Update on USP (US Pharmacopeia)
The Advocacy Council of ACAAI has received several phone calls in response to a recent article about the allergy exemption to the USP compounding regulations. As you may recall, in 2007 the Advocacy Council (formerly the Joint Council) presented data to USP demonstrating our long track record of sterility and safety of allergy extracts mixed in allergist’s offices. We successfully negotiated with USP to exempt allergy from its full sterile compounding standards that include laminar flow hoods, positive pressure rooms and 28-day expiration dates; alternative procedures were accepted.
In Oct. 2015, the Advocacy Council became aware of USP’s plan to revise its sterile compounding standards and, at the same time, eliminate the allergy exemption. We have since partnered with several organizations who will be equally affected by this change – AAAAI and AAOA – and retained the services of a consultant familiar with the workings of USP to initiate a dialogue with USP on our behalf. Although the exchanges with USP have not yielded the quick resolution we had hoped for, our discussions are still ongoing.
So, what can you as a College member who mixes allergy extract do to help? First of all, don’t panic. If you want to make USP aware of your views, we suggest you focus your comments on the safety and sterility of vial preparation and the importance of allergy immunotherapy to your patients; angry inflammatory letters will not help.
Please trust that we are taking a multi-tiered approach, working with our partners to resolve this issue. We sincerely appreciate the many offers of assistance, and the help given by several of our members.
We will notify you when it is time for additional action, and that time may come sooner instead of later.