The 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.

MEDERA's drug labeling and ingredient review service helps companies determine their drug's likely classification and compliance with applicable labeling requirements. MEDERA can help modify your drug labeling to comply with U.S. FDA regulations. At MEDERA we cross reference your labeling against thousands of pages within the Code of Federal Regulations as well as the Federal Register, Center of Drug Evaluation and Research (CDER)'s Listing of OTC Active Ingredients, Rulemaking History for Non-prescription Products, Guidance Documents and Warning Letters issued by U.S. FDA.

MEDERA's label review service provides:

  • A detailed report prepared by scrutinizing 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 90 days at no extra cost.

The U.S. FDA now requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format.

Having your drug labeling reviewed by MEDERA can prevent costly errors. To learn how this service would be beneficial for your particular product, simply contact us to request a free estimate or to find out more about our regulatory consulting services. Click here to receive a free copy of our white paper on marketing a drug product in US.