Is it permissible to replace the water-aided cleansing of hands with a waterless antiseptic hand preparation to prepare hands for the compounding and dispensing of sterile CSPs?

Yes. USP <797> states: "The use of technologies, techniques, materials, and procedures other than those described in this chapter is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described herein." In addition, however, a policy should be developed and enforced requiring conventional hand cleansing whenever the hands or arms are visibly soiled.

USP <797> describes the hand cleansing procedures as follows:

"After donning dedicated shoes or shoe covers, head and facial hair covers, and face masks, a hand cleansing procedure shall be performed by removing debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing. Hands and forearms shall be washed to the elbows for at least 30 seconds with soap (either non-antimicrobial or antimicrobial) and water while in the ante-area. The use of antimicrobial scrub brushes is not recommended because they can cause skin irritation and skin damage. Hands and forearms to the elbows will be completely dried using either lint-free disposable towels or an electronic hand dryer."

Avagard™ (chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w; 3M Health Care, St. Paul, MN) antiseptic hand preparation is designed to replace water-aided antimicrobial hand scrub brushes and antimicrobial soaps. Avagard™ hand antiseptic product has obtained FDA NDA approval, which includes a complete review by FDA of all safety and efficacy data.