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Category Archives: Drug Supply Chain Security Act

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Abbott Secures Preliminary Injunction in Gray Market Case

Posted in Drug Quality and Security Act, Drug Supply Chain Security Act, Intellectual Property, Litigation, Medical Devices, Risk Management

Medical equipmentOn November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle diabetes test strips designed for sale internationally to U.S. Continue Reading

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished Prescription Drugs: How to Exchange Product Tracing Information

Posted in Drug Supply Chain Security Act, Guidance

On December 8, 2014, FDA issued new guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.  As the title suggests, the Guidance is part of FDA’s implementation of the Drug Supply Chain Continue Reading

Drug Supply Chain Expert Warns that Counterfeiters Can Game Drug Supply Laws Unless Congress Mandates Randomization of Drug Serial Numbers

Posted in Drug Quality and Security Act, Drug Supply Chain Security Act, Drugs

Drug supply chain expert, Dirk Rodgers of RxTRace, issued a warning about how criminals will be able to game the drug distribution system even in the wake of the Drug Supply Chain Security Act (DSCSA), legislation that was enacted last … Continue Reading