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  1. CDER Offices and Divisions

Office of Drug Security, Integrity, and Response

Who We Are

The Office of Drug Security, Integrity, and Response (ODSIR) protects the integrity of the legitimate drug supply chain. ODSIR uses a risk-based approach to minimize consumer exposure to dangerous products marketed outside the legitimate supply chain.

What We Do

  • Reduce threats to the global drug supply chain:
    • Serve as FDA coordinator for drug supply chain integrity breaches;
    • Coordinate responses to confirmed incidents involving counterfeits, unapproved drugs, manufacturing quality issues, cargo thefts, and diversions;
    • Conduct drug supply chain surveillance activities and initiate appropriate regulatory actions against entities that violate the law; and
    • Communicate with industry and stakeholder groups about drug security and supply chain issues.
  • Lead FDA’s implementation of the Drug Supply Chain Security Act’s policies and activities.
  • Remove defective drug products from the supply chain:
    • Coordinate recalls and follow-up activities; and
    • Ensure risk information regarding recalls is clearly communicated to the public.
  • Coordinate Office of Compliance activities to prevent and mitigate drug shortages.
  • Ensure drug importation and exportation adhere to federal laws and regulations:
    • Serve as FDA coordinator for all human drug import and export compliance issues;
    • Promote goodwill and cooperation between the United States and foreign governments through the Export Certificate Program; and
    • Monitor the integrity of imported and exported drugs and facilitate trade for compliant drug products.

Organization

  • Division of Supply Chain Integrity
  • Division of Global Drug Distribution & Policy

Contact Us

Email: CDERDrugSupplyChainIntegrity@fda.hhs.gov

Phone: 301-796-3130

Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 4271
Silver Spring, MD 20993-0002

 
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