The Controlled Drugs and Substances Act (CDSA), including its Narcotic Control Regulations (NCR) and the Benzodiazepine and Other Targeted Substances Regulations (BOTSR), prohibits the repackaging and/or sale of controlled substances from one pharmacy to another, except in shortage or emergency situations. Controlled substances include narcotics, controlled drugs, and targeted drugs.
Given this, regulated members have asked when the sale of controlled substances between pharmacies IS permitted. Health Canada’s Controlled Substances and Cannabis Branch has advised the following:
“Scenarios are evaluated on a case-by-case basis. Generally speaking, emergency purposes could include an urgent public health need, a critical shortage of stock, or an order that could not be processed by a pharmacist that required immediate action. The sections of the regulations that allow for emergency sale or provision of controlled substances are not intended to be used for stock management purposes. Such sales or provisions are to be done on a prescription basis. Typically, the quantities involved would be limited to what is necessary to fill a single prescription.”
Thus, the legislation prohibits a pharmacy from acting as a wholesaler without a dealer’s licence. If your pharmacy is engaged in supplying other pharmacies with narcotics, controlled drugs, or targeted substances through a compounding and repackaging agreement then this activity must stop, unless you can show evidence supporting these specific circumstances. As of March 31, 2022, this also includes the sale of tramadol, which will be added to Schedule 1 of the CDSA as of that date.
It is also important to be aware that ACP’s Standards of Practice for Pharmacists and Pharmacy Technicians (SPPPT) include the following definition of emergency:
“Emergency means a circumstance where a patient urgently requires a professional service that includes a restricted activity for the purposes of preventing imminent mortality or morbidity.”
For example, if a compounding and repackaging pharmacy sold a controlled substance (e.g., tramadol) to another pharmacy on a regular basis, that would not be considered a shortage or an emergency. That activity would be considered illegal according to federal legislation.
If there is a need to normalize the practice of compounding or repackaging controlled substances, a compounding and repackaging pharmacy must hold a licensed dealer permit issued by Health Canada, as provided for under the Narcotic Control Regulations C.R.C. 1041, the BOTSR, and as required in s2.6 of the model agreement approved by Council.
For more information, refer to Section 55(1) of the BOTSR and sections 8-16, 31(1), 34, 35, 36, and 45 of the Narcotic Control Regulations.
Remember, the Pharmacy and Drug Act requires that a compounding and repackaging agreement approved by Council be established and entered into between every pharmacy holding a compounding and repackaging licence, and each community pharmacy that it provides compounded and repackaged drugs to.