- (a) Outer gloves used for HD compounding shall be carefully removed and discarded immediately into a waste container approved for trace contaminated waste inside the C-PEC, or contained in a sealable bag for discarding outside the C-PEC as established in USP 800, Section 7.6.
- (b) PPE removal process shall be done in a manner to avoid transferring contamination to skin, the environment, and other surfaces. Outer PPE worn during compounding shall be disposed of in the proper waste container before leaving the C-SEC. SOPs shall detail the donning and doffing of PPE and where it takes place in the C-SEC.
In addition to the standards in USP Chapter 800, the following requirements apply to a facility where compounding of HDs is performed.
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).