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Code of practice for own use

The ACVM Group has finalised the code of practice that must be followed when using compounds that are not trade name products as agricultural compounds or veterinary medicines (see page 2, AgVetLink 30).

The Group received written comments only from the Department of Conservation. In light of those comments some minor adjustments were made to the proposal presented in the AgVetLink article.

The code was approved under section 28 of the ACVM Act and can be viewed on the ACVM Group website or you can request a copy from the ACVM Group.

It must be noted that it is now an offence under the ACVM Act not to comply with the code if you are using generic compounds (substances that are not trade name products) as agricultural compounds or veterinary medicines on your own animals and plants.

If convicted of an offence, the penalty can be a fine up to $30,000 for individuals and $150,000 for corporations.

While the ACVM Group cannot proactively monitor own use situations, it will investigate any suspicions or allegations of non-compliance and will take action accordingly.

Exemption from registration for veterinary medicines compounded by veterinarians

The ACVM Regulations 2001 provide an exemption from registration for preparations compounded and used by veterinarians. This exemption applies only if:

• the veterinarian uses the preparation in accordance with the code of practice that has been approved under section 28 of the Act; and
• the preparation is not used on animals except under the direct care, authority, or prescription of the veterinarian.

In effect, such a preparation becomes a prescription animal remedy that can be used only by or under the prescription of the veterinarian who compounded it or directed that it be compounded. The preparation cannot be offered for sale or use except to the person responsible for the animals that are under the direct care of the veterinarian or under his or her prescription.

The exemption does allow for a veterinarian to contract a second party, such as a chemist, to compound the preparation for the veterinarian's use or to fill the veterinarian's prescription. However, all parties must be careful not to market or be associated with the marketing of a compounded preparation as a trade name product, except under  the circumstances prescribed in the regulations.

Clarification of Good Laboratory Practice (GLP) expectations

A clarification of the GLP requirements for residue data was provided in the December issue of AgVetLink. It stated that data from the laboratory component of residue trials submitted after 1 January 2003 must be GLP compliant, i.e. all analytical laboratory trial studies must be carried out by a GLP accredited laboratory.

Some parties have interpreted this requirement to mean that the work had to be done in a GLP accredited laboratory but the work did not have to be GLP compliant.This is not an acceptable interpretation. The ACVM Group expects the work done in a GLP accredited laboratory to be GLP compliant.

Data from trials that are not GLP compliant will not be accepted after 1 January 2003, even if the work was done in what appears to be a GLP accredited laboratory. If you are making an application with non-GLP data after this date, you will need to use the 'information waiver' process and provide an argument as to why the data being provided should be considered equivalent to that from a GLP accredited facility.

Parties are advised to ensure that, when contracting services from a laboratory, the studies will actually be GLP compliant.