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AgVetLink March 2004 - Special Issue for Veterinarians: Page 5

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acceptable, the veterinary medicine label will (usually) have a statement to the effect of ‘It is a legal requirement that this product be used only according to label directions’ in addition to lacking the discretionary use condition. Where this applies, it is NOT OK for the veterinary medicine to be used off-label. Where possible the discretionary use condition will be preserved; however, specific prohibitions may appear on a label.

Veterinarians must also be aware that certain compounds are restricted and may not be used to treat food-producing animals. Currently, the list only contains substances that have been banned for use in food-producing animals by our major trading partners for reasons other than proven toxicity. (This list has been included in this issue–see page 10.)

When is it OK to compound?

Where possible, veterinarians must use veterinary medicines in preference to human medicines or compounded medicines. If a necessary treatment cannot be acquired in a registered form, veterinarians may compound (or direct a second party to compound for them) a veterinary medicine of their own design.

In general, the ACVM Group interprets ‘own design’ as being all of the following:

• The veterinarian has personally constructed, or knows exactly what the formulation of the product is (active and excipients) and has verified that it contains no restricted or prohibited substances.

• The veterinarian has sufficient information to expect the product will be efficacious and provide the desired therapeutic outcome. 

• The veterinarian has sufficient information to know that the product will be safe to the treated animal. 

• Where a food-producing animal is to be treated, the veterinarian has set a withholding period that will manage any residue risks. 

• Where using a second party to compound the product, the veterinarian has provided: 
  a) full details regarding the type and quality as well as quantities of all ingredients to be used; 
  b) full details regarding the method of manufacture of the product and any quality control processes required; 
  c) full details regarding the type of packaging to be used; and 
  d) full directions regarding the label text to be included.

When is it NOT OK to compound?

Veterinarians must not compound and provide for general sale any veterinary medicine that requires registration unless they have registered that product. Compounded veterinary medicines may be used only to treat animals in the care of the compounding veterinarian.

It is common practice within certain specialised branches of veterinary medicine for veterinarians to compound veterinary medicines. The nature of the process is such that to be economically viable, larger quantities than are needed by the vet at the time must be produced. Compounding veterinarians MUST NOT advertise (which includes via newsletters) or sell the surplus product to other vets* or the general public. To do so would be in breach of the ACVM Act (i.e. marketing/selling an unregistered veterinary medicine).

* Veterinarians may request that a veterinarian engaged in compounding activities compound a veterinary medicine on their behalf. It must be noted, however, that the rules of ‘own design’ discussed above apply.

Default withholding periods

The following is a list of default withholding periods applied to the registration of veterinary medicines where no residue data are provided. The figures have been arrived at following consideration of all residue data provided to the Group and can be considered conservative.

These withholding periods do not apply to sustained release formulations because the withholding period must apply to the time after the release period, not after administration.

AVIANS 
Meat 63 days 
Eggs 10 days

RUMINANTS (including deer) 
Meat 91 days 
Milk 35 days

CAMELIDS 
Meat 63 days

LAGOMORPHA
(e.g. rabbits)
Meat 63 days

MONOGASTRICS
(e.g. pigs, horses)
Meat 63 days

FISH, CRUSTACEA, MOLLUSCS 
Meat 35 days