What is DSCSA Mandate?
Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines a phased approach towards building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Unique Identifiers has to be integrated to certain drug packages by: Manufacturer (No later than 27/11/2017), Repackager(No later than 27/11/2018)
Nov 2017 – Manufacturers and repackages must serialize packages of drug products using a product identifier (GS1 Global Trade Item Number® [GTIN®] or FDA National Drug Code [NDC]), serial number, lot number and expiration date, and embed this information in a DataMatrix barcode. Provision of TI, TH, TS in electronic format should be available.
Nov 2019 – Wholesalers must accept only serialized products and must verify unique product identifiers
Nov 2023 – They will be required to make available information that would allow supply-chain partners to trace the ownership back to the initial manufacturer or repackager.
How PharmaSecure can help
PharmaSecure is one of the leading providers of regulatory serialization solutions to pharmaceutical companies operating around the world. Our solutions are backed by an experienced team that understands the criticality of plant operations and the complexities of Printers and Vision systems. Our teams support your during the entire lifecycle of your DSCSA journey and ensure you maintain compliance with regulations moving forward.
- Serving pharmaceutical clients for around a decade
- Solutions based on non-proprietary and latest technology to deliver maximum value
- Seamless integration using industry standards
- Modular and easily customisable applications to fit your business process
- Require minimal training/education to end users
- Secure Application access can be enabled to 3PL or Distribution warehouse.
For more details, please contact us or mail to: email@example.com or call us on 022-67556011