Veterinary practitioner requirements
Labels and advice notes
In Victoria, the Agricultural and Veterinary Chemical (Control of Use) Regulations 2007 and Drugs Poisons and Controlled Substances Regulations 2006 prescribe the information veterinary practitioners must include on a veterinary medicine dispensing label.
This requirement is to ensure clients are fully informed about the product they are being given to use.
The basic requirements for dispensing labels for veterinary medicines are set by the 'Standard for the Uniform Scheduling of Medicines and Poisons' and are incorporated into the Victorian Drugs and Poisons and Controlled Substances legislation. Additional requirements for food producing animals (i.e. stock animals) are provided by the Agricultural and Veterinary Chemicals (Control of Use) legislation.
Information required on a dispensing label or advice note
Dispensing labels and advice notes must comply with the Agricultural and Veterinary Chemical (Control of Use) Regulations 2007 and the Drugs Poisons and Controlled Substances Regulations 2006, and should include the information necessary for record keeping under the Livestock Production Assurance (LPA) Quality Assurance scheme.
The following information must be included:
- signal heading
- the words 'KEEP OUT OF REACH OF CHILDREN' in red on a white background
- if the substance is intended for external use only, the word 'POISON' or the words 'FOR EXTERNAL USE ONLY' in red on a white background
- the words 'FOR ANIMAL TREATMENT ONLY'
- business name, address and telephone number of the veterinary practitioner
- the identity of the animal(s) to be treated; e.g. tag number, species, breed, age, sex
- the name of the animal's owner or person in charge
- the date the product was used or sold
- the trade name which unambiguously identifies the poison or controlled substance and its strength, and form, or the name of the active constituent and its strength and form for unregistered products
- the quantity in the container
- adequate directions for treating the animal with the product including the method of administration, dose rate, dose frequency and number of days of treatment
- the withholding period or the statement 'Nil withholding period required' when treating food producing animals.
This information must be detailed on dispensing labels in a font that is at least 1.5 mm in height.
Failure to include the above information could result in prosecution if found during DPI audits or traceback investigations, or in cases where an adverse result has occurred from failure to provide this information.
Fastening dispensing labels
Dispensing labels must be fastened to the immediate container containing the medication. Where possible, labels should avoid obscuring important information (e.g. batch number, expiry date, product trade name, quantity, active ingredient, safety information and signal headings) as this information may be used by the user. If these details be obscured by a label, they should be included on the dispensing label. The box containing this container may also be labelled, however this is not a substitute for labelling the immediate container.
There are exceptions to labelling the immediate container. For example, boxes containing mastitis or pinkeye syringes for herd or flock treatments can be labelled, unless the syringes are dispensed in small numbers or individually. In this instance, individual syringes must have a dispensing label or be placed in a labelled ziplock bag.
Labels must be fastened to containers so that they cannot be removed or easily damaged. Ideally, this should be done by wrapping the label around the container, in the case of a bottle, or fastening it to the side of the box for mastitis treatments. For small containers, labels may be attached as a flag.
Veterinary advice notes
Veterinary practitioners are legally required to provide the owner or person in charge of the animal with an advice note before treatment of the animal commences, or at the time of the initial treatment. The veterinary practitioner should also keep a copy of the advice note provided as a reference.
A veterinary advice note should be used by veterinarians:
- when treating stock animals with any registered veterinary medicine off-label
- when treating single stock animals with an unregistered medicine, or
- when treating an animal with a Prescription Animal Remedy or animal health product that has a withholding period, as a producer record, when there is no follow-on treatment.
Veterinary advice notes ensure product details (e.g. withholding periods and other required label details) can be recorded and followed by the person in charge of the animal. They may be used in addition to a dispensing label (not instead of one unless it is for a treatment and there is no labelled medicine supplied for ongoing treatment) to reinforce withholding periods for off-label treatments or use of unregistered products, both of which must only be used in accordance with the Agricultural and Veterinary Chemical (Control of Use) legislation.
It is good practice to have the owner or person in charge of the animal(s) sign the advice note at the time of treatment. This validates that they have witnessed the treatment and shifts the onus for adhering to the treatment directions and withholding period directly back to them.
Veterinary advice notes for mass medication of herds and flocks
Veterinary advice notes may be used when dispensing multiple containers for treatments of multiple animals in herds or flocks. In this situation, each container dispensed must, as a minimum, be labelled with:
- the business name, address and telephone number of the veterinary practitioner
- the name of the owner or person in charge of the animal(s)
- the species of animal
- the date the medicine is dispensed.
Advice notes may be useful in all cases where there isn't room on the dispensing label for all the directions. Note that the above minimum label details, required for 'mass medication', must be included on the Veterinary advice note.
Veterinary advice note template: Veterinary advice note (veterinary practitioners)
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 to meet the needs of the individual practice as required. Self duplicating pads allow for a record to be kept by the veterinarian while also providing the information to the producer. Veterinary advice notes must be provided to the producer before or at the time of treatment of the animal/s.
Veterinary chemical products with 'Do Not' statements
Veterinarians are not permitted to use a veterinary chemical product contrary to a specific restraint on the manufacturer's label (e.g. 'Do not use in food producing animals' or 'Not for use in cattle that are producing milk'). In some states, it is permitted to treat a single major species animal contrary to a 'Do Not' statement in the same way as for unregistered products. Other states do not permit any treatment contrary to a 'Do Not' statement (NT and Vic), hence it is important to check the relevant legislation.
Use of unregistered veterinary chemical products
A veterinary practitioner or pharmacist acting in accordance with the written directions of a veterinary practitioner must not sell an unregistered veterinary chemical product unless:
- the unregistered veterinary chemical product is for the treatment of an animal other than a stock animal and the unregistered veterinary chemical product is accompanied by the following written information –
- the business name, address and telephone number of the veterinary practitioner or pharmacist selling the product; and
- the date the product was sold; and
- the species and type (breed, age and sex) of the animal to be treated; and
- the directions for treating the animal with the product; and
- the name of the active constituent and the concentration of the active constituent: or
- the unregistered veterinary chemical product is for the treatment of a stock animal and the quantity of the unregistered veterinary chemical product is sufficient to treat only a single stock animal: or
- the sale is in accordance with a permit under section 25(2)(b) of the Act.
Veterinary practitioner records
All veterinary practitioners who sell or use a veterinary chemical product to treat stock animals (i.e. any animal of which any part is used as, or which produces any product that is ordinarily used as, or manufactured into, food for humans, and includes bees, fish, and birds) are now required to make specified records within 24 hours of selling or using a chemical product.
The following requirements apply to the sale or use of a veterinary chemical product that:
- contains a Schedule 4 Poison substance
- is not registered as a veterinary chemical product by the Australian Pesticides and Veterinary Medicines Authority (APVMA)
- is sold without an APVMA approved label
- is sold for a use not specified on the product label, or
- has an applicable WHP.
Veterinary practitioners are required to make the following records within 24 hours of selling or using a veterinary chemical product for the treatment of a stock animal:
- the product name
- the date the product was sold/used
- the directions for use
- the name and address of the person purchasing the product
- the quantity of the product sold/used
- the species of animal to be treated
- the location of the animal to be treated, and
- any applicable WHPs.
If the veterinary chemical product is unregistered, three additional records must be made:
- the name of the active constituent
- the concentration of the product at time of sale/use, and
- the form of product at time of sale/use.