For more than 100 years, physicians have safely prepared allergen extracts using the aseptic technique.
These extracts have helped make allergen immunotherapy a proven, clinically effective treatment for patients with allergic rhinitis, allergic asthma and hypersensitivity to insect stings. To ensure our patients continue to receive the best care possible, the Advocacy Council monitors and works against rules that would affect an allergist’s ability to prepare and administer allergen extracts in the office.
The College estimates more than 4,200 allergists across the United States safely prepare and provide allergen immunotherapy extracts to their patients, administering almost 5 million immunotherapy injections annually to more than 440,000 patients.
The Advocacy Council works to protect the specialty from any changes to rules on sterile compounding, including the preparation of allergen extracts for in-office use with patients. The sterility record of allergen extracts prepared under these rules is well-established in both medical literature and clinical reviews.
By protecting access to allergen immunotherapy, and by preventing cost increases for such care, we will help ensure that overall patient health does not suffer.
What We’re Doing
The Advocacy Council, on behalf of the College and other allergy/immunology organizations, advocated for many years on the proposed changes to USP Chapter <797> that would allow for an allergy exception. Our advocacy has resulted in standards that allow for the continued compounding of allergen extract prescription sets for individual patients in allergists’ offices. The final standards published June 1, 2019, mirror the proposed standards released in July 2018. The final standards mirror the proposed standards released last July. We supported those standards in our comments to USP, and we believe they are reasonable and achievable. The implementation date is pending. We encourage you to download the complete version; Section 21 is the allergy section. We recommend anyone who prepares extract, takes the allergenic extract preparation quiz, media-fill test and gloved fingertip-thumb tests annually.
USP 797 College Resources
- Get a brief summary of the final USP 797 rule.
- View our archived webinar USP & me: steps to implement the new extract mixing standards.
- Still have questions? Review our USP 797 FAQs.
Let’s DASH to Defend Affordable Shots – together!
Read our latest Advocacy Insider article on extracts.