Back in November 2013 the U.S. congress enacted the Drug Supply Chain Security Act (DSCSA). Part of the regulation is that actors within the U.S. pharmaceutical industry must verify the U.S. state license, which is issued by the U.S. Drug Enforcement Administration (DEA), status (and thus the authenticity) of every trading partner within their supply chain. And this does not stop just by direct trading partners a pharmaceutical supply chain actor might have, the regulation states, that also indirect trading partner’s U.S. state license status must be proofed.
The overall objective of these new upcoming regulations is to better protect the U.S. pharmaceutical supply chain of illegitimate products, thus increasing U.S. consumer’s security. The authorities set the deadline to the industry to be compliant with the law by November 2023. The DSCSA demands the industry to implement a full interoperable electronic system to be able to verify also indirect trading partner relationships in less then 24h.
Today in 2021, U.S. pharmaceutical supply chain actors have no mechanism to validate their trading partners licenses. There are 70.000 interacting trading partners involved in the U.S. pharmaceutical industry. Saying, a solution to be compliant with the regulations by 2023 is highly demanded.