Commonwealth Coat of Arms of Australia

 

National Health (Pharmaceutical Benefits)

(Pharmacist Substitution of Medicines without

Prescription during Shortages) Amendment (No. 5) Determination 2023

I, Nikolai Tsyganov, as delegate of the Minister for Health and Aged Care, make the following determination.

Dated 31 July 2023

 

 

 

Nikolai Tsyganov

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care

 

Contents

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  Name

(1)    This instrument is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 5) Determination 2023.

(2)    This instrument may also be cited as PB 78 of 2023.

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.  The whole of this instrument

1 August 2023

1 August 2023

Note: This table relates only to the provisions of this instrument as originally made.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 subsection 89A(3) 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 Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 1—Amendments

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: Warfarin

Form:  Tablet containing warfarin sodium 5 mg

Manner of administration: Oral

Brand: Coumadin

Listed drug:  Warfarin  

Form:   Tablet containing warfarin sodium 1 mg

Manner of administration: Oral

Brand: Coumadin

2

Listed drug: Warfarin

Form:  Tablet containing warfarin sodium 5 mg

Manner of administration: Oral

Brand: Coumadin

Listed drug:  Warfarin  

Form:  Tablet containing warfarin sodium 2 mg

Manner of administration: Oral

Brand: Coumadin

3

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Phenoxymethylpenicillin-AFT

Listed drug: Phenoxymethylpenicillin 

Form: Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Cilicaine V

 

4

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Phenoxymethylpenicillin-AFT

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Phenoxymethylpenicillin-AFT

 

5

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Phenoxymethylpenicillin-AFT

Listed drug: Phenoxymethylpenicillin 

Form: Capsule 250 mg phenoxymethylpenicillin (as potassium)

Manner of administration: Oral

Brand: Any of the following:

a)       Cilicaine VK

b)      LPV

 

 

 

6

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Phenoxymethylpenicillin-AFT

Listed drug: Phenoxymethylpenicillin 

Form: Tablet 250 mg phenoxymethylpenicillin (as potassium)

Manner of administration: Oral

Brand: Aspecillin VK

 

7

Listed drug: Phenoxymethylpenicillin 

Form: Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Cilicaine V

Listed drug: Phenoxymethylpenicillin

Form: Powder for oral liquid 125 mg (as potassium) per 5 mL, 100

Manner of administration: Oral

Brand:  Phenoxymethylpenicillin-AFT

 

8

Listed drug: Phenoxymethylpenicillin 

Form: Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL

Manner of administration: Oral

Brand:   Cilicaine V

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Phenoxymethylpenicillin-AFT 

 

9

Listed drug: Phenoxymethylpenicillin 

Form: Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL

Manner of administration: Oral

Brand:   Cilicaine V

Listed drug: Phenoxymethylpenicillin 

Form: Capsule 250 mg phenoxymethylpenicillin (as potassium)

Manner of administration: Oral

Brand: Any of the following:

a)       Cilicaine VK

b)       LPV

10

Listed drug: Phenoxymethylpenicillin 

Form: Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL

Manner of administration: Oral

Brand:   Cilicaine V

Listed drug: Phenoxymethylpenicillin 

Form: Tablet 250 mg phenoxymethylpenicillin (as potassium)

Manner of administration: Oral

Brand:  Aspecillin VK

11

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand:  Phenoxymethylpenicillin-AFT

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand:  Phenoxymethylpenicillin-AFT

12

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL

Manner of administration: Oral

Brand:  Phenoxymethylpenicillin-AFT

Listed drug: Phenoxymethylpenicillin 

Form: Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Cilicaine V

 

13

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL

Manner of administration:  Oral

Brand:  Phenoxymethylpenicillin-AFT

Listed drug: Phenoxymethylpenicillin 

Form: Capsule 250 mg phenoxymethylpenicillin (as potassium)

Manner of administration: Oral

Brand: Any of the following:

a)       Cilicaine VK

b)       LPV

 

14

Listed drug: Phenoxymethylpenicillin 

Form: Powder for oral liquid 250 mg (as potassium) per 5 mL, 100 mL

Manner of administration:  Oral

Brand:  Phenoxymethylpenicillin-AFT

Listed drug: Phenoxymethylpenicillin

Form: Tablet 250 mg phenoxymethylpenicillin (as potassium)

Manner of administration: Oral

Brand: Aspecillin VK

15

Listed drug: Cefaclor

Form: Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Ceclor

Listed drug: Cefaclor

Form: Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

Manner of administration: Oral

Brand: Any of the following

a)       Ceclor

b)       Keflor

c)       APO-Cefaclor

d)       Aclor 250

16

Listed drug: Cefaclor

Form:  Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Keflor

Listed drug: Cefaclor

Form: Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

Manner of administration: Oral

Brand: Any of the following

a)       Ceclor

b)       Keflor

c)       APO-Cefaclor

d)       Aclor 250

17

Listed drug: Cefaclor 

Form: Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

Manner of administration: Oral

Brand: Ceclor

Listed drug: Cefaclor 

Form: Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Brand: Any of the following:

         a) Ceclor

         b) Keflor

         c) Aclor 125

18

Listed drug: Cefaclor 

Form: Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL

Manner of administration: Oral

Brand: Keflor

Listed drug: Cefaclor

Form: Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand: Any of the following:

         a) Ceclor

         b) Keflor

         c) Aclor 125

19

Listed drug:  Insulin degludec with insulin aspart

Form:   Injections, pre-filled pen, 70 units-30 units per mL, 3 mL, 5

Manner of administration: Injection

Brand:  Ryzodeg Flextouch

Listed drug:  Insulin degludec with insulin aspart

Form:   Injections, cartridges, 70 units-30 units per mL, 3 mL, 5

Manner of administration: Injection

Brand:  Ryzodeg Penfill

20

Listed drug: Cefalexin 

Form: Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:  any of the following:

(a)     Cefalexin Sandoz

(b)    Ibilex 125

(c)     Keflex

Listed drug: Cefalexin 

Form: Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brands: any of the following:

(a)     Cefalexin Sandoz

(b)    Ibilex 250

(c)     Keflex

21

Listed drug: Cefalexin 

Form: Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:  any of the following:

(a)     Cefalexin Sandoz

(b)    Ibilex 125

(c)     Keflex

Listed drug: Cefalexin 

Form:  Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL (s19A)

Manner of administration: Oral

Brand: Keforal (s19A)

22

Listed drug: Cefalexin 

Form: Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:  any of the following:

(a)     Cefalexin Sandoz

(b)    Ibilex 125

(c)     Keflex

Listed drug: Cefalexin

Form: Capsule 250 mg (as monohydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Cephalexin

(b)    Ibilex 250

(c)     Keflex

23

Listed drug: Cefalexin 

Form:  Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:  any of the following:

(a)     Cefalexin Sandoz

(b)    Ibilex 250

(c)     Keflex

Listed drug: Cefalexin 

Form:  Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brands: any of the following:

(a)     Cefalexin Sandoz

(b)    Ibilex 125

(c)     Keflex

24

Listed drug: Cefalexin 

Form:  Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand: any of the following:

(a)     Cefalexin Sandoz

(b)    Ibilex 250

(c)     Keflex

Listed drug: Cefalexin 

Form:  Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL (s19A)

Manner of administration: Oral

(a)     Brand: Keforal (s19A)

25

Listed drug: Cefalexin 

Form:  Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand: any of the following:

(a)     Cefalexin Sandoz

(b)    Ibilex 250

(c)     Keflex

Listed drug: Cefalexin 

Form:  Capsule 250 mg (as monohydrate)

Manner of administration: Oral

Brand: any of the following:

(a)     APO-Cephalexin

(b)    Ibilex 250

(c)     Keflex