By: Allergy and Asthma Network

Did you know that 1 in 5 Americans suffer from allergies? Millions of these patients benefit from allergen immunotherapy (AI) each year. Allergy & Asthma Network has learned; however, that if the U.S. Pharmacopeial Convention (USP) implements its latest proposal, doctors would be unable to prepare AI in their offices and millions of patients could lose access to appropriate care.
USP’s proposal, if adopted, would make it difficult, if not impossible for most doctors to prepare allergen immunotherapy extract in their offices. For example, vials would need to be made in an ISO Class 5 environment; be subject to ongoing sterility tests; and refrigerated vials would need to be discarded every 28 days.  Furthermore, USP has provided no scientific data to support its position that more stringent rules are required.
The goal of our advocacy efforts regarding this issue is to maintain the current USP allergy exception for allergen extracts which requires mixing to be done with aseptic technique, but without the environmental and other controls required for more dangerous compounding drugs. The Network will be commenting formally on this crucial issue, but we need each of you to join us in this grassroots effort. Submit a personalized email to the USP via CompoundingSL@USP.ORG on or before January 31, 2016 and share your experience of living with allergies and/or how allergen immunotherapy has helped.

A sample letter addressed to the USP follows:


United States Pharmacopeial (USP) Convention
12601 Twinbrook Parkway
Rockville, Maryland 20852-1790

Re: USP Proposed allergy exemption to the USP compounding regulations.

To Whom It May Concern:

I am writing about USP’s plan to revise its sterile compounding standards and at the same time, eliminate the allergy exemption. The allergy exemption to the USP compounding regulations should be maintained.

It is estimated that one in five Americans suffers from allergies and millions of patients are being treated with allergen immunotherapy (AI) each year. [I am one of those patients OR I am a mother, father, son, daughter or caregiver to a patient who receives allergy immunotherapy OR I am the allergist who administers allergen immunotherapy].

These allergy shots are an essential form of long-term treatment that decreases [my, my daughter’s, son’s, or my patient’s] symptoms of [allergic rhinitis, allergic asthma, conjunctivitis (eye allergy) or stinging insect allergy]. This critical treatment allows my [patients, son or daughter] to better manage [my or their] allergies and have a greater quality of life. [personal impact]

If USP implements its proposal, doctors would be unable to prepare AI in their offices and my [name your relationship, OR patients] could lose access to appropriate care. This would have a negative impact to me. [What is the financial impact to you of no in-office allergy vaccination kits?].

The sterility of allergy immunotherapy vials prepared with aseptic technique in the allergist office is working and is backed by over a hundred years of clinical practice.

I ask that you maintain the current USP allergy exception for allergen extracts.



blog comments powered by Disqus

Carolina Allergy and Asthma Consultants Blog