1. (a) Records shall be maintained as required by USP Chapter 795 and this article in a readily retrievable form for at least three years from the date the record was created or relied upon to meet the requirements of this article. If only recorded and stored electronically, on magnetic media, or in any other computerized form, the records shall be maintained as specified by Business and Professions Code section 4070.
2. (b) Records shall be created and maintained in a manner that will provide an audit trail for revisions and updates of each record document. Prior versions of each record must be maintained for at least three years from the date the record was created, modified, or relied upon, in a readily retrievable format and include all changes to the document, identification of the individual who made each change, and the date of each change.

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, 4301 and 4332, Business and Professions Code.

History

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