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Allergy Practices: Response Needed Regarding Serum Compounding

Monday, January 25, 2016  
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If you are currently doing allergy in your office and mixing your own allergy serum vials, please read and respond using this template and add your concerns about the patients in terms of safety, accessibility and cost if the exemption is allow to be taken out of the current regulation. The closing date for comments is Jan. 31, 2016 and you must use the template. Thank you for your assistance in advocating for this important issue.

As part of a review process begun in mid-2010, the U.S. Pharmacopeial Convention (USP) made a decision to eliminate the allergy exemptions and alternative testing procedures that applied to General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. Previously, the American College of Allergy, Asthma and Immunology had presented data demonstrating a long track record of sterility and safety in allergy extracts mixed in allergists’ and physicians’ offices and negotiated an exemption to these stringent testing procedures. A draft of the new requirements excludes these exemptions. Should the revision stand, the preparation of allergy vials and compounding of allergy extracts will be subject to much stricter regulation, leading to potential negative consequences for patients dependent upon immunotherapy treatment. Your ability to provide a high level of patient care could be compromised.

The American Academy of Otolaryngic Allergy (AAOA) has been working in concert with the ACAAI and other influential organizations to initiate a dialogue with the USP and the <797> subcommittee intended to resolve the issue and maintain the current exemptions. We have provided extensive data relating to the safety of alternative procedures and stressed that an elimination of these exemptions will result in diminished patient access to allergy immunotherapy, reducing their likelihood of receiving effective long-term care and raising the costs associated with treatment.

The proposed revisions have not yet been enacted, and the guidelines are currently open for public comment. You can help the cause by contacting USP directly and sharing your views. A mandatory submission template, summary of the revisions and other information can be found on the USP website. Please note that your comments must be received no later than Jan. 31, 2016.

We suggest you focus your comments on the safety and sterility of vial preparation and the importance of allergy immunotherapy to your patients.


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