National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 5) Determination 2022 (Cth)

Case

PB 131 of 2022

National Health (Pharmaceutical Benefits)

(Pharmacist Substitution of Medicines without

Prescription during Shortages) Amendment (No. 5) Determination 2022

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

Dated       20  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. 5) Determination 2022.

(2)    This instrument may also be cited as PB 131 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 21 December 2022 21 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Note: This table relates only to the provisions of this instrument as originally made.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), after item 23 dealing with isosorbide mononitrate

Insert:

Prescribed and substitute pharmaceutical benefits
Item Column 1
Prescribed pharmaceutical benefit
Column 2
Substitute pharmaceutical benefit
24

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

25

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

26

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

27

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

28

Listed drug: Cefalexin 

Form:  Capsule 500 mg (as monohydrate)

Manner of administration: Oral

Brands: any of the following:

(a)     APO-Cephalexin

(b)     Cefalexin Sandoz

(c)     Cephalex 500

(d)     Cephalexin generichealth

(e)     Ibilex 500

(f)   NOUMED CEFALEXIN

(g)     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

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