Q:

6/11/2013
We are an ENT practice with a large allergy clinic. We are considering a backup generator for our extracts and patient serums. As a private practice, are there any inspections that we might be held accountable to (such as OSHA) as far as proper storage of allergen extracts, testing and treatment boards and patient vials?

A:

Thank you for your inquiry.

If you are in a clinic in which you are a part of a hospital where the extracts are prepared by the institution, you must follow the guidelines of USP 797. This is a complex document, and you will need to download it. You can download a PDF at no charge.

However, you need not worry about USP 797 at this time if you are a separate private practice who makes your own dilutions and stores them solely in your office. The requirements that you should follow are clearly elucidated in the Allergen Immunotherapy Parameters produced by the Joint Task Force. These are also available online at no charge at the site of the Joint Council of Allergy, Asthma, and Immunology. The reference is: Linda Cox, Harold Nelson, Richard Lockey, Christopher Calabria et al Allergen immunotherapy: A practice parameter third update Journal of Allergy and Clinical Immunology Vol. 127, Issue 1, Supplement, Pages S1-S55.

Thank you again for your inquiry and we hope this response is helpful to you.

Sincerely,
Phil Lieberman, M.D.

AAAAI - American Academy of Allergy Asthma & Immunology