Formulations

We know that everything from the chemicals to the base to the formula to the support all add up to the final compounded preparation that can change a life, or even save it. That’s why The PCCA Standard doesn’t just apply to our chemicals and bases; it applies to the formulas we develop and the science behind them, all to help PCCA members confidently and carefully compound prescriptions for their patients.

Our Formulation Development team creates, monitors and tests formulas at the request of PCCA members or our Clinical Services department, and to support new PCCA bases and APIs. They also test and update our formulas continually, support them with research whenever possible, and maintain our unparalleled database so that the latest versions are always available.

This means that PCCA members have access to tested, well-supported compounding formulas that abide by the latest regulations, use new and improved technologies, and incorporate the most clinically relevant bases and APIs to provide options for patients who need them.

These PCCA formulas are backed by solid science. They have gone through and passed stability-indicating testing and are denoted in our database with the “BUD Study” designation in the title and accompanied by the FormulaPlus symbol: Formulaplus Bug. Stability-indicating testing methods are so precise that they are capable of not only detecting the specific API in the preparation, but also the presence of other substances, such as impurities, degradation products and excipients, and clearly differentiating between all of them to provide an incredibly precise measure of the potency of the API over time, thereby verifying the stability of the preparation.

Benefits of FormulaPlus Formulas

  • Lower operating costs by allowing prolonged BUDs without having to spend thousands of dollars on stability testing
  • Increased operational efficiency by granting extended BUDs for compounders making anticipatory batches

These allow you to use a single formula to create a number of compounds with extended BUDs as long as the API in each compound is within the range of strengths listed in the formula. For bracketed formulas, we use a stability-indicating assay to test the potency of the low concentration and the high concentration of the API(s) in the formulation over time. This establishes the potency over time of the entire range of strengths for the API.

Over the years, our Formulation Development department has created formulas using our exceptional ingredients and industry-defining bases at the request of PCCA members and our Clinical Services department. Formulation Development has also created them to support new PCCA bases and ensure that our members have what they need to start using those new vehicles.

These PCCA formulas are backed by solid science. They have gone through and passed stability-indicating testing and are denoted in our database with the “BUD Study” designation in the title and accompanied by the FormulaPlus symbol: Formulaplus Bug. Stability-indicating testing methods are so precise that they are capable of not only detecting the specific API in the preparation, but also the presence of other substances, such as impurities, degradation products and excipients, and clearly differentiating between all of them to provide an incredibly precise measure of the potency of the API over time, thereby verifying the stability of the preparation.

Benefits of FormulaPlus Formulas

  • Lower operating costs by allowing prolonged BUDs without having to spend thousands of dollars on stability testing
  • Increased operational efficiency by granting extended BUDs for compounders making anticipatory batches

These allow you to use a single formula to create a number of compounds with extended BUDs as long as the API in each compound is within the range of strengths listed in the formula. For bracketed formulas, we use a stability-indicating assay to test the potency of the low concentration and the high concentration of the API(s) in the formulation over time. This establishes the potency over time of the entire range of strengths for the API.

Blue Box Note

In all PCCA formulas, we include a statement enclosed in a blue text box. It indicates that using ingredients other than the ones listed in the formula may negatively affect the resulting preparation and will invalidate the BUD shown in the formula.

This statement is not arbitrary. Rather, there is sound scientific reasoning behind it: We don’t know the important functional and physical attributes of other chemicals that pharmacopeial standards may not account for, and that may impact how those chemicals behave in formulations. We also don’t know the specifications of other chemicals and bases, nor what their repackaging processes and containers are, among other variables that can affect chemicals and their stability over time.