Innovations-Magazine-Nov-Dec-2024 - 11

ASSOCIATION NEWS
Section 3: Documentation and Record Keeping
1. Do the pharmacy's MFRs contain all
requirements in compliance with USP
<795> standards?
2. Does the pharmacy complete a CR for all
compounded nonsterile preparations in
compliance with USP <795> standards?
33%
29%
67%
71%
Accurate documentation is important for maintaining high standards in nonsterile compounding. The master formulation record (MFR)
and compounding record (CR) ensure consistency and accountability, detailing each step of the compounding process. While there were not
significant changes to this section of the standards, 33% of pharmacies inspected by NABP are not fully compliant with MFR requirements
and 29% are not completing CRs to the standards required by USP <795>. This gap in documentation can lead to inconsistencies, putting
patient safety at risk. Regulators should focus on helping pharmacies improve record-keeping practices by utilizing templates, audits, and
educational resources.
Compliance with USP <795> ensures safe and effective
nonsterile compounded products. Regulators are encouraged
to provide ongoing support through audits, educational
resources, and guidelines.
NOV/DEC 2024 | 9

Innovations-Magazine-Nov-Dec-2024

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