Proposed amendment to the Food and Drug Regulations

PDF Format

Help on accessing alternative formats, such as PDF, MP3 and WAV files, can be obtained in the alternate format help section.

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

November 2, 2004

Dear Stakeholders:

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. I would appreciate your collaboration in providing comments and soliciting feedback from your members.

More specifically, VDD has identified the need to amend the Canadian Food and Drug Regulations to prohibit the importation of unapproved drugs¹ for use in food-producing animals.

Reason for the proposed amendment to the Food and Drug Regulations

The Food and Drug Regulations prohibit the importation of veterinary drugs intended for sale in Canada, but does not prohibit their importation for personal use.

Under the Food and Drug Regulations, drugs (including veterinary drugs) must undergo a thorough assessment of their quality, safety and efficacy prior to being marketed in Canada. In regard to veterinary drugs, the safety of potential residues of these drugs in foods intended for human consumption is an essential aspect of the review process leading to the establishment of Maximum Residue Limits² (MRLs) and appropriate withdrawal periods so that residues in food products derived from treated animals meet the MRLs. Unapproved drugs circumvent this important mechanism and therefore pose potential risks to human health and food safety when they are administered to food-producing animals.

Public health risks associated with the use of unapproved drugs in food producing animals include the presence of potentially harmful drug residues in food of animal origin (meat, milk, honey, eggs, etc.), environmental contamination, occupational safety hazards, and increased risk of antimicrobial resistance development. Prohibiting personal use importation of unauthorized drugs destined for use in food-producing animals will contribute to food safety by curtailing a source of drugs that have not been subjected to the drug review process and will enable more focused efforts insofar as residue testing and monitoring of foods in the Canadian marketplace.

Considering that all non-regulatory options would lack the necessary legal basis for enforcement and compliance, the preferred risk-management option is to amend the Food and Drug Regulations to prohibit personal use importation of unapproved drugs for use in food-producing animals.

Context of the proposed regulatory amendment

The proposed amendment will not affect existing regulatory mechanisms to authorize importation of veterinary drugs for medical reasons - Emergency Drug Release (EDR), experimental use - Experimental Studies Certificate (ESC) and clinical trials - Investigational New Drug (IND) ³.

This proposed regulatory amendment is one part of a broader policy and regulatory strategy VDD plans to implement to deal with the issue of unapproved veterinary drugs in Canada.

The following related issues are being addressed concurrently:

1. Active Pharmaceutical Ingredients (APIs) for veterinary use
   The Health Products and Food Branch Inspectorate is working on a Regulatory Framework for the implementation of the ICH Guideline Q7A - Good Manufacturing Practices for Active Pharmaceutical Ingredients (GMPs for APIs). Consultations with partners and stakeholders were held on May 26 and 27, 2004. A letter of notification was previously sent to stakeholders (December 2003) regarding Health Canada's intention to adopt GMPs for Active Pharmaceutical Ingredients for Veterinary Use.
   The Policy for the Importation or Sale of Active Pharmaceutical Ingredients for Veterinary Use⁴ (1999) remains in place, and will complement the proposed regulatory amendment.
   
   
2. Compounding
   The Health Products and Food Branch Inspectorate has published a guidance document to
   differentiate manufacturing from compounding activities (Manufacturing and Compounding Drug Products in Canada⁵). This document is currently under review, and representatives from various stakeholder groups were consulted on April 23^rd, 2004.
   
   In addition, the Canadian Veterinary Medical Association, along with Health Canada and other partners in animal health and public health, are in the process of developing national guidelines for the legitimate compounding of drugs for animals.
   
   
3. Extra-Label Drug Use (ELDU, also called Off-Label Drug Use) VDD continues to work with stakeholders as well as federal, provincial and territorial partners to better identify ELDU practices and mitigate potential health risks.

While this consultation focuses on the personal use importation of unapproved drugs for use in food-producing animals, there will also be opportunities for your organization to comment on the regulation of Active Pharmaceutical Ingredients (APIs), compounding, and extra-label drug use, at appropriate stages of policy development.

We look forward to collaborating with our stakeholders in developing the partnerships required to ensure adequate implementation of and compliance with the proposed regulatory amendment.

Responses to this consultation will help us identify all positive and negative impacts of this regulatory amendment on our stakeholders. After consideration of all comments received, Health Canada intends to submit the proposed regulatory amendment for consideration by the Governor-in-Council and potential publication in the Canada Gazette, Part I.

I would appreciate receiving your comments on this proposal by Thursday January 20^th, 2005. Comments should be sent to the attention of Dhurata Ikonomi, Public Involvement Officer, at the above noted address.

Thank you for your cooperation in this matter.

Sincerely,

Diane C. Kirkpatrick,
Director General

1. "unapproved drugs" refers to drugs which do not have a Drug Identification Number (DIN) and whose sale has not been authorized in Canada.

2. A Maximum Residue Limit (MRL) is an amount of residue that could remain in the tissue or food product derived from a food-producing animal that has been treated with a veterinary drug. This residue is considered to pose no adverse health effects if ingested daily by humans over a lifetime. More information available at: http://www.hc-sc.gc.ca/dhp-mps/vet/faq/faq_mrl-lmr_e.html

3. http://www.hc-sc.gc.ca/dhp-mps/vet/part/glossary_terms_glossaire_e.html

4. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/int/export-import/pol/pol_18_tc-tm_e.html

5. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/man_comp-fab_prep_tc-tm_e.html