Project Team: Marco Carvalho, Baiju Jacob
Email addresses (comma separated):
Description:
- Using Blockchain for Drug Supply Chain Security Act (DSCSA)
Purpose/Benefit:
- How Blockchain can be used to address the FDA's DSCSA regulatory requirements
Scope:
- What is the DSCSA?
DSCSA stands for Drug Supply Chain Security Act. It is a regulation passed by FDA aimed at eliminating counterfeit drugs from entering the supply chain and enable real-time tracking, tracing avd verification of drugs. The regulation is being rolled out in phases with complete rollout scheduled to happen in 2023.
- Why is the DSCSA important?
The DSCSA is important as it aims to eliminate counterfeit drugs from entering the supply chain.
- What is the impact of the DSCSA?
DSCSA compliance is mandatory for any company that is part of pharma supply chain in US
- What are the various options to address the DSCSA?
There are many ways to address DSCSA and it is not necessary to use a blockchain. A blockchain based solution is appealing however as it enables creation of a central repository without the control being in hands of any single company.
- How can Blockchain be used to address DSCSA regulation?
As a drug moves in the supply chain, its transfer from one company to another will be recorded onto the blockchain. This will enable tracking and tracing of a drug as well as verification of its legal owner and complete provenance.
- How can Blockchain be used beyond the DSCSA requirements?
- and more..