The FDA recently announced a one-year delay in enforcing the electronic tracking requirement under the Drug Supply Chain Security Act (DSCSA). While many companies continue to race to the DSCSA November 2023 deadline, the enforcement of an interoperable package-level electronic data exchange has now shifted from November 27, 2023, to November 27, 2024. The updated guidance document for the DSCSA 2023 deadline extension can be found here.
Section 582(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C) was introduced as the Drug Supply Chain Security Act in 2013 to provide guidance on how to track and trace transaction histories as prescription drugs move from the manufacturing sites to the pharmacies. The intent of the guidance is to outline requirements necessary to ensure that counterfeit, stolen, or adulterated drugs cannot enter the U.S. drug supply chain. The requirements fundamentally change how all supply chain stakeholders do business. Once implemented, the guidance requires manufacturers, re-packagers, distributors, shippers, and dispensers to be able to:
- Identify a product using unique product identifiers (barcodes) that are applied to drug packages and can be read electronically.
- Trace a product’s transfer of ownership through the secure electronic exchange of transaction information which includes information such as product name, strength, lot number, number of containers, transaction date, etc.
- Authorized trading partners (ATPs) must be able to be identified electronically.
- Set verification requirements for saleable returned products using a Verification Router Service (VRS).
Since this was expected to be such an immense undertaking for all parties involved with the supply chain, the FDA allowed for a 10-year implementation period. That implementation period was set to complete on November 27, 2023, until the agency provided a guidance update in August 2023. This is likely a relief to pharmaceutical trading partners that have serialization programs that are still underway.
Why is there a DSCSA 2023 Deadline Extension?
According to the guidance, the agency had received feedback from stakeholders about “concerns regarding trading partner readiness and the need for the clarity and flexibility to ensure trading partners can continue to move product through the supply chain” when the requirements take effect. The FDA took this feedback very seriously since any break in the chain could cause delays in patients having access to their medications. As a result, the FDA expects activity to show implementation progress but extended the enforcement deadline until next year.
According to the updated guidance, the DSCA 2023 deadline extension is intended to provide clarity and flexibility to trading partners and avoid impact on the supply of medication. The extension may also be used to provide additional time to “implement, troubleshoot, and mature” the trading partners’ systems. The FDA made it very clear that the extension is not intended to justify delaying any efforts in the implementation of the enhanced drug distribution security requirements.
Preparing for the Extended Deadline
So, whether you’re on track to meet the original deadline or if you’re still working on your implementation, there’s still work that can be done and no time for delay. The year will be over before you know it.
If you have any questions on the DSCA 2023 deadline extension or DSCSA serialization requirements, Clarkston Consulting has experience with both the regulations and how to implement them. Connect with one of our serialization experts today.
Subscribe to Clarkston's Insights
Contributions from Eric Borries and Lance Parker