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Two More Compounders Warned for Poor Sterile Drug Manufacturing

May 22, 2015 By MedNews Leave a Comment

Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October. [Read more…]

Filed Under: Drug Industry News Tagged With: Drug Compounding

FDA releases draft guidance on animal drug compounding from bulk drug substances

May 21, 2015 By MedNews Leave a Comment

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today 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.   [Read more…]

Filed Under: FDA News & Alerts Tagged With: Drug Compounding, Drug Quality and Security Act

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