Verbatim response from Perplexity
The FDA ended the shortage-based broad allowance for compounded semaglutide and tirzepatide after determining the national shortages were resolved, then gave pharmacies short grace periods to stop making copycat versions.[3][2] After those grace periods expired, routine compounding of GLP-1s that are essentially copies of FDA-approved drugs is generally no longer allowed, except in narrow patient-specific or shortage-related situations.[3][4]
Who is still operating legally depends on why they are compounding and what they are making:
- 503A state-licensed pharmacies and physicians can still compound a GLP-1 when there is a legitimate patient-specific medical need, such as a formulation or dose that is not commercially available or a documented “significant difference” for that patient.[3][4]
- 503B outsourcing facilities can also compound under federal law, but they cannot mass-produce copycat semaglutide or tirzepatide just because it is popular; FDA’s grace period for those shortage-based copies ended in 2025.[3][2]
- FDA has said it currently does not intend to take action against a compounder making an essentially copied semaglutide product if it fills four or fewer prescriptions in a calendar month under the conditions it described.[3]
- Compounding that relies on unapproved ingredients or salts with no lawful basis is not legal; FDA specifically says there is no lawful basis for using semaglutide or tirzepatide salt forms in compounding, and it also says drugs like retatrutide and cagrilintide cannot be used in compounding under federal law.[4]
In practical terms, the businesses most likely still operating legally are traditional compounding pharmacies serving individualized prescriptions, and outsourcing facilities only when they are not making prohibited copycats at scale and are following the 503A/503B rules.[3][4]
If you want, I can also break this down into a simple “legal vs. risky vs. not legal” chart for compounded GLP-1 sellers.