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T-3-45 - PRODUCTS FOR FORCEABLE ADMINISTRATION

July 1, 1993

The purpose of this Trade Memorandum is to update and clarify the regulatory status of products for forceable administration to livestock.

Products for forceable administration are considered drugs and are subject to the Food and Drugs Act. In the past, product presentation and packaging was a major criteria for establishing the product's status as a drug for all these types of products, regardless of the proposed directions for use.

The decision has been made in conjunction with the Bureau of Veterinary Drugs to allow pastes, pumps and non-injectable syringes that are: (1) labelled for inclusion into feed and (2) for which no drug claims as made, will be regulated under the Feeds Act and Regulations. All products must indicate physical form in their product name (e.g. paste).

All products for forceable administration will continue to require registration under the Food and Drugs Act. Examples of products for forceable administration include, but are not limited to, injectables, boluses, drenches and pastes, pumps and non-injectable syringes which do not meet the criteria for feed registration as indicated above. Prior to marketing the aforementioned products, an application must be submitted to the Bureau of Veterinary Drugs, Health Canada and a Drug Identification Number (D.I.N.) obtained.

If you have any questions regarding registration requirements under the Food and Drugs Act, please contact:

Bureau of Veterinary Drugs
Sir Frederick G. Banting Research Centre
Tunney's Pasture, P.L. 2202A1
Area 290, 2nd Floor West
Ottawa, Ontario K1A 0L2
613-957-3867

Questions regarding this memorandum may be forwarded to:

Feed Section,
Animal Health and Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario, K1A 0Y9
Tel: 613-225-2342 Fax: 613-228-6614