Duane Morris LLP: FDA Publishes Revised Guidance on Product Tracing Requirements for Dispensers

Duane Morris LLP: FDA Publishes Revised Guidance on Product Tracing Requirements for Dispensers

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States.” This year, trading partners were required to exchange product tracing information, as well as maintain the information for at least six years after the date of the transaction. To further this effort, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product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.” This guidance provided “initial standards” for exchanging the product tracing information required by the DSCSA.

For dispensers, the requirements for tracing products under the DSCSA went into effect on July 1, 2015. However, FDA published a guidance entitled “DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy” on July 6, 2015, which stated that “FDA does not intend to take action against dispensers who, prior to November 1, 2015, (1) accept ownership of product without receiving product tracing information, prior to or at the time of a transaction ... or (2) do not capture and maintain the product tracing information.”

On October 28, 2015, the FDA revised this guidance, “extending this compliance policy to transactions that occur before March 1, 2016.” It is important to note that FDA will still require that other trading partners provide dispensers with product tracing information and that dispensers provide “the subsequent owner with product tracing information, including transaction history.” In instances where a dispenser does not receive product tracing information from its trading partners, FDA recommends that the dispenser “work with the previous owner to receive this information.”

For Further Information

If you have any questions about this Alert, please contact Rachael G. Pontikes, Carolyn A. Alenci, any member of the Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.

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