The long-awaited final transition of the Drug Supply Chain Security Act (DSCSA) will take effect on November 27, 2023. The multi-phased DSCSA was created in 2013 to provide the FDA with more regulatory teeth in the drug supply chain, adding layers of protection to enhance supply chain security over the span of 10 years. The Act outlines the steps to building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S.
In 2015, the first implementation phase dealt with lot-level traceability through the exchange of transaction information (T3 information). The DSCSA’s midterm phase mandated drug re-packagers and manufacturers to serialize individual packages with unique product identifiers.
2023: Drug Supply Chain Security Act
In November 2023, the final requirements will build upon previous phases to allow the interoperable, electronic tracing of products at the package level. All trading partners involved in the drug supply chain must utilize product identifiers and have a system capable of tracking these identifiers throughout the entire chain, reaching what’s referred to in the DSCSA as “Enhanced Drug Distribution Security.”
To the frustration of pharmaceutical supply chain industry stakeholders, there has been a dearth of clear guidance regarding the highly technical final implementation. The FDA held a public meeting in November 2021 on enhanced drug distribution security at the package level, during which industry participants expressed concerns about 2023 compliance.
The FDA is required to publish regulatory guidance to clarify the DSCSA’s 2023 requirements and will continue to develop the electronic interoperable system. At a November 2021 traceability seminar, FDA’s acting associate director for policy and compliance, Connie Jung, indicated that additional FDA guidance is forthcoming, including standardization of interoperable data exchange and trading partner guidance.
During the summer, industry consortium Partnership for DSCSA Governance (PDG) released the first chapter of a blueprint to help the pharmaceutical industry set up electronic systems as required by the DSCSA’s 2023 compliance deadline. This chapter “defines baseline business requirements that frame the general systems and processes for implementation of the main components of the DSCSA: secure, electronic, interoperable systems and processes for the exchange of serialized transaction information (TI) and transaction statements (TS), secure, electronic, interoperable systems and processes for product-identifier verification, and secure, electronic, interoperable systems and processes for tracing.”
Preparing for the Drug Supply Chain Security Act
While awaiting final guidance on 2023 compliance pending from the FDA, stakeholders should be reviewing their policies, procedures, processes, and systems against the existing guidance already released and keep in mind there are DSCSA compliance services vendors that can alleviate some of the manual effort involved by providing data collection and product traceability services. Many organizations in the drug supply chain should also be reviewing existing contracts to ensure the appropriate DSCSA compliance provisions are in place.