Monograph Modernization Initiative Looks To Close OTC Quality Loopholes
This article was originally published in The Tan Sheet
Executive Summary
A collaboration among industry, FDA and U.S. Pharmacopeia aims to address what FDA sees as a lack of insight into the quality and purity of OTC monograph drugs
You may also be interested in...
CHPA Offers OTC Testing, Degradant Standards For Monograph Modernization
The Consumer Healthcare Products Association looks to shape U.S. Pharmacopeia's revision of monographs for OTC drug ingredients and products with proposals for the standard-setting organization's monograph modernization process.
In Brief
FDA reverses on OTC PPI fracture risk
Senate Bill Expands FDA's OTC Manufacturing Oversight
Legislation introduced in the Senate to give FDA mandatory recall authority for all drugs would bar the agency from considering a drug's prescription status when assessing risk to prioritize inspections