The U.S. Food and Drug Administration (FDA) has announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, which identifies bulk drug substances approved for compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The 503B bulks list allows certain bulk substances to be used in compounding only when there is a clinical need, such as shortages or the absence of FDA-approved versions of these drugs. The FDA reviewed nominations for semaglutide, tirzepatide, and liraglutide and found no clinical necessity for these drugs to be compounded from bulk substances by outsourcing facilities. These drugs are already available as FDA-approved products.
FDA Commissioner Marty Makary, M.D., M.P.H., emphasized that outsourcing facilities must have a clear clinical need to compound drugs from bulk substances if FDA-approved versions exist. He stated this action aims to protect patient safety and uphold the drug approval process while maintaining transparency and allowing public input.
The FDA’s evaluation considered patient safety and medical necessity under the law and did not find sufficient evidence to include these three drugs on the 503B bulks list. The agency is currently seeking public comments on the proposal through June 29, 2026, before making a final decision.
Why it matters
This proposed exclusion prevents outsourcing facilities from compounding semaglutide, tirzepatide, and liraglutide from bulk substances when FDA-approved alternatives are available, reducing risks associated with compounded drugs. It reinforces regulatory oversight ensuring that compounded medications are only produced when medically necessary and helps maintain the integrity of the drug approval system.
Background
Section 503B of the FD&C Act permits outsourcing facilities to compound drugs from bulk substances listed on the FDA’s 503B bulks list or drugs on the FDA’s shortage list. This framework is intended to balance access to compounded drugs with patient safety by restricting use to situations where no approved, readily available product exists. Semaglutide, tirzepatide, and liraglutide are injectable medications commonly used to treat type 2 diabetes and obesity, all of which currently have FDA-approved versions on the market.
Sources
This article is based on reporting and publicly available information from the following source:
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