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The Importance of FDA registration

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. The FDA is also responsible for the safety and security of most of our nation’s food supply, all cosmetics, dietary supplements and products that give off radiation.

Over-the-counter and prescription drugs, including generic drugs, are regulated by FDA's Center for Drug Evaluation and Research (CDER). This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, shampoos and sunscreens are all considered "drugs." Cosmetic products are regulated by FDA's Center for Food Safety and Applied Nutrition (CFSAN). CFSAN is responsible for assuring that cosmetics are safe and properly labeled. Cosmetics include color additives found in makeup and other personal care products, skin moisturizers and cleansers, and nail polish and perfume.

Calumet Penreco white oil facilities are registered with the Food and Drug Administration (FDA) as a Bulk Pharmaceutical Manufacturer and conform to current Good Manufacturing Practices (cGMP) as outlined in the Code of Federal Regulations (21CFR211).

For Calumet Penreco Drug Establishments Current Registration Site letter go here>

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