FDA Tightens Rules on Compounded GLP-1 Drugs

The FDA has determined that the shortage of tirzepatide injection, an approved GLP-1 medication, has been resolved after running since 2022, according to an FDA statement. With supply stabilizing, the agency is spelling out when compounded versions of drugs like semaglutide and tirzepatide can still be legally prepared by pharmacies and outsourcing facilities.

Under section 503A, compounders can only fill individual prescriptions and cannot regularly produce drugs that are essentially copies of a commercially available product, unless a prescriber documents a meaningful clinical difference for that patient. The FDA gave a concrete example: combining semaglutide with vitamin B12 at strengths within 10 percent of approved products would likely count as an unlawful copy. The agency also said it will not act against compounders filling four or fewer such prescriptions per month.

For outsourcing facilities under section 503B, bulk compounding is only permitted if the substance is on FDA's approved bulk drug list or the drug shortage list. Since tirzepatide and semaglutide are on neither list now, that pathway is effectively closed for these two active ingredients going forward.

The update also recaps earlier court rulings that ended temporary enforcement discretion for compounded tirzepatide and semaglutide injections.

This article is for education only. It is not medical advice. Compounds discussed here are sold for research purposes. Talk to a licensed clinician before making health decisions.