Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program): SOR/2021-271

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2022-01-15 01:30:07

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program) pursuant to

1 (1) The definitions pharmacist and prescription in section J.01.001 of the Food and Drug Regulations footnote 1 are repealed.

(2) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part if they are acting as the agent or mandatary of a person referred to in paragraph (1)(a), (b), (d) or (e).

3 (1) The portion of the definition narcotic in subsection 2(1) of the Narcotic Control Regulations footnote 2 before paragraph (a) is replaced by the following:

Drugs that have not been approved for sale in Canada can generally be requested through Health Canada’s Special Access Program in instances where conventional therapies have failed, are unsuitable, or unavailable. As a result of regulatory amendments made to Part C of the Food and Drug Regulations in 2013, restricted drugs became the only category of controlled substances that could not be requested through the Special Access Program.

Restricted drugs are controlled substances that are listed in the Schedule to Part J of the Food and Drug Regulations. footnote 3 Restricted drugs generally do not have approved medical uses. Since the regulatory changes were made in 2013, the science pertaining to the efficacy and safety of certain restricted drugs has continued to advance, with some now demonstrating potential therapeutic uses, including in Phase II and Phase III clinical trials. footnote 4

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