Lab Final - Master Formulation Record

Components of the Master Formulation Record: Calculations needed to determine and verify quantities of components and doses of active pharmaceutical ingredients

- Calculations you used to determine the amounts listed, and/or - Calculations that the compounder using the Master Formulation Record would use to scale up or down - Notes to the compounder about approach to the calculations:

Components of the Master Formulation Record: Equipment and other Supplies Required

- DO specify the number of each if >1 - DO not specify the size as that will change with the amount actually compounded

Components of the Master Formulation Record: Container Used in Dispensing

- Do not specify the size of the package - For oral liquids, "tight, light resistance container" = amber plastic prescription bottle (or oval)

Master Formulation Record

- Is a recipe that must be followed - Can scale up or scale down as needed - Other deviations require a new master formulation record - Is developed before compounding a prescription

Components of the Master Formulation Record: Mixing instructions

- Not as detailed as in your lab handout, but rather - Sufficient for a compounder or compounding technician to know exactly what to do. (Depends on the personnel doing the compounding.) - For lab, assume a pharmacist will be following the instructions

Components of the Master Formulation Record: Stability Criteria and Beyond-Use Dating

- These are maximum periods and only guidelines when you have no other information - Set BUDs conservatively

Where do compounders find formulas? How do compounders develop formulas?

1) Find formulas in medical/pharmaceutical literature - Some have very complete data on stability and efficacy. 2) Develop the formula based on the needs of your patient. - Consider stability *Takes experience to develop formulas

USP <795> section on "Compounding Documentation"

1) Master Formulation Record - The recipe for the drug preparation that must be followed. - It should be created before compounding a preparation for the first time. 2) Compounding Record - The record completed each time a preparation is compounded. - It refers to a Master Formulation Record

Components of the Master Formulation Record: Packaging and storage requirements

Examples: - At room temperature - In the refrigerator - Away from light - In a cool dry place - Do not freeze *Often Packaging, Storage Requirements, & BUD go together