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From: Philbert Chen MD
Date: 20 Oct 2004
Time: 09:33:20 -0700
Remote Name: 63.184.161.35
I guess the question I have is this: Do we as MROs have to obtain quantitative level results for the SAP every time they ask- regardless of the "reason" they give us for wanting them? I have this SAP who wants levels all the time because he finds them "useful for monitoring compliance". While I can buy the story of trends(decreasing levels) showing compliance for drugs with longer half lives, it makes no sense for short half life drugs. The SAP I have to deal with wants quants all the time. The regs (Subpart O, 40.293 (g)) state: "As the MRO, you are required to cooperate with the SAP and provide available information the SAP requests." My interpretation is that if the levels are not "available" in that I did not order them- that I would not release (or obtain) the levels for the SAP if I did not feel the request was warranted. The SAP feels that he has a right to the levels, and that I MUST obtain the levels for him. He feels that non-compliance with his requests to obtain the levels is grounds for a Public Interest Exclusion, if you can believe that. I would be curious to hear others thoughts on this.