Australian Government

Federal Register of Legislation

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

In force

Administered by

Department of Health, Disability and Ageing

This item is authorised by the following title:

Therapeutic Goods Act 1989

Latest version

F2026L00041

23 January 2026

Table of contents

1 Name
2 Commencement
3 Authority
4 Definitions
5 Declaration of serious scarcity
6 Substitution of scarce medicine by pharmacists
7 Period instrument in force
8 Repeals
- Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific
- 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