FDA Updates List of Drugs that May Not Be Compounded Under 503A and 503B: Preamble Reminds Industry when Listed Drugs Can Still Be Compounded

James e. valentine | October 9, 2016

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On October 6, 2016, the Food and Drug Administration (FDA or the Agency) amended its regulations to update the list of drugs that may not used in compounding under the exceptions set forth in sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). This list reflects those drugs that have been withdrawn or removed from the market because the drugs or components of such drugs have been found to be unsafe or not effective.

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The Fishawack Group of Companies is an independent organisation of healthcare communications agencies with a reputation built on excellence, creativity and transparency.

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