USP Monograph Modernization Requires Flexibility For OTCs, Experts Agree
This article was originally published in The Tan Sheet
Executive Summary
The U.S. Pharmacopeia monograph modernization initiative must take a flexible approach in order to accommodate formulation of complex OTC products, experts say.
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OTC industry executives advise U.S. Pharmacopeia to proceed cautiously with novel approaches to modernizing its monographs, lest USP develop standards unenforceable by FDA.
OTC Firms Question Enforceability Of Proposed USP Monograph Shake-Up
OTC industry executives advise U.S. Pharmacopeia to proceed cautiously with novel approaches to modernizing its monographs, lest USP develop standards unenforceable by FDA.