Section Phar 15.32 - Personnel hygiene, garbing and protective gear(1) Personnel suffering from rashes, sunburn, oozing tattoos or sores, conjunctivitis, active respiratory infection, or other active communicable disease shall be excluded from working in compounding areas until the condition is resolved.(2) All personnel who engage in compounding sterile preparations shall comply with all of the following requirements before entering the compounding area:(a) Remove personal outer garments, all cosmetics, exposed jewelry and piercings, headphones, ear buds, and cell phones.(b) Abstain from eating, chewing gum or drinking in the compounding area or bringing food, gum, or drink into the compounding area.(c) Artificial nails, nail extenders or nail polish may not be worn while working in the compounding area. Nails shall be neat and trim.(d) Don personnel protective equipment and perform hand hygiene in the following order: 1. Low-lint, disposable shoe covers.2. Low-lint, disposable covers for head and facial hair that cover the ears and forehead and face masks.3. Eye shields, if required due to working with irritants or hazardous drugs.4. Wash hands and forearms up to the elbows with unscented soap and water for at least 30 seconds. Hands and forearms to the elbows shall be completely dried using either lint-free disposable towels or wipes.5. Don low lint disposable gown or overalls.6. Prior to donning sterile gloves, hand antisepsis shall be performed using an alcohol-based hand rub with sustained antimicrobial activity following the manufacturers labeled instructions and application times.(3) Gloves on hands and gauntlet sleeves on RABS shall be routinely inspected for holes, punctures, or tears and shall be replaced immediately if any are detected. Sterile gloves shall be donned over the RABS gloves.(4) Disinfection of contaminated gloved hands shall be accomplished by wiping or rubbing sterile 70% isopropyl alcohol on all contact surface areas of the gloves and letting the gloved hands dry thoroughly. Routine application of sterile 70% isopropyl alcohol shall occur throughout the compounding process and whenever non-sterile surfaces, including vials, counter tops, chairs, and carts, are touched.(5) When compounding personnel exit the buffer or segregated compounding area, a gown may be removed and retained in the ante area or segregated compounding area if not visibly soiled, to be worn again during the same work shift. Coveralls, shoe covers, hair and facial hair covers, face masks, eye shields, and gloves shall be replaced with new ones before re-entering the compounding area.(6) Garbing items, including gowns, shall be segregated and stored before use in an enclosure to prevent contamination.(7) Visibly soiled gowns shall be changed immediately.(8) Gloves shall be sterile and powder free and tested by the manufacturer for compatibility with alcohol disinfection.Wis. Admin. Code Pharmacy Examining Board Phar 15.32
Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018