RG-7
Regulatory Guidance: Fact Sheet - Prudent Use of Veterinary Drugs in Livestock Feeds

Health Canada and the CFIA are concerned about the unauthorized use of drugs in livestock feed resulting in unsafe food products and potential human health risks. This information sheet outlines the specific requirements mentioned in federal law and clarifies permissible practices concerning the addition of drugs to livestock feeds, particularly drug products that are dispensed by licensed professionals (i.e. veterinarians and/or pharmacists).

In Canada, the Food and Drugs Act and Food and Drug Regulations (FDR), and the Feeds Act and Feeds Regulations (FR), regulate the sale and use of drugs in livestock feeds. "Livestock" is defined in the Feeds Act as meaning cattle, sheep, goats, swine, horses, poultry, fish, rabbits, mink and foxes, and includes such other creatures as may be designated by regulation as livestock for the purpose of that Act.

The addition of drugs to livestock feed must comply with both sets of legislation, as follows:

Pursuant to the FR, all medicated livestock feed imported, manufactured or sold in Canada must meet the standards set out in the CFIA's Compendium of Medicating Ingredient Brochures (CMIB), unless the feed is a veterinary prescription feed (a feed that is manufactured pursuant to a veterinary prescription). The CMIB is a listing of drug premixes that have been assigned a Drug Identification Number (DIN) and approved for use in livestock feeds by Health Canada.

A medicated feed is exempt from complying with the standards set out in the CMIB only if the medicated feed has been manufactured pursuant to a veterinary prescription and if, amongst other criteria, the source of the medicating ingredient prescribed and used in the medicated feed is in compliance with the FR and with the conditions set out in section C.08.012 of the FDR.

Pursuant to paragraph C.08.012 (1) (a) of the FDR, a person may sell a medicated feed, pursuant to a written prescription of a veterinary practitioner, if all drugs used in the medicated feed as medicating ingredients have been approved for sale by Health Canada, i.e. each drug has either:

1. a valid DIN; or
2. been permitted for sale through an Investigational New Drug (IND), an Emergency Drug Release (EDR), or an Experimental Studies Certificate (ESC).

Also, in accordance with the FDR:

1. The prescription for the medicated feed shall contain the information required by the FDR.
2. Veterinarians have the responsibility to ensure that drugs prescribed for food-producing animals will not result in harmful or violative residues in food, and meet other regulatory requirements set out in the FDR and FR.
3. A person may sell a medicated feed, pursuant to a written prescription of a veterinary practitioner, if the medicated feed is for the treatment of animals under the direct care of a veterinary practitioner who signed the prescription.

In addition, CFIA would like to remind feed manufacturers that:

1. Feed manufacturers must ensure that any medicating ingredient used in the preparation of medicated feed is in accordance with the CMIB or the veterinarian's prescription, whichever the case may be.
2. Feed manufacturers must ensure that any medicating ingredient which is used in the preparation of a medicated feed, including medicating ingredients supplied by a compounded product, originates from a drug that is approved for sale by Health Canada, e.g., bears a DIN.
3. Medicated livestock feeds must be labelled as per the requirements of the FR
4. Medicated livestock feeds that do not comply with the FR may be subject to compliance and/or enforcement actions including detention and prosecution.

For more information, please contact:

Ray Perron, Canadian Food Inspection Agency, 613-221-4371
Hélène Chagnon, Veterinary Drugs Directorate, Health Canada, 613-941-9269
February 9, 2009