3 ways your distributor can help you prepare for DSCSA compliance
It has been 10 years since congress passed the Drug Supply Chain Security Act (DSCSA). Two milestones toward full compliance required in the Act have already been achieved — namely, lot-level tracking in 2015 and product serialization in 2017. But November 27, 2023 looms large as the true, more-difficult-to-achieve deadline – i.e., the date when DSCSA will require the enhanced electronic tracing of products at the package level..
Without a doubt, implementing the DSCSA’s objectives of protecting the supply chain from counterfeit, unapproved, or potentially dangerous drugs has far-reaching implications across the pharmaceutical supply chain. For pharmaceutical dispensers, such as retail pharmacies, hospital pharmacies and physicians' offices that administer medications, the DSCSA-mandated changes can create uncertainty. That's why you should be able to rely on your pharmaceutical distributor to educate, inform, and help prepare you for the upcoming changes necessary for you to meet your DSCSA compliance requirements..
How can the right supply chain partner help you be ready for November 2023? Here are three important ways your distributor should be investing time, talent, and capital to ensure you are prepared for DSCSA compliance.
1. Leveraging leading-edge technology to ensure compliance when it counts
From barcode scanning and labeling systems that ensure they can read and confirm receipt of the required DSCSA transaction information (TI), distributors are investing in sophisticated methods of recording and sharing information about their transactions with other supply chain authorized trading partners. In fact, the inventory management systems provided by distributors such as AmerisourceBergen have been able to provide DSCSA transaction information some time now in anticipation of product-level serialization.
Distributors are also finding ways to access data more quickly and easily regarding the origin, movement, and possession of a product. Using data analytics and visualization tools, distributors can share the data with both regulators and downstream trading partners. And the benefits of cutting-edge use of data are helpful in ways beyond facilitating the fulfillment of DSCSA safety compliance requirements. Yes, supply chain data can help your distributor identify patterns and trends that may indicate a potential supply chain security risk, but they also create business efficiencies, improved inventory management, optimized distribution planning and better product receipt opportunities.
Ultimately, these technology investments impact DSCSA compliance for everyone the distributor works with — pharmacies, health systems, physician practices, and manufacturers alike.
2. Keeping you informed and educated
Your distributor should be helping you prepare for November 2023 by not only regularly communicating DSCSA updates and any changes that will be required on your part, but also by keeping you informed about what you should expect from them.
Distributors are an essential source of training and education on DSCSA requirements and best practices for compliance for their trading partners, given their cross-functional role in the supply chain.
In order to do what they do, distributors must know how regulatory requirements impact every part of the supply chain and set up the necessary processes for both manufacturers and customers. Distributors can assist manufacturers with their compliance by providing guidance and support on the DSCSA requirements and by helping manufacturers validate compliance through audits or inspections.
3. Collaborating across the industry to ensure interoperability
Distributors can collaborate with trading partners in advance of compliance deadlines to identify potential risks and vulnerabilities in the supply chain and develop mitigation strategies. You should also expect your distributor to advocate for supply chain efficiency and safety by working with members of various trade associations, professional organizations, and government entities on DSCSA-related initiatives.
"It takes time to move an entire industry toward one technical solution or a connected set of technical solutions that don't exist yet," said AmerisourceBergen's Matt Sample of the industry's interoperability efforts in 2019. He added, "we are trying to get some 500 manufacturers, 200 wholesalers, 200,000 dispensers and 10 to 20 solutions providers aligned on the use of the right standards.”
No surprises in November
Distributors play a crucial role in protecting you from surprises related to the November 2023 DSCSA deadline. Your distributor should be proactive in communicating any changes or updates related to the deadline and ensuring they have the necessary systems and processes in place to comply with the regulations. This communication and process might include implementing new technology or making changes to how they work with you to ensure your compliance.
Additionally, distributors should work with their partners to identify any potential challenges or risks and develop strategies to mitigate them. It is important for distributors to take a proactive approach to compliance in order to help protect their trading partners from any potential disruptions or penalties. It’s also our role as a distributor to work with the FDA to make sure they understand regulatory risk and secondary implications to product access that may stem from varying stages of trading partner readiness.
"Distributors have been preparing for 2023 by fine tuning returns systems to ensure a smooth transition to DSCSA requirements. They're also evaluating how they store DSCSA data with serialized information," says Sample. "AmerisourceBergen is establishing systems to verify product identifiers on all its DSCSA products. This verification system will allow us to efficiently notify any customers in cases of recalls or when drugs are deemed dangerous by the FDA or pharmaceutical companies."
AmerisourceBergen has worked diligently to explore and deploy technology and processes that ensure the authenticity and traceability of pharmaceutical products throughout the supply chain. From barcode scanning and electronic data exchange to exploring blockchain and advocating for governance over interoperability solutions through our participation in industry workgroups,
AmerisourceBergen has been recognized as a leader in DSCSA readiness and continues to be at the forefront of efforts to improve the safety and security of the pharmaceutical supply chain.