Reviewing Recent FDA Activity In Bulk Drugs Lists

Law360 (September 11, 2019, 2:37 PM EDT) -- Just as the U.S. Food and Drug Administration promised in its 2019 compounding priorities statement, the FDA recently published a notice and proposed rule in the Federal Register related to bulk drug substances that can be compounded subject to the conditions of Section 503A and Section 503B of the Federal Food, Drug and Cosmetic Act.

On Sept. 5, the FDA published a proposed rule regarding its intent to amend its regulations to add five bulk drug substances that can be used in compounding under Section 503A and proposed excluding another 26 bulk drug substances from the 503A bulks list. 

Specifically, the FDA...

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