Are you wholesaling in the USA?

by | Apr 27, 2015 | Blog

So how do you do your bona fides checks on new customers and new suppliers?

Do you know where your medicines are being exported to or ending up and what responsibilities do you have?

News this week of the FDA sending marshalls into a pharmaceuticals company and seizing unapproved prescription drugs valued at US$1.5m got me a little curious.  Whilst there is not much more to report the news makes you wonder who was involved and why these drugs were being held.  Bring that back to your own business and remember the laws are there for a reason and doing the wrong thing or even questionable actions does actually mean breaking the law.  Sometimes we might forget this in lieu of getting a deal done or potential profit but this serves as a reminder to do your homework and keep everything above board.

This is your life and your licence and no need to jeopardise your livelihood.

Just a thought.

How do your SOPs protect you from wrongdoing?

What bona fides do you collect?

What are the warning signs?

Will you deal with someone who has a mark on their record?

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Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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