Pharmacy Board of Australia and Medical Board of Australia
Joint statement on compounded medicines
The Pharmacy Board of Australia and Medical Board of Australia remind medical practitioners andpharmacists about their respective responsibilities in the prescribing and dispensing of compoundedmedicines.
Good practice involves effective communication between medical practitioners prescribing andpharmacists dispensing prescribed medicines. It also involves an understanding of the important role ofeach profession to ensure that the interests of the patient are their primary priority.
The issue
A compounded medicine may be a suitable treatment option for some patients. For example, if a patient:••has an allergy or sensitivity to an excipient (such as a preservative) in the commercial product (i.e.
ready prepared product), orrequires a different dose form to the commercial product, such as for a patient who has difficulty
swallowing.

Unlike medicines on the Australian Register of Therapeutic Goods (ARTG), compounded medicines are
not subject to rigorous assessment for product efficacy, quality and safety by the Therapeutic Goods
Administration (TGA), and therefore additional considerations are required.
Good practice
1. A compounded medicine should only be prescribed by a medical practitioner and prepared by apharmacist where it is clinically indicated and if:•••

an appropriate commercial product is unavailable, ora commercial product is unsuitable, and
it is not prohibited by law.

2. As is the case for any commercial product, when prescribing and compounding a medicine, medical
practitioners and pharmacists must know and comply with the requirements of their state or territory
drugs and poisons (or equivalent) legislation, and consider any relevant practice standards andguidelines.
3. Medical practitioners and pharmacists have individual legal and professional responsibilities when acompounded medicine is prescribed and subsequently compounded and dispensed. They haveresponsibilities to:
3.1 assess whether the compounded medicine is safe and appropriate for the patient. This
includes considering:•whether the substance(s) in the compounded medicine are suitable and approved for humanuse
Australian Health Practitioner Regulation Agency
National Boards
GPO Box 9958 Melbourne VIC 3001

Ahpra.gov.au

1300 419 495

Ahpra and the National Boards regulate these registered health professions: Aboriginal and Torres Strait Islander
health practice, Chinese medicine, chiropractic, dental, medical, medical radiation practice, midwifery, nursing,occupational therapy, optometry, osteopathy, paramedicine, pharmacy, physiotherapy, podiatry and psychology.

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whether there is sufficient evidence to support the intended use based on recognised
therapeutic standards
whether the medicine will remain stable for the duration of use, andthe possibility of contamination of the medicine and the level of risk that contamination wouldpresent. An example is the risk of contamination of injections and eye drops that should besterile.

3.2 consider the need for any specialised equipment required to compound the medicine
3.3 support patients to make an informed decision about their treatment by ensuring that they:• have been provided with information about the medicine which has been prescribed forcompounding, and• understand that unlike medicines on the ARTG, compounded medicines have not beenassessed by the TGA for efficacy, quality and safety.
4. A pharmacist who receives a request to prepare a compounded medicine for which there is a close
formulation to a suitable commercial medicine (including those on the ARTG) and which is unlikely toproduce a different therapeutic outcome to the commercial medicine should consult with theprescribing medical practitioner regarding alternative treatment options1.
5. If a pharmacist believes that it is not safe or appropriate to compound a prescribed medicine, theymust communicate their concerns to the prescriber and patient so that alternative options can beconsidered. This may include not compounding the prescribed medicine and recommending anothersuitable medicine.
The Pharmacy Board of Australia has issued Guidelines on compounding of medicines 2 for pharmacists,which are published on its website.
The Joint statement on professional responsibilities for prescribing and dispensing medicines from Ahpra
and the Medical, Nursing and Midwifery and Pharmacy Boards of Australia also addresses professional
obligations when prescribing, compounding and dispensing medicines in the context of new models ofcare. Read the joint statement here.

1 An example is an order for 450mg amoxicillin capsules instead of the commercially available 500mg capsules.
2 Updated on 1 October 2024.

Pharmacy Board of Australia and Medical Board of Australia joint statement
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