Veterinary practitioner requirements
The supply and use of veterinary chemicals (medicines) by veterinary practitioners is regulated under a number of Acts administered by different bodies.
Medicines and poisons requirements
Veterinary practitioners in Victoria are authorised under the Drugs Poisons and Controlled Substances Act 1981 to obtain, possess, use or supply scheduled poisons, which include veterinary chemicals.
All veterinary practitioners are subject to regulatory requirements including:
- Possession and storage
- Supply, administration and records
- Prescribing
- Labelling of containers
- Treating an animal under one’s care
- Establishing therapeutic need
For details of these requirements and how they link to Veterinary Practitioners Registration Board of Victoria Guidelines, see further information on the Department of Health Medicines and Poisons webpage for Veterinary practitioners.
APVMA requirements
Veterinary chemicals require registration with the Australian Pesticides and Veterinary Medicines Authority (APVMA) unless exempted from registration. These requirements are made under Commonwealth legislation Agricultural and Veterinary Chemicals Code Act 1994 (Agvet code).
The Agvet code excludes veterinary practitioners from some possession, registration, supply and labelling requirements where they are undertaking an action that is permitted under other state and territory laws (e.g. dispensing a compounded veterinary chemical in accordance with the Drugs Poisons and Controlled Substances Act 1981).
Importation of unregistered agricultural or veterinary chemicals or unapproved active constituents is restricted under the Commonwealth Agricultural and Veterinary Chemicals (Administration) Act 1992. Veterinary practitioners or a person acting under the direction of a veterinary practitioner may be issued with an Import Consent by the APVMA in limited circumstances.
For details of these requirements and links to the legislation, see information on the APVMA webpage for veterinary practitioners and consent to import chemical products.
Victoria’s agvet chemical requirements
Veterinary practitioners are also regulated in Victoria under the Agricultural and Veterinary Chemicals (Control of Use) Act 1992. This Act includes controls on off-label use, the supply and use of unregistered chemicals, labelling and advice notes, and record keeping by veterinary practitioners.
There are a range of restrictions and allowances that veterinary practitioners need to follow when using or advising the use of off label use and unregistered veterinary chemicals. These include restrictions on:
- Off-label use on 'major' species'
- Label rates and frequency
- Specific label prohibitions
- Administering veterinary chemicals by injection
- Use of agricultural chemicals on animals
- Prohibited and restricted active ingredients
- Use of unregistered veterinary chemicals
See the Agriculture Victoria webpage on Off-label use of veterinary chemicals for further information.
Supply by veterinary practitioners of registered veterinary chemicals for on-label use (except Schedule 4 Poisons)
If a registered veterinary chemical (other than a Schedule 4 Poison) is supplied for use in a manner — meaning a manner consistent with the instructions on a label registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA) — then no addition information needs to be provided as long as the APVMA label is attached to the container.meaning a manner consistent with the instructions on a label registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA) — then no addition information needs to be provided as long as the APVMA label is attached to the container.
If a registered veterinary chemical (other than a Schedule 4 Poison) is supplied for use in a manner — meaning a manner consistent with the instructions on a label registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA) — then no addition information needs to be provided as long as the APVMA label is attached to the container.meaning a manner consistent with the instructions on a label registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA) — then no addition information needs to be provided as long as the APVMA label is attached to the container.
When supplying a veterinary chemical product for the treatment of stock (e.g. a sheep or pig), veterinary practitioners must provide a label attached to each product container or provide an advice note to the buyer before or at the time of the initial treatment when supplying:
- A veterinary chemical that is a Schedule 4 Poison
- A registered veterinary chemical product for use other than in accordance with the APVMA approved label (off-label use).
- A registered veterinary chemical product supplied without an APVMA approved label.
Note: An advice note is to be provided when any of the above veterinary chemical products are sold in bulk quantities or if a complex dosage regime applies.
The label or advice note provided by the veterinary practitioner must include the following information:
- business name, address and telephone number of the veterinary practitioner
- date the product was sold
- species, breed, age and sex of the animal to be treated
- directions for treating the animal with the product
- product name (unless it is sold in a container bearing the manufacturer's label or it is an unregistered chemical product)
- name and concentration of the active constituent (if the veterinary chemical product is unregistered.
- the withholding period for the species of animal to be treated or, if no such period applies, the statement "Nil withholding period required"
- the batch number of the product and its expiry date (if known).
Supply by veterinary practitioners of unregistered veterinary chemicalsThe sale of unregistered chemicals is generally prohibited. However, there are allowances for veterinary practitioners or a pharmacist acting in accordance with the written instructions of a veterinary practitioner.
Unregistered veterinary chemicals are:
- substances for veterinary use that require an APVMA registration but are not registered or
- substances or mixture of substances for veterinary use that have been prepared by a veterinary practitioner or pharmacist but are not registered.
Unregistered veterinary chemicals can include:
- Human medicine formulations registered with the Therapeutic Goods Administration
- Imported internationally registered veterinary medicines (where the product is not registered in Australia, even if the active ingredient is approved)
- Compounded medicines.
Veterinary practitioners or a pharmacist acting in accordance with the written instructions of a veterinary practitioner can sell an unregistered chemical for the treatment of a stock animal (e.g. a sheep or pig), only if the quantity of chemical is sufficient to treat a single stock animal and is supplied with the following information:
- business name, address and telephone number of the veterinary practitioner
- date the product was sold
- species, breed, age and sex of the animal to be treated
- directions for treating the animal with the product
- name and concentration of the active constituent
- the withholding period for the species of animal to be treated or, if no such period applies, the statement "Nil withholding period required"
- the batch number of the product and its expiry date (if known).
Veterinary practitioners or a pharmacist acting in accordance with the written instructions of a veterinary practitioner can sell an unregistered chemical for the treatment of a non-stock animal (e.g. horse, dog or cat), only If the veterinary chemical is supplied with the following information:
- business name, address and telephone number of the veterinary practitioner or pharmacist
- date the product was sold
- species, breed, age and sex of the animal to be treated
- directions for treating the animal with the product
- name and concentration of the active constituent.
Note: This information must be provided via a label attached to each product container or in an advice note supplied to the buyer before or at the time of the initial treatment.
A veterinary advice note template has been developed by Agriculture Victoria:
The information recommended for recording in the veterinary advice note template meets the legislative requirements for chemical use records for both veterinarians and producers. The template is only a suggested format and may be customised as required.
Veterinary practitioners must ensure that the withholding period specified on the label or advice note accompanying a veterinary chemical product will ensure that any stock or produce derived from stock treated with that product (meat, milk, fibre) will not be contaminated with unacceptable chemical residues as a result of the treatment.
The withholding period set cannot be less than that specified by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
If no withholding period is required, the statement "Nil withholding period required" must be included on the label or advice note.
Veterinary practitioners are required to make records of their use or sale of a veterinary chemical product for the treatment of a stock animal. This requirement applies to any veterinary chemicals that:
- contain a Schedule 4 Poison
- are an unregistered veterinary chemical product
- are a registered veterinary chemical sold without an APVMA approved label
- are a registered veterinary chemical sold for a use not specified on the APVMA approved label
- has an applicable withholding period.
The required records for the sale or use of a veterinary chemical product are:
- product name
- date the product was sold or used
- directions for use of the product
- name and address of the buyer
- quantity (amount) of the product sold or used
- species of animal treated or intended to be treated
- location of the animal treated or intended to be treated
- withholding period (if any) for the product.
If the veterinary chemical product is unregistered, the following additional records are required:
- the name of active constituent
- the concentration in which the product was sold or used
- the form in which the product was sold or used.
Veterinary practitioners must make the required records within 24 hours of selling or using a veterinary chemical product and keep them for 2 years.
Another person may make records of veterinary chemical use on behalf of a veterinary practitioner, such as a receptionist or veterinary nurse, however the veterinary practitioner is responsible for ensuring that the records are made in a timely and accurate manner.
As outlined in Guideline 7, the Veterinary Practitioners Registration Board of Victoria requires additional records over and above the minimum outlined in law to be kept. This reflects the Board's view of best practice and is the standard against which they will measure compliance with their expectations of veterinary practitioners. For example, the legal minimum length of time records must be kept is 2 years, however Guideline 14 states the records of all veterinary medications administered or supplied must be retained for at least 7 years.
A person (including a veterinary practitioner) must not sell or use any veterinary chemical product to be administered to stock or horses if it contains Chloramphenicol as an active constituent.
A person (including a veterinary practitioner) must not sell or use any veterinary chemical product to be applied topically to stock if it contains any arsenical compounds as an active constituent.
A person (including a veterinary practitioner) must not sell or use any veterinary chemical product to be administered to stock if it contains any of the following active constituents:
- carbadox
- mercury compounds other than thiomersal and phenyl mercuric acetate when used as preservatives
- organochlorine chemicals including DDT, dieldrin, lindane endrin, aldrin, and BHC
- reserpine
- nitrofuran antibacterials
- diethylstilboestrol and related compounds
- sulfonamide antibacterials (except sulfadiazine, sulfadimidine, sulfadoxine, sulfaquinoxaline, sulfatroxazole).