Dear Fellow Allergists:
We urge you to submit comments to the FDA on its Draft Guidance on Insanitary Conditions at Compounding Facilities (FDA Docket No. D-2268-0001). If this Draft Guidance is not changed, preparation of allergen extracts in our offices would be considered “insanitary compounding” in violation of FDA laws. The Comment period closes October 3 so please submit comments by that date. We have prepared the template below for you to use as a model, but personalize to fit your experiences.
I am a practicing allergist and have been preparing allergen extracts in my office for my patients using aseptic technique for many years. The FDA Draft Guidance would require that allergen extracts now be prepared in an ISO Class 5 environment. Meeting this standard would be prohibitively costly and would make it impossible for me to continue to provide allergy immunotherapy to my patients. In all the years that I have been practicing I have seen no incidence of infections or other problems associated with allergen extracts prepared in my office. The Draft Guidance goes beyond what is necessary to ensure patient safety and would threaten patient access to care. I strongly urge the FDA to create an exception for allergenic extracts prepared by physicians for their own patients as requested in the comments submitted by the Advocacy Council of the American College of Allergy, Asthma and Immunology.
The comments should be submitted on-line. Click “comment now” and cut and paste your comments into the comment box.