FDA DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy (Revised)
The Drug Supply Chain Security Act (DSCSA) requires most of the entities along the drug supply chain–from manufacturers to wholesale distributors to dispensers (primarily pharmacies)–to comply with new requirements regarding product tracing. The intent of the law is to enhance the FDA’s ability to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful by improving detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. The development of the system will be phased in with new requirements over a 10-year period. The DSCSA mandates that the FDA develop standards, guidance documents, pilot programs, and conduct public meetings, in addition to other efforts, to support efficient and effective implementation.
Starting in 2015, manufacturers, wholesale distributors, dispensers, and repackagers are required to provide the subsequent purchaser of certain prescription drugs with product tracing information. The trading partners are to obtain product tracing information and maintain the applicable information for at least six years following the date of the transaction.
The FDA had previously issued a Compliance Policy on July 6, 2015, which stated that the FDA did not intend to take action until November 1, 2015, against dispensers that accepted ownership of product without receiving the product tracing information, or dispensers who did not capture and maintain the product tracing information as required by law. This essentially gave dispensers a “free pass” and a bit more time to get their procedures in compliance with the law.
With the November 1 deadline rapidly approaching, last week, the FDA issued a new guidance, DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy (Revised). The new guidance “addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act … related to the exchange of transaction information, transaction history, and transaction statements (product tracing information).”
This most recent guidance announced that the FDA will extend the previously issued Compliance Policy grace period from November 1, 2015 to March 1, 2016 because some dispensers have expressed that they needed additional time to comply with the law. The FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of a product without receiving the product tracing information, under section 582(d)(1)(A)(i) of the FD&C Act. This compliance policy, however, does not extend to the requirements under section 582(b)(1), (c)(1), and (e)(1) that other trading partners (manufacturers, wholesale distributors, and repackagers) provide product tracing information to dispensers.
This new compliance policy also does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history, as required by section 582(d)(1)(A)(ii).
As a result of the FDA not taking action against most dispensers who accept ownership of a product without a transaction history, transaction information, and transaction statement, the FDA does not intend to take action against dispensers who do not maintain the product tracing information for a minimum of six years as required under section 582(d)(1)(A)(iii).
However, the grace period was extended by only four months and it is uncertain if the FDA will continue to extend the grace period. Therefore, if a dispenser has not received product tracing information prior to, or at the time it takes ownership of a product, the FDA recommends that the dispenser work with the previous owner to receive this information to ensure complete compliance with the law.
It is important to note that this guidance does not change the current requirements for manufacturers, wholesale distributors, nor repackagers. This guidance only affects dispensers who do not need to provide a subsequent owner with product tracing information. All other dispensers, or manufacturers, wholesale distributors, and repackagers are still required to obtain and maintain tracing information as required under the FD&C Act.