FDA to Crackdown on Non-Approved GLP-1 Drugs
On February 6, 2026, the FDA announced its intent to take decisive action against the mass marketing of non-FDA-approved compounded GLP-1 drugs. The FDA says companies, including Hims & Hers and various compounding pharmacies, have been promoting these products as alternatives to FDA-approved medications. The FDA emphasizes that such actions violate the Federal Food, Drug, and Cosmetic Act, as the agency cannot verify the quality, safety, or efficacy of these unapproved drugs.
FDA's Concerns with Compounded GLP-1 Medications
Compounded drugs are typically reserved for patients whose medical needs cannot be met by FDA-approved products. However, the FDA has raised several concerns regarding compounded GLP-1 medications:
- Quality and Safety Issues: The FDA has received reports of compounded GLP-1 drugs arriving with inadequate refrigeration, potentially compromising their quality. Patients are advised not to use any injectable GLP-1 drug that arrives warm or with insufficient refrigeration.
- Fraudulent Products: Instances of fraudulent compounded semaglutide and tirzepatide have been identified, with labels containing false information about the compounding pharmacy. Such products pose significant health risks to patients.
- Use of Unapproved Ingredients: Some compounded GLP-1 drugs have been found to contain unapproved salt forms, such as semaglutide sodium and semaglutide acetate. The FDA has not evaluated these forms for safety and efficacy, raising concerns about their use in compounding.
The FDA’s recent actions signal heightened regulatory attention on non-FDA-approved GLP-1 drugs, particularly those produced through compounding. For pharmacists and healthcare professionals, this underscores the importance of understanding both regulatory requirements and clinical considerations when evaluating GLP-1 therapies. Patient education and professional discretion continue to play a central role as guidance and enforcement evolve.
