DSCSA – 2020 deadline is rapidly approaching

May 21, 2020By Behind the Shelf Blog, Focus on the Pharmacy Front End Blog, Resources focused on Independent Pharmacy

By Brittany Benson, CLSSS, Lean Project and Research Specialist, for the Preparing for Track and Trace blog series

In our previous posts in the Preparing for Track and Trace blog series, we explained DSCSA and what your responsibilities are under the law. We discussed T3 documentation, suspect or illegitimate products, important dates to know, serialized products, product identifiers, and trading partner roles. This post will cover upcoming deadlines.

The next big deadline is upon us! Perhaps because the FDA has not begun rigorous inspections or enforcement of the regulation, some across the supply chain may have been waiting until 2023. Wait no more; there are specific deadlines THIS year

Here’s what you need to know about the 2020 deadline:

  • Enforceable as of November 27, 2020, wholesaler distributors must verify saleable returns and only accept products that contain the required product identifier and verify it before redistributing returned products.
  • Effective November 27, 2020, dispensers (pharmacies) can only accept products that contain the required product identifier and can only buy or sell products that are serialized (unless grandfathered or otherwise exempt). Inventory clean-up may be wise prior to this date.

At this point in time, dispensers (pharmacies) have begun seeing 2D barcodes come through on Rx packaging. They are also already held responsible within DSCSA for verifying their trading partners, implementing investigation procedures for suspect or illegitimate product, and familiarity with the requirements of the law. Preparations should be well under way in terms of working with their suppliers and/or a third party to be compliant by November 27, 2020, when these product identifiers will play a bigger role in the supply chain. Pharmacies should also determine how they will comply with the DSCSA requirement to store T3 data for no less than six years (that is a requirement for all trading partners, not just dispensers). Although most distributors offer to store this data on behalf of pharmacies, be aware that the requirements requires ALL data from ALL sources be collected, verified, and stored.

Everyone is or will be sharing in the overall expenses that are required to make these changes and the industry compliant, and that is what will allow for DSCSA to be fully electronically interoperable by the 2023 deadline. Even today, a little more than six years after DSCSA was enacted, a lot of the players involved are still trying to figure out how to adhere to a standardized format and make sure everything will become truly interoperable with traceability data sharing by November 27, 2023. That is why the FDA asked for pilot project participants in 2019 to explore and evaluate methods to enhance the safety and security of the drug supply chain. The goal was to “test new technologies, processes, or methods that can help spur greater accountability and improve the ability to trace prescription drugs at every point in the supply chain” (https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/dscsa-pilot-project-program).

The ultimate goal (and enforceable requirements) for November 27, 2023 is to have complete unit level traceability throughout the supply chain (sans excluded grandfathered or exempt products).

Are you ready?