Commonwealth Coat of Arms of Australia

National Health (Continued Dispensing) Determination 2012

made under subsection 89A(3) of the

National Health Act 1953

Compilation No. 2

Compilation date: 1 October 2020

Includes amendments up to: PB 98 of 2020

Registered: 12 October 2020

About this compilation

This compilation

This is a compilation of the National Health (Continued Dispensing) Determination 2012 that shows the text of the law as amended and in force on 1 October 2020 (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 Legislation 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 series page on the Legislation 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 series page on the Legislation Register for the compiled law.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

1.03 Definitions

1.04 Purpose

Part 2—Conditions

2.01 General

2.02 Not practicable to obtain prescription

2.03 Previous supply of pharmaceutical benefit

2.04 Stability of therapy

2.05 Prior clinical review by PBS prescriber

2.06 Prescription for last supply of pharmaceutical benefit

2.07 No continued dispensing in previous 12 months

2.08 Declaration by person supplied with pharmaceutical benefit

2.09 Maximum quantity of supply

2.10 Preparing and recording information

Part 3—Pharmaceutical benefits

3.01 Pharmaceutical benefits

Schedule 1—Pharmaceutical benefits

Part 1—Oral hormonal contraceptives

Part 2—Lipid modifying agents

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Part 1Preliminary

 

1.01  Name of determination

  This determination is the National Health (Continued Dispensing) Determination 2012.

1.03  Definitions

 (1) In this determination:

Act means the National Health Act 1953.

PSA Guidelines means the document titled Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, issued by the Pharmaceutical Society of Australia.

requested supply: see subsection 2.01(1).

 (2) In this determination, the following terms have the same meaning as in Part VII of the Act:

  approved pharmacist

  listed brand

  PBS prescriber

  pharmaceutical benefit

  pharmaceutical item.

  Schedule equivalent

1.04  Purpose

  This determination specifies the pharmaceutical benefits that may be supplied, and the conditions that must be satisfied when those pharmaceutical benefits are supplied, by an approved pharmacist without a current prescription, but on the basis of a previous prescription from a PBS prescriber.

Part 2Conditions

 

2.01  General

 (1) For paragraph 89A(3)(b) of the Act, this Part sets out the conditions that must be satisfied when making a supply (the requested supply) of a pharmaceutical benefit to a person under subsection 89A(1) of the Act.

 (2) An approved pharmacist must consider the PSA Guidelines when:

 (a) satisfying the conditions set out in this Part; or

 (b) deciding whether those conditions are satisfied.

 (3) In this Part:

 (a) a reference to the person is a reference to the person who requested the supply of a pharmaceutical benefit under subsection 89A(1) of the Act; and

 (b) 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 person.

 (c) a reference to “the pharmaceutical benefit” in sections 2.03, 2.05, 2.06 and 2.07 includes a pharmaceutical benefit that is Schedule equivalent.

2.02  Not practicable to obtain prescription

  A condition is that the approved pharmacist is satisfied that it is not practicable for the person to obtain a prescription for the pharmaceutical benefit from a PBS prescriber before the person needs the supply of the pharmaceutical benefit.

2.03  Previous supply of pharmaceutical benefit

  A condition is that the approved pharmacist is satisfied that:

 (a) the person 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 person 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.

2.04  Stability of therapy

  A condition is that the approved pharmacist is satisfied that the person’s therapy is stable.

2.05  Prior clinical review by PBS prescriber

  A condition is that the approved pharmacist is satisfied that:

 (a) the person 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 person’s condition and decided that there is a need for ongoing treatment with the pharmaceutical benefit.

Note: See paragraph 2.01(3)(b) for references to the PBS prescriber.

2.06  Prescription for last supply of pharmaceutical benefit

  A condition is that the approved pharmacist is satisfied that the person had a valid prescription under Part VII of the Act for the last supply of the pharmaceutical benefit to the person before the requested supply.

2.07  No continued dispensing in previous 12 months

  A condition is that the approved pharmacist is satisfied that the person was not supplied with the pharmaceutical benefit under subsection 89A(1) of the Act in the 12 months before the requested supply.

2.08  Declaration by person supplied with pharmaceutical benefit

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

2.09  Maximum quantity of supply

  A condition is that the approved pharmacist supplies a maximum quantity or number of units of the pharmaceutical item in the pharmaceutical benefit determined under paragraph 85A(2)(a) of the Act.

2.10  Preparing and recording information

 (1) A condition is that, when the pharmaceutical benefit is supplied, the approved pharmacist:

 (a) records the information that the pharmacist used to support his or her decision to supply the pharmaceutical benefit; and

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

Note: See the PSA Guidelines for guidance about when the information should be sent to the PBS prescriber.

 (2) The information that must be recorded and prepared includes the following:

 (a) a statement that the pharmaceutical benefit supplied is a pharmaceutical benefit determined under paragraph 89A(3)(a) of the Act;

 (b) a statement that the conditions mentioned in sections 2.02 to 2.05 are satisfied;

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

Part 3Pharmaceutical benefits

 

3.01  Pharmaceutical benefits

 (1) For subsection 89A(3)(a) of the Act, an approved pharmacist may supply without a prescription a pharmaceutical benefit, being any listed brand of a pharmaceutical item mentioned in Schedule 1.

 (2) For subsection (1), the pharmaceutical item is the listed drug mentioned in Schedule 1:

 (a) in the form mentioned in Schedule 1 for the listed drug; and

 (b) with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

 

Schedule 1Pharmaceutical benefits

(section 3.01)

Part 1Oral hormonal contraceptives

 

Listed Drug

Form

Manner of Administration

Levonorgestrel

Tablets 30 micrograms, 28

Oral

Levonorgestrel with ethinylestradiol

Pack containing 21 tablets 100 micrograms20 micrograms and 7 inert tablets

Oral

 

Pack containing 21 tablets 125 micrograms50 micrograms and 7 inert tablets

Oral

 

Pack containing 21 tablets 150 micrograms30 micrograms and 7 inert tablets

Oral

 

Pack containing 6 tablets 50 micrograms30 micrograms, 5 tablets 75 micrograms40 micrograms, 10 tablets 125 micrograms30 micrograms and 7 inert tablets

Oral

Norethisterone

Tablets 350 micrograms, 28

Oral

Norethisterone with ethinylestradiol

Pack containing 21 tablets 500 micrograms35 micrograms and 7 inert tablets

Oral

 

Pack containing 21 tablets 1 mg35 micrograms and 7 inert tablets

Oral

Norethisterone with Mestranol

Pack containing 21 tablets 1 mg50 micrograms and 7 inert tablets

Oral

Part 2Lipid modifying agents

 

Listed Drug

Form

Manner of Administration

Atorvastatin

Tablet 10 mg (as calcium)

Oral

 

Tablet 20 mg (as calcium)

Oral

 

Tablet 40 mg (as calcium)

Oral

 

Tablet 80 mg (as calcium)

Oral

Fluvastatin

Tablet (prolonged release) 80 mg (as sodium)

Oral

Pravastatin

Tablet containing pravastatin sodium 10 mg

Oral

 

Tablet containing pravastatin sodium 20 mg

Oral

 

Tablet containing pravastatin sodium 40 mg

Oral

 

Tablet containing pravastatin sodium 80 mg

Oral

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

 

Tablet 10 mg (as calcium)

Oral

 

Tablet 20 mg (as calcium)

Oral

 

Tablet 40 mg (as calcium)

Oral

Simvastatin

Tablet 5 mg

Oral

 

Tablet 10 mg

Oral

 

Tablet 20 mg

Oral

 

Tablet 40 mg

Oral

 

Tablet 80 mg

Oral

 

 

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 the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/subsubparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

SubCh = SubChapter(s)

cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

National Health (Continued Dispensing) Determination 2012

29 June 2012 (F2012L01465)

1 July 2012 (s 1.02)

 

National Health (Continued Dispensing) Amendment Determination 2013 (No. 1) (PB 45 of 2013)

9 Aug 2013 (F2013L01561)

10 Aug 2013 (s 2)

National Health (Continued Dispensing) Amendment Determination 2020 (No. 1) (PB 98 of 2020)

30 Sept 2020 (F2020L01252)

1 Oct 2020 (s 2(1) item 1)

 

Endnote 4—Amendment history

 

Provision affected

How affected

Part 1

 

s 1.02...................

rep LA s 48D

s 1.03...................

am PB 45 of 2013; PB 98 of 2020

Part 2

 

s 2.01...................

am PB 45 of 2013

Part 3

 

s 3.01...................

rs PB 45 of 2013

Schedule 1

 

Schedule 1................

rs PB 45 of 2013

Part 1

 

Part 1...................

am PB 98 of 2020

Part 2

 

Part 2...................

am PB 98 of 2020