FDA moves to exclude three GLP-1s from 503B compounding

The FDA today proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. It's important to note what this does and doesn't affect: this proposal applies specifically to 503B outsourcing facilities, not 503A compounding pharmacies.

To understand the significance, a bit of context helps. During the GLP-1 drug shortages that stretched across several years, FDA-registered outsourcing facilities played an important role in helping meet patient demand when commercially available options were unavailable. Under existing law, 503B facilities can still compound these drugs during a shortage – this proposal doesn’t change that. What it would prevent, if finalized, is these APIs appearing on the permanent 503B bulks list, which allows compounding outside the shortage context – potentially closing the door on a broader future role for 503B outsourcing facilities.

APC is already reviewing the proposal and will be submitting comments. We believe any final policy should fully reflect both the statutory framework established by Congress and the practical realities of patient care. The FDA is accepting public comments through June 29, 2026. We’ll have more analysis as we work through the full implications.