Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

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
View All Articles in Issue

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

Printer-Friendly Version

Download in electronic PDF format for $65

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Compounding OTC Drugs: A Legal Perspective Gibbs Jeffrey N, Mazan Kate Duffy May/Jun 2000 180-181 Buy
Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines Allen Loyd V Jr Jul/Aug 2016 351 View Sample
Is Veterinary Compounding Illegal Under Federal Law? Gibbs Jeffrey N Nov/Dec 2004 449-450 Buy
PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs Allen Loyd V Jr Sep/Oct 2017 356 Buy
U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs Allen Loyd V Jr Nov/Dec 2015 487-488 Buy
Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA Cabaleiro Joe Sep/Oct 2021 358-362 Buy
U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances Miller David G Jul/Aug 2015 303-305 Buy
Allowing Compounding Pharmacies to Address Drug Shortages Broughel James Mar/Apr 2022 100-109 Buy
Drugs Banned for Use in Food Animals: An Explanation Davidson Gigi S Mar/Apr 2001 101-103 Buy
U.S. Food and Drug Administration List of Drugs NOT to be Used in Compounded Medications for Humans (The Negative List) Nov/Dec 2016 457-458 Buy
Particle Measuring Systems - USP <797> Environmental Monitoring Solutions