Verbatim response from Perplexity
The FDA has ended the shortage-based justification for routine compounded semaglutide and tirzepatide, and it has since moved to restrict mass-marketed, non-approved compounded GLP-1 products and misleading advertising.[1][4][7] In practical terms, most compounders can no longer legally make copies of commercially available GLP-1s just because they are popular or in demand.[1][2]
What happened:
- FDA determined the semaglutide injection shortage was resolved on Feb. 21, 2025, and allowed only short grace periods before enforcement would resume: 503A pharmacies/physicians until Apr. 22, 2025 and 503B outsourcing facilities until May 22, 2025.[1]
- FDA had already treated the tirzepatide injection shortage as resolved before that, and by spring 2025 the shortage-based compounding window for both drugs had closed.[2]
- In 2025–2026, FDA then cracked down on mass-marketed compounded GLP-1s, warning that companies cannot market them as generics, claim they are the same as FDA-approved drugs, or make unsupported efficacy/sameness claims.[4][7]
- FDA also warned that some products marketed as compounded semaglutide/tirzepatide were fraudulent or mislabeled, and that certain ingredients such as retatrutide and cagrilintide cannot be used in compounding under federal law.[4]
Who is still operating legally:
- 503A state-licensed pharmacies and physicians may still compound GLP-1s only in limited, patient-specific situations, such as when the compounded drug is not an “essentially a copy” or when there is a documented significant difference for an individual patient.[1][6]
- 503B outsourcing facilities may also continue only under the same basic federal limits, including the no-copy rule and other applicable FDA requirements.[1][4]
- FDA also said it does not intend to take action against a compounder making an “essentially a copy” only if it fills four or fewer prescriptions in a calendar month in the relevant circumstances described in its policy update.[1]
- Legal importation of compliant GLP-1 APIs is still allowed; FDA’s import alert targets APIs with quality concerns, not compliant manufacturers.[4]
What is not broadly legal anymore:
- Routine compounding of copycat semaglutide or tirzepatide just because they were in shortage before.[1][2]
- Mass marketing compounded GLP-1s as “equivalent,” “generic,” or clinically identical to FDA-approved products.[4][7]
- Use of certain prohibited ingredients in compounded GLP-1 products.[4]
If you want, I can also break this down into a simple “legal / probably illegal / needs patient-specific justification” checklist for consumers or clinics.