The US DSCSA was enacted on Nov 2013 and since then we have seen a phased approach from the US FDA to implement the requirements
The US FDA Drug Supply Chain Security Act (DSCSA) is progressing towards establishing requirements for manufacturers and trading partners to have full interoperable electronic track and trace systems in place by November 2023.
The goal is to improve traceability of drugs by creating a consistent and efficient process for verifying and protecting the legitimacy of drug products at the unit level, as they move throughout the U.S. pharmaceutical supply chain.
The US DSCSA was enacted on Nov 2013 and since then we have seen a phased approach from the US FDA to implement the requirements. The upcoming deadline requires the partners to exchange all TI (Transaction Information), TH (Transaction History) and TS (Transaction Statement) in a secure, interoperable, and electronic manner. The TI must include the unique product identifier at the package level for all the packages included in the transaction. Also, a system needs to be in place to support the request for verification or investigation of suspects or illegitimate products.
The timeline below highlights the key steps for implementation over the period of 10 years:
However, 3PLs are encouraging pharma companies to be ready by milestone date of Nov 2022.
Serialisation has been made mandatory by the FDA which requires all players in the secure drug supply chain to adhere to the traceability requirements. Which means that manufacturers, re-packagers, distributors, and dispensers must generate, authenticate, and verify the serial numbers for all products in the supply chain.
The Standardised Numeric Identifiers (SNI) for the serial numbers must be generated as per the FDA directive
Aggregation is the process of building a relationship between unique identifiers assigned to packaging containers. Shipping cases also require an SNI with a Serial Shipping Container Code (SSCC).
To prevent counterfeiting of saleable returns, wholesalers need to ensure that saleable returns are verified before being introduced to the supply chain again and has an interoperable system that provides interoperable data exchange. This is achieved by initiating a verification request by the wholesaler to the manufacturer to verify the returned products and the manufacturer must provide a response within 24 hours. The verification router service enables real time exchange of this information between the parties.
This includes the Product Information, the following four items are part of the Product Information
The DSCSA will continue to use The Electronic Product Code Information Services (EPCIS) standard for exchanges.
So, to summarise, the transactional information including the Product Information should contain.
Complete outline of all the transactions the product has gone through in its journey right from the manufacturer to the dispenser which summarises the product's entire supply chain journey and has the required transaction information.
These statements identify if the seller:
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