When is a Master Formulation Record (MFR) necessary?

A Master Formulation Record (MFR) is essential when preparing batches that are intended for more than one patient. This document provides a comprehensive guide detailing the specific compounding process, including the formulation, necessary calculations, equipment needed, and step-by-step instructions to ensure consistency and accuracy in preparing the compounded medication.

When the compounding is aimed at multiple patients, the MFR plays a critical role in maintaining the integrity of the preparation process and ensuring that the resulting batches meet the required quality standards. It serves as a foundational resource for compounding pharmacists, ensuring that all necessary information is documented and accessible.

In contrast, the other scenarios do not necessitate an MFR. For instance, single patient use might not require a full MFR if the process is straightforward and already established within the workflow. The use of sterile ingredients alone does not inherently require an MFR unless compounded for multiple patients. Lastly, a situation where no ingredients are involved contradicts the very premise of the need for a formulation record, as MFRs are inherently tied to compounding practices involving active or inactive ingredients.