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  • 1.  Allergy Serum Mixing and USP 797 Guidelines

    Posted 09-08-2023 07:24

    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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  • 2.  RE: Allergy Serum Mixing and USP 797 Guidelines

    Posted 09-09-2023 01:27

    Hi Shannon,

    I also work at an allergy clinic where we mix our own serums. I can check on Monday with our mixing nurse and back to you then.

    Best,

    Eileen Green, RN, BSN



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    Eileen Green RN
    Los Alamos Medical Care Clinic
    Los Alamos NM
    (505)695-5507
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  • 3.  RE: Allergy Serum Mixing and USP 797 Guidelines

    Posted 09-10-2023 11:29
    Good morning everyone,

    My understanding is that it applies across the board, to include ambulatory setting. In our allergy clinic pharmacy mixes allergens. 





  • 4.  RE: Allergy Serum Mixing and USP 797 Guidelines

    Posted 09-11-2023 14:20

    Shannon

    We also have staff that mix allergy serums in our clinic. We are planning to assure we meet the new 797 guidelines as it is our understanding from reviewing the information and conversations with our pharmacy team that these will apply to the clinic.

     






  • 5.  RE: Allergy Serum Mixing and USP 797 Guidelines

    Posted 09-11-2023 08:58

    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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