Cosmetic Good Manufacturing Practices Guidelines

The FDA has never published current good manufacturing practice (cGMP) regulations for cosmetics, although the agency has actively promoted good manufacturing practices by firms marketing cosmetics in the United States. The agency has published Cosmetic Good Manufacturing Practice Guidelines, patterned in pertinent part after the food cGMP regulations [13a] but applicable to the cosmetic manufacturing environment, in the FDA's Cosmetics Handbook [13b]; the latter document references the FDA Investigation Operations Manual (IOM) [31]. The Cosmetic Good Manufacturing Practice Guidelines is a guidance document reflecting FDA policy, but it is not legally binding, either on the cosmetics industry or on the agency. The FDA has also published drug cGMP regulations [32], which apply to prescription drugs and cosmetic-drugs (i.e., OTC drug products making cosmetic claims).

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