- (a) The pharmacist with supervision and control of compounding shall not allow personnel with potentially contaminating conditions to enter the designated compounding area.
- (b) The pharmacist with supervision and control of compounding shall not allow personnel to enter the compounding area with visible non-removable piercings, which could increase the risk of contamination of CSPs.
- (c) With the exception of sterile gloves, garb shall be donned in an anteroom or immediately outside the segregated compounding area (SCA). Sterile gloves shall be donned in a classified room or SCA. Donning and doffing garb shall not occur in the anteroom at the same time unless the facility's SOPs define specific processes that must be followed to prevent contamination.
- (d) Restricted access barrier system and pharmaceutical isolator sleeves and gloves shall be changed according to both the manufacturer's recommendations and the facility's SOPs.
- (e) Any garbing accommodations provided by a designated person shall be documented and the documentation shall include the name of the individual granted the accommodation, date granted and description of the reasons for granting the accommodation. The record shall be retained in accordance with Business and Professions Code section 4081.
In addition to the requirements in USP Chapter 797, the following requirements apply to sterile compounding.
Note: Authority cited: Sections 4005, 4126.8 and 4127, Business and Professions Code. Reference: Sections 4005 and 4126.8, Business and Professions Code.
History
1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).