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USA’s Food and Drug Administration (FDA) is seeking comments for the draft guidance titled Evaluation of Bulk Drug Substances for Drug Compounding Under Section 503B of the Federal Food, Drug and Cosmetic Act.
This guidance describes policies that the FDA proposes to use in evaluating bulk drug substances for inclusion on the list of bulk drug substances that can be used in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act, also known as the 503B Bulks List.
The draft is open for public consultation until May 25, 2018.