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.
- Risk- and science-based policy development, surveillance, and enforcement.
- Reducing the likelihood that unsafe, ineffective, and poor quality drugs will enter the supply chain and reach consumers; and
- Raising public awareness of drug security threats and vulnerabilities in the supply chain.
- Enforcing legal requirements that pertain to imported drugs to prevent consumer exposure to unsafe, ineffective, and poor quality imported drugs.
- Providing support and guidance on drug imports compliance and policy to promote the quality and integrity of imported products.
- Providing support and guidance on export policies and procedures to promote the quality and integrity of exported drugs.
- Enforcing legal requirements that pertain to drug recalls and monitoring resolution of drug recalls to prevent consumer exposure to unsafe or ineffective drug products.
- Communicating information about drug product recalls, defective drug products FDA determines pose a risk to consumers.
- Coordinating activities among sub-offices within the Office of Compliance to address drug shortages.
- Serving as the central repository and point of coordination for obtaining health hazard evaluations of defective products for Office of Compliance.
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.
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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