Gazette APVMA 10, 4 October 2005 page 46

NOTICE

Labels for Medicated Stockfoods and Premixes

The September 2004 APVMA Gazette (pages 57 and 58) notified amendments to the agvet chemical legislation including changes to the Agricultural and Veterinary Chemicals Code Regulations 1995 consequent to the Agricultural and Veterinary Chemicals Legislation Amendment Act 2003 [No. 13, 2003].

The December 2004 APVMA Gazette (page 65) provided further guidance on the word ‘instructions’ in regulation 8(4) of the Code Regulations relating to medicated stockfoods and premixes.

This notice amends the December 2004 APVMA Gazette notice to better take into account the dilution of the registered product in the final stock feed.

Details of the amended instructions are outlined below.

In order for a label for a medicated stockfood or premix to be labelled in accordance with the instructions on the approved label for the registered veterinary chemical product, the medicated stockfood/premix must include all of the following matters from the label of the registered veterinary chemical product:

· the name of the registered veterinary chemical product incorporated into the medicated stockfood or premix;
· the active constituent in the registered veterinary chemical product incorporated into the stockfood or premix;
· all relevant directions for use extrapolated as necessary from the registered product label to ensure correct dosing, or otherwise as prescribed by a veterinary surgeon;
· all restraints, warnings and contra-indications;
· the withholding period from the approved label or as prescribed by a veterinary surgeon;
· any Export Slaughter Interval (ESI) information contained on an approved label.

Dilution of the registered product should be taken into account, and signal headings are required on the final stockfeed only if the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) does not provide a lower cut-off limit.

Similarly, FAISD directions from the label of the registered product are required on the final stockfeed only if the SUSDP does not provide a lower cut-off limit. The APVMA, in consultation with the States/Territories, will be adopting a more rigorous regulatory approach in relation to medicated stockfoods and premixes aimed at ensuring that all labels for these products are properly and fully labelled in accordance with the approved label of the incorporated registered veterinary chemical product. The APVMA may notify the manufacturer of any medicated stockfoods and premixes which do not properly include all of the instructions of the approved label of the registered product on the stockfood/premix label and requiring them to immediately amend these labels.

The APVMA points out that a failure to properly label a medicated stockfood or premix means that they are veterinary chemical products that require registration. It is an offence against section 78 of the Agvet Code to sell an unregistered chemical product. A breach of section 78 could attract a penalty of up to $165,000 for a body corporate.

For more information about this matter please contact:

Veterinary Medicines Contact Officer
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 3744
Fax: (02) 6272 3755
Email: Vet_Products@apvma.gov.au