The Drug Supply Chain Security Act (“DSCSA”) was enacted in 2013 with the goal of creating an interoperable electronic system to trace certain prescription drugs as they are distributed in the United States.
The DSCSA’s requires:
- Product identification (such as a bar code)
- Product tracing (trading partners, such as manufacturers, wholesalers, and pharmacies must trace the product from creation until dispensing)
- Product verification (trading partners must establish a system and processes to be able to verify products)
- Product investigation (trading partners must quarantine and promptly investigate a drug that has been identified as suspect (i.e. counterfeit, unapproved, or potentially dangerous))
- Notification (trading partners must notify FDA if they suspect that the product is illegitimate).
The Act sets six compliance deadlines. The last one is coming up on November 27, 2023 and pertains to enhanced product tracing.
Currently, pharmacies are required to ensure that they receive 3Ts (transactional information, transactional statement, and transaction history) from their wholesalers. Starting November 27, 2023, wholesalers must provide 2Ts in an electronic format (EPCIS) with serial number of the product. Product labels will need to have:
- serial number
- Lot Number
- Expiration date
To be able to log in to EPCIS, pharmacies must obtain a GLN (global location number).
The EPCIS will be used to track the movement of the products. Some wholesalers issued letters explaining that pharmacies with no technical capabilities to access EPCIS will be able to access 2Ts via wholesalers’ portals.
So is there anything that pharmacies need to start doing now to comply with the last stage of the DSCSA?
There are two things pharmacies can start doing now:
(1) update their policies and procedures on how they verify legitimacy of the product received starting November 27, 2023 and
(2) contact their wholesalers who should be able to assist with obtaining GLN and provide further information on how to log in into EPCIS.
Most of the wholesalers have sent letters and other notices on how they will be providing 2Ts and what assistance they will be providing to pharmacies regarding compliance with the last stage of the Act. If you need new policies and procedures addressing this upcoming change, our RxPolicy platform has templates available for download.