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FDA Postpones Comments on Vet Guidance But Asks More Questions
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On the very day they were due, the Food & Drug Administration (FDA) granted IACP’s requested extension for comments from stakeholders on their Guidance for Industry: Compounding Animal Drugs from Bulk Substances: Please click here to view. As previously reported, this new guidance document replaces the previous 2003 Compliance Policy Guideline: Veterinary Compounding but includes what IACP believes to be a gross overreach of the FDA’s authority without Congressional authorization.

“Although the comment extension was a big win for IACP our work is now even more complicated,” said Legislative Committee Chair Erik Tosh, RPh. “FDA is asking for opinions and answers to questions that aren’t included in the draft GFI  released in May. That means we need to get our member input because so many of those relate directly to day-to-day pharmacy/veterinary practice.” Some of the questions included in the FDA’s notice of August 17, 2015 include: 

 

•    Should the final guidance address the issue of FDA-approved animal and human drugs that are in shortage or are otherwise unavailable (e.g., disruptions in the manufacture or supply chain; business decisions to stop marketing the drug; drug is subject to Agency action based on safety, effectiveness, or manufacturing concerns)?

 

•    Do United States Pharmacopeia and National Formulary (USP-NF) chapters 795 and 797 provide suitable standards for animal drugs compounded by veterinarians, and if not, what standards of safety, purity, and quality should apply to animal drugs compounded by veterinarians?

 

•    Should licensed veterinarians be able to sell or transfer an animal drug compounded from bulk drug substances by a State-licensed pharmacy or an outsourcing facility to owners or caretakers of animals under the veterinarian's care?

 

•    Should the final guidance include a condition on the amount or percentage of compounded animal drugs that a pharmacy or outsourcing facility can ship in interstate commerce? If so, what would a reasonable amount be?

 

•    Is additional guidance needed to address the repackaging of drugs for animal use?  How widespread is the practice of repackaging drugs for animal use?  What types of drugs are repackaged for animal use, and why are they repackaged?  Have problems been identified with repackaged drugs for animal use?

 

IACP members can submit their thoughts on the GFI and the new questions to the IACP Legislative Committee at iacpinfo@iacprx.org. All comments and input should be sent to the Committee no later than Wednesday, September 30, 2015.

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