Essential Elements for Creating a Compliant Master Formula Record 

Creating Effective Master Formula Records

A Master Formula Record (MFR) is an essential document in hospital pharmacies that ensures the consistent, safe, and accurate preparation of compounded medications. Compliance with USP 795 (non-sterile compounding), USP 797 (sterile compounding), and state Board of Pharmacy regulations is critical for maintaining high standards of patient safety and regulatory adherence. The following essential elements must be included in a compliant MFR to meet these standards. 

1. Formula Name and Dosage Form 

Each MFR must clearly state the medication’s name and its dosage form, such as oral suspension, cream, or injectable solution. This allows pharmacy staff to quickly identify and select the correct formula for compounding. 

2. Purpose and Intended Use 

The MFR must specify the purpose of the compounded medication and its intended route of administration (oral, topical, or injectable). This ensures proper compounding and use in patient care, preventing misuse or dosing errors. 

3. Ingredients and Quantities 

A complete list of ingredients—both active and inactive—must be included in the MFR. It should detail the exact quantities, strengths/concentrations, as well as any special sourcing or handling requirements (e.g., temperature-sensitive ingredients). This ensures consistency and accuracy, meeting both USP and Board of Pharmacy guidelines. 

4. Compounding Instructions 

Clear, step-by-step instructions for preparing the medication are essential. For USP 795 (non-sterile compounding), this includes accurate mixing and blending methods, while for USP 797 (sterile compounding), it must also specify aseptic techniques to prevent contamination. Each instruction should ensure consistency and quality, as mandated by both USP and Board of Pharmacy standards. 

5. Required Equipment and Tools 

The MFR should list all required equipment, such as balances, mixers, and sterilization devices, as well as their proper usage. Equipment calibration and maintenance are crucial for both sterile and non-sterile preparations, ensuring compliance with USP regulations and state pharmacy boards’ quality standards. 

6. Environmental Controls 

For USP 797 (sterile compounding), the MFR must include specific environmental requirements, such as ISO-classified cleanrooms, HEPA filters, and positive pressure rooms. Non-sterile compounding under USP 795 requires a clean and organized environment. Compliance with state Board of Pharmacy regulations often includes specific requirements regarding air quality, ventilation, and facility design. 

7. Quality Control and Testing 

Quality control (QC) procedures must be outlined in the MFR. This includes weight checks, pH tests, and visual inspections to ensure product consistency and accuracy. For sterile compounding, additional sterility tests may be required. Both USP standards and Board of Pharmacy guidelines emphasize the importance of QC in ensuring medication safety and effectiveness. 

8. Packaging and Storage Instructions 

The MFR must specify how the compounded medication should be packaged (e.g., glass or plastic containers) and stored (e.g., refrigeration or room temperature). Proper packaging and storage help maintain the stability and integrity of the medication. Both USP guidelines and Board of Pharmacy regulations require detailed storage instructions to prevent degradation. 

9. Beyond-Use Date (BUD) Assignment 

The MFR must assign a Beyond-Use Date (BUD) based on the stability of the ingredients and the compounding method. The BUD is critical for ensuring the medication’s safety and efficacy. Compliance with USP 795, USP 797, and Board of Pharmacy regulations requires proper documentation of the BUD to avoid expired medications being dispensed to patients. 

10. References  

Compliance with USP 795, USP 797, and Board of Pharmacy regulations require that the MFR include scientific stability data and documented references to support beyond-use dates (BUDs) for compounded preparations. This ensures that compounded products are used within a time frame that maintains their safety, potency, and quality. 

10. Labeling Requirements 

The MFR must include detailed labeling instructions, ensuring that the compounded product is properly labeled with the medication name, strength, dosage form, BUD, storage instructions, and any necessary warnings. State pharmacy boards may have additional requirements regarding label content, including patient-specific information or cautionary statements. 

11. Documentation and Record-Keeping 

Proper documentation is essential for regulatory compliance. The MFR must provide space to document batch numbers, lot numbers of ingredients, compounding personnel, and any deviations from standard procedures. Both USP guidelines and Board of Pharmacy regulations emphasize the importance of detailed records for audits, inspections, and traceability in the event of quality issues. 

Creating a compliant Master Formula Record is crucial for hospital pharmacies to meet USP 795, USP 797, and Board of Pharmacy requirements. By including key elements like detailed instructions, quality control procedures, and thorough documentation, pharmacies can ensure safe, effective, and consistent compounded medications. Compliance with these standards not only protects patient safety but also helps maintain regulatory adherence and high-quality pharmacy operations. 

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