DSCSA

FDA Announces Start Of DSCSA Voluntary Piloting Program

Starting tomorrow companies in the US supply chain wishing to volunteer to participate in FDA-sanctioned Drug Supply Chain Security Act (DSCSA) pilots will have just 30 days to apply.  Applicants are asked to propose pilots aimed at the goals of the FDA program.  These include:

  1. “…identifying the system attributes needed to implement the requirements of section 582 of the FD&C Act, particularly the requirement to utilize a product identifier for product tracing and verification purposes, and
  2. assessing the ability of supply chain members to satisfy the requirements of section 582 of the FD&C Act; identify, manage, and prevent the distribution of suspect and illegitimate products […], and exchange product tracing information across the pharmaceutical distribution supply chain in an electronic and interoperable manner.”

Specifically,

“FDA is seeking pilot project participants from the pharmaceutical distribution supply chain (e.g., authorized manufacturers, repackagers, wholesale distributors, and dispensers) and other stakeholders.  FDA expects potential participants to propose the design and execution of their pilot project in their submission to FDA; however, FDA intends to meet with selected pilot project participants to ensure that the learnings from the pilot project(s) will be complementary in informing all stakeholders in the development of the electronic, interoperable system that will go into effect in 2023.  

FDA encourages potential participants to focus their proposed pilot project(s) on the DSCSA requirements related to the interoperable, electronic tracing of products at the package level.  Specifically, the pilot project(s) should focus on the enhanced requirements for package-level tracing and verification that go into effect in 2023.  […]  If there is an adequate number of pilot project submissions, FDA may establish more than one pilot project to accomplish the goals of the DSCSA Pilot Project Program.”

In the announcement (available here), FDA provides a long list of potential things that applicants might propose to test.  Applicants have until March 10 (if my calculation is correct) to submit their application through DSCSAPilotProjects@fda.hhs.gov.  See the announcement for more details.

See also, “FDA Looking For Consulting Org To Run DSCSA Pilots“, “The 2016 FDA Pilots Workshop“, “What Should FDA Pilot?” and “HDMA Responds To FDA Pilots RFC“.

Dirk.