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U.S. FDA Drug Labeling Requirements

U.S. FDA CITATION: 21 C.F.R. § 201 Subparts A and C (2015)

U.S. FDA Drug Labeling Regulations Can Be Complicated

Registrar Corp’s team of Regulatory Advisors can provide a Free Assessment of how these regulations apply to your particular product. Simply click below to provide information about your products.

Learn how FDA drug labeling regulations apply to your product >>

label_beforeafter_drugThe U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines “labeling” as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term ‘accompanying’ is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.

Registrar Corp’s Drug Labeling and Ingredient Review service helps companies determine their drug’s likely classification and compliance with applicable labeling requirements. Registrar Corp cross references your labeling against thousands of pages within the Code of Federal Regulations as well as the Federal Register, CDER’s Listing of OTC Active Ingredients, Rulemaking History for Nonprescription Products, Guidance Documents and Warning Letters issued by U.S. FDA. Registrar Corp’s label review service provides:

  • A detailed report (typically 30-40 pages) prepared by our team of regulatory specialists who scrutinize each element of your labeling (including inner packaging, outer packaging, website, etc.).
  • A print-ready graphic file of your revised label which incorporates our recommended changes.
  • A generous revision policy providing additional reports and revisions for the same label within 30 days at no extra cost.

Learn how FDA drug labeling regulations apply to your product >>