About 8-10 years ago we had to start having our serum made by our pharmacy to be in compliance with the USP 797 rules. It became too time consuming for our pharmacy staff and pharmacists, so we ended up having to outsource the making of our patient's serum at a considerable increase in cost to our patients, but most of them did not want to forego their immunotherapy and continued with the new process.
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Midge Birkholz, RN-BC
Altru Health System
Health Coach/Medical Home
mbirkholz@altru.org (701)732-7616
Grand Forks, ND ND
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Original Message:
Sent: 09-08-2023 07:23
From: Shannon Hilliard
Subject: Allergy Serum Mixing and USP 797 Guidelines
We have an allergy clinic that mixes its own serum for patients and one of the providers recently shared the new USP 797 guidelines that go into effect on 11/1. We have no regulatory body that audits us and am wondering if anyone else is debating whether or not these new guidelines apply to ambulatory care or not? I am also wondering for those of you who do mix, do you have a second nurse verify doses and if so, what is your process for this verification?
Thank you
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Shannon Hilliard RN
Mount Nittany Physician Grp
shilliard@mountnittany.org
Bellefonte PA
(814)278-4865
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