The Drug Supply Chain Security Act (DSCSA) is also known as Track-and-Trace law. It creates a system to identify and trace certain prescription drugs to improve detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain. The DSCSA has two parts.
Phase I is product tracing. Manufacturers, wholesalers, repackagers, and many dispensers (primary pharmacies) must provide information about a drug and who handled it each time it was sold in the US market. Dispensers are defined as retail pharmacies, hospital pharmacies, or any other persons or entities authorized by law to dispense or administer prescription drugs (prescribers are exempt).
Some transfers are exempt:
- If the transfer is among entities under common control
- If an entity is purchasing a product from a Group Purchasing Organization or from another entity that is a member of the GPO
- Transfer by a charitable organization to a non-profit affiliate.
- Does not apply to drug samples
- Minimal quantity transfer by a retail pharmacy to licensed practitioner for office use.
Every time a product is transferred, certain transactional data must be recorded and exchanged between the parties. This includes Transactional information, Transactional history, and Transactional statement – known as the “3Ts.”
Phase II requires manufacturers and repackagers to put a unique product identifier on certain prescription drug packages. For example, a bar code that can be easily read electronically. Unlike phase one (product tracing) this section expressly applies to prescribers.
The DSCSA outlines a ten-year plan to build an electronic interoperable system to identify and trace prescription drugs through distribution.
All manufacturers, wholesalers, repackagers, and dispensers must have policies and procedures describing proper procedures to quarantine and promptly investigate a drug that had been identified as “suspect” meaning that it maybe counterfeit, unapproved, or potentially dangerous.