Mitigating Risk and Extending Beyond-Use Dates (BUDs)

BUDs are Essential and Multifaceted

There is a great amount of knowledge and risk involved in assigning beyond-use dates (BUD) to your compounded preparations. If a BUD is not properly assigned, it could negatively affect your patient.

Stability is a major factor because a formulation could start to precipitate or experience chemical reactions over time.

Overseas, the United States Pharmacopeia (USP) have been paying closer attention to the data used to substantiate the beyond-use dates (BUDs) of compounded preparations.

So too, in Australia, regulators such as the Pharmacy Board of Australia have been concerned that pharmacists may not have the appropriate data to support long beyond-use-by dates.
 

Confidence With the Formula Database

Imagine a database of formulas, available online, each with instructions and a BUD. Becoming a member of PCCA (Professional Compounding Chemists of Australia) grants you access to such a database. It provides BUDs for PCCA’s 8,000 proprietary formulas.

Additionally, PCCA membership includes a program that studies the physicochemical stability of its members’ favorite formulas — over 100 and counting.

Utilising a stability-indicating method, the FormulaPlus™ program ensures accurate beyond-use dates backed by solid science.
 

Mitigate Risk, Extend BUDs

The FormulaPlus program has two purposes. First, it is designed to evaluate the chemical potency of a formula using a stability-indicating assay, over a period of time, at refrigerated and room temperatures.

Second, it is tasked with determining prolonged beyond-use dating for popular PCCA formulas.
 

Method Validation

PCCA’s bracketed FormulaPlus studies have been subjected to an even greater level of testing. These studies have undergone full method validations in addition to the stability-indicating BUD/potency testing.

Method validation is a process to validate an analytical procedure. This is achieved by performing a wide range of characteristic analyses and evaluating the suitability of the analytical procedure for its intended application.

FormulaPlus bracketed studies are analyses of formulas using a range of a low and high concentration of the active pharmaceutical ingredients (APIs).

A compounded preparation containing the API(s) at a concentration that is equal to or between these bracketed strengths may be assigned the same BUD determined in the study (assuming all other ingredients remain the same). This means that each FormulaPlus bracketed study offers you BUDs for a range of API concentrations backed by solid science.

Note that FormulaPlus testing is applicable only to stability testing — potency testing, method validation and degradation study. It does not include sterility testing.

BUD testing has been carried out using only PCCA chemicals and procedures, and therefore cannot be claimed if all ingredients and processes do not match the formula and are within the range of concentration/strength of API studied.
 

Cost Savings

The PCCA FormulaPlus BUD program can translate to significant savings for the compounding pharmacist. When comparing a 30-day versus a 90-day supply of medication, the compounding pharmacy saves on multiple set-up, labour and overhead costs.
 

Get Access

Do you want access to these resources? PCCA’s formula database, FormulaPlus Program and bracketed FormulaPlus studies are immediately available to PCCA members. Discover the wealth of support offered by PCCA. Call today on 02 9316 1500.

 
About PCCA

Three decades ago, a physician encountered a patient who required an anti-nausea medication that was no longer commercially available. The physician challenged a Houston-area pharmacist to compound the medication, so the pharmacist consulted with his peers and procured the chemicals necessary to prepare it.

The prescription was a success, and the pharmacist realised that others in his field faced similar demands to help patients who require compounded medications. This network of pharmacists, united by a commitment to meet patient needs, was the foundation of PCCA (Professional Compounding Chemists of Australia), which was incorporated in 1981.

Today, PCCA has become the independent compounding pharmacist’s complete resource for pharmaceutical grade chemicals, equipment, devices, flavours, CPD accredited training and education, pharmacy software, marketing, business and pharmacy consulting assistance.

Our membership includes more than 3,900 independent community pharmacists in the United States, Canada, Australia and other countries around the world.

PCCA is licensed by TGA and endorsed by The Pharmacy Guild of Australia.