On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements applicable to dispensers. In particular, the FDA indicated that it does not intend to take enforcement action against dispensers that, prior to November 1, 2015, accept ownership of drug product without receiving product tracing information, prior to or at the time of a transaction, or do not capture and maintain the product tracing information. As noted in an earlier McDermott article, the Drug Supply Chain Security Act (DSCSA), passed on November 27, 2013, required that dispensers undertake these compliance measures by July 1, 2015.
In its guidance notice, the FDA explained that some dispensers had expressed concern that electronic systems used to exchange, capture and maintain product tracing information would not be operational by July 1. Although the DSCSA allows product tracing information to be exchanged through paper in certain circumstances, most dispensers intend to use electronic systems to capture and maintain product tracing information.
The FDA’s delay in enforcement against dispensers follows on its earlier enforcement delay regarding product “track and trace” requirements applicable to trading partners (manufacturers, wholesale distributors, dispensers and repackagers). Trading partners’ initial compliance deadline was January 1, 2015, but the FDA announced an enforcement delay until May 1, 2015.
Notwithstanding its delay in enforcing the dispenser requirements, the FDA noted in the dispenser guidance that trading partners are still required under the DSCSA to provide the subsequent purchaser with product tracing information when engaging in transactions involving certain prescription drugs. The FDA further noted that the DSCSA also requires trading partners to capture the product tracing information and to maintain applicable information for at least six years after the date of the product transaction.
The DSCSA requires a number of subsequent staged steps (described in McDermott’s previous article) over the coming years. The goal is to build an electronic, interoperable system by November 27, 2023, to identify and trace certain prescription drugs as they are distributed within the United States. The system is expected to enhance the FDA’s ability to help protect U.S. consumers by improving detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain.
The enforcement delay will allow dispensers additional time to ensure electronic interface compatibility, to consider contractual arrangements with trading partners, and to put in place standard operating procedures or other policies regarding required data elements and maintenance of “track and trace” data. The FDA noted, however, that the enforcement delay does not extend to other requirements applicable to dispensers under the DSCSA (including those in section 582 of the Federal Food, Drug & Cosmetic Act), such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping), and requirements related to engaging in transactions only with authorized trading partners.