National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2022 (Cth)

Case

PB 119 of 2022

National Health (Pharmaceutical Benefits)

(Pharmacist Substitution of Medicines without

Prescription during Shortages) Amendment (No. 4) Determination 2022

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

Dated       5  December 2022

Nikolai Tsyganov

Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care

Contents

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

  1. Commencement .......................................................................................................... 1

  1. Authority ..................................................................................................................... 1

  1. Schedules .................................................................................................................... 1

Schedule 1—Amendments

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines

2
without Prescription during Shortages) Determination 2021 2

1  Name

(1)    This instrument is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2022.

(2)    This instrument may also be cited as PB 119 of 2022.

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 6 December 2022 6 December 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Note: This table relates only to the provisions of this instrument as originally made.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.

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

Schedule 1—Amendments

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of

Medicines without Prescription during Shortages) Determination 2021

1  Subsection 5(8)

Omit:

Prescribed and substitute pharmaceutical benefits
Item Column 1
Prescribed pharmaceutical benefit 		Column 2
Substitute pharmaceutical benefit
5

Listed drug: Isosorbide mononitrate

Form: Tablet 120 mg (sustained release)

Manner of administration: Oral

Brand: either of the following:

(a) Imdur 120 mg;

(b) Monodur 120 mg

Listed drug: Isosorbide mononitrate

Form: Tablet 60 mg (sustained release)

Manner of administration: Oral

Brand: any of the following:

(a) APO‑Isosorbide Mononitrate;

(b) Duride;

(c) GenRx Isosorbide Mononitrate;

(d) Imdur Durule;

(e) ISOBIDE MR;

(f) Isomonit;

(g) Isosorbide AN;

(h) Monodur 60 mg

Insert:

Prescribed and substitute pharmaceutical benefits
Item Column 1
Prescribed pharmaceutical benefit 		Column 2
Substitute pharmaceutical benefit
1

Listed drug: Amoxicillin

Form: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Manner of administration: Oral

Brand:

(a)     Amoxil

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil

(c)     NOUMED AMOXICILLIN
2

Listed drug: Amoxicillin

Form: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Manner of administration: Oral

Brand:

(a)     Amoxil

Listed drug: Amoxicillin

Form: Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil Forte

(c)     Amoxycillin Sandoz

(d)     Cilamox

(e)     NOUMED AMOXICILLIN
3

Listed drug: Amoxicillin

Form: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Manner of administration: Oral

Brand:

(a)     Amoxil

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxicillin 250mg/5 ml Oral Suspension Sugar Free BP (Kent)
4

Listed drug: Amoxicillin

Form: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Manner of administration: Oral

Brand:

(a)     Amoxil

Listed drug: Amoxicillin

Form: Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:

(a)     Maxamox
5

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil

(c)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

Form: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Manner of administration: Oral

Brand:

(a)     Amoxil
6

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil

(c)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

Form: Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil Forte

(c)     Amoxycillin Sandoz

(d)     Cilamox

(e)     NOUMED AMOXICILLIN
7

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil

(c)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxicillin 250mg/5 ml Oral Suspension Sugar Free BP (Kent)
8

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil

(c)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

Form: Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:

(a)     Maxamox
9

Listed drug: Amoxicillin

Form: Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil Forte

(c)     Amoxycillin Sandoz

(d)     Cilamox

(e)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

Form: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Manner of administration: Oral

Brand:

(a)     Amoxil
10

Listed drug: Amoxicillin

Form: Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil Forte

(c)     Amoxycillin Sandoz

(d)     Cilamox

(e)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil

(c)     NOUMED AMOXICILLIN
11

Listed drug: Amoxicillin

Form: Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil Forte

(c)     Amoxycillin Sandoz

(d)     Cilamox

(e)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

Form: Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:

(a)     Maxamox
12

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxicillin 250mg/5 ml Oral Suspension Sugar Free BP (Kent)

Listed drug: Amoxicillin

Form: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Manner of administration: Oral

Brand:

(a)     Amoxil
13

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxicillin 250mg/5 ml Oral Suspension Sugar Free BP (Kent)

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil

(c)     NOUMED AMOXICILLIN
14

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxicillin 250mg/5 ml Oral Suspension Sugar Free BP (Kent)

Listed drug: Amoxicillin

Form: Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:

(a)     Maxamox
15

Listed drug: Amoxicillin

Form: Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:

(a)     Maxamox

Listed drug: Amoxicillin

Form: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Manner of administration: Oral

Brand:

(a)     Amoxil
16

Listed drug: Amoxicillin

Form: Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:

(a)     Maxamox

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil

(c)     NOUMED AMOXICILLIN
17

Listed drug: Amoxicillin

Form: Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:

(a)     Maxamox

Listed drug: Amoxicillin

Form: Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Amoxycillin

(b)     Amoxil Forte

(c)     Amoxycillin Sandoz

(d)     Cilamox

(e)     NOUMED AMOXICILLIN
18

Listed drug: Amoxicillin

Form: Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL

Manner of administration: Oral

Brand:

(a)     Maxamox

Listed drug: Amoxicillin

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

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxicillin 250mg/5 ml Oral Suspension Sugar Free BP (Kent)
19

Listed drug: Amoxicillin

Form: Capsule 500 mg (as trihydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     AMILOXYN

(b)     APO-Amoxycillin

(c)     Alphamox 500

(d)     Amoxil

(e)     Amoxycillin Sandoz

(f)   Amoxycillin generichealth 500

(g)     Cilamox

(h)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

Form: Capsule 250 mg (as trihydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     AMILOXYN

(b)     APO-Amoxycillin

(c)     Alphamox 250

(d)     Amoxil

(e)     Cilamox
20

Listed drug: Amoxicillin

Form: Capsule 500 mg (as trihydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     AMILOXYN

(b)     APO-Amoxycillin

(c)     Alphamox 500

(d)     Amoxil

(e)     Amoxycillin Sandoz

(f)   Amoxycillin generichealth 500

(g)     Cilamox

(h)     NOUMED AMOXICILLIN

Listed drug: Amoxicillin

Form: Tablet 1 g (as trihydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxycillin Sandoz

(b)     Maxamox
21

Listed drug: Amoxicillin

Form: Tablet 1 g (as trihydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxycillin Sandoz

(b)     Maxamox

Listed drug: Amoxicillin

Form: Capsule 250 mg (as trihydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     AMILOXYN

(b)     APO-Amoxycillin

(c)     Alphamox 250

(d)     Amoxil

(e)     Cilamox
22

Listed drug: Amoxicillin

Form: Tablet 1 g (as trihydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     Amoxycillin Sandoz

(b)     Maxamox

Listed drug: Amoxicillin

Form: Capsule 500 mg (as trihydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     AMILOXYN

(b)     APO-Amoxycillin

(c)     Alphamox 500

(d)     Amoxil

(e)     Amoxycillin Sandoz

(f)   Amoxycillin generichealth 500

(g)     Cilamox

(h)     NOUMED AMOXICILLIN
23

Listed drug: Isosorbide mononitrate

Form: Tablet 120 mg (sustained release)

Manner of administration: Oral

Brand: either of the following:

(a) Imdur 120 mg;

(b) Monodur 120 mg

Listed drug: Isosorbide mononitrate

Form: Tablet 60 mg (sustained release)

Manner of administration: Oral

Brand: any of the following:

(a) APO‑Isosorbide Mononitrate;

(b) Duride;

(c) GenRx Isosorbide Mononitrate;

(d) Imdur Durule;

(e) ISOBIDE MR;

(f) Isomonit;

(g) Isosorbide AN;

(h) Monodur 60 mg
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