SUMMARY: “The Food and Drug Administration (FDA) is issuing a final rule establishing a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products. § 201.25 - Bar code label requirements. 1. 201 et seq.)).
Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat.
Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 - Statement of identity
§ 201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile. (a) Applicability. According to the FDA, all labels printed for use in the pharmaceutical and healthcare industry are required to be designed and applied so they can remain in place and be read in different environments through distribution, storage, and use. Labeling Responsibilities. (b) Exemptions. § 201.24 - Labeling for systemic antibacterial drug products.
632, as amended (42 U.S.C. General Requirements for Prescription Drug Labeling (21 CFR 201.56) Summary for the safe and effective use of the drug Informative and accurate Not promotional, false, or misleading
The package insert or other labeling for in vitro diagnostic products is required to contain the revision date [21 CFR 809.10(b)(15)]. Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements; Search for FDA Guidance Documents