PSA Regulation Hub
This information was last updated Friday 15 September 2023
PSA has prepared this information to support pharmacists using the best and most up-to-date information available.
PSA members can contact the Pharmacist-to-Pharmacist Advice Line for practice guidance and support, including navigating regulatory queries and concerns on
1300 369 772 (business hours AEST)
This information is a guide and should not be used as a substitute or replacement for review of regulation and legislative instruments.

Medicine shortages: Therapeutic substitution (updated 02 August 2023)
Therapeutic substitution is the supply of alternative strengths, quantities or dose forms of a medicine by a pharmacist without prior approval from the prescriber. This is to ensure continuity of therapy during a verified national shortage of the prescribed medicine.
Supply of a substitutable (alternative) medicine by a community pharmacist must be in accordance with a specific Serious Scarcity Substitution Instrument (SSSI).
Current SSSIs
PBS subsidy: arrangements are in place for the substitutable (alternative) medicine under the insulin degludec and insulin aspart SSSI – refer to PBS website
Scarce medicine | Substitutable (alternative) medicine | Dose unit equivalence |
Insulin degludec + insulin aspart Injections, pre-filled pen 70 units-30 units per mL, 3mL (Ryzodeg 70/30 Flextouch) |
Insulin degludec + insulin aspart Injections, cartridges 70 units-30 units per mL, 3mL (Ryzodeg 70/30 Penfill) |
One 3mL pre-filled pen (70 units-30 units per mL) is equivalent to one 3mL cartridge (70 units-30 units per mL) |
Additional considerations for pharmacists:
- When determining whether the substitution is appropriate for the patient consider, for example, their level of dexterity to load a cartridge into the delivery device (or that they will have access to a carer to assist). If the substitution is not appropriate, refer the patient back to the prescriber.
- You must ensure patient/carer has, or is provided with, a suitable insulin delivery device for use with the Penfill cartridges. Any NovoPen device (NovoPen 4, NovoPen Echo or NovoPen 6) is suitable. Patients can access these devices for free through the NovoPen 6 Pharmacy Program.
- Advise patient/carer on how to administer the substitutable medicine (cartridges), including how to use the insulin delivery system.
- Advise the patient/carer of the number of dose units of the substitutable medicine that must be administered in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the above table.
- Advise the patient/carer of the differences between the scarce medicine and the substitutable medicine.
Further information:
- About the shortage of Ryzodeg 70/30 FlexTouch insulin prefilled pens (TGA)
- Information for pharmacists
- Information for patients
- NovoPen 6 (a reusable insulin delivery device) is required to administer Ryzodeg Penfill cartridges. The device is free through the NovoPen 6 Pharmacy Program at participating community pharmacies listed via the online pharmacy locator (Novo Nordisk).
- NovoPen 6 – how to use video (Novo Nordisk)
- Substitution allowed to address shortage of Ryzodeg 70/30 FlexTouch insulin (TGA, 6 July 2023)
- Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Degludec and Insulin Aspart) Instrument 2023 (Federal legislative instrument)
- National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2023 (Federal legislative instrument)
PBS subsidy: arrangements are in place for the substitutable (alternative) medicines under the cefalexin SSSI – refer to PBS website.
Scarce medicine |
Substitutable (alternative) medicine |
Note |
Cefalexin 125 mg/5 mL powder for oral liquid, 100 mL
|
Cefalexin 250 mg/5 mL powder for oral liquid, 100 mL
Cefalexin 250 mg capsule, 20
|
250 mg of cefalexin is equivalent to:
|
Cefalexin 250 mg/5 mL powder for oral liquid, 100 mL
|
Cefalexin 125 mg/5 mL powder for oral liquid, 100 mL
Cefalexin 250 mg capsule, 20
|
Additional considerations for pharmacists:
Pharmacists are required to:
- advise the patient of 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 specified in the above table
- ensure the correct dose of substitutable medicine is written in millilitres on the dispensing label (liquid formulations only)
- if multiple bottles of substitutable medicine are dispensed—ensure the patient’s treatment course will be completed prior to the expiry of each bottle;
- only dispense capsules as the substitutable medicine where the prescribed dose of scarce medicine is divisible by 250 mg;
- where capsules are to be dispensed as the substitutable medicine, ensure the patient is able to take a capsule dosage form; and
- ensure the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine.
Further information:
- Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023 (Federal legislative instrument)
PBS subsidy: arrangements are in place for the substitutable (alternative) medicines under the cefaclor SSSI – refer to PBS website
Scarce medicine | Substitutable (alternative) medicine | Dose unit equivalence |
Cefaclor
Powder for oral suspension, 100 mL 125 mg (as monohydrate) / 5 mL (Keflor or Ceclor) |
Cefaclor
Powder for oral suspension, 75 mL 250 mg (as monohydrate) / 5 mL (Ceclor, Keflor, APO-Cefaclor or Aclor 250) |
125 mg (5 mL) of scarce medicine is equivalent to:
2.5 mL of 250 mg / 5 mL in an oral liquid |
Cefaclor
Powder for oral suspension, 75 mL 250 mg (as monohydrate) / 5 mL (Keflor or Ceclor) |
Cefaclor
Powder for oral suspension, 100 mL 125 mg (as monohydrate) / 5 mL (Ceclor, Keflor or Aclor 125) |
250 mg (5 mL) of scarce medicine is equivalent to:
10 mL of 125 mg / 5 mL in an oral liquid |
Additional considerations for pharmacists:
- Advise the patient to contact their prescriber if cefaclor is not available from your pharmacy so they can consider an alternative antibiotic if necessary.
- Confirm with the patient/carer their understanding that: a different strength of cefaclor liquid medicine has been supplied as the prescribed strength is unavailable; the active ingredient is the same; and by taking the medicine as directed they will receive the same amount of cefaclor they were originally prescribed.
- Advise the patient of the dose (volume) of substitutable medicine that must be taken in substitution of the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the above table.
- Ensure correct dose (volume) of substitutable medicine, written in millilitres, is included on the dispensing label. Consider how accurate dosing by the patient or carer can be facilitated e.g. supply a measuring device.
- If multiple bottles of medicine are being dispensed, manage the reconstitution and supply of the bottles so that the patient’s treatment course will be completed prior to the expiry of each bottle.
- Consider how you will explain to the patient/carer the total duration of their course of cefaclor (and that there may be some medicine left over at the end of their course).
- Always ensure the patient, or person acting on behalf of the patient, has access to information to support them in safely administering the substitutable medicine.
Further information:
- Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefaclor) Instrument 2023 (Federal legislative instrument)
- National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 3) Determination 2023 (Federal legislative instrument)
- Antibiotics shortage update and substitution allowed to address shortage of cefaclor (TGA)
- About the shortage of cefaclor (TGA)
PBS subsidy: arrangements are in place for the substitutable (alternative) medicines under the phenoxymethylpenicillin SSSI – refer to PBS website
Scarce medicine | Substitutable (alternative) medicine | Dose unit equivalence |
Phenoxymethylpenicillin
Powder for oral liquid, 100 mL 125 mg (as potassium) / 5 mL (Phenoxymethylpenicillin-AFT) |
Phenoxymethylpenicillin
Oral suspension, 100 mL 150 mg (as benzathine) / 5 mL (Cilicaine V) OR Phenoxymethylpenicillin Powder for oral liquid, 100 mL 250 mg (as potassium) / 5 mL (Phenoxymethylpenicillin-AFT) OR Phenoxymethylpenicillin Capsule 250 mg (as potassium) (Cilicaine VK OR LPV) OR Phenoxymethylpenicillin Tablet 250 mg (as potassium) (Aspecillin VK) |
125 mg of scarce medicine is equivalent to:
4.2 mL of 150 mg / 5 mL oral suspension OR 2.5 mL of 250 mg / 5 mL oral liquid |
Phenoxymethylpenicillin
Oral suspension, 100 mL 150 mg (as benzathine) / 5 mL (Cilicaine V) |
Phenoxymethylpenicillin
Powder for oral liquid, 100 mL 125 mg (as potassium) / 5 mL (Phenoxymethylpenicillin-AFT) OR Phenoxymethylpenicillin Powder for oral liquid, 100 mL 250 mg (as potassium) / 5 mL (Phenoxymethylpenicillin-AFT) OR Phenoxymethylpenicillin Capsule 250 mg (as potassium) (Cilicaine VK OR LPV) OR Phenoxymethylpenicillin Tablet 250 mg (as potassium) (Aspecillin VK) |
150 mg of scarce medicine is equivalent to:
6 mL of 125 mg / 5 mL oral liquid OR 3 mL of 250 mg / 5 mL oral liquid |
Phenoxymethylpenicillin
Powder for oral liquid, 100 mL 250 mg (as potassium) / 5 mL (Phenoxymethylpenicillin-AFT) |
Phenoxymethylpenicillin
Powder for oral liquid, 100 mL 125 mg (as potassium) / 5 mL (Phenoxymethylpenicillin-AFT) OR Phenoxymethylpenicillin Oral suspension, 100 mL 150 mg (as benzathine) / 5 mL (Cilicaine V) OR Phenoxymethylpenicillin Capsule 250 mg (as potassium) (Cilicaine VK OR LPV) OR Phenoxymethylpenicillin Tablet 250 mg (as potassium) (Aspecillin VK) |
250 mg of scarce medicine is equivalent to:
10 mL of 125 mg / 5 mL oral liquid OR 8.3 mL of 150 mg / 5 mL oral suspension |
Additional considerations for pharmacists:
- Advise the patient to contact their prescriber if phenoxymethylpenicillin is not available from your pharmacy so they can consider an alternative antibiotic if necessary.
- Only dispense the substitutable medicine in a solid dose form where the prescribed dose of the scarce medicine is divisible by 250 mg (i.e. 250 mg, 500 mg, 750 mg or 1 gram).
- Determine whether the patient is able to take a solid dose form before dispensing the substitutable medicine in capsule or tablet form.
- Advise the patient of the number of dose units of substitutable medicine that must be taken in substitution of the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the above table.
- Ensure correct number of dose units of substitutable medicine is on the dispensing label attached to the substitutable medicine.
- Where multiple bottles of substitutable medicine are dispensed, manage reconstitution / supply of the bottles so that the patient’s treatment course will be completed prior to the expiry of each bottle of substitutable medicine.
- Always ensure the patient, or person acting on behalf of the patient, has access to information to support them in safely administering the substitutable medicine.
Further information:
- Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Phenoxymethylpenicillin) Instrument 2023 (Federal legislative instrument)
- National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2023 (Federal legislative instrument)
- About the shortage of phenoxymethylpenicillin (TGA)
PBS subsidy: arrangements are in place for the substitutable (alternative) medicines under the warfarin SSSI – refer to PBS website
Scarce medicine | Substitutable (alternative) medicine | Dose unit equivalence |
COUMADIN warfarin 5mg tablet | COUMADIN warfarin 1mg tablet | One tablet of scarce medicine is equivalent to FIVE tablets of substitutable (1mg) medicine |
COUMADIN warfarin 5mg tablet | COUMADIN warfarin 2mg tablet | One tablet of scarce medicine is equivalent to TWO AND A HALF tablets of substitutable (2mg) medicine |
Note: Pharmacists are only permitted to substitute with EITHER five Coumadin 1mg tablets OR two and a half Coumadin 2mg tablets – NOT a combination of 1mg and 2mg tablets.
Additional considerations for pharmacists:
Pharmacists are required to:
- advise the patient of 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 specified in the above table
- for 2mg tablets only, as cutting of the tablet is required to obtain the correct dose of substitutable medicine—provide instructions to the patient on how to cut the tablet; and,
- ensure the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine.
Further information:
- Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Warfarin) Instrument 2023 (Federal legislative instrument)
- National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2023 (Federal legislative instrument)
- Information sheet for patients (TGA/Viatris)
General requirements and information for pharmacists – dispensing according to a SSSI
- Confirm there is evidence of a valid prescription for the scarce medicine for the patient.
- Substitution can only be made under the SSSI if the pharmacist does not have access to the scarce medicine.
- Confirm the prescriber has not indicated on the prescription for the scarce (original) medicine that substitution is not permitted.
- Apply professional and clinical judgement to determine whether the patient is suitable to receive the substitutable (alternative) medicine.
- If deemed suitable, ensure the patient is fully informed and has consented to receiving the substitutable medicine.
- The total amount of substitutable medicine dispensed must provide for an equivalent treatment regimen (dosage and duration) as the scarce medicine.
- A record of dispensing the substitutable medicine in substitution of the scarce medicine must be made at the time of dispensing.
- The pharmacist must have, and follow, an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine.
Further general information:
- Serious Scarcity Substitution Instruments (SSSIs) (TGA) – Dispensing information and FAQs for pharmacists
- National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Federal instrument)
- PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument
Continued dispensing is the supply of a standard quantity (usually 1 month’s supply) of an essential Prescription Only Medicines (S4) without a prescription in an emergency.
Prior to COVID-19, PBS Continued Dispensing was limited to oral contraceptives and statins. PBS Expanded Continued Dispensing and state/territory regulation have enabled supply of nearly all Prescription Only Medicines via this temporary measure during COVID-19; subject to professional and regulatory requirements.
These temporary PBS arrangements ended on 1 July 2022 and have been replaced by permanent measures. These permanent PBS Continued Dispensing measures, based of a list of medicine endorsed by PBAC in November 2021:
- include a substantially larger formulary of medicines for stable chronic diseases than what was in place prior to 2019
- do not include a large range of medicines able to be supplied under the temporary measures in place since early 2020.
Tasmania has authorised non-PBS supply (private supply) of most Prescription Only Medicines under permanent regulation changes.
Temporary authorities during the acute phase of COVID-19 pandemic to supply full-pack quantities without a prescription where not covered by PBS Continued Dispensing have now lapsed in all jurisdictions.
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Legality to supply – ACT regulation
These requirements must be met to supply as PBS Continued Dispensing or private supply |
Eligibility to supply under the PBS – Commonwealth legislation
These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines |
|
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Effective to | Permanent (PBS Continued Dispensing)
Duration of public health emergency (where PBS Continued Dispensing does not apply) |
Permanent |
Summary of conditions | A Schedule 4 medicine may be supplied to a patient without a prescription in an emergency if the pharmacist is satisfied:
|
The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:
|
Eligible medicines and subsidy |
These measures only applies to Prescription Only Medicines (Schedule 4) which are not anabolic steroids, designated Appendix D medicines, benzodiazepines. Controlled Drugs (Schedule 8) cannot be supplied without a prescription. |
Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022:
Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients. |
Quantity |
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Record and communication |
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Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:
Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’ |
More information | – |
Last updated 20 December 2022 (ACT)
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Legality to supply – NSW regulation
These requirements must be met to supply as PBS Continued Dispensing or private supply |
Eligibility to supply under the PBS – Commonwealth legislation
These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines |
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Effective to |
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Permanent |
Summary of conditions | A Schedule 4 medicine may be supplied to a patient without a prescription in an emergency if the pharmacist is satisfied:
Emergency supply under this authority is permitted if patient has not received any such emergency supply of the medicine from any NSW pharmacy in previous 12 months Pharmacist must promptly report supply to regular or most recent prescriber |
The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:
|
Eligible medicines and subsidy |
Temporary authority only applies to Prescription Only Medicines (Schedule 4) which are not Schedule 4D medicines. Controlled Drugs (Schedule 8) cannot be supplied without a prescription. |
Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022:
Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients. |
Quantity |
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Record and communication | Must record consistent with the requirements of temporary authority, including:
The pharmacist must report the supply to the patient’s usual or last known prescriber. |
Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:
Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’ |
More information |
Last updated 7 December 2022 (NSW)
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Legality to supply – NT regulation
These requirements must be met to supply as PBS Continued Dispensing or private supply |
Legality to supply – NT regulation | |
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Effective to | As per Commonwealth instrument | Permanent |
Summary of conditions | Commonwealth instrument automatically adopted – Continued Dispensing fully enabled under the Act (see also information sheet) | The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:
|
Eligible medicines & subsidy |
Privately funded and non-PBS prescriptions are not permitted under this measure |
Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.
Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients. |
Quantity |
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Record and communication | Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:
Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’ |
|
More information |
Last updated 1 July 2022 (NT)
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Legality to supply – Queensland regulation
These requirements must be met to supply as PBS Continued Dispensing or private supply n |
Eligibility to supply under the PBS – Commonwealth legislation
These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines |
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---|---|---|
Effective to | Permanent (PBS Continued Dispensing)
Duration of public health emergency (where PBS Continued Dispensing does not apply) |
Permanent |
Summary of conditions | A Schedule 4 medicine may be supplied to a patient without a prescription in an emergency if the pharmacist reasonably believes:
|
The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:
|
Eligible medicines & subsidy |
These measures only applies to Prescription Only Medicines (Schedule 4). Controlled Drugs (Schedule 8) cannot be supplied without a prescription. Diversion-risk medicines may only be supplied under this measure where a decision not to supply the medicine could be life-threatening for the person. |
Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.
Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients. |
Quantity |
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Record and communication | Supply must be recorded, including:
The pharmacist must notify the authorised prescriber as soon as practicable, but no later than 7 days later |
Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:
Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’. |
More information | Updates and alerts – Queensland Health |
Last updated 20 December 2022 (Queensland)
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Legality to supply – South Australian regulation
These requirements must be met to supply as PBS Continued Dispensing or private supply |
Eligibility to supply under the PBS – Commonwealth legislation
These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines |
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Effective to |
PBS Continued Dispensing: Ongoing |
Permanent |
Summary of conditions | A Schedule 4 medicine may be supplied to a patient without a prescription if the pharmacist is satisfied:
|
The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:
|
Eligible medicines & subsidy |
Excludes:
|
Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.
Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients. |
Quantity |
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Record and communication |
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Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:
Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’ |
More information | Regulation 21(2f) of the Controlled Substances (Poisons) Regulations 2011 |
Last updated 7 July 2022 (SA)
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Legality to supply – Tasmanian regulation
These requirements must be met to supply as PBS Continued Dispensing or private supply |
Eligibility to supply under the PBS – Commonwealth legislation
These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines. Only eligible restricted substances (see left column) can be supplied. |
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Effective to | Ongoing | Permanent |
Summary of conditions | An eligible restricted substance (see below) may be supplied to a patient without a prescription if:
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The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:
|
Eligible medicines & subsidy | Eligible restricted substances able to be supplied include the following substances:
|
Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.
Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients. |
Quantity |
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Record and communication |
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Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:
Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’ |
More information |
Note: Prior to 1 July 2022, PBS Continued Dispensing was enabled by an emergency order. This order issued by the Secretary in accordance with section 14 of the Public Health Act 1997 ceased to be in effect at when the Public Health Emergency Declaration expired at 12.01am on 1 July 2022. |
Last updated 7 June 2023 (Tasmania)
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Legality to supply – Victorian regulation These requirements must be met to supply as PBS Continued Dispensing or private supply |
Eligibility to supply under the PBS – Commonwealth legislation
These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines |
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Effective to | 22 December 2022 | Permanent |
Summary of conditions | A Schedule 4 medicine may be supplied to a patient without a prescription in an emergency if the pharmacist is satisfied:
|
The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:
|
Eligible medicines & subsidy |
PHEO#2 only applies to Prescription Only Medicines (Schedule 4). Controlled Drugs (Schedule 8) cannot be supplied without a prescription. |
Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.
Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients. |
Quantity |
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Record and communication |
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Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:
Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’ |
More information |
|
Last updated 19 October 2022 (Victoria)
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Legality to supply – WA regulation
These requirements must be met to supply as PBS Continued Dispensing or private supply |
Eligibility to supply under the PBS – Commonwealth legislation
These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines |
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Effective to | Permanent | Permanent |
Summary of conditions | An Schedule 3 or Schedule 4 medicine listed in the Continued Dispensing determination may be supplied to a patient without a prescription if:
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The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:
|
Eligible medicines & subsidy |
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Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.
Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients. |
Quantity |
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Record and communication |
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Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:
Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’ |
More information | Note: Between March 2020 and June 2022, through a special authority linked to a declaration of public health emergency enabled PBS and non-PBS supply of most Schedule 4 medicines under this measure. This authority has now been revoked. The SASA has also been updated to align with the National Health (Continued Dispensing) Determination 2022. | Non-PBS medicines are not subsidised under the PBS |
Last updated 8 July 2022
A phone/fax order is the communication of a prescription from a prescriber to a pharmacist via phone, fax or email (where permitted). The prescriber is then responsible for immediately dispatching the original hard-copy prescription to the supplying pharmacist.
Phone/fax orders, often referred to as ‘owing prescriptions’, must generally be reconciled (‘owing mark off’) before repeats can be issued or the item claimed through the PBS.
Phone/fax order requirements are not relevant when electronic prescriptions are issued as the legal copy of these prescriptions is accessed via prescription exchange services and downloaded directly into a pharmacy’s dispensing software.
May be subsidised under the PBS
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Legality to supply – ACT regulation | |
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Prescriber requirements on issuing a phone/fax order |
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Requirement for prescriber to send paper prescription to the pharmacist | June 2020 amendment to faxed prescription requirements
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Permitted medicines |
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Pharmacist obligations | |
Legislative instrument | S31 and S120 Medicines Poisons and Therapeutic Goods Regulation 2008 |
Relevant resources | Telehealth prescribing fact sheet (ACT Health) |
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Legality to supply – NSW regulation | |
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Prescriber requirements on issuing a phone/fax order |
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Requirement for prescriber to send paper prescription to the pharmacist |
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Permitted medicines |
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Pharmacist obligations |
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Legislative instrument | Clauses 36, 44, 81 & 96 Poisons and Therapeutic Goods Regulation 2008 (NSW) |
Relevant resources | NSW Health Guide to poisons and therapeutic goods legislation for pharmacists |
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Legality to supply – NT regulation | |
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Prescriber requirements on issuing a phone/fax order | Verbal prescription:
Prescriptions, including faxed prescriptions, may be issued electronically in accordance with the Electronic Transactions Act (NT) 2020. |
Requirement for prescriber to send paper prescription to the pharmacist |
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Permitted medicines |
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Pharmacist obligations |
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Legislative instrument | Section 19, 61, 97 Medicines Poisons and Therapeutic Goods Act 2012 |
Relevant resources | Supplying without a prescription- Pharmacist fact sheet (NTG Department of Health) |
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Legality to supply – QLD regulation | |
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Prescriber requirements on issuing a phone/fax order | Verbal prescriptions:
Faxed prescription:
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Requirement for prescriber to send paper prescription to the pharmacist |
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Permitted medicines |
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Pharmacist obligations |
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Legislative instrument | 84, 92, 227 Medicines and Poisons (Medicines) Regulation 2021 |
Relevant resources |
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Legality to supply – SA regulation | |
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Prescriber requirements on issuing a phone/fax order | Prescription via telephone or fax:
Emailed prescriptions are not provided for in SA under the Controlled Substances (Poisons) Regulations 2011 |
Requirement for prescriber to send paper prescription to the pharmacist |
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Permitted medicines |
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Pharmacist obligations | |
Legislative instrument | Regulation 33 Controlled Substances (Poisons) Regulations 2011 (SA) |
Relevant resources |
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Legality to supply – TAS regulation | |
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Prescriber requirements on issuing a phone/fax order | Verbal prescription:
|
Requirement for prescriber to send paper prescription to the pharmacist |
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Permitted medicines |
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Pharmacist obligations | |
Legislative instrument | Regulations 23 and 47 Poisons Regulations 2018 (Tas) |
Relevant resources |
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Legality to supply – VIC regulation | |
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Prescriber requirements on issuing a phone/fax order | A prescriber may issue a verbal instruction to supply a medicine an emergency.
As of 31 March 2023, a prescriber may now also send an emergency transmission of digital image to pharmacists (e.g. fax or email) if, in the opinion of the prescriber an emergency exists. Under this regulation:
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Requirement for prescriber to send paper prescription to the pharmacist |
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Permitted medicines |
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Pharmacist obligations | |
Legislative instrument | 25, 25A, 47(1), 48 Drugs, Poisons and Controlled Substances Regulations 2017 |
Relevant resources |
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Legality to supply – WA regulation | |
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Prescriber requirements on issuing a phone/fax order |
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Requirement for prescriber to send paper prescription to the pharmacist |
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Permitted medicines |
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Pharmacist obligations |
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Legislative instrument | Regulation 17 Medicines and Poisons Regulations 2016 (WA) |
Relevant resources |
Emergency supply of medicines allows a pharmacist to initiate a small quantity supply (usually 3 days’) of a Prescription Only Medicine (S4) in an emergency without a prescription when it’s not possible to contact the patient’s prescriber. Under this arrangement there is no requirement for a follow up prescription.
Medicines supplied under what is commonly known in most jurisdictions as the ‘3-day rule’ are ineligible to be supplied under the PBS and can’t be changed into a full quantity dispensing at a later date on presentation of a prescription.
These permanent provisions existed within state/territory regulation prior to COVID-19. They may remain relevant during COVID-19 if Schedule 4 medicines are unable to be supplied under Expanded Continued Dispensing and other temporary expanded emergency supply provisions.
Not subsidised under the PBS
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Legality to supply – ACT regulation | |
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Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. | Pharmacist satisfied:
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Maximum quantity able to be supplied |
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Labelling and recording requirements |
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Medicine excluded |
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Other requirements of supply | Pharmacist must send notification to ordinary prescriber in writing within 24 hours |
Legislative instrument(s) | S251 – S254 Medicines Poisons and Therapeutic Goods Regulation 2008 |
Relevant resources |
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Legality to supply – NSW regulation | |
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Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. | Pharmacist satisfied:
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Maximum quantity able to be supplied |
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Labelling and recording requirements |
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Medicine excluded |
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Other requirements of supply | |
Legislative instrument(s) | Clauses 7, 45, Appendix A Poisons and Therapeutic Goods Regulation 2008 (NSW) |
Relevant resources |
Last updated 7 December 2022 (NSW)
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Legality to supply – NT regulation | |
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Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. | Pharmacist satisfied:
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Maximum quantity able to be supplied |
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Labelling and recording requirements |
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Medicine excluded |
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Other requirements of supply | |
Legislative instrument(s) |
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Relevant resources |
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Legality to supply – QLD regulation | |
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Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. | Pharmacist reasonably satisfied:
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Maximum quantity able to be supplied |
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Labelling and recording requirements | Labeling requirements:
Recording:
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Medicine excluded |
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Other requirements of supply | |
Legislative instrument(s) |
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Relevant resources |
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Legality to supply – SA regulation | |
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Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. | Pharmacist satisfied:
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Maximum quantity able to be supplied |
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Labelling and recording requirements |
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Medicine excluded |
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Other requirements of supply | |
Legislative instrument(s) |
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Relevant resources |
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Legality to supply – TAS regulation | |
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Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. | Pharmacist satisfied, on reasonable grounds:
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Maximum quantity able to be supplied |
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Labelling and recording requirements |
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Medicine excluded |
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Other requirements of supply | |
Legislative instrument(s) |
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Relevant resources |
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Legality to supply – VIC regulation | |
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Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. | Pharmacist satisfied:
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Maximum quantity able to be supplied |
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Labelling and recording requirements |
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Medicine excluded |
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Other requirements of supply | |
Legislative instrument(s) | |
Relevant resources |
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Legality to supply – WA regulation | |
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Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. | Pharmacist satisfied on reasonable grounds:
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Maximum quantity able to be supplied |
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Labelling and recording requirements |
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Medicine excluded |
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Other requirements of supply | Regulation 29 Medicines and Poisons Regulations 2016 (WA)*
* information regarding non-divisible packs drawn from WA Health fact sheet |
Legislative instrument(s) | |
Relevant resources |