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FDA reform bill adopted Nov. 9 preserves states' safety authority over cosmetics.

This article was originally published in The Rose Sheet

Executive Summary

FDA COSMETICS-DRUGS RECORDS INSPECTION AUTHORITY GRANTED IN REFORM BILL in a provision that expands the agency's records inspection jurisdiction to over-the-counter drugs. "Cosmetic products that are also OTC drugs subject to records inspection by FDA," according to a Senate/House conference committee statement released Nov. 9 after passage of the FDA reform bill by both chambers. The clause amends the Good Manufacturing Procedures (GMP) provision in the FD&C Act that authorizes the agency to inspect the manufacturing facility records of prescription drug manufacturers. Cosmetic-drug products that will be required to comply with the records inspection clause include sunscreens, acne products, dandruff shampoos and antiperspirant/deodorants.

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