Misbranding Federal Food, Drug

The USP Convention is the publisher of the United States Pharmacopeia and National Formulary (USPINF). These texts and supplements are recognized as official compendia under the Federal Food, Drug Cosmetic Act (FD C Act). As such, their standards of strength, quality, purity, packaging, and labeling are directly enforceable under the adulteration and misbranding provisions without further approval or adoption by the FDA (http //www.usp.org frameset.htm http //www. usp,org/standards/fda/jgv testimony.htm). 

Deliberate contamination of Tylenol capsules in 1982 with cyanide prompted the Federal Antitampering Act (P.L. 98-127) (18 U.S.C. 1365). This act applies to all consumer products, including any food, drug, device, or cosmetic. If a product is not packaged according to the Food, Drug, and Cosmetic Act, the product is considered misbranded or adulterated. For the purpose of consumer products, tampering refers to any alteration of the product with the intent to make the product ohjectionahle without the authority to make the alteration. 

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