On January 5, 2022, amendments came into force amending the Food and Drug Regulations to allow practitioners to request access to restricted drugs through the Special Access Program (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 (LSD). Health Canada revised its Special Access Program for drugs: 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 authorized for sale through the SAP.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
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