By Donna Boulieu, senior product & strategic pricing analyst, for the Preparing for Track and Trace blog series

 In our previous posts in the Preparing for Track and Trace  blog series, we explained what the Drug Supply Chain Security Act (DSCSA) was and what your responsibilities are under the law. We dove into details about T3 documentation, suspect or illegitimate products, important dates to know, serialized products, and product identifiers. This post will cover trading partner roles.

A big piece of the DSCSA puzzle was, and still is, figuring out a way for manufacturers and wholesalers to verify product validity when it comes to saleable returns. Verification Router Service (VRS) solutions are being developed and fine-tuned to help with this communication as close to real-time as possible. There was even a task force established by the Healthcare Distribution Alliance (HDA) to help with this development, as the industry didn’t want viable product to get held up in warehouses unable to be re-distributed to patients in need because they were waiting to be verified as having valid serial numbers prior to re-entering the supply chain. This development of DSCSA is so complicated with all the players involved that the FDA postponed enforcement of this verification from November 27, 2019 to November 27, 2020 so the industry could continue to prepare for the requirement. (Despite the delay in enforcement, requirements of the law are and have been in effect since November 2019.) prescription medications

Another part of the law required the industry to establish national standards for licensure for wholesale distributors and third‐party logistics providers. This requires all trading partners to make sure they are only doing business with licensed distributors and providers (and for those distributors and providers to be licensed and remain current with their license). This may all seem like common sense or something a company would do out of good faith, but also remember that there were enough instances where this didn’t happen (bad players) that precipitated the DSCSA regulations to come into existence.

And, lest we forget, dispensers (pharmacies — retail, hospital, and others) are also required to comply with the law. Storage of the transaction data (chain of custody of goods) for a minimum six-year period, ability to be completely interoperable (electronically interconnected) by 2023, and more.

Make no mistake, DSCSA has affected everyone in the supply chain up to this point. Industry leaders had to collaborate; standardization company(s) had to develop standards and communicate them; manufacturers had to work with their vendor(s) to determine how to incorporate this new data and how to best print it so it was readable and scannable; packaging layout had to be redesigned; and software had to be developed and paid for in order to help these changes go smoothly in the supply chain. In addition, data companies had to learn these new standards and work with customers to develop solutions that were both compliant and valuable, and everyone had to share the burden of understanding the law and working toward adherence to the new standards within the given timeframe. Additionally, discussion about returned goods and the overall safety and security of the supply chain needed to be ensured.

In the next post we’ll be covering upcoming deadlines.