Office of Drug Security, Integrity, and Recalls
The Goals of Office of Drug Security, Integrity, and Recalls include:
- Promoting the quality, integrity, and security of human drugs for U.S. consumers.
- Addressing the increasingly complex global drug supply chain.
- Minimizing consumer exposure to substandard drugs by addressing supply chain integrity and security issues, such as counterfeit, diverted, or intentionally adulterated drugs, drug imports and exports, and drug recalls.
Office of Drug Security, Integrity, and Recalls Accomplishes this through:
- Risk- and science-based policy development, surveillance, and enforcement.
Recalls and Shortages Branch
The Recalls and Shortages Branch within the Office of Drug Security, Integrity, and Recalls/ Division of Import Operations and Recalls:
Monitors, screens and evaluates incoming recall alerts to identify events that may pose a significant health risk that require immediate FDA response, including the need for press statements or other regulatory action.
Evaluates and coordinates Health Hazard Evaluation (HHE) requests, and assigns classifications to recall actions initiated to remove violative and defective human drug products from the market.
Serves as the coordinator between the Office of Compliance and the CDER Shortage Staff to help avert drug shortages of medically necessary drugs.
Import Operations Branch
Mission: To promote compliance with FDA’s standards for human drug import and export in order to protect the public health. More specifically to:
Serve as FDA focal point at CDER 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.
Assure the integrity of imported and exported drugs by monitoring investigational and unapproved new drugs.
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