[8] Food and Drug Administration (FDA), “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss,” (September, 2025).
– FDA: Medical Minute with the Illinois Department of Financial and Professional Regulation, Consumer Alert”; see also University of Illinois Chicago Drug Information Group. “What Are the Safety Concerns Regarding Compounded GLP-1 Receptor Agonists?” (FAQs, August 2025).
[9] Food and Drug Administration (FDA), “FY 2024 Report on the State of Pharmaceutical Quality,” (August 8, 2025).
[10] “FDA GLP-1 THREAD PDF”
[11] Montero, A. et.al., “KKF Health Tracking Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs” (KKF, May 10, 2024).