§355e Pharmaceutical Security

Summary

The Secretary must create standards and find proven technologies to keep the drug supply safe from fake, stolen, weak, bad, tampered, mislabeled, or expired drugs. The Secretary must work with drug makers, distributors, pharmacies, other supply chain groups, and Federal agencies (for example, the Department of Justice, Department of Homeland Security, and Department of Commerce). Not later than 30 months after September 27, 2007, the Secretary must set a standardized numeric identifier to be placed on prescription drugs at manufacturing and on repackaged items (at the package or pallet level) and linked to the manufacturer’s identifier. The standards must cover promising tools such as RFID, nanotechnology, encryption, and other tracking or authentication methods. The Secretary must also strengthen FDA teams, tools, and facilities for regulatory and criminal enforcement, work jointly with Federal and State partners, and build regional ability to validate drugs and inspect the supply chain. "Prescription drug" means a drug subject to section 353(b)(1) of this title.