Robenidine Chemical Review

In August 1997, the APVMA (formerly the NRA) began a review of robenidine because of an unintentional lapse in the registration of the product containing robenidine, Cycostat 66 Coccidiostat (36654).

In the early 1990s (pre-NRA), the then National Drugs and Poisons Scheduling Committee of the National Health and Medical Research Council had moved robenidine from Appendix B of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) to Appendix M (now the Standard for the Uniform Scheduling of Medicines and Poisons) When the applicant sought to re-register the product, it had to be reviewed by the APVMA because the registration system and legislation had changed since its original registration.

These changes in the law meant that there were new, stricter standards for evaluating and registering robenidine and the APVMA had to assess more environmental, safety, residue and toxicological data to be sure that robenidine was safe and effective to use.

In June 1998, the APVMA released the Robenidine review final report. The report was based on information obtained from a variety of sources, including scientific studies and other information submitted by registrants, contributions from members of the public, community and government organisations, and a search of the scientific literature.

The APVMA found that the conditions of registration of the product containing robenidine could be varied to meet the current standards for registration.

In the review final report, the APVMA recommended:

• establishing a maximum residue limit (MRL) for poultry meat and offal at 0.1 mg/kg
• establishing a five-day withholding period for poultry meat.

In the report, the APVMA also supported the recommendations of the then National Drugs and Poisons Scheduling Committee to place robenidine in Schedule 5 of the SUSDP, and to not schedule it in preparations containing 20 per cent or less of robenidine (for example, when it is used in medicated premix feed).

In conjunction with the review, the then Department of Health and Ageing established an acceptable daily intake (ADI) for robenidine of 0.005 mg/kg bw/d (incorporated into the Australian ADI list on 17 September 1997).