Questions and Answers - Product

Question:

Answer:

A drug used by the aquaculture industry must be:

1. approved by Health Canada specifically for use in fish or crustaceans;

2. authorized as an Emergency Drug Release by Health Canada when the drug has not been approved in Canada (i.e., the drug has not been assigned a Drug Identification Number (DIN) by Health Canada);

3. authorised for testing purposes under an Experimental Studies Certificate, issued by Health Canada;

4. approved as an Investigational New Drug Submission by Health Canada for clinical trials; or

5. prescribed by a licensed veterinarian for "off-label" use (only products with an assigned Drug Identification Number).

The Bureau of Veterinary Drugs, Health Canada is responsible for the first four activities and set the maximum residue limits (MRLs), administrative maximum residue limits (AMRL) or tolerances for these drugs.

When an antiparasitic is orally administered to fish (via feed or another mechanism) it is deemed to be a drug and is therefore regulated by the Food and Drugs Act and Regulations.

When the same antiparasitic is applied externally to fish (not ingested) it is defined as a pesticide and is regulated according to the Pest Control Products Act. The Pest Management Regulatory Agency within Health Canada approves or grants emergency release permits for pesticides under the Pest Control Products Act.
The Bureau of Veterinary Drugs, Health Canada has approved six drug products (eight drug substances) for use in aquaculture.

¹ Administrative MRL
² Regulated biological substance, ubiquitous in nature
³ MRL is specified for the metabolite, florfenicol amine

Pesticides presently approved or granted use in fish by the Pest Management Regulatory Agency. A Time-Limited Registration has been granted for the use of azamethiphos in Eastern Canada until the end of 2000.

⁴ Default for agricultural chemicals, Food & Drug Regulations, Section B.15.002.

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