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News & Press: Regulatory Update

FDA releases draft guidance on animal drug compounding from bulk drug substances

Thursday, May 28, 2015   (0 Comments)
Posted by: Susan Curtis
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FDA releases draft guidance on animal drug compounding from bulk drug substances

 

U.S. Food and Drug Administration
As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration recently released a draft "Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances." Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option. FDA's GFI #230 outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians and facilities registered as outsourcing facilities when drugs are compounded for animals from bulk drug substances.

 

Please note that the FDA guidance is not legally binding and should be viewed only as recommendations. 

The MVMA has filed legislation in Massachusetts to provide an exemption for veterinarians to stock compounded substances. The AVMA's Task Force on Veterinary Compounding Legislation is also reviewing this draft and will issue a response within the 90-day response period (which began May 19).


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