Opioid Treatment Program legislative requirements

​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​F​rom 5 November​ 202​6, the Poisons and Therapeutic Goods Act 1966 and Poisons and Therapeutic Goods Regulation 2008 will be replaced respectively by the:

This webpage outlines the requirements that apply from 5 November 2026 onwards.

Information for prescribers on the current requirements is available on Opioid Treatment Program (OTP) webpage.

​​​​​​​​​​​​​​​​​​​​​​​​​​​On this page​

  1. Key definitions
  2. Prescribers
    1. Key legal requirements for ​prescribers
    2. Standard treatment and non-standard treatment​
    3. Registration, notification, and approval​ 
  3. ​ ​OTP dosing points
    1. ​​​Key legal requirements for dosing points
  4. Starting treatment workflow
  5. ​ More information​​​

​​Key definitions

  • ​NSW Opioid Treatment Program (OTP) is a public health program administered by NSW Health that provides treatment for people dependent on opioids.
  • Opioid Dependence Treatment (ODT) refers to the clinical treatments that may be provided for opioid dependence. This includes both medications (such as methadone and buprenorphine) and psychosocial interventions.
  • A ‘dosing point’ refers to a location where the OTP medicine is supplied, dispensed and/or administered and includes community pharmacies, OTP clinics and other medical services which are registered to provide ODT.​

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​Prescribers​

​Key legal requirements for prescribers

Under the new laws, the legal requirements have been simplified for prescribers who manage patients under the OTP, and include the following:

Registration

You must register to prescribe, supply or administer methadone or buprenorphine under the OTP.

Note that registration occurs automatically when you submit your first notification or are granted approval by NSW Health.

Notification

You must notify NSW Health before commencing a patient on standard treatment under the OTP.

Approval

You must obtain approval from NSW Health before treating a patient under the OTP with a medicine or dose that is not standard treatment.

OTP Standards

The OTP Standards set out the minimum requirements for individuals and services providing treatment under the NSW OTP. Compliance with these standards is mandatory.

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​​Standard treatment

Standard treatment under the OTP refers to:

  • methadone doses of 200 mg per day or less, or
  • buprenorphine doses of 32 mg per day or less.

Treatment above these ranges, or with other medicines, is considered non-standard treatment.

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​Non-standard treatment

This includes:

  • methadone doses greater than 200 mg per day
  • buprenorphine doses greater than 32 mg per day
  • other Schedule ​8 medicines

A prescriber must apply for approval from NSW Health to prescribe, supply, or administer non-standard treatment.

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Registration, notification and approval​

Registration to treat patients with methadone or buprenorphine under the OTP

  • Under the new laws you must register to prescribe, supply, or administer methadone or buprenorphine under the OTP, except in the limited circumstances listed in the exemptions section below.
  • Registration occurs automatically when you first submit a notification or are granted an approval to treat a patient under the OTP.

​Note: Prescribers who currently hold authority such as an approval to prescribe or supply medicines under the NSW OTP will be automatically registered when the new legislation commences.​

​Notification to NSW Health (standard treatment)

  • You must notify NSW Health when:
    • Starting standard treatment for a new patient, before prescribing, supplying or administering the medicine.
    • Changing an existing patients standard treatment medicine, such as switching between methadone and buprenorphine at standard doses.
  • There are some circumstances where notification is not required and these are listed in the exemptions section below.
  • Notifications submitted via SafeScript NSW are preferred, however submissions via the applicable PDF form are accepted for manual processing.

​Approval from NSW Health for medicines or doses that are not standard treatment

  • An approval from NSW Health is required to prescribe, supply, or administer other Schedule 8 medicines, doses that fall outside the definition of standard treatment, or when methadone and buprenorphine are used in combination. Exceptions apply in the circumstances listed in the exemptions section below.
  • Approval applications are submitted using a PDF application form. These will require review and assessment before a decision is processed.
  • Approval outcomes are sent directly to the prescriber and are available in the 'Correspondence' section in ​SafeScript NSW.

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​Exemptions when registration, notification or approval is not required

You do not require registration, notification or approval when:

Replacing or covering another prescriber temporarily

When prescribing, supplying, or administering medicines under the NSW OTP on behalf of another OTP registered prescriber who is temporarily unavailable, the replacing or covering prescriber must:

  • Only provide continuation treatment
  • Practise at the same practice or premises as the original practitioner or be nominated by the original practitioner to provide the medicines under the OTP​to their patients.

Treating patients in hospital

  • The treatment must be for a patient who is admitted to, or receiving emergency treatment in, a public or private hospital.

Continuing treatment in correctional centres and upon transition back to the community

Treatment for a person already receiving medicines under the NSW OTP may continue during custody in a correctional centre. Treatment may also continue for up to 28 days after the person returns to the community to support transition of care.​

Note: Although this exemption is in place, local OTP​​ policies and procedure must be followed.

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​OTP Standards must be followed

The OTP standards outline the minimum expectations and rules for all individuals and services that provide treatment under the NSW OTP. The standards detail the requirements that apply to each dosing point and to​ each prescriber.

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​​OTP dosing points

​​Key legal requirements for dosing points

Pharmacies and healthcare facilities that operate as an OTP dosing point must meet the requirements outlined below.

Note:  The Medicines Storage Standards, and Electronic Register Standards​ are yet to be published. These will be made available in August 2026.

Compliance with OTP Standards

  • The OTP Standards set out the minimum requirements for individuals and services providing OTP treatment. All dosing points must comply with the OTP Standards.

Compliance with Medicines Storage Standards

  • Schedule 8 medicines​, including methadone and buprenorphine, and Schedule 4D medicines must be stored in accordance with the Medicines Storage Standards.

Compliance with Electronic Drug Register Standards

  • Electronic drug registers used to record Schedule 8 medicine transactions must comply with the Electronic Register Standards.

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​​Additional requirements for dosing points

Community pharmacy OTP dosing points

  • Community pharmacies providing treatment under the OTP must hold an OTP registration. Applications for registration are submitted to the Pharmaceutical Services Unit (PSU).
  • A new OTP dosing point registration application must be submitted every time there is a change in address or pharmacy ownership structure.
  • Community pharmacies that are already registered as OTP dosing points will be automatically registered when the new legislation comes into effect.
  • Application forms for new OTP dosing point registrations will be available on the PSU website closer to the implementation date.

Private clinics​​

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​Starting treatment workflow

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Start: Starting a patient on opioid dependence treatment under the NSW OTP.

Decision point: Determine whether exemptions apply for proposed OTP treatment.

If exemptions apply:

Treatment can commence immediately. Treatment must comply with NSW OTP Standards. Prescriptions or directions for treatment must be provided directly to the OTP dosing point

If exemptions do not apply:

Determine whether the proposed treatment is standard or non-standard.

Standard treatment: Methadone 200 mg daily or les​s, or buprenorphine 32 mg daily or less.

Action: Submit a notification (online via SafeScript NSW is preferred).

Non-standard treatment: Methadone greater than 200 mg daily, buprenorphine greater than 32 mg daily, or any other Schedule 8 opioid medicine.

Action: Submit an approval application using forms on the Pharmaceutical Services website.

After submitting a notification or approval application, check correspondence in SafeScript NSW and then proceed with treatment.

OTP Standards​ must be followed when providing treatment.

Prescriptions or directions for treatment must be provided directly to the OTP dosing point.

Additional information:

  • Dosing at a community pharmacy requires a prescription.
  • Dosing at a clinic requires a direction, such as a prescription or medication chart.
  • Take-away doses must be dispensed by a pharmacist.

Notes:

1. For the full list of exemptions, see "Exemptions – When registration, notification and approval is not required" on this page.

2. If a prescriber has never registered to provide treatment under the NSW OTP, the initial notification or application will be used to register the prescriber.

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​​More information​

Supporting information to help understand the requirements of the legislation are available on the Pharmaceutical Services Medicines, Poisons and Therapeutic Goods legislation  ​web​page.​​  

Disclaimer

The information on this webpage is provided for general guidance only. While reasonable care has been taken to ensure the accuracy, reliability, and currency of the information, users should refer to the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 for full and current legal requirements.

Current as at: Monday 6 July 2026
Contact page owner: Pharmaceutical Services