Controls over stock medicine use in NSW

Legislation

In NSW the use of all veterinary chemical products or veterinary medicines is regulated by the Stock Medicines Act 1989 (“the Act”) and the related Regulation.

While the Act provides controls which are like those in other Australian jurisdictions there are some differences, particularly relating to flea, tick, lice and fly treatments used on animals.

Any use prohibited by the Act may be allowed by a permit issued by the Australian Pesticides and Veterinary Medicines Authority (APVMA) or by an Order issued under Section 46 of the Act.

The registration and supply of all veterinary chemical products is regulated by the APVMA. The APMVA prohibits the supply (sale) of date-expired products.

Categories of animals

The Act categorises animals in three ways. There are two food animal groups: food producing species (FPS) and major food producing species (major FPS), which is included within FPS. Then there are all other animals – mostly companion animals such as dogs, cats or cage birds (pets) and horses.

Treatment of major FPS requires veterinary intervention if off-label use (any change to the label use instructions) is contemplated. Off-label use requires that veterinarians provide written directions for use, primarily to ensure that meat, milk or eggs from treated animals do not contain illegal residues. Illegal residues are any residues which exceed the Maximum Residue Limit (MRL) set for the chemical in a food product. If no MRL exists, then any detectable residue is illegal.

Although horses are not defined as food producing species, all horse treatments should be recorded by both veterinarians and owners in order to allow accurate completion of the National Vendor Declaration (Horses).

General controls

• Stock medicines may not be used contrary to label instructions (unless a permit or order is in place) except as specifically provided below (Section 39 of the Act).
• Owners and veterinarians may treat companion animals (e.g. dogs, cats, cage birds) with unregistered products because they are not defined as food producing species (Section 38).
• Unregistered stock medicines may not be used to treat food producing species except as specifically provided below (Section 38).
• Possessing unregistered stock medicines for food producing animals is illegal (Section 37).

Off-label use and “prescription” by veterinarians

• Veterinarians may use any registered product “off-label” (change in species, dose rate, frequency of use etc.) to treat non food producing species (Section 39A).
• Food producing species may only be treated off-label with a product already registered in another major food producing species (Section 39A(2)).
• In relation to any off-label use, written directions must be provided by a veterinarian to the owner of the animal to be treated (Section 39D).
• Veterinarians must keep records for two years of all treatments they undertake, provide or prescribe for major food producing species. This includes use of any unregistered stock medicine, use of any registered stock medicine off-label, or use of any restricted substance (Prescription Animal Remedy or S4 poison)(Section 39E).
• A single animal (as defined) of a food producing species may be treated by a veterinarian with any unregistered product, including a companion animal or human product, provided they comply with certain essential conditions (Section 39A(3)) and in spite of the prohibitions below.
• Veterinarians must comply with all label instructions included under a “RESTRAINT/S” heading, e.g. “Not for use in lactating animals” (Section 39A(2)).
• Veterinarians must observe all prohibitions against use in food producing species of any products registered only for animals which do not belong to food producing species, e.g. “Not for use in food producing species of animals” on the label of a dog product (Section 39A(2)).
• Veterinarians may not inject products registered only for oral or topical use (Section 39A(2)).
• If veterinarians order medication of stock feeds for clients they must supply a copy of the order to both the feed mill and the client (Section 39D(2))

Other controls for veterinarians

• Veterinarians may only supply or prescribe an unregistered product for a companion animal if it is a human pharmaceutical, compounded by the veterinarian or made by a pharmacist on the veterinarian’s prescription (Section 39C). This does not preclude their using other unregistered products on these animals.
• Treatments for fleas, ticks, lice and flies which require dilution prior to their application to animals as a spray or wash cannot be used off-label in NSW (though they may be legally used off-label in other jurisdictions). Such sprays and washes are regulated as pesticides in NSW under the Pesticides Act 1999. No off-label exemptions are provided for veterinarians or owners under the Pesticides Act.
• NSW Poisons and Therapeutic Goods legislation allows veterinarians to repack and dispense smaller quantities of any product which they are legally permitted to supply.

Other Controls

• Food producing species must not be slaughtered for human consumption, or food harvested from them, while they are within a treatment withholding period (Section 40B).
• Potential buyers of food producing species must be notified if treated stock are sold while they are still within a treatment withholding period (Section 40A).
• Owners may, under certain strict conditions, use a product registered for use on a major food producing species on other food producing species of animals which are not major food producing species (Section 39B).
• All supply of injectable anabolic steroids and testosterone  is restricted by an Order under Section 46 of the Stock Medicines Act.  It requires veterinarians to treat all animals and not supply steroids. Details of all purchase and use of injectable steroids must be maintained and the bottles kept in a locked container when not in use.  Records may be kept in the S8/Controlled Drug register.
• Injectable testosterone products used for treating balano-posthitis in sheep may still be dispensed by veterinarians but strict conditions and record-keeping requirements apply, including use of a register similar to an S8 register.

Advertising controls

• In NSW the Stock Medicines Regulation prohibits the advertising of prescription only  (Schedule 4 / Prescription Animal Remedy) stock medicines except directly to veterinarians (Clause 7).
• In most other jurisdictions advertising of prescription only stock medicines is regulated by Health Departments.

State and Territory variations

Similar legislative principles to these apply in most jurisdictions, but there are differences of detail which must be followed by veterinarians not operating in NSW.

© State of New South Wales through Department of Trade and Investment, Regional Infrastructure and Services 2012. You may copy, distribute and otherwise freely deal with this publication for any purpose, provided that you attribute the Office of the Department of Primary Industries within the Department of Trade and Investment, Regional Infrastructure and Services as the owner.

Disclaimer: The information contained in this publication is based on knowledge and understanding at the time of writing (Jan 2012). However, because of advances in knowledge, users are reminded of the need to ensure that information upon which they rely is up to date and to check currency of the information with the appropriate officer of the Department of Trade and Investment, Regional Infrastructure and Services or the user’s independent adviser. Any decision to treat animals “off-label” based on the legislation is made entirely by the attending veterinarian.