By Linda Rouse O’Neill
Your customers and traceability
Phase I of the Drug Quality and Security Act (DQSA) begins Jan. 1, 2015, and requires pharmaceutical manufacturers, wholesalers, and repackagers to comply with national prescription drug traceability requirements; dispensers must comply by July 1, 2015. The law establishes for the first time ever a system aimed at enhancing patient safety and supply chain integrity through applicable traceability requirements.
As a result, compliance knowledge has become just as important as product knowledge in supply chain transactions. Fortunately, HIDA has anticipated this growing trend for several years and has the resources and information you need to help your customers benefit from DQSA changes. So what does track and trace implementation mean for you and your customers?
The Drug Quality and Security Act: A Snapshot
- Provides a national uniform solution that preempts the patchwork of state pedigree laws.
- Requires pharmaceutical manufacturers to provide transaction information, transaction history, and transaction statements to downstream trading partners (see HIDA’s web site for more information).
- Establishes national licensure standards for pharmaceutical wholesalers that ensure uniformity in all 50 states. The bill outlines key requirements, such as background checks, physical inspections, bonding requirements, and fingerprinting.
The Food and Drug Administration (FDA) recently released draft guidance regarding the proper exchange of transaction information, transaction history, and transaction statements (TI/TH/TS) for tracing prescription drugs through the supply chain. The FDA reinforced many of the recommendations supported by HIDA and the industry, which includes allowing the use of:
- Paper or electronic invoices
- Paper packing slips
- Electronic Data Interchange (EDI) standards, such as Advance Ship Notice (ASN), which is currently used to provide receiving entities with advance data on shipments
- EPCIS (Electronic Product Code Information Services), which defines a data-sharing interface that enables supply chain partners to capture and communicate data about the movement and status of objects in the supply chain
- Email or web-based platforms (such as web portals) to transmit or access tracing information, as long as the information is captured, maintained, and provided in compliance with the law.
If you haven’t already, it is important to talk with your trading partners and ensure they have:
- Accessible information: Ask and verify via testing that your customers can access TI/TH/TS
- Compliance expertise: Make sure your manufacturer and distributer partners are compliant with the DQSA. Front line supply chain employees should be just as knowledgeable and aware of key tracing requirements and dates.
- Open communication: Ensure your sales team is well-equipped to handle any DQSA inquiries or related questions, while having open communication channels to direct unanswered questions to appropriate people within your organization.
If you or your customers have more questions regarding the DQSA or would like additional information, please contact us at HIDAGovAffairs@HIDA.org.