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MUSC Otolaryngology - Head & Neck Surgery E-Update                 August 2016 
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Although the ability of allergists to compound allergy vaccines has not been severely restricted or limit ed by the USP (United States Pharmacopeia) section 797 , additional measures are required to ensure sterility. These guidelines are described below by Mark J. Hoy, M.D., Assistant Professor, General Otolaryngology and Allergy. 

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Paul R. Lambert, M.D.
Professor and Department Chair

The Effect of USP 797 Compounding Guidelines and The Compounding Bill on the Administration of Allergen Immunotherap
Mark J. Hoy, M.D.
In November of 2013, Congress passed legislation known as the Compounding Bill. This bill serves to regulate and oversee compounding pharmacies. This legislation came about as a direct result of numerous widely publicized reports of morbidity and mortality surrounding the injection of contaminated compounded drugs. A total of 64 patients lost their lives as a result of a failure to assure sterility of injected compounds. Under the law, preparation of allergenic extracts is considered compounding and, as such, can be subject to the provisions in the Compounding Bill. Although the ability of allergists to compound allergy vaccines has not been severely restricted or limited, additional measures are required to ensure sterility based primarily on USP (United States Pharmacopeia) section 797. In addition, a Joint Task Force comprised of members of the American Academy of Allergy, Asthma and Immunology (six members), The American College of Allergy, Asthma and Immunology (six members) and the Joint Council of Allergy, Asthma and Immunology (one member) have developed their own set of guidelines for antigen preparation. More recently, the American Academy of Otolaryngic Allergy reviewed and subsequently endorsed the guidelines developed by the Joint Task Force which were first published in 2011. The goal of these guidelines is to ensure sterile mixing, optimize the stability and potency of treatment vials and to reduce practice variance. All of the above guidelines emphasize strict aseptic technique, handwashing, storage temperatures, use of personal protective equipment, expiration dating, accurate patient identification and staff competency. The Joint Commission accreditation organization has adopted the USP 797 guidelines and most hospitals are expected to fully comply with these standards. Non-hospital based allergy practices (which comprise the vast majority of practicing allergists) must individually determine which guidelines will be followed to meet the needs of the practice.
USP 797 contains specific rules for allergy vaccine compounding that are less stringent than rules applicable to other compounded sterile products. And although not draconian (no filtered air or laminar flow hoods), the standard for sterility is increased by these rules.
Directly from USP 797:
"Allergen extracts, as compounded sterile preparations (CSPs) are single dose and multi-dose intra-dermal or subcutaneous injections that are prepared by specially trained physicians and personnel under their direct supervision. Allergen extract, as CSPs, is not subject to the personnel environmental and storage requirements for all CSP microbial contamination risk levels in this chapter, BUT only if all of the following criteria are met:"
USP 797 goes on to list no less than 11 criteria that addresses, among other issues: sterility of needles and syringes, micro-organism growth prevention, hand and nail cleansing, hair covers and gowns, powder free sterile glove use, glove dis-infection, ampule dis-infection, proper labeling and storage.
Individuals who compound allergenic extracts as compounded sterile preparations need to be cognizant of the fact that there exists a greater risk of microbial and foreign material contamination when extracts are compounded with the foregoing 11 criteria as opposed to the more stringent standards in USP 797. In addition, although allergenic extracts as CSPs can pose health risks to patients when injected intradermally or subcutaneously, these risks are substantially amplified if inadvertent intravenous injection occurs.
In addition, the Compounding Bill statutes require that all compounded sterile preparations have a prescription including those for allergenic extracts. This requirement is not thought to have much impact on allergy practices as most should already be utilizing some form of written instructions and documentation that suffices to fulfill this requirement. If not, some form of "order sheet" or prescription should be prepared for each new or renewal vail preparation. These should be labeled with the patient's identifying data and provide a space for a licensed provider's signature.
In summary, non-hospital based allergy practices preparing allergenic extracts for their patients need to realize that these extracts are considered compounded sterile preparations under the law and are subject to oversight and strict guidelines with significant penalties for non-compliance. Fortunately, the requirements that must be met as outlined in USP 797, The Compounding Bill and the Joint Task Force for non-hospital based practices are less stringent than hospital based practices, but no less important. It is the responsibility of each individual practice to make certain that they are complying fully with these recommendations so as to avoid penalization and ensure patient safety.
  1. Lay PC, Bass R, Hughes LF, Lin, SY. Risks of Allergy Vial Contamination: Comparison of mixing in office versus under ventilation hood. Otolayngol Head Neck Surg. 2008 Sep;139(3) 364-6.
  2. USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations. http://www.usp.org/prducts/797/guidebook/
  3. Text of the Drug Quality and Security Act
Mark J. Hoy, M.D.

Assistant Professor

M.D.: Medical University of South Carolina
Residency: University of Louisville
Special Interests: General Otolaryngology & Allergy
Email: hoymark@musc.edu

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