Cal. Code Regs. tit. 16, § 1736.15 – Use of Conventionally Manufactured Products as Components.

(a) A single-dose container entered or punctured outside of an ISO Class 5 area, must be discarded immediately.
(b) A single-dose container entered or punctured inside of an ISO Class 5 area must be discarded within 12 hours.

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).