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District Court Affirms FDA Policy on Compounding with Bulk Drug Substances—Bringing Much Needed Clarity for the Outsourcing...

On August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration’s (FDA’s) decision to exclude the bulk drug substance vasopressin from the agency’s List of Bulk Drug...more

FDA Finalizes Criteria, and First Two Exclusions, for Outsourcing Facility Compounding with Bulk Drug Substances

• Five years after passage of the DQSA, FDA issued final decisions prohibiting the use of two bulk substances by outsourcing facilities, and finalized criteria for ongoing evaluations of other bulk substances that are...more

The DQSA: Five Years In - Part One of Two

November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law. The law addresses two distinct areas of drug oversight, but it was the combined concerns about the quality...more

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