A Compounding Record (CR) is a document that records the preparation of a compounded medication. It is important to maintain compounding records to demonstrate compliance with USP standards.
For nonsterile preparations, a CR must be created for all preparations to ensure the traceability of all components. This document must be reviewed for completeness before the preparation is released. The name, or unique identifier, of the reviewer and the date must be recorded. A master formulation record (MFR), a detailed recipe for preparing a drug product, may be used as the basis for a CR by incorporating spaces to fill in the necessary information to complete the compounding record.
For sterile preparations, a CR must be created for all Category 1, Category 2, and Category 3 preparations and immediate-use CSPs prepared for more than one patient. A written or electronic template, prescription, medication order, label, retrievable electronic information stored in an Automated Compounding Device (ACD), or a copy of the MFR may serve as a compounding record.
For more information on Compounding Records and required contents, visit USP <795> and <797>.
Compounding Records and Quality Control Testing
Compounding Records are essential to provide testing laboratories with information on the drug product’s preparation. Submitting a CR with every sample helps improve the on-time delivery of test results and reduces potential out-of-specification (OOS) investigations.
ARL uses the CR to review:
- Actual quantities used to compound a preparation
- Total quantity of preparations made in a compounding process
- Balance quantities
- Purity of starting material (e.g. moisture content accounted for in compounding)
- Calculations used in compounding (e.g. salt form conversions)
Submitting CRs can help identify and resolve discrepancies during sample receiving, test analysis, and reporting of the results.
For more information about submitting Compounding Records, contact ARL at 800-393-1595 or info@arlok.com.