FDA Gains Ground in Development of Pilot Program Required Under Drug Supply Chain Security Act

The Drug Supply Chain Security Act (DSCSA), which was signed into law in November 2013, “outlines critical steps to build an electronic, interoperable system” to identify and trace prescription drugs as they are distributed throughout the US. One of the “critical steps” included in the act requires FDA to establish pilot programs “to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.”

Proposed Pilot Program & Public Workshop

In February 2016, FDA announced plans to establish of one of the pilot programs as required by the DSCSA.  On April 5^th and 6^th, the Agency held a public workshop to gain feedback from interested pharmaceutical distribution supply chain members about issues related to the proposed program.

In advance of the workshop the FDA provided a list of discussion topics, but clarified that it was published only for the purpose of facilitating discussions, and explicitly stated that workshop discussion was not limited to the topics outlined in its list.  Furthermore, in order to input from more than just the workshop’s attendees, the Agency asked interested stakeholders to submit comments regarding the specific design of the proposed pilot programs on or before April 21, 2016.

FDA Requests Information from Stakeholders

On April 15, 2016, the FDA published a notice in the Federal Register requesting information “regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the DSCSA.”  This information will assist FDA with the design and development aspects of the proposed pilot projects.

Above all, FDA is interested in information concerning current or past pilot programs on the supply chain’s safety and security; as well as the practices, processes, and systems that have been used such pilot projects, including:

• “Utilizing the product identifier for tracing of a product, which may include verification of the product identifier of a product, including the use of aggregation and inference;
• Technical capabilities each sector of the supply chain to comply with systems and processes needed to utilize the product identifier to enhance the tracing of a product; or
• System attributes that are necessary to implement the requirements established under the DSCSA.”

FDA noted that stakeholders such as manufacturers, repackagers, wholesale distributors, dispensers, State and Federal authorities, solution providers, and standards organizations may be interested in responding to the request.  These along with any other interested persons are asked provide information on the above mentioned subjects, as well as any other relevant information that could assist in the pilot program’s development.

FDA is accepting electronic and paper (written) comments until May 16, 2016.