On April 30, 2026 the FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list. For clinics that administer medications in the office, the proposal answers a question many had been asking since the GLP-1 shortages ended: is there any route to office-use compounded GLP-1s from an outsourcing facility? The answer, both before and after the proposal, is no.
What the 503B bulks list does
A 503B outsourcing facility, the FDA-registered, CGMP-regulated compounder that may prepare office-use product without patient-specific prescriptions, can only compound from a bulk drug substance in two situations: the substance appears on the FDA's 503B bulks list, or the compounded drug is on the FDA drug shortage list at the time of compounding, distribution and dispensing.
Semaglutide, tirzepatide and liraglutide have never been on the 503B bulks list. They were compounded by 503B facilities during 2023 and 2024 only because the finished drugs were in shortage. The tirzepatide shortage was resolved in October 2024 (reaffirmed December 19, 2024), and the semaglutide shortage on February 21, 2025, with enforcement discretion for 503B facilities ending March 19 and May 22, 2025 respectively.
What the FDA proposed
The agency reviewed the nominations for the three drugs and concluded it had not found sufficient evidence of a clinical need for outsourcing facilities to compound them from bulk substances. It proposed excluding all three from the list and opened a public docket for comment. The comment period has since closed. No final decision had been published as of October 2026.
Legal and trade commentary described the proposal as closing the last broad pathway for large-scale compounding of these drugs. That is accurate as far as 503B facilities go, but the proposal does not change the day-to-day position: with no shortage and no listing, outsourcing facilities already cannot compound these drugs from bulk.
What it means for clinics
- No office-use GLP-1s. Office stock comes from 503B facilities. Under current rules they cannot supply compounded semaglutide, tirzepatide or liraglutide, and ScriptLinkRx does not offer GLP-1 products through its 503B office-use pathway.
- 503A is a separate question. Patient-specific compounding by 503A pharmacies is governed by the essentially-a-copy rules, not the 503B bulks list. The FDA restated those rules on April 1, 2026 and applied them in its September 2026 warning letter to Empower Pharmacy. A 503A pharmacy may still compound a GLP-1 product for an individual patient where it is not essentially a copy of the approved drug, and not regularly or in inordinate amounts.
- Watch for the final decision. If the FDA finalizes the exclusion, the three drugs cannot be added to the 503B bulks list without a new nomination and review, which makes a return of 503B GLP-1 compounding unlikely outside a future shortage.
For the full picture on patient-specific GLP-1 ordering, see the compounded GLP-1 sourcing guide for clinics.
Sources
- FDA: FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (April 30, 2026)
- FDA: Bulk Drug Substances Used in Compounding Under Section 503B
- FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (April 1, 2026)
- Frier Levitt: FDA Proposes to Exclude GLP-1 Receptor Agonists from the 503B Bulks List
- NABP: FDA Considers Excluding Certain GLP-1 Receptor Agonists From 503B Bulks List