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Negocios · 1/5/20261 min de lectura
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
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Resumen
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →