Animal Medicines Australia (AMA) is concerned by the NSW Government’s decision to exempt pharmacists compounding unregistered veterinary medicines under the new Medicines, Poisons and Therapeutic Goods Regulation 2026 that commenced today.
AMA Chief Executive Ben Stapley said the exemption risks undermining Australia’s veterinary medicines regulatory framework and risks an animal health and welfare from compounded medicines not subject to the quality and safety checks imposed on all veterinary medicines.
“We support these reforms and are disappointed by the NSW Government’s decision to exempt veterinary compounding. This exemption is a step backwards for animal health, animal welfare and regulatory integrity,” Mr Stapley said.
“Veterinary compounding serves an important and legitimate purpose when a suitable registered or permitted product is not available. However, it was never intended to facilitate the manufacture and sale of unregistered veterinary medicines in bulk quantities.”
“Australian veterinarians, livestock producers and pet owners should be able to have confidence that veterinary medicines have been independently assessed, manufactured to recognised quality standards and are supported by systems for monitoring adverse events,” Mr Stapley said.
“When businesses are permitted to manufacture and distribute large volumes of unregistered medicines under the banner of ‘compounding’, it undermines those safeguards and creates an uneven playing field for companies that invest millions of dollars in research, development and regulatory approvals.”
AMA calls on the NSW Government to urgently review the genuine need for wholesale manufacturing of unregistered Schedule 4 or Schedule 8 veterinary medicines and revoke the exemption as soon as possible.
“Animal health outcomes are best served by maintaining a robust, science-based regulatory system that encourages innovation while ensuring appropriate safeguards for animals, veterinarians and owners,” Mr Stapley said.
