FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities

FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities

Late last week, a U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding. We are pleased with the court’s decision, which is a victory for public health in the first such case since the Drug Quality and Security Act (DQSA) was enacted. FDA had previously announced that vasopressin is not a “bulk drug substance for which there is a clinical need” because there is already a product on the market that is FDA-approved to meet patients’ medical needs. The agency, therefore, decided not to place the bulk drug substance vasopressin on a list of bulk drug substances that can be used in compounding by ...

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