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Compounding OTC Drugs: A Legal Perspective

Author(s):  Gibbs Jeffrey N, Mazan Kate Duffy

Issue:  May/Jun 2000 - Compounding for the Ear, Nose and Throat
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Abstract:  In this article, the authors (two attorneys) provide a brief legal perspective on over-the-counter compounding under both federal and state laws and practical guidance to pharmacists regarding the compounding of such drugs. They conclude that pharmacists compounding over-the-counter products for instore use are les likely to face enforcement action from either the US Food and Drug Administration or their own states if their compounding practices for such drugs are limited to nonprescription drugs and meet the basic criteria used for compounding prescription drugs. Since the state boards of pharmacy have primary jurisdiction over compounding, and state laws vary, pharmacists should verify that over-the-counter compounding is not illegal in their state.

Related Keywords: compounding provision, Congress, Current Good Manufacturing Practices, FDC, Federal Food Drug, and Cosmetic Act, Food and Drug Administration, illegal, jurisdiction, law, legal, legislative, New Drug Approval, nonprescription, OTC, over the counter, preparations, Section 503A, section 510, state board

Related Categories: LEGAL, FDA

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