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Focus on Regulation

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United States, pursuant to Congressional mandates in the Drug Supply Chain Security Act (DSCSA).  The notices announce a new pilot program to evaluate electronic tracking methods and a series of meetings for FDA to solicit stakeholder input on developing such a system.

Passed in November 2013, DSCSA introduces a variety of new requirements for manufacturers, wholesale distributors, repackagers, dispensers, and third-party logistics providers to track and trace certain prescription drugs as they move through the supply chain and to verify the identity and history of product as it is distributed.  One of its provisions requires that a system for the “interoperable, electronic tracing of product at the package level” go into effect by November 27, 2023.  See 21 USC 360eee-1(g)(1).  Once operational, the system must permit the exchange of transaction information and transaction history between manufacturers, wholesale distributors, third-party logistics providers, repackagers, and dispensers “in a secure, interoperable, electronic manner.”  Id.  As part of the process of developing this system, FDA is directed to conduct at least 5 public meetings to gather ideas on strengthening the safety and security of the supply chain and to oversee at least 1 pilot program “to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.”  21 USC 360eee-1(j)(1).  In these notices, FDA announces the commencement of both efforts.

For the pilot projects, FDA is recruiting participants from the pharmaceutical distribution supply chain and other stakeholders.  FDA asks participants to propose the design and execution of their own pilot project, but will share “learnings” among all members.  FDA encourages participants to focus their proposed projects on the interoperable, electronic tracing of product at the package level.  FDA has identified a long list of issues to examine in the areas of Product Identifier, Barcode Quality, Interoperability, Data/Database/System Issues, Aggregation/Disaggregation, Verification/Notification, Exception Handling/Errors/Inconsistencies, and Special Scenarios.  To apply, interested stakeholders should submit a request with contact information, names of all partnering entities that would participate, the types of partnering entities participating, the number of employees for each partnering entity that would participate, proposed start and finish dates, a commitment to begin the project within 4 months of acceptance by FDA, a list of products to be used in the project, a list of locations where the project will be performed, and a description of the pilot project, including its goals, objectives, processes to be studied, and evaluation methods.  Pilot projects should not exceed 6 months in duration.  Participants are expected to submit status reports during the project and a final report within 30 days of completion.

For the public meetings, FDA has announced a schedule of three public meetings to discuss topics related to the safety and security of the pharmaceutical supply chain.  The proposed meetings are as follows:

  • August 23, 2017: Discuss “What supply chain security should look like in 2023” and “What is needed for enhanced drug distribution security.” Advanced registration closes July 31, 2017. A comment period on these topics will remain open until September 22, 2017.
  • December 5-6, 2017: Discuss “What is needed for electronic interoperability,” “Standards for product tracing,” “Data architecture options for an electronic interoperable system,” and “The management and maintenance of product tracing data.” Advanced registration closes October 27, 2017. A comment period on these topics will remain open until January 5, 2018.
  • February 28, 2018: Discuss “The use of aggregation and interference for enhanced product tracing and verification” and “Building capacity for a unit-level system for product tracing and verification.” Advanced registration closes January 26, 2018. A comment period on these topics will remain open until March 30, 2018.

All meetings will be held on FDA’s White Oak campus and will be simultaneously webcast.

The pilot program and meetings provide an opportunity for interested stakeholders to provide feedback and raise concerns with the agency about the design and implementation of the electronic information exchange system. This gives stakeholders the chance to comment early on, while FDA is still developing an idea of how the system might look. On the other hand, participation in the pilot program, as announced by FDA, involves complying with many demands, and it is unclear at this time what, if any, benefit will be realized by participants.

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