Proposal for Amoxicillin

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Veterinary Drugs Directorate
Holland Cross Complex
Ground floor, Suite 14
11 Holland Avenue
Address Locator: 3000A
Ottawa, ON K1A OK9

File No: 9457-5-27

April 5, 2007

Dear Stakeholder:

The Veterinary Drugs Directorate (VDD) of Health Products and Food Branch, Health Canada, is considering a regulatory amendment which may be of interest to your organization. Since you are the designated contact for your organization, I would appreciate your collaboration in distributing this information to the attention of all interested parties to solicit their comments.

More specifically, the Veterinary Drugs Directorate is proposing to establish Maximum Residue Limits (MRLs) in Table III to Division 15, Part B of the Food and Drug Regulations for Amoxicillin in edible tissues of food-producing animals as indicated in the following table:

Column I Common Name (or brand name of drug)	Column II Name Of Substance For Drug Analysis Purposes	Column III MRL p.p.m.	Column IV Foods
Amoxicillin	Amoxicillin	0.01	Swine and chickens Edible tissues

Amoxicillin is a semi-synthetic penicillin antibiotic with a broad spectrum of bactercidal activity against a wide range of common gram-positive and gram-negative pathogens. It differs from Ampicillin by an additional parahydroxy group. Amoxicillin also has potential for producing allergic reactions. It is rapidly absorbed after oral administration. Amoxicillin has a low capacity for protein binding and is widely distributed in various tissues after absorption. Like all beta-lactam antibiotics, it prevents the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. Amoxicillin has been marketed in Canada under the name of Paracillin SP in chickens and swine.

The result of our Health Risk Assessment shows residues at the above-noted concentrations will not pose any undue health risk for consumers. The proposed MRL will be published in the Canada Gazette, Part I, after consideration of comments from Stakeholders.

I would appreciate receiving your comments on this proposal by July 3, 2007. Comments should be sent to the attention of Julie Cameron, Public Involvement Administrator, at the above noted address.

Thank you for your cooperation in this matter.

Yours sincerely,

Siddika Mithani, Ph.D
Director General