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Expert Analysis

Reviewing Recent FDA Activity In Bulk Drugs Lists

By Rachael Pontikes and Kelly Kearney (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....

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