Over-the-Counter (OTC) Drug Substances and Drug Products Workshop

This two–day workshop provided a forum for OTC drug manufacturers, FDA, and USP to discuss the compendial needs and challenges related to OTC drugs and drug products and help shape future directions. USP’s mission is to create and keep current public standards (i.e., monographs) and as such, it has developed monographs for OTC ingredients and products. The FDA has an OTC monograph system as well, and the USP monographs are linked to it. USP is working with the FDA and OTC manufacturers to strengthen the monographs for OTC ingredients and to strengthen or create their corresponding dosage form monographs. Many of the USP OTC monographs are in need of modernization to replace outdated technology with newer, more specific methodology. Participants in this workshop learned about the regulatory roles of USP and FDA OTC drug monographs and the USP monograph modernization initiative.

Monograph modernization includes revisions such as replacing packed column GC procedures with capillary procedures, adding a test for impurities/degradants where none exists, and replacing we--t chemistry techniques with instrumental or chromatographic procedures. Monograph modernization also includes the deletion of procedures that add little value. Participants were asked to help identify issues with the current USP monograph system as it relates to OTC drug products and to help influence USP’s future directions for developing monographs for OTC drug products not currently covered by a USP monograph (e.g., shampoos, mouth washes, etc.)