- (a) A record of preparation must include a compounding record compliant with section 9.2 of USP Chapter 825.
(b) A record for preparation with minor deviations or a record of compounding shall be maintained and, upon request, be produced as a single document. The document shall satisfy the requirements of USP Chapter 825, as well as the following:
- (1) The assigned internal identification number shall be unique for each preparation.
- (2) The manufacturer, lot number, and expiration date shall be recorded for each component for radiopharmaceutical. Documenting the National Drug Code (NDC) alone does not meet this requirement.
- (3) The total quantity compounded shall include the number of units made and either the volume or the weight of each unit.
- (4) The identity of each person performing the compounding and pharmacist verifying the final drug preparation.
- (5) When applicable, endotoxin level calculations and readings.
- (c) Records required by USP Chapter 825 or this Article, shall be maintained 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 4081 and 4105.
- (d) 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 shall be maintained, for a least three years from the date the record was created, modified or relied upon, in a readily retrievable and easily readable, or rendered in an easily readable, 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 standards in USP Chapter 825, the processing of radiopharmaceuticals shall meet the requirements of this section.
Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4081, 4105, 4126.8, 4301 and 4306.5, Business and Professions Code.
History
1. .New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).