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  1. Center for Drug Evaluation and Research | CDER

Office of Drug Security, Integrity, and Response

Who We Are

Office of Drug Security, Integrity, and Response (ODSIR) uses risk-based approaches to promote and protect the integrity of the global supply chain to minimize consumer exposure to unsafe, ineffective and poor-quality drugs.
 

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

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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