USP IDENTITY STANDARDS LACKING FOR 55 OTC MONOGRAPH INGREDIENTS
USP IDENTITY STANDARDS LACKING FOR 55 OTC MONOGRAPH INGREDIENTS, FDA OTC Drug Policy Staff Director Michael Kennedy informed the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association in March 17 letters. The agency said that the U.S. Pharmacopoeia has encountered difficulty in establishing USP monographs, which contain ingredient identity standards and specifications, for 55 ingredients that have been included by FDA in OTC tentative final monographs or in final monographs.
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