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Agvetlink Special Issue for Veterinarians March 2005

COMPOUNDING

Under Schedule 2 of the ACVM Regulations 2001 preparations compounded and used by veterinarians are exempted from the requirement for registration, provided certain conditons are met.  

The ACVM Group is working with representatives from the pharmaceutical and pharmacy industries and the veterinary profession to develop minimum standards for compounding veterinary medicines. These standards will include a definition of compounding that will make it clear what activities are considered ‘compounding’. In the meantime, the ACVM Group has a working policy in regard to compounding.

Working policy

Compounding means the preparation by (or under the compounding order from) a veterinarian of veterinary medicines from generic active ingredients and excipients or other trade name products for use on a particular animal(s) under the care of that veterinarian. The resulting preparations do not have the characteristics (formulation, packaging, and labelling as proprietary products) that allow them to be registered and marketed as trade name products. They are not prepared in large quantities in anticipation of future cases.

Compounding includes the reformulation of a trade name product(s) for a particular purpose (e.g. formulating an injectable preparation from an oral product) or combining more than one product into a composite preparation.

Compounding does not include the practice of combining more than one product in a syringe for a single administration even though that activity poses compatibility questions that must be addressed by the veterinarian.

Criteria to remember

The important matters to keep in mind are:

•    The animal(s) must be under the care of the veterinarian.

•    The conditions of discretionary use of an unregistered veterinary medicine must be met.

•    The formulation and preparation must be carried out by the veterinarian or under specific instructions (compounding order) from the veterinarian.

•    No more should be prepared than is necessary for the case(s) at hand or immediately anticipated.

•    Minimum labelling requirements must be met.

•    The preparation must not be supplied to, offered for sale or advertised/promoted to the general public.

Breach of conditions

Compounding veterinarians are reminded that the following circumstances are likely to breach the conditions of the exemption from registration and result in the requirement for the compounded product to be registered:

1.       Selling the compounded preparation for the treatment of animals not under your direct care (unless the product is exempted elsewhere in the ACVM Regulations), e.g. placing compounded preparations in the clinic for sale as OTC products. 

2.       Selling the compounded preparation to another veterinarian for treatment of animals that are not under your direct care unless the purchasing veterinarian has specifically requested that you compound the product on his/her behalf.  In this case he/she is the compounding veterinarian and must have full knowledge of the product being compounded.