Section 1751.5 - Sterile Compounding Attire(a) When compounding sterile drug preparations the following standards must be met: (1) Personal protective equipment consisting of a non-shedding gown, head cover, face mask, facial hair covers (if applicable), and shoe covers must be worn inside the designated area at all times. For hazardous compounding double shoe covers are required.(2) Personal protective equipment must be donned and removed in an ante-area or immediately outside the segregated compounding area.(3) Personnel shall don personal protective equipment in an order that proceeds from those activities considered the dirtiest to those considered the cleanest. The following order is to be followed unless the pharmacy has a procedure in place that documents a method equivalent to or superior to the method described here: The donning of shoe covers or dedicated shoes, head and facial hair covers and face masks shall be followed by the washing of hands and forearms up to the elbows for 30 seconds with soap and water, drying hands, and then the donning of a non-shedding gown.(4) Compounding personnel shall not wear any wrist, hand, finger, or other visible jewelry, piercing, headphones, earbuds, or personal electronic device.(5) Sterile gloves that have been tested for compatibility with disinfection with isopropyl alcohol are required. Hand cleansing with a persistently active alcohol-based product followed by the donning of sterile gloves may occur within the ante or cleanroom. Gloves are to be routinely disinfected with sterile 70 percent isopropyl alcohol before entering or re-entering the PEC and after contact with non-sterile objects. Gloves shall also be routinely inspected for holes, punctures, or tears and replaced immediately if such are detected.(6) Individuals experiencing exposed rashes, sunburn, weeping sores, conjunctivitis, active respiratory infections or other communicable disease, or those wearing cosmetics, nail polish, or artificial nails shall be excluded from the ISO Class 5 and ISO Class 7 compounding areas until their conditions are remedied.(b) When preparing hazardous agents, appropriate gowns and personal protective equipment shall be worn regardless of the PECs used (e.g., biological safety cabinet and compounding aseptic containment isolator).Cal. Code Regs. Tit. 16, § 1751.5
1. New section filed 10-6-86; effective thirtieth day thereafter (Register 86, No. 42).
2. Change without regulatory effect amending NOTE filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
3. Amendment filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Renumbering of section 1751.5 to section 1754.6 and renumbering of section 1751.4 to section 1751.5, including amendment of section heading, subsection (c) and NOTE, filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
5. Amendment of section heading and section filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38). Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052 and 4127, Business and Professions Code.
1. New section filed 10-6-86; effective thirtieth day thereafter (Register 86, No. 42).
2. Change without regulatory effect amending Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
3. Amendment filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Renumbering of section 1751.5 to section 1754.6 and renumbering of section 1751.4 to section 1751.5, including amendment of section heading, subsection (c) and Note, filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
5. Amendment of section heading and section filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).