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FDA Grants Extension for Certain Companies to Comply with DSCSA

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Will Garvin
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Will Garvin
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The Food and Drug Administration (FDA) announced on October 9, 2024, that it was issuing an exemption for certain companies to give them more time to comply with the requirements of the Drug Supply Chain Security Act (DSCSA). The exemption given depends upon where you are in the drug supply chain: 

  • Manufacturers and Repackagers: May 27, 2025
  • Wholesale Distributors: August 27, 2025
  • Dispensers with 26 or more full-time employees: November 27, 2025

FDA stated that this exemption would be given to those companies that had made documented efforts to comply with the law. 

FDA is issuing an exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners. This exemption applies to any product transacted by eligible trading partners, which are trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.
www.fda.gov/...
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration (FDA), a federal agency of the Department of Health and Human Services (HHS).

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dscsa, fda & biotechnology

Get in touch

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Will Garvin
Shareholder

Get in touch

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Will Garvin
Shareholder

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