On 5 January 2022, amendments to the Food and Drug Regulations came into force to allow practitioners to request access to restricted drugs through the special access programme (SAP), which was previously prohibited. "Restricted drugs" are controlled substances that are listed in the Schedule to Part J of the Food and Drug Regulations, which includes, for example, certain amphetamines and lysergic acid diethylamide.
Health Canada revised its guidance document for industry and practitioners to reflect these amendments. The guidance also addresses the need for an exemption under the Controlled Drugs and Substances Act if a restricted drug is authorised for sale through the SAP.
For further information on this topic please contact Katie Lee at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.