§355e Pharmaceutical Security

Summary

The Secretary must create standards and pick and test technologies to protect the drug supply from fake, stolen, too-weak, low-quality, contaminated, wrongly labeled, or expired medicines. The Secretary must work with drug makers, distributors, pharmacies, other users, and federal agencies (including the Department of Justice, Department of Homeland Security, and Department of Commerce) to set rules for identifying, authenticating, and tracking prescription drugs. Within 30 months after September 27, 2007, the Secretary must create a standard numerical ID to put on drug packages or pallets at manufacture and when repackaged, and the rules should consider technologies like RFID, nanotech, encryption, and other tracking or authentication tools. The Secretary must also boost FDA resources and facilities for regulatory and criminal work, team up with federal and state agencies for stronger enforcement, and build regional abilities to validate and inspect the prescription drug supply, including biological products and active pharmaceutical ingredients from inside and outside the U.S. Prescription drug — a drug covered by section 353(b)(1) of this title.