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DQSA CGMP

Epstein Becker & Green

FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding

Epstein Becker & Green on

On May 18, 2015, the U.S. Food and Drug Administration (“FDA”) withdrew its 2003 Compliance Policy Guide – Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding...more

Akin Gump Strauss Hauer & Feld LLP

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

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