Code of Practice for the Supply and Use of Veterinary Chemical Products

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Code of Practice for the Supply and Use of Veterinary Chemical Products (86 KB)


Background

A number of veterinarians have recognised inconsistencies in the quality of advice given to managers of production animals; in particular, the provision of advice notes containing appropriate withholding period information and inconsistencies between labels. If mismanaged, these matters have the potential to severely impact on trade through residue violations in meat and other animal products.

In March 1999 the Standing Committee on Agriculture and Resource Management (SCARM) endorsed national regulatory principles for controls over the use of veterinary chemicals and agreed that the principles should be incorporated into State and Territory legislation.

As a result of the Commonwealth Government's Drugs in Sport initiatives, the Agriculture and Resource Management Council of Australia and New Zealand (ARMCANZ) agreed in August 1999 to examine opportunities to tighten up access to and use of veterinary drugs, specifically anabolic steroids. This Code attempts to address each of these issues concurrently.

Application

This Code is published by the Agricultural, Silvicultural and Veterinary Chemicals (ASCHEM) Council and applies under the Agricultural and Veterinary Chemicals (Control of Use) Order 2001. It prescribes responsibilities and minimum standards that apply to the supply and use of veterinary chemical products(i) in Tasmania. The Code applies only in respect of veterinary chemical products that are scheduled poisons(ii) for the treatment of animal species that are used by people in Tasmania for food, or from which food products are derived.
Sections 1 - 4 apply to veterinarians. Section 5 applies to non-veterinarians. Sections 6 - 8 apply to all users of veterinary chemical products.

Section 1 - Use of Chemical Products by Veterinarians

This section prescribes responsibilities for the use of chemical products by veterinarians.
1.You may treat an animal with a registered veterinary chemical product off-label(iii) except where such treatment is prohibited by this code or in other legislation.
2.You must not treat an animal of a major food species(iv) with a veterinary chemical product unless:
(a) the product is registered for that species, or
(b) it is registered for another major food species, or
(c) its use on that species is authorised by a valid permit; or
(d) you only treat a single animal(v) which is fully identified, as per clause 34.
3.You must not treat an animal of a food species(vi) with a registered product off-label, with unregistered products, or with registered human pharmaceuticals unless the animal is under your care and it is fully identified, as per clause 34.
4.If you treat an animal of a food species with a veterinary chemical product, you must provide the person in charge of the animal with an advice note.
5.You must not treat an animal of a food species with a veterinary chemical product in a manner contrary to an instruction under a "Restraints" heading on the product label, except for a single animal. You may treat an animal in a manner contrary to a label "Precautions" heading, if necessary.
6.You must not inject an animal with a product that is labelled only for oral or topical use.
7.You must not apply an agricultural chemical product(vii) to an animal of a food species except for a single animal.
8.If you treat an animal with an injectable steroid(viii), you must either inject the animal yourself, or supervise the injection of the animal by a person in your presence.

Section 2 - Supply of Veterinary Chemical Products

This section prescribes responsibilities for the supply of chemical products by veterinarians.
9.You must not supply or prescribe to a person a veterinary chemical product for the treatment of an animal of a food species unless the product is packaged and labelled appropriately
10.You must not supply or prescribe to a person a veterinary chemical product for the treatment of an animal of a major food species unless the product is registered for that species, or another major food species, or the supply or prescription is for a single animal.
11.You must not supply an unregistered or re-packaged veterinary chemical product to a veterinarian other than one within the same veterinary practice.
12.You must not supply or prescribe a veterinary chemical product, when there are reasonable grounds for suspecting that the product may be used for human use, or otherwise misused.
13.Where there is a veterinary chemical product already registered for a specific treatment, you must not supply an equivalent product that you have prepared or repacked for that treatment.
14.Where you have prepared a veterinary chemical product, you should only supply a quantity sufficient for a single course of treatment.
15.Except as permitted under clause 8 or clause 39, you must not supply, or prescribe the supply of an injectable steroid.
16.You must not supply a sheep testosterone product(ix) to any person unless you know that person is a primary producer who has sheep which you know require treatment with such a product, or the person is an employee of that producer.
17.You must not supply a sheep testosterone product in a quantity that is more than sufficient to give a single course of treatment to each animal that is under the care of a person described in clause 16.

Section 3 - Advice Notes and Labels

This section prescribes responsibilities for the provision of advice notes and labels by veterinarians.
18.Where you are required to provide an advice note, the note must be in the form provided in the Agricultural and Veterinary Chemicals (Control of Use) Regulations 2012 and include the following information:
(a) name of the chemical product,
(b) name of the person prescribing or dispensing the product,
(c) particulars of the animal(s) to be treated, including their location, number, description and identification,
(d) amount of product to be administered to each animal,
(e) date of treatment, or the proposed treatment date,
(f) re-treatment interval and
(g) withholding period(x)
19.If you supply a registered veterinary chemical product in its original container, you must ensure that it is labelled with its APVMA-approved label.
20. If you supply a veterinary chemical product that you have prepared or repackaged, you must ensure it is packaged and labelled in accordance with the Poisons Regulations 2008. The container must be labelled with -
(a) the words "Keep out of reach of children" in red on a white background,
(b) the name of the owner of the animal,
(c) your name and address,
(d) if the product is for external use - the words "Caution not to be taken" in red,
Note: The Poisons Regulations impose further labelling requirements where a product or any constituent causes or may cause birth defects, or has sedative properties.
21.You must ensure that the person in charge of any animal you treat, or which is treated under your direction, is advised that directions from your advice note or label override any product label directions, where these differ.

Section 4 - Keeping Records by Veterinarians

This section prescribes responsibilities for the keeping of records by veterinarians.
22.You must keep records for at least two years of the use, supply or prescription of any veterinary chemical product that is used for the treatment of an animal of a food species and which is:
(a) a product you have prepared yourself, or have had prepared by a pharmaceutical chemist, or
(b) a restricted substance (listed in Schedule 4 of the Poisons List), or
(c) a registered product for off-label use.
23.The records required to be kept by clause 22 must contain the following information -
(a) the name and address of the owner of the animal treated, or to be treated,
(b) a description of the animal,
(c) the date on which the animal was treated, or the product was supplied for treatment
(d) the directions for use of the product if the veterinarian supplies, or writes a prescription for the product,
(e) the name, strength and form of the product,
(f) the quantity of product supplied and
(g) the withholding period as specified in the advice note that accompanied the product.
24.You must keep a record of any injectable steroid and any sheep testosterone product that you keep, use, supply or dispose of. The record must include -
(a) the name of each steroid or product kept,
(b) the name and address of the source from which each steroid or product was obtained,
(c) the date each steroid or product was obtained, used, supplied or disposed of,
(d) the total quantity of each steroid or product obtained, used, supplied or disposed of,
(e) in the case of use, details sufficient to identify the animals treated and the name and address of the owner or person in charge of the animals,
(f) in the case of disposal, how and where a steroid or product was disposed of, including the name of the recipient, if any, of the steroid or product, and
(g) the amount of each steroid or product remaining after use, supply or disposal out of the total quantity as recorded for the purposes of this clause.
25.You must report any theft, misplacement or other loss of an injectable steroid in excess of a total of 50mL during any 28 day period to the Registrar of Chemical Products, DPIPWE. This report must be made within 48 hours of the discovery of the theft, misplacement or other loss.
26.Your records must be made available for inspection if requested by an inspector authorised under the Agricultural and Veterinary Chemicals (Control of Use) Act 1995.

Section 5 - Use of Chemical Products by Non-veterinarians

This section prescribes responsibilities for the use of chemical products by people, other than veterinarians.
27.You must not treat an animal with a veterinary chemical product unless:
(a) the product is registered for that use, or
(b) its use in that manner is authorised by a valid permit, or
(c) the product is supplied or prescribed by a veterinarian and is handled in accordance with the product label and where provided, an advice note, or
(d) the product is administered by a person in the presence and under the direction of a veterinarian.
28.You must not use a veterinary chemical product in a manner other than in accordance with the product label, a permit, or an advice note or label provided by a veterinarian.
29.You must not use veterinary chemical product in a manner contrary to an instruction under a label "Precautions" heading, except in accordance with an advice note or label provided by a veterinarian.
30.use a veterinary chemical product in a manner contrary to an instruction under a label "Restraints" heading except in the case of a single animal that is treated in accordance with an advice note or label provided by a veterinarian.
31.You must comply with all instructions on an advice note or label provided by a veterinarian.
32.You must not inject an animal with a product that is labelled only for oral or topical use.
33.If you use a veterinary chemical product to treat an animal of a food species belonging to another person, you must ensure that all label information relating to withholding periods, handling requirements, relevant directions for use and any information provided on an advice note or label from a veterinarian is supplied to the person in charge of the animal.

Section 6 - Identification of Animals

This section prescribes responsibilities for the identification of animals by users of veterinary chemical products.
34. If you treat an animal of a food species, you must ensure that the animal or its location is sufficiently identified for the person in charge of the animal to be able to comply with the relevant withholding or re-treatment periods.

Section 7 - Storage of Veterinary Chemical Products

This section prescribes responsibilities for the storage of veterinary chemical products.
35.You must not store a restricted substance (listed in Schedule 4 of the Poisons List) in a part of any premises that is accessible to the public.
36.You must keep veterinary chemical products separate and apart from other goods that are suitable for human or animal consumption in such a way that, if the container of the chemical product breaks or leaks, the product will not mix with or contaminate those goods.
37.A veterinarian who keeps any injectable steroid must ensure that until it is to be used, the steroid is kept in a locked container to which only he or she has access.

Section 8 - Disposal of Veterinary Chemical Products

This section prescribes responsibilities for the disposal of veterinary chemical products.
38. Where a veterinary chemical product is to be disposed of, you must dispose of it in accordance with its label directions, or where this is not applicable, in a manner acceptable to the DPIPWE.
39.Where an injectable steroid is no longer required, a veterinarian must either supply the steroid to another veterinarian, return the steroid to the source from which it was obtained, or otherwise dispose of the steroid in a manner approved in writing by the Registrar of Chemical Products, DPIPWE. Records of the disposal must be kept in accordance with clause 24.

Section 9 - Interpretations

(i) Veterinary chemical product has the same meaning as that used in the Agricultural and Veterinary Chemicals (Control of Use) Act 1995.
(ii) A scheduled poison is a substance included in the Poisons List for the purposes of the Poisons Act 1971.
(iii)Off-label means treatment in a manner that is different from that shown on the label, for example - use on a different species, application of a different dose rate, or treatment for a condition that is not indicated on the label.
(iv)Major food species means any cattle, sheep, pigs or chickens that are a major source of food for people in Tasmania.
(v)A single animal means one animal on its own, or one animal from a group of animals in which no other animals in the group, or on the same property are similarly treated with a veterinary chemical product.
(vi) Food species means any species of animal that is used by people in Tasmania for food, or from which food products are obtained.
(vii)An agricultural chemical product has the same meaning as that used in the Agvet Code of Tasmania, including insecticides, herbicides, fungicides etc.
(viii)An injectable steroid means an injectable product known as an anabolic steroid, including any anabolic steroid which is declared to be a restricted substance under section 36 of the Poisons Act 1971 and any testosterone product included in schedule 4 of the Poisons List. It does not include a sheep testosterone product.
(ix) Sheep testosterone product means an injectable testosterone product registered and labelled for the treatment or prevention of pizzle rot in wethers, or for the preparation of teasers.
(x) A withholding period is the period of time that must elapse between the last treatment of an animal with a chemical product and the slaughter of the animal or the collection of milk, eggs, honey, fibre or other food products from it. The period must be sufficient to ensure that chemical residues from application of the product will not exceed the Maximum Residue Limit for the species of animal treated, or any commodity derived from it.

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