FDA is the subject of a lot of criticism, some deserved, and some not. However, I don't think FDA gets enough praise when it does something right. Therefore, I thought it was important to follow up on my previous blog and let everyone know that FDA has cleared up some of the ambiguities I mentioned there.
Specifically, on December 9th, FDA issued draft guidance making it clear that federal, and not state, law determines whether a company needs to register with FDA as a wholesale distributor or 3PL as required by the DSCSA. This clarification likely has the greatest impact on prescription ...
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