June 9, 2017
Update on USP 797 and FDA Activities Related to Compounding of Patient Specific Allergen Vials for Immunotherapy
Specialty leaders representing physicians from the American Academy of Allergy, Asthma & Immunology, American College of Allergy, Asthma & Immunology, American Academy of Otolaryngic Allergy and the American Academy of Otolaryngology – Head and Neck Surgery, along with the American Medical Association, the American Rhinologic Society and the Allergy and Asthma Network—representing patient concerns—have been actively engaged with the United States Pharmacopeia (USP) and the U.S. Food and Drug Administration (FDA) regarding proposed standards and regulations impacting in-office compounding of allergen extract for immunotherapy.
In follow up to a February 2017 Stakeholder Roundtable on Allergen Immunotherapy, a workgroup has been formed including leadership of the USP Compounding Expert Committee, representatives from the specialty societies and USP staff. This group met on Friday, June 2 for an update on the continuing effort to revise Chapter 797. Discussions included appropriate standards for training of compounding personnel and processes for ensuring sterility in the office setting. The specialty societies reiterated that there is insufficient data to indicate that additional safety equipment or procedures are necessary beyond the current Chapter 797 standards. Representatives of USP stressed the importance of not creating an exception for any group that would appear to require insufficient safety standards compared to those applicable to other compounding settings. All groups agreed to continue working together in pursuit of an approach that will allow for practitioners to continue to provide this life-changing and life-saving evidence-based treatment, while following procedures designed to ensure patient safety.
On Tuesday, June 6 the FDA Center on Drug Evaluation and Research (CDER) Office of Compounding hosted a series of listening sessions with seven different healthcare constituencies regarding compounding practices in different settings. Our specialty societies participated in similar sessions held in June 2016, but it is significant to note that the allergy/immunology and otolaryngology specialties were invited to a separate session from other specialties for the first time this year. This allowed the discussion to focus extensively on concerns related to compounding and administration of allergen immunotherapy. Discussion focused on the 2016 FDA Proposed Guidance on Insanitary Conditions, which the FDA regarded as a follow up to previous regulations and not the precursor to a set of sweeping new requirements on physical facilities. The FDA acknowledged that the implications on a practice such as allergen immunotherapy were not taken into account in its development. Specialty leaders urged an approach that would balance the potential for infectious adverse events, which the FDA admits has not been identified as a problem, with the increased threat of anaphylactic reactions possible if source extract products are not controlled for consistency and patient status in the physician's office.
We will continue to work together and to keep our members apprised as compounding rules and standards are considered and developed.