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Master formulation records and drug profiles must be accurate and complete

March 31, 2021

It’s an important step to meet ACP’s Standards for Pharmacy Compounding of Non-sterile Preparations. 

Master formulation records and drug profiles for compounded preparations in your pharmacy software must be accurate and complete to meet the Standards for Pharmacy Compounding of Non-sterile Preparations and prevent drug errors. 

The deadline for compliance with ACP’s non-sterile compounding standards is July 1, 2021. ACP pharmacy practice consultants inspecting non-sterile compounding practices have identified that master formulation records (MFRs) are not always complete and comprehensive with respect to the requirements outlined in section 6.2 of the Guidance Document for Pharmacy Compounding of Non-sterile Preparations.    

The development of a new MFR is based on scientific data and includes all appropriate references. The MFR for a non-sterile preparation includes all necessary information to compound the preparation such as, but not limited to, the PPE needed, references used for the formulation, detailed mixing instructions, and quality control processes. For the complete list, please refer to the guidance document as well as the ACP MFR template that may be used to complete your MFRs. 

To ensure preparation quality and safety, the MFR should be current. Changes made in the MFR should include supporting rationale and references, and compounding personnel must be informed of the change. 

Computer-generated mixture instruction sheets may be used, provided they meet documentation requirements as outlined in section 6.2 of the Guidance Document for Pharmacy Compounding of Non-sterile Preparations. MFRs should be kept together, in hard copy or electronic format, and be readily available. Note that the MFR is not the same as the compounding record, as explained in our Master formulation record vs. compounding record document.  

Another important reason to ensure that MFRs are comprehensive and completed in detail is that sometimes when medications are compounded, healthcare professionals become familiar with certain strengths of compounds and it may be easy to make assumptions about the concentration of these compounded drugs which may lead to drug errors. 

It is important for pharmacists and pharmacy technicians to ensure that drug profiles for compounded preparations and their corresponding MFRs identify the compounded preparation’s ingredients and concentrations. This can be made available to other healthcare professionals who may need to review this information. Sometimes this information from the patient record does not get uploaded into Netcare properly. If you are reviewing a patient’s profile and the concentration of a compounded preparation does not appear to be specified, contact the pharmacy that the prepared the compound to confirm the concentration to prevent a drug error. 

For more tips and tools on how to achieve compliance with ACP’s non-sterile compounding standards, visit our non-sterile compounding webpage.  


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