Disinfectants

Amendments to the Food and Drug Regulations were published in Canada Gazette, Part II on December 15, 2004 (SOR/2004-282). These amendments exempt antimicrobial agents (disinfectants used for environmental surfaces and certain medical devices) from requirements respecting Good Manufacturing Practices and establishment licencing while still regulating them as drugs under the Food and Drugs Act and Regulations. These regulations are now in force.

• Canada Gazette Part II (December 15, 2004) Regulations Amending the Food and Drug Regulations (1356 - Disinfectants)

Antimicrobial agents continue to be required to comply with all other requirements of the Food and Drugs Act and Regulations including DIN requirements.

A new standard has been developed by the Health Products and Food Branch Inspectorate for those antimicrobial agents that are now subject to the Food and Drugs Act and are exempt from the Pest Control Products Act.

Higher risk disinfectants such as chemosterilants and high level disinfectants used to sterilize invasive devices or devices used for circulation, reintroduction of a body fluid or for introduction in a body cavity continues to be subject to the current Good Manufacturing Practices Guidelines and Regulations.

• Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices Version 2 (GUIDE-0049)