Health Canada’s Special Access Program for psilocybin, step by step

Psilocybin is not an approved medicine in Canada. Health Canada’s own page says there are no approved therapeutic products containing psilocybin in Canada or elsewhere (Health Canada). One legal route to it exists outside a clinical trial: the Special Access Program, which Health Canada runs for unapproved drugs of every kind. This guide follows that process using Health Canada’s published pages and the regulations themselves.

We describe what the official text says and where it stops. We do not say who qualifies, and nothing here is a how-to. Individuals cannot apply to the program at all, and the sections below explain why.

What is the Special Access Program, and does it cover psilocybin?

Through the SAP, health, dental and veterinary practitioners may access drugs and medical devices that are not yet authorized for sale in Canada (Health Canada, overview). For drugs, the legal basis is sections C.08.010 and C.08.011 of the Food and Drug Regulations, which let the Minister of Health issue a “letter of authorization” allowing a manufacturer to sell a specified quantity of a new drug to a practitioner for the emergency treatment of a person under that practitioner’s care (Food and Drug Regulations, C.08.010).

Psilocybin sits in a category called restricted drugs. Health Canada’s 2021 notice says that regulatory changes made in 2013 meant restricted drugs could not be accessed through the SAP (Health Canada, 2021 notice). Its psilocybin page says the ability for practitioners to request them was restored in January 2022 through amendments to the Food and Drug Regulations (Health Canada). The 2021 notice described the proposal as treating restricted drugs like all other drugs for the purposes of the SAP, with no guarantee that any request would be approved.

Health Canada also states that the SAP and individual exemptions are “not mechanisms to encourage the early use of unauthorized drugs” and are not a way to get around clinical development or drug review. It describes clinical trials as the most appropriate way to advance research with an unapproved drug such as psilocybin (Health Canada). The overview page adds that the SAP is not to be used to promote early use of a drug, conduct research or bypass the clinical trial and drug review process (Health Canada, overview).

Who can apply to the Special Access Program for psilocybin?

Only a practitioner can apply. Health Canada’s page for patients is blunt: only health or dental practitioners, typically physicians, can apply, and they must make the request on behalf of a patient under their care. “Patients cannot apply directly” (Health Canada, for patients). The psilocybin page repeats it: individuals cannot apply directly to request access to restricted or unauthorized drugs (Health Canada).

For SAP purposes, a practitioner is someone who is entitled under the laws of a province or territory to treat patients with an unapproved prescription drug, practises in that province or territory, and has prescribing privileges there. Health Canada says that most often this is a licensed physician and that a practitioner in doubt should consult their professional college about their scope of practice (Health Canada, request a drug). For psilocybin, Health Canada adds that the practitioner must also meet the practitioner requirements under the Controlled Drugs and Substances Act (Health Canada).

A patient can still be involved in the sense that matters: the practitioner must make sure the patient is well informed of the possible risks and benefits of the drug and of its development status (Health Canada, request a drug). A patient’s question about a request goes through the practitioner too, because SAP requests are confidential and only the practitioner who made one can contact the program about it (Health Canada, for patients).

What conditions must be met: serious, life-threatening, and conventional therapies?

The Food and Drug Regulations speak of a “medical emergency” without defining it. Health Canada interprets the term as serious or life-threatening conditions when conventional therapies have failed, are unsuitable or are unavailable in Canada (SAP guidance). Its request page lists the three alternatives: conventional treatments that have “failed”, “are unsuitable” or “are unavailable in Canada” (Health Canada, request a drug).

Health Canada defines a serious or life-threatening condition by the need for hospitalization or inpatient care, the risk of adverse pregnancy outcomes, the risk of persistent or significant disability without treatment, and the overall prognosis, and says other factors can also be taken into account (Health Canada, request a drug). The patient page stresses that the program is only intended for medical emergency situations (Health Canada, for patients).

Two further limits follow from the guidance. The program checks that there are no marketed alternatives in Canada and no Canadian clinical trial the patient could enrol in (SAP guidance). And the SAP “does not have a wait list, as it is meant for emergency access”, in the words of Health Canada’s 2021 notice (Health Canada, 2021 notice).

What does a Special Access request contain?

In general terms, the practitioner completes and signs a Special Access Request form for a specific patient, or a different form for future use, and faxes it to Health Canada’s program office (Health Canada, request a drug). The regulation sets out what the practitioner must give the Minister (C.08.010(1)):

• the name of the drug and details of the medical emergency for which it is required;
• the quantity required;
• the information the practitioner has on the drug’s use, safety and efficacy;
• the name and civic address of the person the drug is to be shipped to, who must be a practitioner or a pharmacist;
• any other information the Minister asks for to decide whether to issue the authorization.

The practitioner must also agree to report the results to the manufacturer and the Minister, including any adverse drug reactions observed, and to account to the Minister for all quantities received (C.08.010(1)(b)). Health Canada’s request page adds that the decision to prescribe must be supported by credible evidence from the medical literature or provided by the manufacturer, and that the practitioner must keep accurate records (Health Canada, request a drug).

The guidance says the supporting rationale should be specific to the patient’s condition and history, and lists what the program weighs: the seriousness of the condition, the patient’s clinical status and prognosis, other therapies tried or ruled out, any prior experience with the drug, and supporting references (the guidance asks for the most recent, no older than ten years, such as clinical trial results, published guidelines or case reports) (SAP guidance). For psilocybin, Health Canada says requests must provide sufficient evidence to support the use of the drug for the patient’s condition (Health Canada).

What is decided, and by whom?

The Minister’s power is discretionary: the regulation says the Minister “may” issue a letter of authorization (C.08.010(1)). In practice the SAP, part of Health Canada’s Pharmaceutical Drugs Directorate, processes requests administratively and triages them by urgency (Health Canada, request a drug). The guidance says the program may consult expert reviewers within Health Canada, and that a reconsideration is reviewed by a health professional, who may be a pharmacist or practitioner within Health Canada (SAP guidance).

Health Canada says every request is assessed individually, and for psilocybin that “there is no guarantee” a request will be granted. It weighs the level of evidence on safety, efficacy and proposed use, together with the patient’s condition and clinical status (Health Canada). The patient page says the review checks whether the request fits within the SAP, whether there is sufficient evidence that the proposed treatment may work, and whether it poses any unnecessary risks (Health Canada, for patients).

Note what is not decided. Authorization does not oblige anyone to supply the drug: the manufacturer must also agree to provide it, and Health Canada cannot require it to (Health Canada, for patients; SAP guidance).

How long does a decision take?

Health Canada gives no fixed time. Timelines vary with the nature of the emergency, the completeness of the request, the availability of marketed alternatives and the evidence supplied. It says time-sensitive requests for immediate life-threatening conditions are typically resolved within hours, while requests for drugs new to the SAP, or with limited evidence of safety and efficacy for a given condition, may need more time (Health Canada, request a drug). Health Canada says the program receives about 1,000 requests a month across all drugs.

What happens after a request is authorized?

The authorization is a letter to the manufacturer, not to the patient. It allows the manufacturer to sell the specified quantity to the named practitioner, with shipping arranged directly with the practitioner or institution named in the letter (SAP guidance). Health Canada says practitioners are responsible for identifying a manufacturer that can supply psilocybin, and that a Canadian manufacturer must be a licensed dealer under the Controlled Drugs and Substances Act with psilocybin on its licence (Health Canada).

Afterwards the practitioner must report outcomes, including adverse reactions, on a follow-up form (Health Canada, request a drug). A Health Canada class exemption under subsection 56(1) of the Controlled Drugs and Substances Act, effective 5 January 2022 and announced for revocation when the new regulations took effect on 1 October 2026, covered the other legal activities that follow a psilocybin authorization (possession, transport, administration and so on) by practitioners, their agents, pharmacists, hospital staff and licensed dealers (Health Canada, class exemption). Health Canada’s guidance said that exemption did not allow patients to possess or transport psilocybin (SAP guidance). That brings us to the regulations that took its place.

What changed on 1 October 2026?

The Controlled Substances Regulations (SOR/2025-242) were published in Canada Gazette, Part II, on 17 December 2025. Section 239 reads: “These Regulations come into force on October 1, 2026” (Canada Gazette). The Justice Laws consolidation, which was current to 21 September 2026 when we read it and so still marked the provisions as not yet in force, carries the same section (Justice Laws). As of 4 October 2026 we found no notice postponing that date, and the Ontario College of Pharmacists, whose page was updated on 2 October 2026, says the Regulations came into effect on 1 October (Ontario College of Pharmacists).

What they do to the SAP class exemption is stated in the regulatory impact analysis statement published with them. Sections 237 and 238 repeal Parts G and J of the Food and Drug Regulations (Part J governed restricted drugs) and four other regulations, and Health Canada said it would revoke the psilocybin and MDMA class exemption on the day the Regulations come into force. The same statement says the Regulations authorize practitioners to administer, sell or provide a restricted drug to a patient if the sale was authorized under the SAP under section C.08.010 of the Food and Drug Regulations, and let licensed dealers sell a restricted drug to a practitioner when a letter of authorization exists (Canada Gazette). In short, the exemption was revoked and its substance was moved into regulation, rather than the route being closed.

Here is what the regulation text says about psilocybin and the SAP:

• Psilocin (item 8) and psilocybin (item 9) are listed in Part 1 of Schedule 4, restricted drugs.
• A “letter of authorization” is defined as the letter issued under section C.08.010 of the Food and Drug Regulations, so the SAP’s legal basis in the Food and Drug Regulations is unchanged.
• Section 6(1) authorizes certain people to possess a restricted drug obtained in accordance with the Regulations, including a licensed dealer, a practitioner named in a letter of authorization, and an individual who obtained the drug “for their own use” from a practitioner named in a letter of authorization.
• Under section 58(2), a licensed dealer may sell or provide a restricted drug to a practitioner only if it first receives a letter of authorization naming it, the practitioner is named at a specified practice address, and the quantity is the one in the letter.
• Under sections 130(2) and 131(2), a practitioner may sell, provide or administer a restricted drug to an individual they are treating in their professional capacity, if they have received a copy of the letter of authorization naming them.

One difference stands out. Health Canada’s guidance on the old class exemption said it did not allow patients to possess or transport restricted drugs (SAP guidance), whereas section 6(1)(g) names an individual who obtained the drug for their own use from a named practitioner. We read the regulation, not Health Canada’s implementation of it, and we do not know how Health Canada will apply that paragraph. When we first read them, the Health Canada pages we opened were last modified before the in-force date (the psilocybin page in October 2025, the class exemption page in December 2025, the request pages in April 2026) and described the class exemption as current or due to be revoked. Health Canada updated the psilocybin page on 20 October 2026, but only its sentence on clinical trials changed, and it still describes the class exemption (Health Canada); we found no Health Canada page describing the new rules for psilocybin. The restored SAP route itself, with a request by a practitioner and a letter of authorization, continues in the new text.

How many psilocybin requests have been authorized?

We found no recent psilocybin statistics published by Health Canada itself. Two sources can be named, each with its origin and date.

The first is a Health Canada question period note dated 14 December 2022. It says that “as of November 4, 2022, Health Canada has authorized, though SAP, the use of psilocybin for 50 patients”, and that Health Canada had also approved 16 clinical trials involving psilocybin, 13 of them since the start of 2022 (Question Period Note, Health Canada, 2022). This counts patients.

The second is a 2025 comment in Nature Mental Health by Garel, Plourde, Greenway and Dorval. It reports figures that Health Canada and the Public Health Agency of Canada provided in response to the authors’ formal Access to Information request. Between January 2022 and December 2024, the SAP processed 436 requests for clinical access to psilocybin. 304 (69.7%) were authorized (Garel et al., 2025). This counts requests, so it is not comparable with the patient count above.

Two details sit beside the table. The 2024 authorized total includes two requests for a migraine attack. The 132 requests that were not authorized in the three years break down, by the authors’ reason codes taken from Health Canada, into 73 incomplete, 41 withdrawn, 15 denied and 3 cancelled (Garel et al., 2025). Only one request in the period concerned a substance use disorder (alcohol), and it was denied. Across the three years the authors report approval rates of 67.2% for major depressive disorder and 88.0% for end-of-life distress.

How to read these numbers is limited. The authors write that approval rates fell while request numbers stayed stable, and they offer possible explanations from the literature and from their own experience providing psilocybin therapy through the SAP; those are interpretations, not findings. An authorization is also not a treatment: it is permission for a manufacturer to sell. The figures say nothing about whether treatment took place or what happened to patients, and we cannot tell you how they have moved since December 2024.

What does an SAP authorization not mean?

It is not market approval. Health Canada says drugs authorized under the SAP have not gone through its full review for safety, efficacy or quality (Health Canada, for patients). The guidance goes further: these drugs are exempt from the Food and Drugs Act and its regulations, decisions rest on the practitioner’s rationale for the patient, and an authorization “does not constitute an opinion that a drug is safe, efficacious or of high quality” (SAP guidance). Evidence on psilocybin remains under study; for the trials, see our review of the depression trials.

It is also not the only legal route Health Canada names. Its psilocybin page lists clinical trials, the SAP and individual subsection 56(1) exemptions, and says the SAP and clinical trials should generally be pursued before an individual exemption (Health Canada). That third route is covered in section 56 exemptions and psilocybin.

What could we not confirm?

• Whether Health Canada has published updated SAP or psilocybin guidance for the Regulations, and how it applies section 6(1)(g) to patients. Apart from the psilocybin page, whose 20 October 2026 update changed only a sentence on clinical trials, the Health Canada pages we read pre-date 1 October 2026; check them and the Regulations’ current version on Justice Laws.
• Any SAP psilocybin figures after December 2024. We found none from Health Canada itself, and we left out unsourced numbers that circulate elsewhere.
• How many authorized requests led to treatment, or how patients fared. No source we opened reports this.
• How individual provinces, territories and professional colleges treat practitioners who make these requests; this varies and we did not review it.

For the wider picture, see Are magic mushrooms legal in Canada? and psilocybin-assisted therapy in Canada.

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.