DSCSA compliance now vs. after Nov 27, 2023 —Trading Partners and T3 info.

So, let's briefly discuss a few matters related to how your site should be in compliance with DSCSA now. Changes for the future will be discussed in upcoming post.

For this post and to keep from overwhelming you with too much information let's do this in small, bite-sized chunks of discussion. Let's focus on "trading partners" and T3.

So, as you are most likely aware, you purchase from entities such as a wholesaler, manufacturer, third party logistics facility, etc. According to DSCSA, These entities are known as "trading partners." There are other types of trading partners as well...a prime example is the pharmacy down the street that you currently borrow/loan to. Borrowing/loaning we will discuss a little more in detail on a later post but spoiler...I will recommend that you do not borrow/loan.

So, now we've established trading partners...what is required related to your relationships with the trading partners? It is absolutely incumbent on you as a pharmacy to ensure that the trading partner you are working with is properly licensed or registered with the state and/or at a federal level with the FDA.

The link here is for a guidance document from the FDA that discusses proper registrations and how to identify that the trading partners are licensed/registered properly:

https://www.fda.gov/files/drugs/published/Identifying-Trading-Partners-Under-the-Drug-Supply-Chain-Security-Act-Guidance-for-Industry.pdf

Ex... toverify the state licensure of wholesalers you can search on your states license lookup. FDA has also published what department to look for each state:

https://www.fda.gov/drugs/drug-supply-chain-integrity/verify-wholesale-drug-distributor-licenses

As a side note and to give you a little preview for future posts...there are DSCSA compliance tools by third party entities (ex. LSPedia, Inmar RxTransparent, ConsortiEX, TraceLink, etc.) that can be helpful in your determinations of compliance. Also, NABP is currently working on a tool titled "Pulse" that will have a search engine to help verify licensure/registrations (I.e., one stop shop).

So, we've verified the trading partner...now we've got to be able to obtain the tracing information from them. There are currently three required "parts" to the tracing information--Transaction Information (TI), Transaction Statement (TS), and Transaction History (TH). These are sometimes referred to as the T3s.

Since we are talking about current and not future state (I.e., after November 27, 2023), the trading partner can choose to send you hard copies of the T3. Some trading partners will use a "web portal" to store the information for you. So the current state...if you are handling the information in either way both are required to be maintained for 6 years. Verify if web portals are being used that your trading partner will maintain them for 6 years.

*****What happens if you change trading partners that use web portals? You will NEED to verify with them how you will access the data if needed.

******Things will change after Nov. 27, 2023 regarding T3 data!!! Keep a watch for the future post that I discuss these changes!