Regulations Amending the Food and Drug Regulations (Project 1688 - Arsenic Trioxide)

250 Lanark Avenue
Graham Spry Building
Address Locator 2005D
OTTAWA, Ontario
K1A 0K9

File # 9010-2C-1688
MECS # 12-122330-725

December 17, 2012

Provincial and Territorial Deputy Ministers of Health
Provincial and Territorial Drug Program Managers
Deans of Faculties of Pharmacy
Registrars of Provincial Medical and Pharmacy Associations
Industry and Consumer Associations
Regulatory and Health Professional Associations
Other Interested Parties

Dear Sir/Madam:

Re: Food and Drug Regulations - Project Number 1688 - Arsenic Trioxide

The purpose of this letter is to inform you that the following proposed  regulatory amendment and Regulatory Impact Analysis Statement are pre-published in Canada Gazette, Part I for a 75-day comment period (from December 17, 2012 until March 2, 2013).

The proposal is to amend the Food and Drug Regulations (Regulations) to exempt the sale of a drug for human use that contains arsenic trioxide as a medicinal ingredient from the prohibition contained in subsection C.01.040 (b) of the Regulations, and to add arsenic trioxide when used as a medicinal ingredient to Part I of Schedule F to the Regulations (list of prescription drugs).