law://au/li/2026/f2026l01050@2026-11-13| Commencement information | ||
|---|---|---|
| Column 1 | Column 2 | Column 3 |
| Provisions | Commencement | Date/Details |
| 1. The whole of this instrument | 14 August 2026. | 14 August 2026 |
| 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 | LINK MEDICAL PRODUCTS DAPSONE dapsone 25 mg tablet bottle, registration number 104482 | DAPSOMED dapsone 50 mg tablet blister pack, registration number 403657 | half a tablet of the substitutable medicine is equivalent to one tablet of the scarce medicine | all of the following:(a) the pharmacist has ensured the prescribed dose of scarce medicine is divisible by 25 mg;(b) the pharmacist has advised the patient, or person acting on behalf of the patient, of:(i) 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(ii) suitable instructions for cutting a tablet of the substitutable medicine to obtain the correct prescribed dose of scarce medicine; and(iii) the differences between the scarce medicine and the substitutable medicine;(c) the pharmacist has advised the patient, or person acting on behalf of the patient:(i) of suitable instructions for administering the substitutable medicine; or(ii) to obtain instructions for administering the substitutable medicine from the prescriber or a general practitioner |
| 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 practicable after, dispensing the substitutable medicine |
Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.