In Keeping With the Spirit of the Season, FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements

By Anne Marie Murphy –

On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act ("DSCSA") prior to May 2015. The guidance, states in relevant part:

FDA recognizes that some manufacturers, wholesale distributors, and repackagers may need additional time beyond January 1, 2015, to work with trading partners to ensure that all of the product tracing information required under section 582 of the FD&C Act is provided to and captured by the recipient trading partner. To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. This compliance policy is limited to the requirements that trading partners provide and capture product tracing information; it does not extend to other requirements in section 582 of the FD&C 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.

This enforcement discretion aims to avoid possible disruptions in the prescription drug supply chain as the new requirements come into effect.  For more recent news on the DSCSA, see our prior posts here, here, and here.