DSCSA regulations came into full force in March of 2016 for dispensers (e.g., pharmacies, clinics, and hospitals). At this point, you should have certain systems, processes and policies in place to comply with these federal regulations.
Many, however, have put off compliance measures, for various reasons. Most are relying on wholesale distributors to store T3 documentation for them. Others have literally no idea what DSCSA is, let alone how to comply with it! For those familiar with the regulations, it is quickly becoming clear that DSCSA is not a trivial task.
Drugs are acquired from so many different sources. Whether it is borrowing from one another, buying directly from a manufacturer, buying from a secondary supplier, it is clear, there are many sources of trade. All of these transactions deserve your attention in complying with DSCSA.
Like any government regulation, it has taken time to catch up to what is being asked to comply. One thing is certain, DSCSA data is increasingly becoming fractionated. Suppliers will often provide a portal for your DSCSA, for the products you purchase from them. The next thing you know, you have at least a dozen portals, storing data for you. Not exactly the most optimal way of doing business, particularly considering the 2 business day response requirement!
In the background, companies like ours are participating in projects, to move towards centralized data exchange. A centralized, standard electronic interchange for supply chain data is the goal the US government has set forth. A timeline has been proposed and is available on the FDA website. Starting to organize your data now, will save you both time and money in the future.
To raise awareness as to what you should be doing now, we have assembled a DSCSA compliance checklist. You can view it here or download it as a PDF. Please contact us through our website if you have questions or would like to get better organized with DSCSA compliance!