FDA Announces Delayed Enforcement of DSCSA to 2024

The FDA recently announced a 1-year delay on the new electronic prescription tracking system outlined under the Drug Supply Chain Security Act (DSCSA), according to a recent press release. The DSCSA requires a series of actions that allow the FDA to use serialized electronically tracing mechanisms to track prescription drugs distributed across the country. This “track and trace” system aims to improve the removal of dangerous drugs from the US drug supply chain.^1,2 The original start date of package level electronic tracing shifted from November 27, 2023, to November 27, 2024.¹

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“Additional time beyond November 27, 2023 may be needed for systems to stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange,” according to the FDA announcement.¹

The National Association of Chain Drug Stores (NACDS) advocated for the 1-year delay, stating in a press release that the additional year will allow themselves—and other stakeholders— to overcome operational and technical issues that may be associated with DSCSA implementation, thus reducing the risk of delayed medication distribution as a result.²

Under the DSCSA, wholesale distributors, repackagers, dispensers, and other third-party logistics providers would be required to implement interoperable and electronic tracing of prescription products at the package level. Tracing the packages could make it easier to identify and remove risky prescription products (be it counterfeit, stolen, contaminated, or damaged) for the safety of the consumer and market. ^2,3

In addition, DSCSA requires that wholesale distributers and third-party logistics providers send annual licensed reports to the FDA. It also asks that supply chain partners accept saleable return as part of DSCSA requirements, and the FDA will delay enforcement of these saleable returns until 2024.^2,3

In a December 2022 virtual public meeting, stakeholders admitted to being “at different stages of readiness” for the November 2023 DSCSA enforcement date. For example, concerns emerged regarding what distributers should do with non-serialized products that are already in the supply chain. Additionally, another point of concern was the distributer’s ability to predict how much tracing information the federal and state authorities would ask for, and how many resources would be needed for their response.²

“There are many complexities associated with implementing DSCSA,” said B. Douglas Hoey, MBA, pharmacist, and CEO of the National Community Pharmacists Association (NCPA), in a recent statement.⁴

“This additional time will be beneficial to ensuring that all sectors of the pharmaceutical supply chain are sufficiently prepared and helping prevent any unintended consequences impacting patient care,” Hoey said in the press release.⁴

References

1. Eglovitch JS. FDA gives firms one-year reprieve from DSCSA track and trace requirements. Regulatory Focus. News Release. August 25, 2023. Accessed August 28, 2023. https://www.raps.org/News-and-Articles/News-Articles/2023/8/FDA-gives-firms-one-year-reprieve-from-DSCSA-track
2. NACDS Praises FDA Move to Delay Enforcement of Certain DSCSA “Track and Trace” Requirements Until November 27, 2024. NACDS. News Release. August 25, 2023. Accessed on August 28, 2023. https://www.nacds.org/news/nacds-praises-fda-move-to-delay-enforcement-of-certain-dscsa-track-and-trace-requirements-until-november-27-2023
3. Drug Supply Chain Security Act (DSCSA). FDA. August 21, 2023. Accessed August 28, 2023. https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
4. DSCSA Delay a Win for Pharmacy Supply Chain and Patients, NCPA Says. NCPA. News Release. August 25, 2023. Accessed on August 28, 2023. https://ncpa.org/newsroom/news-releases/2023/08/25/dscsa-delay-win-pharmacy-supply-chain-and-patients-ncpa-says