Compounded semaglutide and tirzepatide: what changed

Both sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act restrict compounding a drug that is “essentially a copy” of a commercially available, FDA-approved product. The exception hinges on shortage: when a drug is on FDA’s shortage list, the compounding restrictions attached to commercial availability relax.

Semaglutide and tirzepatide were both on the shortage list, and an entire industry of compounded GLP-1 telehealth grew inside that window. When FDA declared the shortages resolved, the legal basis for that industry closed with them — not by a new rule, but by the disappearance of the condition the exception depended on.

FDA gave compounders a defined period before it would act, and published the deadlines. Note that the tirzepatide and semaglutide timelines are different — secondary reporting frequently conflates them, quoting the tirzepatide dates for both drugs.

FDA’s page states plainly that for state-licensed pharmacies and physicians compounding these products under section 503A, “the period of enforcement discretion … has ended.” The same is true for outsourcing facilities under 503B, whose later deadlines have also now passed.

FDA states that tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list. An outsourcing facility is restricted from compounding from a bulk substance unless that substance is on the 503B bulks list (or the drug is on the shortage list). Neither condition is met.

There remains a documented, narrow exception: FDA states it considers a compounded product to be essentially a copy unless a prescriber determines and documents that it contains a change producing a significant difference for an identified individual patient. FDA has also indicated that a combination such as semaglutide with vitamin B12 may still be treated as essentially a copy.

Separately, FDA has said that at this time it does not intend to act against a compounder who fills four or fewer prescriptions of an essentially-a-copy product in a calendar month — an enforcement posture about scale, not a licence to mass-produce.

The regulatory question is separate from the safety one, and FDA has been explicit on the latter. It has reported fraudulent compounded semaglutide and tirzepatide whose labels named compounding pharmacies that do not exist; unapproved salt forms such as semaglutide sodium and semaglutide acetate, which are different active ingredients from the approved drug; active ingredients imported from plants FDA has never inspected; and hundreds of adverse-event reports, many involving dosing errors where patients self-administered from multi-dose vials.

Counterfeits are not confined to the grey market either. FDA seized counterfeit Ozempic that had entered the legitimate U.S. supply chain carrying an authentic lot number, with counterfeit needles whose sterility could not be confirmed.

If you are using a compounded product, our source checker walks the compounded-channel checks specifically: is the facility named and licensed, is it the base peptide rather than a salt form, is there a beyond-use date, and are the dosing instructions expressed in the units printed on your syringe.