Supply Chain Companies Win Four-Month Reprieve From Product Tracing Requirement
The FDA has acquiesced to industry concerns and promised not to take action against drug supply chain companies for failing to exchange product information before May 1.
Drug supply chain trading partners such as manufacturers, wholesale distributors and repackagers initially had been required to start capturing and passing on details about their products on Jan. 1. However, in guidance published Dec. 24, the FDA says firms along the supply chain that don’t capture and pass on product history and other information during the first four months of this year will not face any sanctions.
The decision stems from industry concerns that some parties in the supply chain aren’t ready to comply with the track-and-trace requirements, and that unforeseen complications with the tracing requirements could disrupt the supply chain and impact patient access, the FDA says.
The reprieve mirrors concerns expressed by the Healthcare Distribution Management Association. In a Nov. 25 letter to the FDA, HDMA President and CEO John Gray asked the agency to exercise discretion in enforcing the requirements, noting that while most of the supply chain is ready, some firms would not be able to fully meet the obligations by Jan. 1.
Draft guidance published in November suggested a variety of ways drugmakers can track the data in print and digital formats, but the timing of its release gave firms little time to comply by the deadline. Still, the guidance contained no surprises and many companies had already begun to preemptively implement track-and-trace procedures based on common industry practices.
While industry will get a reprieve from the product tracing requirements, other elements envisioned under the 2013 Drug Quality and Security Act are skated to take effect as planned Jan. 1. These include illegitimate product verification and response and restricting business to authorized trading partners.
Also still on schedule: a July 1 deadline for drug dispensers to meet the tracking obligation.
Be ready for the FDA’s product tracing requirements with Preparing for Global Track & Trace Regulations.