On July 20, 2017, the Food and Drug Administration (FDA) published a notice announcing three public meetings entitled “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act” (DSCSA), and a notice announcing a pilot program project under the DSCSA. The FDA requests comments on the meeting topics and the pilot program.

The DSCSA, enacted on November 27, 2013, established a new track-and-trace system for prescription drugs distributed in the United States, and sets forth a series of requirements that will culminate in the establishment of a fully electronic, interoperable system to identify and trace certain prescription drugs by 2023. This system is intended to enhance the FDA’s ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain.

The requirements of the DSCSA and the dates on which they become effective vary among the different actors in the supply chain, including manufactures, wholesale distributors, dispensers, repackagers and third-party logistics providers. The statute sets forth requirements for accepting, providing, capturing and maintaining Transaction History (TH), Transaction Information (TI) and a Transaction Statement (TS) (product tracing information); using only authorized trading partners; and establishing verification systems. The statute also sets forth licensing requirements for wholesale distributors and third-party logistics providers, attempting to standardize some of the mess the states created after the Prescription Drug Marketing Act of 1987 mandated state licensure.

Sidley is aware that companies are still confused about DSCSA requirements, and have raised issues such as how to determine what role a trading partner is playing in the drug supply chain in any given transaction, what statutory requirements are triggered by any given role, whether a firm’s systems and practices or proposed systems and practices are sufficient to meet DSCSA standards and whether one of the DSCSA exceptions applies in a given scenario. Additional guidance on some of these issues will hopefully be gained through these additional meetings.

Public Meetings

The FDA intends to hold three meetings, divided by topic, to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with the FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. The public meetings will be held on:

  • August 23, 2017, from 9 a.m. to 4 p.m ET.
    • Topics:
      • Supply chain security in 2023
      • Enhanced drug distribution security needs
  • December 5 and 6, 2017, from 9 a.m. to 4 p.m. ET.
    • Topics:
      • Electronic interoperability
      • Standards for data exchange
      • Data architecture
      • Aggregation and inference
  • February 28, 2018, from 9 a.m. to 4 p.m. ET.
    • Topics:
      • Further refinement of enhanced drug distribution security needs
      • Building capacity for a unit-level system

The FDA is also soliciting comments on all aspects of the meeting topics.

Pilot Project Program

On July 20, the FDA also announced the DSCSA Pilot Project Program. Under this program, the FDA says that it will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.

The FDA expects that participants will propose the design and execution of their pilot projects. The pilot projects should focus on the requirements for package-level tracing and verification that go into effect in 2023 rather than lot-level tracing. Once the DSCSA Pilot Project Program is established, volunteers interested in participating in the DSCSA Pilot Project Program will be able to submit a request to participate by email to the FDA. The notice contains application instructions and details the proposed content for the submission. Participants will also be expected to submit progress and final reports to the FDA.

The FDA is soliciting comments on the proposed collection of information associated with establishment of the DSCSA Pilot Project Program before submitting the proposed collection to the Office of Management and Budget (OMB) for approval. The FDA does not intend to begin the proposed DSCSA Pilot Project Program or accept requests to participate in the program until the OMB has approved the proposed collection of information. Comments on the pilot project program must be submitted by September 18, 2017.