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. A second hallmark of Phase II is the transition away from the requirement under Phase I that each transfer of a product include the full transaction histories of the product back to the manufacturer. Instead, under Phase II, a “one up and one back” model will be in effect. Under this approach each supply chain participant must essentially capture the transaction information associated with its own receipt and distribution of a product, which comprehensively, will allow the product to be traced back to the manufacturer.
A series of assessments, public meetings, and pilot activities will be conducted over the interim period to develop the precise requirements for, and ensure the technological feasibility of, Phase II. PDSA is actively engaged in identifying a pathway for migrating to a Phase II solution and expects to publish portions of that work soon.