In order to prepare a compounded medication a pharmacy must have a set of instructions that include an ingredient list and preparation/preparatory instructions. In the compounding pharmacy this document is called the Master Formulation Record (MFR). It is comparable to a “recipe” in cooking. In addition to a MFR, each time a preparation is made a Compounding Record (CR) must be produced. The CR documents a patient-specific preparation. For example, the CR will list the lot numbers, expiration dates and weights of all the actual ingredients used, the names of the persons preparing and checking the formulation and the results of any quality control tests performed on the preparation.
For a given preparation, the MFR is prepared before the preparation is compounded. The CR is used during the preparation to guide and record the actual process. This learning module will discuss MFR’s and CR’s in detail.
As previously stated, MFRs are the recipe a pharmacy follows to prepare a particular formulation. Using a MFR to prepare each formulation helps to guarantee that the preparation is made and packaged in a consistent manner each time it is referenced. This assures the appearance and activity is consistent every time it is prepared and dispensed.
Formulations may be obtained by the pharmacy from many sources. These may include, among others, medical literature, professional organizations, hospitals, physicians, and other compounding pharmacies. In addition, the pharmacy may develop its own formulations. Regardless of the source of the formulation, the pharmacy must use a consistent format for its MFRs.
MFR’s may be electronic or paper, but either form should contain:
A MFR is often a complex and detailed document. Consequently, human error in numerical entries, order of steps, etc..., is not unexpected. A new MFR should be “locked”, and not used until a second qualified individual has verified it in detail. This second individual should independently verify all of the information on the MFR and perform calculations independently of its creator. Once the MFR is verified as 100% correct, it can be used to prepare formulations.
The pharmacy must develop a system to secure and protect its MFRs. An accidental change in the MFR may result in an improperly prepared compounded medication that could result in serious injuries to a patient. All personnel must understand that only authorized personnel can change a MFR, and each time a MFR is changed, it must be verified by a second individual. Old versions of MFRs should be removed from active use, but archived for reference.
While a MFR is the recipe for producing a compounded medication, the CR details particulars of a patient-specific prescription. A MFR is very similar to a CR. A MFR can be designed to collect data necessary for use as a CR. CRs contain much the same data as MFRs, but it is specific to the particular prescription:
Compounding Records contain information about the medications that were dispensed to a particular patient and, as such, they are considered a part of the patient's medical record. CRs should be retained in accordance with the pharmacy's medical record retention policies. As previously noted, the CR is the primary document a pharmacy uses to determine which preparations contained a particular lot of ingredients in case of a recall. As such CRs should be readily available. Paper versions of CRs may require a tedious manual search to determine if a particular CR contained a particular ingredient. Computerized CR’s are often able to perform this search electronically.
Master Formulation Records are one of the most important components for assuring that preparations are compounded properly, accurately and consistently every time they are prepared. Extreme diligence must be given to the preparation of MFRs, as technical expertise and attention to detail is required to avoid errors. An error that goes undetected in a MFR will result in that error repeating itself with every issue of its related CR. Therefore, the implementation of a system of double checks before a MFR is released for use in a compounding practice is paramount.
The CR is the pharmacy's documentation that a particular batch of a preparation was prepared according to its corresponding MFR. The CR is used to perform a final check of the preparation. The CR is used to determine what ingredients were contained in the preparation that a particular patient received, which is important in case of a recall. For all of these reasons, pharmacists and technicians must assure that CRs are always accurate and complete.
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Please note that MEDISCA will no longer accept any returns and will not issue any credits for active pharmaceutical ingredients (APIs).
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