Drugs
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Resources for You
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Drug Integrity and Supply Chain Security
The Office of Drug Security, Integrity, and Recalls (ODSIR) in CDER’s Office of Compliance works to ensure the quality, integrity, and security of human drugs for U.S. consumers. ODSIR addresses globalization’s challenges and an increasingly complex drug supply chain through risk- and science-based policy development, surveillance, and enforcement. ODSIR staff minimize consumer exposure to substandard drugs by dealing with a number of issues related to supply chain integrity and security, such as counterfeit, diverted, or intentionally adulterated drugs, drug imports and exports, and drug recalls.
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News and Events
Manager of Johnson City Cancer Clinic Pleads Guilty to Receiving Unapproved Drugs Man convicted for role in international counterfeit drug distribution scheme August 23, 2012: California Man Sentenced for Importing Adulterated Cancer Drugs; Forfeits $1.4 Million & Land Rover Automobile - FDA warns consumers about counterfeit version of Teva's Adderall
Letters to Doctors about Risks of Purchasing Medications from Foreign or Unlicensed Suppliers Another counterfeit cancer medicine found in U.S. - Illegal practice puts patients at risk Counterfeit Vicodin ES Purchased Through the Internet 
Counterfeit Version of Avastin in U.S. Distribution Notice of Risks of Purchasing Unapproved Injectable Cancer Medications (PDF - 31KB)DOJ Press Release - Local Cancer Doctor Pleads Guilty To Receiving Misbranded Cancer Drugs WHO Warns Consumers in Pakistan of Risks Associated with Contaminated Medicines
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Supply Chain Security Initiatives
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Cargo Theft/Diversion
Cargo Thefts Reporting Prescription Drug Sample Losses, Known Thefts, and Possible Diversion to the FDA in the Aftermath of a Natural Disaster August 10, 2012: South Carolina Pharmaceutical Distribution Company Pleads Guilty in Multi-Million Dollar Scheme to Purchase and Sell Drugs in the Grey Market - March 18, 2010: Three Indicted for Diversion of Prescription Drugs
FDA Urges Industry to Take Additional Steps to Prevent Cargo Theft
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Prescription Drug Marketing Act (PDMA)
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Contact FDA
(301) 763-3130
Office of Drug Security, Integrity, and Recalls
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