Health Canada is proposing to amend Schedule III to the Controlled Drugs and Substances Act (CDSA) by expanding the listing of methylphenidate and its salts to include its derivatives, isomers, and analogues, as well as salts of the derivatives, isomers and analogues.
Activities with methylphenidate and its salts are authorized under Part G to the FDR, where they are scheduled as controlled drugs. However, as the derivatives, isomers and analogues of methylphenidate (as well as salts of derivatives, isomers and analogues) have no approved therapeutic uses, Health Canada is proposing to list them under Part J to the FDR. Research or scientific use of these substances could be authorized under Part J of the FDR.
Health Canada is requesting your comments on the proposal. The publication of this notice in the Canada Gazette, Part I, initiates a 30-day comment period.
Anyone interested in this process or having comments on this notice should contact Legislative and Regulatory Affairs, Controlled Substances Directorate, Healthy Environments and Consumer Safety Branch, Health Canada by mail at Address Locator: 0302A, 150 Tunney’s Pasture Driveway, Ottawa, Ontario K1A 0K9, or by email at ocs_regulatorypolicy-bsc_politiquereglementaire@hc-sc.gc.ca.