Managing the Drug Supply Chain is complex and challenging for any organization. Risks associated with supply disruptions and drug shortages have the potential to impact patient’s lives. With the introduction of the Drug Supply Chain Security Act (DSCSA), all players within the pharmaceutical industry are confronting the challenge of implementing a serialized drug tracing system with little guidance on data standards, roles, or accountabilities.
“The Drug Supply Chain Security Act (DSCSA) is a federal standard that “outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States,” according to FDA.
“The DSCSA is more than a rule… It is a global mandate, requiring any company wishing to sell a pharmaceutical product in the U.S.A. to facilitate product ‘traceability’ by 2023. In theory, this means a consumer should be able to pick up a bottle at a pharmacy and see all the hands that touched it prior to the point of sale.”
Read more about the three distinct stages of implementation (Product verification, Serialization, and Traceability).