Nonprescription Drug Regulation in the United States
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Drug lnfomrion Journal. Vol. 34, pp. 323-327. 2000
Printed in the USA. All rights reserved.
NONPRESCRIPTION DRUG REGULATION IN THE UNITED STATES DEBRABOWEN,MD Deputy Director, Ofice of Drug Evaluation V, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland
In the United States, nonprescription drug products are regulated through implementation of laws enacted by Congress. The Food and Drug Administration (FDA)follows specific procedures that allow for public notice and comment when promulgating implementing regulations. Drug products may be marketed directly to consumers, unless they are limited to prescription use only because they meet certain criteria. Nonprescription drug products are marketed over the counter (OTC) pursuant to drug ingredient-use monographs or as approved new drugs for an OTC use. These United States regulatory pathways require evidence of safety, eflcacy, and labeling that consumers can understand that renders the product not adulterated or misbranded. All new drugs are required to comply with specific postmarketing surveillance practices. Key Words: Nonprescription drug; Over-the-counter drug; Regulation; Monograph
LAWS AND REGULATIONS LAWS ENACTED BY Congress are the basic enabling authority for the Food and Drug Administration's regulation of nonprescription drug products. Several laws guide the regulation of OTC drug products including the Food, Drug and Cosmetic Act (1) (FDCA) as amended, the FDA Modernization Act with standalone provisions (2), the Poison Prevention Packaging Act (3), the Fair Packaging and Labeling Act (4),and the Federal Trade Commission Act ( 5 ) . To implement applicable provisions of the law, FDA promulgates regulations and must follow specific administrative procedures that allow for public notice and comment (6). In addition, the agency may issue guidance ~~
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Presented at the DIA 35* Annual Meeting, June 27July 1. 1999, Baltimore, Maryland. Reprint address: Debra Bowen, MD, Deputy Director, Office of Drug Evaluation V, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857.
documents, policy statements, and advisory opinions that provide FDA's interpretation of applicable laws and regulations. These statements, however, are not legally binding on either FDA or the public. Generally, the preamble of a regulation explains the F'DA's reasoning and serves as an advisory opinion to the public.
LEGAL DEFINITIONS Several legal definitions determine whether a product is a drug and whether a drug can be marketed directly to consumers over the counter. A drug is an article that is recognized in the official United States Pharmacopoeia (USP), official Homeopathic Pharmacopeia United States, or official National Formulary; and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of man or other animals (if not a food); and articles intended for use as a component of articles
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