Vol. 139, No. 19 September 21, 2005
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (Ketamine)
P.C. 2005-1518 August 31, 2005
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, hereby makes the annexed Regulations Amending the Food and Drug Regulations (Ketamine).
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (KETAMINE)
1. The reference to
Ketamine and its salts
in Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is repealed.
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations nor the Order.)
The purpose of this regulatory initiative is to remove the substance ketamine from Schedule F of the Food and Drug Regulations (FDR) and explicitly list it under item 14 of Schedule I to the Controlled Drugs and Substance Act (CDSA), and item 14 of the Schedule to the Narcotic Control Regulations (NCR).
Ketamine is a non-barbiturate anaesthetic used in humans and animals. It has been listed in Schedule F, Part I of the FDR since at least 1995. As such ketamine requires a prescription for human and veterinary use. In Canada, ketamine is most commonly used as an anaesthetic for animals.
Ketamine is commonly referred to as "special k", "kit kat", and "cat valium" on the streets, and has become popular as a "party or club drug" due to its dissociative effects; it creates the illusion of an "out of body experience". It is also used as a "date rape" drug. Ketamine seizures by police have been increasing in recent years. The clandestine manufacture of ketamine is a complex and costly process, therefore the main source of illicit ketamine is through the diversion of legitimate pharmaceutical products.
Concern expressed by health professionals and law enforcement resulted in requests to Health Canada for action to be taken to prevent the theft, diversion, and illicit use of this substance. On February 7, 2004 Health Canada published a Notice to Interested Parties in the Canada Gazette, Part I, with respect to a proposal to control ketamine under the CDSA and its Regulations.
Further research and analysis of the scheduling options under the CDSA concluded that ketamine is an analogue of phencyclidine (PCP), and is therefore captured under item 14 in Schedule I to the CDSA, and item 14 in the NCR which states:
"Phencyclidine (1-(1-phenylcyclohexyl)piperidine), its salts, derivatives and analogues and salts of derivatives and analogues".
The CDSA defines an analogue as "a substance that, in relation to a controlled substance, has a substantially similar chemical structure."
Section 58 of the CDSA gives priority to substances listed under its Act and Regulations, stating:
"In the case of any inconsistency or conflict between this Act or the regulations made under it, and the Food and Drugs Act or the regulations made under that Act, this Act and the regulations made under it prevail to the extent of the inconsistency or conflict."
Consequently, regulatory amendment is not necessary to bring ketamine under the control of the CDSA. Nevertheless, Health Canada is removing ketamine from Schedule F of the FDR, and explicitly listing it under Schedule I to the CDSA and the Schedule to NCR to ensure that no confusion exists regarding the regulatory status of this substance, which could compromise the control over ketamine and the health and safety of Canadians.
Due to the more technical nature of this issue and the need to clarify the regulatory status of ketamine, Health Canada requested approval for an exemption from pre-publication in the Canada Gazette, Part I.
The CDSA provides a legislative framework for the control of substances that can alter mental processes and may produce harm to the health of an individual or to society when diverted or misused. Except as authorized under its Regulations, activities such as possession, possession for the purpose of trafficking, trafficking, importation, exportation, possession for the purpose of exportation, and production of controlled substances are prohibited under the CDSA. Regulating ketamine under the CDSA and the NCR will enhance protection of the health and safety of Canadians by reducing the availability of this drug on the illicit market.
The NCR governs the activities of producers, distributors, importers, exporters, health care professionals, and hospitals related to narcotic drugs. Depending on the activities to be carried out, persons must obtain a dealer's licence as well as separate permits to import or export narcotic drugs. Licensed dealers, hospitals, pharmacists and practitioners are required to provide adequate security for controlled substances in their possession and to maintain records of all movements of controlled substances into and out of their inventory.
Canada is a signatory to United Nations drug control conventions, and as such has an obligation to meet international requirements. Although ketamine is not currently listed in any of the United Nations drug control conventions, it has been recommended for critical review by the World Health Organization's Expert Committee on Drug Dependence with a view to determine if it should be added to the Schedules of the Conventions. A number of countries have already elected to impose strict controls over ketamine, including the United States, Australia, Belgium, Italy, France, Greece, Luxembourg, and China.
No alternatives were considered. Ketamine is an analogue of PCP and is therefore captured under Schedule I of the CDSA. Ketamine is a popular substance that has been used licitly in veterinary medicine for many years as a Schedule F prescription drug. Clarifying the placement of ketamine within legislation will avoid confusion about its regulatory status.
Benefits and Costs
The increased control over the distribution of ketamine will affect practitioners, pharmacists, hospitals, the pharmaceutical industry, law enforcement, and the Canadian public as presented in the following section.
Practitioners, Pharmacists, and Hospitals
Physicians and veterinarians [practitioners], pharmacists and hospitals who administer or provide ketamine to patients will now be required to meet the stricter requirements of the NCR which include:
The impact on these groups is expected to be minimal as most practitioners, pharmacists and hospitals already use or distribute drugs regulated under the NCR and have the required security measures in place, as well as experience with the various record keeping requirements.
Persons that fabricate, package or label, perform tests, distribute, import or wholesale products containing Schedule F drugs require an establishment licence to carry out these functions as prescribed by section C.01A.008 of the FDR. In order to continue performing these functions in relation to products containing ketamine, importers, exporters, manufacturers and distributors must also obtain a licence under the NCR. Those currently holding a dealer's licence for other controlled substances will have to apply to have their licences amended to include ketamine. It will also be necessary to obtain import and export permits for each transborder shipment of ketamine; permits are not required for Schedule F drugs.
To obtain a licence, applicants must meet the physical security requirements detailed in the "Directive on Physical Security Requirements for Controlled Substances" available at: www.hc-sc. gc.ca/hecs-sesc/ocs/pdf/psreqs_e.pdf. Licensed dealers will be required to keep more detailed records concerning acquisitions and disbursements of all ketamine products and to report thefts and losses to Health Canada.
In Canada, all Schedule F drugs must display "Pr" on the outside label of the product; all drugs regulated under the NCR must display "N" on the outside labels as dictated by section C.01.004 of the FDR. Manufacturers will therefore be required to change their labels for ketamine products.
Only seven manufacturers of ketamine operate in Canada; three of these companies already possess licences under the Regulations to the CDSA. Many of the companies that distribute ketamine distribute other controlled substances and therefore, also have licences under the Regulations to the CDSA. The incremental costs associated with the change in the Regulation of ketamine are expected to be minimal for those companies who already possess a licence. Those who do not currently distribute any controlled substances may incur costs to upgrade the physical security at the site where ketamine will be handled in order to meet the requirements of the NCR.
All manufacturers of ketamine will incur costs to change the product labels to bear the "N" symbol. Reasonable transition periods will be negotiated with each licensed dealer to minimize these costs.
The determination that ketamine is a controlled substance under Schedule I of the CDSA will enable law enforcement officers to take enforcement action against persons who import, export, traffic, produce and possess ketamine for illicit uses. Law enforcement agencies and prosecutors may incur additional costs in dealing with offences under the CDSA in relation to ketamine, however these actions should ultimately serve to decrease the illicit activity in respect to this substance. Explicitly listing ketamine under the CDSA and the NCR should minimize the risks and costs associated with potential litigation challenging the interpretation of the regulatory status of ketamine.
This regulatory amendment will benefit Canadians as the increased control of ketamine will serve to minimize diversion, and the health risks and crime associated with its illicit use. Those possessing it illegally will be at risk of being subject to sanctions under the CDSA. This amendment, however, will not affect the availability and use of ketamine for legitimate medical or scientific purposes.
A Notice to Interested Parties was published in the Canada Gazette, Part I, on February 7, 2004. The following stakeholders were notified directly of the publication:
Comments were received from six stakeholders; all were supportive of the decision to place ketamine within the framework of the CDSA.
Notification of the determination that ketamine is a controlled substance was sent to federal prosecutors, law enforcement agencies, manufacturers and distributors of ketamine, hospital associations, health professional licensing authorities and associations in May 2005.
Compliance and Enforcement
Enforcement activities are carried out by local and federal law enforcement agencies. This amendment will provide law enforcement with the tools necessary to combat illegal possession, trafficking, importation, exportation, and production of ketamine. Offences under the CDSA are subject to criminal prosecution. Monitoring of compliance with the NCR is the responsibility of Health Canada. This amendment will not alter existing compliance mechanisms. Failure to comply with the Regulations could lead to administrative sanctions such as revocation of a licence or permit.
S.C. 1999, c. 33, s. 347
C.R.C., c. 870