§355e Pharmaceutical security

Summary

The Secretary must create rules and pick proven technologies to protect the drug supply from fake, stolen, weak, poor-quality, contaminated, wrongly labeled, or expired medicines. The Secretary must work with drug makers, distributors, pharmacies, other supply chain groups, and federal agencies to set standards for how to identify, verify, and track prescription drugs. Not later than 30 months after September 27, 2007, the Secretary must create a standard numeric ID to be put on each package or pallet when drugs are made or repackaged, linked back to the maker’s ID and aligned with international standards when possible. The standards should cover technologies like RFID, nanotech, encryption, and other tracking or verification tools. The Secretary must also strengthen FDA enforcement staff and facilities, work with federal and state partners on joint enforcement, and build regional capacity to test and inspect drugs and the drug supply chain, including biological products and active pharmaceutical ingredients from U.S. and foreign sources. Prescription drug = a drug covered by section 353(b)(1) of this title.