By Ben Stapley, CEO Animal Medicines Australia
Australia’s regulatory framework for veterinary medicines is facing increasing pressure from unregistered and illegally compounded products risking animal health and welfare, regulatory integrity and veterinary innovation.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) oversees the pre-market approval and regulation of veterinary medicines, ensuring products meet strict standards for safety, quality and efficacy. Veterinary medicine compounding is controlled via a hodge-podge of state and territory controls designed to allow reasonable access to products when registered alternatives are unavailable, but that have been exploited to undermine appropriate regulatory oversight, creating unacceptable risks to animal health and welfare. Gaps in current regulatory systems for compounded and unregistered veterinary products need to be closed to minimize risks and restore the integrity and robustness of regulatory oversight.
Within tightly controlled limits, veterinary compounding plays an established and essential role in veterinary practice. Veterinary compounding can facilitate tailored treatments, and better administration when no suitable registered product exists.
Instances of compounded products being manufactured in commercial quantities, supplied between practitioners, and promoted as alternatives to registered veterinary medicines are increasing. This trend undermines safeguards imposed on APVMA-registered products and blurs the line between bespoke compounding and unregistered manufacturing.
Identified Risks
Unlike registered veterinary medicines, compounded products are exempt from APVMA registration and are not required to undergo an independent pre-market assessment, comply with Good Manufacturing Practice (GMP) standards, and are not required to be manufactured in an audited and licensed manufacturing facility. As a result, compounded risks can present elevated risks, including:
- Quality and contamination: Inconsistent formulation, lack of homogeneity, and ad-hoc quality control systems may increase risks of contamination or variable potency.
- Safety and stability: Without rigorous stability testing, compounded medicines risk degradation or becoming unsafe during storage – even after relatively short periods. Negative animal welfare outcomes could result from a lack of safety and efficacy assessments, especially from novel combinations of active ingredients.
- Batch production risks: Large-scale ‘batch’ manufacturing without GMP oversight can amplify risks from formulation errors across multiple animals.
- Residue uncertainties: Altering the formulation, composition and route of administration may affect residue depletion and excretion in treated animals, with potential risks to food safety and/or trade access, non-compliance with industry standards and auditing requirements, or non-compliance with racing or other sport or competition rules and regulations.
- Legal risk for veterinarians: Compounded veterinary medicines lack registered label instructions for insurers to assess legal and best-practice use, potentially exposing veterinarians to liability if adverse reactions occur or residues are detected.
- Animal welfare risks: Ineffective or unstable compounded products may result in treatment delays, prolonged illness, or disease progression beyond effective intervention.
The risks are not merely hypothetical. While comprehensive data is limited, several incidents internationally have highlighted the potential consequences. In 2009, 21 ponies died after being administered an incorrectly compounded health supplement, receiving fatal doses of selenium¹, three other horse deaths followed administration of a compounded parasite treatment with 18-21 times the labeled active concentration². In 2015, a compounded feline pain relief cream containing high concentrations of flurbiprofen (used for treating osteoarthritis or rheumatoid arthritis), was found to have caused kidney and intestinal damage in treated animals³.
Beyond the elevated animal health and welfare risks unregistered compounded products discourage innovation and investment in veterinary medicines. Veterinary compounding systems that bypass key regulatory controls and costs diminish the available market for legitimate, registered veterinary medicines. This reduces the pipeline of innovative, new treatments and increases reliance on unregulated products, compromising safety and efficacy. Perversely, the increased availability of compounded products increases their need.
Ultimately this results in illegal and unregistered compounded medicines undermining key components of the regulatory system for veterinary medicines and creates an uneven playing field. Reform is now essential to ensure that when veterinarians and animal carers use veterinary medicines, they can be assured that the highest quality, safety and efficacy standards have been applied – and independently assessed by a rigorous and diligent regulator.
To protect animal health and uphold regulatory integrity, Animal Medicines Australia is calling for veterinary compounding rules to be tightened in three key areas:
1. National consistency: The Agvet Chemicals Subcommittee of AgSOC should be tasked – as a matter of priority – to develop nationally harmonised rules for veterinary compounding.
2. Mandatory reporting: APVMA should be provided with public funds to implement and administer a structured adverse event reporting system for compounded veterinary medicines, in partnership with relevant state and territory authorities.
3. Stronger compliance: Extend and enforce restrictions on batch production of compounded veterinary medicines and increase enforcement activity targeting unregistered large-scale compounding.
These measures should be accompanied by enhanced education for veterinarians and pharmacists about their legal requirements and ethical boundaries of veterinary compounding. Primarily, wherever possible, veterinarians should reach for the registered product in preference to any compounded veterinary medicine.
Outlook
Compounded veterinary medicines remain an important clinical tool for veterinarians when used sparingly, appropriately and legally. However, unregulated manufacturing, inconsistent quality, and potential animal welfare impacts, undermine Australia’s veterinary medicine regulatory system. In the long term, uncontrolled veterinary compounding risks discouraging the investment and innovation necessary to minimize the need for compounded veterinary medicines.
Regulatory authorities, state and federal governments and industry groups must act decisively to close these loopholes, enforce compliance, and preserve the integrity of a rigorous and effective veterinary medicines regulatory system.
[1] Desta B, Maldonado G, Reid H, et al. Acute selenium toxicosis in polo ponies. Journal of Veterinary Diagnostic Investigation. 2011;23(3):623-628. doi:10.1177/1040638711404142
[2] United States Food and Drug Administration, 2019. Compounded Unapproved Animal Drugs from Rapid Equine Solutions Linked to Three Horse Deaths. Available at: https://www.fda.gov/animal-veterinary/cvm-updates/compounded-unapproved-animal-drugs-rapid-equine-solutions-linked-three-horse-deaths
[3] Forbes, 2015. Pet Owner Alert: Compounded Flurbiprofen Pain Creams Can Kill, Sicken Cats. Available at https://www.forbes.com/sites/davidkroll/2015/04/17/pet-owner-alert-compounded-flurbiprofen-pain-creams-can-kill-sicken-cats/
