Later this month, IWLA (via the Pharmaceutical Distribution Security Alliance) will sign comments drafted to the U.S. Food and Drug Administration (FDA) related to the standards for the interoperable exchange of information for tracing of human, finished, prescription drugs, in paper or electronic format.
The document addresses specific questions from the FDA’s Request for Information on the section of the law that establishes a national system for tracing pharmaceutical products. Prescription drugs in finished dosage form for human use will be traced through the supply chain via product “transactions,” meaning each transfer of ownership. Because warehouse logistics services providers never take ownership of the product, this is not a direct requirement for IWLA members. However, it may indirectly fall into the hands of a 3PL if the customer considers it within the scope of services.
The comments raise challenges and recommendations for what kind of information should be exchanged and the best processes behind the transfer. The comment document cites several existing processes in the supply chain as sufficient for the tracking of product: advanced-ship notices, databases, electronic invoices and electronic product code information services.
The comments also highlight challenges related to use of paper or electronic forms of information. Because no standard tracking method previously existed, the methods used in the supply chain vary greatly and will have significant impact to the transition by Jan. 1, 2015, when the law goes into effect.
The comments state,” While PDSA recognizes the goal of moving to an electronic solution for exchanging transaction-related information, an estimation of the timeframe for this move is difficult to forecast, even for individual participants in the supply chain.”
PDSA urges the FDA to have appropriate flexibility over the formats of information exchanged in the initial implementation, and long-term guidance for transitioning to electronic formats.
Under the circumstance of reporting and notification of illegitimate product, “PDSA recommends that FDA move forward with a process for notification that will promote efficiencies and avoid over-notification, in order to avoid undue disruptions in the supply of important medicines.”
The reporting recommendations are for the FDA to communicate in writing to stakeholders and for the FDA to create a central point of contact (or portal) for stakeholders to communicate with the FDA on security issues in the future.
These drafted comments still present an opportunity for IWLA members to contribute recommendations and challenges to the FDA. Please send us your comments to mail@IWLA.com or attend the FDA’s public workshop on “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format,” May 8-9, 2014 at FDA’s White Oak campus in Silver Spring, Md. Registration requests should be received by April 24, 2014.