Verbatim response from Perplexity
The FDA’s core move was to shut down the shortage-based legal pathway that had allowed many compounded GLP-1 copies, first as the shortages for semaglutide and tirzepatide resolved and then by moving to restrict broader bulk compounding of GLP-1 ingredients.[1][3][6][13] In 2026, the FDA also stepped up enforcement against mass-marketed, non-FDA-approved GLP-1 products, including warning letters and stated intent to take action against companies marketing them as alternatives to approved drugs.[2][4][5]
Who is still operating legally depends on which compounding channel they use:
- 503A pharmacies: These can still legally compound patient-specific prescriptions for GLP-1s when they meet normal compounding requirements; they are not supposed to mass-produce essentially identical copies for general sale.[6][10]
- 503B outsourcing facilities: Their ability to make compounded GLP-1s has been much more limited. The FDA proposed in April 2026 to permanently exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, which would close the last major legal pathway for large-scale compounded GLP-1s if finalized.[6][11]
- Licensed pharmacies and prescribers acting within 503A rules: These remain the clearest legal route for compounded GLP-1s that are made for an individual patient rather than marketed in bulk.[6][10]
The practical bottom line is that mass-market compounded GLP-1 businesses are under heavy FDA pressure and many have stopped or are winding down, while patient-specific compounding by 503A pharmacies may still be lawful if all prescription and state/federal compounding rules are met.[4][6][10][12]
If you want, I can also give you a plain-English “who can still sell what” chart for semaglutide vs. tirzepatide, or explain the difference between 503A and 503B in one minute.