Status of ketamine under CDSA
2 May 2005
Status of ketamine under CDSA
The following notice is from the Office of Controlled Substances, Health Canada.
On February 7, 2004, Health Canada published a Notice to Interested Parties in Canada Gazette, Part I, with respect to a proposal to control ketamine under the Controlled Drugs and Substances Act (CDSA) and its Regulations.
Ketamine is a non-barbiturate anaesthetic approved for use in both humans and animals. It has been listed in Schedule F of the Food and Drug Regulations (FDR) since at least 1995. Ketamine has become popular as a "party or club" drug due to its dissociative effects; it creates the illusion of an "out of body experience". Ketamine is also used as a "date rape" drug.
Further research and analysis of the options for scheduling under the CDSA concluded that ketamine is an analogue of phencyclidine (PCP), and is, therefore, captured as item 14 in Schedule I of the CDSA and item 14 in the Narcotic Control Regulations (NCR) which states:
"Phencyclidine (1--(1--phenylcyclohexyl)piperidine), its salts, derivatives and analogues and salts of derivatives and analogues"
This notice is to inform you that because ketamine is captured under Schedule I of the CDSA, all offences and penalties associated with this schedule are now applicable to ketamine. These offences include possession, trafficking, possession for the purpose of trafficking, importation, exportation, possession for the purpose of exportation, and production.
All importers, exporters, manufacturers, and distributors of products containing ketamine will now require a licence under the NCR in order to continue these activities. Permits will also be required for all imports and exports of ketamine.
Companies currently holding a dealers licence under the NCR, Part G or J of the FDR or the Benzodiazepine and Other Targeted Substances Regulations are required to submit a request for amendments of their licence to add ketamine within 30 days of the date of this notice. All others must apply for a new licence within 30 days of the date of this notice. Please find attached a copy of the application form. Note that licences are site specific; a separate application must be submitted for each site where ketamine products are stored or handled. Issuance of a licence is dependent upon the company conforming to certain security requirements as well as other criteria. The security required for controlled drugs depends on the value of the substance and the location of the site to be licenced.
The value of ketamine for the purposes of the security directive has been set at $50,000/kg. Information on security requirements is contained in the document "Directive on Physical Security Requirements for Controlled Substances" available at http://www.hc-sc.gc.ca/hecs-sesc/ocs/pdf/psreqs_e.pdf.
The Office of Controlled Substances is committed to aiding new applicants for a licence through the application process. Applications will be reviewed on a case by case basis, and where necessary and appropriate, transition periods may be negotiated.
Health Canada will take action to remove ketamine from Schedule F of the FDR and explicitly list it in Schedule I to the CDSA and the Schedule to the NCR within the next months to avoid further confusion with respect to the regulatory status of this substance. Notification of this amendment will be published in Canada Gazette, Part II.
Similar notices have been sent to licensing authorities and associations for practitioners and pharmacists to alert their members of the new requirements. They have been advised that effective immediately, verbal orders and prescriptions for ketamine are no longer permitted.
Members with questions concerning the licence requirements for ketamine under the NCR should contact the Licences and Permits Division, Office of Controlled Substances, Address Locator: 3502A, 123 Slater St., Ottawa, Ontario, Canada, K1A 1B9, by phone: (613) 948-7796 by fax: (613) 941-5360 or by email at: Controlled_Drugs@hc-sc.gc.ca.