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ACVM Standard for Unregistered Veterinary Medicines Requiring Veterinary Overview

ISBN 0-478-07785-8

48 ACVM 05/06

This document may be altered at any time. It was current as at the date in the footer of each page of the document. It is recommended that anyone intending to use this document should contact the ACVM Group of the New Zealand Food Safety Authority or check its website (http://www.maf.govt.nz/ACVM/) to confirm that it is the current version.

Endorsement:

Date:

CONTENTS

1 INTRODUCTION

1.1 Scope

1.2 Definitions specific to this standard

1.3 Classification of veterinary medicines requiring veterinary overview

1.4 References

2 REQUIREMENTS FOR HUMAN MEDICINES USED AS VETERINARY MEDICINES

2.1 General

2.2 Prohibition on promotion and advertising

2.3 Prescribing

2.4 Veterinary authorisation

2.5 Importation requirements

2.6 Requirements to hold and sell

3 REQUIREMENTS FOR SPECIALLY COMPOUNDED PREPARATIONS USED AS VETERINARY MEDICINES

3.1 General

3.2 Prohibition on promotion and advertising

3.3 Prescribing

3.4 Compounding

3.5 Importation prohibited

4 REQUIREMENTS FOR UNREGISTERED VETERINARY MEDICINE TRADE NAME PRODUCTS

4.1 Imported veterinary medicines

4.2 Separating off proprietary veterinary medicines

5 REQUIREMENTS FOR USE OF ANY CLASS OF VETERINARY MEDICINE REQUIRING VETERINARY OVERVIEW

GLOSSARY OF ACVM TERMS

APPENDIX

Packaging and labelling requirements for human medicines and specially compounded veterinary medicines used as veterinary medicines

ACVM STANDARD FOR UNREGISTERED VETERINARY MEDICINES REQUIRING VETERINARY OVERVIEW

1 INTRODUCTION

1.1 Scope

This standard covers the requirements for management of products that are not registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 but could be used as veterinary medicines. It covers the requirements for management of:

• human medicines;

• specially compounded veterinary medicines;

• trade name product veterinary medicines not registered in New Zealand; and

• over-the-counter registered veterinary medicines used in a discretionary manner (see section 1.3), or decanted or broken down proprietary veterinary medicines.

1.2 Definitions specific to this standard

(see Glossary for general ACVM terms)

Human medicine

Any substance or article, other than a medical device, that is manufactured, imported, sold, or supplied wholly or principally:

• for administering to one or more human beings for a therapeutic purpose; or

• for use as an ingredient in the preparation of any substance or article that is to be administered to one or more human beings for a therapeutic purpose.

Human medicines include:

• Pharmacy only, restricted and prescription medicines as defined in the Medicines Act 1981 that are not registered as animal remedies under the ACVM Act.

• Substances specified in the Misuse of Drugs Act 1975 that are not registered under the ACVM Act. These substances will still be classified as controlled drugs and subject to the requirements of the Misuse of Drugs legislation.

• Also included in the definition for this standard are any other generic chemical, biological or radioactive substance manufactured, imported, sold or supplied for administration to one or more human beings for a therapeutic purpose.

• ’Human medicine’ does not include foods and dietary supplements for humans.

Unregistered veterinary medicine trade name product

A trade name product that is not registered under the ACVM Act or exempt from registration under that Act.

1.3 Classification of veterinary medicines requiring veterinary overview

The requirements for registered prescription animal remedy (PAR) veterinary medicines are covered in the ACVM Standard for Prescription Animal Remedy Veterinary Medicines rather than in this standard. This standard covers the requirements for preparations or products that are not registered PAR products but could be used as veterinary medicines.

The following classes of products may be used as veterinary medicines in New Zealand under certain circumstances and in accordance with this standard:

• human medicines;

• specially compounded veterinary medicines; and

• unregistered veterinary medicine trade name products, including decanted or broken down registered veterinary medicines.

Because these types of preparations and products (and/or certain uses of them) have not been assessed by the ACVM Group of the New Zealand Food Safety Authority (NZFSA) for use in New Zealand as veterinary medicines, professional supervision during their use is required. They may be used only at the discretion of a veterinarian acting in accordance with this standard. In effect they must be managed as if they were PARs. In the case of decanted or broken down proprietary products, the veterinarian’s responsibility is restricted to maintaining the integrity and quality of the product and providing appropriate packaging and labelling.

1.3.1 Human medicines

Products approved for human use under the Medicines Act 1981 may be used as veterinary medicines only if prescribed by a veterinarian and when used in accordance with this standard. This includes medicines, new medicines, pharmacy-only, prescription and restricted medicines and substances.

Human medicines have not been assessed for safety or efficacy in animals, nor have they been assessed in regard to potential residues if used in food-producing animals. They will have been manufactured according to good manufacturing practices but they may not have been manufactured in facilities that have been approved by the ACVM Group. They are not necessarily formulated or packaged appropriately to use as veterinary medicines, they could include prohibited substances (see www.nzfsa.govt.nz/acvm for current list), and their labelling is likely to be irrelevant to their use as veterinary medicines.

This means that there is no information assessed by the ACVM Group that supports the use of human medicines as veterinary medicines. Nevertheless, they may be used as such when a veterinarian accepts full responsibility for their use and takes due care to manage the risks. While they are not registered PAR products, they may be used as veterinary medicines only if prescribed by a veterinarian.

1.3.2 Specially compounded veterinary medicines

Specially compounded veterinary medicines are either compounded by a veterinarian or by a competent manufacturer or contracted compounding pharmacist on behalf of that veterinarian. They must be prescribed for a specific clinical need identified in a veterinary consultation for animals under the care of that veterinarian. Specially compounded veterinary medicines may be prescribed only by the veterinarian who directed the compounding.

This class does not include preparations formulated by veterinarians for general sale or for sale to other veterinarians or traders. The latter products must be registered unless they are specifically exempt from the requirement to be registered. The authority to compound and the exemption from registration has been provided to ensure veterinarians can address a specific clinical need. The provision must not be used by veterinarians to circumvent the product registration process.

This class does not include the decanted or broken down proprietary veterinary medicines when there is no change in the product itself. These are included in unregistered veterinary medicines.

The compounding specifications (equivalent to the manufacturing specifications, such as formulation, packaging and labelling) are according to the instructions of the veterinarian as specified in a compounding order issued by that veterinarian. If the specially compounded medicinal preparation is prepared by someone other than the veterinarian, the instruction must be detailed in that compounding order.

Like human medicines, specially compounded veterinary medicines are not assessed by the ACVM Group, so there is no information assessed by the Group that supports their use as veterinary medicines. Nevertheless, they may be used as such when a veterinarian accepts full responsibility for their use and takes due care to manage the risks. While they are not registered PAR products, they may be used as veterinary medicines only if prescribed by a veterinarian.

1.3.3 Unregistered veterinary medicine trade name products

There are many proprietary veterinary medicine trade name products registered in other countries that are not registered in New Zealand. The availability of these products is promoted internationally and they can be purchased overseas or ordered electronically or by mail. However, they must not be imported without prior approval of the ACVM Group.

Under normal circumstances trade name products that are not registered under the Agricultural Compounds and Veterinary Medicines Act 1997 or specifically exempted from the requirement to be registered under the Agricultural Compounds and Veterinary Medicines Regulations 2001 must not be used as veterinary medicines in New Zealand. However, under very special circumstances approval for their use (and, consequently, approval to import) will be issued by the ACVM Group. In this instance, approval will be issued only if there is an immediate welfare need that cannot be effectively met by using a product that is currently approved in New Zealand.

This class also includes decanted or broken down registered veterinary medicines because products that have been altered are no longer the registered products.

1.3.4 Registered over-the-counter veterinary medicines used in a discretionary manner

Registered over-the-counter veterinary medicines are trade name products for which veterinary overview is considered to be unnecessary when the product is used as recommended on the species and class of animals recommended. The products have been assessed by the ACVM Group so there is adequate information supporting their use as veterinary medicines for those recommended uses only.

The use of registered over-the-counter trade name products for uses other than the ones approved in the current registration for the product is not allowed unless the user has relevant veterinary advice first. This advice could be in the public domain but endorsed by the veterinary profession as a whole or by specialist veterinarians in a particular field and does not have to be advice of a particular veterinarian after a consultation. This means that compendium veterinary advice published by or endorsed by veterinarians working in a relevant specialist area would be acceptable to support a use that was different from those approved in the current registration of a product.

It is considered that either advice from a specific veterinarian or publicly available general veterinary advice provides sufficient veterinary overview of the particular product and use to manage the risks without requiring a prescription or restricting use that is in accordance with that advice. Consequently, this standard does not contain specific requirements for over-the-counter veterinary medicines used in a discretionary manner. Risks are with the user and the veterinary advice should be followed.

1.3.5 Decision rationale for prescribing unregistered veterinary medicines

It is recognised that there are circumstances in which there is no registered veterinary medicine trade name product approved for a particular use or suitable to be used in a discretionary manner to meet a particular need. There may also be circumstances in which a human medicine is more suited to a particular need than any registered veterinary medicine.

Because human medicines have not been assessed in New Zealand under the ACVM Act as veterinary medicines, they must not automatically be the medication of first choice. If any registered veterinary medicine product is suited for the purpose, the veterinarian must use the registered veterinary medicine. Suitability must be considered from the perspective of the welfare of the animal(s) to be treated. Cost differential is insufficient reason on its own to justify the use of a human medicine over that of a registered veterinary medicine. The decision should be made at the discretion of the prescribing veterinarian. The suitability of a human medicine over a registered veterinary medicine must be based on the professional judgement of the prescribing veterinarian. However, the veterinarian must be able to defend that judgement successfully in light of common practice of the veterinarian’s peers.

If the veterinarian comes to the professional conclusion that a human medicine is more suitable, the veterinarian must take due care to assess the risks posed by the use of that medicine in that kind of animal for that purpose and take appropriate measures to:

• protect the safety and welfare of treated animals;

• avoid unacceptable residues and banned substances;

• provide suitable packaging and labelling with use instructions and warnings;

• advise the user on safe storage, handling, use and disposal; and

• provide or make arrangement for emergency and follow-up care.

Even though human medicines have not been assessed as veterinary medicines, they are manufactured according to good manufacturing practices by a manufacturer that has been approved by a New Zealand regulatory agency (Medsafe). Therefore, such products are the preferred option over specially compounded veterinary medicines.

If there is no registered veterinary medicine or human medicine that will effectively meet a particular need, suitably qualified veterinarians may compound (or contract to compound on their behalf) a specially compounded veterinary medicine. Because there has been no assessment by any New Zealand regulatory agency for such preparations, the veterinarian is solely responsible for every aspect of the preparation and use of specially compounded veterinary medicines.

If the veterinarian comes to the professional conclusion that a specially compounded veterinary medicine is the most effective option to meet a particular need, the veterinarian must take due care to assess the risks posed by the use of the preparation in that kind of animal for that purpose and take appropriate measures to:

• protect the safety and welfare of treated animals;

• avoid unacceptable residues and banned substances;

• provide suitable packaging and labelling with use instructions and warnings;

• advise the user on safe storage, handling, use and disposal; and

• provide or make arrangement for emergency and follow-up care.

It must be noted that there are always new veterinary medicine products being registered. Therefore, a veterinarian should not assume that, because the prescribing of a human medicine or specially compounded veterinary medicine was justifiable in the past, it is still justifiable. It should always be a conscious decision after application of the above rationale.

Because the importation of unregistered veterinary medicines is limited to circumstances of immediate welfare needs and only with specific approval from the ACVM Group, veterinarians must rule out the other options first before applying to the ACVM Group for approval.

1.3.7 Prescribing, supplying, writing a prescription and writing a compounding order

Only veterinarians may prescribe human medicines or specially compounded veterinary medicines to be used as veterinary medicines.

Prescribing is the act of deciding the appropriate medication and specifying the treatment regime. Writing a prescription is the act of documenting an order to supply the specified treatment product. Frequently, the prescribing veterinarian either immediately administers or supplies the prescribed product. Under those circumstances a prescription is not written, but the veterinarian must document in the case records that the product is supplied in response to his or her consultation and prescribing decision.

However, when the medication is not supplied immediately and the person who is likely to dispense the prescribed product is not the prescribing veterinarian, then the prescribing veterinarian must write a prescription to support the subsequent supply of the product. If the product is a human medicine, the veterinarian must specify the packaging and labelling as well as the product itself. If the product is to be specially compounded, and the person who is compounding and supplying it is not the veterinarian, then the veterinarian must also include packaging and labelling instructions in the compounding order.

This means that there are separate activities that may have to be carried out in accordance with this standard:

• prescribing a human medicine or specially compounded medicinal preparation;

• writing a prescription for the supply of a human medicine or specially compounded medicinal preparation by a third party;

• writing a compounding order to a manufacturer or contracted compounding pharmacist; and

• supplying (dispensing) the prescribed product.

Because unregistered veterinary medicines may not be imported except by approval from the ACVM Group, a veterinarian might want to prescribe the product but must apply to the ACVM Group to import it directly. The veterinarian would subsequently supply the product directly to the client. The product must not be supplied by any person other than the veterinarian holding the specific approval from the ACVM Group unless special arrangements are made with the ACVM Group. Writing a prescription for such a product is therefore not relevant.

1.4 References

Agricultural Compounds and Veterinary Medicines Act 1997

Agricultural Compounds and Veterinary Medicines Regulations 2001

ACVM New Zealand Labelling and Advertising Guide for Veterinary Medicines Requiring Registration

ACVM Operational Procedures Standard 2: the Use of Veterinary or Human Medicines by Non-veterinarians

ACVM Standard for Prescription Animal Remedy Veterinary Medicines

Veterinary Council of New Zealand (VCNZ) Code of Professional Conduct

2 REQUIREMENTS FOR HUMAN MEDICINES USED AS VETERINARY MEDICINES

2.1 General

Only veterinarians may prescribe human medicines as veterinary medicines. In all cases, prescribing veterinarians must comply with the conditions imposed on the exemption from registration for such products. These are:

• they must not be used on animals except under the direct care, authority or prescription of the veterinarian;

• the veterinarian must act in accordance with any applicable code of practice in force under section 28 of the ACVM Act.

The code of practice must ensure that the following requirements are met.

2.2 Prohibition on promotion and advertising

Human medicines must not be advertised or promoted as veterinary medicines to the general public. They must not be displayed for sale to the general public. The transfer of disease state awareness and therapy options information to veterinarians is acceptable.

2.3 Prescribing

2.3.1 General requirements

Human medicines may be prescribed only after a veterinary consultation and only for animals under the care of the prescribing veterinarian. Prescribing human medicines for animals not under the care of the veterinarian would be a breach of the conditions of exemption from registration for human medicines and the veterinarian may be prosecuted. There are also likely to be obligations under other relevant legislation such as the Medicines Act 1981, Hazardous Substances and New Organisms Act 1996, Animal Products Act 1999 and Veterinarians Act 2005.

The prescribing veterinarian must gather sufficient information in a veterinary consultation to support the prescribing decision. Failure to carry out an adequate veterinary consultation would be a breach of the conditions of exemption from registration for human medicines, and the veterinarian may be prosecuted. The adequacy of the veterinary consultation must be based on the professional judgement of the veterinarian. However, the veterinarian must be able to defend that judgement successfully in light of common practice of the veterinarian’s peers. The standard for veterinary consultation is as specified in the VCNZ Code of Professional Conduct. Consultation must include either:

• a physical examination of that animal being an animal in the immediate care of that veterinarian; or

• the obtaining by that veterinarian of sufficient information about that animal in the immediate care of that veterinarian to enable that veterinarian to make an informed decision with respect to the treatment of the animal, which may include administration, dispensing, or prescribing of the human medicine to or in respect of that animal.

It must also include:

• the obtaining by a veterinarian of an accurate history and case signalment relating to the animal(s) in question;

• communication to, or discussion with the owner of the animal(s) regarding selection of treatment options as well as likely prognosis; and

• providing the necessary instructions and training to be confident that the owner will be available to provide the follow-up that is likely to be needed.

• It may include other matters from a veterinary professional conduct perspective but, from an ACVM perspective, it must be sufficient to justify the selection of a particular product.

The animal(s) must be under the direct care of the veterinarian. For the purposes of this standard the criteria for immediate care as define by the VCNZ are the same as for direct care as specified in the ACVM Amendment Regulations 2005. The veterinarian must be given and accept responsibility for the health and welfare of the animal. The provision of ongoing and continuing care of the animal must be a reality and not merely nominal. Evidence of care would include the keeping of a file recording details of that animal’s care and or the care of other animals in the same herd/flock. Either the animal, herd or flock must have been seen immediately before prescription or supply of the product; or the animal, herd or flock must have been seen recently enough or often enough for the veterinarian to have personal knowledge of the condition or current health status of the herd or flock in order to make an informed diagnosis and prescribe appropriately.

The veterinarian must maintain adequate case records detailing any treatment regimes of that animal, herd or flock.

Inherent in prescribing a human medicine as a veterinary medicine is the ability and commitment to provide adequate emergency or follow-up care should that be necessary as a result of the treatment with the product, given the potential for adverse effects from or failure of the product. A veterinarian must either:

• provide the emergency and follow-up care personally; or

• make arrangements for another veterinarian to provide the care; or

• provide the necessary instructions and training to be confident that a person, acceptable to the veterinarian, will be available to provide the emergency care or follow-up care that is likely to be needed.

The third option is acceptable only when the veterinarian is confident that the person will follow his or her instructions and those instructions comply with the ACVM Operational Procedures Standard 2: the Use of Veterinary or Human Medicines by Non-veterinarians Generally. If none of these options are practical, then the veterinarian must not prescribe the human medicine as a veterinary medicine. Provision of or arrangements for, immediate care must be available at all times.

Before prescribing a human medicine as a veterinary medicine, a veterinarian must be confident that there is not a specific prohibition on use of the active ingredient(s) or excipients as a veterinary medicine (or in a veterinary medicine) in that kind of animal. If in doubt, the veterinarian must clarify the requirement with the ACVM Group. The veterinarian must confirm that the human medicine is the most appropriate medication to prescribe given the decision rationale provided in 1.3.5 above.

2.3.2 Veterinarians supplying human medicines directly to clients

Veterinarians may provide the human medicines they prescribe directly to their clients. If this is done the case records must show that the products were supplied directly as a result of a prescribing decision based on a veterinary consultation.

If purchasing human medicines from a wholesaler that has a licence to sell the medicines by wholesale in human medicines, the veterinarian must comply with any requirements of the Medicines Act 1981 or the Misuse of Drugs Act 1975. (A controlled drug may be purchased only from a wholesaler licensed to deal in controlled drugs.)

When supplying a human medicine to clients for use as a veterinary medicine, the veterinarian must provide adequate and appropriate packaging for the product with appropriate labelling for the use for which it is being prescribed. The labelling must also identify and provide the contact information of the prescribing veterinarian. If veterinarians supply human medicines in proprietary packaging, the veterinarians must ensure that all the pertinent information is passed on to the clients to allow the human medicine to be used safely and appropriately as a veterinary medicine, and not as a human medicine. They must make it clear that the product is for animal use only and only for the purpose specified. They must also provide instructions on how to dispose of any surplus medicine or empty containers.

2.3.3 Issuing a veterinary prescription for human medicines

When the prescribing veterinarian is not supplying the human medicine directly to the client, then a prescription that contains all the required information must be written. While the form of a prescription may vary it must:

• be readily recognisable as a prescription;

• contain the essential information; and

• be sufficiently clear and unambiguous to allow an authorised person to dispense or fill the prescription.

Veterinarians may not phone or fax controlled drug prescriptions to pharmacies.

As above, prescribing veterinarians must ensure that all the pertinent information is passed on to the clients to allow the human medicine to be used safely and appropriately as a veterinary medicine and not as a human medicine. They must make it clear that the product is for animal use only and only for the purpose specified. They must also provide instructions on how to dispose of any surplus medicine or empty containers.

If a prescription is issued, it must:

• be legible and indelibly printed;

• be signed and dated personally by the prescribing veterinarian or identified in a manner that allows the prescribing veterinarian to recognise it as the one he or she issued (i.e. identification compatible with electronic transfer of the prescription);

• carry the printed name of the prescribing veterinarian, the address and name of the veterinary practice or organisation of the prescribing veterinarian;

• set out the surname, initial of any given name, and address of the owner (or person in charge) of the animal(s);

• describe the essential identification details of the animal(s);

• if the medication is to be administered by injection, or by insertion into any cavity of the body, or oral administration, specify the dose and the frequency of the doses; or

• if the medication is to be applied externally, specify the method and frequency of use;

• if it is the intention of the prescribing veterinarian that the medicine should be supplied on more than one occasion, then the number of occasions the medicine may be supplied must be specified, or the interval to elapse between each supply, or the period of treatment during which the medicine is intended to be used;

• draw to the attention of the owner, or person in charge of the animal(s), any additional instructions to be followed or precautions to be taken;

• provide instructions on the packaging and labelling to the person supplying the product;

• contain the following statement, or words of similar meaning,“Not for human use”;

• if the prescription is for a controlled drug, the prescription must bear the words “For Animal Treatment Only”.

If the medicine is to be administered to a food-producing animal, the prescription must provide sufficient information to prevent the occurrence of residues of the prescribed medicine that contravenes any requirements of the Animal Products Act 1999 or the Food Act 1981. The veterinarian must specify the withholding period based on a reasonable assessment of the likelihood of unacceptable residues being present. If the veterinarian is unable to determine a safe withholding period, then a withholding period that is consistent with the default withholding periods set by the ACVM Group must be specified. Failure to provide this information is a specific offence under section 55 of the ACVM Act.

The veterinarian must be aware of and not prescribe treatments containing prohibited or restricted substances. If in any doubt about the status of a substance, a veterinarian should contact the ACVM Group for the latest information on prohibited or restricted substances.

The veterinarian must provide the information necessary to complete the animal status declaration if it is required under the Animal Products Act 1999.

The quantity of medicine prescribed and the duration of the prescription, if it is to be used for refilling, must be specified on the prescription and be only what is necessary and sufficient to achieve the purpose as identified in the associated veterinary consultation.

The prescription must contain information that it must be first dispensed (filled) within 30 days of the date of writing and specify a period of treatment, not to exceed six months, for which the prescription is valid.

The actual human medicine must be specified in the prescription if, in the professional judgement of the prescribing veterinarian, no other product would be appropriate. If a range of products is considered appropriate, then the prescribing veterinarian must specify the optional products or provide sufficient guidance to allow the authorised person to fill the prescription accurately. The prescribing veterinarian must not specify only the active ingredient.

The prescribing veterinarian must keep records of each prescription issued for at least five years. These should be cross-referenced to the details of the associated veterinary consultation.

Should a veterinarian require a prescription for a human medicine to be filled urgently, that veterinarian may, if necessary, communicate the prescription orally to the person authorised to sell human medicines. However, within seven days the veterinarian must provide the prescription in writing to that authorised person as confirmation of the request made orally. Whether or not that is acceptable to the person authorised to fill a prescription for a human medicine is a decision of that person.

2.4 Veterinary authorisation

There are no known circumstances in which it is justified to use a human medicine for mass medication in feed or water to food-producing farmed animals. If the circumstances do arise, the veterinarian must obtain prior approval from the ACVM Group before supplying the product or issuing a prescription. The authorisation to hold an active ingredient that is coincidentally an ingredient in a human medicine is covered by the requirements for specially compounded veterinary medicines (section 3 below).

There are circumstances in which human medicines may have to be held in stock in anticipation of a need, e.g. in dispensaries for research, teaching or testing institutions or organisations. Under these circumstances a veterinarian may issue an authorisation to purchase human medicines. However, the veterinarian must be satisfied that the research, teaching or testing institution or organisation has satisfactory security and dispensing systems to ensure that the human medicines are dispensed:

• only under a veterinary prescription; or

• in accordance with a research, teaching or testing protocol endorsed by a veterinarian.

2.5 Importation requirements

The importation of human medicines is subject to control placed under the Medicines Act 1981. Because they appear to be human medicines, they must be imported as human medicines as a treatment for an animal by veterinarians. Once imported, their use as veterinary medicines may be considered, but they may not be imported as veterinary medicines.

2.6 Requirements to hold and sell

2.6.1 General

The authority to sell human medicines is granted under the Medicines Act 1981. There are special provisions and appropriate exemptions for the sale and use of human medicines as veterinary medicines. Persons selling human medicines as veterinary medicines must have the appropriate authorisation under that Act and nothing in the ACVM Act or in this standard alters the provisions of the Medicines Act.

Human medicines must be sold for use as veterinary medicines only:

• to a veterinarian registered under the Veterinarians Act 2005 or his/her bone fide agent or employee; or

• to a person who has the appropriate authorisation under the Medicines Act to hold and trade in human medicines; or

• if the trader has the appropriate authority under the Medicines Act to fill veterinary prescriptions to a person in possession of a relevant, bone fide veterinary prescription or authorisation from a veterinarian.

Assuming the trader has the appropriate authorisation, human medicines destined to be dispensed as veterinary medicines must be transported and stored in a manner that is:

• secure and prevents diversion to other uses; and

• in compliance with any requirements under the Medicines Act 1981 and the Misuse of Drugs Act 1975.

They must not be displayed for general sale. They must be kept out of public view and access.

Traders must not alter in any way the packaging of a ‘human’ medicine, whether it is separating off portions, repacking or relabelling the product. The Medicines Act 1981 specifically prohibits this without proper authority or licence.

2.6.2 Dispensing human medicines under a veterinary prescription

Assuming the trader has the proper authorisation under the Medicines Act, the documented procedures of that trader must give effect to the following requirements (guidance is provided in the appendix):

A trader must be confident that the prescription is valid. If in doubt, the trader must contact the prescribing veterinarian to confirm its validity.

A trader must fill the prescription exactly in accordance with the instructions of the prescribing veterinarian. If in doubt, the trader must contact the prescribing veterinarian to clarify the veterinarian’s instructions.

Separating off portions, repackaging and relabelling must be in accordance with the instructions of the prescribing veterinarian. If the instructions are not clear or are incomplete, then the trader must contact the prescribing veterinarian before filling the prescription.

A trader must not break down, repackage and relabel a product unless they have the proper authorisation from the Ministry of Health to do so and it is essential to comply with the instructions of the prescribing veterinarian. Where the packaging and/or labelling have to be altered in order to comply with the instructions of the prescribing veterinarian, the trader must ensure that this is done in a manner that does not:

• jeopardise the identity of the product;

• result in the loss of the prescribing veterinarian’s identity or instructions or any other essential consumer information;

• introduce additional risks to the user or any persons who might have access to the product; or

• increase the risk of environmental contamination.

Traders must not break down and repackage products that have quality characteristics (e.g. sterility, formulation stability, efficacy etc.) that may be compromised by such an action. If a prescribing veterinarian gives instructions to break down a proprietary product in a way that the trader considers would compromise any quality characteristics, the trader must confirm those instructions with the prescribing veterinarian.

The trader must label the product with the identity and contact information of the prescribing veterinarian, and provide any information required by the prescribing veterinarian.

A trader must not substitute an alternative product or recommend a substitution to the purchaser. If there is an opportunity or need to substitute an alternative product, the trader must first discuss the matter with the prescribing veterinarian and only substitute a product under the direction of the prescribing veterinarian.

A trader who is not a veterinarian must not provide any veterinary advice in association with dispensing a prescription. A trader who is a veterinarian must ensure that providing the veterinary advice is in conjunction with and endorsed by the prescribing veterinarian. If this is not possible, then the prescription must be filled exactly as specified by the prescribing veterinarian. The only exception is when the trader notices that the prescription is for a substance that is prohibited from use as a veterinary medicine. Under those circumstances the trader must alert the prescribing veterinarian and must not fill the prescription. Traders can check on the ACVM website (www.nzfsa.govt.nz/acvm) for the current list of prohibited and restricted substances.

A trader must not return the prescription to the purchaser after dispensing a prescription unless the directions from the prescribing veterinarian indicate that it is to be used for refilling the prescription at a later date. If in doubt, the trader must contact the prescribing veterinarian to confirm the intention. Where a prescription is to be used for specified refills, the trader must record on the prescription each dispensing event and retain the prescription after the last dispensing event that could occur under that prescription.

2.6.3 Sale subject to a veterinary authorisation

In some cases parties may have a need to hold human medicines in anticipation of a veterinary prescription. These parties may be research, teaching or testing organisations or other persons under programmes established by veterinarians that maintain a veterinary medicine dispensary. In these cases a trader may sell human medicines to a person in possession of a veterinary authorisation. Such an authorisation must specify:

• the product(s) and quantities;

• the person who will be responsible for the security of the product(s); and

• the name and contact details of the authorising veterinarian.

The trader must label the products supplied with the authorising veterinarian’s name and contact information.

2.6.4 Advertising or promoting

No one may advertise or promote the use of human medicines for use as veterinary medicines.

2.6.5 Record keeping

A trader must keep records of all prescriptions and veterinary authorisations for a period of five years after dispensing the prescriptions or filling a veterinary authorisation. The records must be available for inspection by a person authorised by the ACVM Group.

3 REQUIREMENTS FOR SPECIALLY COMPOUNDED VETERINARY MEDICINES

3.1 General

Only veterinarians may compound and/or prescribe specially compounded veterinary medicines as veterinary medicines under the exemption from registration in the Agricultural Compounds and Veterinary Medicines Regulations 2001. In all cases, prescribing veterinarians must comply with the conditions imposed on the exemption from registration for such products. These are:

• they must not be used on animals except under the direct care, authority or prescription of a veterinarian;

• the veterinarian must act in accordance with any applicable code of practice in force under section 28 of the ACVM Act.

These are the same conditions imposed on a veterinarian prescribing a human medicine as a veterinary medicine, which are equivalent to the basic conditions on registered PAR veterinary medicines. Because specially compounded veterinary medicines have not been assessed by the ACVM Group, it is expected that the level of veterinary overview will be the same as that for a PAR Class I product. The veterinarian, therefore, assumes responsibility. Any code of practice related to compounding veterinary medicines to be approved under section 28 must include practical guidance in regard to the following requirements.

3.2 Prohibition on promotion and advertising

Specially compounded veterinary medicines must not be advertised or promoted as veterinary medicines. They may be prescribed only because the prescribing veterinarian considers that there is no satisfactory alternative.

They must not be displayed for sale to the general public.

3.3 Prescribing

Specially compounded veterinary medicines may be prescribed only after a veterinary consultation and only for animals under the care of the prescribing veterinarian. The prescribing must comply with the requirements for human medicines (Ref: section 2.3) which are the same for prescription animal remedy (PAR) veterinary medicines (Ref: ACVM Standard for Prescription Animal Remedy Veterinary Medicines).

3.4 Compounding

3.4.1 Veterinarians compounding preparations

Veterinarians must be competent in all aspects of formulation and manufacturing commensurate with the type, complexity and potential hazards of the preparations they are compounding. In the first instance, it is up to the compounding veterinarian’s judgement as to whether or not he or she is competent to compound a particular product. However, the veterinarian must be able to defend that judgement successfully in light of common practice of the veterinarian’s peers. Any code of practice approved under section 28 must include guidance in regard to the particular competencies considered to be the minimum requirements for formulation, preparation of the formulation, packaging, labelling and quality control.

Veterinarians must not use or specify an ingredient that is prohibited from use as an agricultural compound or specify an ingredient or use that is inconsistent with limitations on its use as a veterinary medicine. The most current list of prohibited/restricted substances can be obtained for the ACVM Group.

Because prescribing a specially compounded veterinary medicine should be restricted to those cases in which there is no suitable alternative, the veterinarian should not compound any more of the preparation than would be needed to meet his or her short-term requirements. The prescribing veterinarian must take full responsibility for the product, its preparation, packaging and labelling.

The veterinarian should not store quantities of specially compounded veterinary medicines in anticipation of future needs beyond the short term. The veterinarian must be satisfied that stored product will continue to meet the compounding specifications.

3.4.2 Third parties compounding preparations under a compounding order

When a prescribing veterinarian contracts the compounding to a third party, the veterinarian retains full responsibility for the product. The veterinarian must ensure that the third party is competent and reliable to carry out the preparation. The veterinarian must issue a compounding order specifying the product, quantity required, packaging and labelling.

It is recognised that specialist compounding pharmacists may have more detailed and current information than veterinarians regarding formulation specification, manufacture and quality control. It is acceptable practice for veterinarians and specialist compounding pharmacists to collaborate in the specification and manufacture preparations. It is also acceptable practice to include an ingredient that is a human medicine approved for sale in New Zealand or a veterinary medicine that has been registered under the ACVM Act without specifying its full formulation. However, there must be sufficient information to judge that, even without the full formulation information, the medicine or veterinary medicine can safely be considered fit for the purpose.

Proprietary ingredients of the compounding pharmacists that have not been registered or approved for sale in New Zealand and for which the pharmacist refuses to disclose the formulation should not be acceptable to the veterinarian issuing the compounding order. Any code of practice approved under section 28 must address the responsibility of the veterinarian in regard to adequate knowledge about the preparation.

The quantity of the specially compounded veterinary medicine should be only what is necessary and sufficient to meet the prescribing veterinarian’s short-term requirements. If the veterinarian intends to do the packaging and/or labelling personally, the compounding order must specify this. The veterinarian must specify an expiry date, if relevant.

The third party compounding a preparation in accordance with a compounding order must follow the instructions of the prescribing veterinarian and prepare no more than was specified in the compounding order. Where the specification of the formulation has been a collaborative effort, the acceptance by the veterinarian of any lack of disclosure must be apparent. The acceptability of a lack of disclosure must be based on the professional judgement of the veterinarian issuing the compounding order. However, the veterinarian must be able to defend that judgement successfully in light of common practice of the veterinarian’s peers.

The prescribing veterinarian must ensure that the compounding order is clear and complete in its instructions and limits the quantity to the amount that meets the short-term requirements. The third party must keep records of compounding orders and be able to relate their preparations to specific compounding orders. The full quantity prepared must be given to the veterinarian (or his or her agent) who issued the compounding order. The third party must not retain or hold any part of the order.

3.5 Importation prohibited

Specially compounded veterinary medicines may not be imported without prior approval from the ACVM Group.

4 REQUIREMENTS FOR UNREGISTERED VETERINARY MEDICINES

4.1 Imported veterinary medicines

Products that are registered as veterinary medicine trade name products in other countries but not registered in New Zealand must not be imported, sold or used in New Zealand without prior approval of the ACVM Group (see exemption in Schedule 2 of ACVM Amendment Regulations 2005). The approval will be granted only in cases where there is an immediate animal welfare need that cannot be filled by either a product registered in New Zealand, a human medicine or a specially compounded veterinary medicine. The product must be used in accordance with any conditions placed on the approval.

Prescriptions must not be issued for unregistered trade name products. Any person supplying veterinary medicines must not fill a prescription for any unregistered veterinary medicine that has not been approved by the ACVM Group or any human medicine that is not approved for sale in New Zealand. Any trade in imported unregistered veterinary medicine trade name products without prior approval of the ACVM Group is an offence under section 55(1) of the ACVM Act. Any person found guilty of trading in unregistered trade name products is liable on summary conviction to a fine of up to $30,000 (or $150,000 for a corporation).

4.2 Separating off portions of registered veterinary medicines

Separating off portions of registered veterinary medicine trade name products is not considered to be compounding because the formulation of the product should not be changed in anyway other than to alter the amount supplied. However, the portion of the product supplied is not the registered product because the proprietary packaging in which it has been approved for supply has been breached. This nullifies the relevance of the registration approval, making the separated off portion an unregistered veterinary medicine, subject to the specifications of this standard.

Two of the considerations in the assessment and registration of veterinary medicine trade name products are:

• the container or packaging in which they will be offered for sale; and

• the labelling of the products.

Breaching the original container/packaging and removal of a portion of the product may result in significant changes in the product. It also separates that portion from information that must be provided with the product. Both the container/package and label are tools used to manage risks. Consequently, they are integral components of the ACVM approval for the product.

While there may be circumstances in which separating off portions of products may be appropriate, such practices are likely to alter the risks posed by the products and nullify the risk management effect of the packaging and labelling.

The following are the rules of acceptable practice governing the separating off of portions of registered veterinary medicine trade name products.

4.2.1 Acceptable sales practices

Separating off portions of product into different containers with different labels for sale or supply could be selling or supplying an unregistered product and that would be a breach of the ACVM Act. Separated off portions are also still subject to the requirements of the relevant approvals under the HSNO Act and separating off portions may lead to breaches under that Act. There are only specific circumstances under which supply of separated off portions of products would still comply with regulatory requirements.

4.2.2 Provision for separating off portions as part of registration

Where separating off portions of a product and subsequent sale was anticipated and provided for in the registration of a product, then the practice is not a breach of the ACVM Act as long as it is carried out in accordance with the approved instructions for the product. The registration will specify what the minimum requirements (re containers, labels and management of the process) are for the product. Persons doing this must still comply with any HSNO approval requirements as well.

If separating off portions was not provided for in the registration, then it must not be carried out and the results offered for sale. Traders in registered products should stock products in appropriate container/packaging sizes to meet their customers’ needs. Traders should recommend appropriate alternatives for over-the-counter products, if certain products are not marketed in convenient sizes. Traders must not recommend to the purchasers any alternatives for PAR products prescribed by a veterinarian.

4.2.3 Provision of separating off portions of veterinary medicines by a veterinarian or under the direction of a veterinarian

There is an exception to 4.2.2 above. A veterinarian who determines that, for the health and/or welfare of the animals concerned, a specific quantity (less than the total quantity in an approved package size) of a registered veterinary medicine is required, that veterinarian may separate off a portion of a registered trade name product and sell/supply the required amount. If this is done, the veterinarian must take full responsibility for the appropriate packaging and labelling of the product supplied to ensure that:

• the quality or the product is not jeopardised;

• the container packaging is safe and appropriate;

• sufficient information is provided to allow the product to be used according to the veterinarian’s instructions and complies with both the ACVM registration and HSNO approval requirements (including the provision of health and safety information); and

• the veterinarian and/or veterinary practice and contact information are included.

Veterinarians must not offer for general sale separated off portions of registered products. Those portions offered for sales are trade name products in their own right and require registration.

Traders in prescription animal remedy veterinary medicines may (but are not obliged to) separate off a portion of a registered product under the instructions of a veterinarian. However, in doing so the trader must always follow exactly the instructions of the prescribing veterinarian, including instructions about appropriate packaging and labelling. If some aspect is uncertain or might require variation from those instructions, this must be discussed with and endorsed by the directing veterinarian.

5 REQUIREMENTS FOR USE OF ANY CLASS OF VETERINARY MEDICINE REQUIRING VETERINARY OVERVIEW

The requirements for the use of any class of unregistered veterinary medicine requiring veterinary overview are equivalent to those for registered PAR veterinary medicines and are directed by the prescribing veterinarian. The products must be used only in accordance with the instructions of the prescribing veterinarian. Failure to do so is a breach of the conditions of exemption from registration and an offence under sections 8 and 55(1) of the ACVM Act. Any person who knowingly uses an unregistered product or breaches a condition of exemption from registration is liable on summary conviction to a fine of up to $30,000 (or $150,000 for a corporation).

This means that the product must not be used for a different purpose or any surplus used for either the same purpose or a different purpose without a veterinarian prescribing it for that purpose.

Users should comply with the instructions of the prescribing veterinarian and dispose of any waste or surplus as directed.

GLOSSARY

ACVM TERMS

Advertisement

Any publication to the community or to any section of the community of any words, whether written, printed, spoken, or in any electronic form, or of any pictorial representation or design or device, used to promote the sale of any agricultural compound. ‘To advertise’ has a corresponding meaning.

Agricultural compound

Any substance, mixture of substances, or biological compound, used or intended for use in the direct management of plants and animals, or to be applied to the land, place, or water on or in which the plants and animals are managed, for the purposes of:

a) Managing or eradicating pests, including vertebrate pests; or

b) Maintaining, promoting, or regulating plant or animal productivity and performance or reproduction; or

c) Fulfilling special nutritional requirements; or

d) The manipulation, capture, or immobilisation of animals; or

e) Diagnosing the condition of animals; or

f) Preventing or treating conditions of animals; or

g) Enhancing the effectiveness of an agricultural compound used for the treatment of plants and animals; or

h) Marking animals;

and includes any veterinary medicine, any substance, mixture of substances, or biological compound used for post-harvest pest control or disinfestation of raw primary produce, and any substance, mixature of substances, or biological compound declared to be an agricultural compound for the purpose of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 by Order in Council.

Animal

Any living stage of any member of the animal kingdom except human beings. It does not include invertebrates unless specified, as in the case of honey bees.

Animal material

Any live or dead animal, or any tissue or other material taken or derived from an animal.

Approval

Means approval by the Agricultural Compounds and Veterinary Medicines (ACVM) Group of the New Zealand Food Safety Authority.

Code of practice

Any document developed to specify the means by which parties meet the requirements in a standard. A code may be approved in accordance with section 28 of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997, but does not have to be approved unless specified in the conditions of product registration or any product specific approval.

Compounding order

An instruction from a veterinarian to a manufacturer or contracted compounding pharmacist, detailing the formulation of a specially compounded medicinal preparation and any additional details on the method of compounding, packaging and labelling.

Control

To maintain full responsibility for and direction of the actions of others, and relates to the control of specified persons by persons approved or licensed by the ACVM Group to manufacture, trade in or use agricultural compounds or veterinary medicines.

Controlled copy

An operational or quality control reference document for which:

• responsibility for maintenance, updates, and changes will be undertaken by a limited and defined group of people; and

• all changes and updates will be recorded in writing and maintained for audit.

Direct management

Direct management includes any treatment used on/in the animal or plant; or any treatment that will be in direct contact with the animal or plant; or any treatment where the animal remains in the water/on the land during the treatment period; or when the animals are reintroduced to the water or land and the agricultural compound is still present.

Dispensing

To supply agricultural compounds or veterinary medicines as per instructions specified in a purchase/supply order, compounding order, veterinary prescription or veterinary authorisation.

Label

Any written, pictorial, or other descriptive matter under which the trade name product is sold and which purports to give some information about the agricultural compound or veterinary medicine. Includes any information that must be provided with the product at the time it is supplied.

Label content

The intended written, pictorial, or other descriptive information that can be provided with a product because it is consistent with and not beyond or in excess of what is permissible under the current approval for that product. The label content must be approved by the ACVM Group.

Prescribing

The act of deciding and specifying the appropriate veterinary medicine and treatment regime.

Prescription

A documented instruction to an approved trader in veterinary medicines from a veterinarian specifying:

• a particular veterinary medicine;

• an animal or group of animals to be treated;

• a dosage and frequency; and

• instructions to be provided to the named person responsible for the animal(s) regarding warnings and/or associated care.

A prescription is required for the purchase of a registered PAR product by a person who is not a veterinarian. Only veterinarians may issue a prescription for a registered PAR product. A prescription may be issued for but is not required for the purchase of a veterinary medicine that is not a PAR product.

Prescription animal remedy (PAR) veterinary medicine

• A veterinary medicine registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 with a condition limiting sale to:

• an approved trader in prescription animal remedies;

• a veterinarian currently registered under the Veterinarians Act 2005; or

• a person in possession of a relevant, bone fide veterinary prescription or authorisation from a veterinarian currently registered under the Veterinarians Act 2005.

Product specific approval

That part of an ACVM registration of an agricultural compound or veterinary medicine trade name product that specifies the particular use requirements for that product in regard to manufacture, importation, sale, establishing control, identifying treated plants or animals, avoiding violative residues, notifying purchasers or processors, etc.

Prohibited substance

Prohibited substances are those substances prohibited from use as agricultural compounds or as ingredients in agricultural compounds. These substances are listed in Schedule 8 of the Agricultural and Veterinary Medicines Regulations 2001.

Promotion

To encourage the sale of an agricultural compound or veterinary medicine trade name product by any means, including advertising.

Proprietary trade name product

An agricultural compound or veterinary medicine marketed under and protected by a registered trade name.

Relabelling

To transfer the relevant label information (provided with the product before separating off portions and repackaging) to the package or container in which the agricultural compound or veterinary medicine trade name product is supplied for use.

Sale

Includes barter, and also includes offering, exposing, or attempting to sell, or having in possession for sale, or sending or delivering for sale, or causing or allowing to be sold, offered, or exposed for sale; and also includes:

• delivering or disposing of by way of gift, loan, or otherwise; and

• giving or distributing, in the course of business, as a sample or otherwise, without charge.

‘General sale’ means to make available to the public at large.

Separating off portions of trade name products

To adjust the size, volume, number or weight of a proprietary trade name product and to place into an alternative package or container (should also have an alternative label).

Trade

Trade in agricultural compounds or veterinary medicine trade name products includes general sale and sale to specified/approved persons (wholesale and retail sales transactions as well as distribution, transport and storage). It also includes gifting or offering as samples as stated in the definition of sale.

Trader

Any person/corporate body/company who sells agricultural compounds or veterinary medicines. Traders can include, importers, product registrants, manufacturers, distributors, wholesalers and retailers, veterinarians and agricultural consultants if they carry out any of the activities listed in the definition of sale above.

Veterinarian

A person registered as a veterinarian under the Veterinarians Act 2005 and who holds a current practising certificate.

Veterinary authorisation

A documented approval from a registered veterinarian to a person to purchase and hold particular PAR veterinary medicines in anticipation of:

• their incorporation into other products (e.g. animal feeds) to be used under prescription; or

• their use under operating instructions issued by a registered veterinarian.

APPENDIX

PACKAGING AND LABELLING REQUIREMENTS FOR HUMAN MEDICINES AND SPECIALLY COMPOUNDED VETERINARY MEDICINES USED AS VETERINARY MEDICINES

HUMAN MEDICINES

The packaging and labelling of human medicines is likely to be irrelevant and misleading when they are used as veterinary medicines. They may still look like human medicines. This must be avoided. If they are supplied in their proprietary packaging, their original identity as human medicines must be removed or invalidated and replaced with labelling that is appropriate for the veterinary medicine uses specified by the prescribing veterinarian.

If repackaged, the packaging must be appropriate for the kind of product and minimise the opportunity for inappropriate or inadvertent use.

The dispensed product must be labelled ‘for animal treatment only’. The packaging and labelling must meet the controls imposed under the relevant approvals issued under the Hazardous Substances and New Organisms Act 1996.

The label must contain the following information:

• the name of the prescribing veterinarian;

• the contact information of the prescribing veterinarian;

• the name of the person specified in the prescription as the person to whom the product is to be dispensed;

• the name or description of the product;

• the quantity of product dispensed;

• the treatment instructions;

• any additional warnings specified by the prescribing veterinarian, including instruction for: withholding the treated animal or its produce from human consumption, and safe disposal of surplus product and empty packaging.

SPECIALLY COMPOUNDED VETERINARY MEDICINES

Packaging and labelling must be as specified by the prescribing veterinarian. The dispensed product must be labelled ‘for animal treatment only’. The packaging and labelling must meet the controls imposed under the relevant approvals issued under the Hazardous Substances and New Organisms Act 1996.

The labels must contain the following information:

• the name of the prescribing veterinarian;

• the contact information of the prescribing veterinarian;

• the name of the person specified in the prescription as the person to whom the product is to be dispensed;

• the name of the product;

• the quantity of product dispensed;

• the treatment instructions;

• any additional warnings specified by the prescribing veterinarian, including instruction for: withholding the treated animal or its produce from human consumption, and safe disposal of surplus product and empty packaging.