Drug Supply Chain Security Act
Effective March 1, 2016, the U.S. Food and Drug Administration (FDA) began enforcing Title II of the Drug Quality Security Act (DQSA) the Drug Supply Chain Security Act (DSCSA). DSCSA requires organizations that dispense prescription medicines to maintain storage of the transactional record of those medicines, known in the pharmacy industry as T3s, for six years.
Future DSCSA implementation includes…
- November 27, 2017 – Manufacturers must affix human and bar code readable unique identifiers including lot number and expiration date (serialization) to package and case
- November 27, 2020 – Pharmacy must have lot-level traceability