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 changes make it 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.

The changes also update references to Pharmaceutical Society of Australia’s documents.

The Determination has been published on the Federal Register of Legislative Instruments National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017.

Pharmacists are encouraged to familiarise themselves with the amendments.

Frequently Asked Questions: Changes to the Conditions of Approval for Approved Pharmacists

The information below is intended as general information only about the changes to the conditions of approval for approved pharmacists. The contents do not constitute legal advice and should not be relied on as such.

Are online pharmacies allowed to dispense PBS medicines and deliver to a patient’s home?

Yes. The revised conditions will not impact approved pharmacies which have an online presence, where patients submit a PBS prescription for supply to a patient’s home.

Are non-PBS pharmacies allowed to be involved in the supply of PBS medicines?

No. The revised conditions provide that an approved pharmacist must not enter into an arrangement which facilitates the supply and/or claiming of a PBS medicine to a patient who presents a prescription at a non-approved pharmacy.

Any medicines supplied at (or from) a non-PBS pharmacy cannot be claimed as a PBS supply by an approved pharmacist.

Is an approved pharmacist able to operate a depot arrangement in a remote location?

Yes. The revised conditions do not impact any depot arrangements in remote locations where the depot is not a pharmacy.

The changes only prohibit a non-approved pharmacy, claiming to be an agent/depot for an approved pharmacy, from being involved in the supply and/or claiming of PBS medicines.

Do the changes affect Telepharmacy arrangement in South Australia?

No. The South Australian Telepharmacy arrangements are limited to supply of non-PBS medicines.

PBS medicines can only be dispensed and supplied when a pharmacist is present at the pharmacy premises at the time of dispensing. The changes to the conditions reinforce this legislative requirement.

Do the changes affect the Professional Services Room arrangements in NSW?

No. The NSW Professional Services Rooms (PSR) arrangements are premises associated with, but separate to, approved pharmacy premises. A PSR is limited to the preparation and packaging of medicines.

The National Health Act 1953 prohibits the supply of PBS medicines at (or from) a PSR, unless the PSR is an approved premises. The changes to the conditions reinforce this legislative prohibition.

Are pharmacies allowed to engage with a Dose Administration Aid (DAA) packaging service operated by a third-party (e.g. TGA licenced facility or another pharmacy)?

Yes. A pharmacist may engage the services of a third party to pack a Dose Administration Aid on their behalf, providing the medicine is dispensed at the pharmacy’s approved premises. The changes to the conditions do not alter this requirement and the packing of DAAs by a third party continues to be permitted under the changes to the conditions.

A third party cannot dispense medications outside of the pharmacy’s approved premises. This is not currently permitted under the Therapeutic Goods Administration legislation or the National Health Act 1953. It is the responsibility of the supplying pharmacist to make the supply of the DAA to the patient or their agent. Further information on the packaging of DAAs can be found on the Therapeutic Goods Administration website.

Can an approved pharmacist arrange for a TGA licenced manufacturer to manufacture a medicine and dispense that medicine to a patient?

Yes. The current legislation allows an approved pharmacist to dispense and supply a manufactured medicine if the medicine is extemporaneously compounded by a TGA licenced manufacturer for an identified person for therapeutic application to that person. Further information on the compounding of medicines by a licenced manufacturer can be found on the Therapeutic Goods Administration website.

Can an approved pharmacist dispense and supply a PBS medicine to a prescribing medical practitioner for administration to an anticipated future patient?

No. The National Health Act 1953 requires a PBS prescription must be for the treatment of the person named on the prescription and the changes to the conditions of approved pharmacists reinforce that requirement.

The only medications that can be supplied to a medical practitioner directly is a Prescriber Bag supply. Further information on Prescriber Bag supplies can be found on the Department of Health and Aged Care’s website.

Do the changes impact the supply of PBS medications under the Remote Area Aboriginal Health Services (RAAHS) Program supplies?

No. The conditions of approval do not apply to the supply of PBS medicines under the RAAHS program. Details on the section 100 National Health (Remote Area Aboriginal Health Services Program) Special Arrangement can be found on the Department of Health and Aged Care’s website.

Do the changes impact the supply of PBS medications by an approved hospital authority to patients receiving treatment at the hospital?

No. The conditions of approval do not apply to approved hospital authorities, they only apply to approved community pharmacists, that is a pharmacist approved under section 90 of the National Health Act 1953.

Can a registered pharmacist work in a non-PBS pharmacy?

Yes. The National Health Act 1953 and the conditions of approval do not regulate where a registered pharmacist can (or can’t) work.

Do I need to close my non-PBS pharmacy?

No. The conditions of approval do not apply to non-PBS pharmacies, so there is no requirement to close the pharmacy.

As a non-PBS pharmacy, only private prescriptions can be supplied.

The conditions of approval reinforce the legislative requirement that PBS medicines can only be supplied at (or from) approved premises and that any non-PBS pharmacy cannot be involved in the supply of PBS medicines.