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Essentials: What are the regulations around compounded medicine?


In this essentials article we take a top-line look at how commercial and compounded medicines are regulated. We also highlight the importance of being an ISO9001 certified compounding pharmacy.

All components of a compounded product (i.e. the active ingredient and the other substances formulated alongside the active ingredient), are subject to quality standards set out in the Therapeutic Goods Act 1989. Compounding pharmacists are obligated to source their raw ingredients from compounding supply companies that undertake rigorous quality-assurance testing.

The Therapeutic Goods Administration (TGA) specifies that all medicinal products must meet the PIC/S* Guide to Good Manufacturing Practice for Medicinal Products, which is an international standard.

However, it is important to be aware that the final medicine produced by extemporaneous compounding is exempt from assessment by the TGA. The reason for this is that all compounded products are prepared for an individual patient and are not mass produced.


Commercially Available Medicines

Commercially available medicines are those medicines that are mass produced. These medicines must be listed or registered in the Australian Register for Therapeutic Goods (ARTG), unless exempt by the Therapeutic Goods Regulations.

They are manufactured by TGA-licensed manufacturers and undergo extensive testing to ensure an accurate dose of the active drug will be delivered in a reasonably reproducible manner. Commercially available medicines are also tested for stability so an expiry date can be provided.


Compounded Medicines (also known as Extemporaneously Compounded Medicines)

These are medicines that have been prescribed and produced for an individual patient. As a result they are not listed or registered, and no assessment of the final medicinal product in terms of quality, stability or efficacy is required.

However, there are some compounding pharmacies that go over and above to ensure the consistency of a high quality medicine for their patients.

One of the many measures, that Kingsway Compounding has implemented, to ensure a high standard of any compounded medicines that are made within its facilities is to be ISO9001 certified.

Kingsway Compounding is Australia’s only ISO9001 certified compounding facility and this means we are recognised globally for the quality standards we keep in the provision of customised, tailor-made medicines,

Learn more about what being ISO9001 certified means for you here.



How are issues prioritised by the TGA?

Below is taken directly from the TGA website:

"The TGA uses a combination of monitoring strategies to support our compliance programs. Our monitoring programs are both proactive and responsive, including acting upon signals and reports of non-compliance from a number of external sources.

 All signals of non-compliance, including complaints, are recorded and considered. We use triage systems across our compliance functions to determine the priority of the matter and how it will be actioned. While the triage criteria can be specific to the particular regulatory requirements and related compliance function, in deciding on a course of action the following will generally be considered:

  • the seriousness of the alleged non-compliance and failure to follow the regulatory requirements
  • the risk of harm or injury related to a product itself, including the way in which a product is used or being promoted for use
  • the indirect risk of harm from reliance on misleading or inaccurate information in lieu of seeking professional health care advice and treatment
  • the compliance history and behaviour of the responsible person or business
  • the level of compliance of the particular industry sector.

The TGA cannot pursue all matters that come to our attention. We will focus on those matters that concern public safety, allege serious breaches of the Act and regulations, and involve repeated or willful non-compliance."

We thought it was important to highlight issue prioritisation as this provides both patients and practitioners an understanding of how issues are resolved by the TGA.