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 the last of several deadlines approaches, actors in the pharmaceutical supply chain are working hard to fulfill its mandates – and some are struggling to keep up. Here’s a look at what DSCSA compliance means, how the pharmaceutical industry is meeting traceability requirements, and how to be ready for the final step on the DSCSA implementation timeline as we look forward to 2023.
What is DSCSA?
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. This will act as an additional level of security for the FDA in hopes to diminish exposure to counterfeit, stolen, and potentially dangerous drugs for consumers in the US.
One example of a DSCSA provision that’s already in effect is a mandate for how long a dispenser must maintain their DSCSA records. Dispensers are now required to keep records (such as transaction information, lot level information, transaction history, and transaction statement) for at least six years.
How far along is implementation in the pharmaceutical industry?
Starting in January 2015, manufacturers were required to print lot numbers on packaging for all prescription drugs. Next up was including unique serial numbers and expiration dates – in human and machine-readable formats. Later deadlines affected pharma wholesalers, then distributors, culminating in full traceability throughout the entire pharmaceutical supply chain by the end of next year. At least, that is the end goal.
The HDA (Healthcare Distribution Alliance) Foundation recently published its Serialization Readiness Survey and found the industry is making progress, but not as quickly as could be hoped:
- 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.
- Healthcare distributors cited “collaboration with trading partners” (90%), “technical challenges” (72%), and “establishing standards” (48%) as top concerns leading up to the final milestone.
The report highlights that many pharmacies, manufacturers, and other partners feel they are well along their way to stronger drug traceability, but there is still work to be done ahead of 2023.
The last phase of the DSCSA implementation timeline
The final phase for DSCSA compliance will take effect on November 27, 2023. 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:
- “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.
- 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.
- 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 compliance is simpler with a trusted partner
The Axway Track & Trace solution has helped pharmaceutical companies solve traceability challenges for over a decade. For those companies, Axway has provided a solution that helps supply chains meet regulatory traceability mandates. This work includes helping regulatory bodies, administrative agencies, and others 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 November 2023. Axway Track & Trace, along with our reliable and helpful 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.
Learn more about how Axway Track & Trace enables DSCSA compliance.