What is the Origin of Master Formulation Record?

The term combines "master," signifying the primary, controlling document, with "formulation record," which denotes the official written history of a drug's composition and preparation method. This concept originates from Good Compounding Practices (GCP) and Good Manufacturing Practices (GMP) within pharmaceutical science, establishing a formal system for reproducible and traceable medication production. The MFR is a cornerstone of quality control in pharmaceutical compounding.

What is the Mechanism of Master Formulation Record?

The MFR mechanism functions as a procedural control system by standardizing every step of the compounding process, from the verification of raw material purity to the final packaging and labeling of the finished product. It dictates the specific equipment to be used, the order of ingredient addition, and the required in-process checks, such as pH or weight verification. Adherence to the MFR minimizes human error and chemical variability, thereby ensuring that each patient receives a compounded hormone preparation of consistent therapeutic quality.

Master Formulation Record

Meaning

A Master Formulation Record (MFR) is a comprehensive, meticulously documented blueprint used in compounding pharmacies that specifies the exact ingredients, precise quantities, detailed compounding procedures, and quality control steps required to consistently prepare a specific compounded medication. This document serves as the authoritative standard for replicating a pharmaceutical preparation, ensuring uniformity, potency, and purity across all batches. It is a critical regulatory requirement that upholds the quality assurance standards for customized hormonal preparations.

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How Do Compounding Pharmacies Ensure the Purity of Hormonal Preparations?

Compounding pharmacies ensure hormonal purity through a system of regulatory standards, process controls, and analytical testing.

∞ USP 797
∞ Hormone Therapy
∞ USP 795

HRTioAugust 3, 2025

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What Specific Quality Control Tests Are Performed on Compounded Hormones?

Compounded hormone quality control involves rigorous testing for potency, purity, and sterility to ensure patient safety and therapeutic accuracy.

∞ Sterile Compounding
∞ United States Pharmacopeia
∞ High-Performance Liquid Chromatography

HRTioAugust 3, 2025

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What Are the Specific Quality Control Measures in Compounding?

Quality control in compounding ensures the prescribed medication is molecularly pure, potent, and safe for your unique physiology.

∞ United States Pharmacopeia
∞ Primary Engineering Controls
∞ Bacterial Endotoxins

HRTioJuly 31, 2025

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How Do Compounding Pharmacies Ensure the Long-Term Stability of Hormonal Preparations?

Compounding pharmacies ensure hormonal stability through rigorous adherence to USP standards, formulation science, and stability-indicating analytical testing.

∞ Long-Term Stability
∞ Pharmaceutical Excipients
∞ HPLC

HRTioAugust 23, 2025