Drug Labeling

Excerpt

On January 24, 2006, The Food and Drug Administration (FDA), an entity of the United States Department of Health and Human Services, published a final rule on the content and format of labeling for human prescription drugs and biologics. These regulations are within Title 21 of the Code of Laws of the United States of America. The term “drug labeling” in this article generally refers to any information provided with prescription drugs under the regulation of the FDA in the United States. The exact definitions of “drug” and “labeling” have been included in the U.S. Code of Laws. Under this law, the definition of a drug is: “(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C)...” And label and labeling are defined as the following: “(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such an article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) A label means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.”