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:

• 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.