1. (a) The facility's documentation of each occurrence of the cleaning and sanitizing of the compounding area shall include the identity of the person completing the cleaning and sanitizing, as well as the product name(s) of the cleaning and sanitizing agent(s) used.
2. (b) Any cleaning or sanitizing agents used by the facility to meet the requirements in this article shall be used in accordance with manufacturers' specifications.

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 4005, 4081, 4126.8, 4301 and 4332, Business and Professions Code.

History

1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).

2. Amendment filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).

3. Repealer and new section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).