DSCSA Requirement for Dispensers
The Drug Supply Chain Security Act (DSCSA) sets out multiple phases of compliance that started Nov. 27, 2013 and finish rolling out Nov. 27, 2023. This includes Serialization and Product Tracing. Understanding the DSCSA Requirement for Dispensers is vital in today’s market.
Serialization: Dispensers may not accept DSCSA Products that are not serialized with a product identifier on each smallest saleable package and homogenous case that meets the FDA Standard Numerical Identifier (SNI) requirement. Dispensers may accept non-serialized products manufactured before Nov. 27, 2018 provided there is documentation of such “grandfathered” status. Dispensers must still verify the lot number of suspect product and validate any applicable transaction history and transaction information in their possession.
Electronic product tracing: Dispensers must provide the Transaction Information, Transaction History and Transaction Statement in an electronic format. Paper packing lists or paper invoices can’t be accepted by trading partners as of Nov. 27, 2017. Shipments received by trading partners without electronic product tracing or proper TI, TH, TS information in the electronic product tracing will be returned to the manufacturers.
Interoperable electronic tracing: Dispensers may not accept DSCSA Products that aren’t serialized or properly aggregated starting Nov. 27, 2023. To meet this requirement, manufacturers need to aggregate unit packages to case packages, case packages to pallet, and provide the aggregated shipment data to downstream trading partners.
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LSPediA's OneScan VRS Solution and Investigator Module improved a lot of my daily work. Rather than manually entering each individual product as they come in, I'm now able to go straight from the scanner to the system.Beverly Wyles, Supply Chain Operations Analyst, Attain Med
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We invested a lot of time and effort looking into other software solutions for VRS. When we spoke to other companies that had partnered with LSPediA, it confirmed they had what we were looking for: personalized attention for individual companies and quick responses to inquiries.Petra Huegel, Traffic Coordinator & Certified Quality Inspector, Drugs Unlimited
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I would seriously recommend LSPediA. Their leadership has been awesome. Their project management skills have been terrific. The expertise and knowledge around Manufacturing, regulations, serialization, integrating systems has been incredibly valuable to us.Ken Riester, VP Supply Chain, Kowa Pharmaceuticals
We consider LSPediA to be experts when it comes to the DSCSA and Serialization. They know and understand the ever changing regulations are are proactive on putting things in place to get us ready to go live with serialization.Brad King, Business Operations, Kowa Pharmaceuticals
LSPediA has been a very valuable partner for Blue Link. By utilizing LSPediA's VRS our customers are able to scan 2D barcodes on returned product and get a response instantaneously. It's amazing how fast it works.Darren Myher, CTO, Blue Link