Allergy Extract Compounding Requirements Updates
The AAAAI continually works to protect and advance patient access to evidence-based care, including allergen immunotherapy. This practice requires a very personalized approach, as each patient’s allergen extracts are mixed individually, and vials of extract may be modified over the course of treatment to adapt for treatment progress, ongoing symptoms, or changes in the patient’s treatment schedule or overall condition. This makes it necessary that allergists and their staff be able to manage these extracts in the physician’s office, both at the start of treatment and sometimes later in the course of treatment.
In September 2015, the United States Pharmacopeia proposed revisions to its General Chapter 797, which outlines standards for pharmaceutical sterile compounding. The current Chapter 797 sets forth varying requirements for sterile compounding based on risk, with a special exception for allergen extracts. The 2015 proposed revision treats all compounding as equally and inherently dangerous, thereby requiring the same procedures for allergen extract compounding as all other compounded materials, despite the significant difference in potential risk between the administration of allergy shots and other kinds of injections. The response to the proposed revisions has been enormous, and consideration of the comments and their implications have pushed the USP’s timeline for updating Chapter 797 beyond 2017.
In August 2016, the FDA issued a draft guidance titled “Insanitary Conditions at Compounding Facilities,” and specifically includes physicians’ offices. The draft guidance describes a set of conditions for which any compounding should be considered insanitary, and those conditions include any environment that does not utilize the kinds of extraordinary and expensive safety protocols previously only required for higher level risk procedures under the existing Chapter 797.
Although an FDA draft guidance is non-binding and does not carry the weight of law, the draft guidance encourages state regulatory agencies to actively enforce these recommendations under their own state laws, thus superseding existing FDA regulation that requires those engaged in compounding activities to follow current requirements set forth under USP Chapter 797.
The AAAAI and others are actively seeking a reversal of the draft guidance.
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