3. Supplying Medicines — What Pharmacists Need to Know

Page last updated: 12 April 2024

Eligible suppliers

Pharmaceutical benefits are mainly supplied by approved pharmacists.  These pharmacists are approved under section 90 of the National Health Act 1953 (the Act) to dispense pharmaceutical benefits from particular pharmacy premises (approved premises).  Approved pharmacists are issued with a unique PBS Pharmacy Approval Number for each approved premises.

Other suppliers include approved doctors (usually practising in isolated areas), Friendly Society pharmacies, and approved hospitals. All suppliers are issued with approval numbers by the Department of Health and should follow the procedures in these Explanatory Notes.

An approved pharmacist may only supply pharmaceutical benefits at or from premises for which they have been approved.

Unapproved pharmacists cannot be involved in the supply of pharmaceutical benefits as the Act also provides that payment to an approved pharmacist for the supply of a pharmaceutical benefit cannot be made if it was supplied at or from unapproved premises, or otherwise than in accordance with a condition of approval.

Conditions of Approval for approved pharmacists

As part of their approval under section 90 of the Act, all approved pharmacists are subject to certain conditions.  These include that the approved pharmacist will:

• not supply to anyone any pharmaceutical benefit that attracts a Commonwealth contribution for free, or for a price that is less than the relevant patient contribution;
• clearly advertise that any offer for free or cut-price medicines does not include pharmaceutical benefits which have a Commonwealth contribution; and
• not pay rebates or refunds of patient contributions.

The Act also allows the Minister to determine any other conditions with which approved pharmacists must comply.  These additional conditions are set out in the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017.

Changes made by the Minister for Health and Aged Care, the Hon Mark Butler MP, to the conditions for approved pharmacists, came into effect on 1 June 2023.

The changes provide greater consistency with the National Health Act 1953 regarding the supply of PBS medicines.

The conditions of approval provide the following constitute a breach of a pharmacist’s conditions of approval where:

• a claim is made, or advance payment sought, for PBS medicines not supplied at (or from) the approved premises;
• PBS medicines are dispensed via remote access to the pharmacy including, but not limited to, where the dispensing pharmacist is not an Australian registered pharmacist;
• the approved pharmacist shares their PBS approval number with another pharmacist for the purpose of allowing that other pharmacist to dispense PBS medicines at an unapproved pharmacy premises; and
• the approved pharmacist has entered into any form of arrangement which facilitates the supply of PBS medicines by the approved pharmacist to patients presenting at pharmacy premises which are not approved.

Approved pharmacists should be aware that where a breach of a condition of approval has been deemed to occur, the Act also provides that the following compliance measures can be undertaken:

• recovery of monies;
• reprimand, suspension or revocation of approval (following referral to the Pharmaceutical Services Federal Committee of Inquiry); and/or
• prosecution for criminal offence under the Act or Criminal Code.

Should you have concerns about a potential breach of the Conditions of Approval for approved pharmacists, or any other compliance matter, you can report your concerns to the Provider Benefits Integrity Hotline by calling 1800 314 808 or submitting the details to the Department online by completing the Tip-off form.

Please note that the Department is not able to provide complainants with updates due to legislated privacy and secrecy provisions.

Other requirements for approved pharmacists

A pharmacist approved to supply medicines under the PBS:

• will publicly display a notice setting out the pharmacy's normal trading hours;
• is obliged to supply pharmaceutical benefits at the pharmacy at any hour if a PBS prescription is marked 'urgent' and initialled by the prescriber;
• will keep adequate stocks for the supply of pharmaceutical benefits;
• may be called on by Services Australia to provide details of stocks of pharmaceutical benefits or preparations for pharmaceutical benefits; and
• must keep copies of all paper-based and electronic PBS prescriptions for at least two years from the date of supply. This includes PBS prescriptions ordering repeats when it is the final supply, and order forms for prescriber bag supplies. Please note that some State/Territory laws require these copies to be kept for longer periods.

Before supplying pharmaceutical benefits

Several steps must be taken before a pharmaceutical benefit is supplied.

Firstly, a pharmacist must endorse the PBS prescription and duplicate with his/her name and approved supplier number.

Secondly, a PBS prescription identifying number must be given to the PBS prescription item on both the PBS prescription and duplicate. Any recognised series of numbers may be used.

If more than one item is on a PBS prescription, a separate identifying number should be allocated to each item.

In the case of a repeat authorisation, the same PBS prescription identifying number(s) must be carried through for each item. A pharmacist must also allocate his/her own identifying number on the repeat authorisation. It must be written alongside the date and place of supply.

Supplying pharmaceutical benefits

Do's and Don'ts

Except in urgent cases (see details under '02. Prescribing Medicine – Information for PBS Prescribers'), pharmacists are authorised to supply pharmaceutical benefits only after they receive:

• the pharmacist/patient and Services Australia or DVA copies of a valid PBS prescription which is not more than 12 months old; or
• the pharmacist/patient and Services Australia or DVA copies of an approved authority PBS prescription or an authority to prescribe which is not more than 12 months old; or
• a repeat authorisation attached to a patient/pharmacist PBS prescription not more than 12 months after the date of the original PBS prescription.

A pharmacist must not supply an Authority required (STREAMLINED) item unless the prescriber has written the four digit streamlined authority code on an authority PBS/RPBS prescription.

A pharmaceutical benefit cannot be supplied more times than specified in the PBS prescription.

A pharmacist cannot add to, delete from, or alter a PBS prescription in any other way. However, there may be circumstances where after contacting a prescriber, the pharmacist can clarify the prescriber's intentions and endorse the PBS prescription accordingly.

A pharmaceutical benefit may not be supplied if the same or an equivalent pharmaceutical benefit (any brand) has already been supplied for the patient within the period specified by legislative instrument for early supply purposes – or,

if there is no specified period:

• on the same day or within the previous 20 days, if it is a pharmaceutical benefit (other than an eye preparation) that has five or more repeats allowed in the PBS Schedule, (e.g., if a pharmaceutical benefit is supplied on Tuesday 4 June, it cannot be supplied again for that patient until Tuesday 25 June) or otherwise;
• on the same day or within the previous four days for all other items (e.g., if a pharmaceutical benefit is supplied on a Monday, it cannot be supplied again for that patient until the next Saturday).

This is unless:

• the repeated supply is prescribed on a PBS prescription endorsed with the words ‘one supply’ or ‘1 supply’ (it is also valid if the prescription is endorsed ‘Regulation 49’, ‘Reg 49’, ‘Section 49’, 'Regulation 24' or ‘Reg 24') or on an RPBS prescription endorsed ‘hardship conditions apply’ (see below under 'Regulation 49 '); or
• if the pharmacist believes a repeat supply is needed without delay for the treatment of the person, or a previous supply has been destroyed, lost or stolen. In this case, the pharmacist can provide another supply but must write ‘immediate supply necessary’ and sign the PBS prescription.

A pharmacist can supply an alternative pharmaceutical benefit without reference to the prescriber, provided that:

• the PBS prescription does not indicate that only the pharmaceutical benefit prescribed is to be supplied (ie substitution is not permitted); and
• the Schedule states that the prescribed benefit and the substitute benefits are equivalent; and
• supply of the substitute benefit does not contravene relevant State/Territory law; and
• the substitute benefit is a listed brand in the Schedule.

Pharmacists must heed State/Territory laws when supplying drugs listed as narcotic, specified or restricted in legislation of the particular State or Territory.

What to do if the Schedule changes

If an item or brand is deleted from the Schedule, it cannot be supplied as a pharmaceutical benefit from the date the deletion takes effect – regardless of whether the PBS prescription was written before this date. This includes repeat authorisations. (Special conditions applying to RPBS prescriptions are detailed in the RPBS Explanatory Notes.)

If an item or brand is Supply Only on the Schedule, it can be supplied as a pharmaceutical benefit. PBS Prescriptions written prior to the Supply Only period are able to be dispensed using either the Supply Only product where available, or an equivalent product as specified on the PBS schedule.

However, if restrictions on the prescribing of a pharmaceutical benefit change, or the maximum quantity or number of repeats is altered in the Schedule, valid PBS prescriptions written before the date of effect of the change may still be supplied as pharmaceutical benefits, under the conditions applying at the date of prescribing.

Suspected forgery

Pharmacists should take all reasonable steps to satisfy themselves that all items on a PBS prescription were written by a medical practitioner, a dentist, an optometrist, a midwife or a nurse practitioner.

Regulation 49

This regulation allows pharmacists to supply a pharmaceutical benefit prescription and all of its repeats at the one time. This regulation was previously Regulation 24 prior to the remaking of the Regulations in 2017.

A PBS prescriber who is a medical practitioner, midwife or nurse practitioner can write a PBS prescription under this provision. The prescription is written with the quantity to be supplied and the number of repeats required as usual and annotated  with the words ‘one supply’ or ‘1 supply’. It is also valid to use the words ‘Regulation 49’, ‘Reg 49’, ‘Section 49’, 'Regulation 24' or ‘Reg 24’. RPBS prescriptions should be endorsed with the words 'hardship conditions apply'. (For more information see under `2. Prescribing Medicines ... Regulation 49). Regulation 49 does not apply for supply of pharmaceutical benefits on optometrist or dentist prescriptions.

Repeat authorisations

When a PBS prescription calls for repeat supplies, the pharmacist shall prepare a Repeat Authorisation Form, except when the PBS prescription is marked  ‘one supply’ or ‘1 supply’.

The repeat may be requested on a standard PBS prescription, an authority PBS prescription or an Authority to Prescribe Form, or on an earlier repeat authorisation. In the latter case, it must come with the duplicate PBS prescription, or in the new format, the "patient/pharmacist copy".

Preparing Repeat Authorisation Forms

A Repeat Authorisation Form must show:

• the category of benefit (concession or general) – by placing a cross (x) in the relevant box;
• the patient's name and full address;
• in the case of repeats authorised on authority PBS prescriptions, the authority prescription number;
• details of the original PBS prescription stating the item, form, strength, quantity and directions;
• if substitution has occurred, the name of the brand actually supplied;
• for the first supply, the pharmacy name, address and approval number, the date of the original PBS prescription and the allotted PBS prescription identifying number;
• for subsequent supplies, the pharmacy approval number, and the date and PBS prescription number of the original prescription;
• the number of times the item is to be repeated and the number of times it has been supplied;
• the name and pharmacy approval number of the pharmacist issuing the repeat authorisation; and
• the date of supply.

When a repeat authorisation is prepared for any further repeats or deferred supply, a pharmacist must attach the duplicate copy of an old format PBS prescription, or the patient/pharmacist copy of a new format PBS prescription, and give both to the patient at the time of supply.

Repeat authorisations for deferred supply

When a PBS prescription orders a number of pharmaceutical benefit items, but the patient does not need all of the items at the same time, a separate repeat authorisation for each deferred item must be prepared. The words 'original supply deferred' should be indicated across the relevant item on the original PBS prescription, its duplicate, and on the repeat authorisation.

Deferred items must not be claimed on the original PBS prescription.

The Repeat Authorisation Form when it is used for a deferred supply, is issued in the same way as normal repeat authorisations except that:

• '0' is to be inserted in the space for 'no. of times already dispensed'; and
• if no repeats are ordered, '0' is to be inserted in the space for 'no. of repeats authorised'.

Supplying a benefit on a deferred supply repeat authorisation is to be treated as if it is the first time of supply. If repeats are directed, the normal procedure for repeat authorisations applies. Details of the pharmacy at which the deferred supply was authorised are to be written onto subsequent repeat authorisations.

Authority PBS prescriptions

If a pharmacist is presented with an authority PBS prescription and is not sure if it has been approved, he or she should contact Services Australia. Please note that Services Australia will not provide clinical information.

If the authority PBS/RPBS prescription is for an Authority required (STREAMLINED) item the pharmacist should ensure that the prescriber has written the four digit streamlined authority code on the prescription, this enables the pharmacist to supply the item as a PBS benefit.

The pharmacist is required to include the four digit streamlined authority code on the claim for the PBS dispensing.

Urgent cases

In urgent cases and where State/Territory law allows, pharmacists can supply a pharmaceutical benefit to a person without a PBS prescription, provided details of the prescription are given by the prescriber via telephone or other means. The prescriber must then forward the written PBS prescription and duplicate to the pharmacist within seven days of the date of supply.

Where a pharmaceutical benefit needs prior approval from Services Australia or the DVA, the prescriber must obtain approval and then advise the pharmacist of the PBS prescription and approval details. Only an original supply can be provided in this manner, not repeats.

Receipts

From 1 April 2024, patients are no longer required to sign and date receipt of a pharmaceutical benefit. Additionally, pharmacists are no longer required to certify why it was not practical to obtain a patient acknowledgement of receipt, including for urgent cases.

Further information on the repeal of these requirements under the National Health (Pharmaceutical Benefits) Regulations 2017 can be found in the Explanatory Statement to the National Health (Pharmaceutical Benefits) Amendment (2024 Measures No. 1) Regulations 2024.

Prescriber bag supplies

Pharmacists may supply certain pharmaceutical benefit items free of charge to a PBS prescriber if they receive a prescriber bag order form in duplicate, signed by the prescriber. Only items listed under prescriber bag provisions for the relevant prescriber type can be supplied to the prescriber.

Pharmacists must be satisfied the form was completed by a PBS prescribers and includes the prescriber’s name and address. If a pharmacist does not know the prescriber, he/she should confirm the prescriber’s registration or PBS prescriber number and endorse this on the back of the form.

For more information see '2. Prescribing Medicines ... Prescriber bag supplies'.