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News & Press: Compounding

FDA Statement on Court Ruling Related to Compounded Bulk Drug Substances

Tuesday, August 6, 2019   (0 Comments)
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For Immediate Release:
August 06, 2019
Statement From:
Acting Commissioner of Food and Drugs - Food and Drug Administration
Norman E. "Ned" Sharpless MD
Director - Center for Drug Evaluation and Research
Janet Woodcock M.D.

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 outsourcing facilities (the “503B Bulks List”). Last week, the court agreed, finding that the agency’s method of determining whether there is a “clinical need” for a bulk drug substance is consistent with the law. We will continue to evaluate bulk drug substances nominated for use in compounding by outsourcing facilities in accordance with our interpretation of clinical need.


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