USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
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Legal Recognition1848 Drug Import Act: <strong>USP</strong> legislatively m<strong>and</strong>ated1906 Federal Pure Food & Drugs Act: <strong>USP</strong> st<strong>and</strong>ardsrecognized1938 Federal Food, Drug, <strong>and</strong> Cosmetic Act: <strong>USP</strong>st<strong>and</strong>ards recognized as FDA-enforceable1994 Dietary Supplement Health & Education Act: Adietary supplement represented as conforming to <strong>USP</strong>–NFspecifications shall be deemed misbr<strong>and</strong>ed if it fails to doso.2003 Medicare Prescription Drug, Improvement, <strong>and</strong>Modernization Act: <strong>USP</strong> will create Model Guidelines – alist of categories <strong>and</strong> classes that prescription drug plansmay use as they design their formularies
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