NSW Opioid Treatment Program (OTP): Key regulatory changes

​​​​New medicines, poisons and therapeutic goods laws

From 5 November 2026, the Poisons and Therapeutic Goods Act 1966 and Poisons and Therapeutic Goods Regulation 2008 will be replaced, respectively, by the:

Further information is available at Medicines, Poisons and Therapeutic Goods legislation.

Opioid Treatment Program legislative requirements

Changes to the management of patients receiving treatment under the NSW Opioid Treatment Program (OTP) will also commence on 5 November 2026.

The Opioid Treatment Program legislative requirements outline key legal requirements for OTP prescribers and OTP dosing points. The OTP legislative requirements refer to the OTP Standards.

The new legislative framework strengthens safeguards for patients and the community, supports contemporary clinical practice, and simplifies legal requirements for prescribers managing patients under the OTP.

The OTP Standards

The OTP Standards will take effect from 5 November 2026 and outline the minimum expectations for the safe and consistent delivery of treatment under the NSW OTP to provide opioid dependence treatment (ODT) with medicines including methadone and buprenorphine. Compliance will be mandatory for practitioners, pharmacists, and operators of public and private OTP clinics providing treatment under the program. The OTP standards comprise of three separate standards for:

  • medical practitioners and nurse practitioners providing treatment under the OTP.
  • pharmacists practising at community pharmacy dosing points.
  • health practitioners and other persons administering or supplying ODT medicines at dosing points other than community pharmacies.

 

Further OTP documentation

A broader suite of updated OTP documents, including clinical guidance and supporting resources, will be progressively released over the coming months. Information regarding these updates will be published as it becomes available.

Current as at: Wednesday 12 August 2026