OTC records inspection
This article was originally published in The Rose Sheet
Executive Summary
Cosmetic-drug products, including sunscreens, acne products, dandrushampoos and antiperspirant/deodorants, will be required to comply with the new OTC records inspection provision of the FDA Modernization Act. Industry concerns regarding implementation of FDAMA's new OTC records inspection provisions were raised at an "exploratory" meeting between FDA and the Consumer Healthcare Products Association Sept. 15. Agency inspection of OTC company records is likely to begin only after FDA has provided "sufficient time and guidance" to industry, according to a Senate/House conference statement released in conjunction with passage of the bill (1"The Rose Sheet" Nov. 17, 1997, p. 1)