Definitions & 2015 Obligations
The DSCSA establishes a new system for traceability of prescription drug products through phased-in requirements for manufacturers, repackagers, wholesale distributors, and dispensers. The DSCSA will enhance supply chain security through a series of new obligations phased in over the ten-year period from 2013 to 2023. Four key requirements took effect in 2015 as part of that phased approach:
- All supply chain participants must work only with authorized (i.e., duly registered or licensed) trading partners.
- Companies must pass, capture, and maintain certain information with respect to each product transaction.
- Companies must implement processes and procedures to respond to requests for information from federal and state officials.
- Companies must have systems and processes to investigate, verify, and respond to suspect and illegitimate products.
The DSCSA immediately preempts all state laws, regulations, and requirements for tracing products through the supply chain, including any recordkeeping and pedigree requirements. All such laws are preempted, regardless of whether they are more burdensome, less burdensome, or inconsistent with the federal traceability requirements. The preemption provision applies to state requirements for tracing “products.” Therefore, the preemption provision does not extend to items that are not products under the DSCSA, such as animal drugs, medical devices, over-the-counter drugs, active pharmaceutical ingredients, and clinical trial drugs, and states retain the authority to impose tracing or pedigree requirements on such items.
The DSCSA seeks to further enhance the security of the supply chain through the serialization of drug products. Serialization is accomplished by affixing to packages and cases a “product identifier,” which is a standardized graphic (i.e., a two-dimensional dot matrix) that carries, among other data, the product’s standardized numerical identifier (SNI),33 lot number, and expiration date in both human- and machine-readable format.
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 the 2023 requirements 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 the 2023 requirements, 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.
In addition to establishing a national, interoperable traceability system, the DSCSA also seeks to secure the drug supply chain by establishing uniform standards for licensure of wholesale distributors and third-party logistics providers. The Act sets out general topics to be addressed in federal standards, such as facility inspections, document maintenance, bond requirements, and classes of individuals prohibited from managing facilities, but the FDA is left to establish specific standards through regulation. States that choose to license wholesale distributors and third-party logistics providers must utilize these federal standards. If a state does not operate such a licensing program, a federal license will be available to wholesale distributors and third-party logistics providers in those states.