LP3 Network Free Webinar - Veterinary Compounding, A Customized Approach

Download in electronic PDF format for $25



Search the Complete Journal Archives

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

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 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
U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs Allen Loyd V Jr Nov/Dec 2015 487-488 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
Drugs Banned for Use in Food Animals: An Explanation Davidson Gigi S Mar/Apr 2001 101 Buy
The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists Parks Kenneth Chase, Bernard Brian, Cogdill Christopher Blake Sep/Oct 2015 377-380 Buy
Standing Together Fixing the Drug Quality and Security Act Miller David G Mar/Apr 2015 104-106 Buy
Nominations of Difficult to Compound Drugs to the U.S. Food and Drug Administration--Pharmacy Compounding Advisory Committee: Part 1 Allen Loyd V Jr Sep/Oct 2015 389-390 Buy
The U.S. Food and Drug Administration Responds to the International Academy of Compounding Pharmacists' Outsourcing Letter Miller David G May/Jun 2014 208 Buy