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PB 109 of 2020 Other as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) and the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) to allow for pharmaceutical benefits which are available for supply purposes only.
Administered by: Health
Registered 30 Oct 2020
Tabling HistoryDate
Tabled HR09-Nov-2020
Tabled Senate09-Nov-2020
Date of repeal 16 Feb 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

Commonwealth Coat of Arms of Australia

 

PB 109 of 2020

 

National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020

I, Paul Hansen, as delegate of the Minister for Health, make the following instrument.

Dated 29 October 2020

Paul Hansen
Acting Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division

Department of Health

 

  

  


Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments                                                                                                                          1

Part 1—Listing of pharmaceutical benefits                                                                                  1

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)      1

Part 2—Highly specialised drugs                                                                                                    11

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)            11

 


1  Name

             (1)  This instrument is the National Health Legislation Amendment (Listing of Pharmaceutical Benefits for Supply Only) Instrument 2020.

             (2)  This instrument may also be cited as PB 109 of 2020.

2  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.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

1 November 2020.

1 November 2020

2.  Schedule 1, Part 1

Immediately after the commencement of the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 10) (PB 102 of 2020).

1 November 2020

3.  Schedule 1, Part 2

Immediately after the commencement of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 9) (PB 106 of 2020).

1 November 2020

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.

3  Authority

                   This instrument is made under section 88 and subsection 100(2) of the National Health Act 1953.

4  Schedules

                   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.


Schedule 1Amendments

Part 1Listing of pharmaceutical benefits

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

1  Section 9 (heading)

Repeal the heading, substitute:

9  Authorised prescribers—Part 1 of Schedule 1

2  Subsection 9(1A)

After “benefit”, insert “mentioned in Part 1 of Schedule 1”.

3  Subsections 9(1), (2), (3), (4) and (5)

Before “Schedule 1” (wherever occurring), insert “Part 1 of”.

4  Schedule 1 (heading)

Repeal the heading (including the note), substitute:

Schedule 1Ready‑prepared pharmaceutical benefits

Note:       See sections 5 to 10, 16 to 18, 20, 21 and 23 to 26.

Part 1Ready‑prepared pharmaceutical benefits for prescription and supply

  

5  Schedule 1, at the end

Add:

Part 2Ready‑prepared pharmaceutical benefits for supply only

  

Note:       Section 9 (authorised prescribers) does not apply to pharmaceutical benefits listed in this Part.

 

Listed Drug

Form

Manner of Administration

Schedule Equivalent

Brand

Responsible Person

Authorised Prescriber

Circumstances

Purposes

Maximum Quantity

Number of Repeats

Pack Quantity

Determined Quantity

Section 100/ Prescriber Bag only

Aciclovir

Eye ointment 30 mg per g, 4.5 g

Application to the eye

 

Zovirax

GK

MP NP

C5965

 

1

0

1

 

 

Aciclovir

Eye ointment 30 mg per g, 4.5 g

Application to the eye

 

Zovirax

GK

AO

C5964

 

1

0

1

 

 

Amisulpride

Tablet 100 mg

Oral

a

Pharmacor Amisulpride

CR

MP NP

C4246

 

30

5

30

 

 

Amisulpride

Tablet 200 mg

Oral

a

Pharmacor Amisulpride

CR

MP NP

C4246

 

60

5

60

 

 

Amisulpride

Tablet 400 mg

Oral

a

Pharmacor Amisulpride

CR

MP NP

C4246

 

60

5

60

 

 

Amlodipine

Tablet 5 mg (as besilate)

Oral

a

Pharmacor Amlodipine

CR

MP NP

 

 

30

5

30

 

 

Amlodipine

Tablet 10 mg (as besilate)

Oral

a

Pharmacor Amlodipine

CR

MP NP

 

 

30

5

30

 

 

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

a

Clavam 875 mg/125 mg

CR

MP NP

C5832 C5893 C10413

P5832 P5893

10

0

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

a

Clavam 875 mg/125 mg

CR

MP NP

C5833 C5894

 

10

0

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

a

Clavam 875 mg/125 mg

CR

MP NP

C5832 C5893 C10413

P10413

20

0

10

 

 

Cefazolin

Powder for injection 1 g (as sodium)

Oral

a

Cefazolin Sandoz

SZ

MP NP

C5861 C5882 C5883 C5891

 

10

0

10

 

 

Codeine

Tablet containing codeine phosphate hemihydrate 30 mg

Oral

 

Aspen Pharma Pty Ltd

AS

MP NP

C10479

 

20

0

20

 

 

Cyproterone

Tablet containing cyproterone acetate 50 mg

Oral

a

Cyprostat

SY

MP

C5532

 

20

5

20

 

 

Darunavir

Tablet 150 mg (as ethanolate)

Oral

 

Prezista

JC

MP

C5094

 

240

5

240

 

D(100)

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

a

Pharmacor Diclofenac 50

CR

PDP

C6256 C6282

 

50

0

50

 

 

Diclofenac

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

a

Pharmacor Diclofenac 50

CR

MP NP

C6149 C6214 C6283

 

50

3

50

 

 

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

a

Pharmacor Donepezil 10

CR

MP NP

C10099 C10100 C10107 C10108 C10110

P10107 P10110

28

1

28

 

 

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

a

Pharmacor Donepezil 10

CR

MP NP

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

28

5

28

 

 

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

a

Pharmacor Donepezil 10

CR

MP NP

C10108

 

28

5

28

 

 

Escitalopram

Tablet 10 mg (as oxalate)

Oral

a

Pharmacor Escitalopram 10

CR

MP NP

C4755

 

28

5

28

 

 

Escitalopram

Tablet 20 mg (as oxalate)

Oral

a

Pharmacor Escitalopram 20

CR

MP NP

C4755

 

28

5

28

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

a

Pharmacor Esomeprazole

CR

MP NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

a

Pharmacor Esomeprazole

CR

MP NP

C8774 C8775 C8776 C8780 C8827

P8776 P8780 P8827

30

5

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

a

Pharmacor Esomeprazole

CR

MP NP

C8777 C8778 C8902

C8902

30

1

30

 

 

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

a

Pharmacor Esomeprazole

CR

MP NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

Famciclovir

Tablet 250 mg

Oral

a

Famciclovir SCP 250

CR

MP NP

C5951 C5971

P5951

21

0

21

 

 

 

 

 

 

 

 

MP NP

C5951 C5971

P5971

56

5

56

 

 

Flucloxacillin

Capsule 250 mg (as sodium)

Oral

a

Medsurge

DZ

PDP

C5298

 

24

0

28

 

 

 

 

 

 

 

 

MP NP MW

C5414

 

24

0

28

 

 

Flucloxacillin

Capsule 500 mg (as sodium)

Oral

a

Medsurge

DZ

PDP

C5298

 

24

0

100

 

 

 

 

 

 

 

 

MP

C5414 C6169

P5414

24

0

100

 

 

 

 

 

 

 

 

NP MW

C5414

 

24

0

100

 

 

 

 

 

 

 

 

MP

C5414 C6169

P6169

48

1

100

 

 

Fluconazole

Solution for I.V. infusion 200 mg in 100 mL

 

a

Fluconazole Sandoz

SZ

MP NP

C6956 C6965 C6969 C6974 C6978 C7897

 

7

0

1

 

 

Folinic acid

Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL

Injection

a

Calcium Folinate Ebewe

SZ

MP

 

 

10

1

1

 

 

Ketoconazole

Shampoo 10 mg per g, 100 mL

Application

 

Nizoral 1%

JT

MP NP

C6434

 

1

1

1

 

 

Lenograstim

Powder for injection 13,400,000 I.U. (105 micrograms)

Injection

 

Granocyte 13

PF

MP

C6502 C6507 C6516 C6522 C6523 C6532 C6535 C6634 C6644 C6653 C6654 C6657 C6673 C6682 C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327

 

20

11

1

 

D(100)

Lenograstim

Powder for injection 33,600,000 I.U. (263 micrograms)

Injection

 

Granocyte 34

PF

MP

C6502 C6507 C6516 C6522 C6523 C6532 C6535 C6634 C6644 C6653 C6654 C6657 C6673 C6682 C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327

 

20

11

1

 

D(100)

Levodopa with carbidopa

Tablet 250 mg‑25 mg (USP)

Oral

 

Carbidopa and Levodopa Tablets, USP

DZ

MP NP

 

 

100

5

100

 

 

Nifedipine

Tablet 20 mg (controlled release)

Oral

 

Adalat Oros 20mg

BN

MP NP

 

 

30

5

30

 

 

Olanzapine

Tablet 7.5 mg (as benzoate)

Oral

 

Olanzapine generichealth 7.5

GQ

MP NP

C5856 C5869

 

28

5

28

 

 

Omeprazole

Tablet 20 mg

Oral

a

Pharmacor Omeprazole

CR

MP NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

Omeprazole

Tablet 20 mg

Oral

a

Pharmacor Omeprazole

CR

MP NP

C8774 C8775 C8776 C8780 C8866

P8776 P8780 P8866

30

5

30

 

 

Oxaliplatin

Solution concentrate for I.V. infusion 50 mg in 10 mL

Injection

 

Oxaliplatin SUN

RA

MP

 

 

See Note 3

See Note 3

1

 

D(100)

Phenelzine

Tablet 15 mg (as sulfate) (USP)

Oral

 

Nardil

LM

MP

C6236

 

100

1

60

 

 

Phenoxybenzamine

Capsule containing 10 mg phenoxybenzamine hydrochloride

Oral

 

Dibenzyline

BZ

MP NP

C6145 C6178

 

100

5

100

 

 

Ranitidine

Tablet, effervescent, 150 mg (as hydrochloride)

Oral

 

Zantac

AS

MP NP

 

 

60

5

30

 

 

Risperidone

Tablet 0.5 mg

Oral

a

Rispericor 0.5

CR

MP NP

C5903 C6898 C6899 C10020 C10021

P6898 P6899 P10020 P10021

60

2

60

 

 

 

 

 

 

 

 

MP NP

C5903 C6898 C6899 C10020 C10021

P5903

60

5

60

 

 

Risperidone

Tablet 1 mg

Oral

a

Rispericor 1

CR

MP NP

C4246 C5907 C6898 C6899 C10020 C10021

P6898 P6899 P10020 P10021

60

2

60

 

 

 

 

 

 

 

 

MP NP

C4246 C5907 C6898 C6899 C10020 C10021

P4246 P5907

60

5

60

 

 

Risperidone

Tablet 2 mg

Oral

a

Rispericor 2

CR

MP NP

C4246 C5907 C6897 C6938

P6897 P6938

60

2

60

 

 

 

 

 

 

 

 

MP NP

C4246 C5907 C6897 C6938

P4246 P5907

60

5

60

 

 

Sofosbuvir

Tablet 400 mg

Oral

 

Sovaldi

GI

MP NP

 

C5969 C5972

P5969

28

2

28

 

 

 

 

 

 

 

 

MP NP

 

C5969 C5972

P5972

28

5

28

 

 

Tenofovir with emtricitabine and efavirenz

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg

Oral

 

Atripla

GI

MP NP

C4470 C4522

 

60

5

30

 

D(100)

Tramadol

Capsule containing tramadol hydrochloride 50 mg

Oral

a

Tramadol SCP

CR

MP NP

C10764 C10766 C10771 C10772

P10766

10

0

20

 

 

 

 

 

 

 

 

PDP

C10766 C10768

P10766

10

0

20

 

 

 

 

 

 

 

 

MP NP

C10764 C10766 C10771 C10772

P10764 P10771 P10772

20

0

20

 

 

 

 

 

 

 

 

PDP

C10766 C10768

P10768

20

0

20

 

 

Part 2Highly specialised drugs

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

6  At the end of section 8

Add:

             (6)  Subsection (1) does not apply to an HSD pharmaceutical benefit mentioned in Part 2 of Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (ready‑prepared pharmaceutical benefits for supply only).