Call for Abstracts for DPL XXXVII Is Now Open!
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Latest NewsFDA Proposes to Exclude GLP-1s from 503B Bulks List The FDA announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing. After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances. The FDA is now inviting interested parties to submit comments electronically through June 30, 2026. The agency will consider submitted comments before making a final determination. [FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List. FDA 30 Apr 2026.]
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