Letter to Licensed Dealers Regarding the Controlled Release Formulations of Oxycodone Products

November 26, 2012

To all Controlled Substances Licensed Dealers:

The purpose of this letter is to reiterate your responsibilities in helping reduce risks of diversion of prescription drugs in Canada and to highlight new conditions which will apply if you are performing activities with controlled release formulations of oxycodone products.

The  Controlled Drugs and Substances Act (CDSA) provides for the control of substances that can alter mental processes and that may produce harm to health and to society when diverted or misused. Under the CDSA, "controlled substances" includes any drug that contains a controlled substance. The Narcotic Control Regulations (NCR) sets out the circumstances and requirements in which producers, distributors, importers, exporters, pharmacists, practitioners and hospitals may conduct regulated activities including possession, sale, distribution, importing and exporting, and production of narcotics.  Examples of narcotics are cocaine, opium, codeine, morphine, cannabis (marihuana) and oxycodone.

Under the NCR, licensed dealers must comply with all security (storage, personnel and transportation) and record keeping requirements, and with any additional conditions listed on their licences. For the system to function properly, manufacturers and distributors must be vigilant in determining whether a prospective customer is legally authorized to receive and dispense controlled substances. You, as licensed dealers, should know your clients and must verify that the person placing the order is authorized by Health Canada or by his/her provincial/territorial licensing authority. Your vigilance in considering whether the controlled substances provided to your customers are being used for legitimate medical, scientific, and industrial purposes is critical.

There are restrictions under the NCR concerning to whom licensed dealers may sell/provide narcotics: another licensed dealer, a pharmacist, a practitioner, a hospital employee or practitioner in a hospital or, a person holding an exemption under the CDSA. Dealers must also maintain appropriate records of these transactions.  The NCR further set out conditions pertaining to the orders that may be acted upon, and how controlled substances may be imported, exported, packaged or transported.  For specific orders made through computer programs noted in section 27 of the NCR, these regulations specify the capabilities of such computer programs, and indicate that these programs must be able to detect unusual orders to enable intervention by the licensed dealer.

In order to further address the risks of diversion associated with controlled release formulations of oxycodone products, Health Canada requires that all licensed dealers performing activities with controlled release formulations of oxycodone products meet the following additional conditions:

1. Sales reports of all controlled release formulations of oxycodone products must be submitted separately to Health Canada within 15 days following the last day of the  month being reported on, in a manner and format specified by Health Canada.
2. Reports of theft or unusual loss of controlled release formulations of oxycodone products must be made to the police force of jurisdiction (local police force) within 24 hours after becoming aware of the occurrence.  Licensed dealers must confirm to Health Canada within 72 hours after becoming aware of the occurrence that such report has been made and provide a summary of such report, in a manner and format specified by Health Canada.
3. Report of any unusual orders involving controlled release formulations of oxycodone products must be made to Health Canada within 72 hours of becoming aware of such orders, in a manner and format specified by Health Canada.

Please refer to the accompanying guidelines for additional information and guidance on the above conditions and other matters pertaining to this letter.

Health Canada will closely analyse the information provided and will use this information in planning its compliance and enforcement activities. Non compliance with any condition of your licence or any other legislative and regulatory requirements could lead to the suspension, revocation or refusal to renew the licence. In certain circumstances, the information you provide to Health Canada may also be shared with law enforcement agencies.

Health Canada intends to include these conditions on amended licenses and all new licences issued for 2013 to licensed dealers who are authorized to conduct activities with controlled release formulations of oxycodone products.  In order to ensure the timely renewal of licences for 2013, and to avoid business disruptions, please note that it is your responsibility to submit a completed licence renewal application to Health Canada.

For any question concerning this letter, you may communicate with the Licences and Permits Division of the Office of Controlled Substances, at controlled_drugs_office@hc-sc.gc.ca.

As a licensed dealer, your role in the proper handling of controlled substances is critical for public safety as it helps to protect individuals and communities against the harms associated drug diversion.

Yours sincerely,

Director
Office of Controlled Substances
Health Canada