A national system for pharmaceutical track and trace did not materialize during congressional agreement on "The Food and Drug Administration Safety and Innovation Act of 2012." The bill reauthorizes the Prescription Drug User Fee Act (PDUFA), and legislators had been debating additional language that would have put a national drug track-and-trace system into motion.
The Pharmaceutical Distribution and Security Alliance (PDSA), for instance, had originally proposed the Pharmaceutical Traceability Enhancement Code (RxTEC) Act, which would have had manufacturers apply a 2-D bar code including the NDC in a GTIN, with appended serial number, and lot number and expiry dates. Product tracking, however, would have been required at the lot level. (The approach also included federal standards for licensing of wholesalers and other logistics providers, established stiff penalties for counterfeiters, and called for regulations requiring electronic labeling.) PDSA sponsors were negotiating with sponsors of a house bill that called for item-level tracking, which FDA has favored.
PDSA issued a statement thanking "the many lawmakers and staffers who worked to develop a single, uniform and comprehensive pharmaceutical traceability solution within the FDA user fee legislation. We are particularly grateful for the leadership and work of Senators Michael Bennet and Richard Burr and Congressmen Brian Bilbray and Jim Matheson who have advanced these enhanced protections for American patients further than ever before."
Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani issued its own statement of thanks: “It is important to highlight a critical issue that was not resolved in this legislation – ‘downstream’ supply chain security. Protecting American patients from counterfeit and adulterated medicines is a public policy priority for PhRMA, Congress, FDA, and a multitude of stakeholders, and we commend Congress’s efforts to address this issue."
PDSA remains hopeful that stakeholders and legislators continue to work toward a national system. “PDSA is disappointed these protections have not been included as part of the PDUFA bill; however, we remain hopeful all parties will continue to work – right now – on this historic effort to protect America’s patients. PDSA appreciates the assurances from the committees to continue working with stakeholders to make this laudable legislation a reality as soon as possible,” the group stated.
PhRMA desires a national system as well: "We strongly encourage Congress to continue working to pass legislation that establishes a national uniform system to protect our drug distribution system, from manufacturers to dispensers, this year. We stand ready to support and actively engage in any legislative process to achieve this goal," PhRMA stated.
California's Electronic Pedigree requirements, which begin phasing in January 2015, are the only state requirements existing in the United States for electronic item-level identification and chain-of-custody tracking.
Visit here for more details on the RxTEC Act.