FDA proposes excluding GLP-1s from 503B list

The U.S. Food and Drug Administration said on April 30 that it is proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, the roster of active ingredients that outsourcing facilities may use in compounding under federal law. The agency said it found no clinical need for 503B outsourcing facilities to compound those drugs from bulk substances. If the proposal is finalized, it would further narrow one of the main routes that large-scale compounders used to make GLP-1 products during the obesity-drug shortage boom. ### What is the 503B bulks list, and why does it matter here? Section 503B covers outsourcing facilities, which are larger compounders that can make medicines without patient-specific prescriptions under certain conditions. In most cases, those facilities cannot compound from bulk drug substances unless the ingredient appears on the 503B bulks list or the compounded drug is on the FDA’s shortage list at the time of compounding, distribution and dispensing, the FDA said. (fda.gov) The FDA said semaglutide, tirzepatide and liraglutide do not currently appear on the 503B bulks list, and semaglutide and tirzepatide also do not currently appear on the agency’s drug shortage list. That makes the current proposal important because it addresses whether those ingredients could gain a future pathway onto the 503B list through the nomination process. (fda.gov) ### Why did the FDA say no? The agency said it reviewed nominations for all three substances and “did not identify sufficient evidence” to include them on the 503B bulks list. The legal test, the FDA said, is whether there is a clinical need for outsourcing facilities to use the bulk substance in compounding, a determination based on patient safety and medical necessity. (fda.gov) FDA Commissioner Marty Makary said in the agency’s release that when FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a “clear clinical need.” He said the action reflects the agency’s responsibility to protect patients and preserve the integrity of the drug approval process while keeping a public pathway for comment. (fda.gov) ### How does this fit with the earlier GLP-1 shortage fight? Pharmacy Times reported that demand-driven shortages beginning in 2022 helped create a large market for compounded GLP-1 products after brand supply fell short. The publication said compounded versions were often sold for about $150 to $300 per month, compared with branded products priced above $1,000 per month. (fda.gov) The FDA said on April 1 that national GLP-1 supply had begun to stabilize and reminded compounders that copies of commercially available drugs are generally not permitted unless statutory conditions are met. The agency also said some compounded combinations, including semaglutide with vitamin B12, may still be considered essentially copies of commercially available products in certain circumstances. (pharmacytimes.com) ### Does this end all compounded GLP-1 use? The proposal targets 503B outsourcing facilities’ use of bulk substances, not every possible form of compounding. The FDA’s April 1 guidance separately described the rules for 503A pharmacies, which compound for an individual patient based on a prescription and may proceed only if other statutory conditions are met, including limits on making products that are essentially copies of commercially available drugs. (fda.gov) Pharmacy Times said the proposal signals that large-scale compounding of these GLP-1 agents has “no regulatory future.” That phrasing was the publication’s characterization of the proposal’s practical effect on outsourcing facilities, not language used in the FDA press release itself. ### What happens next? (fda.gov) The Federal Register notice was published on May 1 and says electronic or written comments must be submitted by June 30, 2026. The FDA said it will review those comments before making a final determination on whether semaglutide, tirzepatide and liraglutide should be excluded from the 503B bulks list. (federalregister.gov) (pharmacytimes.com)