U.S. Pharmacopeial Convention Update Could Change In-House Compounding

The AAAAI Board of Directors has become aware that the U.S. Pharmacopeial Convention (USP) released an updated draft of requirements for Pharmaceutical Compounding: Sterile Preparations for public comment.

This draft omits the chapter on allergen immunotherapy extract compounding requirements it previously included. The impact of this omission, if finalized, has the potential to make compounding of allergy immunotherapy extracts extremely difficult and burdensome, the result of which is the very real consequence of limiting patient access to this proven therapeutic modality for management of patients with allergic diseases.

The AAAAI and ACAAI are working together to address this proposed change. As these are draft guidelines open for public comment, AAAAI members are encouraged to submit comments to the USP regarding the safety and efficacy of allergen immunotherapy as practiced following the current USP 797 provisions. Members are also encouraged to submit comment regarding the negative impact which diminished access to immunotherapy could have on patient care.

Stay tuned for more information and submit your comments online.