Off-label use of veterinary chemicals

Off-label use refers to situations when a registered veterinary chemical is used in a manner that is not specified on the product label.

This page outlines requirements for people treating animals under their care with off-label or unregistered veterinary chemicals. These requirements also apply to veterinarians unless stated.

Some off-label uses by animal owners are not prohibited. Use of off-label or unregistered veterinary chemicals can also be undertaken in some circumstances in accordance with written instructions of a veterinarian or in accordance with a permit from the Australian Pesticides and Veterinary Medicines Authority (APVMA).

If livestock owners or a veterinarian chooses to use a product off-label, it is their responsibility to manage the risk of any adverse outcomes that may result from the off-label use such as unacceptable chemical residues in meat, milk or fibre.

Managing residues and other risks

Livestock owners have a responsibility meet legislative requirements not to sell livestock or agricultural produce (e.g. meat, milk or fibre) that contain unacceptable chemical residues.

If veterinary chemicals are used off label, a sufficient withholding period (WHP) must be observed to ensure there is no risk of unacceptable chemical residues occurring. A WHP specified on the label only applies to the animal and use pattern on the label and may not be suitable for an off-label use pattern. Determining a suitable WHP can be very difficult and requires knowledge of residue depletion in the animal or produce and the applicable Maximum Residue Limit (MRL) standards for Australia and potential export markets.

Additionally, livestock owners are not permitted to sell treated animals before all WHPs have expired unless the purchaser is advised of this in writing on the National Vendor Declaration /PigPass (or similar applicable document).

The use of off-label or unregistered veterinary chemicals can also impact the health and welfare of animals.

If off-label use may be required, livestock owners should seek professional advice from a veterinarian. If such off-label use is appropriate, the veterinarian may choose to use their professional judgement to set an appropriate WHP. In many circumstances, an APVMA permit may be required to authorise the use and set both an appropriate MRL and WHP for the use.

'Prescription animal remedy' products

'Prescription animal remedy' products (for example, antibiotics) are Schedule 4 substances dispensed by veterinarians for animals under their care.

These products must be used according to the directions provided by the veterinarian, which might be different from the directions found on the APVMA approved label attached to the product packaging. In this situation, the veterinarian must provide an appropriate withholding period to ensure unacceptable chemical residues are not detected at slaughter or in any produce obtained from treated animals e.g. milk/fibre.

Once dispensed, a 'prescription animal remedy' product must not be used to treat a different animal than the one specified in the directions provided by the veterinarian.  A new prescription must be obtained to use the product on the different animal.

'Over-the-counter' veterinary chemical products

'Over-the-counter' veterinary chemical products are Schedule 5, 6 and 7 substances that are available for purchase by retail (such as worm drenches and lice treatments).

Unless restricted, some off-label use is allowed for 'over-the-counter' products. If livestock owners choose to use a product off-label, it is their responsibility to manage the risk of any adverse outcomes that may result from the off-label use. It is also their responsibility to meet legislative requirements not to sell animals or agricultural produce (e.g. meat, milk or fibre) that contain unacceptable chemical residues.

Restrictions on veterinary chemical off-label uses

Restrictions on unregistered veterinary chemical product use

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 for veterinary use 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.

A person must not use an unregistered chemical product unless:

• the APVMA has issued a permit authorising the use of the unregistered chemical product

or

• the chemical product is used no later than two years after its registration ends, and the chemical product was in the user's possession immediately before its registration ended

or

• the use is by, or in line with the instructions provided by a veterinary practitioner acting in the course of the practitioner's profession, and it complies with the legislative requirements for using unregistered products (meaning, the quantity of unregistered product provided is enough to treat only a single food-producing animal and an appropriate withholding period is provided)

or

• they are using the unregistered veterinary chemical for the purpose of carrying out a scientific procedure in line with the Prevention of Cruelty to Animals Act 1986, and
• the use is within a scientific established licensed under the Prevention of Cruelty to Animals Act 1986, and
• no more than 10 animals are treated, and
• any animal treated with the unregistered chemical product is not sold for human or animal consumption.

Note: Other prohibitions or restrictions may continue to apply regardless of the exemptions above.