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.
'Prescription animal remedy' products
'Prescription animal remedy' products (e.g. antibiotics) are dispensed by veterinary practitioners for animals under their care.
These products must be used according to the directions provided by the veterinary practitioner , which can differ from the directions found on the product packaging. In this situation, the veterinary practitioner will provide an appropriate withholding period to ensure unacceptable chemical residues are not detected at slaughter.
Once dispensed, a 'prescription animal remedy' product cannot be used for a different purpose without written permission from the veterinary practitioner.
Some off-label use is allowed for 'over-the-counter' products (e.g. worm drenches, lice treatments).
These products may be used at or below the label rate and frequency in food producing species other than cattle, pigs, sheep and chickens, unless specifically prohibited on the label.
They must be used in accordance with any other label directions. If producers choose to use a product off-label, it is their responsibility to manage any adverse outcomes that may result from the off-label use, such as unacceptable chemical residues.
In Victoria, veterinary chemical products administered to cattle, sheep, pigs, or chickens (Gallus domestica) must not be used off-label unless:
- the person administering the product is a veterinary surgeon, or
- the administration has been authorised in writing by a veterinary surgeon, or
- the dose rate is less than that stated on the label for that particular species and for that particular use.
Any other off-label use requires a permit from the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Prohibitions on the sale and use
Prohibited veterinary chemical off-label uses
There are a number of off-label use prohibitions in place for veterinary chemical products.
A person (i.e. non-veterinarians) must not treat cattle, sheep, pigs or chickens with a veterinary chemical in an off-label manner unless:
- They are a veterinary practitioner; or
- They are acting in accordance with the written instructions of a veterinary practitioner; or
- the dose rate is less than that stated on the label for that particular use pattern in that particular species.
Unless a permit has been issued by the APVMA, a person (including a veterinary practitioner) must not use a veterinary chemical product in a way that is specifically prohibited on the label.
For example, if a product has a restraint, 'DO NOT use in food producing animals' on the label, the product cannot be used on such an animal.
No one is permitted to formulate, dispense or use as an injection a veterinary chemical that is registered for oral or topical use only.
A person must not sell or use a veterinary chemical product as specified in column 1 of the following table, if the chemical contains an active constituent specified in column 2
Any veterinary chemical product to be administered to stock
Mercury compounds other than thiomersal and phenyl mercuric acetate when used as preservatives
Organochlorine chemicals including DDT, dieldrin, lindane endrin, aldrin, and BHC
Diethylstilboestrol and related compounds
Sulfonamide antibacterials except –
Any veterinary chemical product to be administered to stock or horses
Any veterinary chemical product to be applied topically to stock
Products that cannot be used off-label without a permit
The following products cannot be used off-label by any person (other than as indicated below) unless a permit has been issued by the department or APVMA:
- streptomycin and dihydrostreptomycin
- products containing clenbuterol and related beta-agonists
- products that are anabolic or androgenic steroids, or hormones, including boldenone ethyloestrenol, megestrol, methandriol, nandrolone, oestradiol, progesterone, stanozolol, testosterone, trenbolone or zeranol and their derivatives other than:
- progesterone and testosterone and their derivatives, when used in conjunction with the artificial insemination of sheep and the use occurs under written instructions of a registered veterinary surgeon.
Use of unregistered veterinary chemical products
A person must not use an unregistered chemical product unless:
- the APVMA has issued a permit authorising the use of the unregistered chemical product
- 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
- the use is by, or in accordance with the instructions provided by a veterinary practitioner acting in the course of his or her profession, and it complies with the legislative requirements for using unregistered products. That is, the quantity of unregistered product provided is sufficient to treat only a single food producing animal and an appropriate withholding period is provided.
- They are using the unregistered chemical for the purpose of carrying out a scientific procedure in accordance 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 ten animals area treated; and
- Any animal treated with the unregistered chemical product is not sold for human or animal consumption.
Prohibited use of agricultural chemicals on animals
A person must not administer or apply a registered agricultural chemical product to an animal unless:
- the use is by, or in accordance with the written instructions of a veterinary practitioner acting in the course of his or her profession, and the quantity of the agricultural product is sufficient to treat only a single food producing animal and an appropriate withholding period is provided; and
- the product does not contain a prohibited constituent by an Order by the Governor in Council under section 25 or 25A of the Agricultural and Veterinary Chemical (Control of Use) Act 1992.