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  5. OTC Products and Dietary Supplements
  1. Reporting Serious Problems to FDA

OTC Products and Dietary Supplements

Public Law 109-462, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, was signed by President George Bush on December 22, 2006. Public Law 109-462 amends the Federal Food, Drug, and Cosmetic Act (the Act) to add safety reporting requirements for OTC drug products that are marketed without an approved application under section 505 of the Act (21 U.S.C. 355):  These reporting requirements become effective December 22, 2007.

Nonprescription Drug Products

Dietary Supplements


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