The Drug Supply Chain Security Act (DSCSA) went into effect on November 27, 2023, despite what you may have heard about a one-year extension until November 2024. All stakeholders along the supply chain are required to exchange EPCIS data and implement electronic interoperable systems for compliance now. The FDA has delayed enforcement for one year after the implementation timeline, deferring penalties for noncompliance until November 2024. This period is not an extension but a strategic respite.
The ultimate objective is unchanged: the DSCSA calls for a fully integrated, end-to-end electronic data exchange network. This stabilization period is essentially a safety net. It provides an opportunity to examine how track and trace technology operates in real-time, rather than in a test environment, without the threat of a penalty.
Key DSCSA pillars and their key components are:
1. EPCIS: Exchange EPCIS (Electronic Product Code Information) with authorized trading partners
- TI/TS exchanged at the transfer of ownership
- Include each product identifier at package level
- Secure, interoperable, electronic manner
- Saleable returns must link to TI/TS
2. Verification: Leverage a VRS (verification router service) to:
- Verify the legitimacy of saleable returns
- Suspect or illegitimate product investigation
- Exceptions processing d. Product status checks APR_April2024.indd 62 4/12/24 10:54 AM
3. Credentialing
The DSCSA regulation states that only registered Authorized Trading Partners (ATP) can transact with other ATPs. Authorized trading partners are crucial to DSCSA in keeping bad actors out of the supply chain. Trading partners can be authorized manually or electronically. They’re registered in the specialty system as long as they are authorized. The DSCSA regulation states that only registered Authorized Trading Partners (ATP) can transact with other ATPs. This aspect guarantees that the manufacturer is selling and delivering products to an authorized wholesaler and that the wholesaler is selling and delivering to an authorized dispensing location.
It affects manufacturers, distributors, dispensers, repackagers, 3PLs, and their trading partners. Implementing credentialing through authorized trading partners will also be key to product tracing under the DSCSA.
4. Tracing
Implement a traceability platform to:
- Provide product tracing information with all transactions
- Respond to tracing requests in less than 24 hours
- Store tracing information for at least six years
Another critical issue is the transfer of data associated with the product prior to 2023. With the delay, it is, in essence, required to do the data transfers now. FDA can’t change the dates in the law, but they can change whether or not they enforce during this one-year enforcement delay. Today, trading partners should be providing the PCI messages from the manufacturer to the wholesaler and the wholesaler to the dispensers that contain the specific data associated with the shipment.
If the data doesn’t match the shipment, the product can’t move. It has to go through some form of exception handling to correct the data so the product matches it and can move through the supply chain.
The last issue has two separate components. Verification Router Service (VRS) involves verifying that sellable returns are authentic. Once compliance is enforced, the FDA can ask someone to trace a suspect product, and every person who touched that product needs to be able to respond with the appropriate information related to their handling of that product. Over time, the VRS and the traceability from a system perspective use the same mechanism to support it. Different vendors have different approaches, but there is one standard for doing both transactions.
The new pillar game is to be able to trace any product if there is a suspect event or product returns. Falsified products can often enter the supply chain with product returns. Today, e-commerce is predominant. Bad actors can easily infiltrate that process and sell expired, counterfeit, mislabeled, or over-labeled products.
Strategic Planning: Where Do You Stand?
The stabilization period impacts the entire supply chain, from manufacturers to wholesalers to dispensers. The FDA’s recent guidance for the industry confirms that while the DSCSA compliance deadline was November 2023, additional time may be needed to address technical and operational challenges. This stabilization period is a collective call to action for the industry to redouble its efforts. Here are the key strategic components to consider during this period:
- Budget Planning: Have you allocated sufficient funds and staff hours? It’s the first step in a successful compliance strategy.
- Technology Vendor Selection: Ensure you’ve chosen the right technology partners. Whether it’s serialization solutions or traceability software, technology streamlines compliance.
- Standard Operating Procedures (SOPs): Develop and implement SOPs specific to DSCSA compliance to help all employees understand roles and responsibilities.
- Partner Onboarding: DSCSA requires trading partner connections. Well-understood processes, plus proper integration and testing will make onboarding connections correct and repeatable.
- Ongoing Assessment: Regularly evaluate your DSCSA strategy to identify gaps and make necessary adjustments. Internal audits and third-party assessments provide a complete view.
The degree to which you automate tasks like generating and receiving Electronic Product Code Information Services (EPCIS) data significantly affects accuracy. A higher level of automation ensures smoother data exchange with your partners, which is essential for traceability and transparency. Are there areas for improvement in your current technology capabilities? Assess your readiness compared to peers. If you’re behind, it’s a sign to intensify your efforts. If you’re ahead, use the time to refine your processes.
Lessons Learned from FMD
The Falsified Medicines Directive (FMD), a key regulation in the European Union, shares similarities with the United States’ DSCSA, particularly in its focus on serialization and anti-counterfeit measures. Implemented in February 2019, the FMD mandates that pharmaceutical products distributed within the EU must carry a unique identifier and tamper-evident seal to ensure traceability and authenticity. Medicines are then validated and authenticated at dispense.
EU FMD compliance has offered a wealth of experience and valuable insights, especially in areas like establishing external data connections, functional testing, and data quality. As U.S. companies implement solutions for full DSCSA compliance, it is good to know several countries in the EU also went through stabilization periods for FMD compliance to enable more comprehensive end-to-end systems and integration testing.
Pharmacies and Data Coordination
As the final touchpoint in the pharmaceutical supply chain, pharmacies play a pivotal role in ensuring the successful implementation of end-to-end technology solutions. They are the gatekeepers between the drug supply chain and the consumer, making their compliance role especially critical. The DSCSA adjustment phase is a crucial window for pharmacies to refine operations. This phase includes enhancing data connectivity with upstream suppliers and optimizing product verification processes to ensure data records match the physical products of the medications they dispense.
The stabilization period provides a much-needed reprieve to tackle the issue of data and product misalignment. Given the sheer volume of prescriptions filled annually, even minor discrepancies can lead to significant disruptions. The extra time afforded by this phase enables pharmacies to rigorously test, refine, and ultimately improve systems.
Managing Exceptions
Exception management focuses on identifying and resolving issues arising during pharmaceutical product manufacturing and distribution. It is critical in the pharmaceutical sector due to patient safety and regulatory compliance concerns and to avoid supply chain delays and product quarantine.
As trading partners continue to implement and fine-tune their processes to adhere to the DSCSA requirements through the stabilization period, the volume of errors related to discrepancies between the data received and the product received in the shipment is expected to grow 5 to 10x. Considering the increasing challenges related to counterfeits, drug shortages and patient safety, efficient handling of exceptions becomes imperative. Some large wholesale distributors have stated that products without corresponding data will be quarantined until the data is provided. They anticipate exceptions as the data continues to flow over the next year and are prepared with refrigerated trucks if high product volumes are needed.
Aggregation
While the DSCSA does not explicitly require aggregation, the FDA recognizes it as an essential process in pharmaceutical supply chains and data management—and all major players in the industry are aligned on the need for it. Given the sheer volume of product that passes through the Big Three wholesalers daily, it becomes clear that it would be nearly impossible to adhere to compliance without aggregation data.
Collaboration and Industry Readiness
Stakeholders who work together will quickly identify gaps to assess readiness. Pharmacy organizations have emphasized the need for a phased approach to DSCSA implementation. Collaboration is crucial for identifying and addressing gaps, gauging the industry’s overall readiness, and ensuring uninterrupted patient care.
- Manufacturers are responsible for the serialization of products, transmitting both the goods and accompanying data to wholesalers.
- Wholesalers act as intermediaries, taking in serialized products and data from manufacturers and distributing them to dispensers.
- Dispensers are responsible for receiving and verifying serialized products and their related data, flagging discrepancies.
- All parties must guarantee that transactions occur exclusively with Authorized Trading Partners (ATP).
It’s an ideal time to invest in advanced traceability technologies. The FDA’s stabilization period is designed to resolve issues and ensure a reliable, safe drug supply chain. The industry aims not just to meet regulations but to create a secure and efficient drug distribution system that keeps patient safety front and center. The stakes in anti-counterfeiting and brand protection are too high to ignore.
Author Details
David DeJean - Vice President Of Global Strategic Accounts, Systech
David DeJean is vice president of global strategic accounts at Systech. Systech provides digital identification and traceability solutions that establish essential product data, ensure digital connectivity, and enable real-time insights on the packaging line and throughout the supply chain.
Publication Details
This article appeared in American Pharmaceutical Review:Vol. 27, No. 3April 2024Pages: 62-64
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