Medication - Sterile Compounding - Non-sterile Master Formulary
What is required in the master formulary requirement listed in the MC.05.05.01 ? (OME)
Any examples are for illustrative purposes only.
The requirements listed in MC.05.05.01 EP 5 list the minimum required elements for the master formulary of Non-Sterile Compounded Medications. These items may be stored in a paper or electronic format.
The minimum requirements Include:
The requirements listed in MC.05.05.01 EP 5 list the minimum required elements for the master formulary of Non-Sterile Compounded Medications. These items may be stored in a paper or electronic format.
The minimum requirements Include:
- Official or assigned name, strength, and dosage form of the nonsterile compounded preparation
- Calculations needed to determine and verify quantities of components and doses of active pharmaceutical ingredients
- Description of all ingredients and their quantities
- Compatibility and stability information, including references when available
- Equipment used for the preparation, when appropriate
- Mixing instructions including, but not limited to, order of mixing, temperature, duration of mixing, and related factors important to the replication of the compounded preparation
- Dispensing container used for nonsterile compounded preparation
- Packaging and storage requirements
- Description of final preparation
- Quality control procedures and expected results
- For sample labeling, in addition to legally required information, the manufacturer should include generic name, quantity/concentration of each active ingredient, assigned beyond-use date (BUD), storage conditions, and prescription or control number.
Manual:
Home Care
Chapter:
Medication Compounding MC
First published date: January 23, 2018
This Standards FAQ was first published on this date.
This page was last updated on November 01, 2021
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