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FDA issues draft guidance on compounding of animal drugs from bulk substances
The FDA released a draft Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Substances. The agency noted that “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. [The draft guidance] outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians, and facilities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.”
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2015 DPLXXVI Seminar
November 12-15, 2015