Last week concluded the 2020 Traceability Seminar, put on by the Healthcare Distribution Alliance (HDA). As a content-rich, information-heavy event, the transition this year to a virtual conference was easy and allowed attendees to participate in every seminar from the comfort of their own home or office. An annual event, the Traceability Seminar "looks to bring together healthcare supply chain leaders to learn more about upcoming DSCSA implementation milestones, innovative approaches and lessons learned. This helps to aid distributors, manufacturers and dispensers in implementing serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain." - HDA, Traceability Seminar
As an HDA member, and sponsor, Blue Link ERP participated in each of the 2020 sessions and has summarized some of the key points below.
Verification of Saleable Returns
Enforcement of verification for Saleable returns of products has been pushed until Nov. 27, 2023 – and there is little chance that the FDA will delay enforcement longer than this date
FDA Form 3911 – Identification of Suspect Product Notification
- If a distributor receives product either from a purchase order or from a return, that they believe is suspicious, they are responsible for submitting Form 3911 to the FDA
- If the distributor has implemented VRS, and are unsure about whether a product is suspicious or not, they can scan the item to get a response from the manufacturer – if the response does not indicate a legitimate product, they must submit Form 3911
- If not using VRS for verification, a distributor can use their discretion about the suspect level of the product as long as they work through their SOP to determine suspect or not
- Manufacturers receiving a manual request for suspicious product must respond within 24 hours to the distributor
- The FDA has seen an increase in submission of Form 3911 as a result of more and more companies implementing VRS technology and identifying potentially illegitimate product
Partnership for DSCSA Governance
A new organization called "Partnership for DSCSA Governance” (PDG) was established in December of 2019
- This is a not-for-profit organization
- The PDG is a "collaborative forum and FDA public-private partnership dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the U.S." - PDG
- Note: since the release of this blog post, Blue Link has joined the DSCSA Governance "PDG". It is important to ensure compliance discussed in the industry are taken into consideration within Blue Link Pharmaceutical ERP Software)
EPCIS
- As of today, primary distributors are receiving EPCIS files from about 25% of their manufacturers in the supply chain
- Many primary distributors are facing issues receiving EPICS files due to syntax errors and issues with the data itself
- The industry is currently using EPCIS 1.2 as the standard, with version 2.0 (JSON format) expected in early Q1 of 2021
- The industry expectation is to be able to have electronic data checks between EPCIS and scanned products, but that not all products will need to be scanned
- The industry as a whole is working towards the aggregation of data for EPCIS – which is the ability to provide information at the each, box, case, and pallet level etc. so a supplier does not have to break a case to scan all products in that case
- While the industry recognizes that EPICS data received by the Primary Distributor from the Manufacturer is legitimate, Secondary Distributors will still need VRS to verify product
- There was discussion around the possibility of a “Global Data Synchronisation Network” (GDSN) as a standard – this is a Product Data network being used by other countries for managing data for interoperability
About Blue Link
Blue Link ERP provides complete end-to-end inventory management and accounting ERP software for the pharmaceutical industry. Blue Link works best for pharmaceutical wholesalers and distributors and includes a variety of features to aid in DSCSA and FDA compliance.
