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Abstract:  The United States Food and Drug Administration (FDA) has taken the position that all pharmaceutical compounding is illegal under the Federal Food, Drug, and Cosmetic Act. The FDA has said that it will exercise its discretion to allow compounding to fill valid prescriptions, but it has conditioned this right to compound on pharmacies meeting criteria that the FDA has developed. A review of legislative and judicial actions on compounding indicate that the FDA is wrong, because Congress has never banned compounding.

Related Keywords: Jeffrey N. Gibbs, BA, JD, US Food and Drug Administration, FDA, Federal Food, Drug, and Cosmetic Act, FDC Act, good manufacturing practice, GMP

Related Categories: LEGAL, VETERINARY, FDA

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