Subsection 56(1) class exemption for practitioners, agents, pharmacists, persons in charge of a hospital, hospital employees, and licensed dealers to conduct activities with psilocybin and MDMA in relation to a special access program authorization

Pursuant to subsection 56(1) of the Controlled Drugs and Substances Act (CDSA), and subject to the terms and conditions herein, persons in charge of a hospital, hospital employees, licensed dealers, pharmacists, practitioners and their agents are exempted from the application of certain provisions of the CDSA when conducting certain activities with the specified quantity of the following substances authorized for sale under subsection C.08.010(1) of the Food and Drug Regulations (FDR):

• 3-[2-(dimethylamino) ethyl]-4-phosphoryloxyindole and any salt thereof (Psilocybin); and
• N-methyl-3,4-methylenedioxyamphetamine and any salt thereof (MDMA)

Definitions

In respect of this exemption and unless otherwise defined below, the terms used in this exemption have the same meaning as those provided in the CDSA and its regulations.

Agent

Means a psychotherapist, nurse, or nurse practitioner who is acting as the agent or mandatary of a practitioner for the purposes of transporting or administering Psilocybin or MDMA authorized for sale under subsection C.08.010(1) of the FDR to a patient and who is permitted by their province/territory to transport or administer Psilocybin or MDMA to patients.

Hospital

means a facility

• (a) that is licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or
• (b) that is owned or operated by the Government of Canada or the government of a province and that provides health services.

Hospital employee

means a psychotherapist, nurse, or nurse practitioner who is conducting activities in a hospital with Psilocybin or MDMA authorized for sale under subsection C.08.010(1) of the FDR and who is permitted to do so in their practice under the laws of a province or territory in which they are entitled to practice.

Letter of authorization

means a letter of authorization issued by the Minister of Health under subsection C.08.010(1) of the FDR.

Licensed dealer

means the holder of a licence issued under section J.01.015 of the FDR for Psilocybin or MDMA that has been authorized for sale under subsection C.08.010(1) of the FDR.

Patient

means an individual who is receiving emergency treatment with Psilocybin or MDMA that has been authorized for sale pursuant to a request made by their practitioner under subsection C.08.010(1) of the FDR.

Pharmacist

means a person who

• (a) is entitled under the laws of a province or territory to practise pharmacy and who is practising pharmacy in that province or territory;
• (b) has not been named in a notice under subsection 48(1) of the Narcotic Control Regulations, G.03.017.2(1) of the Food and Drug Regulations, 79(1) of the Benzodiazepine and Other Targeted Substances Regulations or section 181 or 344 of the Cannabis Regulations or has been named in a notice under any of these regulations but a notice of retraction has been issued; and
• (c) practices at or is in charge of a pharmacy at a hospital.

Practitioner

means a person who

• (a) is entitled under the laws of a province or territory to treat patients with a prescription drug including controlled substances,
• (b) is practising their profession in that province or territory,
• (c) has not been named in a notice under subsection 59(1) of the Narcotic Control Regulations, G.04.004.2(1) of the Food and Drug Regulations, 79(1) of the Benzodiazepine and Other Targeted Substances Regulations or section 189 or 335 of the Cannabis Regulations or has been named in a notice under any of these regulations but a notice of retraction has been issued; and
• (d) has submitted a request under subsection C.08.010(1) of the FDR in connection with Psilocybin or MDMA that was subsequently authorized for sale under that subsection.

Purpose of the Exemption

The purpose of this exemption is limited to enabling persons in charge of a hospital, hospital employees, practitioners and their agents, pharmacists, and licensed dealers to conduct necessary activities with Psilocybin or MDMA that has been authorized for sale pursuant to subsection C.08.010(1) of the FDR. For that purpose, as set out in the remaining sections, this exemption authorizes:

• i. licensed dealers to sell and provide Psilocybin or MDMA to practitioners or pharmacists
• ii. practitioners and their agents and pharmacists to possess, transport, sell and provide Psilocybin or MDMA;
• iii. practitioners to prescribe and administer Psilocybin or MDMA and order Psilocybin or MDMA from a licensed dealer or a pharmacist, and agents of a practitioner to administer Psilocybin or MDMA pursuant to a written order or prescription from a practitioner.
• iv. persons in charge of a hospital and hospital employees to possess, administer or provide Psilocybin or MDMA to a patient in a hospital on receipt of a written order or prescription signed and dated by a practitioner.

Scope of the Exemption

In relation to Psilocybin or MDMA authorized for sale under subsection C.08.010(1) of the Food and Drug Regulations (FDR), practitioners and their agents, pharmacists, licensed dealers, persons in charge of a hospital, and hospital employees are exempt from the provisions of the CDSA as outlined below.

Practitioners and their agents who have received Psilocybin or MDMA are exempt from the following provisions of the CDSA, so long as the patient is under their professional treatment:

1. Subsection 4(1) as it applies to the possession of Psilocybin or MDMA, for the purpose of emergency treatment of a patient and destruction of psilocybin or MDMA.
2. Subsections 5(1) and 5(2) as it applies to the purchase, sale, administration and/or transport of Psilocybin or MDMA for the purpose of emergency treatment of a patient and returning the Psilocybin or MDMA by the Practitioner to the licensed dealer for destruction.

Pharmacists receiving a shipment of Psilocybin or MDMA are exempt from the following provisions of the CDSA, so long as they have received a written order or prescription for the drug that is signed and dated by the practitioner who is named in the letter of authorization.

1. Subsection 4(1) as it applies to the possession of Psilocybin or MDMA, for the purpose of dispensing to a patient for emergency medical treatment and for the purpose of destruction of Psilocybin or MDMA.
2. Subsections 5(1) and 5(2) as it applies to the sale or transport of Psilocybin or MDMA, for the purpose of dispensing or delivering the drug for emergency treatment of a patient and for the purpose of returning the Psilocybin or MDMA to the licensed dealer for destruction.

Licensed dealers, who have received an authorization to sell Psilocybin or MDMA are exempt from the following provisions of the CDSA:

1. Subsections 5(1) and 5(2) as they apply to the sale and transport of Psilocybin or MDMA to the practitioner or pharmacist named in the letter of authorization.
2. Subsections 5(1) and 5(2) as they apply to the sale and transport of Psilocybin or MDMA to the pharmacist in charge of the hospital pharmacy, if the hospital pharmacy is named in the letter of authorization.

Persons in charge of a hospital and hospital employees

1. Subsection 4(1) as it applies to the possession of Psilocybin or MDMA, for the purpose of dispensing to a patient for emergency medical treatment or for the purpose of destroying Psilocybin or MDMA.
2. Subsections 5(1) and 5(2) as it applies to the administration or transport of Psilocybin or MDMA for emergency treatment of a patient and for the purpose of returning Psilocybin or MDMA to the licensed dealer for destruction.

Terms and Conditions

This exemption is applicable only if the following conditions are met:

Record Keeping

1. A practitioner who receives Psilocybin or MDMA authorized for sale under subsection C.08.010(1) of the FDR from a licensed dealer, must record the following information and keep such records for a period of 2 years from the date that each record is made:

1. the name and quantity, and if applicable, the brand name, form and strength of Psilocybin or MDMA requested in accordance with section C.08.010(1) of the FDR, and the date of the request,
2. the reference number and the issuing date of the letter of authorization for which the request was made,
3. the name and quantity, and if applicable, the brand name, form and strength of the Psilocybin or MDMA received, and the date of receipt,
4. the name and address of the licensed dealer that sold and provided the Psilocybin or MDMA,
5. if applicable, the name and address of the pharmacist to whom Psilocybin or MDMA is shipped as indicated in the letter of authorization,
6. the name and quantity, and if applicable, the brand name, form and strength of the Psilocybin or MDMA administered, sold or provided to the patient, and the date of administration, sale or provision, and
7. the name and quantity, and if applicable, the brand name, form and strength of the Psilocybin or MDMA returned to the licensed dealer who sold and provided it, and the date of the return.

2. A pharmacist who receives Psilocybin or MDMA authorized for sale under subsection C.08.010(1) of the FDR from a licensed dealer must record the following information and keep such records in the pharmacy for a period of two years from the date that each record is made:

1. the name and quantity, and if applicable, the brand name, form and strength of the Psilocybin or MDMA received, and the date of the receipt,
2. the name and address of the licensed dealer that sold and provided the Psilocybin or MDMA,
3. the name and address of the practitioner who is specified in the letter of authorization and from whom the pharmacist received a written order or prescription,
4. details of the written order or prescription including:
   1. the name and quantity, and if applicable, the brand name, form and strength of the Psilocybin or MDMA,
   2. the date of the order
5. the name and quantity, and if applicable, the brand name, form and strength of the Psilocybin or MDMA sold or provided in accordance with the written order or prescription, and the date of the sale or provision, and
6. the name and quantity, and if applicable, the brand name, form and strength of the Psilocybin or MDMA returned to the licensed dealer who sold and provided it and the date of the return.

3. The person in charge of a hospital, who receives Psilocybin or MDMA authorized for sale under subsection C.08.010(1) of the FDR from a licensed dealer must:

• (a) keep or cause to be kept in a book, register or other record maintained for such purposes:
  1. the name and quantity of any Psilocybin or MDMA received,
  2. the name and address of the licensed dealer from whom the Psilocybin or MDMA was received and the date received,
  3. the name and quantity of any Psilocybin or MDMA used in the making or assembling of a product or compound containing either Psilocybin or MDMA;
  4. the name and quantity of any product or compound that was made or assembled and that contains Psilocybin or MDMA and the date on which the product or compound was made or assembled,
  5. the name of the patient for whom Psilocybin or MDMA was dispensed,
  6. the name of the practitioner ordering or prescribing Psilocybin or MDMA and
  7. the date the Psilocybin or MDMA was ordered or prescribed and the form and quantity thereof;
• (b) maintain the recorded information in such form as to enable an audit to be made from time to time for a period of not less than two years from the making thereof;
• (c) furnish such information respecting the use of Psilocybin or MDMA therein, in such form and at such times as the Minister may require;
• (d) produce to an inspector any books, records or documents required by this exemption to be kept;
• (e) permit an inspector to make copies thereof or take extracts from such books, records and documents; and
• (f) permit an inspector to check all stocks of Psilocybin and MDMA in the hospital.

This exemption will remain in effect until the date on which this exemption has been replaced or the date on which the exemption is revoked.

This exemption may be suspended without prior notice if the Minister deems that such suspension is necessary to protect public health, safety or security. The Minister may suspend or revoke the exemption if he believes that it is no longer necessary.

Signed for and on the behalf of the Minister of Health,

Original signed by

Carol Anne Chénard, Acting Director General
Controlled Substances and Cannabis Branch
Health Canada

Effective Date: January 5, 2022