Section 56 exemptions for psilocybin, explained: what the law says and what is publicly known

Magic mushrooms, psilocybin and psilocin are illegal to produce, sell or possess in Canada unless Health Canada authorizes the activity, for example through a licence or an exemption (Health Canada). A section 56 exemption is one of those authorizations. It is one of the least understood, because it is discretionary, individual and mostly unpublished.

This article explains what section 56 says, how Health Canada describes the process for psilocybin, what has been reported about exemptions that were granted or refused, and how the route differs from the Special Access Program and clinical trials. It is a description of the rules, not a guide to using them. We say where the record runs out.

What does section 56 of the CDSA say?

Subsection 56(1) of the Controlled Drugs and Substances Act (CDSA) lets the Minister of Health, on any terms and conditions the Minister considers necessary, exempt “any person or class of persons” or “any controlled substance” from all or any of the Act’s provisions or its regulations. The test is the Minister’s opinion that the exemption is “necessary for a medical or scientific purpose” or is “otherwise in the public interest” (Justice Laws, s. 56). The text we read was current to 21 September 2026, the date of Justice Laws’ latest consolidation of the Act when we checked on 4 October 2026.

Four features matter. It is a power, not a right: nothing in the section entitles anyone to an exemption. It is discretionary and conditional: the Minister sets the terms. It can be individual or a class: Health Canada uses both. And it is broad: the section is not about psilocybin at all, and covers every substance the Act controls. Subsection 56(2) adds one limit: no medical-purpose exemption may allow activities with a substance obtained in a way the Act does not authorize to take place at a supervised consumption site (Justice Laws, s. 56).

Why would psilocybin need an exemption at all? Because the Act prohibits possessing a Schedule III substance except as authorized under the regulations (Justice Laws, s. 4), and psilocin and psilocybin are listed in Schedule III (Justice Laws, full text). An exemption is one way for the federal government to authorize what the prohibition would otherwise forbid.

Health Canada describes an exemption as a formal document issued to a person or group that authorizes specific activities with controlled substances that would otherwise be illegal. It says it weighs potential benefits, potential risks or harms to the health and safety of Canadians, whether the substance is necessary, and the safeguards for use and storage (Health Canada, exemptions).

How does Health Canada describe the exemption process for psilocybin?

Health Canada’s psilocybin page, last modified 20 October 2026, names three legal routes to psilocybin for therapeutic use, each with the support of a regulated health care practitioner: clinical trials, the Special Access Program (SAP) and individual subsection 56(1) exemptions. It says the first two are existing regulatory options that should generally be pursued instead of an individual exemption, unless it can be shown that access is not possible or suitable through them. It adds that the SAP and individual exemptions are not meant to encourage early use of unauthorized drugs or to get around the drug review and approval process (Health Canada).

What does Health Canada say it considers?

For an individual request tied to a medical condition, the page says each request is considered case by case, in light of the public health and public safety aims of the CDSA (Health Canada). The factors it lists, which it says are not exhaustive, are:

• whether clinical trials or another regulatory pathway, such as the SAP, are available;
• the medical condition the psilocybin is requested for;
• the scientific evidence supporting its use for that condition;
• whether conventional therapies have been considered;
• whether a health care practitioner supports the use;
• the public health and public safety objectives of the CDSA;
• other federal, provincial or municipal laws that may apply;
• risks, including the risk of diversion.

The page says such a request should include a letter of support from a medical practitioner, showing that other legal routes were pursued or are not available or suitable, and giving the diagnosis, prognosis, clinical evidence of psilocybin use if applicable and the recommended treatment regime. It names the Office of Controlled Substances as the contact for individuals who want more information (Health Canada). We have not repeated the contact details here, because this article is a description of the rules, not a guide to applying.

What about exemptions for researchers?

Research uses a separate form. Health Canada’s clinical-studies page says a qualified investigator who needs a controlled substance for research that includes giving it to people in a clinical trial must obtain a section 56 exemption. The investigator first files a clinical trial application and receives a no-objection letter, then submits the exemption application with the protocol. The page gives an average processing time of 45 calendar days once all required information is provided, and says exemptions are valid for two years and may be extended (page modified 5 July 2023; Health Canada, clinical studies).

A January 2022 Health Canada notice adds that clinical research with psilocybin also needs a clinical trial application under the Food and Drug Regulations and, because psilocybin is a restricted drug, authorization under Part J of those regulations (Health Canada notice, 11 January 2022). That notice pre-dates the new Controlled Substances Regulations, which repeal Part J (section 237) and carry restricted-drug rules into the new regulations (Canada Gazette), so read it as background, not as the current rule. Health Canada’s psilocybin page, updated on 20 October 2026, now says that authorization under the Controlled Substances Regulations is required to permit the sale of psilocybin for clinical testing (Health Canada). Health Canada’s clinical-studies page, which we also read, has not been updated since 2023 and describes the exemption route as it stood then.

What are class exemptions?

A class exemption covers a defined group rather than one named person. Two touch psilocybin. One, effective 20 September 2025 (page modified 2 February 2026), covers participants in an authorized clinical trial with at-home administration of MDMA or psilocybin, who may hold the drug only in the form and amount the trial authorizes and must return what is unused (Health Canada, at-home trials). The other, effective 5 January 2022, let practitioners, pharmacists, hospital staff and licensed dealers handle psilocybin that the SAP had authorized for sale (Health Canada, SAP class exemption).

The second has changed. The Controlled Substances Regulations (SOR/2025-242), published in the Canada Gazette on 17 December 2025, came into force on 1 October 2026 (section 239). They repeal Parts G and J of the Food and Drug Regulations and several other drug regulations (sections 237 and 238), and the regulatory impact analysis says they fold six class exemptions, including this SAP one, into the regulations, with Health Canada revoking those class exemptions on the day the regulations came into force (Canada Gazette). In place of the exemption, a licensed dealer may sell or provide a restricted drug to a practitioner if the SAP has granted a letter of authorization (Canada Gazette). The Ontario College of Pharmacists posted on 1 October 2026 that the regulations are now in effect (OCP).

Two limits on that. We read the Gazette text and the pharmacy regulator’s notice, not a Health Canada notice announcing the in-force date, and the Health Canada pages we opened (including the SAP class exemption page, last modified 17 December 2025) had not been updated and still speak in the future tense. Health Canada’s psilocybin page was updated on 20 October 2026, but only its sentence on clinical trials changed (Health Canada). The Justice Laws consolidation of the regulations we opened was current only to 21 September 2026 (Justice Laws). For anything that turns on the new regulations, check the official pages. Nothing we found in them changes section 56(1) itself, which stays in the Act (Justice Laws, s. 56).

What is publicly known about psilocybin exemptions that were granted?

Less than you might expect. We found no Health Canada page that totals the individual psilocybin exemptions granted, and Health Canada told CBC in 2023 that it does not comment on individual applications for privacy and safety reasons (CBC, 2 March 2023). What exists is a handful of official notes and dated news reports. Treat every figure below as a snapshot, not a current count.

The 2021 Health Canada note is the official statement of practice: patients can seek an exemption by exception, case by case, with terminally ill patients prioritized (Health Canada question-period note, 16 December 2021). The same note says an exemption is not the same as a drug authorization under the Food and Drugs Act. The August 2021 figures come from a news report, not from Health Canada (Filter, 9 August 2021). The report is a single news article from 2021, we could not match it to any official count, and Health Canada’s own December 2021 note gives no totals, so please read these numbers as one outlet’s reported figures from that date.

The practice changed in 2022. A December 2022 Health Canada note records that on 9 June 2022 the Minister refused a group of section 56(1) applications, and that applicants filed a court challenge on 11 July 2022 (Health Canada question-period note, 14 December 2022). By March 2023, CBC reported, Health Canada had told a patient whose exemption was first granted in October 2020 and expired in October 2021 that it intended to refuse a new one, citing existing pathways such as the SAP (CBC).

What did the Federal Court of Appeal decide in 2025?

The case, Toth v. Canada (Mental Health and Addictions), 2025 FCA 119, concerned health care practitioners who asked for exemptions to use psilocybin as part of experiential training in psilocybin-assisted psychotherapy. We could not open the judgment: the CanLII and Federal Court of Appeal pages returned access errors when we tried on 4 October 2026. What follows is therefore from two summaries, not the court’s own words. CBC reported that 96 practitioners were involved, that in 2020 the then Minister granted exemptions to 19 practitioners, and that this was reversed in 2022 (CBC, 19 June 2025). Torys, a law firm, describes the 2022 requests as nearly identical to the one granted in 2020 (Torys, 25 June 2025).

According to Torys, the Court of Appeal found the Minister’s decision unreasonable because it did not justify the departure from the earlier position, and remitted it to the Minister for redetermination. It did not order exemptions granted. Torys also reports that the Charter grounds were rejected, and that the remaining grounds, which asked whether experiential training is necessary, invited the Court to settle a scientific debate that is not its role on judicial review (Torys).

What happened next is not public as far as we could find. On 8 July 2025 the Canadian Press reported that a spokesperson for the Minister did not say whether a new decision had been made or an appeal was planned (Canadian Press via Global News, 8 July 2025). Torys had noted that the Minister had until early autumn 2025 to seek leave to appeal to the Supreme Court of Canada. We found no report of a redetermination or of a leave application, and could not search the Supreme Court’s case database successfully, so as of 4 October 2026 we cannot say how it ended.

How is a section 56 exemption different from the Special Access Program and clinical trials?

They answer different questions. A section 56 exemption is a permission under drug-control law: the Minister exempts someone, or a class, from a CDSA prohibition (Justice Laws, s. 56). The SAP is a drug-access program: a practitioner asks Health Canada for a drug that has not been authorized for sale, and approval lets a supplier sell it to that practitioner (Health Canada). A clinical trial is research approved in advance, with an ethics board and a protocol. The table compares them using Health Canada’s own descriptions.

The SAP is covered in detail in our guide to the Special Access Program for psilocybin. For the wider picture, see psilocybin-assisted therapy in Canada. Health Canada’s list of authorized trials is its Clinical Trials Database, and the psilocybin page links to it (Health Canada).

One point of confusion: there is a difference between a legal route and a proven treatment. Health Canada’s psilocybin page says there are no approved therapeutic products containing psilocybin in Canada or elsewhere, and that although some early trials have shown promising results, the evidence is limited (Health Canada). An exemption lets specific activities happen lawfully. It does not mean Health Canada has assessed psilocybin as safe or effective for any condition. For the research itself, see what the depression trials show.

Does a section 56 exemption make magic mushrooms legal?

No. Health Canada says the production, sale and possession of magic mushrooms are illegal in Canada, and that activities are illegal unless Health Canada authorizes them (Health Canada). An exemption covers only the activities, people and conditions written into it. The Controlled Substances Regulations also refer to exemptions: they let a licensed dealer sell or provide a controlled substance to a person exempted under subsection 56(1) only on the terms the exemption itself specifies (Canada Gazette, ss. 50 and 60). For the wider legal picture, see are magic mushrooms legal in Canada? and the history of how they became illegal.

What is unsettled?

• How many individual psilocybin exemptions exist today. We found no official total, and the figures we found are from 2021 and are reported, not published by Health Canada.
• What the Minister decided after the Federal Court of Appeal sent the practitioner-training requests back, and whether any further appeal was sought. We found no public report of either as of 4 October 2026, and we could not read the judgment itself.
• Whether Health Canada’s guidance on exemptions changes now that the Controlled Substances Regulations are in force. Apart from the psilocybin page, whose 20 October 2026 update changed only its clinical-trials sentence, the Health Canada pages we read pre-date 1 October 2026.
• How a decision-maker should weigh a consistent past practice against “evolving” policy. The Court of Appeal said the change needs explaining, but it did not set the outcome.
• Whether Parliament will create a different route. We have not covered pending bills here; see Bill C-286 explained.

Before relying on any of this, check the primary sources: the section 56 text on Justice Laws, Health Canada’s psilocybin page and its exemptions page, all of which can change.

Shroomverse sells mushroom products. This article is general information about Canadian drug regulation. It is not medical, legal or purchasing advice, and it does not encourage anyone to use drugs.