Verbatim response from Perplexity
The FDA ended the shortage-based pathway that had allowed broad compounding of GLP-1 drugs like semaglutide and tirzepatide, so routine copycat versions are no longer broadly legal just because demand is high.[1][2] What remains legal is much narrower: patient-specific compounding under 503A when there is a documented medical need, and some 503B outsourcing-facility compounding only if the drug is on FDA’s bulk-substance list or still in shortage at the time of compounding.[1][3]
What happened, in order:
- The FDA clarified that once GLP-1 products are no longer on the shortage list, compounders must stop making versions that are “essentially copies” of commercially available drugs.[1][2]
- For 503A pharmacies and physician compounding, FDA’s enforcement discretion for compounded semaglutide ended, meaning the shortage-based justification is gone.[1]
- For 503B outsourcing facilities, FDA allowed a short wind-down period for semaglutide-related compounding, with the cited cutoff being May 22, 2025.[1]
- FDA also separately stated that some other GLP-1-related ingredients, including retatrutide and cagrilintide, cannot be used in compounding under federal law.[3]
Who is still operating legally:
- 503A pharmacies can still compound for an individual patient if the prescriber documents a real medical need and the product is not just a routine copy of a brand-name GLP-1.[7][8][9]
- 503B outsourcing facilities can still operate legally, but for GLP-1s they are constrained to FDA-permitted situations such as drugs on the 503B bulks list or drugs still in shortage at the time of compounding.[1]
- In practice, that means some compounded GLP-1s may still be legal, but only in narrow, patient-specific or otherwise FDA-exempt circumstances rather than as mass-market substitutes.[7][8][9]
The key distinction is that “compounded” does not mean automatically illegal; it means the legality depends on whether the product fits a specific FDA exception. Routine large-scale copies of Wegovy/Ozempic or Zepbound/Mounjaro are the part the FDA has been shutting down.[1][2][11]
If you want, I can also give you a simple “who can still compound what” chart for 503A vs. 503B and semaglutide vs. tirzepatide.