FDA Guidance Delays Enforcement of Product Tracing Requirements

Indicating that the pharmaceutical-distribution supply chain is not ready to comply with product tracing provisions in the Food, Drug, and Cosmetic Act of 2013 (FD&C) scheduled to take effect on Jan. 1, 2015, FDA has issued a new guidance document that delays enforcement of the regulations for trading partners.

In the guidance DSCSA (Drug Supply Chain Security Act) Implementation: Product Tracing Requirements Compliance Policy, FDA announced that the agency does not intend to take action against manufacturers, wholesale distributors, and repackagers who do not, prior to May 1, 2015, provide or capture the transaction information, history, and statement associated with finished prescription drugs, as required by FD&C.

According to the FDA guidance, “some trading partners have expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the supply chain, and ultimately could impact patients’ access to needed prescription drugs. 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.”

The compliance policy is limited to the requirements that trading partners provide and capture product tracing information and not extend to other requirements in section 582 of the FD&C Act.

DSCSA outlines steps to build an electronic, interoperable system by Nov. 27, 2023, to identify and trace certain prescription drugs distributed within the United States. FDA published a draft guidance entitled DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (November 2014), which established initial standards for the interoperable exchange of the product tracing information related to each transaction of certain human, finished, prescription drugs covered by the statute, in paper or electronic format, through the extension and/or use of current systems and processes.

FDA notes that guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Source: FDA

DSCSA Implementation: Product Tracing Requirements Compliance Policy

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information