FDA proposed on April 30, 2026 not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list. What the proposal covers, where it stands and what to ask your provider.
What FDA proposed
On April 30, 2026, FDA announced a proposal not to place semaglutide, tirzepatide or liraglutide on the list of bulk drug substances that 503B outsourcing facilities may use when there is a clinical need (the "503B bulks list"). The proposal was published in the Federal Register on May 1, 2026 (91 FR 23431). A second notice (91 FR 38719, June 26, 2026) extended the comment period to July 30, 2026.
Where it stands
As of October 15, 2026, we found no final notice in the Federal Register, and FDA's 503B bulks list page showed no GLP-1 entries. The proposal is still a proposal. We will update this page when FDA publishes a final decision.
Who it affects
If finalized, the decision would mean 503B outsourcing facilities could not compound these three drugs from bulk ingredient on the basis of clinical need. The proposal is about 503B facilities. It does not change the rules for 503A pharmacies, which compound for individual patients with a prescription and may not regularly compound copies of a commercially available drug. Programs that source from 503B facilities are the most exposed. NexLife's plan pages, read November 6, 2026, name three state-licensed 503A pharmacies: Absolute Pharmacy (Lutz, FL), Premium Compounding (Decatur, AL) and Boudreaux's New Drug Store (Lake Charles, LA).
Other 2026 FDA activity on compounded GLP-1s
- FDA warning letter 738238 to Empower Clinic Services, LLC dba Empower Pharmacy, dated September 18, 2026 and posted September 22, 2026, said its compounded tirzepatide/niacinamide and semaglutide/cyanocobalamin products "appear to be essentially copies of FDA-approved semaglutide and tirzepatide products" and cited insanitary conditions.
- FDA's consumer page on unapproved GLP-1 drugs (content current as of October 1, 2026) says retatrutide and cagrilintide cannot be used in compounding under federal law, warns against semaglutide salt forms and gives a 28-day discard rule for compounded multi-dose GLP-1 vials.
What this means for patients
Compounded semaglutide and tirzepatide are made with the drug in Wegovy or Zepbound, but they are not the same product and are not FDA-approved. Before you buy, ask your provider which pharmacy fills the prescription, whether it is a 503A pharmacy or a 503B outsourcing facility, and whether the formula adds ingredients such as B12 or niacinamide. Check the pharmacy's state license and FDA's warning-letter list. If your supply comes from a 503B facility, ask what the program plans to do if FDA finalizes the proposal.
References
- Federal Register, May 1, 2026 (91 FR 23431); comment-period extension, June 26, 2026 (91 FR 38719).
- FDA announcement of the proposal (April 30, 2026) and the FDA 503B bulks list page.
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of October 1, 2026).
- FDA compounding overview: fda.gov/drugs/human-drug-compounding. Related: our 503A vs 503B guide and FDA timeline.