Compounding pharmacies

Bio Balance Health is an education organisation. It is not a clinic or a medical practice and cannot give medical advice.

This page is for practitioners. It is not medical advice.

Bio Balance Health recommends the use of compounding pharmacies for the preparation of targeted supplementation, particularly in the early stages of managing biochemical rebalancing.

Why use Compounding Pharmacies?

Compounding pharmacies fill out prescriptions specific for the individual. Mostly, only medical doctors can request compounding prescriptions.

Compounding pharmacies are not allowed by law to replicate a product which is available commercially.

Bio Balance Health recommends the use of compounding pharmacies in the initial stage of cell biochemistry management as the content of the supplementation can be closely controlled and in many cases the number of tablets needed per day reduced. This can hasten recovery and reduce difficulty with compliance. Patients who may need long term supplementation often do better on targeted prescriptions.

The view of compounding as unregulated and substandard in comparison to large scale manufacturing is surprisingly uninformed.

Compounding has been around since the beginning of pharmacy and, in fact, is strictly regulated, under federal legislation by the TGA; at the State level under the various health regulations; and professionally by the Pharmacy Board of Australia.

Compounders are not permitted to behave as, or conduct, manufacturing. They fit into a specific niche of providing a solution when commercially available products do not meet a patient's needs, as identified by the practitioner.

Quite specific professional standards covering the practice, facilities, equipment, staff competencies, as well as quality of raw materials, are specified in the Australian Pharmaceutical Formulary and Handbook. This Handbook is a required text for Pharmaceutical practice and forms a key part of the curriculum of every pharmacy course in every university within Australia.

It could be shown that, when it comes to complex compounding, the State regulators need to be more vigilant and proactive. Irrespective, compounders are already operating under a comprehensive regulatory framework.

What both Practitioners and Compounders should be aware is responsibility for the correct compounding product rests equally on both parties.

Hence, BBH requests, as practitioners, you know your biochemistry, you test before prescribing, you test regularly to monitor progress, you communicate well with the compounder you prefer, and you educate patients on why compounding fits better at their stage of recovery.

The difference in quality between manufactured nutraceuticals and Compounded nutraceuticals can be described as follows:

Batch Size

Manufacturers are making product in huge batches for potentially thousands of patients. A batch error affects thousands of patients-hence the need for high level procedures at the level of certifiable GMP.

Compounders are preparing products, in most cases, for one patient at a time and, in some cases, very small batches. Quite a different risk assessment proposition. This is recognised in federal and state legislation.

Potency

In addition, manufacturers, in terms of potency, are permitted a plus or minus 10% variation. Most Compounding Pharmacies will not accept any more than a 2% variation.

Dose Precision

In many instances, the very nature of "mechanical" large-scale manufacturing will make it difficult for a manufacturer to achieve the same level of unit dose precision possible with small volume "handmade" formulations.

Allergen control

A Compounder can exclude products with allergen reactions specific for the sensitive individual. A compounder can produce oral, topical or sublingual products if required.

Availability

Compounding Pharmacies have reached over 700 in number compared to before 2010 when they were hard to locate. Patients appreciate the individualised product which provides them with a more satisfactory outcome. They are willing to pay for the benefit.

Flexibility and Control

Practitioners using Compounding Pharmacies can refine the product to suit the individual's biochemistry and lifestyle needs.

Guideline Draft Prescribing Outline

A guideline providing a draft prescribing outline for a compounding pharmacy request is included in the appendix of the Essential Biochemistry for Mental Health™ (How Cells Stay Healthy) Course.