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Federal Food Drug and Cosmetic Act (FFDCA) Drug Compounding Animal Drugs

Quarles & Brady LLP

FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances

Quarles & Brady LLP on

The wait is finally over. On April 14, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk...more

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FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding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

BakerHostetler

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

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