FDA and USP Co-sponsor Over-the-Counter DrugsWorkshop - Sept. 8 & 9

Dr.Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) will keynote the event. Mr. Scott Melville, CEO of the Consumer Healthcare Products Association (CHPA), is a featured speaker.

A number of widely applicable USP monographs for OTC products require modernization to incorporate current, more specific analytical techniques. USP is working with FDA and OTC manufacturers to strengthen USP monographs for OTC ingredients and to create or strengthen the corresponding OTC dosage form monographs. Participants in this workshop will gain an understanding of the monograph modernization initiative and the roles of USP and FDA OTC drug monographs.

The two-day workshop will also provide OTC drug manufacturers, FDA, and USP with a unique forum to discuss and explore the challenges and needs related to setting and strengthening public standards (i.e., USP monographs) for OTC drug substances and drug products. Discussions at the workshop may help shape future directions for OTC public standards.

More information, the workshop agenda, and registration for this unique opportunity are available here.

A USP Pharmacopeial Education course, “Understanding the USP Compendial Process,” is also open for registration to workshop attendees at a specially reduced rate. This USP overview is specifically designed to help OTC manufacturers and their suppliers with an enhanced understanding of USP's, standards-setting process.

For further information, please contact:

Steven Paul
Marketing Director, Pharmaceutical Industry
U.S. Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852
+1-301-816-8210 (voice)
+1-301-816-8236 (fax)
[email protected]