Therapeutic decision-making in veterinary practice requires balancing clinical efficacy, patient safety, and regulatory responsibility, while carefully weighing the potential benefits and risks to the animal. Where suitable commercial options exist, registered and permit veterinary medicines should be considered first-line, providing greater assurance around quality, consistency, and predictable clinical performance.
Registered and permit medicines are subject to extensive regulatory oversight. Having an APVMA approved product means that the product has undergone a rigorous scientific assessment to ensure its safety, effectiveness, and compliance with statutory criteria. This includes evaluating human health safety, animal health, environmental protection, and product efficacy. Approval is not a one-time event; it includes ongoing regulatory oversight to ensure quality, manufacturing process, ingredient sourcing, and packaging consistently meet stringent requirements. APVMA approval is therefore a strong indicator of reliability, quality, and clinical confidence for use in clinics, homes and in the environment.
Compounded medicines on the other hand are made on demand for an individual patient, based on the veterinarian’s careful risk–benefit assessment. They continue to play an important role when no suitable APVMA approved product is available, or when an individual patient has specific clinical requirements that cannot be met by a commercial product1. However, compounded preparations are not evaluated through the same comprehensive regulatory pathways as registered or permitted products. Variability in formulation, limited stability data, and reduced predictability of pharmacokinetics or clinical effect may introduce additional considerations.
These distinctions are particularly relevant in the management of behavioural and emotional wellbeing in companion animals, where consistent pharmacological effects are critical. Trazodone is widely recognised active ingredient known to support calm behaviour across a range of clinical situations.
With the introduction of Trazocalm®, veterinarians now have access to the first APVMA-approved trazodone product in Australia*. This represents an important advancement in behavioural medicine, providing clinicians with:
- A product supported by robust stability data and defined shelf life of 36 months.
- Consistent, high-quality manufacturing under Good Manufacturing Practice (GMP) standards
- Assessed safety and efficacy specific to veterinary use
- Clear dosing guidance aligned with approved indications
Rather than extrapolating from compounded preparations, veterinarians can prescribe a product that has been specifically evaluated and authorised for veterinary application in Australia.
As access to registered and permit veterinary medicines continues to expand, veterinarians are increasingly able to select authorised options for conditions historically managed through compounding. This shift supports greater consistency in clinical outcomes, improved confidence in prescribing decisions, and alignment with regulatory best practice – while ensuring compounding remains appropriately reserved for cases where it is clinically justified.
AVA Policy – Veterinary use of compounded pharmaceutical
‘A compounded product should only be used when no other registered product2 can effectively treat the condition. A compounded product should only be used if the registered product is unavailable or unsuitable; this represents best practice.’
AVA Decision Flow Chart for use of compounded products by veterinarians 3
guidelines-for-the-preparation-and-use-of-compounded-pharmaceuticals
References
*Trazocalm Approved under APVMA Permit 93844
- Board of Australia. Guidelines on compounding of medicines. Effective 1 October 2024. Canberra: Pharmacy Board of Australia; 2024.
- APVMA website: apvma.gov.au
- To search for registered product https://portal.apvma.gov.au/pubcris
- To search for a permit product go to https://portal.apvma.gov.au/permits
AVA website – Policy & Advocacy – Policy Use of veterinary medicines > Veterinary use of compounded pharmaceuticals
- Australian Veterinary Association (AVA). Guidelines for the preparation and use of compounded pharmaceuticals. Veterinary use of compounded pharmaceuticals