GLP-1 Medications – FDA Guidance and Compounded Products
Not long ago, few outside the medical community had heard of semaglutide and tirzepatide—two drugs in the GLP-1 (glucagon-like peptide-1) receptor agonist class, approved for diabetes management. The medications work by decreasing caloric intake through mimicking the natural hormone GLP-1 normally released in the gut after eating. The GLP-1 agonists bind to receptors in the brain, pancreas and intestines, which helps to regulate insulin release, lower blood sugar levels, slow down digestion, and reduce appetite.
However, the widespread publicity and popularity of GLP-1 drugs for weight loss management led to a surge in demand. Brand names such as Ozempic®, Wegovy®, Mounjaro®, and Zepbound® went viral, leading to skyrocketing sales and product shortages. In response, many consumers turned to more accessible and less expensive compounded versions.
FDA Concerns Surrounding Compounded GLP-1
In a May 16, 2025 statement, the U.S. Food & Drug Administration (FDA) expressed safety concerns with compounded GLP-1 drugs. Unlike their FDA-approved brand name counterparts, compounded GLP-1 medications do not undergo the same rigorous review process for safety, efficacy, and quality.
The FDA noted that it had received over 1000 reports of adverse events arising from compounded GLP-1 dosing errors and unapproved ingredients and suggested that such adverse events are likely underreported due to the limited application of federal regulations to state-licensed pharmacies. The FDA statement also cites counterfeit medications illegally marketed in the U.S. that could contain inaccurate amounts of active ingredients.
Market Exclusivity and Compounding
FDA approval of a New Drug Application (NDA) following a rigorous and lengthy review process confers upon the applicant a period of exclusivity during which no Abbreviated New Drug Applications (ANDA’s) for generic versions of the drug may be filed.
- Semaglutide was approved in 2017 as Ozempic® for diabetes, and in 2021 as Wegovy® for obesity. The three-year exclusivity for new patient populations treated for obesity is still active for Wegovy® through December 2025.
- Tirzepatide was approved in 2022 as Mounjaro® for diabetes, and in 2024 as Zepbound® for obesity, with exclusivity running until May 2027.
A limited exception to market exclusivity exists for drugs on the FDA’s shortage list, which indicates a drug in low supply. Under these circumstances:
- 503A pharmacies (state-regulated) may compound drugs for individual patients pursuant to specific United States Pharmacopeia (USP) standards; and
- 503B outsourcing facilities (FDA-regulated) may produce large batches for healthcare providers pursuant to current Good Manufacturing Practices (cGMP).
Thus, compounding of otherwise protected medications may be permitted while a shortage exists.
Both tirzepatide (since 2022) and semaglutide (since 2024) were placed on the shortage list, prompting a surge in sales of compounded alternatives. However, the FDA has tightened oversight and shifted away from enforcement discretion as drug shortages have eased. Tirzepatide was removed from the shortage list in December 2024. Semaglutide was removed in February 2025.
What’s Next for Compounded GLP-1 Drugs?
With the FDA declaring that brand-name supplies of GLP-1 drugs have stabilized, compounded versions are no longer permitted under the shortage exception. Compounding pharmacies and investors have brought legal challenges to enjoin the FDA from enforcing the changes to the shortage list, but have so far been unsuccessful. See
- Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.) – semaglutide
- Outsourcing Facilities Association v. FDA, 4:24-cv-00953 (N.D. Tex.) – tirzepatide
Still some compounding pharmacies argue that they may continue producing “novel” GLP-1 drugs to meet individual patient needs—such as different strengths, dosage forms, or combinations with other drugs (e.g., B vitamins). The FDA has yet to clarify whether such modifications are allowed in order to meet the individual needs of patients or are permissible of constitute prohibited copies of commercially available drugs. Given the FDA’s prior position statement, however, and recent trend towards tightened oversight of GLP-1 compounding, future guidance is anticipated.
As the regulatory landscape surrounding GLP-1 medications continues to evolve, healthcare providers, patients, and compounding pharmacies must navigate a complex intersection of medical need, legal boundaries, and public health priorities. While the FDA’s recent actions underscore its commitment to ensuring drug safety and efficacy, the ongoing demand for affordable and accessible weight management solutions highlights the need for clearer guidance and innovation. As litigation unfolds and regulatory clarity emerges, stakeholders will need to stay informed and adaptable to responsibly meet patient needs in this rapidly changing therapeutic space.
Authored by Lisa Krist, Berkley Life Sciences, VP, Chief Customer Focus Officer