Setting the Standard
in MFR Management
and Compliance

ISMP reported that compounding errors are often tied to inadequate documentation practices, with a significant portion of these errors due to missing or improperly followed master formulation records. In particular, sterile compounding has been identified as a high-risk area, and the lack of proper documentation contributes to errors.

The AJHP study found that 25% of compounding errors were linked to documentation-related issues, including problems with standard operating procedures and missing or incomplete master formulation records.

TJC reported that documentation-related errors, including missing master formulation records, are a significant cause of medication errors and adverse drug events in hospitals. Missing or incomplete master formulation records contribute to errors in compounded medications, particularly in critical care.

USP reported that up to 45% of compounding errors in hospital pharmacies occur in sterile compounding settings, with 20% of these errors attributed to inadequate or missing procedural documentation, such as master formulation records.

The USP outlines the critical role of master formulation records in ensuring consistent, safe, and compliant compounding processes. Inadequate MFRs contribute to up to 30% of compounding violations in hospital and community pharmacy settings.

The FDA reported that documentation errors, including incomplete master formulation records, are a significant contributor to violations during sterile compounding inspections. The report highlights that documentation deficiencies led to issues in 20-30% of observed compounding errors.