National Health (Continued Dispensing) Determination 2022 (Cth)

National Health (Continued Dispensing) Determination 2022

PB 59 of 2022

made under subsection 89A(3) of the

National Health Act 1953

Compilation No. 1

Compilation date:   1 October 2022

Includes amendments up to:            F2022L01306

Registered:   8 October 2022

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 October 2022 (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 ( 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.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

1.02....... Commencement............................................................................................................. 1

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

1.04....... Schedule 2..................................................................................................................... 1

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

1.06....... Purpose......................................................................................................................... 2

Part 2—Pharmaceutical benefits that may be supplied without a prescription      3

2.01....... Pharmaceutical benefits covered by this instrument....................................................... 3

Part 3—Specified conditions for supplying pharmaceutical benefits without a prescription     4

3.01....... General.......................................................................................................................... 4

3.02....... Condition—unable to obtain prescription...................................................................... 4

3.03....... Condition—previous supply of pharmaceutical benefit................................................. 4

3.04....... Condition—stability of therapy..................................................................................... 4

3.05....... Condition—prior clinical review by PBS prescriber..................................................... 4

3.06....... Condition—prescription for last supply of pharmaceutical benefit................................ 5

3.07....... Condition—no continued dispensing in previous 12 months........................................ 5

3.08....... Condition—declaration for supply of pharmaceutical benefit........................................ 5

3.09....... Condition—maximum quantity of supply..................................................................... 5

3.10....... Condition—preparing and recording information.......................................................... 5

Part 4—Application, savings and transitional provisions  7

4.01....... Application of this instrument....................................................................................... 7

Schedule 1—Pharmaceutical benefits that may be supplied without a prescription  8

1............ Pharmaceutical benefits that may be supplied without a prescription by an approved pharmacist            8

Schedule 2—Repeals  14

National Health (Continued Dispensing) Determination 2012  14

National Health (Continued Dispensing – Emergency Measures) Determination 2020     14

Endnotes15

Endnote 1—About the endnotes  15

Endnote 2—Abbreviation key  16

Endnote 3—Legislation history  17

Endnote 4—Amendment history  18

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.

1.02  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 July 2022.	1 July 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1.03  Authority

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

1.04  Schedule 2

Each instrument that is specified in Schedule 2 to this instrument is amended or repealed as set out in the applicable items in that Schedule, and any other item in that Schedule has effect according to its terms.

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 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, 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 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

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 4—Application, 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 1—Pharmaceutical 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	Adefovir
6	Alogliptin
7	Alogliptin with metformin
8	Amlodipine
9	Amlodipine with atorvastatin
10	Amlodipine with valsartan
11	Amlodipine with valsartan and hydrochlorothiazide
12	Atazanavir
13	Atazanavir with cobicistat
14	Atenolol
15	Atorvastatin
16	Beclometasone
17	Beclometasone with formoterol
18	Bictegravir with emtricitabine with tenofovir alafenamide
19	Bisoprolol
20	Budesonide
21	Budesonide with formoterol
22	Candesartan
23	Candesartan with hydrochlorothiazide
24	Captopril
25	Carvedilol
26	Chlortalidone
27	Ciclesonide
28	Cromoglycic acid
29	Dapagliflozin
30	Dapagliflozin with metformin
31	Darunavir
32	Darunavir with cobicistat
33	Darunavir with cobicistat, emtricitabine and tenofovir alafenamide
34	Diltiazem
35	Dolutegravir
36	Dolutegravir with abacavir and lamivudine
37	Dolutegravir with lamivudine
38	Dolutegravir with rilpivirine
39	Dulaglutide
40	Efavirenz
41	Empagliflozin
42	Empagliflozin with linagliptin
43	Empagliflozin with metformin
44	Emtricitabine with rilpivirine with tenofovir alafenamide
45	Emtricitabine with tenofovir alafenamide
46	Enalapril
47	Enalapril with hydrochlorothiazide
48	Enfuvirtide
49	Entecavir
50	Eplerenone
51	Eprosartan
52	Eprosartan with hydrochlorothiazide
53	Ertugliflozin
54	Ertugliflozin with metformin
55	Ertugliflozin with sitagliptin
56	Etravirine
57	Exenatide
58	Ezetimibe and rosuvastatin
59	Ezetimibe with atorvastatin
60	Ezetimibe with simvastatin
61	Felodipine
62	Fluticasone furoate
63	Fluticasone furoate with vilanterol
64	Fluticasone propionate
65	Fluticasone propionate with formoterol
66	Fluticasone propionate with salmeterol
67	Fluvastatin
68	Formoterol
69	Fosamprenavir
70	Fosinopril
71	Fosinopril with hydrochlorothiazide
72	Furosemide
73	Glibenclamide
74	Gliclazide
75	Glimepiride
76	Glipizide
77	Hydrochlorothiazide
78	Hydrochlorothiazide with amiloride
79	Indacaterol
80	Indacaterol with mometasone
81	Indapamide
82	Insulin aspart
83	Insulin aspart with insulin aspart protamine suspension
84	Insulin degludec with insulin aspart
85	Insulin detemir
86	Insulin glargine
87	Insulin glulisine
88	Insulin isophane
89	Insulin lispro
90	Insulin lispro with insulin lispro protamine suspension
91	Insulin neutral
92	Insulin neutral with insulin isophane
93	Irbesartan
94	Irbesartan with hydrochlorothiazide
95	Labetalol
96	Lamivudine
97	Lamivudine with zidovudine
98	Lercanidipine
99	Lercanidipine with enalapril
100	Levonorgestrel
101	Levonorgestrel with ethinylestradiol
102	Linagliptin
103	Linagliptin with metformin
104	Lisinopril
105	Lopinavir with ritonavir
106	Losartan
107	Maraviroc
108	Metformin
109	Metoprolol
110	Metoprolol succinate
111	Nebivolol
112	Nevirapine
113	Nifedipine
114	Norethisterone
115	Norethisterone with ethinylestradiol
116	Norethisterone with mestranol
117	Olmesartan
118	Olmesartan with amlodipine
119	Olmesartan with amlodipine and hydrochlorothiazide
120	Olmesartan with hydrochlorothiazide
121	Oxprenolol
122	Perindopril
123	Perindopril with amlodipine
124	Perindopril with indapamide
125	Pindolol
126	Pioglitazone
127	Pravastatin
128	Propranolol
129	Quinapril
130	Quinapril with hydrochlorothiazide
131	Raltegravir
132	Ramipril
133	Ramipril with felodipine
134	Rilpivirine
135	Ritonavir
136	Rosuvastatin
137	Sacubitril with valsartan
138	Salbutamol
139	Salmeterol
140	Saquinavir
141	Saxagliptin
142	Saxagliptin with dapagliflozin
143	Saxagliptin with metformin
144	Semaglutide
145	Simvastatin
146	Sitagliptin
147	Sitagliptin with metformin
148	Spironolactone
149	Telmisartan
150	Telmisartan with amlodipine
151	Telmisartan with hydrochlorothiazide
152	Tenofovir
153	Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat
154	Tenofovir with emtricitabine
155	Tenofovir with emtricitabine and efavirenz
156	Terbutaline
157	Tipranavir
158	Trandolapril
159	Trandolapril with verapamil
160	Valsartan
161	Valsartan with hydrochlorothiazide
162	Verapamil
163	Vildagliptin
164	Vildagliptin with metformin
165	Zidovudine

Schedule 2—Repeals

National Health (Continued Dispensing) Determination 2012

1  The whole of the instrument

Repeal the instrument.

National Health (Continued Dispensing – Emergency Measures) Determination 2020

2  The whole of the instrument

Repeal the instrument.

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 2(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)	—

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
Schedule 2
Schedule 2................................	rep LA s48C