This content is current only at the time of printing. This document was printed on 4 August 2020. A current copy is located at https://apvma.gov.au/node/11731
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Antibiotic permit breach results in fines for veterinary supplier
A veterinary medicine supplier, Ceva Animal Health (formerly Nature Vet), was convicted last week on two counts under Australia's agvet chemical laws for supplying veterinary antibiotics contrary to their permit conditions.
Under permit, Ceva was allowed to sell a combination of two antibiotics—rifampicin and erythromycin—under very strict conditions to minimise the risk of antibiotic resistance developing. Both these antibiotics are important in human as well as animal medicine, with rifampicin being regarded as "high importance" in treating bacterial infections that are resistant to other antibiotics.
"The APVMA uncovered the permit breaches through a compliance audit, following some irregularities identified through routine internal screening", said APVMA's Compliance Manager, Dr Jan Klaver.
Following Ceva's guilty plea in the NSW Local Court, the court found the offences proven.
Ceva was convicted and fined $5000 for supplying the antibiotics contrary to requirements of Section 78 (1) of the Agricultural and Veterinary Chemicals Code Act 1994.
The company was also convicted and fined a further $3000 for wrongfully supplying these antibiotics beyond their use-by date. Costs were also awarded to the APVMA.
"The APVMA is actively monitoring compliance of agvet chemicals and their supply with relevant manufacturing, registration and permit conditions", Dr Klaver said.
"We make no apologies for taking strong action against companies who take chances with these products and even more so when we are dealing with products that are so important to human medicine as well."
The combination of erythromycin and rifampicin is a treatment of choice for Rhodococcus equi infection—an important cause of pneumonia in foals—which may become established as an endemic disease at breeding facilities. Immuno-compromised people, such as transplant patients or those with HIV-AIDS may also be at risk of contracting R. equi infections.
There are no Australian registered products containing rifampicin or a rifampicin–erythromycin combination. The APVMA decided against registration, so that supply and use could be better controlled under its permit system.
"Information about product irregularities—such as substandard performance, unusual appearance, or lack of an APVMA approval number or product label—should be reported to our Compliance hotline on 1300 700 315", Dr Klaver said.