Veterinary use of compounded pharmaceuticals
Ratification Date: 15 Oct 2010
Compounded medications can be used if there is no alternative registered veterinary or human product available, or if the veterinarian considers use of such compounded medications is scientifically justified. Use of compounded drugs in food producing species should be avoided unless information exists to assure avoidance of illegal drug residues.
Compounding refers to the process by which tailored medications are produced to suit individual circumstances. Compounding allows a veterinarian to achieve optimal clinical outcomes in cases where registered preparations are not appropriate or are not available.
Registered veterinary products must undergo a rigorous assessment by the Australian Pesticides and Veterinary Medicines Authority (APVMA) as part of the registration process. The APVMA’s registration process involves an assessment of the product to ensure that it works as intended and the scientific data confirms that ‘when used as directed on the product label it will have no harmful or unintended effects on people, animals or the environment’. APVMA registration indicates that the product has undergone a quality assurance assessment, is manufactured to strict GMP guidelines and should be effective and safe when used as directed.
Products that are compounded by a veterinarian, or by a pharmacist on the prescription of a veterinarian, are exempt from registration by the APVMA and are therefore not subject to the same testing regimens as registered veterinary medicines. While pharmacists and veterinarians are not overseen by the APVMA, they are regulated under state legislation and bound by professional codes of conduct. Compounded medications are not reviewed by the regulatory authority for efficacy and safety. There is no review by the regulatory authority of the manufacturing and production standards nor the materials and methods used to produce the compounded product. (Refer to APVMA document: Requirements for compounding veterinary chemical products.)
Compounding may only be performed by registered veterinary surgeons or registered pharmacists. The compounding of medications is permitted under the current poisons/therapeutic goods legislation in all states, which allow veterinarians to prescribe products which are not registered or in forms which are not registered. (See Table 1 for guidance on relevant state legislation.)
A decision to use a compounded product should be based on the general principles for prescribing medications as contained in the AVA Guidelines for Prescribing, Authorising and Dispensing Veterinary Medicines, and must comply with individual state legislation relating to the supply and use of veterinary medicines. As with all veterinary medicines, compounded products may only be prescribed for the treatment of a specific condition in an animal under the veterinarian’s care.
When recommending the use of any medication, a veterinarian should provide the client with information about treatment options, including advice on what products would best suit the patient. In most cases the reason that a veterinarian will choose to have a product compounded is that there is no equivalent or suitable registered product available.
Manufacturers of registered products would ordinarily insure against product liability claims. Producers of veterinary medicines, whether registered or unregistered, should maintain an appropriate level of product liability insurance. Many pharmacies also have appropriate insurance arrangements in place. A veterinarian using a compounded veterinary pharmaceutical must have a clear understanding of whether insurance will cover liability claims for its use, as there are no “registered label indications” on which an insurance company can base their decision on whether a product was used in accordance with best practice.
It is recommended that veterinarians using compounded products maintain a professional relationship with a compounding pharmacist to continue to develop their knowledge and understanding of compounding pharmaceuticals.
Compounding of a pharmaceutical by a veterinarian or pharmacist may potentially infringe current patents. A veterinarian prescribing compounded medications should have an understanding of the potential legal implications of such infringement.
Table 1: State and territory legislations relating to control of use of veterinary chemicals.
|Vet Chemical Control||QLD||NSW (DPI)||ACT||VIC||TAS||SA||WA||NT|
|Use of unregistered products (including compounded) permitted in major FPS by vets only (or persons under vet direction)?||Yes but "single" animal only||Yes but "single" animal only||Only with a permit||Yes but "single" animal only||Yes but "single" animal only||Yes||Yes but FPS only "single" animal or low risk or CVO approved chemical||Only with a permit|
|Use of compounded products by vets permitted in companion animals and other FPS?||Yes But only “single” FPS animal||Yes But only “single” FPS animal||No Contact Dept. of Environment||Yes But only “Single” FPS animal (unless label or Order prohibits)||Yes||Yes||Yes But only “Single” FPS animal (unless label or Order prohibits)||Yes|
|Use of compounded products by vets permitted in companion animals and other FPS even if suitable registered product available?||Yes but only “single” FPS animal||Yes but only “single” FPS animal||No Contact Dept. of Environment||Yes but only “single” FPS animal (unless label or Order prohibits)||No||Yes||Yes but only “single” FPS animal (unless label or Order prohibits)||Yes|
FPS = food producing species.
“single” is defined in the legislation of each jurisdiction.
APVMA website: www.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
AVMA Policy Veterinary use of compounded pharmaceuticals - https://www.avma.org/KB/Policies/Pages/Compounding.aspx
State and Territory Control of Use legislation
Most jurisdictions also use Orders and Notices to give effect to their controls.
- Chemical Usage (Agricultural and Veterinary) Control Act 1988
- Chemical Usage (Agricultural and Veterinary) Control Regulation 1999
- Agricultural Chemicals Distribution Control Act 1966
- Agricultural Chemicals Distribution Control Regulation 1998
New South Wales
- Pesticides Act 1999
- Pesticides Regulation 1995
- Stock Medicines Act 1989
- Stock Medicines Regulation 2005
Australian Capital Territory
- Environment Protection Regulation 2005 (clauses 54 & 55)
- Agricultural and Veterinary Chemicals (Control of Use) Act 1992
- Agricultural and Veterinary Chemicals (Control of Use) Regulations 2007
- Agricultural and Veterinary Chemicals (Control of Use) Act 1995
- Agricultural and Veterinary Chemicals (Control Of Use) Order 2001 (Refers to the Code of Practice for the Supply and Use of Veterinary Chemical Products)
- Agricultural and Veterinary Products (Control of Use) Act 2002
- Agricultural and Veterinary Products (Control of Use) Regulations 2004
- Livestock Act 1997
- Controlled Substances (Pesticides) Regulations 2003
- Biosecurity and Agricultural Management Act 2007
- Health (Pesticides) Regulations 1956
- Veterinary Chemical Control and Animal Feeding Stuffs Regulation 2006
- Agricultural and Veterinary Chemicals (Control of Use) Act 2004
- Agricultural and Veterinary Chemicals (Control of Use) Regulation