FDA schedules workshop on DSCSA pilot studies

The US FDA has convened a workshop on April 5-6 to discuss the design of pilot medicine traceability studies.

The workshop will provide a forum to "explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain."

The FDA would like to obtain input on issues related to unique identifiers for product tracing and other factors that "are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA)."

One of the provisions in the act calls for the FDA to establish one or more pilot projects to assess the ability of the traceability provisions in the DSCSA to meet the objectives in preventing the distribution of illicit medicinal products in the supply chain.

In addition to the use of product identifiers, the agency would like feedback on "improving the technical capabilities of the pharmaceutical distribution supply chain, and identifying the system attributes that are necessary to implement the requirements" established under the DSCSA.

The DSCSA was signed into law by President Obama in November 2013, setting a 10-year deadline to implement an individual package level system to track medicines through the supply chain and allow them to be verified using the unique product identifier.


Image courtesy of Shutterstock / Digital Deliverance