FDA Law Blog--Did FDA Shed Light on the Meaning of “Market Withdrawal” in the Updated RPM? Unfortunately, No. By Jessica A. Ritsick, Jay W. Cormier & John R. Fleder –

October 31, 2013

If you have ever needed to determine whether pulling an FDA-regulated product from retail shelves is a “market withdrawal” or a “recall” you know that the line between these two terms at times is murky at best.  So, it is no surprise that there has been some buzz recently about FDA’s October 23, 2013, update to the Agency’s Regulatory Procedures Manual (“RPM”), when FDA stated that “Section 7-5-1, 2(b) ‘Notes,’ was revised to clarify the term ‘market withdrawal.’” 

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Question of the Day November 1, 2013 From a former criminal assistant united states attorney standpoint, I do not find it shocking at all what evidence of guilt or liability is in plain sight on the Internet available to the general public; Remember once on the Internet the information is never gone even if you think it is. My questions is are people just that bold and really waving a red flag just daring someone to come get them, do they not care, or are they just not smart enough to know any better?

An example, of this is someone goes on a discussion board and says my compounding pharmacy requires that I make 10,000 a month...not matter what I have to do to make it.  This statement might mean nothing, but then again it could mean a lot.  Another example, a pharmacy claims it doesn't not engage in false advertising but then a search shows the pharmacy has made some statements or promises on a discussion board  that might be considered false advertising.