Athenex Ruling Helps Clarify FDA Drug Compounding Policy

Law360 (August 9, 2019, 3:49 PM EDT) -- On Aug. 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration's decision to exclude the bulk drug substance vasopressin from the agency's List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act, or 503B bulks list, in Athenex Pharma Solutions LLC v. Azar II.[1]

Although the court affirmed the FDA's decision regarding the fate of a single bulk drug substance, vasopressin, the court's decision endorses the FDA's approach to reviewing all bulk drug substances for use by outsourcing facilities based...

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