This article applies to organisations (or contractors engaged by an organisation) that prescribe drugs or store drugs on their premises or have a pharmacy depot.

Medicines and Poisons (Medicines) Amendment Regulation (No. 2) 2025 (Qld)

On 1 July 2025, the Medicines and Poisons (Medicines) Amendment Regulation (No. 2) 2025 (Qld) (the Amendment Regulation) commenced, amending the Medicines and Poisons (Medicines) Regulation 2021 (Qld) (the Regulation).

What’s new?

The key changes made by the Amendment Regulation are:

• pharmacists can substitute equivalent medicines when dispensing, but will be required to keep a record of such amendments; and
• changes to conditions for pharmacists selling S4 medicines.

Further Information

Equivalent medicines

New regulation 117B in the Regulation allows a pharmacist to dispense an equivalent medicine for a patient to the medicine stated on a prescription (other than a restricted or diversion-risk medicine), if believed to be reasonably necessary for the therapeutic treatment of the patient.

However, before doing so, the pharmacist (as the dispenser) must:

• obtain consent to the amendment from the person obtaining the medicine;
• make the amendment by recording certain details on the prescription (e.g. name and phone number of the dispenser), sign and date the amendment, and by not obscuring the original prescription information;
• take all reasonable steps to ensure the prescriber who made the prescription is advised of the details of the amendment.

Equivalent medicine, to the original medicine, as defined in new regulation 117B of the Regulation, means a medicine that:

• is listed on the register under the Therapeutic Goods Act 1989 (Cth) for the same indication as the original medicine; and
• is able to be dispensed in a dose and for a duration that is intended to have a therapeutic effect equivalent to the therapeutic effect of the original medicine; and
• has the same or similar chemical composition or pharmacological means of action as the original medicine.

Restrictions on selling S4 medicines

Regulation 157 of the Regulation has been amended, which deals with selling S4 diversion-risk medicines. Pharmacists now are prohibited from selling an amount of an S4 diversion-risk medicine that is an amount more than the smallest available size of a manufacturer’s pack (if pre-packed), or otherwise, more than 3 days’ supply.

Regulation 158 of the Regulation has been amended, which deals with selling S4 restricted medicines. Pharmacists are now prohibited from selling an S4 restricted medicine to a patient, unless:

• the pharmacist reasonably believes:
  • the medicine has been previously prescribed to that patient; and
  • continuing with the treatment is urgent and essential for the patient’s wellbeing; and
  • it’s not practicable for the patient to obtain a prescription before needing to continue treatment; and
• the pharmacist does not sell an amount more than the smallest available size of a manufacturer’s pack (if pre-packed), or otherwise, more than 3 days’ supply.

Regulation 159 of the Regulation, which deals with selling “other” S4 medicines, has been amended. This applies to S4 medicines other than an S4 oral hormonal contraceptive, an S4 diversion-risk medicine, and an S4 restricted medicine. Pharmacists can now only sell an S4 medicine if:

• the pharmacist reasonably believes:
  • the patient has not been sold the medicine without a prescription from the pharmacy where the medicine is sought in the previous year; and
  • the medicine has been lawfully supplied to the patient in the 6 months prior;
  • continuing the treatment is urgent and essential for the patient’s wellbeing; and
  • it’s not practicable for the patient to obtain a prescription before needing to continue treatment; and
• the pharmacist does not sell an amount more than the smallest available size of a manufacturer’s pack.

In addition to the above, pharmacists selling an S4 medicine are now required to record a brief description of why the pharmacist is selling the medicine, under amended regulation 160 of the Regulation.

Categories of medicine (e.g. restricted and diversion-risk) are listed in Schedule 2 of the Regulation.

Pre-packed, in relation to a medicine, as now defined in regulation 155 of the Regulation means the medicine is a pre-packed liquid, cream, ointment or aerosol.

What you should do

Organisations should train relevant staff and ensure policies and procedures are up to date with the new requirements.