Recently I contacted Dirk Rodgers from RxTrace (rxtrace.com) and asked him a few questions. He was kind enough to get back to me.
Chris – If a wholesaler purchases directly from the manufacturer do they need to pass down the 3Ts even if they are an exclusive distributor?
Dirk – In my opinion, exclusive distributors must receive the 3Ts from the manufacturer. The HDMA appears to disagree with my opinion. You will need to figure out who you agree with.
Chris – To be an exclusive distributor does it mean that you just purchase directly from the manufacturer? or do you need an agreement signed between both parties?
Dirk – If you are acting as a manufacturer’s exclusive distributor, you would have a contract with that manufacturer stating that fact.
Chris – So in this case you would need to let your downstream trading partners know the reason why some TI/TH are not being passed?
Dirk – Yes, you will need to inform your customers that you are the exclusive distributor for a given product so they know what to expect from you and how they must construct their 3Ts.
Chris – When a wholesale distributor is simply exporting internationally? Do they need to pass any 3Ts?
Dirk – The FDA needs to provide guidance on this question. The DSCSA does not have an explicit exemption for this type of transaction so you should assume you need to document those sales and keep a copy of the 3Ts just like any other sale.
Chris – A lot of companies are complaining that they are showing their customers who their supplier sources are when passing the 3Ts. They fear their customers will stop buying from them and start sourcing from their suppliers. Is this just a reality of the industry or is there anything they can do to protect this information?
Dirk – It may be a valid complaint, but there is nothing you can do about it. The law requires everyone to receive the full supply chain transaction history going back to the manufacturer, repackager, or exclusive distributor of the manufacturer.
Chris – If a trading partner finds a product illegitimate, based on the law they need to report to the FDA. How is this process done?
Dirk – See the FDA guidance document about suspect products here: http://www.fda.gov/downloads/