Master Formulations and Compounding Records
Non-Sterile Compounding <795>

Purpose/ Applicability:  To provide guidelines for compounding nonsterile preparations to document necessary information to be able to systematically trace, evaluate and replicate the steps throughout the compounding process. 

Scope: Applies to all personnel involved in nonsterile compounding.

Equipment:

• N/A

Procedure:

Dispensary will keep and maintain Master Formulation Records and Compounding Records for nonsterile compounding preparations.  

1. When compounding according to manufacturer’s labeling instructions, no further documentation is required (such as reconstituting an oral antibiotic according to the manufacturer’s instructions, the amount of purified water does not need to be recorded)
   
   
2. The Master Formulation Records (or Compounding Record) and associated written procedures shall be followed in execution of the compounding process. Any deviations in procedures shall be documented. The compounder shall check and recheck each procedure at each stage of the process. A trained second person will verify each critical step in the compounding process.
   
   
3. The Master Formulation Record (MFR) shall contain the following information:
   1. The name, strength and dosage form of the preparation

2. Calculations required to determine and verify quantities of components and doses of active pharmaceutical ingredients.

3. Description of all ingredients and their quantities

4. Compatibility and stability information, including references if appropriate.

5. Equipment required to prepare preparation

6. Detailed mixing instructions

7. Sample labeling information, including, generic name and quantity or concentration of each active ingredient, assigned BUD, storage conditions, and prescription or control number

8. Container used in dispensing

9. Packaging and storage requirements

10. Description of final preparation

 11. Quality control measures and expected results

4. The Compounding Record (CR) shall contain the following information:The name, strength and dosage form of the preparation

1. MFR reference for the preparation
2. Names and quantities of all components
3. Source, lot numbers, and expiration dates of components
4. Total quantity compounded
5. Name of person(s) who prepared the preparation, who performed the quality control procedures, and who approved the preparation
6. Date of preparation
7. Assigned control or RX number
8. Assigned BUD
9. Duplicate label as described in the MFR
10. Description of final preparation
11. Results of quality control procedures

5. Documentation of any quality control issues and any adverse reactions or preparation problems reported by patient or caregiver

Report any adverse event or product defect using Form FDA 1932a within 15 business days