FDA Proposes Exclusion of Multiple GLP-1 RAs from Bulks List, With Raechel Sood, NP

On April 30, 2026, the US Food and Drug Administration (FDA) released a proposal to exclude GLP-1 receptor agonists semaglutide, tirzepatide, and liraglutide from the 503B bulks list.1

The 503B bulks list collects bulk drug substances for compounding by outsourcing facilities, according to the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act. These facilities can rarely compound drugs with these substances unless they appear on the list, or if the drug is on the FDA’s drug shortage list.1

“Compounded medications have been around for a very long time,” Rachael Sood, NP, founder and chief executive officer of the Diabetes Collective and a speaker and clinical expert for Sanofi, Eli Lilly, Dexcom, and more, told HCPLive in an exclusive interview. “We’ve been using them in different spaces, not just in GLP-1s. This is not the first time, but there has certainly been some overuse and abuse, I believe, of some privileges and mass production of these medications, which can put patients at harm. The FDA is trying to take precautions.”

This announcement comes on the heels of a statement on April 1, 2026, in which the FDA clarified its policies for compounders as the national shortage of GLP-1 drugs and components stabilized. The statement emphasized the strict criteria for compounded drugs, including that the drug is compounded based on a received prescription and that the manufacturer does not compound drugs considered to be essentially copies of commercially available products.2

From 2022 until February of 2025, the US experienced a nationwide shortage of semaglutide products, specifically Ozempic and Wegovy. This was largely attributed to increased demand, given the drugs’ efficacy and popularity following their release into the market. Prior research indicated that semaglutide prescription fills rose by roughly 442% between January 2021 and December 2023. During this shortage, pharmacies across the country created lower-cost, compounded versions of Ozempic and Wegovy, operating under an exception to produce copies of these drugs.3

On February 21, 2025, the FDA announced the resolution of this shortage after reviewing data from Novo Nordisk regarding its production and inventory of Ozempic and Wegovy. Since then, the drugs have shown no sign of further shortages, and the release of multiple alternative GLP-1 RA treatments has provided a plethora of alternatives should the issue arise again. Sood also addressed this, commenting on the unlikelihood of needing compounded therapies to account for similar shortages in the future.4

“During the shortage, I would switch doses around. I would either increase or decrease a dose. I would try to go to a different pharmacy, I would change a medication we have,” Sood said. “We have 13, 14, maybe 15 different GLP-1s to prescribe now; we don’t have very many shortages of many of these medications, and now that we have so many options, I don’t really see this being a problem.”

Notably, this present announcement is not final – the FDA encourages parties to submit comments via the docket by June 29, 2026. According to the release, the FDA will consider these comments before a final determination is announced.1

Editors’ Note: Sood reports no relevant disclosures.

References

1. US Food and Drug Administration. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List. April 30, 2026. Accessed May 1, 2026. https://content.govdelivery.com/accounts/USFDA/bulletins/41537f8

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

3. Billingsley A. Is Semaglutide in Shortage? The Latest on Ozempic and Wegovy Availability. GoodRX. August 18, 2025. Accessed May 1, 2026. https://www.goodrx.com/classes/glp-1-agonists/semaglutide-shortage?srsltid=AfmBOorCqzazDrEXShxG2U7I3iOpYR7DXNspvQx0wpfw6xRG1rOGtZqW

4. US Food and Drug Administration. Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy). February 21, 2025. Accessed May 1, 2026. https://www.fda.gov/media/185526/download