International Journal of Pharmaceutical Compounding

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U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs

Author(s): Allen Loyd V Jr

Issue: Nov/Dec 2015 - Volume 19, Number 6
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Page(s): 487-488

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Abstract: This is part 2 of a 2-part article on the topic of Nominations of Difficult to Compound Drugs to the FDA-PCAC. Part 1 provided a current list of Nominations of Difficult to Compound Drugs to the FDA-PCAC. This article discusses the evaluation procedure for determining which drugs are demonstrably difficult to compound.

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, U.S. Food and Drug Administration, difficult to compound drugs, FD&C Act 503A, FD&C Act 503B, Pharmacy Compounding Advisory Committee, PCAC

Related Categories: LEGAL

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