Given the TGA’s strict supply pathways it would be easy to assume that medicinal cannabis is reserved solely for humans, however, this is not the case. In fact, veterinarians are also able to use certain cannabinoids to treat pets and livestock.
While the TGA handles human medicines, the control of veterinary medicines is managed through the Australian Pesticides and Veterinary Medicine Authority (the APVMA). However, the APVMA does not have an Authorised Prescriber Scheme nor a Special Access scheme, nor does it control the prescribing rights of veterinarians.
So how are veterinarians able to use cannabinoids?
Veterinarians are held accountable by the Guidelines for Prescribing, Authorising and Dispensing Veterinary Medicines, which is also subject to the classification of drugs and poisons into Schedules 1 – 9 under the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). SUSMP classifications then impact and determine specific veterinary permissions through the different state and territory regulations.
Drugs and poisons legislation in each state/territory designates registered veterinarians as ‘authorised persons’ and allow registered veterinarians to obtain and use, supply, order, authorise or prescribe Schedule 4 and 8 drugs. However, this is not a prescribing free-for-all and there are some rules that need to be followed:
Direct veterinarian-client relationships must be established.
Veterinarians may only prescribe to animals with which they have a “bona fide” veterinarian-client relationship, i.e. animals that they have sufficient knowledge of to initiate at least a general or preliminary diagnosis of their medical condition, and are personally acquainted with the keeping and care of those animals.
Only S4 CBD is allowed.
CBD is considered an unregistered veterinary chemical, and veterinarians may only prescribe Schedule 4 CBD. That means no Schedule 3 low-dose CBD and no Schedule 8 THC. PharmOut have contacted the APVMA, who have confirmed that only S4 CBD is allowed to be prescribed, as all the other preparations under Schedule 3 and 8 are for human use only.
The S4 CBD must be imported.
Veterinarians may only prescribe imported CBD products. Locally cultivated cannabis products cannot be used as the Narcotic Drugs Act 1967 only covers the cultivation, production, and manufacture of medicinal cannabis for use in humans, not animals.
Consent to import is required.
To import CBD for animals, consent to import is required from the APVMA, as well as other government regulators (e.g. Australian Border Force, the Office of Drug Control). In the import consent form, applicants must provide the details of the product being imported and a reason for import. This is assessed by the APVMA when the application is submitted. Only a registered veterinarian or someone acting under the direction of a registered veterinarian can apply for this consent, and the product must be for use in an animal under the direct care of the importing veterinarian.
Alternatively, the APVMA has also indicated that veterinarians would be able to access imported CBD products in Australian pharmacies. As always, veterinarians should follow their local prescribing rights legislation with regard to cannabinoids, which differs in each state.
Need to brush up on your APVMA GMPs? We have an upcoming training course here.
If you want to read more on similar topics, the following blogs may also be of interest: