Commonwealth Coat of Arms of Australia

 

National Health (Pharmaceutical Benefits)

(Pharmacist Substitution of Medicines without

Prescription during Shortages) Amendment (No. 1) DETERMINATION 2025

 

 

I, Rebecca Richardson, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, Disability and Ageing, as delegate of the Minister for Health and Ageing, make the following determination.

Dated 26 May 2025

 

 

 

Rebecca Richardson

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health, Disability and Ageing

 

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

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

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

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

Schedule 1—Amendments 2

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021

 

 

  1.     This instrument is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2025.
  2.     This instrument may also be cited as PB 52 of 2025.
  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

28 May 2025

28 May 2025

Note: This table relates only to the provisions of this instrument as originally made.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.

  1.     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.

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

 Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of

Medicines without Prescription during Shortages) Determination 2021

1  Subsection 5(8)

 

 

  Repeal the table, substitute:

Prescribed and substitute pharmaceutical benefits

Item

Column 1
Prescribed pharmaceutical benefit

Column 2
Substitute pharmaceutical benefit

1.        

Listed drug: Estradiol

Form: Transdermal patches 390 micrograms, 8

Manner of administration: Transdermal

Brand:  Estradot 25

 

Listed drug: Estradiol

Form: Transdermal patches 750 micrograms (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 25

 

2.        

Listed drug: Estradiol

Form: Transdermal patches 750 micrograms (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 25

Listed drug: Estradiol

Form: Transdermal patches 390 micrograms, 8

Manner of administration: Transdermal

Brand:  Estradot 25

 

3.        

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand:  Estradot 50

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand:   Estraderm MX 50

 

4.        

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand:  Estradot 50

Listed drug: Estradiol

Form: Transdermal patches 390 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 25

5.        

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand:  Estradot 50

Listed drug: Estradiol

Form: Transdermal patches 750 micrograms (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 25

6.        

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand:   Estraderm MX 50

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

7.        

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand:   Estraderm MX 50

Listed drug: Estradiol

Form: Transdermal patches 390 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 25

8.        

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand:   Estraderm MX 50

Listed drug: Estradiol

Form: Transdermal patches 750 micrograms (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 25

9.        

Listed drug: Estradiol

Form: Transdermal patches 1.17 mg, 8

Manner of administration: Transdermal

Brand:   Estradot 75

Listed drug: Estradiol

Form: Transdermal patches 585 micrograms, 8

Manner of administration: Transdermal

Brand: any of the following:

(a) Estradot 37.5

(b) Estradiol Transdermal System (Sandoz, USA)

10.     

Listed drug: Estradiol

Form: Transdermal patches 1.56 mg, 8

Manner of administration: Transdermal

Brand:   Estradot 100

Listed drug: Estradiol

Form: Transdermal patches 3 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 100

11.     

Listed drug: Estradiol

Form: Transdermal patches 1.56 mg, 8

Manner of administration: Transdermal

Brand:   Estradot 100

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

12.     

Listed drug: Estradiol

Form: Transdermal patches 1.56 mg, 8

Manner of administration: Transdermal

Brand:   Estradot 100

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 50

13.     

Listed drug: Estradiol

Form: Transdermal patches 3 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand:   Estraderm MX 100

Listed drug: Estradiol

Form: Transdermal patches 1.56 mg, 8

Manner of administration: Transdermal

Brand: any of the following:

(a) Estradot 100

(b) Estradiol Transdermal System (Sandoz, USA)

14.     

Listed drug: Estradiol

Form: Transdermal patches 3 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand:   Estraderm MX 100

Listed drug: Estradiol

Form: Transdermal patches 780 micrograms, 8

Manner of administration: Transdermal

Brand: Estradot 50

15.     

Listed drug: Estradiol

Form: Transdermal patches 3 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand:   Estraderm MX 100

Listed drug: Estradiol

Form: Transdermal patches 1.5 mg (as hemihydrate), 8

Manner of administration: Transdermal

Brand: Estraderm MX 50

16.     

Listed drug: Insulin isophane

Form: Injections (human), cartridges, 100 units per mL, 3 mL, 5

Manner of administration: Injection

Brand:  Protaphane InnoLet

 

Listed drug: Insulin isophane

Form: Injections (human), cartridges, 100 units per mL, 3 mL, 5

Manner of administration: Injection

Brand: Protaphane Penfill 3 mL

 

17.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   FORMET 1000

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 1000 mg
  3.        Diabex 1000
  4.        Diaformin 1000
  5.        Diaformin Viatris
  6.         Glucobete 1000
  7.        METFORMIN-WGR
  8.        Metformin GH
  9.         Metformin Sandoz

 

18.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   FORMET 1000

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   any of the following:

  1.        APO-Metformin XR 1000
  2.        Diabex XR 1000
  3.        Diaformin Alphapharm XR
  4.        Diaformin XR 1000
  5.        METEX XR
  6.         METFORMIN-WGR XR
  7.        Metformin Sandoz XR
  8.        Pharmacor Metformin XR

 

19.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Diaformin Viatris

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:  any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 1000 mg
  3.        Diabex 1000
  4.        Diaformin 1000
  5.        Formet 1000
  6.         Glucobete 1000
  7.        METFORMIN-WGR
  8.        Metformin GH
  9.         Metformin Sandoz

 

20.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Diaformin Viatris

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   any of the following:

  1.        APO-Metformin XR 1000
  2.        Diabex XR 1000
  3.        Diaformin Alphapharm XR
  4.        Diaformin XR 1000
  5.        METEX XR
  6.         METFORMIN-WGR XR
  7.        Metformin Sandoz XR
  8.        Pharmacor Metformin XR

 

21.     

 

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Metformin GH

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand: any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 1000 mg
  3.        Diabex 1000
  4.        Diaformin 1000
  5.        Formet 1000
  6.         Glucobete 1000
  7.        METFORMIN-WGR
  8.        Diaformin Viatris
  9.         Metformin Sandoz

22.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Metformin GH

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   any of the following:

  1.        APO-Metformin XR 1000
  2.        Diabex XR 1000
  3.        Diaformin Alphapharm XR
  4.        Diaformin XR 1000
  5.        METEX XR
  6.         METFORMIN-WGR XR
  7.        Metformin Sandoz XR
  8.        Pharmacor Metformin XR

 

23.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Metformin Sandoz

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 1000 mg
  3.        Diabex 1000
  4.        Diaformin 1000
  5.        Formet 1000
  6.         Glucobete 1000
  7.        METFORMIN-WGR
  8.        Diaformin Viatris
  9.         Metformin GH

 

24.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Metformin Sandoz

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:  any of the following:

  1.        APO-Metformin XR 1000
  2.        Diabex XR 1000
  3.        Diaformin Alphapharm XR
  4.        Diaformin XR 1000
  5.        METEX XR
  6.         METFORMIN-WGR XR
  7.        Metformin Sandoz XR
  8.        Pharmacor Metformin XR

25.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Diaformin 1000

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:  any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 1000 mg
  3.        Diabex 1000
  4.        Metformin Sandoz
  5.        Formet 1000
  6.         Glucobete 1000
  7.        METFORMIN-WGR
  8.        Diaformin Viatris
  9.         Metformin GH

 

26.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Diaformin 1000

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:  any of the following:

  1.        APO-Metformin XR 1000
  2.        Diabex XR 1000
  3.        Diaformin Alphapharm XR
  4.        Diaformin XR 1000
  5.        METEX XR
  6.         METFORMIN-WGR XR
  7.        Metformin Sandoz XR
  8.        Pharmacor Metformin XR

 

27.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand: FORMET 1000  

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand:  any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 500 mg
  3.        Diabex
  4.        Diaformin
  5.        Diaformin Viatris
  6.         FORMET 500
  7.        Glucobete 500
  8.        METFORMIN-WGR
  9.         Metformin GH
  10.         Metformin Sandoz 

28.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   FORMET 1000

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand:  any of the following:

  1.        APO-Metformin XR 500
  2.        Diabex XR 500
  3.        Diaformin Alphapharm XR
  4.        METFORMIN-WGR XR
  5.        Metex XR
  6.         Metformin Sandoz XR
  7.        Pharmacor Metformin XR  

 

29.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand: Diaformin Viatris  

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand: any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 500 mg
  3.        Diabex
  4.        Diaformin
  5.        Diaformin Viatris
  6.         FORMET 500
  7.        Glucobete 500
  8.        METFORMIN-WGR
  9.         Metformin GH
  10.         Metformin Sandoz  

 

30.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand: Diaformin Viatris  

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand: any of the following:

  1.        APO-Metformin XR 500
  2.        Diabex XR 500
  3.        Diaformin Alphapharm XR
  4.        METFORMIN-WGR XR
  5.        Metex XR
  6.         Metformin Sandoz XR
  7.        Pharmacor Metformin XR  

31.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand: Metformin GH  

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand:  any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 500 mg
  3.        Diabex
  4.        Diaformin
  5.        Diaformin Viatris
  6.         FORMET 500
  7.        Glucobete 500
  8.        METFORMIN-WGR
  9.         Metformin GH
  10.         Metformin Sandoz 

  

32.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Metformin GH

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand: any of the following:

  1.        APO-Metformin XR 500
  2.        Diabex XR 500
  3.        Diaformin Alphapharm XR
  4.        METFORMIN-WGR XR
  5.        Metex XR
  6.         Metformin Sandoz XR
  7.        Pharmacor Metformin XR  

 

33.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:  Metformin Sandoz 

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand:  any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 500 mg
  3.        Diabex
  4.        Diaformin
  5.        Diaformin Viatris
  6.         FORMET 500
  7.        Glucobete 500
  8.        METFORMIN-WGR
  9.         Metformin GH
  10.         Metformin Sandoz 

34.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:   Metformin Sandoz

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand: any of the following:

  1.        APO-Metformin XR 500
  2.        Diabex XR 500
  3.        Diaformin Alphapharm XR
  4.        METFORMIN-WGR XR
  5.        Metex XR
  6.         Metformin Sandoz XR
  7.        Pharmacor Metformin XR   

 

35.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand:  Diaformin 1000 

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand: any of the following:

  1.        APX-METFORMIN
  2.        Blooms The Chemist Metformin 500 mg
  3.        Diabex
  4.        Diaformin
  5.        Diaformin Viatris
  6.         FORMET 500
  7.        Glucobete 500
  8.        METFORMIN-WGR
  9.         Metformin GH
  10.         Metformin Sandoz  

 

36.     

Listed drug: Metformin

Form: Tablet containing metformin hydrochloride 1 g

Manner of administration: Oral

Brand: Diaformin 1000  

Listed drug: Metformin

Form: Tablet (extended release) containing metformin hydrochloride 500 mg

Manner of administration: Oral

Brand: any of the following:

  1.        APO-Metformin XR 500
  2.        Diabex XR 500
  3.        Diaformin Alphapharm XR
  4.        METFORMIN-WGR XR
  5.        Metex XR
  6.         Metformin Sandoz XR
  7.        Pharmacor Metformin XR