Amendment of regulations regarding certain label statements on prescription drugs. Final rule.
The Food and Drug Administration (FDA) is amending its regulations concerning certain statements that have been required on the labels of prescription drugs generally and on certain narcotic or hypnotic (habit-forming) drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).
D011307:Drug Prescriptions; D006801:Humans; D007880:Legislation, Drug; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence