FDA Moves to Permanently Close the Door on Compounded GLP-1s

The FDA has announced that it is proposing to formally exclude semaglutide (Ozempic, Wegovy; Novo Nordisk), tirzepatide (Mounjaro, Zepbound; Eli Lilly and Company), and liraglutide (Victoza, Saxenda; Novo Nordisk) from the 503B outsourcing facility bulk drug substances (bulks) list—the regulatory mechanism that governs which active pharmaceutical ingredients large-scale compounding operations may use. If finalized, the rule would prohibit 503B outsourcing facilities from compounding these agents from bulk substances under any circumstances, regardless of future market conditions.¹

The announcement is the latest chapter in a regulatory saga that has unfolded since 2022, when skyrocketing demand for glucagon-like peptide-1 (GLP-1) receptor agonists outpaced brand-name manufacturing capacity, opening the door to a booming compounding market.¹

Background: How Compounders Gained—and Lost—Access

Federal law under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits 503A compounding pharmacies and 503B outsourcing facilities to compound copies of FDA-approved drugs when those drugs appear on the agency's shortage list. Semaglutide and tirzepatide were both added to the shortage list in 2022 due to surging demand, as was liraglutide. The resulting compounding market offered patients access to these agents at $150 to $300 per month, compared with brand-name costs that exceeded $1000.^2,3

That access began to close in late 2024. The FDA resolved the tirzepatide shortage in December 2024 and the semaglutide shortage in February 2025, establishing phased enforcement deadlines for compounders to wind down operations. The Outsourcing Facilities Association filed federal lawsuits challenging both determinations, but courts denied preliminary injunctions in each case, and the enforcement deadlines held. As of mid-2025, compounding of essentially a copy of either agent was no longer legally permissible for 503A or 503B entities.^2,4-6

What the New Proposal Does

Rather than relying solely on shortage-list status to restrict compounding, the FDA is now seeking to codify that there is no clinical need for outsourcing facilities to compound any of the 3 agents from bulk substances.¹

"When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need. This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process,” FDA Commissioner Marty Makary, MD, MPH, stated in the news release from the agency.¹

Under the 503B framework, outsourcing facilities may only use bulk drug substances if the substance is on the bulks list or the compounded drug is on the shortage list. With neither condition met for these 3 agents, a formal exclusion would foreclose any future pathway for bulk compounding, even in the event of a new shortage designation.¹ A public comment period is now open through June 29, 2026, via the federal docket.¹

Safety Concerns That Shaped the FDA's Stance

Patient safety data played a notable role in the agency's posture throughout this process. As of early 2025, the FDA had received more than 455 adverse event reports linked to compounded semaglutide and more than 320 reports associated with compounded tirzepatide, many involving dosing errors from patients self-administering incorrect doses from multidose vials—some of which required hospitalization. Concerns about counterfeit products entering the market through online channels have further reinforced the FDA's enforcement focus.^7,8

Implications for Pharmacy Practice

For pharmacists, the practical message is clear: compounded GLP-1s are not an appropriate routine substitute when FDA-approved therapies are commercially available. Community pharmacists should be prepared to counsel patients still seeking lower-cost alternatives and help them identify manufacturer savings programs offered by Novo Nordisk and Eli Lilly, which have both expanded access initiatives since compounded versions were phased out.³

Pharmacists should also remain alert to patients obtaining unapproved GLP-1 preparations online, given ongoing risks from substandard or counterfeit products.⁸

For 503A pharmacies, narrow exceptions still exist—such as documented excipient allergies or the need for a dose strength not commercially available—but routine patient-specific compounding that amounts to essentially a copy of an approved product remains off-limits.¹

For pharmacists at or consulting 503B outsourcing facilities, the comment period represents an opportunity to submit formal input on patient access and clinical need. Organizations including the National Community Pharmacists Association and the Alliance for Pharmacy Compounding are expected to file comments. Pharmacists with relevant perspectives are encouraged to submit comments through the federal docket before the June 29, 2026, deadline.

REFERENCES

1. FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list. News release. FDA. April 30, 2026. Accessed April 30, 2026. https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list

2. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. FDA. Updated April 1, 2026. Accessed April 30, 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

3. Loria K. GLP-1 no longer on FDA's drug shortage list. Drug Topics. August 9, 2025. Accessed April 30, 2026. https://www.drugtopics.com/view/glp-1-no-longer-on-fda-s-drug-shortage-list

4. Companies find ways around end of GLP-1 shortage. Advisory Board. May 27, 2025. Accessed April 30, 2026. https://www.advisory.com/daily-briefing/2025/05/27/glp-1-compounders

5. Ferruggia K. FDA ends semaglutide shortage listing, contributing to ongoing legal challenges. Pharmacy Times. February 27, 2025. Accessed April 30, 2026. https://www.pharmacytimes.com/view/fda-ends-semaglutide-shortage-listing-contributing-to-ongoing-legal-challenges

6. Halpern L. Concerns surrounding compounded GLP-1s mount as shortages of tirzepatide, semaglutide end. Pharmacy Times. March 20, 2025. Accessed April 30, 2026. https://www.pharmacytimes.com/view/concerns-surrounding-compounded-glp-1s-mount-as-shortages-of-tirzepatide-semaglutide-end

7. Curry JA, Plotkin M, Pollastro M. GLP-1 weight-loss drugs off shortage list; deadlines to stop compounding. Harris Beach Murtha. March 24, 2025. Accessed April 30, 2026. https://www.harrisbeachmurtha.com/insights/glp-1-weight-loss-drugs-off-shortage-list-deadlines-to-stop-compounding/

8. Snyder M, Halpern L. Why “equivalent” isn’t good enough: an obesity specialist’s warning on compounded GLP-1s. Pharmacy Times. March 2, 2026. Accessed April 30, 2026. https://www.pharmacytimes.com/view/why-equivalent-isn-t-good-enough-an-obesity-specialist-s-warning-on-compounded-glp-1s