FDA to Restrict Ingredients Used in Mass-Marketed Compounded GLP-1s, Crack Down on Misleading Ads

The FDA announced Friday that it intends to restrict the active pharmaceutical ingredients of glucagon-like peptide-1 (GLP-1) receptor agonists used in unapproved compounded drugs that are being mass-marketed as alternatives to approved medications.1

To protect patients, the FDA will restrict ingredients in unapproved compounded GLP‑1 drugs and crack down on misleading marketing. | Image Credit: mingnimit - stock.adobe.com

What Are Compounded Drugs?

Compounding is the practice of combining, mixing, or altering drug ingredients to create a medication tailored to an individual patient’s needs.2 Compounded drugs may be used when an FDA-approved medication is not suitable due to a patient’s unique circumstances, as well as when approved drugs are in short supply.3 However, compounded drugs are not approved by the FDA, meaning that unnecessary or inappropriate use can lead to serious injury or death.

Compounded GLP-1s and Their Risks

According to a recent review published in The American Journal of Managed Care® (AJMC), the high public demand for GLP-1s for weight loss, including semaglutide and tirzepatide, led to shortages shortly after their approval.4 These shortages, along with limited insurance coverage and high costs, have driven some patients to seek compounded versions as alternatives.

The FDA recommends that compounded drugs be used only when medically necessary and that patients obtain prescriptions from their doctors and fill them at state-licensed pharmacies, rather than compounding pharmacies.5 Additionally, the agency encouraged patients to consult their doctors or use the FDA’s BeSafeRx campaign for guidance on safely buying prescription medications online if necessary.

On top of the general compounded drug risks, the FDA identified additional areas of concern specific to compounded GLP-1 drugs, including improper storage during shipping. Injectable GLP-1 drugs require refrigeration, but the agency received reports of some compounded GLP-1 drugs arriving warm or with insufficient ice packs, which can compromise drug quality. As a result, the FDA advised patients not to use any injectable GLP-1 drugs in such conditions.

Fraudulent compounded semaglutide and tirzepatide are also a concern. The FDA noted that some are labeled with false information, including nonexistent compounding pharmacies or the names of licensed pharmacies that did not compound the drug.

Consequently, the authors of the AJMC study emphasized the importance of guiding patients toward the safe use of compounded GLP-1s.4

“As the popularity of [GLP-1s] continues to increase, it is important for health care providers to be well-informed about the use of compounded [GLP-1s],” they wrote. “Directing patients to lawful sources of compounded [GLP-1s] and providing counseling regarding [GLP-1] administration are key factors in reducing the risks associated with use of a compounded [GLP-1] product.”

FDA Takes Further Action

With this recent announcement, the FDA is expanding its enforcement against compounded drugs that violate its policies.1 The agency emphasized that it takes potential violations of the Federal Food, Drug, and Cosmetic Act seriously, with restrictions on GLP-1 active pharmaceutical ingredients aiming to protect consumers from drugs whose quality, safety, or efficacy cannot be verified.

Following warning letters sent in the fall of 2025, the FDA said it would also take steps to combat misleading direct-to-consumer advertising and marketing.1,6 Specifically, companies cannot promote their unapproved compounded products by claiming they are generic versions or the equivalent of approved drugs. The companies also cannot state that the compounded drugs use the same active ingredient or produce the same clinical results as the approved drugs.

The FDA stated it will use all available compliance and enforcement tools to address unsubstantiated claims and protect public health.

“Entities engaged in the manufacture, distribution, or marketing of unapproved compounded GLP-1 products should be aware that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction,” FDA Commissioner Martin A. Makary, MD, MPH, stated in the news release.

References

1. FDA intends to take action against non-FDA-approved GLP-1 drugs. News release. FDA. February 6, 2026. Accessed February 9, 2026. https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
2. Human drug compounding. FDA. Updated February 2, 2026. Accessed February 9, 2026. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding
3. Compounding and the FDA: questions and answers. FDA. Updated September 16, 2025. Accessed February 9, 2026. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
4. Liu G, Jarema M, Mo M, Stievater T. Navigating compounded semaglutide: what health care providers need to know. Am J Manag Care. 2025;31(9):480-484. doi:10.37765/ajmc.2025.89787
5. FDA’s concerns with unapproved GLP-1 drugs used for weight loss. FDA. Updated February 4, 2026. Accessed February 9, 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
6. Jeremias S. FDA issues warning letters cracking down on misleading drug advertisements. AJMC®. September 10, 2025. Accessed February 9, 2026. https://www.ajmc.com/view/fda-issues-warning-letters-cracking-down-on-misleading-drug-advertisements