Verbatim response from Perplexity
The FDA ended shortage-based enforcement discretion for compounded GLP-1s after deciding that the national shortages of semaglutide and tirzepatide were resolved, which means pharmacies can no longer routinely make copycat versions of those drugs just because demand is high.[1][2][4]
Who is still operating legally depends on why and how the drug is compounded:
- 503A compounding pharmacies can still make a compounded GLP-1 only if it is not an “essentially copy” of a commercially available drug, or if there is a documented patient-specific clinical need for a meaningful change such as a different strength, formulation, or an added ingredient.[5][7][9]
- 503B outsourcing facilities face the same core limits, and the FDA has said that once a drug is no longer in shortage, copies must stop; some sources describe a wind-down period that has already passed for semaglutide and tirzepatide.[2][3][9]
- Companies that are mass-marketing unapproved compounded GLP-1s as equivalents or generic-like substitutes are now a focus of FDA enforcement, including warning letters and possible seizure or injunction.[4][8][11]
So, in practical terms, legal compounding is now narrow and exception-based, not a blanket permission to sell compounded Ozempic/Wegovy or Mounjaro/Zepbound clones.[5][7][9]
A few important nuances:
- The FDA said its action does not stop legal importation of GLP-1 APIs by compliant manufacturers, but that does not create new permission to make illegal copycat compounded drugs.[5]
- The FDA has also targeted misleading advertising by telehealth and compounding companies that imply their products are the same as FDA-approved drugs.[4][8][11]
- If a patient has a legitimate need for a compounded version that differs from the approved product, that can still be lawful under standard compounding rules.[7][9]
If you want, I can also break this down into a simple “legal vs. illegal” checklist for patients and clinics.