- (a) Facilities shall require individuals entering the compounding area to report to the supervising pharmacist if they have rashes, recent tattoos or oozing sores, conjunctivitis, active respiratory infection, or any other medical condition, to determine if such condition could contaminate a CNSP or the environment, per the facility's SOPs. The supervising pharmacist shall not allow personnel with potentially contaminating conditions to enter the compounding area.
- (b) A gown and face mask shall be used whenever a closed system processing device is required.
- (c) Disposable garb shall not be shared by personnel and shall be discarded if soiled and after each shift. Gowns intended for reuse during the shift must remain in the compounding area.
- (d) Gloves shall be wiped or replaced before beginning a CNSP that contains different components.
- (e) Reusable garb and equipment shall be cleaned with a germicidal cleaning agent and sanitized with 70% isopropyl alcohol at least daily and before use by different personnel. Any reuseable gowns must be laundered per the facility's SOPs before reuse.
- (f) Any garbing accommodations provided by the designated person shall be documented and the record shall include the name of the individual granted the accommodation, date granted and description of the reasons for granting the accommodation. The records shall be retained in accordance with Business and Professions Code section 4081.
In addition to the standards set forth in USP Chapter 795, the following requirements apply to nonsterile compounding.
Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4001.1, 4005, 4081, 4126.8, 4301, 4306.5 and 4332, Business and Professions Code.
History
1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment of subsection (a)(6), repealer of former subsection (a)(7) and subsection renumbering filed 2-6-2013; operative 4-1-2013 (Register 2013, No. 6).
3. Amendment of section heading and section filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).
4. Repealer and new section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).