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Medical practitioners

A patient is requesting that I prescribe a cannabis medicine – what can I do?

As with any prescribing, the legal obligations and the responsibility for the treatment of the patient lies with the prescribing medical practitioner. Most cannabis medicines are not registered on the Australian Register of Therapeutic Goods (ARTG), which means they have not been evaluated to ensure they meet strict standards of safety, quality and effectiveness. For this reason, it is expected that medical practitioners will have considered all clinically appropriate treatment options that are included in the ARTG before applying to access an unregistered cannabis medicine. For further information please visit the TGA website.
 
The NSW Cannabis Medicines Advisory Service provides free clinical support and advice for NSW medical practitioners considering prescribing a cannabis medicine. The Service is available to all NSW medical practitioners including general practitioners and other medical specialists, as well as pharmacists, nurses and other health professionals and services. Medical practitioners can contact the Service Monday to Friday 9:00am to 5:00pm by email HNELHD-CMAS@health.nsw.gov.au or telephone (02) 4923 6200.
 

When does a doctor need authority from NSW Health to prescribe?

NSW Authority under the Poisons and Therapeutic Goods Act 1966 or the Poisons and Therapeutic Goods Regulation 2008 is required when prescribing or supplying a Schedule 8 medicine:
  • to a drug dependent person (for a registered or unregistered medicine)
  • that is compounded
  • for use in a clinical trial (if unregistered).
Additionally, when a medical practitioner is to carry out special medical treatment involving the administration of a Schedule 8 cannabis medicine to a child (under 16 years), they must seek an exemption under the Children and Young Persons (Care and Protection) Act 1998. Exemption is sought by making an application to NSW Health.
 
An NSW Authority from NSW Health is not needed to prescribe a Schedule 4 cannabis medicine.
 
Applications forms to prescribe or supply a Schedule 8 cannabis medicine are published on the NSW Health website.
 

Pharmacists 

Do I need accreditation for myself or my pharmacy to be able to dispense cannabis medicines?

No, there is no accreditation required. The doctor prescribing an unregistered cannabis medicine arranges supply with a pharmacy which will be convenient for the patient to have the prescription dispensed. This can be any registered pharmacy (or hospital pharmacy) in NSW. If the cannabis medicine is registered (Sativex® is currently the only registered cannabis medicine), you may obtain these from the wholesale supplier. If the cannabis medicine is unregistered (non-ARTG), the prescription should be accompanied by a Commonwealth approval under the Special Access Scheme or Authorised Prescriber scheme. The wholesale supplier can only supply you with the unregistered cannabis medicine if you have this document. If the cannabis medicine is not available in Australia, the doctor will need to inform you of the importation arrangements.

Can a community pharmacy be authorised to possess a cannabis product which is not in Schedule 8 or Schedule 4?

No. Their possession is illegal, unless authorised by the Secretary of the NSW Ministry of Health for the purpose of scientific research, instruction, analysis or study.
 

Do all prescriptions need to bear an authority reference number?

A prescription for a S8 cannabis medicine does not need to bear a NSW Authority number unless it is to be extemporaneously compounded for a particular person for therapeutic application to that person. This number is in the format AUxxxxxxx (seven digits preceded by AU).
 
All other requirements for Schedule 8 prescriptions apply such as the requirement for the quantity to be written in words and figures.
 

Can I hold unregistered cannabis medicines in stock in anticipation of being asked to dispense authorised prescriptions in future?

A pharmacist cannot hold stocks of unregistered cannabis medicines that have not been approved by the Commonwealth for supply to a patient under the Special Access Scheme, Authorised Prescriber Scheme, or Clinical Trial Scheme. Registered cannabis medicines (Sativex® is currently the only registered cannabis medicine) can however be kept in stock like any other Schedule 8 medicine.
 

Is it legal for a retail pharmacist to compound a S8 cannabis medicine on presentation of a prescription?

Yes:
  • if there is no suitable commercial product available (pharmacists must comply with Pharmacy Board Guidelines for compounding), and if
  • the prescriber is a medical practitioner who holds Authority to prescribe from the NSW Ministry of Health, and if
  • the prescription bears the NSW Authority number, written by the authorised prescriber, and if
  • the compounded medicine, the ingredients used and any intermediate step of the manufacturing (compounding) comply with all requirements of Therapeutic Goods Order no. 93 , and if
  • the medicine is compounded for and supplied to the individual patient named on the prescription.
It is an offence against the Drug Misuse and Trafficking Act 1985 to issue, compound or dispense such a prescription, where the prescriber has not been so authorised.

Can I advertise the fact that my pharmacy can dispense or compound cannabis medicines?

No, it is illegal to advertise or promote any Schedule 8 or Schedule 4 medicine to the public. It is also illegal to advertise or promote any unregistered medicine to anyone including medical practitioners.
 
Detailed guidance can be found on the TGA website.
 

Does a pharmacy need to have a TGA 'GMP' Licence to compound a cannabis medicine?

Refer to the TGA for advice on when a TGA licence is required - see GMP information for manufacturers of compounded medicines and DAAs on the TGA website.
 

Are compounded medicines exempt from the requirement for TGA (Special Access Scheme) authorisation of prescribing of unregistered cannabis medicines?

Yes. Schedule 5 of the Commonwealth Therapeutic Goods Regulations 1990 exempts 'medicines that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person' from the requirement for all medicines to be registered on the Australian Register of Therapeutic Goods. Hence, they do not need approval under the Special Access Scheme.

Do compounded cannabis medicines require Authority from NSW Health?

All compounded Schedule 8 cannabis medicines require the prescriber to hold prior written Authority issued by the NSW Ministry of Health. It is illegal to prescribe or dispense such medicines without such Authority.

What is the legal classification of Cannabis raw material?

Cannabis (including seeds, extracts, resins and any part of the plant) is classified in Schedule 8 of the Poisons List when prepared or packed for human therapeutic use, and:
  • cultivated, produced, or in products manufactured in accordance with the Commonwealth’s Narcotic Drugs Act 1967, and/or for use in such products; and/or
  • imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989

except those cannabidiol-only products as defined in Schedule 4 of the Poisons Standard.

All cannabis products not classified as Schedule 8 or Schedule 4 (see below) default to their classification as prohibited drugs under the Drug Misuse and Trafficking Act 1985, whose possession is illegal, unless authorised for the purpose of scientific research, instruction, analysis or study.

There are legal provisions allowing possession and supply of these non-therapeutic products:
  • low-THC Hemp and processed hemp fibre products made from it containing 0.1% or less of tetrahydrocannabinols, cultivated, produced and manufactured under licence issued under the NSW Hemp Industry Act
  • hemp seed oil, containing 50mg/kg or less of cannabinoids including 20mg/kg or less of tetrahydrocannabinols (THC), labelled 'Not for internal use' or 'Not to be taken'
  • products not for internal human use containing 50 mg/kg or less of THC

And if approved for supply under the FSANZ Food Standards Code:

  • hulled, non-viable hemp seeds for human consumption containing 5mg/kg or less of THC
  • hemp seed oil for human consumption containing 10mg/kg or less of THC
  • beverages made from hemp seeds containing 0.2mg/kg or less of THC

Can I hold cannabis raw material for compounding in stock in a community pharmacy?

Yes if the raw material ingredient has been imported, or cultivated and produced, with the approval of the Commonwealth Office of Drug Control and/or Therapeutic Goods Administration, in accordance with the Commonwealth’s Narcotic Drugs Act 1967, and/or Therapeutic Goods Act 1989, and if it accords with the Medicinal Cannabis Standard (TGO 93), and is included in Schedule 8 of the Poisons List.

If not, it is illegal to possess of any material derived from cannabis to manufacture medicines.

What does 'for therapeutic use' mean in relation to classification of a substance?

'For therapeutic use' means for preventing, curing or alleviating a disease, or similar purposes. For the full definition see the Poisons Standard Part 1 'Interpretation'.
 

Does the SUSMP Schedule 8 entry for Cannabis 'when prepared or packed for human therapeutic use' mean only the final product for use by a consumer?

No, the Schedule 8 entry includes material at every stage of the process which is approved as fit for, and intended to, manufacture the finished medicine. All such material must be stored, recorded etc as any Schedule 8 drug.
 

Are all cannabidiol (CBD) products in Schedule 4?

No. To be in Schedule 4, the cannabidiol product must:
 
  • be for therapeutic use (i.e. to alleviate a disease etc), and
  • cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation, and
  • any cannabinoids other than cannabidiol which are present, must be only those naturally found in cannabis, and
  • any cannabinoids other than cannabidiol which are present, must comprise 2 per cent or less of the total cannabinoid content of the preparation.
Thus for example, a preparation containing 40 mg per mL of cannabidiol and a total of 1 mg per mL of all other cannabinoids is in Schedule 8 (if compliant with the Narcotic Drugs Act 1967 and Therapeutic Goods Act 1989) or else a Prohibited Drug. This is the case even if the label and other material provided by the supplier mis-states the contents (such as omitting to mention the presence of other cannabinoids).
 

Can I obtain and supply any cannabidiol product that meets the Schedule 4 definition?

Yes, if:
  • it is a registered medicine on the ARTG, or
  • it is subject of an authorisation to manufacture/import the product issued by the Office of Drug Control (ODC), and
  • it is subject of an authorisation to a medical practitioner to prescribe the product to an individual patient, issued by the TGA, and
  • it is supplied from a pharmacy on receipt of a prescription issued by the medical practitioner under the TGA authorisation, or supplied by the authorised medical practitioner.

Can I dispense a Schedule 8 cannabis medicine on the oral, phoned, e-mailed or faxed direction of a medical practitioner?

No, not until you receive the actual prescription, unless it is a registered medicine on the ARTG. (Currently the only ARTG cannabis medicine is Sativex® brand nabiximols oromucosal spray 80mg/mL for treatment of spasticity due to multiple sclerosis.)

Can I dispense an unregistered Schedule 8 cannabis medicine on a prescription from a nurse practitioner, dentist or vet?

No. It is illegal for anyone but a medical practitioner to prescribe unregistered Schedule 8 cannabis medicines under the Authorised Prescriber and Special Access Schemes.
 

Can I dispense an unregistered Schedule 8 cannabis medicine on a prescription from a medical practitioner practising in another State or Territory?

Yes, if all of the following are true:
  • the prescriber is registered with AHPRA as a medical practitioner
  • the pharmacist has evidence that the prescriber holds an approval from the TGA to prescribe the medicine to the patient
  • the prescription has been issued in compliance with the laws of the State or Territory where it was issued
  • the prescriber may lawfully prescribe the medicine in NSW (e.g. has not had his/her authority to prescribe Schedule 8 medicines withdrawn or restricted by NSW Health)
  • all other requirements applying to Schedule 8 prescriptions under the NSW Poisons and Therapeutic Goods legislation are met, noting specific requirements listed below:
    • for a paper prescription, the pharmacist must be familiar with the prescriber’s handwriting, know the patient, or verify the prescription with the prescriber (usually by phone)
    • for an electronic prescription, it must be issued using a prescribing system with a Conformance ID issued by the Australian Digital Health Agency
    • for a medicine that is pharmacist-compounded, the prescriber must be authorised by NSW Health to prescribe it to the patient and the prescription must bear the NSW Authority number
    • for a medicine prescribed for a person who is drug dependent, the prescriber must be authorised by NSW Health to prescribe it to the patient and the prescription must bear the NSW Authority number
    • for a medicine that is for a clinical trial, the pharmacist has evidence that the prescriber is authorised by NSW Health to prescribe it for that clinical trial.

 There is no provision in NSW legislation for recognising interstate authorities to prescribe S8 cannabis medicines.

Can I dispense a Schedule 4 cannabidiol medicine on a prescription from a medical practitioner practising in another State or Territory?

Yes, if all of the following are met:

  • the prescriber is registered with AHPRA as a medical practitioner
  • the pharmacist has evidence that the prescriber holds an approval from the TGA to prescribe the medicine to the patient
  • the prescription has been issued in compliance with the laws of the State or Territory where it was issued. Contact details for medicine regulators are available online.

Can I dispense an unregistered cannabis medicine to a patient living in, or travelling to, another State or Territory?

Yes, if the prescription is valid for dispensing in NSW - see Can I dispense a Schedule 4 cannabidiol medicine on a prescription from a medical practitioner practising in another State or Territory?

Where the patient has a paper prescription for a Schedule 8 and Schedule 4 Appendix B medicine, inform the patient before dispensing that you will need to retain the prescription (including any repeats), as patients from interstate may not be familiar with this NSW requirement. For an electronic prescription with a repeat, you will need to issue a token for the repeat and the next dispensing pharmacist will need to determine if the prescription is valid for dispensing in that State or Territory.

It should not be assumed that an unregistered Schedule 8 medicine lawfully prescribed and dispensed in NSW can be sent to or transit through another State or Territory.  Before dispensing the medicine, confirm from the medicines regulator in the other jurisdictions that it is legal for a carrier to possess the medicine in that State or Territory, and legal for the patient to possess and use the medicine in that State or Territory.

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General

Can I possess a cannabis medicine which was prescribed to me as a patient by an overseas doctor?

No

What authorities have already been issued for cannabis products?

To protect patient privacy the Ministry does not publish details of authorities to prescribe which have been issued, nor does it keep a list of doctors who might be willing to prescribe a cannabis product.
 

Cannabis is a natural plant and has been traditionally used as a folk medicine for centuries. Doesn’t that prove that it is safe and effective?

No. Many plants and substances which are natural are very dangerous or poisonous. Cannabis use can have many serious adverse effects. More information is available on Your Room's Cannabis page.
 

Why are government licences and authorities required?

Requirements for cannabis medicines are the same or similar to those for other Schedule 8 medicines and for other unregistered medicines (which have not been proven safe and effective). In addition, unless it is lawfully prescribed as a medicine, cannabis is a prohibited drug under NSW law, and classified as a narcotic drug, as well as a prohibited import, under Commonwealth law.
 

Can cannabis medicines be supplied for therapeutic use in animals?

The arrangements in place for access to cannabis medicines are only for human therapeutic use. Cannabis for any other use is prohibited under the NSW Drug Misuse and Trafficking Act 1985. Cannabis medicines may only be used in animals in the context of scientific research or analysis; an application for a NSW Authority from the NSW Health for this purpose may be made.
 

Is cannabis legal for recreational use?

The arrangements in place for access to and supply of cannabis medicines are only for the purpose of human therapeutic use and when approved to be prescribed by a doctor. Possession, supply, manufacture, production and cultivation of cannabis for any other purpose, including for recreational use, remain prohibited under the NSW Drug Misuse and Trafficking Act 1985.

​​​​​It is illegal to advertise cannabis medicines to the public

The Therapeutic Goods Administration (TGA) has published guidance on their website to assist providers of cannabis medicines (sponsors, manufacturers, importers, pharmacists, health professionals and marketers) to comply with therapeutic goods advertising restrictions.

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Page Updated: Thursday 15 October 2020
Contact page owner: Pharmaceutical Services