DSCSA compliance and 2024/2025 implementation timeline

The US Congress enacted the Drug Supply Chain Security Act (DSCSA) in late November 2013, with the aim of providing additional oversight of the drug chain of custody throughout distribution. As we approach the final implementation deadline, companies in the pharmaceutical supply chain are working hard to fulfill its mandates – and some are struggling to keep up. The FDA has taken notice, issuing an exemption on October 9th to stagger enforcement of the DSCSA drug requirements to 2025.

Here’s a look at what DSCSA compliance means, how close the pharmaceutical industry is to meeting traceability and serialization requirements, and how you can be ready for the final step of the DSCSA implementation timeline as the deadline closes in.

What is DSCSA serialization?

DSCSA stands for Drug Supply Chain Security Act and outlines, in part, specific steps and protocols for tracing prescription drugs as they are distributed throughout the United States.

The FDA intends this act to provide an additional level of security for consumers by diminishing their exposure to counterfeit, stolen, and potentially dangerous drugs.

Several DSCSA provisions have already become law over the past decade, putting compliance pressure on supply chain companies.

These include a mandate for how long a dispenser must maintain their DSCSA records (transaction information, lot level information, transaction history, and transaction statement must be kept for at least six years) and a requirement to print lot numbers on packaging for all prescription drugs since 2015.

Manufacturers must also now include unique serial numbers and expiration dates – in human and machine-readable formats.

These requirements first impacted wholesalers, then distributors, and are intended to culminate in full traceability throughout the entire pharmaceutical supply chain by the end of 2024.

What is the deadline for DSCSA implementation and compliance?

There has been significant concern that the pharmaceutical industry wouldn’t be ready in time.

So much so, that in June 2023, the Healthcare Distribution Alliance (HDA) sent a letter to the FDA recommending a phased approach to final DSCSA implementation, citing potential for supply disruptions and interruptions to patient care.

In August 2024, the FDA announced a stabilization period to accommodate an additional year (until November 27, 2024) to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems. Then, on October 9th, the FDA issued an exemption to stagger enforcement of the DSCSA drug requirements to 2025.

This exemption provides extra time for eligible trading partners to finish addressing any implementation challenges. The duration of the exemption varies depending on the type of trading partner:

• Manufacturers and Repackagers now have until May 27, 2025
• Wholesale Distributors now have until August 27, 2025
• Dispensers with 26 or more full-time employees now have until November 27, 2025.

It’s also important to note that exemption applies to eligible trading partners who have made a documented effort to start implementing the DSCSA requirements but still face challenges in exchanging data. They need to have successfully completed or at least initiated data connections with their immediate trading partners.

Read the full notice here for more details: Waivers and Exemptions Beyond the Stabilization Period | FDA

How far along is implementation in the pharmaceutical industry?

I had the pleasure of attending the HDA’s Distribution Management Conference (DMC) in Indianapolis, Indiana with more than 500 people from across the pharmaceutical supply chain. We discussed DSCSA implementation and related issues such as product traceability, pharmaceutical trends, contracts and chargebacks, controlled substance regulations, and legislative updates.

Here are a few of my biggest takeaways from the conference and Track & Trace user groups I’ve conducted:

As many have feared, the industry is still lagging. Onboarding and testing are the biggest time sink, and many have yet to make significant progress. Despite companies and solution providers working tirelessly to onboard trading partners there are still many who are not yet engaged.

Supply chain interruption is a very real risk. If the required data is not available, product may be left unloaded from the trucks or worse, sent back. Cold chain product is especially vulnerable here.

There will be challenges with transitional inventory. Companies discussed what should happen to product that was properly processed before November 27^th (and therefore wasn’t held to the same traceability standard) but requires data after the DSCSA serialization deadline to be continued on.

Data quality is now just as important as product quality. Attendees worry the DSCSA’s data requirements pose a real risk of stopping product from making it through the supply chain. Therefore, it’s more important than ever that data quality be top notch.

HDA survey shows wide-ranging concerns

Many of these same issues emerged in the HDA Foundation’s Serialization Readiness Survey. Findings showed that the industry is making progress, but not as fast as could be hoped for. Some key takeaways:

• Much work remains before the DSCSA implementation deadline. Many pharmacies, manufacturers, and other partners feel they are well along their way to stronger drug traceability, but they still have significant work to do ahead of November 2024.
• Many companies need to catch up. Only three-quarters of surveyed pharmaceutical manufacturers said they anticipate sending 100% of the required serialized data with shipped products by the next DSCSA compliance deadline.
• Concerns are varied and widespread. Healthcare distributors cited “collaboration with trading partners” (90%), “technical challenges” (72%), and “establishing standards” (48%) as top concerns leading up to the final milestone.

One of the most common questions raised at the HDA conference this year was what companies can do today to ensure compliance ahead of the deadline. Those that were further along in their DSCSA serialization implementation suggested the following:

• Engage with a strong solution provider to accelerate DSCSA implementation and leverage their knowledge and expertise,
• Get educated on best practices and vendors with proven solutions and DSCSA expertise,
• Look at your implementation deadline as the beginning of a new era of compliance and traceability, not as the end of DSCSA.

It’s clear going forward that many companies could face real supply chain challenges if they are unprepared. Exceptions and data issues will need to be resolved quickly and correctly, and there will be scenarios that we have yet to predict which will require a strong understanding of the DSCSA regulation and how it impacts the supply chain.

In a recent webinar, we discussed how to improve the resilience of your overall digital healthcare supply chain. Here’s a quick look at why it’s so important to combine traditional processes with more modern integration workflows.

The last phase of the DSCSA implementation timeline

As the deadline approaches, the requirements contained in the act will necessitate a new, more capable Track and Trace solution. According to the Pharmaceutical Distribution Security Alliance (PDSA), below are the requirements:

1. “Interoperable Exchange. Trading partners must exchange required transaction information (TI) and transaction statements (TS) in a secure, electronic, interoperable manner, and the TI must include the product identifier at the package level.
2. Interoperable Verification. Trading partners must be able to verify the product identifier on a package or sealed homogenous case in a secure, electronic, interoperable manner.
3. Interoperable Tracing. Trading partners must maintain secure, electronic, interoperable systems and processes to provide TI and TS in response to a request for it and to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.”

DSCSA serialization with a partner for the road ahead

The Axway Track & Trace solution delivers the tools pharma companies need to meet supply chain challenges and achieve DSCSA compliance. For more than a decade, Axway has helped pharma companies solve traceability challenges while contributing technology and expertise to regulatory bodies, administrative agencies, and others to meet their needs.

Prior phases of the DSCSA timeline have shown to be complex and time-consuming during onboarding. As Perry Fri, Executive Vice President of Industry Relations, Membership & Education, HDA; and COO of the HDA Research Foundation points out in the survey press release cited above,

“Healthcare distributors have indicated that onboarding manufacturers well before the deadline is the best way to avoid possible disruptions in product flow — so aligning on plans in short order will be crucial.”

A proactive approach is necessary to implement, test, and troubleshoot your solution so you can ensure compliance to the new standards by 2025. Axway Track & Trace, along with our expert and reliable support, can provide you with a comprehensive, end-to-end traceability solution.

Don’t let traceability implementation hang-ups slow down service delivery and potentially affect pharmacy patients. To discuss your options and learn more about Axway, please click here to get in touch.