USP 797 and its application in the real world

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I've recently seen a lot of random nurse and medical assistant compounding out in the field. Any feedback about how USP 797 applies in these situations? My understanding is that it applies to everybody, but is only enforceable for pharmacists. I just feel really uncomfortable that patients are unknowingly getting infusions made with so few safety precautions, especially in the wake of some of the other recent issues with compounding (ie, the things I've seen recently run along the lines of "who needs a hood? I think I'll just make this Remicade bag in our back closet!").

 

[Ackj]

I've recently seen a lot of random nurse and medical assistant compounding out in the field. Any feedback about how USP 797 applies in these situations? My understanding is that it applies to everybody, but is only enforceable for pharmacists. I just feel really uncomfortable that patients are unknowingly getting infusions made with so few safety precautions, especially in the wake of some of the other recent issues with compounding (ie, the things I've seen recently run along the lines of "who needs a hood? I think I'll just make this Remicade bag in our back closet!").

Check USP "high risk" compounding. It can be done bedside, but it has a very short shelf life. If you're administering it immediately, shelf life won't matter.

However, your state may not allow nurses to do such a thing. For example: http://www.leagle.com/decision-result/?xmldoc/19911029174AD2d855_1508.xml/docbase/CSLWAR2-1986-2006

 

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Check USP "high risk" compounding. It can be done bedside, but it has a very short shelf life. If you're administering it immediately, shelf life won't matter.

However, your state may not allow nurses to do such a thing. For example: http://www.leagle.com/decision-result/?xmldoc/19911029174AD2d855_1508.xml/docbase/CSLWAR2-1986-2006

Thanks! That is super helpful, actually, and explains a lot. 🙂