For months (if not years), we have been hearing alarms from industry trading partners who are subject to requirements for enhanced drug distribution security under section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) about the looming November 27, 2023 deadline for full compliance with all provisions of the Act. While the lead up to the 2023 date actually began about 10 years ago, the sheer size of the supply chain, the complexity of the process and number of trading partners, and the required connectivity and operation of the systems seems to have been somewhat underestimated.

In response to the number of pleas from various impacted components, the Agency too has recognized that it needed to quickly develop an appropriate enforcement policy to accommodate the additional time to assure all were in compliance and that their system worked within the framework as intended. For this reason, today, Friday August 25, 2023 the FDA announced an immediately final guidance entitled Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies Guidance for Industry (here).

The guidance notes that “[W]hile FDA generally expects trading partners to have the systems and processes in place to meet these requirements as of November 27, 2023, we recognize that some technical and operational issues, including issues involving trading partners and other affected stakeholders, may not be fully resolved by that time. The Agency also understands that additional time beyond November 27, 2023 may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.” Further, the FDA warns “[T]his guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”

The Agency explains that it does not intend to take enforcement action until November 27, 2024, to ensure continued access to prescription drugs to “trading partners while processes are being refined for the inclusion of the product identifier at the package level for each package in a transaction into the transaction information in accordance with section 582(g)(1)(B).” On this topic, they continue: “In addition, FDA does not intend to take action to enforce the requirement under section 582(g)(1)(B) of the FD&C Act with respect to product that is introduced in a transaction into commerce by the product’s manufacturer or repackager before November 27, 2024, and for subsequent transactions of such product through the product’s expiry. This means that FDA does not intend to take action if the transaction information for product introduced in a transaction into commerce by the product’s manufacturer or repackager before November 27, 2024, does not incorporate—at the package level for each package in the transaction—the product identifier. This policy will facilitate the use and exhaustion of product supply already in the supply chain prior to November 27, 2024.”

While trading partners can breathe a little easier for a year, their efforts to comply fully should continue to proceed at breakneck speed. November 27, 2024, will be here before you know it. It is obviously not known at this point if the FDA will have any appetite for further extending the period for full compliance. Don’t be left behind!