1. (a) Beyond-use dates (BUDs) assigned with only a date shall expire at 11:59 p.m. (23:59) on that date.

2. (b) A CNSP's BUD shall not exceed any of the following:

   1. (1) The chemical and physical stability data of the active pharmaceutical ingredient (API) and any added component in the preparation,
   2. (2) The compatibility and degradation of the container-closure system with the finished preparation (e.g., possible leaching, interactions, and storage conditions),
   3. (3) The shortest remaining expiration date or BUD of any of the starting components, unless allowed by USP Chapter 795.
3. (c) When antimicrobial effectiveness testing is provided by a current FDA-registered drug establishment or an outsourcing facility, the testing must be USP Chapter 51, Antimicrobial Effectiveness Testing, compliant. If such testing is used, or if relying upon current published peer-reviewed literature sources, the reference or test in its entirety shall be readily retrievable in accordance with Business and Professions Code section 4081 for three years from the last date the CNSP was dispensed.

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, 4105, 4126.8, 4169, 4301 and 4332, Business and Professions Code.

History

1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).