Author: Dr Owen Bradfield, MIPS Chief Medical Officer
From 5 November 2026, the Medicines, Poisons and Therapeutic Goods Act 2022 (NSW) and the Medicines, Poisons and Therapeutic Goods Act 2026 (NSW) will replace the Poisons and Therapeutic Goods Act 1966 in NSW. The reforms introduce changes for health practitioners who prescribe, supply or store Schedule 8 and Schedule 4D medicines. While more prescribers will be exempted from obtaining approval from NSW Health before prescribing, there will also be new requirements. Here are five things prescribers should action before commencement.
1. Work out your oMEDD threshold for opioid patients
If you prescribe, supply or administer morphine, oxycodone, fentanyl or hydromorphone, individually or in combination, you will need NSW Health approval once the total daily dose exceeds 100mg oral Morphine Equivalent Daily Dose (oMEDD). This is a new approval requirement under the reforms. A short exemption allows up to a three-day supply for urgent pain relief without approval, but ongoing high-dose opioid therapy will need to be reviewed against the threshold. The Australian and New Zealand College of Anaesthetists Faculty of Pain Management opioid calculator can help you calculate the oMEDD for patients on multiple opioids. If you have patients currently on doses above this threshold, start the approval process now rather than after commencement.
What counts as criminal history?
The definition is broad. It includes every conviction, every guilty plea or finding of guilt (even where no conviction was recorded), and every charge laid against you, regardless of how long ago it occurred. Spent and aged convictions must also be declared, including those arising in Australia or overseas.
2. Stop self-prescribing Schedule 8 and Schedule 4D medicines
Self-prescribing these medicines, or obtaining them via wholesale for self-administration, will no longer be permitted under any circumstances. The Medical Board of Australia's Good Medical Practice code of conduct, already discourages self-prescribing and prescribing for family members except in limited circumstances. This reform now also makes such self-prescribing unlawful.
3. Adjust your drug register stocktake schedule
If you hold Schedule 8 medicines in private practice, you’ll need to record the balance in your drug register at least once every three months, rather than only in March and September. Private and public hospitals retain a six-monthly stocktake but are no longer restricted to those two months. Update your practice’s calendar reminders accordingly, and check who in your practice is responsible for keeping the register compliant.
4. Check whether you still need approvals you’ve previously applied for
Several approval requirements are being wound back. You will no longer need Ministry of Health approval numbers on prescriptions for Schedule 8 psychostimulants, most Schedule 8 pharmacy compounded medicines, and nominated Schedule 4 medicines such as isotretinoin and clomifene. Expanded exemptions also apply more broadly, including for palliative care. If you’ve built approval applications into your workflow for these medicines, this is a chance to simplify, but check the exemption details before assuming you’re covered.
5. Register and notify under SafeScript NSW if you treat patients under the Opioid Treatment Program
Practitioners prescribing, supplying or administering medicines under the NSW Opioid Treatment Program (OTP) will need to register and notify these activities through SafeScript NSW, and comply with new mandatory OTP Standards. OTP prescriptions must also now be sent directly to the pharmacy rather than given to the patient.
These are the highest-impact changes for day-to-day prescribing, but the reforms also touch drug register standards, medicine storage, sample restrictions and penalties. Practices that prescribe or store Schedule 8 medicines should review the full legislative changes ahead of the 5 November start date.
References
- NSW Health, Legislation changes for medical practitioners: Medicines, Poisons and Therapeutic Goods Act 2022
- Medicine approvals webpage
- SafeScript NSW
- Good Medical Practice: a code of conduct for doctors in Australia
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