The FDA announced that the agency “Does not intend to take action against manufacturers who do not, prior to November 26, 2018, affix or imprint a product identifier to each package and homogeneous case of product intended to be introduced in a transaction into commerce between November 27, 2017 and November 26, 2018 as required by section 582(b)(2)(A) of the FD&C Act.” The delay provides manufacturers additional time and avoids supply disruptions. This delay may impact the ability for providers to have all the pieces in place to deliver the transactional stream for products by 2020.
The FDA pointed out that the new draft guidance applies solely to items without a product identifier during the period and that manufacturers must comply with other DSCSA requirements. The product identifier presents a unique identity for individual prescription drug packages and cases that will allow trading partners to track the packages as they move through the supply chain. The identifiers are expected to include the product’s lot number, expiration date, National drug code (NDC) and a serial number. The serial number is different for each bottle, box, carton or pallet. This serial number is a unique identifier, human and machine readable, to enable product tracing throughout the supply chain and enable all trading partners to better detect counterfeit products within the supply chain.
This delay does not change the deadline, it means that there is a one-year grace period before any fines or penalties will be levied for non-compliance. There are no enforcement-related changes to any of the DSCSA requirements that have already gone into effect, including the product tracing obligations (T3 information). Without the required product identifier, products cannot be introduced by the manufacturer into commerce after November 26, 2018, the FDA recommends that downstream trading partners take concrete steps to determine that a product’s initial transaction date falls with the 1-year discretionary window.
The DSCSA timetable between 2015 and 2023 enables each individual drug package to be uniquely tracked through the supply chain from all distribution channels to dispensing. Even though Lot level tracking went into place starting in 2015; the individual package tracking that was to occur in 2017 is the step that is delayed for enforcement until 2018. The timeline moves forward with the downstream parties of the supply chain (distributors, pharmacies, health systems) were to have their documentation programs in place in successive years, with all of it being fully digitized by 2023. This latest announcement does not move other targets a year back, if a product already contains a product identifier that has been introduced into the supply chain, the FDA expects manufacturers and trading partners to use it for verification.
According to the guidance, products not complying with the DSCSA requirements are considered misbranded. Companies marketing misbranded products may be subject to warning letters, seizure, injunctions, fines, and criminal prosecution.