Benefits of Submitting Master Formulation Records

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Jessica Munson, M.S., ARL Bio Pharma Analytical Supervisor

What is a Master Formulation Record?

A Master Formulation Record is used to document the specific information for each individual batch and is an important component of regulatory compliance and effective process control. This detailed record of procedures describes how the drug product is to be prepared. According to USP <795> and <797>, a Master Formulation Record must be created for: 

  • each unique formulation of a compounded nonsterile preparation (CSNP)
  • compounded sterile preparations (CSP) for more than 1 patient
  • CSP from nonsterile ingredient(s)

Visit USP <795> and <797> for more information on a Master Formulation Record and its required contents.

Master Formulation Records and Potency Testing

It's important for a pharmacy to receive potency results in the time requested.  Submitting a Master Formulation Record with every sample helps improve on-time delivery to the pharmacy and reduces potential out-of-specification (OOS) investigations.  This allows for any discrepancies to be caught during accessioning of the sample, analysis of the sample, and/or reporting of the results. Thus, reducing the need for additional client communication to answer questions that might arise. Some questions that can quickly be answered using the Master Formulation Record are:

  • What form of Active Pharmaceutical Ingredient (API) is to be reported (i.e. Fentanyl vs. Fentanyl Citrate)?
  • Was the formulation compounded using raw material, a triturate, or a commercial product?
  • Was water content/LOD accounted for during compounding?
  • Was the product formulated on a per weight basis or a per volume basis?

Master Formulation Records are essential to providing the laboratory necessary information on how the drug product is prepared. It gives a thorough view of your pharmacy's processes and aids our laboratory in providing you high-quality results. 

For more information about submitting Master Formulation Records, contact ARL at 800-393-1595 or