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.