3 Key Questions to Answer Before the DSCSA Stabilization Period Ends

The Drug Supply Chain Security Act (DSCSA) was signed into law in 2013 to protect consumers from contaminated, stolen, and counterfeit drugs. The U.S. Food and Drug Administration (FDA) allowed a stabilization grace period for companies to meet its requirements. Unless they have applied for an exemption, life sciences and healthcare supply chain organizations must comply with the serialized traceability requirements by Nov. 27, 2024 (more on that below).

Here are three questions to ask yourself before the stabilization period ends:

1) How ready is the industry for EPCIS data exchange?

Electronic Product Code Information Services (EPCIS) is a standard for capturing and sharing detailed information about the movement and status of products across the supply chain. In the context of DSCSA, EPCIS is used to exchange transactional data, including what’s being transferred, the complete record of transactions, and a statement confirming compliance with DSCSA standards.

A recent Partnership for DSCSA Governance survey shows confidence in stabilizing these systems across the three major segments of their supply chains. On a scale of 0-5, manufacturers rated themselves 4.15, wholesale distributors 3.42, and dispensers 3.29.

Despite claims of readiness, the survey revealed few organizations were sending and receiving serialized data for most products. Only one in 10 wholesale distributors said they received a complete set of serialized data for more than 80% of purchased products. Dispensers fared better, with three in 10 receiving complete serialized data for 80% of purchased products.

Why is the industry so confident if many aren’t receiving serialized product data?

It’s all in the definition. Here, readiness means linking with a partner and sending a test file. However, it should mean exchanging EPCIS transitions at scale across all use cases. As transaction volume grows, wholesalers and dispensers will find new issues, increasing resolution time.

2) Will Waivers, Exceptions, and Exemptions help?

The FDA has defined a Waiver, Exception, and Exemption application process for companies seeking relief from DSCSA requirements. Although the FDA advised organizations to submit requests by Aug. 1, waiver requests are open for submission anytime. Failure to comply with DSCSA regulations by the deadline without a waiver, exception, or exemption can lead to legal action.

Delaying the DSCSA go-live date for a waiver doesn’t guarantee approval; the FDA requires detailed justification, supporting documentation, and product circumstances. On Oct. 9, the FDA offered an exemption to supply chain members facing data exchange challenges.

3) What is the optimal way to manage DSCSA exceptions?

DSCSA compliance exceptions could delay product delivery and receiving. Organizations must resolve every exception before the trading partner can send the product downstream or sell it to patients, impacting company profits and medication availability.

Once the life sciences and healthcare supply chain begins exchanging serialized product data (and assessing the quality and accuracy of this data) in earnest, the number of compliance exceptions will surge. Just look at the three months following the launch of the European Union’s Falsified Medicine Directive, which experienced high discrepancies with a nearly 7% alert rate.

Handling compliance exceptions is time-consuming and lacks a defined system under DSCSA, exacerbating the anticipated higher exception rate. As the industry transitions to sharing serialized product data, technical challenges will arise, adding complexity to processes like exception investigations, root cause analysis, and partner coordination.

While some DSCSA solutions address compliance exceptions, they are limited, focusing primarily on formatting errors in EPCIS files and relying mainly on email alerts.

With the Nov. 27 deadline nearing, pharmaceutical supply chain organizations are striving to meet DSCSA’s electronic data exchange standards. Despite progress, challenges implementing serialized data exchange persist across all transactions, meaning continuous efforts are necessary even after the compliance deadline.