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