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Controlled Drugs and Substances Dealer’s Licence requirement

January 25, 2023
When ordering compounded or repackaged controlled substances from a compounding and repackaging pharmacy, community pharmacies must ensure the required licence is in place.

If a pharmacy intends to order a compounded or repackaged controlled substance outside of a shortage or an emergency, the pharmacy team must confirm that the compounding and repackaging pharmacy—with which they have an existing agreement—has a Controlled Drugs and Substances Dealer’s Licence from Health Canada. It should be noted that each Dealer’s Licence is specific to the pharmacy that carries it and specifies which controlled drugs and substances it may sell.

The Controlled Drugs and Substances Act (CDSA), including the 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. Emergency is defined in ACP’ s Standards of Practice for Pharmacists and Pharmacy Technicians as follows:

“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.”

If an emergent need arises and a controlled substance is compounded or repackaged by, and purchased from, a pharmacy without a Dealer’s Licence, both pharmacies are responsible for assessing if it is a true emergency.

When signing or renewing a compounding and repackaging agreement, community pharmacy licensees should determine if the compounding and repackaging pharmacy has a Controlled Drugs and Substances Dealer’s Licence and ask which molecules they are approved for. Licensees should also review their existing compounding and repackaging agreements to ensure their pharmacy and the compounding and repackaging pharmacy meet the federal legislation and ACP standards.