Compounded medicines

Compounded medicines are not evaluated for safety, quality or efficacy.

Instead of approving each compounded medicine as a product, we regulate how these products are supplied or advertised.

About compounded medicines

Compounded medicines are medicines that are prepared by a pharmacist, or certain other healthcare practitioners, for an individual patient when an approved, ready‑made medicine is not suitable. This might be because the person:

• needs a different dose
• is allergic to an ingredient in commercially available medicines
• needs the medicine in a different form, such as a liquid instead of a tablet
• cannot get the medicine because it is unavailable or discontinued.

Compounding is the process of making a medicine. It can involve mixing or changing commercial products or preparing a medicine from individual ingredients to make a medicine that is not commercially available in the required form, strength or formulation.

Regulation of compounded medicines

Compounded medicines are unapproved therapeutic goods.

Rather than approving each compounded medicine as a product, we regulate how these products are supplied or advertised.

Compounding is also subject to other Commonwealth, state and territory legislation and professional practice requirements.

For an overview of the legislative framework that applies to compounding, read Manufacturing, supplying and advertising compounded medicines lawfully.

Manufacturing and quality requirements

Pharmacists and other healthcare practitioners can only manufacture compounded medicines if they hold a TGA manufacturing licence, or if they are exempt from manufacturing licence requirements.

We provide specific guidance to help pharmacists and manufacturers understand their obligations, including guidance for:

• manufacturers of compounded medicines
• manufacturers of dose administration aids

For guidance on meeting manufacturing requirements, read Understanding Good Manufacturing Practice (GMP) for compounded medicines.

For an overview of the broader legislative framework that applies to the manufacture of compounded medicines, read Manufacturing, supplying and advertising compounded medicines lawfully.

Supplying compounded medicines

Generally, therapeutic goods must be included on the ARTG before they can be supplied in Australia.

Compounded medicines are exempt from this requirement where they are supplied to an individual patient on receipt of a valid prescription or request. They are produced as needed and not held as routine stock.

In some circumstances:

• compounded medicines may be prepared in advance - by hospital pharmacists only
• compounded medicines may be prepared in bulk, only after a prescription or order has been received for all of the medicine in that batch.

For further information on the legislative requirements that apply to the supply of compounded medicines, including when additional controls may apply, read Manufacturing, supplying and advertising compounded medicines lawfully.

Advertising compounded medicines

Advertising of compounded medicines is restricted.

In many cases, compounded medicines are either prescription medicines or unapproved therapeutic goods. Advertising these products to the public is prohibited under therapeutic goods legislation.

These restrictions reflect the fact that compounded medicines:

• are not individually assessed for safety, quality and efficacy
• are generally supplied on a patient‑specific basis
• are intended to be used under the direction of a health professional.

To understand your obligations, including what information can be provided about compounded medicines and what constitutes advertising, read Manufacturing, supplying and advertising compounded medicines lawfully.