National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01440 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025

PB  149 of 2025

Purpose

The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to the conditions specified in the Principal Determination.

The Principal Determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI).

Pharmaceutical benefits containing nicorandil 10 mg in the manner of administration oral have been subject to ongoing shortages since February 2025, with resolution expected by the end of March 2026. Similarly, pharmaceutical benefits containing nicorandil 20 mg in the manner of administration oral have experienced shortages since June 2025, which are also anticipated to continue until the end of March 2026. In response, the TGA is working on issuing the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Nicorandil) Instrument 2025, which allows pharmacists to supply different strength of nicorandil tablets at equivalent dose for the duration of the shortage provided specified conditions are met.

The purpose of the Amendment Determination is to allow PBS subsidisation of the arrangements that will be specified in the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Nicorandil) Instrument 2025. The Amendment Determination will specify that a different strength of nicorandil tablets at an equivalent dose can be supplied without a new prescription, in accordance with the specifications and conditions outlined in the SSSI issued by the TGA. This minimises the burden on health care professionals and assists Australians with timely access to medicine supply for patients.

The Amendment Determination permits the supply by an approved pharmacist of any one of the specified substitute pharmaceutical benefits containing the drug nicorandil in the manner of administration oral in situations where the substitute benefit may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989 and the following conditions must be met:

  • the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law
  • the pharmacist does not have access to the scarce medicine
  • the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted
  • the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine
  • the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine
  • the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine
  • the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing
  • the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine

 

In order for the specified substitute pharmaceutical benefits to be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989, the following specific permitted circumstances of substitution apply:

the pharmacist has advised the patient, or person acting on behalf of the patient:

  1.       of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified; and
  2.      where cutting of the tablet is required to obtain the correct dose of the substitutable medicine—of suitable instructions for cutting the tablet; and
  3.       of the differences between the scarce medicine and the substitutable medicine.

The Amendment Determination commences on 28 November 2025.

The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.

A provision-by-provision description of the Amendment Determination is contained in the Attachment.

Consultation

The Amendment Determination reflects the intention of previous consultation.

In relation to the Amendment Determination, consultation was undertaken with the Chair and relevant expert members of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent, expert advisory body that recommends medicines for listing on the PBS. Consultation with PBAC experts focused on specific advice about the appropriateness of PBS subsidisation for the Amendment Determination. The PBAC experts endorsed the proposed approach as they considered that the substitution arrangement is necessary for patients requiring replacement as quickly as possible, with limited other options available to patients during the current shortage.

It is noted the Therapeutic Goods Administration conducted consultation on the appropriateness of the substitutions and consultation on this Amendment Determination was limited to the appropriateness of a PBS subsidy for the substitute medicines. No further consultation was deemed necessary, as consultation with the PBAC Chair drew on the knowledge of relevant experts.


ATTACHMENT

 

Details of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025

Section 1 Name

This section provides that the name of the Amendment Determination is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025

This section also provides that the Amendment Determination may be cited as PB  149 of 2025

Section 2 Commencement

This section provides that the Amendment Determination commences on 28 November 2025.

Section 3 Authority

This section provides that the Amendment Determination is made under subsection 89A(3) of the National Health Act 1953.

Section 4  Schedules

This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

 

 

 

 

 

 

 

 

 

 

 

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025

This Disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. 

Overview of the Disallowable Legislative Instrument

The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to the conditions specified in the Principal Determination.

The Determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI).

The pharmaceutical benefits containing the drug nicorandil in the manner of oral administration are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Nicorandil) Instrument 2025).

The Amendment Determination specifies that a different strength of nicorandil tablets at equivalent dose can be effectively substitutable at the pharmacy level without the need to obtain a new prescription from the prescriber at PBS subsidised prices for the duration of the TGA approval, where conditions in the Principal Determination are met and the supply is in accordance with section 30EL of the Therapeutic Goods Act 1989.

This means that eligible patients accessing a substitute pharmaceutical benefit containing nicorandil under these arrangements will be paying PBS co-payment rates for the supply and will not be out of pocket. This minimises the burden of this shortage on health care professionals by reducing the need for interdisciplinary consultations, and assists Australians with timely and equitable access to medicine. It further bolsters the intended public health outcome of the serious shortage intervention by ensuring the substitution remains an affordable and practical alternative for patients.

Human rights implications

The Amendment Determination engages Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Amendment Determination assists in the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme which assists with providing subsidised access for people to medicines. This is a positive and supportive step towards attaining the highest standard of health for all Australians. Efficient operational arrangements for the PBS support effective administration of the scheme. The Amendment Determination assists in the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health by ensuring that patients have continued access to their medicines while their supply is disrupted.

Conclusion

The Amendment Determination is compatible with human rights, as it promotes the protection of human rights.

 

 

Rebecca Richardson

Assistant Secretary

PBS Listing, Pricing and Policy Branch

Technology Assessment and Access Division

Department of Health, Disability and Ageing

Overview

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025 was enacted to address the ongoing shortages of specific pharmaceutical benefits, particularly nicorandil 10 mg and nicorandil 20 mg tablets. This determination was introduced to ensure that Australians have timely and equitable access to essential medicines, particularly during periods of scarcity. The amendment was made by the Therapeutic Goods Administration under the National Health Act 1953, reflecting a collaborative effort to streamline the pharmaceutical supply chain and reduce the burden on healthcare professionals. The policy objective of the Amendment Determination is to facilitate the substitution of scarce medicines with alternative formulations that are subsidised under the Pharmaceutical Benefits Scheme (PBS), thus ensuring affordability and accessibility for patients. This Amendment Determination aims to provide an efficient and practical solution to the issue of medicine shortages by allowing pharmacists to substitute different strengths of nicorandil tablets at equivalent doses, subject to certain conditions. The determination ensures that patients do not incur additional costs and that the substitution process is recorded and communicated to the prescribers, thereby maintaining the integrity and safety of the healthcare system. It is designed to support the broader public health outcome by ensuring that patients have continued access to their necessary medications during shortages, thereby upholding their right to the highest attainable standard of health.

Scope and Application

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025 applies to approved pharmacists who are authorised to supply substitute pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) in response to medicine shortages. Specifically, the Determination enables pharmacists to supply different strengths of nicorandil tablets, which are currently experiencing shortages, without the need for a new prescription from the prescriber. This applies to situations where the pharmacist does not have access to the scarce medicine, the prescriber has not indicated on the prescription that substitution is not permitted, and other specified conditions are met. The Determination operates across the Commonwealth of Australia and aligns with the provisions of the Therapeutic Goods Act 1989, which governs the supply of therapeutic goods, including medicines, in Australia. There are no explicit exclusions or exemptions stated in the Determination, but it does specify conditions that must be met for the substitution to occur. The Determination extends the application of the principal legislation through subordinate instruments, namely the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Nicorandil) Instrument 2025, which outlines the specific conditions under which substitution of nicorandil can occur. The Amendment Determination is a legislative instrument made under the National Health Act 1953, and it amends the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021. It commences on 28 November 2025 and is compatible with human rights, particularly the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights. The Determination ensures that patients can access necessary medications at PBS co-payment rates, minimising the financial burden during periods of medicine shortage and ensuring timely access to essential treatments.

Key Provisions

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2025 (Amendment Determination) primarily amends the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to include new pharmaceutical benefits that can be supplied without a prescription during shortages, subject to specified conditions. The Amendment Determination (section 4) allows for the substitution of nicorandil tablets of different strengths at equivalent doses by approved pharmacists during shortages, aligning with the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Nicorandil) Instrument 2025 issued by the Therapeutic Goods Administration (TGA). Pharmacists can supply these substitute medicines without a new prescription, provided certain conditions are met, including having a valid prescription for the scarce medicine, exercising professional judgement, and obtaining patient consent. Additionally, the pharmacist must inform the patient about the differences between the scarce medicine and the substitute, provide instructions if the tablet needs to be cut, and record the substitution and notify the prescriber. The Amendment Determination imposes several obligations on parties involved. For pharmacists, it is mandatory to adhere to the conditions specified in the Principal Determination and ensure compliance with the requirements of the Therapeutic Goods Act 1989. They must inform patients about the substitution, provide necessary instructions, and record the substitution, including notifying the prescriber. Patients or their representatives must consent to the substitution and ensure that they have a valid prescription for the scarce medicine unless otherwise permitted by law. The prescriber must not have indicated on the prescription that substitution is not permitted. The Pharmaceutical Benefits Advisory Committee (PBAC) and the TGA have specific roles in endorsing the appropriateness of PBS subsidisation and issuing the Serious Scarcity Substitution Instrument. The Amendment Determination stipulates that breaches of the conditions specified for the substitution of medicines can result in both civil and criminal consequences. Pharmacists who do not comply with the conditions for substitution may face penalties under the Therapeutic Goods Act 1989, which can include fines and imprisonment. For instance, supplying a substitute medicine without meeting the specified conditions can result in civil penalties under section 30EL of the Therapeutic Goods Act 1989. Failure to comply with the requirements for substitution can also lead to criminal penalties, including fines and imprisonment, as stipulated by the Therapeutic Goods Act. The exact penalties for breaches are governed by the Therapeutic Goods Act and may vary based on the severity and nature of the breach.

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Health Law
Pharmaceutical Law
Instrument
Determination
Concepts
Definitions & Interpretation
Offence Provisions
Reporting & Disclosure Obligations
Regulatory Standards
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Pharmaceutical Benefits Scheme
Serious Scarcity Substitution Instrument

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.