Drug Supply Chain Security Act
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of the DQSA the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace prescription drugs throughout the drug supply chain. The goal of the DSCSA is to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful while identifying and removing potentially dangerous drugs from the U.S. drug supply chain.
The DSCSA outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Requirements of the DSCSA are being implemented in a phased approach over a 10-year period, which started in 2013 and ends in 2023 with the fully operational electronic interoperable track and trace system.
Since March 1, 2016, the DSCSA requires hospital pharmacies or dispensers to capture, maintain, and store drug transactional records known in the pharmacy industry as T3s (transaction history, transaction information, transaction statement), for six years.
Future DSCSA implementation requirements include…
- Product serialization by manufacturers affixing human and bar code readable unique identifiers including lot number and expiration date to products at the package and case level
- Pharmacy lot-level traceability
- Pharmacy unit level traceability