1Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Instrument 2026

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Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Instrument 2026

I, George Vuckovic, as delegate of the Minister for Health and Ageing, make the following instrument.

Dated 22 January 2026

 

George Vuckovic

Acting First Assistant Secretary

Medicines Regulation Division

Health Products Regulation Group

Department of Health, Disability and Ageing

 

 

 

 

 

Contents

1  Name

2  Commencement

3  Authority

4  Definitions

5  Declaration of serious scarcity of medicine

6  Substitution of scarce medicine by pharmacists

7  Period of enforcement

8  Repeals

Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence, specific circumstances of substitution

Schedule 2—General permitted circumstances

 

1  Name

  This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Instrument 2026.

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 28 January 2026. 28 January 2026

Note: This table relates only to the provisions of this instrument as originally made.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 30EK of the Therapeutic Goods Act 1989.

4  Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) medicine;

(b) pharmacist;

(c) registration number.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

prescriber means the person who:

 (a) is authorised under a law of a State or Territory to prescribe medicine, and

 (b) prescribed the scarce medicine for the patient.

scarce medicine has the meaning given by section 5.

substitutable medicine has the meaning given by section 6.

tablet has the same meaning as in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.

Note: TGO 101 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.

5  Declaration of serious scarcity

  For paragraph 30EK(1)(a) of the Act, a serious scarcity of the medicine specified in column 2 of each item in the table in Schedule 1 (the scarce medicine) across the whole of Australia is declared.

6  Substitution of scarce medicine by pharmacists

  For paragraph 30EK(1)(b) of the Act, in relation to each item in the table in Schedule 1, a pharmacist is permitted to dispense the medicine specified in column 3 (the substitutable medicine) in substitution for the scarce medicine specified in column 2, in the circumstances specified in:

 (a) column 5 of that item (the specific permitted circumstances); and

 (b) the table in Schedule 2 (the general permitted circumstances).

Note: Substitution is only permitted where both the specific permitted circumstances and the general permitted circumstances exist.

7  Period instrument in force

  This instrument remains in force until 31 May 2026.

8  Repeals

  Unless repealed earlier, this instrument is repealed at the start of 1 June 2026.

Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

Note: See sections 5 and 6.

• Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances
• Column 1 Column 2 Column 3 Column 4 Column 5
• Item Scarce medicine Substitutable medicine Dose unit equivalence Specific permitted circumstances
• 1 PRESOLOL 200 labetalol hydrochloride 200mg tablet bottle, registration number 56476 a registered medicine, or a medicine that is the subject of an approval under section 19A of the Act, that:(a) contains 100 mg labetalol as the only active ingredient; and(b) is manufactured in the dosage form of a tablet two tablets of the substitutable medicine is equivalent to one tablet of the scarce medicine the pharmacist has advised the patient, or person acting on behalf of the patient, of:(a) the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence in column 4; and(b) where cutting of a tablet is required to obtain the correct dose of the substitutable medicine—suitable instructions for cutting a tablet of the substitutable medicine; and(c) the differences between the scarce medicine and the substitutable medicine; and(d) either:(i) suitable instructions for administering the substitutable medicine; or(ii) to obtain instructions for administering the substitutable medicine from the prescriber or a general practitioner
• 2 PRESOLOL 100 labetalol hydrochloride 100mg tablet bottle, registration number 56475 a registered medicine, or a medicine that is the subject of an approval under section 19A of the Act, that:(a) contains 200 mg labetalol as the only active ingredient; and(b) is manufactured in the dosage form of a tablet half a tablet of the substitutable medicine is equivalent to one tablet of the scarce medicine the pharmacist has advised the patient, or person acting on behalf of the patient, of:(a) the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence in column 4; and(b) where cutting of a tablet is required to obtain the correct dose of the substitutable medicine—suitable instructions for cutting a tablet of the substitutable medicine; and(c) the differences between the scarce medicine and the substitutable medicine; and(d) either:(i) suitable instructions for administering the substitutable medicine; or(ii) to obtain instructions for administering the substitutable medicine from the prescriber or a general practitioner

Schedule 2—General permitted circumstances

Note: See section 6.

• General permitted circumstances
• Column 1 Column 2
• Item Circumstances
• 1 the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law
• 2 the pharmacist does not have access to the scarce medicine
• 3 the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted
• 4 the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine
• 5 the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine
• 6 the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine
• 7 the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing
• 8 the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine