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Drug Application Approval Letters

Recently the US Food and Drug Administration (FDA) added the COMPENDIAL STANDARDS section to drug application approval letters to help ensure that drugs meet consistent standards for strength, quality, performance and purity.

  • Compliance Required: A drug named in the official United States Pharmacopeia (USP) or National Formulary (NF) generally must meet the specified standards for strength, quality, performance and purity unless any variations are clearly indicated on the label (according to the Federal Food, Drug, and Cosmetic Act § 501(b), 21 USC 351(b)).
  • Information Sharing Limits: FDA cannot share specific application information with third parties, including USP.
  • Collaboration Encouraged: Drug application holders can work with USP to update official monographs in the USP-NF for continued compliance.

Overall, this language reflects FDA's commitment to maintaining quality standards, safeguarding public health, and providing a clear regulatory framework for the pharmaceutical industry.

Please contact donations@usp.org for additional information.