Mental Health Services Protection Regulation

(Consolidated up to 111/2026) alberta regulation 114/2021 Mental Health Services Protection Act MENTAL HEALTH SERVICES PROTECTION REGULATION Table of Contents 1 Definitions Part 1 Supervised Consumption Services 1.1 Definitions 2 Licence required 3 Exemption required 4 Refusal to issue or renew a licence 5 Requirement to be a custodian or an affiliate 6 Policy and procedure requirements 6.1 Service provider to meet requirements in Standards 6.2 Service provider to ensure all employees are qualified and trained 6.3 Facilities must be equipped and staffed 7 Critical incident reporting 8 Record creation, maintenance and retention 9 Reporting — general Part 2 Narcotic Transition Services 13 Definitions 14 Exemption from application of Act and Regulation 15 Licence required 16 Exemption from licence 17 Facilities must be equipped and staffed 18 Conditions for prescribing, compounding, dispensing, selling or administering designated narcotic drug 19 Responsibility of regulated member 20 Service provider to appoint medical director 21 Service agreement 22 Treatment plan 23 Service provider to ensure best efforts to transition patients 24 Opioid agonist treatment services for opioid use disorder 25 Service provider to provide narcotic transition services on out‑patient basis 26 No costs for services 27 Policy and procedure requirements 28 Service provider to meet requirements in Standards 29 Service provider to ensure all employees are qualified and trained 30 Record creation, maintenance and retention 31 Reporting — general 32 Critical incident reporting Part 3 Psychedelic Drug Treatment Services 33 Definitions 34 Licence required 35 Exemption from licence 36 Conditions for prescribing designated psychedelic drug 37 Conditions for administering, dispensing and sale of designated psychedelic drug 38 Qualifications for conducting psychotherapy 39 Exemption from sections 36, 37 and 38 40 Service provider to appoint medical director 41 Policy and procedure requirements 42 Service provider to meet requirements in Standards 43 Service provider to ensure all employees are qualified and trained 44 Record creation, maintenance and retention 45 Reporting — general 46 Critical incident reporting 47 Approved clinical research trial reporting Part 4 Residential Addiction Treatment Services 48 Definitions 49 Exemption from application of Act and Regulation 50 Complaints policy and procedure requirements 51 Service provider to meet requirements in Standards 52 Service provider to ensure all employees are qualified and trained 53 Additional critical incident notification 54 Additional record creation, maintenance and retention 55 Reporting — general Part 5 Transitional and Expiry 56 Transitional 57 Expiry Definitions 1 In this Regulation, (a) “accredited medical facility” means an accredited medical facility as defined in Schedule 21 to the Health Professions Act ; (a.1) “addiction medicine physician” means a regulated member of the College of Physicians and Surgeons of Alberta who has completed any of the following: (i) certification through the Canadian Society of Addiction Medicine; (ii) certification through the American Society of Addiction Medicine; (iii) certification through the International Society of Addiction Medicine; (iv) certification in addiction medicine through the American Board of Preventive Medicine; (v) certification in addiction medicine through the American Board of Psychiatry and Neurology; (vi) certification through the American Board of Addiction Medicine; (vii) a Certificate of Added Competency in Addiction Medicine through The College of Family Physicians of Canada; (viii) an Area of Focussed Competence (Diploma) program in addiction medicine accredited by the Royal College of Physicians and Surgeons of Canada; (a.2) “administration of a drug” means the supplying of a dose of a drug to a person for the purpose of immediate ingestion, application, inhalation, insertion, instillation or injection; (b) “affiliate” means an affiliate as defined in the Health Information Act ; (c) “approved clinical research trial” means a clinical research trial approved by a research ethics board; (c.1) “approved hospital” means an approved hospital under the Provincial Health Agencies Act ; (c.2) “authorized” means authorized under the Health Professions Act ; (c.3) “clinical research trial” means a study, involving human subjects, for the purpose of discovering or verifying the effects of a drug or of any other intervention; (c.4) “compound” means to mix together 2 or more ingredients of which at least one is a drug for the purposes of dispensing a drug or drugs, but does not include reconstituting a drug or drugs with a diluent like water; (d) “critical incident” means (i) an incident that causes serious injury or death to a client of a service provider, the service provider, an employee or any other individual in relation to the provision of services, or (ii) an incident that threatens to cause serious injury or death to a client of a service provider, the service provider, an employee or any other individual in relation to the provision of services; (e) “custodian” means a custodian as defined in the Health Information Act ; (f) “Department” means the Department administered by the Minister; (f.1) “dispense” means to provide a drug to or for a person pursuant to a prescription, but does not include the administration of a drug to a person; (g) “drug” means (i) a substance or combination of substances referred to in section 31, 32 or 33 of the Pharmacy and Drug Act , (ii) any substance or combination of substances manufactured, sold or represented for use in (A) the treatment of a disease, disorder or abnormal physical state, or its symptoms, or (B) restoring, correcting or modifying organic functions in human beings, (iii) a special access drug, or (iv) any combination of a substance or substances referred to in subclause (i), (ii) or (iii) with any other substance; (g.1) “incident” means an untoward or undesirable event that causes harm or risk of harm to a patient, client, employee or any other individual in the facility or other location where services are provided; (h) “opioid agonist treatment services” means services that use opioid agonist drugs to treat opioid use disorder; (h.1) “pharmacist” means an individual who is registered as a regulated member of the Alberta College of Pharmacy under the Health Professions Act on the clinical pharmacist register, the provisional pharmacist register, the courtesy pharmacist register or the student pharmacist register and who holds a practice permit issued under that Act; (h.2) “prescribe”, with respect to a drug, means to direct that a drug be administered or dispensed to or for a patient by an authorized person in respect of a prescription; (h.3) “prescription” means a direction by a person who is authorized by an Act of the Legislature of Alberta or an Act of the Parliament of Canada to prescribe drugs, directing that a drug be dispensed to or for the patient named in the direction; (h.31) “provincial health agency” means a provincial health agency under the Provincial Health Agencies Act ; (h.32) “provincial health corporation” means a provincial health corporation under the Provincial Health Agencies Act ; (h.4) “psychiatric disorder” means a disorder as defined in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders , published by the American Psychiatric Association; (h.5) “psychiatrist” means a regulated member of the College of Physicians and Surgeons of Alberta who is authorized to use the title “psychiatrist”; (h.6) “psychotherapy” means the treatment of a psychiatric disorder by psychological means; (i) repealed AR 202/2022 s2; (j) “regional health authority” means a regional health authority under the Provincial Health Agencies Act ; (j.1) “research ethics board” means a research ethics board designated under the Designation Regulation (AR 69/2001); (j.2) “sell” means sell as defined in the Pharmacy and Drug Act ; (k) “serious injury” means a life‑threatening injury or an injury that has caused, is causing or may cause significant impairment to an individual’s health or could result in permanent disability. (l) repealed AR 202/2022 s2. AR 114/2021 s1;202/2022;125/2024;199/2025 Part 1 Supervised Consumption Services Definitions 1.1 In this Part, (a) “consumption station” means a room or booth designated by a service provider who offers or provides supervised consumption services for the consumption of drugs by individuals; (b) “Standards” means the Recovery‑oriented Supervised Consumption Services Standards , approved by the Minister and published by the Department, as amended from time to time; (c) “supervised consumption services” means services provided to individuals in which the consumption of drugs that have previously been obtained by those individuals is supervised, in person, by the service provider or an employee of the service provider and emergency care is available and provided in response to an adverse reaction to a drug, but does not include opioid agonist treatment services. AR 202/2022 s3 Licence required 2 A service provider who offers or provides supervised consumption services is prescribed as a service provider requiring a licence. Exemption required 3 A licence for the provision of supervised consumption services must include the requirement that the service provider who offers or provides supervised consumption services be, in respect of a specific location or facility, either (a) exempt under subsection 56(1) or 56.1(1) of the Controlled Drugs and Substances Act (Canada), or (b) authorized by the Province under an exemption granted to the Province under subsection 56(1) of the Controlled Drugs and Substances Act (Canada). Refusal to issue or renew a licence 4 A director shall consider the following criteria when issuing or refusing to issue, amend or renew a licence for the provision of supervised consumption services: (a) community support for the services; (b) coordination of the work of the following in the provision of health services in order to achieve the best health outcome and to avoid duplication of effort and expense: (i) a provincial health agency; (i.1) a regional health authority; (i.2) a provincial health corporation; (ii) the Government of Alberta; (iii) public and private institutions. AR 114/2021 s4;202/2022;125/2024;199/2025 Requirement to be a custodian or an affiliate 5 (1) A service provider shall not offer or provide supervised consumption services unless that service provider is (a) a custodian, or (b) an affiliate of a custodian for the purpose of providing supervised consumption services, as approved by a director. (2) A director may, on a temporary basis, exempt a service provider from the requirements of this section. Policy and procedure requirements 6 (1) A service provider who offers or provides supervised consumption services shall ensure that (a) written policies and procedures are established, implemented and periodically reviewed in accordance with the Standards, and (b) a written complaints policy and procedure is established, implemented and periodically reviewed in accordance with the Standards that (i) allows a client to file a complaint with the service provider in respect of the service provider, any employee of the service provider or the services provided, and (ii) sets out any follow up that can be expected by a client of the service provider. (2) A director may, on a temporary basis, exempt a service provider who offers or provides supervised consumption services from the requirements of this section. AR 114/2021 s6;202/2022 Service provider to meet requirements in Standards 6.1 A service provider licensed under this Part must (a) meet the requirements set out in the Standards, (b) provide other services, if any, as required by the Standards, and (c) comply with any prohibitions set out in the Standards. AR 202/2022 s5 Service provider to ensure all employees are qualified and trained 6.2 (1) A service provider licensed under this Part shall ensure that all of its employees (a) are qualified to provide supervised consumption services, (b) are adequately trained in all matters necessary to provide supervised consumption services according to this Part and the policies and procedures established under section 6, and (c) meet other qualifications and training requirements, if any, set out in the Standards. (2) A service provider who offers or provides supervised consumption services shall require a criminal record check and a vulnerable sector check for each employee if required in the Standards and based on the criteria, if any, set out in the Standards. AR 202/2022 s5 Facilities must be equipped and staffed 6.3 Facilities where supervised consumption services are provided must be equipped and staffed to immediately recognize serious adverse reactions, including potentially fatal respiratory depression and seizures, and to initiate immediate treatment and resuscitation measures if needed. AR 202/2022 s5 Critical incident reporting 7 (1) Subject to subsection (2), a service provider who offers or provides supervised consumption services shall (a) notify a director of a critical incident as soon as possible and no later than 12 hours after the service provider becomes aware of the critical incident, (b) report the critical incident to a director no later than 48 hours after the service provider becomes aware of the critical incident, and (c) provide a 2nd report to a director no later than 2 weeks after the service provider becomes aware of the critical incident in the form and manner determined by the director. (2) A service provider has no duty to notify or report a critical incident to a director if the critical incident relates only to a serious injury that is usual or expected. (3) A notification of a critical incident under subsection (1)(a) must include the date, time, place and nature of the critical incident, as available, and any immediate steps taken by the service provider in response. (4) A first report of a critical incident under subsection (1)(b) must include all of the following information, as available: (a) the date, time, place and nature of the critical incident; (b) the name and age of the client affected, if applicable and known; (c) the name of any witnesses to the critical incident, if applicable and known; (d) the action taken or planned. (5) A 2nd report of a critical incident under subsection (1)(c) must include all of the following information, as available: (a) an analysis of the circumstances leading to the incident; (b) the action taken or planned, including any action taken or planned to mitigate risk with an aim to prevent similar critical incidents in the future; (c) proposed timelines for any action planned in follow up to the critical incident, including any plan to mitigate risk referred to in clause (b). (6) A service provider who offers or provides supervised consumption services shall, as soon as possible after the service provider becomes aware of the critical incident, make all reasonable efforts to notify any critical incident contacts provided by the client and any substitute decision makers who need to know of the critical incident in order to fulfill their duties under their legal authorization. (7) On request by a director, a service provider who offers or provides supervised consumption services shall, within the time period specified by the director, ensure that a report is submitted respecting any other matters specified by the director. AR 114/2021 s7;202/2022 Record creation, maintenance and retention 8 (1) A service provider who offers or provides supervised consumption services shall create and maintain records containing the following: (a) in respect of each client, (i) the name of the client’s critical incident contacts and substitute decision makers, if any, (ii) a unique identifier for the client in the form, if any, set out in the Standards, and (iii) copies of all critical incident reports relating to the client; (b) in respect of each employee engaged in providing supervised consumption services, (i) copies of any criminal record check and any vulnerable sector check of the employee as required in the Standards, and (ii) documentation of the employee’s position title and description and the qualifications and training of the employee for the employee’s position; (c) in respect of each facility or other location at which supervised consumption services are provided, the following information and documents: (i) name, address, phone number and e‑mail address of the facility or other location; (ii) date on which supervised consumption services began to be delivered at the facility or other location; (iii) number of employees at the facility or other location who provide services directly to clients; (iv) staffing ratios, including the number and type of employees per shift; (v) floor plans for the facility or other location, including a demarcation of each consumption station; (vi) hours and days of operation; (vii) other permits issued in respect of the facility or other location that are required to operate the facility or other location, including, without limitation, municipal permits and zoning approval; (c.1) copies of all complaints received in respect of the service provider, any employee of the service provider or the services provided; (d) copies of all critical incident reports; (d.1) copies of all incident reports; (e) a copy of all policies and procedures referred to in section 6; (f) the following information and documents relating to the service provider: (i) a copy of the business licence and business permits issued in respect of the service provider; (ii) a copy of the articles of incorporation or association, if applicable, of the service provider; (iii) proof of insurance, including property and liability insurance; (iv) a declaration signed by or on behalf of the service provider setting out all criminal charges, convictions or investigations concerning the service provider, as required by a director; (v) a declaration signed by or on behalf of the service provider setting out all civil lawsuits concerning the service provider, as required by a director. (2) The records referred to in subsection (1)(a) must be kept by the service provider providing the supervised consumption services for at least 5 years after the date of the last entry in the records respecting the client. (3) A director may, on a temporary basis, exempt a service provider who offers or provides supervised consumption services from the requirements of this section. AR 114/2021 s8;202/2022 Reporting — general 9 (1) A service provider who offers or provides supervised consumption services shall (a) on a periodic basis as required in the Standards report information about service utilization as described in the Standards to a director, (b) submit to a director on a periodic basis as required in the Standards a report respecting complaints received from clients, or persons acting on behalf of clients, including information as required in the Standards, and (c) report any other information as required in the Standards in the form and manner determined by the director. AR 114/2021 s9;202/2022 (2) Information referred to in subsection (1) may include personal information and individually identifying health information. 10 to 12 Repealed AR 202/2022 s9. Part 2 Narcotic Transition Services Definitions 13 In this Part, (a) “designated narcotic drug” means any full agonist opioid drug with the exception of methadone or slow release oral morphine; (b) “medical director” means a medical director appointed under section 20; (c) “narcotic transition services” means services to treat opioid use disorder and includes the use of one or more designated narcotic drugs, but does not include the use of designated narcotic drugs if medically indicated for the purpose of stabilizing a patient suffering from opioid withdrawal during the patient’s admission to a health services sector in a health services sector in an approved hospital for other indications; (d) “Standards” means the Community Protection and Opioid Stewardship Standards , approved by the Minister and published by the Department, as amended from time to time. AR 202/2022 s10;199/2025 Exemption from application of Act and Regulation 14 A person, including a service provider or regulated member, who prescribes, administers, compounds, dispenses or sells a designated narcotic drug for the purpose of treating a medical condition other than opioid use disorder is exempt from the application of the Act and this Regulation. AR 202/2022 s10 Licence required 15 (1) Subject to subsection (2) and section 16, a service provider who offers or provides narcotic transition services is prescribed as a service provider requiring a licence. (2) Only a provincial health agency, regional health authority or provincial health corporation is eligible to apply for a licence to offer or provide narcotic transition services. AR 202/2022 s10;125/2024;199/2025 Exemption from licence 16 (1) A service provider or regulated member who offers or provides narcotic transition services is exempt from the requirement to obtain a licence under section 15 if (a) narcotic transition services are provided for (i) an in‑patient of a health services sector in a health services sector in an approved hospital, (ii) a patient who is admitted to the emergency department of an approved hospital, or (iii) an individual who is lawfully detained at a designated facility under the Mental Health Act , (A) as a formal patient as defined in the Mental Health Act , (B) subject to one admission certificate under section 4 of the Mental Health Act , or (C) subject to a community treatment order and apprehended for non‑compliance under section 9.6 of the Mental Health Act , (b) the patient to whom narcotic transition services are provided is a patient of a service provider licensed under this Part and has been receiving a designated narcotic drug as part of the service provider’s treatment plan for that patient, (c) narcotic transition services are provided only after consultation, or making best efforts to consult and completing consultation as soon as possible after the services are provided, with the regulated member who is responsible for the narcotic transition services of the patient through the service provider licensed under this Part, (d) narcotic transition services are provided for the purpose of maintaining the patient on the designated narcotic drug where, in the opinion of the authorized regulated member at the approved hospital or designated facility, maintaining the patient is in the best interests of the patient, (e) a transitional care treatment plan is developed by the hospital operator or operator of the designated facility for discharge to support the patient’s resumption of narcotic transition services with a service provider licensed under this Part, and (f) the hospital operator, operator of the designated facility and the employees of the hospital operator or operator of the designated facility, as the case may be, comply with sections 17, 18 and 19, as applicable. (2) A service provider, or an authorized regulated member who is an employee of the service provider, who compounds, dispenses or sells a designated narcotic drug is exempt from the requirement to obtain a licence under section 15 if the drug is compounded, dispensed or sold (a) pursuant to a prescription prescribed by an authorized regulated member who is an employee of a service provider licensed under this Part, and (b) in compliance with sections 18 and 19, and the service provider, or the authorized regulated member who is an employee of the service provider, provides no other aspect of narcotic transition services. AR 202/2022 s10;199/2025 Facilities must be equipped and staffed 17 Facilities where narcotic transition services are provided must be equipped and staffed to immediately recognize serious adverse reactions, including potentially fatal respiratory depression and seizures, and to initiate immediate treatment and resuscitation measures if needed. AR 202/2022 s10 Conditions for prescribing, compounding, dispensing, selling or administering designated narcotic drug 18 No person shall (a) prescribe, compound, dispense or sell a designated narcotic drug unless the person is an authorized regulated member, (b) dispense a designated narcotic drug (i) if the prescription does not include the medical indication for which the drug is being prescribed, (ii) directly to a patient, or (iii) for a purpose other than administration of the drug by or under the in‑person supervision of an authorized regulated member, or (c) administer a designated narcotic drug unless (i) the person is an authorized regulated member, or is a patient administering the drug under the in‑person supervision of an authorized regulated member, (ii) the drug is administered at (A) a facility or other location at which the narcotic transition services are provided and that is included in the licence of a service provider licensed under this Part, or (B) a health services sector in an approved hospital or a facility designated under the Mental Health Act and in accordance with section 16, and (iii) the drug is administered in accordance with the requirements set out in the Standards. AR 202/2022 s10;199/2025 Responsibility of regulated member 19 An authorized regulated member may only prescribe, administer, compound, dispense or sell a designated narcotic drug (a) for the purpose of treating severe opioid use disorder, and (b) in compliance with the requirements under (i) the Act, (ii) this Regulation, and (iii) the Standards, if any. AR 202/2022 s10 Service provider to appoint medical director 20 (1) A service provider licensed under this Part shall appoint a medical director to oversee all clinically related aspects of the narcotic transition services. (2) The medical director must be an addiction medicine physician authorized to provide narcotic transition services. (3) The medical director must meet other requirements, if any, set out in the Standards. AR 202/2022 s10 Service agreement 21 (1) A service provider licensed under this Part shall ensure that a service agreement is in place for each patient prior to the patient receiving narcotic transition services from the service provider. (2) Before entering into a service agreement under subsection (1), the service provider shall obtain the consent of the patient or the patient’s substitute decision maker in accordance with the requirements set out in the Standards. (3) A service agreement under this section must comply with the requirements set out in the Standards. AR 202/2022 s10 Treatment plan 22 (1) A service provider licensed under this Part shall ensure that a treatment plan is in place for each patient prior to the patient receiving narcotic transition services from the service provider. (2) A treatment plan referred to in subsection (1) must be developed in conjunction with and approved by an addiction medicine physician and in accordance with the requirements set out in the Standards. (3) The medical director shall ensure that an addiction medicine physician reviews the treatment plan of each patient developed under subsection (2) in a manner and time as specified in the Standards. (4) The service provider shall provide each patient with a copy of that patient’s treatment plan after the patient’s treatment plan is approved under subsection (2). AR 202/2022 s10 Service provider to ensure best efforts to transition patients 23 (1) Subject to subsections (2) and (3), a service provider who offers or provides narcotic transition services shall ensure that best efforts are made to transition patients from designated narcotic drugs to opioid agonist treatment services that use opioid agonist drugs other than designated narcotic drugs. (2) Best efforts to transition a patient must be made in accordance with the requirements set out in the Standards. (3) The duty to make best efforts referred to in subsection (1) does not apply if (a) an examination and assessment of the patient is made by an addiction medicine physician, in person or through videoconference, and the physician is of the opinion that the patient is and likely will be unable to transition at any point in the future, and (b) a 2nd addiction medicine physician is of the opinion that the patient is and likely will be unable to transition at any point in the future, unless, at any point after the opinions in clauses (a) and (b) are determined, the patient’s condition or circumstances change and a transition becomes a reasonable possibility. AR 202/2022 s10 Opioid agonist treatment services for opioid use disorder 24 A service provider licensed under this Part shall offer and provide opioid agonist treatment services that use opioid agonist drugs other than designated narcotic drugs to individuals with opioid use disorder at each facility or other location at which narcotic transition services are provided in accordance with the requirements set out in the Standards. AR 202/2022 s10 Service provider to provide narcotic transition services on out‑patient basis 25 A service provider licensed under this Part shall offer and provide narcotic transition services at each facility or other location at which narcotic transition services are provided on an out‑patient basis. AR 202/2022 s10 No costs for services 26 (1) Subject to the Standards, a service provider who offers or provides narcotic transition services shall not charge any fee directly to a patient for the services under this Part. (2) Subject to the Standards, a patient shall not be liable for any costs, charges or expenses with respect to the narcotic transition services provided by a service provider licensed under this Part. AR 202/2022 s10 Policy and procedure requirements 27 A service provider licensed under this Part shall ensure that (a) written policies and procedures are established, implemented and periodically reviewed in accordance with the Standards, and (b) a written complaints policy and procedure is established, implemented and periodically reviewed in accordance with the Standards that (i) allows a patient to file a complaint with the service provider in respect of the service provider, any employee of the service provider or the services provided, and (ii) sets out any follow‑up that can be expected by a patient of the service provider. AR 202/2022 s10 Service provider to meet requirements in Standards 28 A service provider licensed under this Part must (a) meet the requirements set out in the Standards, (b) provide other services, if any, as required by the Standards, and (c) comply with any prohibitions set out in the Standards. AR 202/2022 s10 Service provider to ensure all employees are qualified and trained 29 (1) A service provider licensed under this Part shall ensure that all of its employees (a) are qualified to provide the narcotic transition services, (b) are adequately trained in all matters necessary to provide the narcotic transition services according to this Part and the policies and procedures established under section 27, and (c) meet other qualifications and training requirements, if any, set out in the Standards. (2) A service provider who offers or provides narcotic transition services shall require a criminal record check and a vulnerable sector check for each employee if required in the Standards and based on the criteria, if any, set out in the Standards. AR 202/2022 s10 Record creation, maintenance and retention 30 A service provider licensed under this Part shall create and maintain records containing the following: (a) in respect of each patient, (i) the name and contact information of the patient’s critical incident contacts and substitute decision makers, if any, (ii) copies of all applicable legal authorizations respecting substitute decision makers, as available, (iii) a copy of the executed service agreement between the service provider and the patient or the patient’s substitute decision maker with authority to execute such agreement if applicable, and (iv) a copy of the treatment plan and any subsequent amendments to the treatment plan as approved by an addiction medicine physician; (b) in respect of each employee engaged in providing narcotic transition services, (i) copies of any criminal record check and any vulnerable sector check of the employee as required in the Standards, and (ii) documentation of the employee’s position title and job description and the qualifications and training of the employee for the employee’s position; (c) in respect of each facility or other location at which the narcotic transition services are provided, (i) the name, physical address, phone number and email address of the facility or other location, (ii) the date on which the narcotic transition services began to be delivered at the facility or other location, (iii) the number of employees at the facility or other location who provide the services directly to patients, (iv) staffing ratios, including the number and type of employees per shift at the facility or other location, (v) floor plans for the facility or other location, (vi) the hours and days of operation of the facility or other location, and (vii) permits issued in respect of the facility or other location that are required to operate the facility or other location, including, without limitation, municipal permits and zoning approvals as applicable; (d) copies of all complaints received in respect of the service provider, any employee of the service provider or the services provided; (e) copies of all critical incident reports; (f) copies of all incident reports; (g) copies of all policies and procedures established under section 27; (h) in respect of each service provider, (i) a copy of the business licence and business permits issued in respect of the service provider, (ii) a copy of the articles of incorporation or association, if applicable, of the service provider, (iii) proof of insurance, including property and liability insurance, issued in respect of the service provider, (iv) a declaration signed by or on behalf of the service provider setting out all criminal charges, convictions or investigations concerning the service provider, as required by a director, and (v) a declaration signed by or on behalf of the service provider setting out all civil lawsuits concerning the service provider, as required by a director. AR 202/2022 s10 Reporting — general 31 (1) A service provider licensed under this Part shall (a) on a periodic basis as required in the Standards, report information about service utilization as described in the Standards to a director, (b) submit to a director on a periodic basis as required in the Standards a report respecting complaints received from patients, or persons acting on behalf of patients, including information as required in the Standards, and (c) report any other information as required in the Standards in the form and manner determined by the director. (2) Information referred to in subsection (1) may include personal information and individually identifying health information. AR 202/2022 s10 Critical incident reporting 32 (1) A service provider licensed under this Part shall (a) notify a director of a critical incident as soon as possible and no later than 24 hours after the service provider becomes aware of the critical incident, (b) report the critical incident to a director no later than 48 hours after the service provider becomes aware of the critical incident, and (c) provide a 2nd report to a director no later than 2 weeks after the service provider becomes aware of the critical incident in the form and manner determined by the director. (2) A notification of a critical incident under subsection (1)(a) must include the date, time, place and nature of the critical incident, as available, and any immediate steps taken by the service provider in response. (3) A first report of a critical incident under subsection (1)(b) must include all of the following information, as available: (a) the date, time, place and nature of the critical incident; (b) the name and age of the patient affected, if applicable and known; (c) the name of any witnesses to the critical incident, if applicable and known; (d) the action taken or planned. (4) A 2nd report of a critical incident under subsection (1)(c) must include all of the following information, as available: (a) an analysis of the circumstances leading to the incident; (b) the action taken or planned, including any action taken or planned to mitigate risk with an aim to prevent similar critical incidents in the future; (c) proposed timelines for any action planned in follow‑up to the critical incident, including any plan to mitigate risk referred to in clause (b). (5) A service provider licensed under this Part shall, as soon as possible after the service provider becomes aware of the critical incident, make all reasonable efforts to notify any critical incident contacts provided by the patient and any substitute decision makers who need to know of the critical incident in order to fulfill their duties under their legal authorization. (6) On request by a director, within the time period specified by the director, a service provider licensed under this Part shall ensure that a report is submitted respecting any other matters specified by the director. AR 202/2022 s10 Part 3 Psychedelic Drug Treatment Services Definitions 33 In this Part, (a) “designated psychedelic drug” means a substance or combination of substances that is or contains any one of the following, whether synthesized or naturally occurring, and includes racemic mixtures, enantiomers and any mixtures of enantiomers, or any compound that, through metabolism in the recipient, yields metabolites that are drugs with equivalent functional effects, where applicable: (i) 3,4‑methylenedioxymethamphetamine (MDMA) and any salt thereof; (ii) Ketamine (2‑(2‑chlorophenyl)‑2‑(methylamino) cyclohexanone), including in racemic or specific enantiomer form (which includes R,S‑ketamine, S‑ketamine [Esketamine] and R‑ketamine [Arketamine]) and any salt thereof; (iii) Lysergic acid diethylamide (LSD) (N,N‑diethyllysergamide) and any salt thereof; (iv) Mescaline (3,4,5‑trimethoxybenzeneethanamine) and any salt thereof; (v) N,N‑Dimethyltryptamine (DMT) (3‑[(2 dimethylamino) ethyl]indole) and any salt thereof; (vi) 5 methoxy DMT and any salt thereof; (vii) Psilocin (3–[2–(dimethylamino)ethyl]–4–hydroxyindole) and any salt thereof; (viii) Psilocybin (3‑[2‑(dimethylamino)ethyl]–4–phosphoryloxyindole) and any salt thereof; (b) “medical director” means a medical director appointed under section 40; (c) “non‑parenteral formulation”, for the purpose of providing psychedelic drug treatment services, means a formulation of a drug to be administered orally, sublingually or intranasally; (d) “non‑psychedelic dose” means a dose of a designated psychedelic drug that is not likely to result in an altered state of consciousness of the patient for whom it is prescribed based on (i) the prescriber’s assessment of the patient, (ii) the information available, if any, in relation to the dose of a particular designated psychedelic drug, and (iii) other criteria set out in the Standards, if any; (e) “parenteral formulation”, for the purpose of providing psychedelic drug treatment services, means a formulation of a drug to be administered by any route of administration other than in a non‑parenteral formulation; (f) “psychedelic assisted psychotherapy” means services to treat a psychiatric disorder with psychotherapy and one or more designated psychedelic drugs, whether or not the administration of the drug and the psychotherapy are provided on the same day or on different days; (g) “psychedelic dose” means a dose of a designated psychedelic drug that is likely to result in an altered state of consciousness of the patient for whom it is prescribed based on (i) the prescriber’s assessment of the patient, (ii) the information available, if any, in relation to the dose of a particular designated psychedelic drug, and (iii) other criteria as set out in the Standards, if any; (h) “psychedelic drug treatment services” means services to treat a psychiatric disorder and includes the use of one or more designated psychedelic drugs; (i) “Standards” means the Psychedelic Drug Treatment Services Standards , approved by the Minister and published by the Department, as amended from time to time. AR 202/2022 s10 Licence required 34 Subject to section 35, a service provider who offers or provides psychedelic drug treatment services is prescribed as a service provider requiring a licence. AR 202/2022 s10 Exemption from licence 35 A service provider is exempt from the requirement to obtain a licence under section 34 if (a) the service provider (i) offers or provides psychedelic drug treatment services in the context of an approved clinical research trial (A) in accordance with the conditions imposed by the relevant research ethics board, and (B) without imposing any costs, charges or expenses on any patient participant in the clinical research trial, or (ii) uses ketamine for a purpose other than providing psychedelic assisted psychotherapy, or (b) the service provider or an authorized regulated member who is an employee of the service provider compounds, dispenses or sells a designated psychedelic drug (i) pursuant to a prescription prescribed by an authorized regulated member who is an employee of a service provider licensed under this Part, and (ii) in compliance with section 37, and provides no other aspect of psychedelic drug treatment services. AR 202/2022 s10 Conditions for prescribing designated psychedelic drug 36 (1) Subject to subsections (2) and (3), no person shall prescribe a designated psychedelic drug to treat a psychiatric disorder unless the person is a psychiatrist and trained as required in the Standards. (2) A physician who is not a psychiatrist may prescribe a designated psychedelic drug if (a) the prescription, or any change to the prescription, is made after and with ongoing consultation with a psychiatrist, (b) the physician is authorized to provide psychedelic drug treatment services and has the qualifications, training and experience as required in the Standards, and (c) consultation with a psychiatrist is conducted as required in the Standards. (3) An authorized regulated member who is not a psychiatrist or not trained as required under subsection (1) may prescribe ketamine if the drug is not prescribed as part of psychedelic assisted psychotherapy. (4) An authorized regulated member prescribing a designated psychedelic drug in a non‑psychedelic dose outside the context of psychedelic assisted psychotherapy shall include in the prescription (a) a direction respecting the quantity of the drug that may be dispensed or sold at any one time, and (b) a direction respecting the intervals of time required between each dispensation or sale after taking into consideration the potential for use of the drug in a manner not contemplated as part of the prescriber’s treatment plan. (5) An authorized regulated member prescribing a designated psychedelic drug shall include in the prescription (a) for a drug other than ketamine, whether the dose prescribed is a psychedelic dose or a non-psychedelic dose, and (b) whether the drug is being prescribed for use in the context of psychedelic assisted psychotherapy in a manner that makes clear to the authorized regulated member, or the person who is otherwise permitted by law dispensing or selling the drug under section 37(3), whether the drug may or may not be directly dispensed or sold to a patient. AR 202/2022 s10 Conditions for administering, dispensing and sale of designated psychedelic drug 37 (1) Subject to subsections (2), (3), (4), (5) and (6), no person shall (a) administer a designated psychedelic drug unless (i) the person is an authorized regulated member, or (ii) the administration of the designated psychedelic drug is directly supervised by an authorized regulated member, or (b) dispense or sell a designated psychedelic drug directly to a patient. (2) A designated psychedelic drug prescribed for a patient may be self‑administered by the patient without direct supervision by an authorized regulated member if (a) the prescribed drug (i) is a drug other than ketamine and is prescribed in a non‑psychedelic dose, or (ii) is ketamine prescribed in a non‑parenteral formulation, and (b) the drug is prescribed outside the context of psychedelic assisted psychotherapy. (3) An authorized regulated member, or a person who is otherwise permitted by law to dispense or sell any designated drug to a pharmacist or physician and to sell the drug directly to a patient, may dispense or sell a designated psychedelic drug directly to a patient only if (a) the drug (i) is a drug other than ketamine and is dispensed or sold pursuant to a prescription and in a dosage that, if taken in accordance with the prescription, is a non‑psychedelic dose, or (ii) is ketamine in a non‑parenteral formulation, (b) the dispensing or sale is not related to psychedelic assisted psychotherapy, and (c) the quantity of the drug dispensed or sold to the patient is not greater than the quantity directed to be dispensed or sold at any one time by the authorized regulated member prescribing the drug. (4) A patient who is administered (a) a designated psychedelic drug, other than ketamine, in a psychedelic dose, (b) ketamine in a parenteral formulation, or (c) a designated psychedelic drug in the context of psychedelic assisted psychotherapy, must be administered the drug at a health services sector in an approved hospital, an accredited medical facility accredited for administering the drug or the facility of a service provider licensed under this Part unless, in the opinion of the authorized regulated member prescribing the drug, the patient is at or near the end of life and the drug is administered as approved by the authorized regulated member prescribing the drug and as required in the Standards. (5) A patient who is administered (a) a designated psychedelic drug, other than ketamine, in a psychedelic dose, (b) ketamine in a parenteral formulation, or (c) a designated psychedelic drug in the context of psychedelic assisted psychotherapy, must be monitored, treated and cared for while the patient is in an altered state of consciousness and for any additional time if directed by the authorized regulated member prescribing the drug. (6) The monitoring, treatment and care required under subsection (5) must be provided as follows: (a) if by a service provider licensed under this Part, (i) in a manner as required in the Standards, and (ii) by an authorized regulated member, or another individual approved by the medical director, and supervised as required in the Standards; (b) if in the health services sector in the approved hospital or accredited medical facility, in accordance with the requirements of the approved hospital or accredited medical facility, as the case may be. AR 202/2022 s10;199/2025 Qualifications for conducting psychotherapy 38 A person providing psychotherapy to a patient as part of psychedelic assisted psychotherapy must (a) be authorized to perform the restricted activity of psychosocial intervention under section 2(1)(p) of Schedule 7.1 to the Government Organization Act and be a regulated member of one of the following colleges under the Health Professions Act : (i) Alberta College of Occupational Therapists; (ii) College of Physicians and Surgeons of Alberta; (iii) College of Alberta Psychologists;

(iv) College and Association of Registered Nurses of Alberta; (v) College of Registered Psychiatric Nurses of Alberta; (vi) Alberta College of Social Workers, (b) if not a psychiatrist or clinical psychologist, (i) have a clinically related master’s or doctoral degree, or (ii) have, in the assessment of the medical director, a minimum of 5 years’ experience in treating post‑traumatic stress disorder, mood disorders or related disorders with evidence‑based psychotherapy, and (c) have the training and experience respecting psychedelic assisted psychotherapy or psychological counselling required by the medical director and as set out in the Standards, if any. AR 202/2022 s10 Exemption from sections 36, 37 and 38 39 A service provider who is exempt under section 35(a)(i) from the requirement to obtain a licence under section 34 is also exempt from the application of sections 36, 37 and 38. AR 202/2022 s10 Service provider to appoint medical director 40 (1) A service provider licensed under this Part shall appoint a medical director to oversee all clinically related aspects of the psychedelic drug treatment services. (2) A medical director must be a psychiatrist authorized to provide psychedelic drug treatment services and must have the qualifications, training and experience as required in the Standards. (3) The medical director shall ensure that (a) an authorized regulated member conducting psychotherapy has the qualifications, training and experience required under sections 38 and 43(1), and meets the requirements set out in the Standards, if any, and (b) the authorized regulated member or other individual approved by the medical director providing in‑person monitoring, treatment and care under section 37(6)(a) has the qualifications, training and experience as required under the Act, this Regulation and the Standards, as applicable. (4) A medical director must meet other requirements, if any, set out in the Standards. AR 202/2022 s10 Policy and procedure requirements 41 A service provider licensed under this Part shall ensure that (a) written policies and procedures are established, implemented and periodically reviewed in accordance with the Standards, and (b) a written complaints policy and procedure is established, implemented and periodically reviewed in accordance with the Standards that (i) allows a patient to file a complaint with the service provider in respect of the service provider, any employee of the service provider or the services provided, and (ii) sets out any follow‑up that can be expected by a patient of the service provider. AR 202/2022 s10 Service provider to meet requirements in Standards 42 A service provider licensed under this Part must (a) meet the requirements set out in the Standards, (b) provide other services, if any, as required by the Standards, and (c) comply with any prohibitions set out in the Standards. AR 202/2022 s10 Service provider to ensure all employees are qualified and trained 43 (1) A service provider licensed under this Part shall ensure that all of its employees (a) are qualified to provide psychedelic drug treatment services, (b) are adequately trained in all matters necessary to provide psychedelic drug treatment services according to this Part and the policies and procedures established under section 41, and (c) meet other qualifications and training requirements, if any, set out in the Standards. (2) A service provider who offers or provides psychedelic drug treatment services shall require a criminal record check and a vulnerable sector check for each employee if required in the Standards and based on the criteria, if any, set out in the Standards. AR 202/2022 s10 Record creation, maintenance and retention 44 A service provider licensed under this Part shall create and maintain records containing the following: (a) in respect of each patient, (i) the name and contact information of the patient’s critical incident contacts and substitute decision makers, if any, and (ii) copies of all applicable legal authorizations respecting substitute decision makers, as available; (b) in respect of each employee engaged in providing psychedelic drug treatment services, (i) copies of any required criminal record check and vulnerable sector check of the employee, and (ii) documentation of the employee’s position title and job description and the qualifications and training of the employee for the employee’s position; (c) in respect of each facility or other location at which the psychedelic drug treatment services are provided, (i) the name, physical address, phone number and email address of the facility or other location, (ii) the date on which the services began to be delivered at the facility or other location, (iii) the number of employees at the facility or other location who provide the services directly to patients, (iv) staffing ratios, including the number and type of employees per shift at the facility or other location, (v) floor plans for the facility or other location, (vi) the hours and days of operation of the facility or other location, and (vii) permits issued in respect of the facility or other location that are required to operate the facility or other location, including, without limitation, municipal permits and zoning approvals as applicable; (d) copies of all complaints received in respect of the service provider, any employee of the service provider or the services provided; (e) copies of all critical incident reports; (f) copies of all incident reports; (g) copies of all policies and procedures established under section 41; (h) in respect of each service provider, (i) a copy of the business licence and business permits issued in respect of the service provider, (ii) a copy of the articles of incorporation or association, if applicable, of the service provider, (iii) proof of insurance, including property and liability insurance, in respect of the service provider, (iv) a declaration signed by or on behalf of the service provider setting out all criminal charges, convictions or investigations concerning the service provider, as required by a director, and (v) a declaration signed by or on behalf of the service provider setting out all civil lawsuits concerning the service provider, as required by a director. AR 202/2022 s10 Reporting — general 45 (1) A service provider licensed under this Part shall (a) on a periodic basis, as required in the Standards, report information about service utilization as described in the Standards to a director, (b) submit to a director on a periodic basis as required in the Standards a report respecting complaints received from patients, or persons acting on behalf of patients, including information as required in the Standards, and (c) report any other information required in the Standards in the form and manner determined by the director. (2) Information referred to in subsection (1) may include personal information and individually identifying health information. AR 202/2022 s10 Critical incident reporting 46 (1) A service provider licensed under this Part shall (a) notify a director of a critical incident as soon as possible and no later than 24 hours after the service provider becomes aware of the critical incident, (b) report the critical incident to a director no later than 48 hours after the service provider becomes aware of the critical incident, and (c) provide a 2nd report to a director no later than 2 weeks after the service provider becomes aware of the critical incident in the form and manner determined by the director. (2) A notification of a critical incident under subsection (1)(a) must include the date, time, place and nature of the critical incident, as available, and any immediate steps taken by the service provider in response. (3) A first report of a critical incident under subsection (1)(b) must include all of the following information, as available: (a) the date, time, place and nature of the critical incident; (b) the name and age of the patient affected, if applicable and known; (c) the name of any witnesses to the critical incident, if applicable and known; (d) the action taken or planned. (4) A 2nd report of a critical incident under subsection (1)(c) must include all of the following information, as available: (a) an analysis of the circumstances leading to the incident; (b) the action taken or planned, including any action taken or planned to mitigate risk with an aim to prevent similar critical incidents in the future; (c) proposed timelines for any action planned in follow‑up to the critical incident, including any plan to mitigate risk referred to in clause (b). (5) A service provider licensed under this Part shall, as soon as possible after the service provider becomes aware of the critical incident, make all reasonable efforts to notify any critical incident contacts provided by the patient and any substitute decision makers who need to know of the critical incident in order to fulfill their duties under their legal authorization. (6) On request by a director, within the time period specified by the director, a service provider licensed under this Part shall ensure that a report is submitted respecting any other matters specified by the director. AR 202/2022 s10 ;158/2025 Approved clinical research trial reporting 47 (1) A service provider who offers or provides psychedelic drug treatment services in the context of an approved clinical research trial shall report to a director the following information: (a) the identification number and any other information that identifies the clinical research trial approved by a research ethics board; (b) the principal investigators; (c) the drugs being used in the clinical research trial; (d) the dosages of the drugs being used in the clinical research trial; (e) the indications for which the drugs are being used and the circumstances or conditions under which the drugs are or will be used in the clinical research trial; (f) the setting prepared and maintained for the clinical research trial; (g) a summary of the clinical research trial. (2) The information under subsection (1) must be reported to a director (a) in the case of the initial approval of the clinical research trial by a research ethics board, within 60 days of the initial approval, and (b) in the case of amendments made to the information referred to in subsection (1), within 60 days of the approval of the amendments by the research ethics board in the form and manner determined by the director. AR 202/2022 s10 Part 4 Residential Addiction Treatment Services Definitions 48 In this Part, “Standards” means the Residential Addiction Treatment Services Standards , approved by the Minister and published by the Department, as amended from time to time. AR 202/2022 s10 Exemption from application of Act and Regulation 49 A person who offers or provides residential addiction treatment services is exempt from the application of the Act and this Regulation if the intended purpose of providing overnight accommodation does not include the offering or provision of services to treat an addiction. AR 202/2022 s10 Complaints policy and procedure requirements 50 A service provider who offers or provides residential addiction treatment services shall ensure that a written complaints policy and procedure is established, implemented and periodically reviewed in accordance with the Standards that (a) allows a client to file a complaint with the service provider in respect of the service provider, any employee of the service provider or the services provided, and (b) sets out any follow‑up that can be expected by a client of the service provider. AR 202/2022 s10 Service provider to meet requirements in Standards 51 A service provider who offers or provides residential addiction treatment services must (a) meet the requirements set out in the Standards, (b) provide other services, if any, as required by the Standards, and (c) comply with any prohibitions set out in the Standards. AR 202/2022 s10 Service provider to ensure all employees are qualified and trained 52 (1) A service provider who offers or provides residential addiction treatment services shall ensure that all of its employees (a) are qualified to provide residential addiction treatment services, (b) are adequately trained in all matters necessary to provide residential addiction treatment services according to the Act and this Part, and (c) meet other qualifications and training requirements, if any, set out in the Standards. (2) A service provider who offers or provides residential addiction treatment services shall require a criminal record check and a vulnerable sector check for each employee if required in the Standards and based on the criteria, if any, set out in the Standards. AR 202/2022 s10 Additional critical incident notification 53 (1) In addition to section 5 of the Schedule to the Act, a service provider who offers or provides residential addiction treatment services shall notify a director of a critical incident as soon as possible and no later than 24 hours after the service provider becomes aware of the critical incident. (2) A notification of a critical incident under subsection (1) must include the date, time, place and nature of the critical incident, as available, and any immediate steps taken by the service provider in response. AR 202/2022 s10 Additional record creation, maintenance and retention 54 In addition to section 6 of the Schedule to the Act, a service provider who offers or provides residential addiction treatment services, in respect of each facility or other location at which the residential addiction treatment services are provided, shall create and maintain records containing the following: (a) copies of all complaints received in respect of the service provider, any employee of the service provider or the services provided; (b) copies of all incident reports; (c) a copy of the complaints policy and procedure established under section 50. AR 202/2022 s10 Reporting — general 55 (1) A service provider who offers or provides residential addiction treatment services shall (a) on a periodic basis as required in the Standards report information about service utilization as described in the Standards to a director, (b) submit to a director on a periodic basis as required in the Standards a report respecting complaints received from clients, or persons acting on behalf of clients, including information as required in the Standards, and (c) report any other information as required in the Standards in the form and manner determined by the director. (2) Information referred to in subsection (1) may include personal information and individually identifying health information. AR 202/2022 s10 Part 5 Transitional and Expiry Transitional 56 (1) In this section, (a) “existing service provider” means (i) a service provider who (A) has been providing services to treat opioid use disorder that include the use of one or more designated narcotic drugs on or after July 1, 2021, and (B) is not a provincial health agency or regional health authority; (ii) a provincial health agency or regional health authority who has been providing services to treat opioid use disorder that include the use of one or more designated narcotic drugs (A) on or after July 1, 2021, and (B) at places other than a facility or other location included in the licence under section 15, only in respect of those places not included in the licence, but does not include a service provider who operates an approved hospital or a designated facility under the Mental Health Act in respect of the approved hospital or designated facility; (b) “transition period” means the period beginning on the coming into force of section 15 and ending 150 days after section 15 comes into force. (2) During the period beginning 30 days after the coming into force of section 15, an existing service provider may only provide narcotic transition services for the purpose of maintaining a patient of the existing service provider on the designated narcotic drug previously prescribed for the patient. (3) During the transition period, Part 2 does not apply to an existing service provider or a pharmacist if the service provider or pharmacist only compounds, dispenses or sells a designated narcotic drug pursuant to a prescription by an authorized regulated member who is an existing service provider or an employee of an existing service provider. (4) During the transition period, for the purpose of a service provider that is an approved hospital or facility designated under the Mental Health Act complying with section 16, every instance of “a service provider licensed under this Part” in section 16 shall be read as “an existing service provider”, and every instance of “the service provider licensed under this Part” in section 16 shall be read as “the existing service provider”, if the patient is a patient of an existing service provider. AR 202/2022 s10;125/2024 Expiry 57 For the purpose of ensuring that this Regulation is reviewed for ongoing relevancy and necessity, with the option that it may be repassed in its present or an amended form following a review, this Regulation expires on June 30, 2031. AR 202/2022 s10;111/2026