Repackaging controlled drugs and substances
August 10, 2022
Compounding and repackaging licensed pharmacies must hold a Controlled Drugs and Substances Dealer’s Licence to repackage controlled drugs and substances.
Through their routine assessments, ACP pharmacy practice consultants have identified pharmacies that are repackaging controlled drugs and substances in the absence of a Controlled Drugs and Substances Dealer’s Licence. 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.
If a pharmacy plans on regularly repackaging controlled drugs and substances for other licensed pharmacies, or if a pharmacy plans on regularly selling compounds containing controlled substances to another licensed pharmacy, a Controlled Drugs and Substances Dealer’s Licence from Health Canada is required.
Health Canada’s Controlled Drugs and Substances Dealer’s Licence is provided for under the NCR C.R.C. 1041, the BOTSR, and section 2.6 of the compounding and repackaging agreement template 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 NCR.
Remember, the Pharmacy and Drug Act also 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/or repackaged drugs to. In these arrangements it is important to remember that only the community pharmacy may dispense directly to patients. Please note that agreements must use the most recent compounding and repackaging agreement template, as amended by Council in 2022.