DSCSA Phase II Requirements
The traceability requirements in effect from 2015 to 2023 generally require products to be traceable at the lot level. A second phase of requirements will go into effect November 27, 2023 to allow the interoperable, electronic tracing of products at the package level. However, the statute provides much less detail with regard to the Phase II requirements for the tracing of products at the package level than was provided for the Phase I requirements. Phase II is comprised of three specific, but highly interrelated statutory components that go into effect on November 27, 2023:
- Interoperable Exchange. Trading partners must exchange required transaction information (TI) and transaction statements (TS) in a secure, electronic, interoperable manner, and the TI must include the product identifier at the package level.
- Interoperable Verification. Trading partners must be able to verify the product identifier on a package or sealed homogenous case in a secure, electronic, interoperable manner.
- Interoperable Tracing. Trading partners must maintain secure, electronic, interoperable systems and processes to provide TI and TS in response to a request for it and to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.
Some Phase I requirements continue to apply in Phase II. However, other Phase I requirements end on November 27, 2023, including the requirement that each transfer of a product be accompanied by the full transaction history (TH) of the product back to the manufacturer. This is consistent with the understanding that the DSCSA is a “one up and one back” model in which each trading partner has record of the entity form which it purchased a product and the entity to which it sold the product. However, FDA has made clear that, while it recognizes the exchange of TH ends in Phase II, it believes interoperable tracing systems and processes should be capable of providing information that is functionally equivalent to a unit-level TH.
FDA Guidance on Phase II Requirements
FDA is required to publish guidance and/or regulations clarifying the Phase II requirements. These guidance documents are expected to address, at a minimum, the system attributes necessary to enable secure tracing at the package level and standards of interoperable data exchange necessary to enhance the security of the pharmaceutical distribution supply chain. A series of assessments, public meetings, and pilot activities have been conducted over the interim period to develop the precise requirements for, and ensure the technological feasibility of, Phase II. In July 2017, the FDA published a notice on Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments. In this notice, FDA requested comments to help in the development of the electronic, interoperable system that will work to identify, and trace prescription drugs distributed within the United States.