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Notice To Industry - Bova Omeprazole 100mg/mL Injection

Racing NSW Stewards refer to the warnings that were issued on 5 and 26 June 2019 in respect of the presence of the Anabolic Androgenic Steroid testosterone in a bottle of Omeprazole 100mg/mL injection manufactured by BOVA Australia used for the management of gastric ulcers.

The Australian Racing Forensic Laboratory (ARFL) was recently requested by Bova Australia to analyse a compounded Omeprazole 100mg/mL injection produced by Bova Australia for the presence of testosterone, following the recent detection of testosterone by ARFL in similarly compounded products used in the management of gastric ulcers.

The bottle analysed by the ARFL did not detect testosterone and, accordingly, Bova Australia publicly released such advice.

In respect to the use of compounded Omeprazole 100mg/mL injection, Racing NSW reminds the industry that the product must only be dispensed by a veterinarian and be in the possession of a trainer in the following circumstances, as required by the relevant Commonwealth and State legislation as it pertains to compounded medications and provides the following points to participants:

1. A compounded medication may be supplied for a horse that has been physically examined or is under the direct care of the prescribing veterinarian and only in respect of that animal (that is, for a particular animal for a particular condition). There is no provision in the relevant legislation for the general preparation and storage of compounded pharmaceutical products. As such, a veterinarian cannot order compounded medications for general use in other animals at a later date nor can they be stored in a veterinary practice or treated as if they were provided in a wholesale manner;

2. A compounded preparation should only be used in circumstances where a suitable registered commercial veterinary preparation is unavailable;

3. Unlike registered veterinary medicines, compounded medicines are not subject to rigorous assessment for product quality, efficacy and safety by the Australian Pesticides and Veterinary Medicines Authority. It is vital to ensure that the compounded product does not contain any substances prohibited under the relevant Rules of Racing and trainers and veterinarians may be subject to sanction under the Rules of Racing in the event that a prohibited substance is detected in a compounded product.

- 29 August 2019

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