Below, CosmoTrace provides a guide to the incoming regulatory changes around drug traceability for 2023
The US DSCSA was enacted in November 2013 with the aim to improve traceability of drugs from the manufacturer to the end user. There have been various changes to the act and the FDA has revised dates multiple times to allow wholesalers, distributors and dispensers to cope with the changes.
When there is credible evidence that points to a product being illegitimate then the FDA expects that Form FDA 3911 is filled out and submitted to the FDA and the training partners within 24 hours.
The FDA recently held a virtual meeting on 16th November 2021 to discuss Enhanced Drug Distribution Security at the Package Level. The aim of this meeting was to take the stakeholder's comments about their current progress, challenges and recommendation. They also discussed some optional non-binding recommendations around aggregation and the secure exchange of information between parties. You can find the details of the meeting here.
The FDA has signalled that there would be no more delays of this upcoming deadline.
Product Identification (Serialisation)
Manufacturers & re-packagers encode product identifiers on prescription drug packages on the smallest individual saleable unit
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.
Enhanced drug distribution security requirements
Implement interoperable, electronic tracing of products at the package level by 2023 that will:
DSCSA mandates that only authorised trading partners (ATPs) may engage in transactions with other ATPs. All parties including manufacturers, distributors, 3PLs and dispensers must be registered as ATPs.
Serialisation has been made mandatory by the FDA which requires all players in the 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 2009 FDA directive which gives the following guidelines:
Aggregation is the process of building a relationship between unique identifiers assigned to packaging containers.
Inference involves examining information for a higher level of packaging to infer information about the next level of packaging and its contents.
This includes the product information. The following four items are part of the product information
The DSCSA continues 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.
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