2024-2025 Jurisprudence Exam Study Booklet_ latest update 01_09_2024.docx.pdf

Jurisprudence Exam Study Booklet [ Class of 2025 ] Table of Contents Table of Contents 2 General Information and Disclaimer Notice 3 Copyright Notice...

Jurisprudence Exam Study Booklet [ Class of 2025 ] Table of Contents Table of Contents 2 General Information and Disclaimer Notice 3 Copyright Notice 3 References and Resources for Studying 4 JE Orientation Videos 4 JE References 4 Exam Information 4 Table of Contents of Study Materials (links to each section) 5 Federal Legislation 6 Overview: Controlled Drugs and Substances Act 6 K1. Narcotic Control Regulations (NCR) 7 K2. Benzodiazepines and Other Targeted Substances Regulations 32 Overview: Food and Drug Act (FDA) 44 K1. Food and Drug Regulations 44 Overview: Practitioners 69 K1. Canadian practitioner/International practitioner 69 Provincial Legislation 72 Overview: Health Professions Act (HPA) and Bylaws 72 K1. Adaptations 74 K2. Scope of Practice 76 K3. Dispensing Requirements 81 K4. Counseling Requirements 85 K5. Interchangeable Drugs 86 K6. Prescription Label 87 K7. Terms of a Prescription 88 K8. Prescription Copy and Transfers 88 K9. Patient Records 89 K10. Marketing and Advertising 90 K11. Incentives 91 Overview: Pharmacy Operations and Drug Scheduling Act (PODSA) and Bylaws 93 K1. Community Pharmacy Security 93 K2. Returned Drugs 95 K3. Sale and Disposal of Drugs 95 K4. Records 96 K5. Emergency Supply for Continuity of Care 98 Drug Distribution 98 Overview: Prescription Regulations Chart 99 K1. Classification and Description 99 K2. Prescription requirements 99 K3. Refills and part-fill 99 K4. Transfers 99 K5. Sales record 99 2  K6. Files and records 99 Overview: Controlled Prescription Program (CPP) 102 K1. Dispensing information required 103 Overview: Drug Schedules Regulation 111 K1. Drug Schedules Regulation 111 Ethics and Professionalism 113 Overview: Ethical Principles 113 K1. Code of ethics 113 Overview: Duty to Report 119 K1. Risk to public 119 Overview: Professionalism 128 K1. Confidentiality/protection of personal information 129 K2. Conflict of interest 134 Recent Legislation Information from the Readlinks and College mailings 136 Additional Guidance 136 3 General Information and Disclaimer Notice The Jurisprudence Exam (JE) is based on legislation contained in federal and provincial acts, their regulations, bylaws and published College Professional Practice Policies that pertain to pharmacy operations and registrant (pharmacist or pharmacy technician) responsibilities in the practice of pharmacy. Successful completion of the JE is required to register as a pharmacist or pharmacy technician in British Columbia. The College has partnered with Prometric to administer the JE as a computer-based examination. The JE may be taken on-site at a Prometric Test Center or as a remotely proctored online examination at a location that meets the requirements. Seats are limited for each sitting and are reserved on a first come, first serve basis. In order to write the JE, candidates must complete registration on eServices and schedule their examination appointment with Prometric. This Study Booklet is created by two PY4 students, with all information and resources being gathered from the College of Pharmacists of British Columbia website. Although the material is directly from the College, there may be new updates or information missing in this booklet. It is recommended that students use this booklet in conjunction with the College website to ensure that they have the most accurate and up to date information to best prepare for the Jurisprudence Exam. The creators of this Study Booklet do not take any responsibility for exam difficulties due to missing information or new updated information that is not reflected through this Study Booklet. Please direct any issues with the information found in this booklet to Allan or Harry immediately, so that they may fix any issues or make additions. They may be contacted at [email protected] Copyright Notice Any concerns or questions regarding the exam should be directed to the College. The purpose of this booklet is not for the purpose of profit, but to consolidate study material and ease stress. Any redistribution or reproduction of part or of all the content in any form is prohibited other than the following: Users with access to this document may print or download to a local hard drive for personal and non-commercial use By using this booklet, you are consenting to the agreement above. Any means to use the material contained within this booklet for the purpose of sale and redistribution for personal benefit may lead to legal action being taken. Sincerely, Allan and Harry 4 References and Resources for Studying *Make sure you have registered for your desired test date 1. Log into your eServices account 2. Click on the “Events & Services” tab and select “Register for Events” 3. Select the event, follow the instructions and pay the fee. To view your exam registration details (i.e. exam location, date, time) please log into eServices, click on "Event Registration", select your registration category, and you will find details under "Itinerary" JE Orientation Videos Keep in mind these videos are from 2013, some information (exam format, things to bring) will be out of date. https://www.bcpharmacists.org/library/8_Multimedia/JE_Orientation_2013.mp4 https://www.bcpharmacists.org/library/8_Multimedia/JE_Podcast_2013.mp3 JE References JE Information Guide: https://library.bcpharmacists.org/3_Registration_Licensure/5029-RegInfo_JE.pdf General Resources: https://www.bcpharmacists.org/JE_Resources Code of Ethics Educational Tutorial, Modules 1-4: https://www.bcpharmacists.org/code-ethics-educational-tutorial Links to relevant information are contained under appropriate headings located below for printed purpose if preferred. Exam Information The JE is a 3-hour examination with an additional 15 minutes to complete a non-disclosure agreement, a brief tutorial at the beginning of the examination, and a 10 minutes Post-Exam Survey at the end of the examination. The exam consists of 150 questions, of which 125 is scored. The remaining 25 questions are unscored. Questions include multiple choice and true or false questions, which are all weighted equally (i.e. 1 mark each). Domains Percent of Questions I: Federal Legislation (Controlled Drugs and Substance Act, Food and Drug Act, 15 Practitioners) II: Provincial Legislation (Health Professional Act and Bylaws, Pharmacy Operations 37 and Drug Scheduling Act and Bylaws) III: Drug Distribution (Prescription Regulations Chart, Controlled Prescription Program, 36 Drug Schedules Regulation) IV: Ethics and Professionalism (Ethical Principles, Duty to Report, Professionalism) 12 5 6 Table of Contents of Study Materials (links to each section) Domain I: Federal Legislation (Weight — 15%) Subdomain: Controlled Drugs and Substances Act Subdomain: Food and Drug Act (FDA) Subdomain: Practitioners Domain II: Provincial Legislation (Weight — 37%) Subdomain: Health Professions Act (HPA) and Bylaws Subdomain: Pharmacy Operations and Drug Scheduling Act (PODSA) and Bylaws Domain III: Drug Distribution (Weight — 36%) Subdomain: Prescriptions Regulation Chart Subdomain: Controlled Prescriptions Program (CPP) Subdomain: Drug Schedules Regulation Domain IV: Ethics and Professionalism (Weight — 12%) Subdomain: Ethical Principles Subdomain: Duty to Report Subdomain: Professionalism 7 Federal Legislation Overview: Controlled Drugs and Substances Act Domain I: Federal Legislation (Weight — 15%) Subdomain: Controlled Drugs and Substances Act K1. Narcotic Control Regulations (NCR) Sections: Skill Statements: Interpretation – section 2 S1. Identify obligations around the recording of Pharmacists – section 30 – 49 narcotics received from licensed dealers Practitioners – section 53 – 54 S2. Apply appropriate legislation to the sale of Hospitals – section 63 – 65 narcotics General – section 70 S3. Describe requirements for narcotic prescription files and records The following will be included in the drug schedules S4. Apply the general obligations of a pharmacist package supplied for the examination: (e.g., reporting loss or theft, destruction of Schedule narcotics, providing information and assisting an inspector) Additional resources pertaining to the destruction of S5. Describe the procedures around the return or Narcotics and Controlled Drug Substances: emergency sale of narcotics CPBC Readlinks S6. Apply the conditions for sale and know how to Letter from Health Canada interpret the drug schedule (e.g., methadone, Health Canada Guidance Document diacetylmorphine) K2. Benzodiazepines and Other Targeted Substances Sections: Regulations Pharmacists – Section 48 – 57 Skill Statements: Hospitals – Section 63 – 67 S1. Identify activities permitted in the regulations. Verification of Identity – Section 70 S2. Describe the general obligations of Storage – Section 71 pharmacists who store/sell targeted substances Security – Section 72 S3. Apply the obligations for the destruction of Destruction – Section 73 benzodiazepines and other targeted substances Advertising – Section 78 The following will be included in the drug schedules package supplied for the examination: Schedule 1 Schedule 2 8 Federal Legislation Subdomain: Controlled Drugs and Substances Act K1. Narcotic Control Regulations (NCR) Interpretation - Section 2 - link Definitions 2 (1) The following definitions apply in these Regulations. Act means the Controlled Drugs and Substances Act. (Loi) advertisement includes any representation by any means for the purpose of promoting, directly or indirectly, the sale or other disposal of a narcotic. (publicité.) common-law partner in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year. (conjoint de fait) competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of narcotics into or from the country. (autorité compétente) compound includes a preparation. (composé) designated criminal offence means (a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code; (b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code; (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code; (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d). (infraction désignée en matière criminelle) destroy means, in respect of a narcotic, to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction) diacetylmorphine (heroin) includes the salts of diacetylmorphine. (diacétylmorphine (héroïne)) 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 or animals 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. (hôpital) international obligation means an obligation in respect of a narcotic set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale) 9 licensed dealer means the holder of a licence issued under section 10.1. (distributeur autorisé) methadone includes the salts of methadone. (méthadone) midwife has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (sage-femme) narcotic means (a) a controlled substance set out in the schedule; or (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance set out in the schedule that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations. (stupéfiant) nurse practitioner has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (infirmier praticien) pharmacist means a person who is entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province. (pharmacien) podiatrist has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (podiatre) prescription means an authorization given by a practitioner that a stated amount of a narcotic be dispensed for the person named in it or the animal identified in it. (ordonnance) qualified person in charge means the individual designated under subsection 9.2(1). (responsable qualifié) Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité) senior person in charge means the individual designated under section 9.1. (responsable principal) test kit means a kit (a) that contains a narcotic and a reagent system or buffering agent; (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a narcotic for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and (c) the contents of which are not intended or likely to be consumed by, or administered to, a person or an animal. (nécessaire d’essai) verbal prescription narcotic means a narcotic that is contained in medication that may be prescribed verbally and that has the following characteristics: (a) it contains two or more medicinal ingredients that are not narcotics, in a recognized therapeutic dose; (b) it is not intended for parenteral administration; and (c) it does not contain diacetylmorphine (heroin), hydrocodone, methadone, oxycodone or pentazocine. (stupéfiant d’ordonnance verbale) 10 Pharmacists – Section 30-49 - link Record of Narcotics Received General information 30 A pharmacist who receives a narcotic from a licensed dealer shall immediately enter the following in a book, register or other record maintained for such purposes: (a) the name and quantity of the narcotic received (b) the date the narcotic was received; and (c) the name and address of the person from whom the narcotic was received. Sale of Narcotics Restriction 31 (1) No pharmacist shall sell or provide narcotics except in accordance with this section and sections 34 to 36 and 45. Exemption or written order or prescription 31 (2) A pharmacist may sell or provide a narcotic to a person (a) if the person is exempted under section 56 of the Act with respect to the possession of that narcotic; (b) except in the case of diacetylmorphine (heroin), if the pharmacist has received a written order or prescription for the narcotic that is signed and dated by a practitioner and has verified the signature of the practitioner, if it is not known to them; or (c) in the case of diacetylmorphine (heroin), if the pharmacist has received a written order or prescription for the narcotic that is signed and dated by a practitioner of medicine or a nurse practitioner and has verified the signature of the practitioner, if it is not known to them. Methadone 31 (3) A pharmacist may sell or provide methadone to the following persons, in addition to the persons referred to in subsection (2): (a) a licensed dealer; (b) another pharmacist; (c) a hospital employee; or (d) a practitioner. Prohibition — pharmacist or practitioner named in notice 32 Subject to section 33 and despite subsections 31(2) and (3) and sections 34 to 36, no pharmacist shall (a) sell or provide a narcotic, other than a verbal prescription narcotic, to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(a); (b) sell or provide a verbal prescription narcotic, other than a preparation mentioned in section 36, to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(b); (c) sell or provide a preparation mentioned in section 36 to a pharmacist named in a notice issued by the Minister under paragraph 48(1)(c); (d) dispense, sell or provide a narcotic, other than a verbal prescription narcotic, to a practitioner named in a notice issued by the Minister under subsection 59(1) or fill a prescription or order for a narcotic, other than a verbal prescription narcotic, from a practitioner named in such a notice; or (e) dispense, sell or provide a verbal prescription narcotic to a practitioner named in a notice issued by the Minister under subsection 59(1) or fill a prescription or order for a verbal prescription narcotic from a practitioner named in such a notice. 11 Exception — notice of retraction 33 Section 32 does not apply to a pharmacist to whom the Minister has issued a notice of retraction of the notice (a) under section 49, in respect of a pharmacist named in a notice issued by the Minister under subsection 48(1); or (b) under section 60, in respect of a practitioner named in a notice issued by the Minister to under subsection 59(1). Verbal prescription narcotic 34 Subject to section 39, a pharmacist may dispense a verbal prescription narcotic on receipt of a verbal order or prescription given by a person whom the pharmacist has taken reasonable precautions to determine is a practitioner. Provision to hospital 35 (1) Subject to subsection (2), a pharmacist may provide a narcotic to an employee of a hospital or a practitioner in a hospital if the pharmacist receives a written order for the narcotic signed and dated by (a) the pharmacist in charge of the hospital’s pharmacy; (b) except in the case of diacetylmorphine (heroin), a practitioner who is authorized by the person in charge of the hospital to sign the order; or (c) in the case of diacetylmorphine (heroin), a practitioner of medicine or dentistry or a nurse practitioner who is authorized by the person in charge of the hospital to sign the order. Signature 35 (2) Before providing a narcotic under subsection (1), the pharmacist receiving the order must know the signature on the order or verify it. Low-dose codeine preparation 36 (1) Subject to subsection (2), a pharmacist may, without a prescription, sell or provide a preparation containing not more than 8 mg or its equivalent of codeine phosphate per tablet or per unit in other solid form or not more than 20 mg or its equivalent of codeine phosphate per 30 mL in a liquid preparation if (a) the preparation contains (i) two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half the regular minimum single dose for each such ingredient, or (ii) three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third the regular minimum single dose for each such ingredient; and (b) there is legibly and conspicuously printed on the inner label and the outer label, as those terms are defined in section A.01.010 of the Food and Drug Regulations, a caution to the following effect: “This preparation contains codeine and should not be administered to children except on the advice of a physician, dentist or nurse practitioner.” Use other than for recognized medical or dental purpose 36 (2) No pharmacist shall sell or provide a preparation referred to in subsection (1) if the pharmacist has reasonable grounds to believe that the preparation is to be used for purposes other than recognized medical or dental purposes. Maximum Quantity 37 A pharmacist must not use an order or prescription to dispense a narcotic after the quantity of the narcotic 12  specified in the order or prescription has been dispensed. Records Written order or prescription 38 If, in accordance with a written order or prescription, a pharmacist dispenses a narcotic, other than dextropropoxyphene, the pharmacist must immediately enter in a book, register or other record maintained for such purposes (a) their name or initials; (b) the name, initials and municipal address of the practitioner who issued the order or prescription; (c) the name and municipal address of the person named in the order or prescription; (d) the name, form and quantity of the narcotic; (e) the date on which the narcotic was dispensed; and (f) the number assigned to the order or prescription. Verbal order or prescription 39 A pharmacist must, before dispensing a verbal prescription narcotic in accordance with a verbal order or prescription, make a written record of it that sets out (a) their name or initials; (b) the name, initials and municipal address of the practitioner who issued the order or prescription; (c) the name and municipal address of the person named in the order or prescription; (d) in accordance with the manner in which it is specified in the order or prescription, the name and quantity of the verbal prescription narcotic or the narcotic and the other medicinal ingredients contained in it; (e) the directions for use given with the order or prescription; (f) the date on which the verbal prescription narcotic was dispensed; and (g) the number assigned to the order or prescription. File by date and number 40 A pharmacist must maintain a special narcotic prescription file in which are filed, in sequence as to date and number, all written orders and prescriptions for narcotics that they have dispensed and the written record of all verbal prescription narcotics that they have dispensed in accordance with a verbal order or prescription. Retention period 40.1 A pharmacist must retain in their possession for a period of at least two years any records which they are required to keep by these Regulations. General Obligations of Pharmacist Providing information and assisting inspector 41 A pharmacist shall (a) furnish such information respecting the dealings of the pharmacist in any narcotic in such form and at such times as the Minister may require; (b) make available and produce to an inspector upon request his special narcotic prescription file together with any books, records or documents which he is required to keep; (c) permit an inspector to make copies of or to take extracts from such files, books, records or documents; and (d) permit an inspector to check all stocks of narcotics on his premises. Loss or theft — report 13 42 A pharmacist shall report to the Minister any loss or theft of a narcotic within 10 days of his discovery thereof. 14 Loss or theft — protective measures 43 A pharmacist shall take all reasonable steps that are necessary to protect narcotics on his premises or under his control against loss or theft. Preparing narcotic – approval of formula 44 (1) No pharmacist shall prepare a narcotic unless the Minister has approved the formula thereof, and if such narcotic is a preparation described in section 36, has approved the label and the size of the container in which it will be sold. Record — preparation 44 (2) A pharmacist who prepares a narcotic shall, in addition to all other records required to be kept, keep a record of the following: (a) the kind and quantity of any narcotic used in the preparation; (b) the name and quantity of the narcotic prepared; and (c) the date that the prepared narcotic was placed in stock. Definition of prepare 44 (3) For the purposes of this section, “prepare” does not include the compounding of a narcotic pursuant to a prescription of a practitioner. Return or Emergency Sale Written order 45 (1) A pharmacist may, on receiving a written order for a narcotic (a) return the narcotic to the licensed dealer who sold or provided it to the pharmacist, if the order is signed and dated by the licensed dealer; or (b) sell or provide to another pharmacist the quantity of the narcotic that is specified in the order as being required for emergency purposes, if the order is signed and dated by the other pharmacist. Record 45 (2) A pharmacist shall, immediately after returning, selling or providing a narcotic under subsection (1) or after receiving a narcotic under paragraph (1)(b) or subsection 65(4), enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions. Notice to Minister 45 (3) A pharmacist shall forthwith after removing, transporting or transferring a narcotic from his place of business to any other place of business operated by him notify the Minister setting out the details thereof. Communication of Information by Minister to Licensing Authority Contraventions by pharmacist 46 The Minister must provide in writing any factual information about a pharmacist that has been obtained under the Act or these Regulations to the provincial professional licensing authority that is responsible for the authorization of the person to practise their profession (a) in the province in which the pharmacist is or was entitled to practise if (i) the authority submits to the Minister a written request that sets out the pharmacist’s name and address, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or (ii) the Minister has reasonable grounds to believe that the pharmacist has (A) contravened a rule of conduct established by the authority, (B) been convicted of a designated substance offence, or 15  (C) contravened these Regulations; or (b) in a province in which the pharmacist is not entitled to practise, if the authority submits to the Minister (i) a written request that sets out the pharmacist’s name and address and a description of the information being requested, and (ii) a document that shows that (A) the pharmacist has applied to that authority to practise in that province, or (B) the authority has reasonable grounds to believe that the pharmacist is practising in that province without being authorized to do so. Notice of Prohibition of Sale Request by pharmacist 47 A pharmacist may make a written request to the Minister to send to the persons and authorities specified in subsection 48(3) a notice, issued under section 48, advising them of one or more of the following requirements: (a) recipients of the notice must not sell or provide a narcotic, other than a verbal prescription narcotic, to that pharmacist; (b) recipients of the notice must not sell or provide a verbal prescription narcotic, other than a preparation mentioned in section 36, to that pharmacist; and (c) the recipients of the notice must not sell or provide a preparation mentioned in section 36 to that pharmacist. Notice by Minister 48 (1) In the circumstances described in subsection (2), the Minister must send a notice to the persons and authorities specified in subsection (3) advising them that pharmacists practising in the notified pharmacies and licensed dealers must not sell or provide to the pharmacist named in the notice one or more of the following: (a) a narcotic, other than a verbal prescription narcotic; (b) a verbal prescription narcotic, other than a preparation mentioned in section 36; or (c) a preparation mentioned in section 36. Circumstances requiring a notice 48 (2) The notice must be sent if the pharmacist named in the notice has (a) made a request to the Minister in accordance with section 47 to send the notice; (b) contravened a rule of conduct established by the provincial professional licensing authority of the province in which the pharmacist is practising and the authority has requested the Minister in writing to send the notice; or (c) been convicted of a designated substance offence or of a contravention of these Regulations. Recipients 48 (3) The notice must be sent to (a) all licensed dealers; (b) all pharmacies within the province in which the pharmacist named in the notice is entitled to practice and is practising; (c) the provincial professional licensing authority of the province in which the pharmacist named in the notice is entitled to practise; (d) all pharmacies in an adjacent province in which an order from the pharmacist named in the notice may be filled; and (e) any provincial professional licensing authority in another province that has requested the Minister in writing to send the notice. Other circumstances 16 48 (4) The Minister may send the notice described in subsection (1) to the persons and authorities specified in subsection (3) if the Minister has taken the measures specified in subsection (5) and has reasonable grounds to believe that the pharmacist named in the notice (a) has contravened a provision of the Act or these Regulations; (b) has, on more than one occasion, self-administered a narcotic, other than a verbal prescription narcotic, contrary to accepted pharmaceutical practice; (c) has, on more than one occasion, self-administered a verbal prescription narcotic, other than a preparation mentioned in section 36, contrary to accepted pharmaceutical practice; (d) has, on more than one occasion, provided or administered a narcotic, other than a verbal prescription narcotic, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice; (e) has, on more than one occasion, provided or administered a verbal prescription narcotic, other than a preparation mentioned in section 36, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice; or (f) is unable to account for the quantity of narcotic for which the pharmacist was responsible under these Regulations. Measures before sending notice 48 (5) The measures that must be taken before sending the notice are that the Minister has (a) consulted with the provincial professional licensing authority of the province in which the pharmacist to whom the notice relates is entitled to practise; (b) given that pharmacist an opportunity to be heard; and (c) considered (i) the compliance history of the pharmacist in respect of the Act and its regulations, and (ii) whether the actions of the pharmacist pose a risk to public health or safety, including the risk of the narcotic being diverted to an illicit market or use. Notice of retraction 49 The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were sent a notice under subsection 48(1) with a notice of retraction of that notice if (a) in the circumstance described in paragraph 48(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was sent by the Minister; or (b) in a circumstance described in any of paragraphs 48(2)(b) and (c) and (4)(a) to (f), the pharmacist named in the notice has (i) requested in writing that a retraction of the notice be sent, and (ii) provided a letter from the provincial professional licensing authority of the province, in which the pharmacist is entitled to practise, in which the authority consents to the retraction of the notice. Practitioners – Section 53-54 - link Administer, Prescribe or Sell Narcotics Restriction 53 (1) No practitioner shall administer a narcotic to a person or animal, or prescribe, sell or provide a narcotic for a person or animal, except as authorized under this section. Conditions 53 (2) Subject to subsection (4), a practitioner may administer a narcotic to a person or animal, or prescribe, sell or 17  provide it for a person or animal, if (a) the person or animal is a patient under their professional treatment; and (b) the narcotic is required for the condition for which the person or animal is receiving treatment. Heroin 53 (4) A practitioner of dentistry or veterinary medicine shall not administer diacetylmorphine (heroin) to an animal or to a person who is not an in-patient or out-patient of a hospital providing care or treatment to persons, and shall not prescribe, sell or provide diacetylmorphine (heroin) for an animal or such a person. Record of narcotics sold or provided 54 (1) A practitioner who sells or provides a narcotic to a person for self-administration or for administration to an animal shall, whether or not the practitioner charges for the narcotic, keep a record showing the name and quantity of the narcotic sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided, if the quantity of the narcotic exceeds (a) three times the maximum daily dosage recommended by the manufacturer or assembler of the narcotic for that narcotic; or (b) three times the generally recognized maximum daily therapeutic dosage for the narcotic if the manufacturer or assembler has not recommended a maximum daily dosage. Accessibility of record 54 (2) The practitioner shall keep the record in a place, form and manner that will permit an inspector readily to examine and obtain information from it. Hospitals – Section 63-65 - link General Obligations 63 A person who is in charge of a hospital shall (a) keep or cause to be kept in a book, register or other record maintained for such purposes, (i) the name and quantity of any narcotic received, (ii) the name and address of the person from whom any narcotic was received and the date received, (iii) the name and quantity of any narcotic used in the making or assembling of a product or compound containing that narcotic, (iv) the name and quantity of any product or compound that was made or assembled and that contains that narcotic and the date on which the product or compound was made or assembled, (v) the name of the patient for whom a narcotic, other than dextropropoxyphene or a verbal prescription narcotic, was dispensed, (vi) the name of the practitioner ordering or prescribing a narcotic, other than dextropropoxyphene or a verbal prescription narcotic, and (vii) the date a narcotic, other than dextropropoxyphene or a verbal prescription narcotic 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) take all necessary steps to protect narcotics in the hospital against loss or theft, and report to the Minister any loss or theft of narcotics within 10 days of his discovery thereof. Providing information and assisting inspector 64 A person who is in charge of a hospital shall (a) furnish such information respecting the use of narcotics therein, in such form and at such times as the 18  Minister may require; (b) produce to an inspector any books, records or documents required by these Regulations to be kept; (c) permit an inspector to make copies thereof or take extracts from such books, records and documents; and (d) permit an inspector to check all stocks of narcotics in the hospital. Selling, providing or administering narcotic 65 (1) No person in charge of a hospital shall permit a narcotic to be sold, provided or administered except in accordance with this section. Written order or prescription 65 (2) On receipt of a written order or prescription signed and dated by a practitioner, the person in charge of a hospital may permit a narcotic, other than diacetylmorphine (heroin), to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided for the person or to the person in charge of the animal. Verbal prescription narcotic 65 (2.1) On receipt of a verbal prescription given by a practitioner, the person in charge of a hospital may permit a verbal prescription narcotic to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided for the person or to the person in charge of the animal. Emergency — other hospital 65 (3) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic to be provided, for emergency purposes, to a hospital employee or practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order. Emergency — pharmacist 65 (4) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist. Signature 65 (5.1) No person in charge of a hospital shall permit a narcotic to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the narcotic or has been verified. Research purposes 65 (6) A person in charge of a hospital may permit a narcotic to be provided to a person who is exempted under section 56 of the Act with respect to the possession of the narcotic and who is employed in a research laboratory in the hospital for the purpose of research. Heroin 65 (7) The person in charge of a hospital may permit diacetylmorphine (heroin) to be sold, provided or administered to a person under treatment as an in-patient or out-patient of the hospital on receipt of a written order or prescription signed and dated by a practitioner of medicine or dentistry or a nurse practitioner. General – Section 70 - link Advertising 70 It is prohibited to 19  (a) advertise a narcotic to the general public; (b) advertise a preparation referred to in section 36 in a pharmacy; or (c) publish any written advertisement respecting a narcotic unless that advertisement displays the symbol “N” in a clear and conspicuous colour and size in the upper left quarter of its first page. Schedule - link *Note: these drug schedules will be included in the drug schedules package supplied for the Jurisprudence Exam) Also available as part of consolidated copy with other schedules - link 1 Opium Poppy (Papaver somniferum), its preparations, derivatives, alkaloids and salts, including: (1) Opium (2) Codeine (methylmorphine) (3) Morphine (7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol) (4) Thebaine (paramorphine) and the salts, derivatives and salts of derivatives of the substances set out in subitems (1) to (4), including: (5) Acetorphine (acetyletorphine) (6) Acetyldihydrocodeine (4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol acetate) (7) Benzylmorphine (7,8-didehydro-4,5-epoxy-17-methyl-3-(phenylmethoxy) morphinan-6-ol) (8) Codoxime (dihydrocodeinone O-(carboxymethyl)oxime) (9) Desomorphine (dihydrodeoxymorphine) (10) Diacetylmorphine (heroin) (11) Dihydrocodeine (4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol) (12) Dihydromorphine (4,5-epoxy-17-methylmorphinan-3,6-diol) (13) Ethylmorphine (7,8-didehydro-4,5-epoxy-3-ethoxy-17-methylmorphinan-6-ol) (14) Etorphine (tetrahydro-7α-(1-hydroxy-1-methylbutyl)-6,14-endo-ethenooripavine) (15) Hydrocodone (dihydrocodeinone) (16) Hydromorphinol (dihydro-14-hydroxymorphine) (17) Hydromorphone (dihydromorphinone) (18) Methyldesorphine (Δ6-deoxy-6-methylmorphine) (19) Methyldihydromorphine (dihydro-6-methylmorphine) (20) Metopon (dihydromethylmorphinone) (21) Morphine-N-oxide (morphine oxide) (22) Myrophine (benzylmorphine myristate) (23) Nalorphine (N-allylnormorphine) (24) Nicocodine (6-nicotinylcodeine) (25) Nicomorphine (dinicotinylmorphine) (26) Norcodeine (N-desmethylcodeine) (27) Normorphine (N-desmethylmorphine) (28) Oxycodone (dihydrohydroxycodeinone) (29) Oxymorphone (dihydrohydroxymorphinone) (30) Pholcodine (3-[2-(4-morpholinyl)ethyl]morphine) (31) Thebacon (acetyldihydrocodeinone) but not including (32) Apomorphine (5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol) and its salts (33) Cyprenorphine (N-(cyclopropylmethyl)-6,7,8,14-tetrahydro-7α-(1-hydroxy-1-methylethyl)-6,14-endo- ethenonororipavine) and its salts (33.1) [Repealed, SOR/2016-239, s. 8] (34) Nalmefene (17-(cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol) and its salts (34.1) Naloxone (4,5α-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one) and its salts (34.2) Naltrexone (17-(cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one) and its salts 20  (34.3) Methylnaltrexone (17-(cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxy-17-methyl-6-oxomorphinanium) and its salts (34.4) Naloxegol (4,5α-epoxy-6α-(3,6,9,12,15,18,21-heptaoxadocos-1-yloxy)-17-(2-propenyl)morphinan- 3,14-diol) and its salts (35) Narcotine (6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo [4,5-g]isoquinolin-5-yl)-1(3H)-isobenzofuranone) and its salts (36) Papaverine (1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxyisoquinoline) and its salts (37) Poppy seed 2 Coca (Erythroxylum), its preparations, derivatives, alkaloids and salts, including: (1) Coca leaves (2) Cocaine (benzoylmethylecgonine) (3) Ecgonine (3-hydroxy-2-tropane carboxylic acid) but not including 123 (4) l-ioflupane 3 Phenylpiperidines, their intermediates, salts, derivatives and analogues and salts of intermediates, derivatives and analogues, including: (1) Allylprodine (3-allyl-1-methyl-4-phenyl-4-piperidinol propionate) (2) Alphameprodine (α-3-ethyl-1-methyl-4-phenyl-4-piperidinol propionate) (3) Alphaprodine (α-1,3-dimethyl-4-phenyl-4-piperidinol propionate) (4) Anileridine (ethyl 1-[2-(p-aminophenyl) ethyl]-4-phenylpiperidine-4-carboxylate) (5) Betameprodine (ß-3-ethyl-1-methyl-4-phenyl-4-piperidinol propionate) (6) Betaprodine (ß-1,3-dimethyl-4-phenyl-4-piperidinol propionate) (7) Benzethidine (ethyl 1-(2-benzyloxyethyl)-4-phenylpiperidine-4-carboxylate) (8) Diphenoxylate (ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate) (9) Difenoxin (1-(3-cyano-3,3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate) (10) Etoxeridine (ethyl 1-[2-(2-hydroxyethoxy) ethyl]- 4-phenylpiperidine-4-carboxylate) (11) Furethidine (ethyl 1-(2-tetrahydrofurfuryloxyethyl)- 4-phenylpiperidine-4-carboxylate) (12) Hydroxypethidine (ethyl 4-(m-hydroxyphenyl)-1-methylpiperidine-4-carboxylate) (13) Ketobemidone (1-[4-(m-hydroxyphenyl)-1-methyl-4-piperidyl]-1-propanone) (14) Methylphenylisonipecotonitrile (4-cyano-1-methyl-4-phenylpiperidine) (15) Morpheridine (ethyl 1-(2-morpholinoethyl)-4- phenylpiperidine-4-carboxylate) (16) Norpethidine (ethyl 4-phenylpiperidine-4-carboxylate) (17) Pethidine (ethyl 1-methyl-4-phenylpiperidine-4-carboxylate) (18) Phenoperidine (ethyl 1-(3-hydroxy-3-phenylpropyl)-4-phenylpiperidine-4-carboxylate) (19) Piminodine (ethyl 1-[3-(phenylamino)propyl]-4-phenylpiperidine-4-carboxylate) (20) Properidine (isopropyl 1-methyl-4-phenylpiperidine-4- carboxylate) (21) Trimeperidine (1,2,5-trimethyl-4-phenyl-4-piperidinol propionate) (22) Pethidine Intermediate C (1-methyl-4-phenylpiperidine-4-carboxylate) but not including (23) Carperidine (ethyl 1-(2-carbamylethyl)-4-phenylpiperidine-4-carboxylate) and its salts (24) Oxpheneridine (ethyl 1-(2-hydroxy-2-phenylethyl)-4-phenylpiperidine-4-carboxylate) and its salts 4 Phenazepines, their salts, derivatives and salts of derivatives including: (1) Proheptazine (hexahydro-1,3-dimethyl-4-phenyl-1Hazepin-4-ol propionate) but not including (2) Ethoheptazine (ethyl hexahydro-1-methyl-4-phenylazepine-4-carboxylate) and its salts (3) Metethoheptazine (ethyl hexahydro-1,3-dimethyl-4-phenylazepine-4-carboxylate) and its salts (4) Metheptazine (methylhexahydro-1,2-dimethyl-4-phenylazepine-4-carboxylate) and its salts 5 Amidones, their intermediates, salts, derivatives and salts of intermediates and derivatives, including: 21  (1) Dimethylaminodiphenylbutanonitrile (4-cyano-2-dimethylamino-4,4-diphenylbutane) (2) Dipipanone (4,4-diphenyl-6-piperidino-3-heptanone) (3) Isomethadone (6-dimethylamino-5-methyl-4,4-diphenyl-3-hexanone) (4) Methadone (6-dimethylamino-4,4-diphenyl-3-heptanone) (5) Normethadone (6-dimethylamino-4,4-diphenyl-3-hexanone) (6) Norpipanone (4,4-diphenyl-6-piperidino-3-hexanone) (7) Phenadoxone (6-morpholino-4,4-diphenyl-3-heptanone) 6 Methadols, their salts, derivatives and salts of derivatives, including: (1) Acetylmethadol (6-dimethylamino-4,4-diphenyl-3-heptanol acetate) (2) Alphacetylmethadol (α-6-dimethylamino-4,4-diphenyl-3-heptanol acetate) (3) Alphamethadol (α-6-dimethylamino-4,4-diphenyl-3-heptanol) (4) Betacetylmethadol (ß-6-dimethylamino-4,4-diphenyl-3-heptanol acetate) (5) Betamethadol (ß-6-dimethylamino-4,4-diphenyl-3-heptanol) (6) Dimepheptanol (6-dimethylamino-4,4-diphenyl-3-heptanol) (7) Noracymethadol (α-6-methylamino-4,4-diphenyl-3-heptanol acetate) 7 Phenalkoxams, their salts, derivatives and salts of derivatives, including (1) Dimenoxadol (dimethylaminoethyl 1-ethoxy-1,1-diphenylacetate) (2) Dioxaphetyl butyrate (ethyl 2,2-diphenyl-4-morpholinobutyrate) (3) Dextropropoxyphene ([S-(R*,S*)]-α-[2-(dimethylamino)-1-methylethyl]-α-phenylbenzeneethanol, propanoate ester) 8 Thiambutenes, their salts, derivatives and salts of derivatives, including: (1) Diethylthiambutene (N,N-diethyl-1-methyl-3,3-di-2-thienylallylamine) (2) Dimethylthiambutene (N,N,1-trimethyl-3,3-di-2-thienylallylamine) (3) Ethylmethylthiambutene (N-ethyl-N,1-dimethyl-3,3-di-2-thienylallylamine) 9 Moramides, their intermediates, salts, derivatives and salts of intermediates and derivatives, including: (1) Dextromoramide (d-1-(3-methyl-4-morpholino-2,2-diphenylbutyryl)pyrrolidine) (2) Diphenylmorpholinoisovaleric acid (2-methyl-3-morpholino-1,1-diphenylpropionic acid) (3) Levomoramide (l-1-(3-methyl-4-morpholino-2,2-diphenylbutyryl)pyrrolidine) (4) Racemoramide (d,l-1-(3-methyl-4-morpholino-2,2- diphenylbutyryl)pyrrolidine) 10 Morphinans, their salts, derivatives and salts of derivatives, including: (1) Buprenorphine (17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3- hydroxy-6-methoxy-α-methyl-6,14-ethenomorphinan-7-methanol) (2) Drotebanol (6ß,14-dihydroxy-3,4-dimethoxy-17-methylmorphinan) (3) Levomethorphan (1-3-methoxy-17-methylmorphinan) (4) Levorphanol (1-3-hydroxy-17-methylmorphinan) (5) Levophenacylmorphan (1-3-hydroxy-17-phenacylmorphinan) (6) Norlevorphanol (1-3-hydroxymorphinan) (7) Phenomorphan (3-hydroxy-17-(2-phenylethyl)morphinan) (8) Racemethorphan (d,1-3-methoxy-17-methylmorphinan) (9) Racemorphan (d, l-3-hydroxy-N-methylmorphinan)but not including (10) Dextromethorphan (d-1,2,3,9,10,10a-hexahydro-6-methoxy-11-methyl-4H-10,4a- iminoethanophenanthren) and its salts (11) Dextrorphan (d-1,2,3,9,10,10a-hexahydro-11-methyl-4H-10,4a-iminoethanophenanthren-6-ol) and its salts 22  (12) Levallorphan (l-11-allyl-1,2,3,9,10,10a-hexahydro-4H-10,4a-iminoethanophenanthren-6-ol) and its salts (13) Levargorphan (l-11-propargyl-1,2,3,9,10,10a-hexahydro-4H-10,4a-iminoethanophenanthren-6-ol) and its salts (14) Butorphanol (l-N-cyclobutylmethyl-3,14-dihydroxymorphinan) and its salts (15) Nalbuphine (N-cyclobutylmethyl-4,5-epoxy-morphinan-3,6,14-triol) and its salts 11 Benzazocines, their salts, derivatives and salts of derivatives, including: (1) Phenazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl- 3-phenethyl-2,6-methano-3-benzazocin-8-ol) (2) Metazocine (1,2,3,4,5,6-hexahydro-3,6,11-trimethyl-2,6-methano-3-benzazocin-8-ol) (3) Pentazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6- methano-3-benzazocin-8-ol) but not including (4) Cyclazocine (1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(cyclopropylmethyl)-2,6- methano-3-benzazocin-8-ol) and its salts 12 Ampromides, their salts, derivatives and salts of derivatives, including: (1) Diampromide (N-[2-(methylphenethylamino)propyl]propionanilide) (2) Phenampromide (N-(1-methyl-2-piperidino)ethyl)propionanilide) (3) Propiram (N-(1-methyl-2-piperidinoethyl)-N-2- pyridylpropionamide) 13 Benzimidazoles, their salts, derivatives and salts of derivatives, including: (1) Clonitazene (2-(p-chlorobenzyl)-1-diethylaminoethyl-5-nitrobenzimidazole) (2) Etonitazene (2-(p-ethoxybenzyl)-1-diethylaminoethyl-5- nitrobenzimidazole) 14 Phencyclidine (1-(1-phenylcyclohexyl)piperidine), its salts, derivatives and analogues and salts of derivatives and analogues, including: (1) Ketamine (2-(2-chlorophenyl)-2- (methylamino)cyclohexanone) 15 Fentanyls, their salts, derivatives, and analogues and salts of derivatives and analogues, including: (1) Acetyl-α-methylfentanyl (N-[1-(α-methylphenethyl)-4-piperidyl]acetanilide) (2) Alfentanil (N-[1-[2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl]-4-(methoxymethyl)-4- piperidyl]propionanilide) (3) Carfentanil (methyl 4-[(1-oxopropyl)phenylamino]-1- (2-phenethyl)-4-piperidinecarboxylate) (4) p-Fluorofentanyl (4′ fluoro-N-(1-phenethyl-4-piperidyl) propionanilide) (5) Fentanyl (N-(1-phenethyl-4-piperidyl)propionanilide) (6) ß-Hydroxyfentanyl (N-[1-(ß-hydroxyphenethyl)-4- piperidyl] propionanilide) (7) ß-Hydroxy-3-methylfentanyl (N-[1(ß-hydroxyphenethyl)-3-methyl-4-piperidyl] propionanilide) (8) α-Methylfentanyl (N-[1-(α-methylphenethyl)-4- piperidyl] propionanilide) (9) α-Methylthiofentanyl (N-[1-[1-methyl-2-(2-thienyl)ethyl]-4-piperidyl] propionanilide) (10) 3-Methylfentanyl (N-(3-methyl-1-phenethyl-4-piperidyl) propionanilide) (11) 3-Methylthiofentanyl (N-[3-methyl-1-[2-(2-thienyl)ethyl]-4-piperidyl] propionanilide) (11.1) Remifentanil (dimethyl 4-carboxy-4-(N-phenylpropionamido)-1-piperidinepropionate) (12) Sufentanil (N-[4-(methoxymethyl)-1-[2-(2-thienyl)ethyl]-4- piperidyl] propionanilide) (13) Thiofentanyl (N-[1-[2-(2-thienyl)ethyl]-4-piperidyl] propionanilide) (14) 4-Anilino-N-phenethylpiperidine (ANPP) (N-phenyl-1-(2-phenylethyl)piperidine-4-amine), its derivatives and analogues and salts of derivatives and analogues 16 Tilidine (ethyl 2-(dimethylamino)-1-phenyl-3-cyclohexene-1-carboxylate), its salts, derivatives and salts of derivatives 23 17 [Repealed, SOR/2018-147, s. 28] 18 Synthetic cannabinoid receptor type 1 agonists, their salts, derivatives, isomers, and salts of derivatives and isomers, including those that fall within the following core chemical structure classes, with the exception of any substance that is identical to any phytocannabinoid and of ((3S)-2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo [1,2,3-de]-1,4-benzoxazin-6-yl)-1-naphthalenyl-methanone (WIN 55,212-3) and its salts: (1) Any substance that has a 2-(cyclohexyl)phenol structure with substitution at the 1-position of the benzene ring by a hydroxy, ether or ester group and further substituted at the 5-position of the benzene ring, whether or not further substituted on the benzene ring to any extent, and substituted at the 3’-position of the cyclohexyl ring by an alkyl, carbonyl, hydroxyl, ether or ester, and whether or not further substituted on the cyclohexyl ring to any extent, including (i) Nabilone ((±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl -9H-dibenzo[b,d]pyran-9-one) (ii) Parahexyl (3-hexyl-6,6,9-trimethyl-7,8,9,10-tetrahydro-6H-dibenzo[b,d]pyran-1-ol) (iii) 3-(1,2-dimethylheptyl)-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran-1-ol (DMHP) (iv) 5-(1,1-dimethylheptyl)-2-(5-hydroxy-2-(3-hydroxypropyl)cyclohexyl)phenol (CP 55,940) (v) 5-(1,1-dimethylheptyl)-2-(3-hydroxycyclohexyl)phenol (CP 47,497) (2) Any substance that has a 3-(1-naphthoyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the naphthyl ring to any extent, including (i) 1-pentyl-3-(1-naphthoyl)indole (JWH-018) (ii) 1-butyl-3-(1-naphthoyl)indole (JWH-073) (iii) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122) (iv) 1-hexyl-3-(1-naphthoyl)indole (JWH-019) (v) 1-(4-pentenyl)-3-(1-naphthoyl)indole (JWH-022) (vi) 1-butyl-3-(4-methoxy-1-naphthoyl)indole (JWH-080) (vii) 1-pentyl-3-(4-methoxy-1-naphthoyl)indole (JWH-081) (viii) 1-(2-morpholin-4-ylethyl)-3-(1-naphthoyl)indole (JWH-200) (ix) 1-pentyl-3-(4-ethyl-1-naphthoyl)indole (JWH-210) (x) 1-pentyl-3-(2-methoxy-1-naphthoyl)indole (JWH-267) (xi) 1-[(N-methylpiperidin-2-yl)methyl]-3-(1-naphthoyl)indole (AM-1220) (xii) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM-2201) (xiii) 1-(5-fluoropentyl)-3-(4-methyl-1-naphthoyl)indole (MAM-2201) (xiv) 1-(5-fluoropentyl)-3-(4-ethyl-1-naphthoyl)indole (EAM-2201) (xv) ((3R)-2,3-dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin- 6-yl)-1-naphthalenyl-methanone (WIN 55,212-2) (3) Any substance that has a 3-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted on the pyrrole ring to any extent and whether or not substituted on the naphthyl ring to any extent, including (i) 1-pentyl-5-(2-fluorophenyl)-3-(1-naphthoyl)pyrrole (JWH-307) (4) Any substance that has a 3-phenylacetylindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the phenyl ring to any extent, including (i) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250) (ii) 1-pentyl-3-(2-methylphenylacetyl)indole (JWH-251) (iii) 1-pentyl-3-(3-methoxyphenylacetyl)indole (JWH-302) 24  (5) Any substance that has a 3-benzoylindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the phenyl ring to any extent, including (i) 1-(1-methylpiperidin-2-ylmethyl)-3-(2-iodobenzoyl)indole (AM-2233) (6) Any substance that has a 3-methanone(cyclopropyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the cyclopropyl ring to any extent, including (i) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (UR-144) (ii) (1-(5-fluoropentyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (5F-UR-144) (iii) (1-(2-(4-morpholinyl)ethyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (A-796,260) (7) Any substance that has a quinolin-8-yl 1H-indole-3-carboxylate structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted on the quinolin-8-yl ring to any extent, including (i) 1-pentyl-8-quinolinyl ester-1H-indole-3-carboxylic acid (PB-22) (ii) 1-(5-fluoropentyl)-8-quinolinyl ester-1H-indole-3-carboxylic acid (5F-PB-22) (8) Any substance that has a 3-carboxamideindazole structure with substitution at the nitrogen atom of the indazole ring, whether or not further substituted on the indazole ring to any extent and whether or not substituted at the carboxamide group to any extent, including (i) N-(adamantan-1-yl)-1-pentyl-1H-indazole-3-carboxamide (AKB48) (ii) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (5F-AKB48) (iii) N-(1-(aminocarbonyl)-2-methylpropyl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) (iv) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) (9) Any substance that has a 3-carboxamideindole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent and whether or not substituted at the carboxamide group to any extent, including (i) N-(adamantan-1-yl)-1-fluoropentylindole-3-carboxamide (STS-135) (ii) N-(adamantan-1-yl)-1-pentylindole-3-carboxamide (APICA) 18.1 Tapentadol (3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol), its salts, derivatives and isomers and salts of derivatives and isomers 19 Tramadol (2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol), its salts, isomers and salts of isomers and the following derivatives of tramadol and the salts, isomers and salts of isomers of those derivatives: (1) O-desmethyltramadol (3-[2-[(dimethylamino)methyl]-1-hydroxycyclohexyl]-phenol) (2) N,O-didesmethyltramadol (3-[1-hydroxy-2-[(methylamino)methyl]cyclohexyl]-phenol) 20 AP-237 (1-(4-cinnamylpiperazin-1-yl)butan-1-one), its salts, derivatives and analogues and salts of derivatives and analogues, including: (1) 2-methyl-AP-237 (1-(4-cinnamyl-2-methylpiperazin-1-yl)butan-1-one) (2) para-methyl-AP-237 ((E)-1-(4-(3-(p-tolyl)allyl)piperazin-1-yl)butan-1-one) (3) AP-238 (1-(4-cinnamyl-2,6-dimethylpiperazin-1-yl)propan-1-one) 25 Additional resources pertaining to the destruction of Narcotics and Controlled Drug Substances 1) CPBC ReadLinks - link 2) Letter from Health Canada - link 26 27 3) Health Canada Guidance Document - link 28 29 30 31 32 33 Federal Legislation Subdomain: Controlled Drugs and Substances Act K2. Benzodiazepines and Other Targeted Substances Regulations Pharmacists – Section 48-57 - link Permitted Activities Application 48 Sections 49 to 56 do not apply to a pharmacist when they are practising in a hospital. Authorization 49 A pharmacist may, in accordance with sections 50 to 57, compound a targeted substance in accordance with a prescription. Record of receipt from licensed dealer 50 If a pharmacist receives a targeted substance from a licensed dealer, a pharmacist in another pharmacy or a hospital, the pharmacist must keep a record of the following information: (a) the brand name of the targeted substance received or, if the targeted substance does not have a brand name, the specified name; (b) the quantity and strength per unit of the targeted substance received, the number of units per package and the number of packages; (c) the name and address of the licensed dealer, pharmacist or hospital that supplied it; and (d) the date on which it was received. Prescription required 51 (1) In addition to the activities authorized under section 55, a pharmacist may, subject to section 52, sell, provide, send, deliver or transport a targeted substance to or for an individual or for the benefit of an animal if (a) the pharmacist sells or provides the substance in a container labelled in accordance with subsection (2); (b) the transaction is made pursuant to a prescription (i) dated and signed by a practitioner, (ii) provided verbally to the pharmacist by a practitioner, or (iii) transferred to the pharmacist under subsection 54(1) in accordance with subsection 54(2); (c) the pharmacist has not transferred the prescription to another pharmacist; and (d) when the prescription has been provided verbally, the transaction is recorded by the pharmacist in accordance with subsection (3). Labelling required 51 (2) A pharmacist who sells or provides a targeted substance to an individual must do so in a container that is labelled with the following information: (a) the name and address of the pharmacy or pharmacist; (b) the date of issuance of the prescription and the number given to it by the pharmacist; (c) the name of the individual for whose benefit the targeted substance is sold or provided or, if it is sold or provided for the benefit of an animal, the name of the individual having caring of the animal or the name of the animal; (d) the name of the practitioner who issued the prescription; (e) the specified name or brand name of the targeted substance; (f) the quantity and, if applicable, the strength per unit of the targeted substance; and 34  (g) the directions for use specified by the practitioner. Record of verbal prescription 51 (3) A pharmacist who receives a verbal prescription for a targeted substance must, before filling it, (a) record the following information: (i) the name and address of the individual for whose benefit the prescription is provided or, if it is provided for the benefit of an animal, the name and address of the individual having caring of the animal and, if applicable, the name of the animal, (ii) the date that the verbal prescription was provided, (iii) the specified name or brand name of the targeted substance, as specified in the prescription, (iv) the quantity and, if applicable, the strength per unit of the targeted substance, (v) the name of the recording pharmacist and the name of the practitioner who issued the prescription, (vi) the directions for use specified by the practitioner, and (vii) if the prescription is to be refilled, the number of times it may be refilled and, if specified, the interval between refills; and (b) keep a hard copy or create a written record of the prescription. Refills 52 A pharmacist may only refill a prescription for a targeted substance if (a) the practitioner who prescribed it expressly directs that the prescription may be refilled and specifies the number of refills; (b) the pharmacist makes a record of each refill in accordance with section 53; (c) less than one year has elapsed since the day on which the prescription was issued by the practitioner; (d) at least one refill remains on the prescription; and (e) in the case where an interval between refills has been specified by the practitioner, it has expired. Records 53 A pharmacist who fills or refills a prescription for a targeted substance must record the following information: (a) the date the prescription was filled or refilled; (b) the quantity of the targeted substance provided at the original filling and at each refill; (c) the pharmacist’s name or initials; and (d) the number assigned to the prescription. Transfer of prescription 54 (1) A pharmacist may transfer a prescription for a targeted substance to another pharmacist, except a prescription that has already been transferred. Additional information 54 (2) Before a pharmacist sells or provides a targeted substance to an individual under a prescription transferred under subsection (1), the pharmacist must (a) in the case of a verbal transfer, record the information required by subsection 51(3); (b) in the case of a written transfer, have obtained from the transferring pharmacist a copy of (i) the prescription written by the practitioner, or (ii) the record made in accordance with subsection 51(3) of the practitioner’s verbal prescription; and (c) in all cases, record (i) the name and address of the transferring pharmacist, (ii) the number of authorized refills remaining and, if applicable, the specified interval between 35  refills, and (iii) the date of the last refill. Records — transferring pharmacist 54 (3) A pharmacist who transfers a prescription under subsection (1) must record the date of the transfer, the name of the pharmacist to whom the prescription was transferred, the name and address of the pharmacy where that pharmacist practises and, if applicable, the number of refills that are being transferred. Activities without a prescription 55 (1) A pharmacist may sell, provide, send, deliver or transport a targeted substance without a prescription to any of the following persons on receipt of an order from that person that specifies the name and quantity of the targeted substance: (a) if the order is written, a licensed dealer who (i) sold or provided the targeted substance, or (ii) is licensed to destroy targeted substances, other than those that the licensed dealer produced, made, assembled, sold or provided; (b) subject to subsection (2), (i) a practitioner, (ii) another pharmacist, if the other pharmacist states that the targeted substance is required because of a delay or shortfall in an order for the targeted substance placed with a licensed dealer, or (iii) a hospital, if the order is placed by a pharmacist practising in the hospital or by a practitioner who is authorized to order the targeted substance on behalf of the hospital; (c) the Minister, if the order is a written order signed on the Minister’s behalf; or (d) a person to whom an exemption with respect to the targeted substance has been granted under section 56 of the Act, if the order is a written order and is accompanied by a copy of the exemption. Verbal orders 55 (2) In the circumstances set out in subparagraphs (1)(b)(i) to (iii), if the order is verbal, the pharmacist must record the following information: (a) the name and address of the pharmacist or practitioner placing the order; (b) if the order was placed on behalf of an establishment, the name and address of the establishment; (c) the date of the order; (d) the specified name or the brand name of the targeted substance ordered, as specified in the order; (e) the quantity and, if applicable, the strength per unit of the targeted substance; and (f) the name of the recording pharmacist. Records 55 (3) A pharmacist who sells, provides, sends, delivers or transports a targeted substance without a prescription must keep a record of the following information: (a) the brand name of the targeted substance or, if the targeted substance does not have a brand name, the specified name; (b) the quantity and strength per unit of the targeted substance; (c) the name and address of the person referred to in subsection (1) to whom the targeted substance was sold, provided, sent, delivered or transported; and (d) the date of the transaction. Copies 55 (4) The pharmacist must keep the written order or, if the order is verbal, must create a hard copy of the order. 36 37 General Obligations of Pharmacists Change of location 56 A pharmacist who closes premises in which a targeted substance has been stored must, not later than 10 days after the closure, inform the Minister of the date of closure, the location to which the targeted substance was moved and the quantity of the targeted substance that was moved. Renunciation of privileges 57 (1) A pharmacist who does not wish to receive or have possession of targeted substances may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under section 79, that states that targeted substances must not be supplied to that pharmacist. Prohibited actions 57 (2) A pharmacist must not, unless their pharmacy has received a retraction issued under section 80, (a) sell or provide a targeted substance to a pharmacist or practitioner named in a notice issued under section 79; or (b) fill a prescription or order for a targeted substance from a practitioner named in a notice issued under section 79. Hospitals – Section 63-67 - link Authorization 63 (1) A hospital may, in accordance with subsection (2) and sections 64 to 67, sell, provide, administer, send, deliver or transport a targeted substance. Ordering targeted substances 63 (2) No person may order a targeted substance on behalf of a hospital other than a pharmacist or practitioner practising in the hospital who is authorized by the person in charge of the hospital to order targeted substances for the hospital. Provision or administration to a patient 64 The person in charge of a hospital must not permit a targeted substance to be sold, provided or administered to a patient or animal under treatment as an in-patient or an out-patient of the hospital except pursuant to a prescription or other authorization of a practitioner practising in the hospital. Supply to non-patients 65 (1) A pharmacist practising in a hospital or an individual who is authorized by the person in charge of a hospital to fill orders for targeted substances on behalf of the hospital may, on receipt of an order specifying the name, quantity and, if applicable, strength per unit of a targeted substance from any of the following persons, sell or provide the targeted substance to that person without a prescription: (a) subject to subsection (2), (i) a licensed dealer who (A) sold or provided the substance, or (B) is licensed to destroy targeted substances other than those that the licensed dealer produced, made, assembled, sold or provided, (ii) a practitioner, if the practitioner states that the substance is required because of a delay or shortfall in an order for the substance placed with a licensed dealer or pharmacist, (iii) a pharmacist, if the pharmacist states that the substance is required because of a delay or shortfall in an order for the substance placed with a licensed dealer, or 38  (iv) another hospital, if the order is placed by a pharmacist practising in the other hospital or a practitioner who is authorized to order the targeted substance on behalf of the other hospital and the order states that the substance is required because of a delay or shortfall in an order placed with a licensed dealer or a pharmacist; (b) the Minister, if the order is a written order signed on the Minister’s behalf; and (c) a person to whom an exemption with respect to the targeted substance has been granted under section 56 of the Act, if (i) the person is an employee of or associated with the hospital, and (ii) the order is a written order accompanied by a copy of the exemption. Verbal orders 65 (2) In the circumstances set out in paragraph (1)(a), if the order is verbal, the pharmacist practising in the hospital or the individual who is authorized by the person in charge of the hospital to fill orders for the targeted substance on behalf of the hospital must, before filling the order, record the following information: (a) the date on which the order was received; (b) the name and address of the person placing the order; (c) the brand name of the targeted substance or, if the targeted substance does not have a brand name, the specified name; (d) the quantity of the targeted substance ordered; and (e) their name. Information 66 The person in charge of a hospital must record, or cause to be recorded, the following information: (a) the brand name or, if the targeted substance does not have a brand name, the specified name, the quantity of any targeted substance received by the hospital and the date on which it was received; (b) the name and address of the licensed dealer, pharmacist or other hospital that sold or provided the targeted substance; (c) the name and quantity of the targeted substance sold, provided, administered, sent, delivered or transported, the name and address of the recipient and the date of the transaction; and (d) the name and address of any out-patient to whom a targeted substance is sold or provided under section 64. Closure 67 If a targeted substance is stored in a hospital or the pharmacy department of a hospital and the hospital or department closes, the person in charge of the hospital must, not later than 10 days after the day of the closure, inform the Minister of the date of closure, the location to which the targeted substance was moved and the quantity of the targeted substance that was moved. Verification of Identity – Section 70 - link Order 70 Every person who fills an order or prescription for a targeted substance must verify the identity of the person who gave the order or issued the prescription if (a) the signature on the order or prescription is unknown to the person; or (b) the order or prescription is verbal and the person placing it is not known to the person. 39 Storage – Section 71 - link Place 71 Subject to section 59, every person who is authorized under these Regulations to deal in a targeted substance and who stores the targeted substance must do so in the place used for the purpose of conducting their business or professional practice and in the area in that place where only authorized employees have access, except if the targeted substance is for their own use or the use of another person for whom, or an animal for which, they are responsible. Security – Section 72 - link Protective measures 72 (1) The following persons must take any measures that are necessary to ensure the security of any targeted substance in their possession: (a) a pharmacist; (b) a practitioner; (c) the person in charge of a hospital; (d) a person to whom an exemption has been granted under section 56 of the Act; and (e) a person who, in accordance with a permit for transit or transhipment, is responsible for the targeted substance while it is in transit or in transhipment in Canada. Theft or loss 72 (2) A person referred to in subsection (1) who becomes aware of a theft or loss of a targeted substance must provide a written report to the Minister within 10 days after becoming aware of the occurrence. Destruction – Section 73 - link Restriction 73 (1) Subject to subsection (2) and sections 36 and 37, a person must not destroy a targeted substance unless they have received it in accordance with these Regulations for their own use or the use of another person for whom, or an animal for which, they are responsible. Conditions 73 (2) A pharmacist, a practitioner or the person in charge of a hospital may destroy a targeted substance if (a) subject to subsection (3), the destruction is witnessed by a pharmacist or practitioner; (b) the targeted substance is destroyed using a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; (c) they record the following information: (i) the municipal address of the place of destruction, (ii) the specified name of the targeted substance to be destroyed and, if applicable, the brand name of the product containing it or the name of the compound containing it, (iii) the form and quantity of the targeted substance to be destroyed or the product or compound containing it and, if applicable, its strength per unit, the number of units per package and the number of packages, (iv) the method of destruction, and (v) the date of the destruction; and (d) immediately following the destruction, the person who carried out the destruction and the pharmacist 40  or practitioner who witnessed it sign and date a joint declaration attesting that the targeted substance was completely destroyed, to which each signatory must add their name in printed letters. Exception — open ampule 73 (3) A targeted substance that constitutes the remainder of an open ampule, the partial contents of which have been administered to a patient, may be destroyed by a hospital employee who is a licensed health professional without a witness. Advertising – Section 78 - link Restrictions 78 It is prohibited to (a) advertise a targeted substance to the general public; or (b) publish any written advertisement respecting a targeted substance unless the advertisement (i) is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals, and (ii) displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page: 41 Schedule 1 - link *Note: these drug schedules will be included in the drug schedules package supplied for the Jurisprudence Exam Also available as part of consolidated copy with other schedules - link 42 43 Schedule 2 - link *Note: these drug schedules will be included in the drug schedules package supplied for the Jurisprudence Exam Also available as part of consolidated copy with other schedules - link 44 45 46 Federal Legislation Overview: Food and Drug Act (FDA) Domain I: Federal Legislation (Weight — 15%) Subdomain: Food and Drug Act (FDA) K1. Food and Drug Regulations Sections: Skill Statements: PART C: DRUGS S1. Interpret and/or apply regulations for Part C C.01.041 - C.01.049. (Drugs) and Part G (Controlled Drugs) PART G: CONTROLLED DRUGS DIVISION 1: GENERAL G.01.001 - G.01.007. DIVISION 3: PHARMACISTS G.03.001 - G.03.017.5. DIVISION 4: PRACTITIONERS G.04.001 - G.04.004.5. DIVISION 5: HOSPITALS G.05.001 - G.05.004. DIVISION 6: GENERAL G.06.001 – G.06.004 The following will be included in the drug schedules package supplied for the examination: DRUG SCHEDULE TO PART G – Part I, II, and III Federal Legislation Subdomain: Food and Drug Act (FDA) K1. Food and Drug Regulations PART C: Drugs Sections C.01.041 – C.01.049 - link C.01.041 (1) No person shall sell a prescription drug unless (a) they are entitled under the laws of a province to dispense a prescription drug and they sell it in that province under a verbal or written prescription that they received; or (b) they sell it under section C.01.043. C.01.041 (2) In the case of a verbal prescription, the person referred to in paragraph (1)(a) or a pharmacy technician shall create a written record of the prescription that includes the following information: (a) the date on which the prescription was received and, if applicable, the number of the prescription; (b) the name and address of the person to whom the prescription was issued; (c) the proper name, common name or brand name of the drug and its quantity; (d) the person’s name and the name of the practitioner who issued the prescription; and (e) the directions for use provided with the prescription, whether or not the practitioner authorized it to be refilled and, if refills are authorized, the number of authorized refills. C.01.041 (3) The person referred to in paragraph (1)(a) shall retain the written prescription referred to in subsection (1) or the record referred to in subsection (2) for at least two years after the day on which the prescription is filled. C.01.041.1 Subject to paragraph C.01.041.3(2)(b), a pharmacist or pharmacy technician may transfer to another 47  pharmacist or pharmacy technician a prescription for a prescription drug. C.01.041.2 (1) Before a pharmacist sells a drug under a prescription that was transferred under section C.01.041.1, the pharmacist or a pharmacy technician shall (a) create a written record of the name and address of the pharmacist or pharmacy technician who transferred the prescription and, if applicable, the number of authorized refills remaining and the date of the last refill; and (b) obtain a copy of the written prescription or of the written record that was created under subsection C.01.041(2), as the case may be, or, in the case of a verbal transfer, create a written record that includes the information referred to in that subsection. C.01.041.2 (2) The pharmacist shall retain the documents referred to in subsection (1) for at least two years after the day on which the prescription was filled. C.01.041.3 (1) A pharmacist or a pharmacy technician who transfers a prescription under section C.01.041.1 shall indicate the date of transfer on the original of the written prescription or of the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be. C.01.041.3 (2) When the pharmacist or pharmacy technician has transferred the prescription, (a) the pharmacist shall not make any additional sales under the prescription; and (b) the pharmacist or pharmacy technician shall not transfer the prescription to another pharmacist or pharmacy technician. C.01.042 A person referred to in paragraph C.01.041(1)(a) shall not refill a prescription for a prescription drug unless authorized by the practitioner and, in the case of such an authorization, they shall not refill a prescription more than the number of times specified by the practitioner. C.01.042.1 A person referred to in paragraph C.01.041(1)(a) shall indicate on the original of or on the copy of the written prescription or the written record created under subsection C.01.041(2) or in a record kept under the name of the patient in question, as the case may be, (a) the date on which the prescription was filled; (b) the date of each refill, if applicable; (c) the quantity of drug sold when the prescription was filled and, if applicable, for each refill; and (d) the name of the person who sold the drug. C.01.043 (1) A person may sell a prescription drug to (a) a drug manufacturer; (b) a practitioner; (c) a wholesale druggist; (d) a pharmacist; or (e) the Government of Canada or the government of a province, for the use of a department or agency of that government, on receipt of a written order signed by the minister responsible for the department or by the person in charge of the agency, or by their duly authorized representative. C.01.043 (2) If a person sells a prescription drug under paragraph (1)(e), they shall retain the written order for the drug for a period of at least two years after the day on which the drug is sold. C.01.044 If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the pro