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FDA Releases Final Guidance on Bulk Drug Compounding Policy
January 07, 2025
WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has announced the availability of a final guidance document for the pharmaceutical industry regarding compounding practices using bulk drug substances.

The guidance, titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act," outlines the interim regulatory stance the FDA will take while developing the official list of bulk drug substa . . .

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