National Health (Continued Dispensing) Determination 2022

PB 59 of 2022

made under subsection 89A(3) of the

National Health Act 1953

Compilation No. 7

Compilation date: 1 November 2024

Includes amendments: F2024L01393

About this compilation

This compilation

This is a compilation of the National Health (Continued Dispensing) Determination 2022 that shows the text of the law as amended and in force on 1 November 2024 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

Part 1—Preliminary

1.01 Name

1.03 Authority

1.05 Definitions

1.06 Purpose

Part 2—Pharmaceutical benefits that may be supplied without a prescription

2.01 Pharmaceutical benefits covered by this instrument

Part 3—Specified conditions for supplying pharmaceutical benefits without a prescription

3.01 General

3.02 Condition—unable to obtain prescription

3.03 Condition—previous supply of pharmaceutical benefit

3.04 Condition—stability of therapy

3.05 Condition—prior clinical review by PBS prescriber

3.06 Condition—prescription for last supply of pharmaceutical benefit

3.07 Condition—no continued dispensing in previous 12 months

3.08 Condition—declaration for supply of pharmaceutical benefit

3.09 Condition—maximum quantity of supply

3.10 Condition—preparing and recording information

Schedule 1—Pharmaceutical benefits that may be supplied without a prescription - pharmaceutical benefits that have certain listed drugs

1 Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist – pharmaceutical benefits that have certain listed drugs

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Part 1—Preliminary

1.01  Name

 (1) This instrument is the National Health (Continued Dispensing) Determination 2022.

 (2) This instrument may also be cited as PB 59 of 2022.

1.03  Authority

  This instrument is made under subsection 89A(3) of the National Health Act 1953.

1.05  Definitions

 (1) In this instrument:

Act means the National Health Act 1953.

electronic prescription has the meaning given by subsection 5(1) of the Regulations.

increased maximum quantity, for a pharmaceutical item, means a quantity or number of units that has been determined under paragraph 85A(2)(a) of the Act as the maximum quantity or number of units of the pharmaceutical item in the pharmaceutical benefit that may, for a relevant purpose, be directed in a prescription to be supplied on any one occasion.

patient: see subsection 3.01(1).

purposes code has the meaning given by the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017.

relevant purpose, for a pharmaceutical benefit, means a purpose, mentioned in Part 1 of Schedule 4 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 for a purposes code specified in Schedule 1 of that instrument for the pharmaceutical benefit, that includes the phrase “The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient”.

requested supply: see subsection 3.01(1).

 (2) Where an expression that is used in this instrument is defined for the purposes of Part VII of the Act, it has the same meaning in this instrument as it has in that Part. Expressions used in this instrument that are defined in Part VII include the following:

 (a) approved pharmacist;

 (b) pbs prescriber;

 (c) pharmaceutical benefit has a drug;

 (d) pharmaceutical benefit;

 (e) pharmaceutical item;

 (f) schedule equivalent.

1.06  Purpose

  The purpose of this instrument is to determine:

 (a) the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription; and

 (b) the conditions that must be satisfied when making a supply of those pharmaceutical benefits.

Part 2—Pharmaceutical benefits that may be supplied without a prescription

2.01  Pharmaceutical benefits covered by this instrument

  For the purposes of paragraph 89A(3)(a) of the Act, each pharmaceutical benefit that has a drug mentioned in an item in Schedule 1 is determined to be a pharmaceutical benefit that may be supplied by an approved pharmacist without a prescription.

Note: A pharmaceutical benefit has the drug or medicinal preparation referred to in paragraph (a) of the definition pharmaceutical benefit in relation to that benefit – see subsection 84ABA(3).

Part 3—Specified conditions for supplying pharmaceutical benefits without a prescription

3.01  General

 (1) For the purposes of paragraph 89A(3)(b) of the Act, the conditions specified in this Part are determined to be the conditions that must be satisfied when making a supply (the requested supply) of a pharmaceutical benefit to a person (the patient) requesting the supply without a prescription in accordance with subsection 89A(1) of the Act.

 (2) In this Part:

 (a) a reference to the PBS prescriber is a reference to the PBS prescriber who most recently prescribed the supply of the pharmaceutical benefit to the patient; and

 (b) a reference to “the pharmaceutical benefit” in sections 3.03, 3.05, 3.06 and 3.07 includes a reference to a pharmaceutical benefit that is a Schedule equivalent.

3.02  Condition—unable to obtain prescription

  The approved pharmacist must be satisfied of either or both of the following:

 (a) the PBS prescriber is unable to be contacted;

 (b) the PBS prescriber is unable to provide an electronic prescription.

3.03  Condition—previous supply of pharmaceutical benefit

  The approved pharmacist must be satisfied that:

 (a) the patient has previously been supplied the pharmaceutical benefit on the basis of a prescription from a PBS prescriber; and

 (b) the PBS prescriber prescribed the supply of the pharmaceutical benefit for the patient in at least one of the circumstances determined for that pharmaceutical benefit under paragraph 85(7)(b) of the Act.

Note: The circumstances determined under paragraph 85(7)(b) of the Act relate to pharmaceutical benefits that are relevant pharmaceutical benefits under section 88A of the Act.

3.04  Condition—stability of therapy

  The approved pharmacist must be satisfied that the patient’s therapy is stable.

3.05  Condition—prior clinical review by PBS prescriber

  The approved pharmacist must be satisfied that:

 (a) the patient has been taking the pharmaceutical benefit regularly for an uninterrupted period; and

 (b) since the start of that period, the PBS prescriber has assessed the patient’s condition and decided that there is a need for ongoing treatment with the pharmaceutical benefit.

Note: See paragraph 3.01(2)(a) for references to the PBS prescriber.

3.06  Condition—prescription for last supply of pharmaceutical benefit

  The approved pharmacist must be satisfied that the patient had a valid prescription under Part VII of the Act for the last supply of the pharmaceutical benefit to the patient before the requested supply.

3.07  Condition—no continued dispensing in previous 12 months

  The approved pharmacist must be satisfied that the patient was not supplied with the pharmaceutical benefit under subsection 89A(1) of the Act in the 12 months before the requested supply.

3.08  Condition—declaration for supply of pharmaceutical benefit

  The approved pharmacist must ensure that the patient, or an agent of the patient (other than the approved pharmacist), signs a declaration acknowledging that the patient is being supplied with the pharmaceutical benefit without the presentation of a valid prescription under Part VII of the Act.

3.09  Condition—maximum quantity of supply

 (1) The approved pharmacist must supply a maximum quantity or number of units of the pharmaceutical item in the pharmaceutical benefit determined under paragraph 85A(2)(a) of the Act.

 (2) However, where an increased maximum quantity has been determined for the pharmaceutical item in the pharmaceutical benefit, the approved pharmacist may only supply that increased maximum quantity if the last supply to the patient of the pharmaceutical benefit, or a pharmaceutical benefit that is Schedule equivalent, was on the basis of a prescription written for:

 (a) a relevant purpose for the pharmaceutical benefit; or

 (b) a relevant purpose for a pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit.

3.10  Condition—preparing and recording information

 (1) The approved pharmacist must, when the pharmaceutical benefit is supplied:

 (a) record the information that the pharmacist used to support the pharmacist’s decision to supply the pharmaceutical benefit; and

 (b) prepare information about the supply to the patient that the pharmacist will send to the PBS prescriber.

 (2) The information that must be recorded and prepared under subsection (1) must include the following:

 (a) a statement that the pharmaceutical benefit supplied is a pharmaceutical benefit covered by Schedule 1;

 (b) a statement that the conditions mentioned in sections 3.02 to 3.05 are satisfied;

 (c) a statement that the approved pharmacist is satisfied that the pharmaceutical benefit needs to be supplied to the patient to facilitate continuity of treatment.

Schedule 1—Pharmaceutical benefits that may be supplied without a prescription - pharmaceutical benefits that have certain listed drugs

Note: See section 2.01.

1  Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist – pharmaceutical benefits that have certain listed drugs

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history