- (a) Records shall be maintained as required by USP Chapter 797 and this article, in a readily retrievable form, for at least three years from the date the record was created or relied upon. 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.
- (b) Records shall be created and maintained in a manner to 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 the changes to the document, identification of the individual who made the change, and the date of each change.
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, 4081, 4105, 4126.8, 4127 and 4332, Business and Professions Code.
History
1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).