Pharmaceutical Regulation
This regulation sets pharmacy registration, licensing, profile disclosure, and continuing education requirements.
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This regulation sets pharmacy registration, licensing, profile disclosure, and continuing education requirements. This provision sets licensing, operational, record-keeping, supervision, and dispensing rules for Manitoba pharmacies and related pharmacy personnel. This part sets rules for pharmacists and members on testing, drug administration, prescribing, insurance, advertising, and college communications.
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Pharmaceutical Regulation — segment 1
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Pharmaceutical Regulation — segment 1
This regulation sets pharmacy registration, licensing, profile disclosure, and continuing education requirements.
Pharmaceutical Regulation, M.R. 185/2013 The Pharmaceutical Act , C.C.S.M. c. P60 Regulation 185/2013 Registered December 16, 2013 bilingual version (HTML) Table of Contents Section PART 1 DEFINITIONS 1 Definitions PART 2 REGISTERS 2 Additional content of registers 3 Additional information in registers is public PART 3 REGISTRATION 4 Registration of pharmacists 5 Continuing obligations 6 Conditional registration of pharmacists 7 Rights and obligations of conditional registration 8 Temporary registration of pharmacists 9 Extended practice pharmacists 10 Students 11 Interns 12 Academic register 13 Accurate disclosure of information PART 4 LICENSING OF PHARMACISTS 14 Application for pharmacist licence 15 Applicant who has been absent from practice 16 Renewal of pharmacist licence 17 Continuing professional development 18 Practice restrictions 19 Labour mobility 20 Accurate disclosure of information PART 5 PHARMACIST PROFILES 21 Council must make pharmacist profiles available 22 How profiles are to be made available 23 Profile content 24 Voluntary information 25 Explanatory information 26 Member must provide required information 27 Change in information 28 Opportunity to dispute information 29 If member fails to provide information PART 6 PHARMACY LICENCES 30 Application for pharmacy licence 31 Separate applications if different buildings 32 Operation restricted to licence category or component 33 Pre-opening inspection 34 Community pharmacy licence 35 Hospital pharmacy licence 36 Clinical practice pharmacy licence 37 Lock and leave component 38 Central-fill component 39 Secondary hospital services component 40 Personal care home component 41 Distance care component 42 External dispensing component 43 Satellite pharmacy component 44 Licence renewals 45 If pharmacy closes 46 Ownership changes that may result in licence cancellation 47 Changes about which the registrar must be notified 48 Change in pharmacy hours 49 Converting licence category or component 50 Converting licence category or component — extenuating circumstances 51 Pharmacy manager requirements 52 Accurate disclosure of information 53 Safe use of automation 54 Permitted business names for pharmacies 55 Licence must be displayed PART 7 STANDARDS OF PRACTICE 56 Standards of practice PART 8 PRACTICE OF PHARMACY BY INTERNS, TECHNICIANS, STUDENTS AND OTHERS 57 Members 58 Interns 59 Academic registrants 60 Pharmacy technicians 61 Pharmacy technicians — continuing qualifications 62 Students 63 Health professionals 64 Other persons 65 Pharmacy manager responsibilities re supervision 66 Performance review for pharmacy technicians 67 Owner or manager responsibilities re tasks performed 68 Member's responsibilities re supervision PART 9 PRESCRIPTIONS AND RECORDS 69 Prescriptions must be authorized 70 Prescription record 71 Drug labels 72 Patient profiles 73 Patient counselling records 74 Central-fill pharmacy records 75 Drug acquisition and sales records 76 Manitoba Prescribing Practices Program (M3P) Schedule 77 M3P prescription requirements 78 M3P dispensing requirements 79 Retention of records PART 10 RESTRICTIONS ON THE DISPENSING AND SALE OF DRUGS 80 Drugs and substances must be approved by Health Canada 81 Child resistant containers 82 No sale of expired drugs 83 Ensuring patient safety 84 Limits on sale of particular drugs 85 Returning drugs to inventory 86 Substitution of drugs in hospital pharmacy 87 Inducements re prescription drugs PART 11 DISPENSING AND COMPOUNDING BY PERSONS WHO ARE NOT MEMBERS 88 Dispensing practitioners' committee 89 Application by practitioner 90 Authority of dispensing practitioner 91 Pharmacy requirements apply 92 Suspending or revoking a designation 93 Veterinarians PART 12 EXTENDED PRACTICE PHARMACISTS (SPECIALTY PRACTICE) 94 Extended practice pharmacist 95 Registration requirements 96 Specialty qualifications 97 Renewal of registration 98 Applicant who has been absent from practice 99 Extended practice advisory committee PART 13 ORDERING TESTS BY MEMBERS 100 Ordering tests — all members 101 Ordering tests — extended practice pharmacists 102 Ordering tests re drugs prescribed by members 103 Ordering tests — hospital pharmacy 104 Compliance with practice directions 105 General requirements 106 Records of tests ordered PART 14 ADMINISTRATION OF DRUGS BY MEMBERS 107 Definition of "advanced method" 108 Administration of drugs — all members 109 Administration of drugs — certified members 110 Drugs that may be administered by certified members 111 Reporting about vaccine administration 112 Collaborative practice required for intravenous administration 113 Drug administration record 114 Certification of members in advanced methods 115 Renewal of certification 116 Cancellation or suspension of certification 117 No representation as certified unless certified PART 15 PRESCRIBING BY MEMBERS 118 Prescribing by members 119 Criteria for prescribing 120 Controlled substances 121 Prescribing record 122 Continued care prescriptions PART 16 PROFESSIONAL LIABILITY INSURANCE 123 Professional liability insurance 124 Pharmacy insurance PART 17 ADVERTISING 125 Definitions 126 Restrictions on advertising 127 No advertising of controlled drug products 128 Advertising of usual services 129 Advertising prices and fees 130 Disclosure of fees PART 18 COLLEGE COMMUNICATIONS 131 College newsletter 132 Publication of disciplinary and related decisions PART 19 COMING INTO FORCE 133 Coming info force Schedule 1 Tests that a member may order 2 Vaccines that a member may administer as part of provincial program 3 Drugs that a member may prescribe PART 1 DEFINITIONS Definitions 1 The following definitions apply in this regulation. "Act" means The Pharmaceutical Act . («  Loi  ») "adaptation of a prescription" means altering the dosage strength, dosing interval or formulation of a prescription drug. (« ajustement d'une ordonnance ») "authorized practitioner" means a practitioner authorized to prescribe drugs under the Controlled Drugs and Substances Act (Canada). (« praticien autorisé ») "child resistant container" means a container that meets the standards for child resistant containers made by the Canadian Standards Association. (« contenant sécurité-enfant ») "collaborative practice" means a practice setting in which a member works closely and cooperatively with other health care professionals to provide care to a common patient or group of patients. (« exercice interprofessionnel ») "direct supervision" means supervision provided by a person who (a) is physically present on the premises where the practice being supervised is being carried out; and (b) is able to observe and promptly intervene and stop or change the actions of the individual who is under supervision. (« surveillance immédiate ») "dispensary" means an area or areas of a pharmacy that is not accessible to the public where drugs listed on Schedule 1 and 2 of the Manual are stored for sale or prepared for dispensing or both. (« officine ») "DPIN" means the Drug Programs Information Network system maintained by or on behalf of the minister. (« Réseau ») "electronic" has the same meaning as in The Electronic Commerce and Information Act . (« électronique ») "electronic signature" has the same meaning as in The Electronic Commerce and Information Act . (« signature électronique ») "extended practice pharmacist" means a member whose name is entered on the register of extended practice pharmacists under Part 12. (« pharmacien ayant un champ d'exercice élargi ») "hospital" means (a) a hospital as defined in The Health Services Insurance Act ; (b) CancerCare Manitoba; (c) St. Amant Centre; and (d) [repealed] M.R. 115/2025 ; (e) Selkirk Mental Health Centre. (« hôpital ») "included practice" means a practice described in subsection 2(2) of the Act. (« actes relevant du champ d'exercice élargi ») "Manual" means the Manual for Canada's National Drug Scheduling System published by the National Association of Pharmacy Regulatory Authorities, as amended from time to time. (« manuel ») "medical device" means an article, instrument, apparatus or contrivance, including any component, part or accessory of any of them, manufactured, sold or represented for use in humans for (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, but not including an orthotic or prosthetic; (b) the diagnosis of pregnancy; or (c) contraception; but does not include a drug. (« matériel médical ») "M3P" means the Manitoba Prescribing Practices Program adopted by the council and the College of Physicians and Surgeons of Manitoba, as amended from time to time. (« Programme ») "M3P schedule" means a schedule of drugs set under M3P that require surveillance and monitoring, as amended from time to time. (« annexe du Programme ») "personal care home" means a personal care home as defined in The Health Services Insurance Act . (« foyer de soins personnels ») "pharmacist profile" or "profile" means a record about a member that includes personal, professional and other information about him or her, compiled for the purpose of being made available to the public. (« profil » ou « profil du pharmacien ») "pharmacy manager" means a member designated as the pharmacy manager under clause 64(2)⁠(d) of the Act. (« gérant de pharmacie ») "PHIN" means a personal health identification number as defined in The Personal Health Information Act . (« NIMP ») "preparing a drug for dispensing" means to count, measure or pour the amount of a drug designated in a prescription into a container and label the container for the purposes of dispensing, and includes pre-packaging a drug before a prescription is received. (« préparation d'ordonnance ») "prescribe" means to authorize the dispensing of a drug in a specified amount for use by a named individual. (« prescrire ») "prescription drug" means a drug designated by the minister under subsection 73(2) of the Act that can only be sold to a practitioner or pursuant to a prescription. (« médicament sur ordonnance ») "prescription number" means a unique identification number or code used to identify or locate a particular prescription. (« numéro d'ordonnance ») M.R. 81/2024 ; 115/2025 PART 2 REGISTERS Additional content of registers 2(1) In addition to the information required by subsection 9(2) of the Act, every register of pharmacists must contain a notation and the date of each voluntary surrender of registration and each reinstatement of registration. 2(2) The register of pharmacists must contain a notation and the date of a pharmacist's retirement from practice or death. 2(3) The register of extended practice pharmacists must contain (a) a notation of each specialty held under subsection 16(2) of the Act and Part 12; and (b) the date of qualification as an extended practice pharmacist. 2(4) When a business address required under clause 9(2)⁠(b) of the Act is not a street address, the register must contain the street address. Additional information in registers is public 3 The additional information required by this Part is designated as public information for the purpose of subsection 9(4) of the Act. PART 3 REGISTRATION PHARMACISTS Registration of pharmacists 4 In addition to the requirements of subsection 11(1) of the Act, an applicant for registration as a pharmacist must (a) submit an application to the registrar in the form approved by the council; (b) demonstrate, to the board's satisfaction, knowledge of the Act, the regulations, by-laws, code of ethics, standards of practice and practice directions, and any applicable federal legislation; (c) serve a period of internship determined by the board; (d) be able to speak and write either English or French in accordance with the language fluency criteria established by the council; (e) if the applicant is licenced as a pharmacist in another jurisdiction, provide a letter of standing from that jurisdiction satisfactory to the board; (f) satisfy the board that the applicant does not suffer from a physical or mental condition, including an addiction to alcohol or drugs, that may interfere with his or her ability to practice in a safe and effective manner, and that therefore makes it desirable in the public interest that he or she not practice pharmacy; (g) establish that his or her past and present conduct affords reasonable grounds for the belief that the applicant will engage in professional practice competently and with decency, integrity and honesty and in accordance with the law; (h) provide a criminal record check, a child abuse registry check under The Child and Family Services Act , and an adult abuse registry check under The Adult Abuse Registry Act , that is satisfactory to the board; (i) provide information satisfactory to the board as to whether the applicant, in Manitoba or in any other jurisdiction, (i) is the subject of a current investigation or proceeding relating to professional conduct under an enactment regulating a health profession, (ii) has had an application to practice a health profession denied, (iii) has previously been disciplined by another regulatory body responsible for the regulation of pharmacists or of another health profession, (iv) has any current or previous conditions placed on the applicant's ability to engage in practice, (v) has been found civilly liable for professional negligence or malpractice in relation to the practice of a health profession, (vi) is the subject of a current proceeding in respect of a criminal offence, or an offence under an Act regulating the practice of pharmacists or relating to the sale of drugs; and (j) provide a recent passport-size image of the applicant in a manner acceptable to the board. Continuing obligations 5 If there is any change in the information provided under clause 4(f), (h) or (i), the member must report the change to the registrar without delay. The report must be in writing and include as much detail about the change as the registrar requires. CONDITIONAL REGISTRATION OF PHARMACISTS Conditional registration of pharmacists 6(1) In addition to the requirements of subsection 12(1) of the Act, an applicant for registration on the conditional register of pharmacists must meet the requirements of clauses 4(a) to (j). 6(2) When registering an applicant on the conditional register, the board must specify a date by which all of the requirements for registration under subsection 11(1) of the Act must be completed, which must not be longer than six months from the date of registration on the conditional register. 6(3) However, the board may, in circumstances that it considers in its sole opinion to be exceptional, grant a person registered on the conditional register an extension or extensions to complete the remaining registration requirements under subsection 11(1) of the Act. 6(4) The registrar must cancel a person's conditional registration if the person fails to complete the remaining requirements for registration within the time specified by the board. 6(5) Subsections (2) to (4) do not apply to a person who has a temporary certificate of registration referred to in section 8. Rights and obligations of conditional registration 7 A person registered on the conditional register has the same rights and obligations as a member, except that such a person may not (a) act as a preceptor; (b) be registered as an extended practice pharmacist, unless under a temporary certificate of registration; or (c) act as a pharmacy manager, unless under a temporary certificate of registration and specifically permitted by the council. TEMPORARY REGISTRATION OF PHARMACISTS Temporary registration 8 In addition to the requirements of subsection 18(1) of the Act, an applicant for a temporary certificate of registration must (a) submit an application to the registrar in the form approved by the council; (b) provide a letter of standing, satisfactory to the council, from each jurisdiction in which the applicant is currently licensed that includes any conditions of practice; (c) evidence of active practice for at least 600 hours over the previous three years; (d) satisfy the board that the applicant does not suffer from a physical or mental condition, including an addiction to alcohol or drugs, that may interfere with his or her ability to practice in a safe and effective manner, and that therefore makes it desirable in the public interest that he or she not practice pharmacy; (e) provide an undertaking that the temporary practice will be conducted in accordance with the Act, regulations, by-laws, code of ethics, standards of practice and practice directions, and any applicable federal legislation; and (f) pay any fee specified in the by-laws. EXTENDED PRACTICE REGISTRATION Extended practice pharmacist registration 9 An applicant who meets the requirements of Part 12 is entitled to be registered on the register of extended practice pharmacists. STUDENTS Registration of students 10(1) In addition to the requirements of section 19 of the Act, an applicant for registration as a student must (a) provide evidence satisfactory to the registrar that the applicant is registered as a student in a pharmacy education program approved by the council; (b) submit an application to the registrar in the form approved by the council at the following times: (i) if the applicant is registered in the Faculty of Pharmacy at the University of Manitoba, by December 31 in the year the applicant enters the faculty, or by another date permitted by the registrar, or (ii) if the applicant is registered in any other pharmacy education program, at least 30 days before the student intends to begin work; (c) pay any late filing fee provided for in the by-laws if the applicant fails to comply with clause (b); (d) be able to speak and write either English or French in accordance with the language fluency criteria established by the council; (e) satisfy the registrar that the applicant does not suffer from a physical or mental condition, including an addiction to alcohol or drugs, that may interfere with his or her ability to practice in a safe and effective manner, and that therefore makes it desirable in the public interest that he or she not be registered as a student; (f) satisfy the registrar that the applicant has not been convicted of an offence that makes the applicant unsuitable for registration as a student; (g) provide a recent passport-size image of the applicant in a manner acceptable to the board; and (h) provide an undertaking that his or her practice as a student will be conducted in accordance with the Act, regulations, by-laws, code of ethics, standards of practice and practice directions. 10(2) The registrar must cancel the registration of a student who ceases to be enrolled in a pharmacy education program approved by the council. 10(3) A student who ceases to be enrolled in the pharmacy education program referred to under clause (1)⁠(a) must promptly notify the pharmacy manager. INTERNS Registration of interns 11(1) In addition to the requirements of section 20 of the Act, an applicant for registration as an intern must (a) satisfy the registrar that the applicant does not suffer from a physical or mental condition, including an addiction to alcohol or drugs, that may interfere with his or her ability to practice in a safe and effective manner, and that therefore makes it desirable in the public interest that he or she not be registered as an intern; (b) satisfy the registrar that the applicant has not been convicted of an offence that makes the applicant unsuitable for registration as an intern; (c) provide a recent passport size image of the applicant in a manner acceptable to the board; (d) provide an undertaking that his or her practice as an intern will be conducted in accordance with the Act, regulations, by-laws, code of ethics, standards of practice and practice directions; and (e) submit an application to the registrar in the form approved by the council. 11(2) The registrar must cancel the registration of an intern who ceases to participate in an internship. ACADEMIC REGISTER Academic register 12(1) The council may direct the registrar to establish an academic register to allow persons entitled to practice in other jurisdictions to receive additional education and training in Manitoba. A person on the register may be referred to as a "pharmacy resident". 12(2) If an academic register is established, the board may approve an application for registration on the academic register if the applicant (a) provides evidence satisfactory to board that the applicant is licensed to practice pharmacy in another jurisdiction and provides a letter of standing from that jurisdiction that is satisfactory to the board; (b) submits an application to the registrar in the form approved by the council that sets out (i) the scope, location and time period of the education and training, and (ii) the name and address of the member who will supervise the applicant during the education and training; (c) satisfies the board that the applicant does not suffer from a physical or mental condition, including an addiction to alcohol or drugs, that may interfere with his or her ability to practice in a safe and effective manner, and that therefore makes it desirable in the public interest that he or she not practice pharmacy; (d) satisfies the board that the applicant has not been convicted of an offence or been subject to professional discipline that, in the board's opinion, makes the applicant unsuitable for registration; (e) provides a recent passport-size image of the applicant in a manner acceptable to the board; and (f) pays any fee specified in the by-laws. GENERAL REQUIREMENTS Accurate disclosure required 13 Every applicant for registration must provide information to the registrar that is truthful and accurate to the best of the applicant's knowledge, and must update the information if it changes during the registration process. PART 4 LICENSING OF PHARMACISTS APPLICATION FOR PHARMACIST LICENCE Application for pharmacist licence 14 In addition to the requirements of subsection 15(1) of the Act, an applicant for a pharmacist licence must (a) advise the registrar of the intended scope of the applicant's practice; (b) provide evidence satisfactory to the registrar that, in the three-year period before the date of application, he or she has (i) supervised or engaged in the practice of pharmacy for at least 600 hours, (ii) successfully served a period of internship determined by the board, or (iii) obtained a degree in pharmacy from a program approved by the council that includes a training program equivalent to an internship; (c) disclose to the registrar whether the applicant has or has had a licence to practice pharmacy in another jurisdiction; (d) disclose to the registrar whether the applicant is under suspension or investigation by a professional regulatory body governing the practice of pharmacy in another jurisdiction; (e) provide a declaration that he or she is covered by professional liability insurance required under Part 16; (f) satisfy the registrar that the applicant does not suffer from a physical or mental condition, including an addiction to alcohol or drugs, that may interfere with his or her ability to practice in a safe and effective manner, and that therefore makes it desirable in the public interest that he or she not practice pharmacy; (g) satisfy the registrar that the applicant has not been convicted of an offence or been subject to professional discipline that, in the registrar's opinion, makes the applicant unsuitable to practice as a pharmacist; and (h) provide the registrar with a satisfactory criminal record check, child abuse registry check and adult abuse registry check every five years after being first licensed. Applicant who has been absent from practice 15 If an applicant who was previously issued a pharmacist licence cannot satisfy the 600-hour requirement of subclause 14(b)⁠(i), the registrar may do one or both of the following, in accordance with policies established by the board: (a) issue a licence subject to the condition that the applicant practice under supervision for a specified time period; (b) require the applicant to successfully complete any approved examinations, tests, assessments, training or education that demonstrate to the registrar's satisfaction that the applicant is currently competent to practice. RENEWAL OF PHARMACIST LICENCE Renewal of pharmacist licence 16 A pharmacist is entitled to have his or her pharmacist licence renewed if he or she (a) meets the requirements of section 14; and (b) provides evidence acceptable to the registrar that, in the preceding 12-month period, the applicant participated in continuing professional development learning activities in accordance with section 17. Continuing professional development 17(1) For the purposes of clause 16(b), a pharmacist must participate in at least 25 hours of professional development learning activities between November 1st of one year and October 31st of the following year, unless the registrar extends the October 31st deadline upon application by a pharmacist. Of the 25 hours, at least 15 must be learning activities that are provided by an accredited provider acceptable to the council. 17(2) Each member must keep available evidence that he or she has complied with the continuing professional development requirements under subsection (1) for three years. Practice restrictions 18 A member may engage only in those aspects of the practice of pharmacy, and perform included practices, (a) that he or she has the requisite knowledge, skill and judgment to provide or perform and that are appropriate to his or her area of practice; and (b) in accordance with any conditions of his or her license. GENERAL Labour mobility 19 Section 4 and sections 14 to 17 are subject to the obligations of the council under subsection 3(1) of The Labour Mobility Act. Accurate disclosure 20 An applicant for a pharmacist licence must provide information to the registrar that is truthful and accurate to the best of the applicant's knowledge, and must update the information if it changes during the duration of the licence. PART 5 PHARMACIST PROFILES AVAILABILITY OF PHARMACIST PROFILES Council must make pharmacist profiles available 21(1) Beginning no later than two years after this regulation comes into force, the council must make available to the public a profile of each member who (a) is registered on either the register of pharmacists or the conditional register of pharmacists; and (b) holds a current pharmacist licence of any category. However, if the council reasonably believes that a member is not currently practising in Manitoba, it need not make a profile of that member available. 21(2) Despite subsection (1), the council must make available the profile of a pharmacist whose licence to practice is suspended, in which case the profile must note the suspension and the date it began. How profiles are to be made available 22(1) A pharmacist profile must be made available to the public through (a) the college website; (b) orally in response to a telephone inquiry; and (c) in writing in response to a written request or telephone inquiry. 22(2) The college may enter into an agreement with the government or any person, organization or entity, including a public or private sector organization or entity, for assistance in making pharmacist profiles available. CONTENT OF PROFILES Profile content 23(1) Each profile must contain the following information about the member and his or her practice in Manitoba and elsewhere: (a) the member's name as shown on the applicable register; (b) subject to subsection (2), the member's sex; (c) the date of the member's initial registration in Manitoba; (d) the member's category of pharmacist licence; (e) subject to subsections (3) and (4), the date and a brief description of any final disciplinary action taken against the member within the last 10 years by the body named in the profile as regulating the profession that the member is or has been licensed to practice, whether in Manitoba or elsewhere, unless the action has been reversed on appeal; (f) if a final disciplinary action taken against a member is appealed, a notation that it is under appeal, until the appeal is finally disposed of; (g) the date and a brief description of any censure of the member published under subsection 36(2) of the Act; (h) any current restrictions, terms or conditions on the member's registration or licence, including any geographic or practice restrictions pending qualification for full registration, but not including information respecting restrictions, terms or conditions imposed as part of final disciplinary action that is already included in the profile under clause (e); (i) the commencement date of any current interim suspension from the practice of pharmacy imposed on the member; (j) any current certification of the member as a specialist or an extended practice pharmacist; (k) subject to subsection (5), the date of any malpractice court judgment against the member by a court in any jurisdiction within the last 10 years, the name of the court that issued it, and if the member has initiated an appeal respecting the malpractice judgment; (l) a description of any offence under (i) the Criminal Code (Canada), (ii) the Controlled Drugs and Substances Act (Canada), or (iii) the Food and Drugs Act (Canada), of which the member has been convicted within the past 10 years, if the council determines that the conviction is reasonably relevant to the member's competence or to the safe practice of pharmacy. The description must include the date of the conviction and the name of the court imposing the conviction. 23(2) The council must not include a member's sex in his or her profile under clause (1)⁠(b) if the member requests, in writing, that this information not be included. 23(3) The council must not include in a member's profile information about (a) any final disciplinary action taken against the member before January 1, 2009; or (b) any final disciplinary action taken against the member on or after January 1, 2009 if the tribunal taking the action ordered that the member's name not be published. 23(4) If the council includes information in a member's profile about a final disciplinary action taken against the member, it must not do so before the earliest of the following dates: (a) the date on which any right the member has to appeal the disciplinary action expires; (b) the date on which the member initiates an appeal of the disciplinary action; (c) the date on which the member waives the right to appeal the disciplinary action. However, if before any of those dates has passed, information about the final disciplinary action has been published by the council under section 58 of the Act, or has been made available to the public by another tribunal that took the final disciplinary action, the published or publicly available information must be included in the pharmacist profile. 23(5) The council must not include any information about a malpractice court judgment in a member's profile under clause(1)⁠(k) until any period available to the member to appeal the judgment has expired. Voluntary information 24 A member may provide the following information to be included in his or her profile: (a) the telephone number of his or her place of practice; (b) languages spoken (including American Sign Language). Explanatory information 25 The council may include in a pharmacist profile any explanatory information about pharmacist profiles and the categories of information specified in subsection 23(1) that it considers appropriate. COMPILING AND UPDATING INFORMATION Member must provide required information 26 A member must provide to the registrar complete and accurate information relating to each category of information specified in subsection 23(1), at the time and in the form required by the registrar. Change in information 27(1) If information in a member's profile in a category specified in subsection 23(1) becomes inaccurate or incomplete, the member must, within 30 days, provide accurate and complete information to the registrar in a form satisfactory to the registrar. 27(2) A member may at any time provide the registrar with updates to the information provided voluntarily under section 24. 27(3) Within 30 days after receiving information under subsection (1) or (2), the registrar must revise the member's profile if the registrar reasonably believes that the information is accurate. 27(4) If the registrar receives information about a member from a source other than the member that (a) relates to a category of information under subsection 23(1); or (b) is information of the kind that a member may provide voluntarily under section 24; the registrar must take reasonable steps to ensure the information is accurate and, at least 60 days before posting it, notify the member of any proposed changes. OPPORTUNITY TO DISPUTE INFORMATION Profile provided to member before publication 28(1) Each member must be given an opportunity to review his or her profile before it is made available to the public. The registrar may satisfy this requirement by providing the member with an electronic version of the profile. 28(2) Within 60 days after receiving a copy of his or her profile under subsection (1), the member may dispute the factual accuracy of any information in it by submitting to the registrar (a) a written statement detailing the basis of the dispute; and (b) any other information the member considers relevant to the dispute. The onus of proving that the information is factually inaccurate is on the member. 28(3) Despite subsection (2), receipt of a written statement disputing the factual accuracy of information does not affect the registrar's ability to make a pharmacist profile available. However, until a final determination is made under subsection (4), the profile (a) must not include the disputed information; and (b) must include a statement in the relevant category that information in the category is under dispute and is not currently available. 28(4) Upon receipt of a written statement of dispute under subsection (2), the council must review the statement and any other information provided by the member that is relevant to the dispute and (a) revise the information in the profile, if the council determines that the member's position on the dispute is correct; or (b) if the council determines that the member's position on the dispute is incorrect, include the information in the relevant category of information in the profile with a statement that the member disputes the information. MEMBERS MUST PROVIDE INFORMATION If member fails to provide information 29(1) If a member fails to provide the information required under this Part, the registrar may note the failure on the member's profile. 29(2) A member must not wilfully provide false, inaccurate or incomplete information under this Part. PART 6 PHARMACY LICENCES APPLICATION FOR PHARMACY LICENCE Pharmacy licence application 30(1) In addition to the requirements of subsection 64(2) of the Act, an applicant for a pharmacy licence must provide the following to the registrar: (a) confirmation that the pharmacy is located in Manitoba and, subject to section 31, the address and description of the practice of pharmacy being performed at each facility covered by the pharmacy licence; (b) the proposed hours of operation of the pharmacy, including hours for each facility covered by the pharmacy licence; (c) evidence of insurance if required by Part 16; (d) evidence satisfactory to the registrar that the owner, if required by law, is registered to conduct business in Manitoba; (e) the main Uniform Resource Locator (URL) of any website used by or affiliated with the pharmacy and access by the registrar to any website. 30(2) An applicant for a pharmacy licence must apply for one or more of the following categories of pharmacy licence: (a) community pharmacy; (b) hospital pharmacy; (c) clinical practice pharmacy. 30(3) An applicant for a community pharmacy or hospital pharmacy licence must indicate whether one or more of the following additional components to the licence is being applied for: (a) central-fill component described in section 38; (b) secondary hospital component described in section 39; (c) personal care home component described in section 40; (d) distance care component described in section 41; (e) external dispensing component described in section 42; (f) satellite pharmacy described in section 43. 30(4) An applicant for a community pharmacy may also apply for a lock and leave component under section 37. 30(5) An applicant who applies for multiple categories or components of a pharmacy licence must meet the requirements of each category or component applied for. Separate applications if different buildings 31(1) An applicant must apply for separate pharmacy licences if the facility used as a pharmacy is not contained within one building or within one building and an adjoining building. 31(2) Despite subsection (1), a separate application is not required for a facility that is not in the same or adjoining buildings if it is (a) an external dispensing site described in section 42; (b) a satellite facility described in section 43; or (c) used only to store drugs or records or as a home office. 31(3) Every facility that is to be included under a pharmacy licence must be located at a fixed location, and may not be mobile or transportable unless approved by the council. Operation restricted to licence category or component 32(1) The operation of a pharmacy must be restricted to the type of service covered by the category of licence and any components to the licence. 32(2) However, a member may provide care inconsistent with a component of their pharmacy licence if (a) urgent and life threatening patient care is needed; (b) the care will be provided for a period no longer than seven days; and (c) written notice has been given to the registrar. Inspection of newly-licensed premises 33(1) If an application for a pharmacy licence is for a location that is not currently licenced, the registrar may require the pharmacy to be inspected by an inspector appointed under Part 10 of the Act. 33(2) The applicant must provide the following to an inspector carrying out an inspection: (a) a description of the pharmacy services to be provided by the proposed pharmacy; (b) evidence satisfactory to the registrar that the pharmacy has the facilities, equipment, and staff required to operate the pharmacy in a safe and legal manner; (c) a sketch of the physical layout of the proposed pharmacy; (d) if the application includes a lock and leave component, a sketch of the larger retail operation, including a depiction of the area within which the pharmacy is to be located. 33(3) After carrying out an inspection, the inspector must report his or her findings to the registrar and the applicant. CATEGORIES OF PHARMACY LICENCES Community pharmacy licence 34(1) An applicant for a pharmacy licence must specify that the applicant is applying for a community pharmacy licence if (a) the pharmacy will offer the retail sale of drugs to the public; and (b) it is intended that the pharmacy will serve patients or their agents who will attend the pharmacy in person to receive their drugs. 34(2) In addition to the requirements of subsection 30(1), an applicant for a community pharmacy licence must provide evidence satisfactory to the registrar that (a) the facility will be accessible to the public; (b) the hours of operation will meet the needs of the community served by the pharmacy as determined by an hours-of-operation policy set by the council; (c) the facility will be staffed and managed by members who have the requisite knowledge, skill and judgment to operate a community pharmacy; and (d) the facility will comply with practice directions respecting community pharmacies. Hospital pharmacy licence 35(1) An applicant for a pharmacy licence must specify that the applicant is applying for a hospital pharmacy licence if the pharmacy will be located within a hospital and serve in-patients and out-patients of the hospital. 35(2) In addition to the requirements of subsection 30(1), an applicant for a hospital pharmacy licence must provide evidence satisfactory to the registrar that (a) the hours of operation will meet the needs of the hospital or hospitals served by the pharmacy as determined by an hours-of-operation policy set by the council; (b) the facility will comply with the practice directions for a hospital pharmacy; and (c) the facility will be staffed and managed by members who have the knowledge, skill and judgment to operate a hospital pharmacy. Clinical practice pharmacy licence 36(1) An applicant for a pharmacy licence must specify that the applicant is applying for a clinical practice pharmacy licence if (a) the pharmacist or pharmacy will not dispense, prepare for dispensing or sell drugs or products (i) that are listed in the Manual, or (ii) for which a drug identification number or natural health product number has been issued under the Food and Drugs Act (Canada); and (b) either (i) the pharmacist will provide care to patients and advise health care professionals about enhancing patient care, or (ii) the use of the pharmacy is for the sole purpose of training and educating pharmacy personnel. 36(2) An applicant for a clinical practice pharmacy licence must provide evidence satisfactory to the registrar that (a) the hours of operation will meet the needs of the persons served by the pharmacy as determined by an hours-of-operation policy set by the council; (b) the facility will be staffed and managed by members who have the requisite knowledge, skill and judgment to operate a clinical practice pharmacy; and (c) the facility will comply with practice directions respecting a clinical practice pharmacy. COMPONENTS OF COMMUNITY AND HOSPITAL PHARMACY LICENCES Lock and leave component Application for lock and leave component 37(1) An applicant for a community pharmacy licence may apply for a lock and leave component if (a) the pharmacy is located within a larger operation; and (b) the applicant intends to close off the dispensary and the public access to drugs listed on Schedule 3 of the Manual when the larger retail operation remains open. 37(2) In addition to the requirements for a community pharmacy licence, an applicant for a lock and leave component must provide evidence satisfactory to the registrar that (a) the lock and leave component will be open at least 25 hours over a minimum of four days per week, unless the applicant can demonstrate to the council that fewer hours will meet the needs of the community and that a member will be available to respond to patients at least 37.5 hours per week; (b) the lock and leave component will be secure when not in operation and, in particular, that (i) the dispensary will be secured and drugs listed on Schedule 3 of the Manual will not be available for sale, and (ii) no person other than a member or a pharmacy technician will be able to enter the dispensary or access drugs listed on Schedule 3 of the Manual; and (c) the facility will comply with the practice directions for a lock and leave component. Central-fill component Central-fill component 38(1) An applicant for a community pharmacy or hospital pharmacy licence must apply for a central-fill component if the pharmacy will store and prepare drugs for dispensing for other pharmacies. 38(2) An applicant for a central-fill component must provide evidence satisfactory to the registrar that (a) the hours of operation will meet the needs of the pharmacies served by the central-fill pharmacy; (b) the central-fill pharmacy will not interact directly with patients for whom prescription services are provided; (c) the central-fill pharmacy has a quality assurance program relating to work performed at the facility and the pharmacies to which it provides services; and (d) the facility will comply with the practice directions for a central-fill pharmacy. 38(3) Unless a drug is being dispensed for a hospital, a pharmacy that uses the services of another pharmacy with a central-fill component must, before dispensing the drug, inform the patient that (a) the drug will be prepared for dispensing at another facility; and (b) the name of the central-fill pharmacy. Secondary hospital services component Secondary hospital services component 39(1) An applicant for a community pharmacy or hospital pharmacy licence must apply for a secondary hospital services component if the facility will provide pharmacy services for hospital patients. 39(2) An applicant for a secondary hospital services component must provide evidence satisfactory to the registrar that (a) the hours of operation will meet the needs of the hospital or hospitals served by the pharmacy as determined by an hours-of-operation policy set by the council; and (b) the facility will comply with practice directions respecting secondary hospital services. Personal care home component Personal care home component 40(1) An applicant for a community pharmacy licence or hospital pharmacy licence must apply for a personal care home component if the pharmacy will serve residents of a personal care home. 40(2) An applicant for a personal care home component must provide evidence satisfactory to the registrar that (a) the facility will be staffed and managed by members with the requisite knowledge, skill and judgment to serve residents of a personal care home; (b) the hours of operation will meet the needs of the personal care home served by the pharmacy as determined by an hours-of-operation policy set by the council; and (c) the facility will comply with practice directions respecting servicing a personal care home facility. Distance care component Distance care component 41(1) An applicant for a community pharmacy or hospital pharmacy licence must apply for a distance care component if it is intended that the pharmacy will also serve patients who do not reside in Manitoba and who will not attend the pharmacy in person. 41(2) An applicant for a distance care component must provide evidence satisfactory to the registrar that (a) the pharmacy will be open at least 25 hours over a minimum of four days per week; (b) the pharmacy can be contacted by distant patients with reasonable ease and without charge for the contact; (c) a member will be available to respond to contacts from distant patients at least 37.5 hours per week; (d) subject to any regulation made under clause 73(2)⁠(c) of the Act, if the pharmacy serves patients described in subsection (1) who reside outside Canada, the pharmacy must post on any website home page maintained by the pharmacy, and include in any patient care agreement or bulletin for the solicitation of business, a disclaimer approved by the council; and (e) the facility will comply with the practice directions respecting distance care pharmacies. External dispensing component External dispensing component 42(1) The following definitions apply in this section. "external dispensing site" means a place where drugs or medications are stored, prepared and packaged and then dispensed directly to patients. Such a site is either staffed by a pharmacy technician or consists only of a mechanical automated dispensing system.
Part document.segment-2
Pharmaceutical Regulation — segment 2
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Pharmaceutical Regulation — segment 2
This provision sets licensing, operational, record-keeping, supervision, and dispensing rules for Manitoba pharmacies and related pharmacy personnel.
(« centre de distribution externe ») "main pharmacy" means a community pharmacy or hospital pharmacy licensed under this Part that wishes to operate an external dispensing site. (« emplacement principal ») 42(2) An applicant for a community pharmacy or hospital pharmacy licence must apply for an external dispensing component if the pharmacy will operate an external dispensing site. 42(3) An applicant for an external dispensing component must provide evidence satisfactory to the registrar that (a) the external dispensing site will be located in a Manitoba community that does not have reasonable access to pharmacy services as determined by a policy set by the council; (b) the technology and equipment of the external dispensing site will comply with any practice directions respecting external dispensing; (c) the hours of operation of the external dispensing site will meet the needs of the community in which it is located as determined by an hours-of-operation policy set by the council; (d) the external dispensing site will meet the physical requirement set out in the standards of practice; (e) a member will conduct an on-site inspection of the external dispensing site at least once every two months and in compliance with any applicable practice directions; (f) the external dispensing site will be linked to the main pharmacy by computer and by a live two-way video and audio telecommunication link, so that patients and health care professionals can communicate with a member at the main pharmacy, and supervision can be provided to any pharmacy technician at the external dispensing site; (g) the external dispensing site will not be open when the main pharmacy is not, unless the external dispensing site is an automated dispensing system, in which case a member at the main pharmacy must be accessible to patients using a video and audio telecommunication link described in clause (f); (h) the main pharmacy must be accessible to the patients serviced by the external dispensing site at least 37.5 hours per week, contact information must be well publicized, and patients must be able to contact the main pharmacy without charge for the contact; (i) no medication covered by the M3P program is stored or dispensed from the external dispensing site; and (j) the external dispensing site and the main pharmacy must have a policy and procedure manual available setting out the following: (i) the records that must be kept, (ii) the requirement that standards of practice and practice directions regarding patient counselling must be complied with, (iii) the procedures with respect to performing a final check on the packaging or pre-packaging of drugs, container selection, and labelling before dispensing, (iv) the requirement that a pharmacist be involved in the sale of non-prescription scheduled drugs. Satellite pharmacy component Requirements for satellite pharmacy component 43(1) An applicant for a satellite pharmacy component must provide evidence satisfactory to the registrar that (a) the satellite facility will be located in a Manitoba community that does not have reasonable access to pharmacy services as determined by a policy set by the council; (b) the satellite facility and equipment will be suitable to meet the needs of the care provided; (c) non-medicinal products or non-medical devices will not be sold; (d) the satellite pharmacy computer will be linked to the primary pharmacy computer that has access to DPIN; (e) a member will be on-site during all hours of operation; (f) drugs will not be left on-site when the satellite is not open; (g) the telephone number and address of the primary pharmacy will be identified on all printed materials and prescription labels. 43(2) An application under subsection (1) must also describe (a) the needs of the community; (b) the collaborative practice, in which at least one other health care professional in the practice is a physician or a registered nurse (extended practice), that will occur; and (c) the location, suitability for the practice of pharmacy and the hours of operation. LICENCE RENEWALS Renewal of pharmacy licence 44 A pharmacy licence may be renewed upon the applicant meeting the requirements of section 66 of the Act and confirming, in a manner acceptable to the registrar, that no changes have occurred in the premises, operation or ownership of the pharmacy that would affect the existing licence. CHANGES IN PHARMACY OPERATION OR OWNERSHIP If pharmacy closes 45(1) If a pharmacy ceases to operate for any reason, it is the joint responsibility of the owner and the pharmacy manager to (a) advise the registrar in writing as to where the records required to be maintained under the Act and this regulation will be located; (b) arrange for the secure storage of the records for the retention period required under section 79 and ensure that patients are able to access their records during that period in accordance with The Personal Health Information Act ; (c) surrender the pharmacy licence to the registrar for cancellation; (d) dispose of all drugs in a manner permitted by law; (e) remove, cancel or recall any signs and advertising indicating that a pharmacy is being operated at the location; (f) at least 30 days before ceasing operation if reasonably possible, and in accordance with practice directions, inform patients of the closure and (i) provide them with the name and contact information of the pharmacy where patient prescription records are to be transferred, as long as the patient does not advise the pharmacy otherwise, and (ii) inform them that a patient who does not wish their prescription record transferred to the pharmacy mentioned in the notice may require a transfer to another pharmacy specified by the patient; and (g) provide a copy of the notice under clause (f) to the registrar. 45(2) The owner or pharmacy manager must comply with clauses (1)⁠(a) to (e) within seven days of the operation ceasing. But with respect to clause 1(d), the registrar may approve an extension of the seven-day period. 45(3) If a pharmacy ceases operation temporarily, the owner or pharmacy manager must notify the registrar in accordance with practice directions of (a) the nature of the closure; and (b) the arrangements that have been made to ensure continuing patient care during the closure. Ownership changes that may result in licence cancellation 46 The following are changes for the purpose of section 70 of the Act: (a) in the case of a pharmacy owned by a corporation, any disciplinary, criminal or administrative sanction against a legal or beneficial owner, officer or director of the corporation such that clause 64(2)⁠(e) of the Act is no longer met; (b) in the case of a pharmacy owned by a partnership, any disciplinary, criminal or administrative sanction against a partner such that clause 64(2)⁠(e) of the Act is no longer met. Changes about which the registrar must be notified 47(1) If the owner of a pharmacy is a corporation, the owner must advise the registrar of any change (a) in the directors of the corporation; or (b) of the ownership of 50% or more of the voting shares of the corporation. If the requirements of section 64 of the Act and of this Part continue to be met, the licence is unaffected. 47(2) If the owner of a pharmacy is a partnership, the owner must advise the registrar of any change in the members of the partnership, or of the general or limited partnership, or of the managing partner. If the requirements of section 64 of the Act and of this Part continue to be met, the licence is unaffected. 47(3) If the pharmacy manager changes, the owner must advise the registrar of the change and surrender the pharmacy licence to the registrar. Upon payment of the fee prescribed in the by-laws, the registrar must issue a new licence to the owner unless the owner no longer meets the requirements of section 64 of the Act or of this Part. 47(4) If the name of the owner changes, or the name or names under which the pharmacy conducts business changes, the owner must advise the registrar of the change and surrender the pharmacy licence to the registrar. Upon payment of the fee prescribed in the by-laws, the registrar must issue a new licence to the owner, unless the owner no longer meets the requirements of section 64 of the Act or of this Part. 47(5) If a pharmacy moves, or if the premises from which the pharmacy operates are renovated or changed in a substantial way, the owner must advise the registrar of the change, and the registrar may require the owner to surrender the pharmacy licence. Upon payment of the fee prescribed in the by-laws and a pre-opening inspection under section 33, the registrar must issue a new licence to the owner unless the owner no longer meets the requirements of section 64 of the Act or of this Part. 47(6) When an owner is required to advise the registrar about a change under this section, notice must be given to the registrar within seven days of the change, except that 30 days advance notice is required under subsection (4). Change of hours 48 If a pharmacy changes its hours of operation, the pharmacy manager or owner must immediately advise the registrar of the change, and the registrar must note the change in the college records. Converting licence category or component 49(1) If the owner of a pharmacy intends to change the operation in a manner that would require a licence of a different or additional category or component, the owner must, at least 30 days before the anticipated change, apply for a new licence in accordance with this Part. 49(2) If the applicant (a) meets all of the requirements for the issuance of a licence of each requested category or component; and (b) pays the fee specified in the by-laws; the registrar must issue a new pharmacy licence of the appropriate category and components. M.R. 115/2025 Converting licence category or component — extenuating circumstances 50(1) Despite any other provision of this regulation, if, because of extenuating circumstances, the owner of a pharmacy wishes to operate temporarily in a manner that would require a pharmacy licence of a different category or component but is unable to give the 30-day notice required by section 49, the owner must (a) complete the application form approved by the council; (b) advise the registrar of the nature of the operation intended to be conducted; (c) provide evidence satisfactory to the registrar that the owner's temporary operation will not place patient safety at risk; and (d) pay the fee specified in the by-laws. 50(2) The registrar may approve an application under subsection (1) if he or she is satisfied that doing so is necessary to meet the needs of the community. The approval may be for a period of not more than three months, with or without conditions. GENERAL REQUIREMENTS Pharmacy manager requirements 51 In addition to the requirements of subsection 64(3) of the Act, a pharmacy manager must (a) be a member; (b) not be a pharmacy manager at more than one pharmacy, unless approved by the council; and (c) demonstrate to the registrar's satisfaction that he or she will personally and adequately supervise the operation of the pharmacy. Accurate disclosure 52 An applicant for a pharmacy licence must provide information that is truthful and accurate to the best of the applicant's knowledge and, after a licence is issued, must update the information if it changes during the duration of the licence. Safe use of automation 53 A pharmacy manager must take reasonable steps to ensure that any automated or computerized system used in prescription filling processes in the pharmacy, or any component of the pharmacy, are in good working order and perform their intended tasks in a safe, secure and appropriate manner. Permitted business names for pharmacies 54 A pharmacy must conduct business (a) under a single business name, unless otherwise approved by the council; and (b) only under a business name registered to the owner for use in Manitoba under The Business Names Registration Act , or under a valid franchise or use agreement. Licence must be displayed 55 A pharmacy must display its pharmacy licence in a location visible to the public at each facility included under the pharmacy licence. PART 7 STANDARDS OF PRACTICE Standards of practice 56(1) The following standards of practice are established: 1. Patient counselling Each time a drug is dispensed pursuant to a prescription, a member must provide the patient with sufficient information to enable the patient to safely and effectively manage his or her drug therapy. 2. Referring a patient A member must refer the patient to another appropriately qualified regulated health professional when (a) the care or treatment required by the patient is beyond the scope of the member's professional practice or competence; (b) the patient's condition cannot be effectively treated within the practice of pharmacy; or (c) the patient's condition has not adequately or appropriately responded to drug therapy or other therapy provided by the member. 3. Collaborative care A member must work collaboratively with other health care professionals and others who provide care to the patient, as circumstances require, in order to provide integrated care and avoid duplication of services. When a member and one or more other persons are providing care to a patient, the member must (a) treat the other provider with respect; (b) recognize the skills, knowledge, competencies and roles of the other provider, and communicate effectively and appropriately with them; and (c) explain to the patient the member's role and responsibility. 4. Prescribing and dispensing drugs A member who prescribes a drug must provide a written prescription to the patient and advise the patient that he or she may choose to have the prescription dispensed at another pharmacy or by the prescribing member. 5. Administration of drugs A member who administers a drug to a patient must (a) do so only with the patient's authorization; (b) have policies and procedures in place respecting the administration of drugs and be prepared to immediately respond in emergencies, like anaphylaxis; and (c) only administer a drug if the pharmacy has facilities that are appropriate for the administration. 6. Drug distribution A member must comply with the conditions of sale for all prescription and non-prescription drugs, in accordance with applicable legislation, to ensure the safety and quality of drugs being distributed. 7. Test interpretation A member must interpret a patient-administered automated test in a competent and accurate manner. 8. Extemporaneous compounding A member must ensure that extemporaneous compounding is done in a manner that ensures the preparation is safe and of an appropriate consistency and quality. 9. Incidents and discrepancies A member must expeditiously address, document and report incidents, discrepancies and adverse events in dispensing drugs and in providing patient care. 10. Transfer of patient care If a patient or his or her authorized representative requests that the patient's care be transferred to another member or to another health care professional, the member must ensure that a copy of the information specified by the patient is provided to the pharmacy or health professional specified by the patient as promptly as the circumstances require. 11. Termination of relationship with patient A member who terminates a relationship with a patient must have reasonable grounds for doing so and document those reasons on the patient record. The member must give the patient notice of the intention to terminate care and provide such notice as is commensurate with the continuing care needs of the patient. However, advance notice is not required if (a) the patient poses a risk to the member or to others at the practice site or if the patient has failed to respect professional boundaries; and (b) the member provides for continuity of care by offering to provide information to another member. 12. Records and information An owner must not request or require a member to use, disclose or otherwise deal with a record containing the personal health information of a patient in a way that is not consistent with the obligations that a member has under the Act, this regulation, The Personal Health Information Act or under any other law. A member and an owner must create, maintain and retain records as required under the Act and this regulation and in a form and manner that allows them to be accessed as promptly as needed in order to provide patient care and to otherwise comply with the requirements of the Act, this regulation, The Personal Health Information Act and any other law. A pharmacy manager and an owner must ensure that the policies and procedures of the pharmacy are consistent with the obligations that members have under The Personal Health Information Act and any other law. 13. Policies and procedures re safe practice A pharmacy manager must establish, implement and maintain written policies and procedures to (a) identify, mitigate and avoid situations that expose patients and staff to inappropriate risk; (b) ensure safe and effective pharmacy practice; and (c) set out the role of staff in the pharmacy with respect to the matters set out in clauses (a) and (b). 14. Pharmacist to staff ratio A member and an owner must ensure that a pharmacy is operated with a ratio of members to pharmacy technicians, interns, students and other staff or workers that ensures safe and effective pharmacy practice. 15. Pharmacy facilities A pharmacy manager and an owner must ensure that the facilities in the pharmacy are safe, sanitary, appropriate and accessible for the professional practice conducted in the pharmacy. 16. Technology A pharmacy manager and an owner must establish, implement and maintain written policies for the assessment and use of technology that ensures safe and effective pharmacy practice. 17. Drug product acquisition and handling A member is responsible for ensuring the safety, accuracy and quality of the products and services that the member acquires or supplies. 56(2) The standards of practice are subject to any practice directions. PART 8 PRACTICE OF PHARMACY BY INTERNS, TECHNICIANS, STUDENTS AND OTHERS MEMBERS Members 57 Unless permitted by the Act or by this Part, no person other than a member may do any of the following in a pharmacy: (a) receive and record a verbal prescription from a practitioner; (b) assess and approve a prescription for filling or refilling; (c) provide a written or verbal transfer of a prescription or receive such a transfer; (d) engage in an included practice; (e) educate a person or health care professional about a drug or drug therapy. INTERNS Interns 58 In a pharmacy, an intern may engage in any aspect of the practice of pharmacy under a member's supervision, including the practices described in section 57. ACADEMIC REGISTRANTS (PHARMACY RESIDENTS) Academic registrants 59 In a pharmacy, a person on the academic register may engage in any aspect of the practice of pharmacy under a member's supervision, including the practices described in section 57. PHARMACY TECHNICIANS Pharmacy technicians 60(1) In a pharmacy, a pharmacy technician who is qualified under subsection (2) may perform the following tasks under a member's supervision: (a) review the information in a prescription for compliance with federal and provincial law; (b) before a drug is dispensed, perform a final check when the process of preparing the drug for dispensing was performed by another technician, student, intern or a person referred to in section 64, but only if the pharmacy manager has applied to the council for approval of the drug packaging preparation processes used in the pharmacy and the council has approved them; (c) dispense a drug, if a member has approved filling the prescription and the standards of practice related to a member's counselling the patient are met; (d) identify drug-related problems that require referral to a member; (e) give instructions to a person about how to operate a medical device, but not an explanation involving the interpretation of the results or value of the device; (f) ask a practitioner and receive his or her instructions as to whether an existing prescription can be refilled as previously prescribed and without any change to the prescription; (g) perform necessary tasks at an external dispensing site. 60(2) For the purpose of this section, a person is qualified as a pharmacy technician if he or she is at least 18 years of age and has (a) graduated from a program of pharmacy technician training approved by the council, or has successfully completed a bridging educational program approved by the council; (b) passed any examinations approved by the council; (c) successfully completed a structured practical training program approved by the council; (d) submitted an application to the registrar in the form approved by the council; and (e) paid any fees specified in the by-laws. 60(3) The college must maintain a list of pharmacy technicians who are qualified under subsection (2). 60(4) Notwithstanding anything in this section, a pharmacy technician in training may perform the tasks described in subsection (1) under the direct supervision of a member or a pharmacy technician. Continuing qualification of pharmacy technicians 61(1) A person who has met the qualifications of a pharmacy technician set out in subsection 60(2) continues to be qualified if he or she has, in the preceding three-year period, worked as a pharmacy technician for at least 600 hours. 61(2) A pharmacy technician who cannot meet the 600-hour requirement may perform the tasks described in subsection (1) only under a member's direct supervision. 61(3) This section does not apply to a pharmacy technician until three years after he or she first qualifies. STUDENTS Students 62 In a pharmacy, a student may perform the following tasks under a member's direct supervision: (a) compounding, if a member has approved the formulation and process; (b) dispensing, if the member has approved filling the prescription and the standards of practice related to a member's counselling the patient are met; (c) advising on the contents, therapeutic values and hazards of drugs; (d) advising on the use, calibration, effectiveness and hazards of medical devices; (e) identifying and assessing drug-related problems and making recommendations to prevent or resolve them; (f) the tasks that a pharmacy technician may perform under subsection 60(1); (g) the tasks referred to in section 64; (h) educating a patient about their drug or drug therapy; (i) receiving and recording verbal prescriptions. HEALTH PROFESSIONALS Dispensing by health professionals 63 In accordance with practice directions, a member may delegate to a person practising as a health professional under an enactment the task of dispensing a drug, if the member has approved filling the prescription and the standards of practice related to counselling the patient are met. OTHERS PERSONS Other persons 64 The following tasks may be performed in a pharmacy by a person who is not a member, intern, pharmacy technician or student under a member's supervision and in accordance with any practice directions: (a) preparing and pre-packaging a drug for dispensing; (b) selecting an appropriate container; (c) replenishing drug storage containers and dispensing machines; (d) attaching the prescription label to a container; (e) recording and retrieving data about a patient or a prescription; (f) compounding, if a member has approved the formulation and process; (g) entering prescription information into a database; (h) collecting information from a patient for a patient profile; (i) managing drug inventory. GENERAL RESPONSIBILITIES FOR SUPERVISION AND RELATED MATTERS Pharmacy manager's responsibilities re supervision 65(1) A pharmacy manager must take reasonable steps to ensure (a) that the pharmacy under his or her management has developed policies about the tasks that interns, pharmacy technicians, students and other persons may perform in the pharmacy having regard to their skill level and professional development; and (b) that those policies are complied with. 65(2) A pharmacy manager must take reasonable steps to ensure that supervision is provided to interns, pharmacy technicians, students and other persons in accordance with this Part, the standards of practice and practice directions. 65(3) A pharmacy manager must take reasonable steps to ensure that members under his or her supervision (a) are competent in the practice of pharmacy being performed; and (b) do not permit or require a person to do a task, unless that person has the requisite knowledge, skill and judgment to engage in the specified task under supervision. Performance review for pharmacy technicians 66(1) At least once every two years, a pharmacy manager must conduct a performance review for each pharmacy technician, or must ensure that one is conducted. 66(2) The performance review must, for the period since the last review, (a) document the hours worked as a pharmacy technician; (b) include an assessment of the pharmacy technician's job performance in terms of quality of patient care, administrative skills and the ability to work consistently within the rules governing the pharmacy and pharmacy practice; and (c) document the professional development activities the pharmacy technician has participated in that are consistent with the program for professional development established by the council. Owner or manager responsibilities re tasks performed 67 An owner or pharmacy manager must not require a member to have an intern, pharmacy technician, student or other person perform a task under supervision if the member is not satisfied that the person has the requisite knowledge, skill and judgment to perform the task under supervision. Members' responsibilities re supervision 68(1) A member must take reasonable steps to ensure that his or her supervision of interns, students, pharmacy technicians and other persons is provided in accordance with this Part, the standards of practice and practice directions. 68(2) A member must not permit or require a person to do a task unless the member is satisfied that the person has the requisite knowledge, skill and judgment to engage in the specified task under supervision. PART 9 PRESCRIPTIONS AND RECORDS Prescriptions must be authorized 69(1) Except when permitted by this regulation, a drug must not be dispensed unless a practitioner has authorized the prescription in writing or verbally. 69(2) An authorization given in writing must include the practitioner's signature. 69(3) An authorization given verbally must be recorded by the person who receives it, and that person must include in the record the name of the practitioner and must sign or initial the record. 69(4) Except as permitted by a practice direction describing the adaptation of a prescription, a member must not change a prescription without the practitioner's consent. Prescription record requirements 70(1) A drug must not be dispensed unless a prescription record is made setting out the following information: (a) the name and address of the patient for whom the drug is prescribed; (b) the name and address of the practitioner; (c) the name of the drug, as prescribed; (d) the number of refills authorized by the practitioner; (e) the manufacturer of the drug, as dispensed, unless the drug name sufficiently identifies the manufacturer; (f) the strength (where applicable) and quantity of the drug; (g) the directions for use, as prescribed; (h) the date the drug and each refill is dispensed; (i) the total price charged; (j) the signature or initials of the person preparing the drug for dispensing, and of the member, intern, student or pharmacy technician doing the final check if the person who prepared the drug for dispensing was not a member or intern; (k) when the final check of a drug being dispensed is performed by someone who is not a member or intern, the signature or initials of the member approving the prescription for filling or refilling. 70(2) Subsection (1) does not apply to a drug prescribed to an in-patient in a hospital. However, in that case, a prescription record is required that sets out the following: (a) the patient's name and location; (b) the name of the practitioner; (c) the name of the person or persons who prepared the drug for dispensing and performed the final check; (d) the date the drug was prepared for dispensing; (e) the drug name, strength and identification of the manufacturer. Drug labels 71(1) A drug must not be dispensed unless the container in which it is dispensed is marked with the following information: (a) the name of the patient for whom the drug is prescribed; (b) the prescription number; (c) the business name of the pharmacy; (d) the address and telephone number of the pharmacy, or where applicable, the external dispensing site or satellite; (e) the name of the drug, as follows: (i) if a single entity drug, its generic name followed by the name of the manufacturer, (ii) if a multiple entity drug, its trade name; (f) the strength (where applicable) and quantity of the drug; (g) the name or initials of the person preparing the drug for dispensing, and of the member, intern, student or pharmacy technician doing the final check if the person who prepared the drug for dispensing was not a member or intern; (h) the date the drug is dispensed; (i) the name of the practitioner; (j) the directions for use, as prescribed; (k) the total price charged; (l) the number of refills, part-fills or doses remaining. 71(2) Subsection (1) does not apply to a drug dispensed for a hospital in-patient or a personal care home resident, but the container in which the drug is dispensed must be marked in accordance with practice directions. 71(3) The information required under this section must be recorded and retained. Patient profiles 72 A drug must not be dispensed unless a patient profile is made in accordance with practice directions. Patient counselling records 73 A drug must not be dispensed unless the standards of practice and practice directions for counselling patients have been met and a counselling record is made. Central-fill pharmacy records 74 If the pharmacy from which a drug is dispensed is not the pharmacy in which the drug was prepared for dispensing, the following additional rules respecting records and labels apply: (a) the prescription record and prescription label must include the name of the pharmacy in which the drug was prepared for dispensing; (b) the pharmacy preparing the drug for dispensing must retain the original prescription record and the drug label record; (c) the patient profile must document that authority was received from the patient or agent to share the patient's personal and personal health information with the pharmacy preparing the drug; (d) the dispensing pharmacy must retain a copy of the prescription record, drug label record and patient profile; (e) each pharmacy must comply with any additional rules out in the standards of practice and practice directions. Drug acquisition and sales records 75 For a period of five years, every pharmacy manager must keep a record of all acquisitions and sales of drugs, other than those sold at retail that do not require a prescription. Manitoba Prescribing Practices Program (M3P) Schedule 76 The council and the College of Physicians and Surgeons of Manitoba may establish an M3P schedule of drugs. M3P prescription requirements 77 A prescription for a drug listed on the M3P schedule must (a) be dated and signed by an authorized practitioner on a form authorized by the by-laws; (b) prescribe only one drug; and (c) clearly and accurately set out the name and dosage form of the drug, the quantity to be dispensed, and directions for use, including intervals at which the drug is to be taken. M3P dispensing requirements 78(1) A drug listed in the M3P schedule must not be dispensed unless (a) a prescription that complies with section 77 is dated by the authorized practitioner within three days before the day it is presented at the pharmacy for filling; (b) the member doing the final check has taken reasonable steps to ensure patient safety under section 83; and (c) the prescription and patient information is entered in DPIN, subject to a patient's direction under subsection (3). 78(2) If an M3P drug cannot be dispensed under subsection (1), the person requested to dispense it must (a) advise the patient or agent, and the authorized practitioner who issued the prescription, that the prescription will not be filled; (b) record that fact on the prescription form and, subject to a patient's direction under subsection (3), in DPIN; and (c) retain the prescription form, unless the patient or agent requests the prescription be returned, in which case a copy of the prescription form must be retained. 78(3) If a patient directs that his or her identifying information not be entered in DPIN, the pharmacist must enter the prescription information from the prescription form using a health information number that by itself or together with other information available to the holder does not identify the patient. 78(4) This section does not apply to a drug on the M3P schedule that is prescribed (a) by an authorized practitioner who is not licensed in Manitoba, as long as the requirements of this section respecting DPIN are met; or (b) for a patient in a hospital or a resident of a personal care home. Retention of records 79(1) The records required by this Part may be recorded and retained either electronically or in written form, except that (a) if a record requires a signature, it must be an original or electronic signature; and (b) if a record requires initials, the initials must be original or electronic initials. 79(2) A member or owner must retain the following records for at least five years: (a) a prescription record; (b) a drug label; (c) a patient profile; (d) a counselling record; (e) a drug acquisition and sales record; (f) prescriptions, or copies of them, if they were refused to be filled under section 83; (g) a drug administration record; (h) a test interpretation record; (i) a test ordering and results record; (j) where the member is authorized to prescribe, a prescribing record. 79(3) The records that must be retained need not be stored in the pharmacy if they are stored in a secure location that is satisfactory to the registrar. PART 10 RESTRICTIONS ON THE DISPENSING AND SALE OF DRUGS Drugs and substances must be approved by Health Canada 80 A member must not sell, dispense or use in a compounded preparation (a) any drug that is not authorized for sale by Health Canada; or (b) any substance that does not meet the standards listed in Schedule B to the Food and Drugs Act (Canada). Child resistant containers 81(1) Except as provided in this section, a drug must be dispensed in a child resistant container. 81(2) A child resistant container is not required for a drug dispensed for a hospital in-patient or a resident of a personal care home. 81(3) A child resistant container is not required if (a) the patient or agent declares in writing they do not wish a child resistant container and the declaration is reasonable given the patient's circumstances; (b) in the professional judgment of the member who is responsible for dispensing the drug, it is advisable not to use a child resistant container given the particular circumstances; or (c) a child resistant container is not suitable because of the physical form of the drug. No sale of expired drugs 82(1) No person may sell a drug in a pharmacy if (a) its use is limited to a prescribed time period, if that period has expired; (b) it has an expiry date, if that date has expired; or (c) it is unlikely the drug would be fully consumed before its expiry date. 82(2) A product described in subsection (1) must be removed from any public or selling area of the pharmacy and disposed of in accordance with the law. Ensuring patient safety 83 Subject to any practice directions, a member must review each prescription and the patient's record and take appropriate action if necessary with respect to (a) appropriateness of drug therapy; (b) drug interactions; (c) allergies, adverse drug reactions and intolerances; (d) therapeutic duplication; (e) correct dosage, route, frequency and duration of administration and dosage form; (f) contraindicated drugs; (g) any other error in the prescription or potential drug therapy problem not mentioned in clauses (a) to (f); (h) a drug prescribed by a practitioner outside his or her authorized scope of practice; or (i) a drug that has not been prescribed consistent with standards of care and patient safety. Limits on sale of particular drugs 84(1) No member may sell by retail a drug listed in Schedule 2 of the Manual, or a drug with pseudoephedrine as the single active ingredient, unless the member (a) sells the drug from a dispensary to the patient or agent; (b) complies with any standards of practice or practice directions; and (c) has made an assessment that the drugs are appropriate in the patient's circumstances. 84(2) A member must not sell a drug with pseudoephedrine as the single active ingredient in a quantity that results in the purchaser receiving, at the time of purchase, more than 3,600 mg of pseudoephedrine. 84(3) A drug listed in Schedule 1 of the Manual may be sold without a prescription to a practitioner or a member, subject to the Controlled Drugs and Substances Act (Canada). 84(4) A drug listed in Schedule 3 of the Manual must only be displayed for retail sale in an area immediately adjacent to the dispensary and as permitted by any applicable practice direction. 84(5) For certainty, subsection (1) does not apply to the following: (a) naloxone hydrochloride injection, when indicated for emergency use for opioid overdose; (b) naloxone hydrochloride nasal spray, when indicated for emergency use for opioid overdose. M.R. 140/2020 Returning drugs to inventory 85(1) A drug must not be returned to inventory if it has been previously dispensed, unless the following conditions are met: (a) the lot numbers and expiry dates of the drug, where applicable, are directly attached to the dispensed container; (b) the drug has not expired; (c) where each dose of the drug or the container of the drug is sealed, the seal is intact when the drug is returned to the pharmacy; (d) the patient or agent has not been in possession of the dispensed drug; (e) the conditions under which the drug has been stored between the time of dispensing and the time of return are known and appropriate; (f) it is reasonably safe to do so. 85(2) When a drug is returned to inventory, the acquisition record must include the following information: (a) the name of the drug returned; (b) the drug identification number or name of the manufacturer of the drug returned; (c) the strength (where applicable) and quantity of the drug returned; (d) the date of the return; (e) the prescription number of the drug returned, where applicable. Substitution of drugs in hospital pharmacy 86(1) Despite subsection 69(4), a member working in a hospital pharmacy may, upon receiving a prescription to be dispensed to a hospital in-patient, (a) substitute for a drug set out in the prescription a different drug deemed equivalent by the facility formulary; or (b) substitute for a dosage or dosage form set out in the prescription, a different dosage or dosage form deemed equivalent by the facility formulary. 86(2) A substitution under subsection (1) or made under Part 9 of the Act must be recorded and form part of the prescription record. Inducements re prescription drugs 87 Except for the retail sale of a drug not pursuant to a prescription, a member or owner must not — in the course of a member's performance of an activity described under subsection 2(1) of the Act — offer or provide any promotion or event that would give a patient (or agent) more than the usual amount of points, loyalty points or rewards offered as part of an inducement program. PART 11 DISPENSING AND COMPOUNDING BY PERSONS WHO ARE NOT MEMBERS Dispensing practitioners' committee 88(1) There is hereby established a dispensing practitioners' committee (referred to as "the committee" in this Part) consisting of the following members: (a) two members appointed by the council, one of whom is to be chair; (b) one representative appointed by the College of Physicians and Surgeons of Manitoba; (c) one representative appointed by the College of Registered Nurses of Manitoba. 88(2) Each committee member must be appointed for a term of two years, and may be reappointed for additional terms at the discretion of the appointing body. 88(3) If a committee member is unable or unwilling to complete his or her term, a vacancy may be filled by the appropriate appointing body. 88(4) A quorum of the committee is two of its members. A quorum must include representatives from at least two of the appointing bodies, one of whom is a member appointed by the council. 88(5) The committee may consult with any other health care professions and individuals that it considers appropriate. Application by practitioner 89(1) A practitioner who is not a member may apply to the committee to be designated as a dispensing practitioner if he or she (a) practices his or her own profession in a remote community that does not have reasonable access to pharmacy services; and (b) pays to the college the fees provided in the by-laws. 89(2) The committee may grant a designation as a dispensing practitioner to an applicant if it is satisfied that (a) the subject community requires better access to pharmacy services; (b) the applicant has the requisite knowledge, skills and judgment to perform the duties of a dispensing practitioner; and (c) the applicant will comply with the Act, this regulation, any applicable practice directions and any terms and conditions imposed by the committee. 89(3) The committee may grant a designation on any terms and conditions it considers appropriate. 89(4) A decision of the committee to refuse to grant a designation may be appealed to the council, but there is no further appeal. Authority of dispensing practitioner 90 A dispensing practitioner may engage in the practice of pharmacy, except an included practice, to the extent permitted by his or her designation. Pharmacy requirements apply 91(1) A dispensing practitioner must comply with the requirements of the Act concerning the operation of a pharmacy in relation to his or her place of business or operation, but need not obtain a pharmacy licence under Part 7 of the Act. 91(2) Part 10 of the Act (Inspections) applies in respect of a dispensing practitioner's place of business or operation. 91(3) A dispensing practitioner must comply with the Act, this regulation and any applicable practice directions in the same manner as if he or she were a member. 91(4) A dispensing practitioner must use his or her designation only for a purpose that is reasonably within the scope of practice of his or her own profession. Suspending or revoking a designation 92(1) If the committee has reason to believe that a dispensing practitioner has failed to comply with the Act, this regulation or a practice direction, it may (a) impose conditions on the dispensing practitioner's designation; or (b) suspend or revoke the designation. 92(2) The designation of a dispensing practitioner is automatically revoked (a) upon the practitioner ceasing to practice his or her own profession; (b) upon the practitioner ceasing to practice at the place designated in his or her application; or (c) 30 days after the community in which the practitioner practices his or her own profession obtains, in the committee's opinion, reasonable access to pharmacy services. 92(3) A decision under subsection (1) may be appealed to the council, but there is no further appeal. Veterinarians 93 A person licensed in Manitoba to practice veterinary medicine, veterinary surgery or veterinary dentistry is deemed to be a dispensing practitioner under this Part for the purpose of treating animals, fish or fowl, and need not apply for a designation under this Part. PART 12 EXTENDED PRACTICE PHARMACISTS (SPECIALTY PRACTICE) Extended practice pharmacist 94(1) A member must not engage in an included practice unless he or she is registered as an extended practice pharmacist under this Part, or as otherwise permitted by this regulation. 94(2) No person except an extended practice pharmacist may use the designation "extended practice pharmacist", a variation of that title or an equivalent in another language. 94(3) The pharmacist licence of an extended practice pharmacist must note the designation and the specialty or specialties of the member. Registration requirements 95(1) An applicant for registration as an extended practice pharmacist must (a) be a member who is qualified as a specialist in an area described in section 96; (b) submit an application to the board in the form approved by the council; (c) practise or undertake to practise in a collaborative practice that meets the requirements of clause (5)⁠(c); and (d) pay the fee provided for in the by-laws. 95(2) When the requirements of subsection (1) are met, the board must approve the application and direct the registrar to enter the applicant's name on the register of extended practice pharmacists. 95(3) An approval may be made subject to any conditions the board considers appropriate. 95(4) If the board does not approve an application under this section or approves it subject to conditions, the board must give notice to the applicant in writing, with reasons for its decision, and advise the applicant of his or her right to appeal the decision to the council. In that case, section 21 of the Act applies with necessary changes. 95(5) An extended practice pharmacist is entitled to practise as an extended practice pharmacist only as long as (a) the member's registration as a pharmacist and the member's pharmacist licence remain in effect; (b) the member practises in a specialty area described in section 96; and (c) the member practises in a collaborative practice (i) with a physician or a registered nurse (extended practice), or (ii) with a registered nurse who is not a registered nurse (extended practice), if the extended practice advisory committee established under section 99 recommends the collaborative practice and its setting, and the minister approves. Specialty qualifications 96 A member is qualified as a specialist in an area upon providing evidence satisfactory to the registrar that he or she has one or more of the following qualifications: (a) board certification from the American Board of Pharmacy Specialties in one of the following specialties, is currently practising, and has practised for at least 1,000 hours in the two years before applying for registration, in a healthcare setting in one of the following specialty areas: (i) ambulatory care pharmacy, (ii) nuclear pharmacy, (iii) nutrition support pharmacy, (iv) oncology pharmacy, (v) pharmacotherapy, (vi) psychiatric pharmacy; (b) board certification in geriatric medicine from The Commission for Certification in Geriatric Pharmacy, is currently practising, and has practised for at least 1,000 hours in the two years before applying for registration, in a geriatric healthcare setting; (c) a postgraduate clinical degree of Pharmacy (Pharm D, M.Sc. or Ph.D.) from a program approved by the council, is currently practising, and has practised for at least 1,000 hours in the two years before applying for registration, in a healthcare setting and in the specialty area;
Part document.segment-3
Pharmaceutical Regulation — segment 3
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Pharmaceutical Regulation — segment 3
This part sets rules for pharmacists and members on testing, drug administration, prescribing, insurance, advertising, and college communications.
(d) successful completion of the Canadian Diabetes Educator Certification Board examination, is currently practising, and has practised for at least 5,000 hours in the five years before applying for registration, in a diabetes healthcare setting; (e) successful completion of the Certified Respiratory Educator examination administered by the Canadian Network for Respiratory Care, is currently practising, and has practised for at least 5,000 hours in the five years before applying for registration, in a respiratory healthcare setting; (f) certification by the National Certification Board for Anticoagulation Providers, is currently practising, and has practised for at least 5,000 hours in the five years before applying for registration, in a related healthcare setting; (g) certification from any other program approved by the council as equivalent to a program described in this section, coupled with a similar practising requirement. Renewal of registration 97(1) A member is entitled to have his or her registration as an extended practice pharmacist continue upon the member renewing their annual pharmacist license and providing evidence to the registrar that (a) confirms the continued certification under clause 96(a), (b), (d), (e), (f) or (g), if the member's certification is based on qualification under one of those clauses; (b) in the three-year period before the member applies for renewal, the member has engaged in the practice of pharmacy in their area of specialty for at least 600 hours; (c) confirms participation in the college's continuing professional development program under section 17, of which at least 15 hours relate to the member's specialty; and (d) the member meets any additional requirements established by the council. 97(2) If renewal of an extended practice designation is refused under subsection (1), the member may appeal the decision, in which case section 21 of the Act applies with necessary changes. Applicant who has been absent from practice 98 If an applicant who was previously registered as an extended practice pharmacist cannot satisfy the 600-hour requirement of clause 97(1)⁠(b), the registrar may do one or both of the following, in accordance with policies established by the board: (a) register the applicant subject to the condition that the applicant practise under supervision for a specified time period; (b) require the applicant to successfully complete any approved examinations, tests, assessment, training or education that demonstrate to the registrar's satisfaction that the applicant is currently competent to practice as an extended practice pharmacist. Extended practice advisory committee 99(1) The council must establish an extended practice pharmacist advisory committee, consisting of (a) three pharmacists who are members, appointed by the council, one of whom is to be chair; (b) two representatives appointed by the College of Physicians and Surgeons of Manitoba; (c) two representatives appointed by the College of Registered Nurses of Manitoba; (d) three public representatives; and (e) one person appointed by the Deputy Minister of Health, Seniors and Long-Term Care, who is a non-voting member. 99(2) Each committee member must be appointed for a term of two years, and may be reappointed for additional terms at the discretion of the appointing body. 99(3) A vacancy on the committee may be filled by the appropriate appointing body. 99(4) A quorum of the committee is five committee members, and must include a representative from at least two of the appointing bodies and two of the members appointed by the council. 99(5) The committee must, on at least an annual basis, review and make recommendations to the council about the provisions of this regulation, the standards of practice, practice directions and the code of ethics that relate to extended practice pharmacists, including reviewing the outcomes of inspections and audits that relate to extended practice pharmacists. 99(6) The committee may consult with any other health care professions and individuals that it considers appropriate. 99(7) The council is not bound by the committee's recommendations. 99(8) For the purpose of this section, the registrar may share with the committee the results of audits or inspections conducted under Part 10 of the Act. M.R. 115/2025 PART 13 ORDERING TESTS BY MEMBERS Ordering tests — all members 100 Any member may order and receive the results of a screening or diagnostic test specified in Schedule 1 to this regulation in relation to a drug prescribed to a patient, when the purpose of doing so is to monitor the patient's drug therapy regime to ensure that it is safe and optimal. Ordering tests — extended practice pharmacists 101 In addition to the tests permitted by section 100, a member who is an extended practice pharmacist may order and receive the results of a screening or diagnostic test that is within the scope of the member's specialty. Ordering tests re drugs prescribed by members 102 Despite section 100, a member may order a screening or diagnostic test in relation to a drug that a member has prescribed only if the prescribing member is an extended practice pharmacist. Ordering tests — hospital pharmacy 103 A member practising in a hospital pharmacy may, in accordance with hospital policy, order and receive the results of a screening or diagnostic test for a person who is an in-patient of the hospital. In that case, sections 105 and 106 do not apply. Compliance with practice directions 104 A member who orders and receives the results of tests under this Part must comply with any applicable practice directions. General requirements 105(1) Before ordering a screening or diagnostic test, a member must (a) give the patient sufficient information about the reason for ordering the test so that the patient can make an informed decision about whether to have the test; and (b) if the drug in relation to which the test was ordered was dispensed pursuant to a prescription, notify the practitioner who last prescribed the drug of the test to be ordered and the reason for doing so. 105(2) Upon receiving the results of screening or diagnostic test, the member must promptly forward the test results to the practitioner referred to in clause (1)⁠(b), along with recommendations about patient care. Record of tests ordered 106 A member who orders and receives the results of a screening or diagnostic test must make and retain a record of the following: (a) the patient's name and address; (b) the test ordered and the reason for ordering it; (c) the name of the member ordering the test; (d) the date the test was ordered; (e) the results of the test and the date they were received; (f) the practitioner to whom the results were forwarded and the date they were forwarded; (g) any recommendations made to the practitioner and the date they were forwarded. PART 14 ADMINISTRATION OF DRUGS BY MEMBERS Definition of "advanced method" 107 In this Part, "advanced method" means any of the following methods for administering a drug: (a) through intradermal, subcutaneous or intramuscular injection; (b) intravenously through an established central or peripheral venous access device; (c) rectally. MEMBERS MAY ADMINISTER DRUGS Administration of drugs — all members 108(1) A member or an intern may administer a prescription drug or a non-prescription drug to a patient by the following means: (a) orally, including sublingual and buccal; (b) topically, including ophthalmic, otic and intranasal; (c) via inhalation. 108(2) Despite subsection (1), a vaccine may not be administered to a patient who is under the age of seven. Administration of drugs — certified members 109(1) A member may administer a drug using an advanced method only if he or she holds a current certification in that method under section 114. 109(2) A member who is completing a course or program of study for certification in an advanced method may administer a drug using that method if, while doing so, he or she is under the direct supervision of (a) a member who is certified in that method; or (b) another health care professional who is legally permitted and competent to administer a drug using that method. Drugs that may be administered by certified members 110 A member who is certified in an advanced method may use that method to administer any of the following drugs: 1. A member may administer a vaccine that is prescribed by an authorized practitioner to a person who is at least seven years of age, using an advanced method described in clause 107(a) or (b). 2. A member may administer a drug other than a vaccine that is prescribed by an authorized practitioner to a person over the age of five years. 3. A member may administer a vaccine listed in Schedule 2 to this regulation, which is provided under a provincial immunization program free of charge to patients who meet provincial criteria, as long as the member complies with the program requirements. Reporting about vaccine administration 111 A member who administers a vaccine to a patient must report the details of the administration (which may include personal health information as that term is defined in The Personal Health Information Act ) to the electronic public health information network that is operated by the Department of Health. The report must be in the form and be provided at the time that the minister requires. M.R. 132/2022 Collaborative practice required for intravenous administration 112 A member who is certified to administer a drug intravenously through an established central or peripheral venous access line may use that advanced method only when (a) he or she is practising in a collaborative practice with other regulated health professionals, including one or more physicians or registered nurses (extended practice); and (b) the practice meets requirements approved by the council. DRUG ADMINISTRATION RECORD Drug administration record 113 A member who administers a drug to a patient must make and retain a record in the pharmacy of the following: (a) the patient's name and address; (b) the name of the drug and total dose administered; (c) for an advanced method or vaccination by any method, identification of the manufacturer, lot number and expiry date of the drug; (d) for an advanced method, the route of administration and the location on the body where the drug was administered; (e) the name of the member administering the drug; (f) the date and the time of administration; (g) any adverse events; (h) the price, if there is a charge for administration. CERTIFICATION OF MEMBERS IN ADVANCED METHODS Certification of members in advanced methods 114(1) A member who wishes to be certified in an advanced method must (a) establish that he or she has successfully completed the education and training requirements approved by the council; (b) apply to the registrar in the form approved by the council; and (c) pay the fee provided for in the by-laws. 114(2) The registrar may certify a member in an advanced method subject to any conditions the registrar considers advisable. 114(3) If an application for certification in an advanced method is not approved, or is approved subject to conditions, the registrar must (a) give notice to the applicant in writing with reasons for the decision; and (b) inform the applicant of their right to appeal the decision to the council. Sections 21 and 22 of the Act apply with necessary changes to an appeal. Renewal of certification 115(1) A certification under section 114 must be renewed annually in accordance with the by-laws. 115(2) A member must apply for renewal within the time period provided in the by-laws, pay the renewal fee provided in the by-laws and meet the continuing competency requirements approved by the council. 115(3) If an application for renewal is not approved because the applicant has not met the continuing competency requirements, subsection 114(3) applies, with necessary changes. Cancellation or suspension of certification 116 Sections 23 to 25 of the Act apply to the cancellation and suspension of a certification, with necessary changes. REPRESENTATION AS A CERTIFIED MEMBER No representation as certified unless certified 117 No member may represent that they are certified in an advanced method unless they hold current certification under this Part. PART 15 PRESCRIBING BY MEMBERS Prescribing by members 118(1) Subject to this Part, any member may prescribe the following: (a) a drug listed on Schedule 2 of the Manual; (b) a drug listed on Schedule 3 of the Manual; (c) a drug not listed in the Manual if it has been issued a drug identification number or a natural health product number under the Food and Drugs Act (Canada); (d) a medical device approved by Health Canada, in accordance with applicable practice directions. 118(2) Subject to this Part, a member who has completed a training program approved by the council may prescribe a drug included in the category for a condition listed in Schedule 3 to this regulation. 118(3) Subject to this Part, a member who is an extended practice pharmacist may prescribe a drug listed on Schedule 1 of the Manual, within the scope of his or her specialty, in accordance with applicable practice directions. 118(4) If the minister gives the council written notice that a public health emergency exists in all or part of the province, which necessitates that members be able to prescribe a drug or drugs not referred to in subsection (1), the council may approve members to prescribe those drugs, under any conditions the council considers appropriate, until the state of emergency ends. 118(5) Subject to this Part, a member who has completed a training program approved by the council may prescribe a drug for use in the treatment of uncomplicated cystitis if the drug is specified for the treatment of uncomplicated cystitis in a product monograph authorized by Health Canada. M.R. 124/2021 Criteria for prescribing 119 A member may only prescribe when the following conditions are met: (a) the member has made reasonable inquiries for the purpose of assessing whether the drug will be safe and effective in the circumstances of the patient, including (i) the patient's symptoms, (ii) the patient's medical history or information, (iii) the patient's allergies, (iv) other medications the patient may be taking, and (v) any other inquiries reasonably necessary in the circumstances; (b) the member has assessed the patient in person, unless a practice direction permits an assessment that is not in person; (c) the member has complied with applicable practice directions; (d) unless the prescription is being issued for an in-patient of a facility under The Health Services Insurance Act , the member has discussed with the patient or their agent any other reasonable and available therapeutic options and their cost. Controlled substances 120 This Part is subject to the restrictions set out in the Controlled Drugs and Substances Act (Canada) and the regulations made under that Act. Prescribing record 121(1) A member who issues a prescription must make and retain a record of (a) the patient's name and address; (b) the patient's date of birth; (c) the name of the drug or medical device prescribed; (d) the strength (where applicable) and quantity of the prescription drug or the medical device; (e) the directions for use; (f) the number of refills available to the patient; (g) the name of the member issuing the prescription; (h) the date of the prescription; and (i) the treatment goal, diagnosis or clinical indication at the time the prescription was issued. 121(2) A member who issues a prescription must include on the prescription, at the time it is issued, the treatment goal, diagnosis or clinical indication. Continued care prescriptions 122(1) Subject to this section, a member may authorize a refill of a prescription, beyond those authorized by the original practitioner issuing the prescription, if (a) the patient has a continuing need or chronic condition; (b) the prescribing practitioner (i) has died or retired within the previous six months, or (ii) has not responded to an inquiry for refill authorization, and it would be onerous or impossible for the patient to contact or attend the original practitioner issuing the prescription in a timely manner; (c) the patient's history with the prescribed drug has not changed; (d) the patient advises that they have not recently experienced any adverse reactions to the drug that would indicate that the prescription should not be refilled; (e) the prescription was previously filled at the same pharmacy; and (f) the prescription is filled in compliance with any applicable practice directions. 122(2) A member who authorizes a refill under subsection (1) must (a) promptly notify the original practitioner who issued the prescription, unless the practitioner has died or retired; and (b) keep the records noting the pharmacist that authorized the refill and the other prescription records required by Part 9. 122(3) A member must not authorize a refill under subsection (1) if (a) the refill quantity is in excess of the original prescribed refill amount; (b) the drug is a benzodiazepine, unless (i) the drug is used to manage a convulsive disorder, or (ii) there is a serious risk of seizure due to sudden withdrawal; or (c) the patient appears to be using continuing care refills to avoid obtaining ongoing medical care. 122(4) A member prescribing under this section is not required to keep the prescribing record described in subsection 121(1). PART 16 PROFESSIONAL LIABILITY INSURANCE Professional liability insurance 123 Every member, unless registered under section 14 of the Act (emergency registration), must be covered by professional liability insurance that provides a minimum of $2,000,000 per claim or per occurrence and a minimum $4,000,000 annual aggregate. Pharmacy insurance 124 Every owner must be covered by commercial general liability insurance with a minimum limit of $5,000,000. PART 17 ADVERTISING Definitions 125 The following definitions apply in this Part. "advertising" includes printed material, a radio or television advertisement and any other promotional material made available to the public, including by electronic means, for the purpose of promoting a member, a pharmacy or pharmacy services. (« publicité ») "total price" of a drug means the cost of the drug plus the fee for dispensing it. (« prix total ») Restrictions on advertising 126(1) A member or an owner must ensure that any advertising by the member or the pharmacy complies with this Part and with any practice directions. 126(2) A member or an owner must ensure that any advertising that the member or owner places (a) is factual information that is clear and verifiable; (b) does not use descriptive or qualifying words such as "professional", "trusted", "prompt", "licensed", "accurate", "cheap" or words of similar intent; (c) does not claim or purport to claim exclusivity of any aspect of the practice of pharmacy; (d) does not use the word "specialist" or a word with similar meaning, unless the member to whom the advertising relates has been qualified as a specialist under the Act; and (e) is in keeping with the honour and integrity of the image of a pharmacist and the practice of pharmacy. No advertising of controlled drug products 127 A member or an owner must not advertise a drug product that is listed in a Schedule to the Controlled Drugs and Substances Act (Canada). Advertising of usual services 128 When advertising is of pharmacy services that are necessary for the practice of pharmacy under provincial or federal law, the advertising must include the statement "required by law in all Manitoba pharmacies". Advertising prices and fees 129(1) Subject to any practice direction, a member or an owner may advertise the total price of a prescription drug and the fee for dispensing it, if the following conditions are met: (a) the advertising includes the following information: (i) the proprietary name of the drug if it has one, or the name of the manufacturer, (ii) the generic name of the drug, (iii) the dosage form and strength of the drug, (iv) the total price for a specific number of dosage units or quantity of the drug, where that price is the same for all payers or, if the total price varies with the payer, all of the prices must be indicated in the advertisement in the same text size and prominence, and (v) a note that the drug is only available by prescription; (b) if the fee for dispensing the drug is listed separately from the total price of the drug, the member or owner must ensure that the total price of the drug and the fee for dispensing it are indicated in the advertisement in the same text size and prominence. 129(2) The fee for dispensing a prescription drug may only be included in an advertisement if the total price of the drug is included in the same advertisement. Disclosure of fees 130 A member or an owner must disclose the total price of the drug and the fee for dispensing it (a) to a patient at the patient's request; or (b) to a person responsible to pay for the drug if the person is authorized by law to obtain the information. PART 18 COLLEGE COMMUNICATIONS College newsletter 131(1) The council must publish a newsletter and distribute it to members and owners at least four times each calendar year. 131(2) The newsletter may be distributed by mail, facsimile, personal delivery, electronically or through a website. 131(3) Subject to any applicable by-laws, the newsletter may be used to provide notice to members and owners of matters concerning: (a) annual or special general meetings; (b) regulations or consultation about regulations; (c) by-laws; (d) the code of ethics or consultation about the code of ethics; (e) practice directions; (f) council resolutions; (g) any other matter of concern to the profession. Publication of disciplinary and related decisions 132(1) After a decision and any order of the discipline committee is served on the investigated person, the council must publish an article in the next newsletter that summarizes, at a minimum (a) the matters and circumstances considered by the discipline committee; and (b) the findings and orders of the discipline committee; unless the investigated person obtains a stay pending an appeal under section 59 and 61 of the Act. 132(2) Except in the case of a voluntary surrender, if the complaints committee suspends an investigated person's licence or registration under section 40 of the Act, the registrar must immediately notify the profession of the following, and publish that information in the newsletter: (a) when the licence or registration is suspended pending the outcome of proceedings under Part 6 of the Act, a summary of the reasons of the complaints committee; and (b) the name of the investigated person. 132(3) When the registrar cancels or suspends a person's licence or registration under section 23 or 24 of the Act, the council must immediately notify the profession of the following, and publish that information in the newsletter: (a) a summary of the registrar's reasons for the cancellation or suspension; and (b) the name of the person whose licence or registration was cancelled or suspended. PART 19 COMING INTO FORCE Coming into force 133 This regulation comes into force on the day The Pharmaceutical Act , S.M. 2006, c. 37, comes into force. SCHEDULE 1 (Section 100) TESTS THAT A MEMBER MAY ORDER Serum drug levels Serum creatinine Blood Urea Nitrogen International Normalized Ratio Partial Thromboplastin Time Lipid panel HbA1C (glycolated hemoglobin) Blood glucose Thyroid function Complete Blood Count Liver function Electrolytes Iron Indices Vitamin levels Total & Direct Bilirubin Albumin Total Protein SCHEDULE 2 (Section 110) VACCINES THAT A MEMBER MAY ADMINISTER AS PART OF A PROVINCIAL PROGRAM human papillomavirus (HPV) vaccine influenza vaccine pneumococcal vaccine severe acute respiratory syndrome coronavirus 2 (COVID-19) vaccine tetanus-diphtheria-acellular pertussis (Tdap) vaccine tetanus-diphtheria (Td) vaccine M.R. 136/2016 ; 132/2022 ; 81/2024 SCHEDULE 3 (Subsection 118(2)) DRUGS THAT A MEMBER MAY PRESCRIBE (IF TRAINING PROGRAM COMPLETED) Condition Prescription Drug Category (ATC — (anatomic therapeutic chemical classification) Atopic dermatitis Allergic contact dermatitis Irritant contact dermatitis Urticaria D07AA: Corticosteroids, weak (group I) D07AB: Corticosteroids, moderately potent (group II) Acne vulgaris D10AE01: Benzoyl Peroxide D10AF01: Clindamycin D10AF51: Clindamycin, combinations Tinea pedis D01AE: Other antifungals for topical use Candidal stomatitis A07AA02: Nystatin Unspecified haemorrhoids without complication C05AA: Corticosteroids Vasomotor and allergic rhinitis R01AD: Corticosteroids R01AX03: Ipratropium Bromide Seborrhoeic dermatitis (excluding pediatric) D01AE: Other antifungals for topical use Recurrent oral aphthae A01AC: Corticosteroids for local oral treatment Vomiting of pregnancy, unspecified R06AA59: Doxylamine, combinations Smoking Cessation N07BA: Drugs used in nicotine dependence
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