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National Health (Continued Dispensing) Determination 2022

Authoritative Version
  • - F2023C00808
  • In force - Superseded Version
  • View Series
PB 59 of 2022 Determinations/Health as amended, taking into account amendments up to National Health (Continued Dispensing) Amendment Determination 2023 (No. 2)
This instrument expands the list of eligible medicines that can be obtained under Continued Dispensing arrangements and repeals the National Health (Continued Dispensing) Determination 2012 and the National Health (Continued Dispensing – Emergency Measures) Determination 2020.
Administered by: Health and Aged Care
Registered 15 Sep 2023
Start Date 01 Sep 2023
End Date 30 Nov 2023

Commonwealth Coat of Arms of Australia

National Health (Continued Dispensing) Determination 2022

PB 59 of 2022

made under subsection 89A(3) of the

National Health Act 1953

Compilation No. 3

Compilation date:                              1 September 2023

Includes amendments up to:            F2023L01156

Registered:                                         15 September 2023

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 September 2023 (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

1.01....... Name............................................................................................................................. 1

1.03....... Authority....................................................................................................................... 1

1.05....... Definitions..................................................................................................................... 1

1.06....... Purpose......................................................................................................................... 1

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

2.01....... Pharmaceutical benefits covered by this instrument....................................................... 2

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

3.01....... General.......................................................................................................................... 3

3.02....... Condition—unable to obtain prescription...................................................................... 3

3.03....... Condition—previous supply of pharmaceutical benefit................................................. 3

3.04....... Condition—stability of therapy..................................................................................... 3

3.05....... Condition—prior clinical review by PBS prescriber..................................................... 3

3.06....... Condition—prescription for last supply of pharmaceutical benefit................................ 4

3.07....... Condition—no continued dispensing in previous 12 months........................................ 4

3.08....... Condition—declaration for supply of pharmaceutical benefit........................................ 4

3.09....... Condition—maximum quantity of supply..................................................................... 4

3.10....... Condition—preparing and recording information.......................................................... 4

Part 4—Application, savings and transitional provisions                                                        5

4.01....... Application of this instrument....................................................................................... 5

Schedule 1—Pharmaceutical benefits that may be supplied without a prescription  6

1............ Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist            6

Endnotes                                                                                                                                                               12

Endnote 1—About the endnotes                                                                                                      12

Endnote 2—Abbreviation key                                                                                                          13

Endnote 3—Legislation history                                                                                                       14

Endnote 4—Amendment history                                                                                                     15

 


Part 1Preliminary

  

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.

patient: see subsection 3.01(1).

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

requested supply: see subsection 3.01(1).

             (2)  An expression that is used in this instrument and in Part VII of the Act has the same meaning in this instrument as it has in that Part.

Examples:

(a)    approved pharmacist;

(b)    listed brand;

(c)    PBS prescriber;

(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 2Pharmaceutical 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, the pharmaceutical benefits covered by an item in the table in Schedule 1 (being the listed drugs specified in the item) are determined to be pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription.

Part 3Specified 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

                   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.

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.

Part 4Application, savings and transitional provisions

  

4.01  Application of this instrument

                   Despite the repeal of the National Health (Continued Dispensing – Emergency Measures) Determination 2020, that instrument (the emergency instrument) continues to have effect, on and after 1 July 2022, for the purposes of the National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022 in relation to a supply of a pharmaceutical benefit made in accordance with the emergency instrument on or before 30 June 2022 as if the repeal had not happened.

Schedule 1Pharmaceutical benefits that may be supplied without a prescription

Note:       See section 3.01.

  

  

1  Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist

 

Item

Listed drug

1

Abacavir

2

Abacavir with lamivudine

3

Abacavir with lamivudine and zidovudine

4

Acarbose

5

Alogliptin

6

Alogliptin with metformin

7

Amlodipine

8

Amlodipine with atorvastatin

9

Amlodipine with valsartan

10

Amlodipine with valsartan and hydrochlorothiazide

11

Atazanavir

12

Atazanavir with cobicistat

13

Atenolol

14

Atorvastatin

15

Beclometasone

16

Beclometasone with formoterol

17

Bictegravir with emtricitabine with tenofovir alafenamide

18

Bisoprolol

19

Budesonide

20

Budesonide with formoterol

21

Candesartan

22

Candesartan with hydrochlorothiazide

23

Captopril

24

Carvedilol

25

Chlortalidone

26

Ciclesonide

27

Dapagliflozin

28

Dapagliflozin with metformin

29

Darunavir

30

Darunavir with cobicistat

31

Darunavir with cobicistat, emtricitabine and tenofovir alafenamide

32

Diltiazem

33

Dolutegravir with abacavir and lamivudine

34

Dolutegravir with lamivudine

35

Dolutegravir with rilpivirine

36

Dulaglutide

37

Empagliflozin

38

Empagliflozin with linagliptin

39

Empagliflozin with metformin

40

Emtricitabine with rilpivirine with tenofovir alafenamide

41

Emtricitabine with tenofovir alafenamide

42

Enalapril

43

Enalapril with hydrochlorothiazide

44

Eplerenone

45

Eprosartan

46

Eprosartan with hydrochlorothiazide

47

Etravirine

48

Ezetimibe and rosuvastatin

49

Ezetimibe with atorvastatin

50

Ezetimibe with simvastatin

51

Felodipine

52

Fluticasone furoate

53

Fluticasone furoate with vilanterol

54

Fluticasone propionate

55

Fluticasone propionate with formoterol

56

Fluticasone propionate with salmeterol

57

Fluvastatin

58

Formoterol

59

Fosamprenavir

60

Fosinopril

61

Fosinopril with hydrochlorothiazide

62

Furosemide

63

Glibenclamide

64

Gliclazide

65

Glimepiride

66

Glipizide

67

Hydrochlorothiazide

68

Hydrochlorothiazide with amiloride

69

Indacaterol

70

Indacaterol with mometasone

71

Indapamide

72

Insulin aspart

73

Insulin aspart with insulin aspart protamine suspension

74

Insulin degludec with insulin aspart

75

Insulin detemir

76

Insulin glargine

77

Insulin glulisine

78

Insulin isophane

79

Insulin lispro

80

Insulin lispro with insulin lispro protamine suspension

81

Insulin neutral

82

Insulin neutral with insulin isophane

83

Irbesartan

84

Irbesartan with hydrochlorothiazide

85

Labetalol

86

Lamivudine

87

Lamivudine with zidovudine

88

Lercanidipine

89

Lercanidipine with enalapril

90

Levonorgestrel

91

Levonorgestrel with ethinylestradiol

92

Linagliptin

93

Linagliptin with metformin

94

Lisinopril

95

Lopinavir with ritonavir

96

Maraviroc

97

Metformin

98

Metoprolol

99

Metoprolol succinate

100

Nebivolol

101

Nevirapine

102

Nifedipine

103

Norethisterone

104

Norethisterone with ethinylestradiol

105

Olmesartan

106

Olmesartan with amlodipine

107

Olmesartan with amlodipine and hydrochlorothiazide

108

Olmesartan with hydrochlorothiazide

109

Oxprenolol

110

Perindopril

111

Perindopril with amlodipine

112

Perindopril with indapamide

113

Pioglitazone

114

Pravastatin

115

Propranolol

116

Quinapril

117

Quinapril with hydrochlorothiazide

118

Ramipril

119

Ramipril with felodipine

120

Rilpivirine

121

Ritonavir

122

Rosuvastatin

123

Sacubitril with valsartan

124

Salbutamol

125

Salmeterol

126

Saxagliptin

127

Saxagliptin with dapagliflozin

128

Saxagliptin with metformin

129

Semaglutide

130

Simvastatin

131

Sitagliptin

132

Sitagliptin with metformin

133

Sotalol

134

Spironolactone

135

Telmisartan

136

Telmisartan with amlodipine

137

Telmisartan with hydrochlorothiazide

138

Tenofovir

139

Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat

140

Tenofovir with emtricitabine

141

Tenofovir with emtricitabine and efavirenz

142

Terbutaline

143

Trandolapril

144

Trandolapril with verapamil

145

Valsartan

146

Valsartan with hydrochlorothiazide

147

Verapamil

148

Vildagliptin

149

Vildagliptin with metformin

150

Zidovudine

 


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

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

/sub‑subparagraph(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

Sub‑Ch = Sub‑Chapter(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 2022 (PB 59 of 2022)

30 June 2022 (F2022L00884)

1 July 2022 (s 1.02(1) item 1)

 

National Health (Continued Dispensing) Amendment Determination 2022 (No. 1) (PB 88 of 2022)

30 Sept 2022 (F2022L01306)

1 Oct 2022 (s 2(1) item 1)

National Health (Continued Dispensing) Amendment Determination 2023 (No. 1) (PB 70 of 2023)

31 July 2023 (F2023L01045)

1 Aug 2023 (s 2(1) item 1)

National Health (Continued Dispensing) Amendment Determination 2023 (No. 2) (PB 83 of 2023)

31 Aug 2023 (F2023L01156)

1 Sept 2023 (s 2(1) item 1)

 

Endnote 4—Amendment history

 

Provision affected

How affected

Part 1

 

s 1.02........................................

rep LA s 48D

s 1.04........................................

rep LA s 48C

Schedule 1

 

s 1.............................................

am F2022L01306; F2023L01045; F2023L01156

Schedule 2................................

rep LA s 48C