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.
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