HDA DSCSA 2019 Compliance Scenarios
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1 HDA DSCSA 2019 Compliance Scenarios
2 DSCSA Overview and Milestone Timeline The Drug Supply Chain Security Act (DSCSA) takes effect over a 10 year period (from 2013 to 2023) and is punctuated by requirement milestones. The HDA pilot examined the 2019 milestone. The law requires that Beginning [11/27/2019], upon receipt of a returned product that the wholesale distributor intends to further distribute, before further distributing such product, the wholesale distributor shall verify the product identifier, including the standardized numerical identifier for each sealed homogeneous case or on each package 582(c)(4)(D), 360eee- 1(c)(4)(D). An abbreviated version of the milestone timeline of this regulation between 2017 and 2023 is shown below Milestone: s must verify the unique product identifiers of saleable returns. s may only engage in transactions involving product encoded with product identifier Milestone: Manufacturers must affix a unique product identifier to each smallest saleable unit and homogeneous case. Manufacturers must provide all transaction information to trading partners in electronic format. Manufacturers must respond to verification requests from trading partners Milestone: All partners must participate in a full electronic traceability system, passing full product identifier data. The following pages detail the nine scenarios that were considered for compliance with the 2019 verification of saleable returns requirements.
3 Manufacturer sends purchased unit product identifiers to respective (Scenario 1) Manufacturer sends purchased unit product identifier information Manufacturers send aggregated product identifier information to each for ONLY the units purchased by that. The stores these data in an internal. This is the only scenario which requires aggregation verifies product identifiers against internal Upon receiving a saleable return, the is able to reference an internal comprised of the product data it received from the Manufacturer in order to verify the product identifier information. Live Pilot, Internal Solution HDA DSCSA Compliance Scenarios 2
4 Manufacturer sends product identifiers for all units produced to trading partners (Scenario 2) Manufacturer sends product identifier information for all units Manufacturers send product identifier information for ALL units shipped within the United States to every direct purchase. The stores these data in an internal. verifies product identifiers against internal Upon receiving a saleable return, the is able to reference an internal comprised of the product data it received from the Manufacturer to verify the product identifier information. White Paper Pilot HDA DSCSA Compliance Scenarios 3
5 Manufacturers send all data to central that the s access for verification (Scenario 3) Build a centralized A centralized houses all product identifier information. Point-to-point connections will be established from each Manufacturer and to the centralized. Product information sent to central Manufacturers will send product information for all units shipped within the United States to the centralized via point-to-point connections. Verify product identifiers Upon receiving a saleable return, s will verify the product identifier information against the central. The collection and parsing of data by the can be executed manually or automatically via scanners with connectivity to the. Live Pilot, External Solution HDA DSCSA Compliance Scenarios 4
6 builds point-to-point interface to Manufacturer (Scenario 4) Manufacturers build internal s Each Manufacturer stores its product identifier information in its own internal. s establish pointto-point connections with Manufacturers Each builds and maintains a point-to-point connection with each Manufacturer s verification service. Verify product identifiers Upon the return of saleable products, s will use the point-to-point connections with Manufacturers to automatically verify product identifier information. White Paper Pilot HDA DSCSA Compliance Scenarios 5
7 accesses Manufacturer portal (Scenario 5) Manufacturer builds internal Each Manufacturer develops its own internal to store all product identifier information. Manufacturer builds portal access for s Each Manufacturer builds a portal and controls access. The Manufacturer s portal would be designed independently by each entity and the different portals may have a completely different look, interface, and operation, adding complexity for s. s verify product identifiers through portal s query the Manufacturer s portal to verify the product identifier information for saleable returns. This scenario requires a manual query of a specific Manufacturer s portal, rather than automatically routing the query to the appropriate Manufacturer based upon a scan of the product identifier affixed to the product. Desktop Pilot HDA DSCSA Compliance Scenarios 6
8 scans product on inbound and builds internal for verification (Scenario 6) scans product on inbound receipt scans every product identifier at the smallest saleable unit on inbound receipt. stores product identifier information stores scanned product identifier information in an internal. The internal must be developed by each prior to program rollout. verifies returns against its internal When products are returned, the scans and verifies the product identifiers against its internal. White Paper Pilot HDA DSCSA Compliance Scenarios 7
9 s scans product on outbound and builds internal for verification (Scenario 7) scans product on outbound scans the homogeneous case or smallest saleable unit product identifier on outbound. stores product identifier information After the product identifier is scanned, the stores all product identifier information in an internal. verifies returns against its internal As saleable products are returned, the verifies the product identifier(s) against its internal. Live Pilot, Internal Solution HDA DSCSA Compliance Scenarios 8
10 manually confirms with Manufacturers at time of return via phone or (Scenario 8) Product returned receives the returned serialized product. verifies by phone or contacts the Manufacturer via or phone to verify the product identifier information. Or Desktop Pilot HDA DSCSA Compliance Scenarios 9
11 Verification Router Service query is routed to appropriate Manufacturer (Scenario 9) Develop Verification Router Service A router service is built. It will return verification response utilizing connections with Manufacturers s. s and Manufacturers build and maintain a single connection to the router instead of connecting with each individual trading partner. All Manufacturer information continues to be held internally. Returns verified through router The captures the product identifier information and parses the data to the router service, which references the associated GTIN to automatically query the appropriate Manufacturer and return a response in real-time. Collection and transmission of the data can be done automatically by scanners which are connected to the or performed manually. Live Pilot, External Solution HDA DSCSA Compliance Scenarios 10
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