O. Reg. 202/94: GENERAL
under Pharmacy Act, 1991, S.O. 1991, c. 36
Skip to contentPharmacy Act, 1991
Loi de 1991 sur les pharmaciens
ONTARIO REGULATION 202/94
GENERAL
Historical version for the period May 15, 2013 to July 18, 2013.
Last amendment: O. Reg. 154/13.
This Regulation is made in English only.
CONTENTS
Sections | ||
INTERPRETATION |
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1 | ||
GENERAL PROVISIONS RE CERTIFICATES OF REGISTRATION |
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2 | ||
3 | ||
Requirements for Issuance of Certificate of Registration, any Class |
4 | |
5 | ||
REGISTRATION — PHARMACISTS |
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6 | ||
7 | ||
8 | ||
9 | ||
REGISTRATION — REGISTERED PHARMACY STUDENTS |
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10 | ||
11 | ||
12 | ||
REGISTRATION — INTERNS |
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13 | ||
14 | ||
15 | ||
REGISTRATION — PHARMACY TECHNICIANS |
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16 | ||
17 | ||
18 | ||
SUSPENSIONS, RESIGNATIONS, REINSTATEMENTS, ETC. |
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19-21 | ||
22 | ||
23 | ||
24 | ||
25 | ||
NOTICES OF MEETINGS AND HEARINGS |
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26 | ||
27 | ||
ADVERTISING |
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28 | ||
29 | ||
30 | ||
CONTROLLED ACTS |
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31-32 | ||
33-40 | ||
QUALITY ASSURANCE |
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41-42 | ||
43 | ||
44-46 | ||
47-48 | ||
49-50 | ||
51 | ||
INSPECTION OF DRUG PREPARATION PREMISES |
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52 | ||
53 | ||
54-60 | ||
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1. In this Regulation,
“direct supervision” means supervision that is provided by a person who is physically present on the premises where the practice that is being supervised is being carried out;
“non-restricted registration” means the holding of a licence, permit, certificate or registration as a pharmacist from an authority responsible for the regulation of pharmacists in one of the states of the United States of America, or in another non-Canadian jurisdiction that has been approved by the Council, where that licence, permit, certificate or registration is not subject to any restrictions, terms, conditions or limitations, including terms, conditions or limitations that,
(a) relate to the holder’s ability to practise independently,
(b) require the holder to practise under supervision or direction,
(c) require the holder to maintain a position or appointment as a condition of continued registration,
(d) require the holder to practise only in a part of the geographical area over which the authority has jurisdiction,
(e) restrict the holder to temporary or time-limited registration or practice,
(f) were imposed by that authority or any committee or panel of that authority as a result of a disciplinary, registration, fitness to practise or similar proceeding, or
(g) were placed on the holder’s registration by agreement between the holder and that authority;
“pharmacy” has the same meaning as in subsection 1 (1) of the Drug and Pharmacies Regulation Act;
“remote dispensing location” has the same meaning as in subsection 1 (1) of the Drug and Pharmacies Regulation Act. O. Reg. 451/10, ss. 1, 6 (1).
PART II
GENERAL PROVISIONS RE CERTIFICATES OF REGISTRATION
Classes of Certificates of Registration
2. (1) The following are prescribed as classes of certificates of registration:
1. Pharmacist.
2. Registered pharmacy student.
3. Intern.
4. Pharmacy technician. O. Reg. 451/10, s. 1.
(2) Every certificate of registration that was in existence immediately before December 3, 2010 is continued as the equivalent certificate of registration with the same status under this Regulation until such time as it otherwise ceases to be effective. O. Reg. 451/10, s. 1.
(3) Where an application for a certificate of registration had been made but not finally dealt with before December 3, 2010, the application shall be dealt with in accordance with this Regulation as amended by Ontario Regulation 451/10. O. Reg. 451/10, s. 1.
Application for Certificate of Registration
3. A person may apply for a certificate of registration by submitting a completed application in the form provided by the Registrar together with any supporting documentation requested by the Registrar and the applicable fees. O. Reg. 451/10, s. 1.
Requirements for Issuance of Certificate of Registration, any Class
4. (1) The following are requirements for the issuance of a certificate of registration of any class:
1. The applicant must possess sufficient language proficiency, in either English or French, to be able to communicate and comprehend effectively, both orally and in writing.
2. The applicant must not have been found guilty of any offence in any jurisdiction.
3. The applicant must not be the subject of a current proceeding in respect of any offence in any jurisdiction.
4. The applicant must not have been the subject of a finding of professional misconduct, incompetence or incapacity or any like finding in Ontario or any other jurisdiction in relation to pharmacy or any other profession or occupation and must not be the subject of any current professional misconduct, incompetence, or incapacity proceeding or any like proceeding in Ontario or any other jurisdiction in relation to pharmacy or any other profession or occupation.
5. The applicant must be a Canadian citizen or permanent resident of Canada or must hold the appropriate authorization under the Immigration and Refugee Protection Act (Canada) to permit the applicant to engage in the practice of pharmacy in Ontario as a pharmacist, registered pharmacy student, intern or pharmacy technician in the manner permitted by the certificate of registration for which he or she has applied.
6. The applicant’s past and present conduct must afford reasonable grounds for the belief that the applicant,
i. will practise pharmacy with decency, honesty and integrity, and in accordance with the law,
ii. does not suffer from any physical or mental condition or disorder that could affect his or her ability to practise pharmacy in a safe manner,
iii. has sufficient knowledge, skill and judgment to competently engage in the practice of pharmacy authorized by the certificate of registration, and
iv. will display an appropriately professional attitude.
7. The applicant must provide evidence satisfactory to the Registrar that the applicant will have professional liability insurance in the amount and in the form as required by the by-laws as of the anticipated date for the issuance of his or her certificate of registration.
8. The applicant must have paid any fees required under the by-laws for the issuance of the certificate of registration for which the applicant applied. O. Reg. 451/10, s. 1.
(2) The requirement under paragraph 8 of subsection (1) is non-exemptible. O. Reg. 451/10, s. 1.
(3) An applicant must meet all of the requirements for registration within one year following the filing his or her application, but this does not prevent the applicant from filing a new application. O. Reg. 451/10, s. 1.
(4) An applicant shall be deemed not to have satisfied the requirements for the issuance of a certificate of registration if the applicant makes a false or misleading statement or representation in his or her application or supporting documentation. O. Reg. 451/10, s. 1.
Terms, etc., of Every Certificate
5. Every certificate of registration is subject to the following terms, conditions and limitations:
1. The member shall provide to the Registrar the details of any of the following that relate to the member and that occur or arise after the registration of the member:
i. a finding of guilt arising in any jurisdiction relating to any offence,
ii. a charge arising in any jurisdiction relating to any offence,
iii. a finding of professional misconduct, incompetence or incapacity or any like finding in any jurisdiction in relation to pharmacy or any other profession or occupation,
iv. a proceeding for professional misconduct, incompetence or incapacity or any like proceeding in any jurisdiction in relation to pharmacy or any other profession or occupation.
2. The member shall not engage in the practice of pharmacy unless the member is a Canadian citizen or permanent resident of Canada or has authorization under the Immigration and Refugee Protection Act (Canada) permitting the member to engage in the practice of pharmacy in Ontario in the manner permitted by the certificate of registration.
3. The member shall immediately advise the Registrar in writing in the event the member ceases to be a Canadian citizen or permanent resident of Canada or to have authorization under the Immigration and Refugee Protection Act (Canada) permitting the member to engage in the practice of pharmacy in Ontario in the manner permitted by the certificate of registration.
4. If a member to whom paragraph 3 applies subsequently obtains Canadian citizenship or becomes a permanent resident of Canada or attains authorization under the Immigration and Refugee Protection Act (Canada) permitting the member to engage in the practice of pharmacy in Ontario permitted by the certificate of registration, the member shall immediately advise the Registrar in writing of that fact.
5. The member shall maintain professional liability insurance in the amount and in the form as required by the by-laws.
6. A member who fails to meet the condition in paragraph 5 shall immediately advise the Registrar in writing of that fact and immediately cease to engage in the practice of pharmacy until such time as the member obtains professional liability insurance as required in paragraph 5.
7. Where a member to whom paragraph 6 applies subsequently obtains professional liability insurance, the member shall notify the Registrar in writing of that fact and, if requested by the Registrar, shall provide details of that coverage. O. Reg. 451/10, s. 1.
PART III
REGISTRATION — PHARMACISTS
6. (1) The following are additional requirements for the issuance of a certificate of registration as a pharmacist:
1. The applicant must,
i. have a minimum of a baccalaureate degree in pharmacy evidencing the successful completion of a program designed to educate and train persons to be practising pharmacists which was,
A. awarded on or before December 31, 1993 by a constituent faculty of the Association of Faculties of Pharmacy of Canada, or
B. awarded by a university as a result of successful completion of a program which was, at the time of the award, accredited by the Canadian Council for Accreditation of Pharmacy Programs or by another accrediting body approved by the Council for that purpose, or
ii. have a university degree in pharmacy that does not meet the requirements of subparagraph i but that evidences the successful completion of a program designed to educate and train persons to be practising pharmacists, and,
A. have successfully completed a program that, at the time the applicant commenced it, was approved by the Council as one whose graduates should possess knowledge, skill and judgment at least equal to those of current graduates of a program mentioned in sub-subparagraph i B, or
B. have successfully completed the examination provided for in paragraph 4 on the applicant’s first attempt and have successfully completed any further education or training or combination of education and training that was specified by a panel of the Registration Committee to evidence that the applicant possesses knowledge, skill and judgment at least equal to those of current graduates of a program mentioned in sub-subparagraph i B.
2. The applicant must have successfully completed an examination in pharmaceutical jurisprudence approved by the Council for applicants for a certificate of registration as a pharmacist.
3. Subject to subsection (5), the applicant must have successfully completed a structured practical training program approved by the Council, while holding a certificate of registration as an intern and while under the supervision of a preceptor approved by the Registration Committee.
4. The applicant must have successfully completed the qualifying examination of the Pharmacy Examining Board of Canada for pharmacists at a time when the examination was approved by the Council or have successfully completed another examination that has been approved by the Council for that purpose. O. Reg. 451/10, s. 1.
(2) With the approval of the Council, all or any part of a structured practical training program referred to in paragraph 3 of subsection (1) may be completed as part of a program referred to in paragraph 1 of subsection (1), even if the applicant did not hold a certificate of registration as an intern at the time. O. Reg. 451/10, s. 1.
(3) The requirement in paragraph 1 of subsection (1) must be met within two years before the date on which the applicant met all of the other requirements for the issuance of a certificate of registration as a pharmacist unless the applicant,
(a) satisfies the Registrar or a panel of the Registration Committee that the applicant has practised pharmacy within the scope of practice of the profession as set out in section 3 of the Act for at least 600 hours during the three years before the date on which the applicant met all of the other requirements for the issuance of a certificate of registration as a pharmacist in the course of providing patient care while practising as a pharmacist in Canada, the United States of America or another jurisdiction approved by the Council;
(b) undergoes a review of his or her practice conducted in a manner approved by the Registration Committee, meets any requirements regarding continuing education or remediation set by a panel of the Registration Committee within the time set by the panel, and pays the required fees; or
(c) successfully completes the examination referred to in paragraph 4 of subsection (1) within three years of the date on which he or she meets all of the other requirements for the issuance of a certificate of registration as a pharmacist. O. Reg. 451/10, s. 1.
(4) The requirement in paragraph 2 of subsection (1) shall not be considered to be met unless the applicant is issued a certificate of registration as a pharmacist within three years of meeting that requirement. O. Reg. 451/10, s. 1.
(5) An applicant is deemed to have met the requirement in paragraph 3 of subsection (1) if, at the time of application, the applicant,
(a) has successfully completed a structured practical training program which is, in the opinion of the Registration Committee at least equivalent to the program mentioned in paragraph 3 of subsection (1); or
(b) has other education, training or experience that is, in the opinion of a panel of the Registration Committee at least equivalent to the program mentioned in paragraph 3 of subsection (1). O. Reg. 451/10, s. 1.
(6) The requirement in paragraph 3 of subsection (1) shall not be considered to have been met unless the applicant is issued a certificate of registration as a pharmacist within two years of meeting the requirement or within such greater time as is specified by a panel of the Registration Committee. O. Reg. 451/10, s. 1.
(7) Subject to subsection (8), the requirement in paragraph 4 of subsection (1) is not considered to have been met unless the applicant,
(a) successfully completed the examination within three attempts; or
(b) successfully completed the examination on the applicant’s fourth attempt having first successfully completed the further education or training or combination of education and training required by the examining body responsible for the administration of the examination or, if no further education or training was required by that body, the further education or training or combination of education and training, if any, specified by a panel of the Registration Committee. O. Reg. 451/10, s. 1.
(8) Where, by virtue of subsection (7), an applicant is not considered to have met the requirement in paragraph 4 of subsection (1), the applicant may not attempt the examination again until the applicant obtains a new degree mentioned in subparagraph 1 i of subsection (1). O. Reg. 451/10, s. 1.
(9) An applicant is only eligible to take the examination referred to in paragraph 2 of subsection (1) three times in any 24-month period. O. Reg. 451/10, s. 1.
(10) The requirements in paragraphs 1, 3 and 4 of subsection (1) are deemed to have been met by an applicant,
(a) who previously held a certificate of registration as a pharmacist in Ontario; and
(b) who,
(i) satisfies the Registrar or a panel of the Registration Committee that the applicant has practised pharmacy within the scope of practice of the profession as set out in section 3 of the Act for at least 600 hours during the three years before the date on which the applicant met all of the other requirements for the issuance of a certificate of registration as a pharmacist in the course of providing patient care while practising as a pharmacist in Canada, the United States of America or another jurisdiction approved by the Council, or
(ii) undergoes a review of his or her practice conducted in a manner approved by the Registration Committee, meets any requirements regarding continuing education or remediation set by a panel of the Registration Committee within the time set by the panel, and pays the required fees. O. Reg. 451/10, s. 1.
(11) An applicant who has a university degree in pharmacy mentioned in subparagraph 1 ii of subsection (1), and who successfully completes any further education or training or combination of education and training specified by a panel of the Registration Committee shall be deemed to have met the requirement in paragraph 1 of subsection (1) if the applicant,
(a) was registered as an intern on December 3, 2010; or
(b) becomes registered as an intern after December 3, 2010 but before December 3, 2011. O. Reg. 451/10, s. 1.
(12) Subject to subsections (2), (5), (10) and (11) and sections 7 and 8, the requirements in subsection (1) are non-exemptible. O. Reg. 451/10, s. 1.
(13) A reference in this section or section 7 to “all of the other requirements for the issuance of a certificate of registration” includes, without being limited to, a requirement set out in subsection 4 (1) or subsection (1) of this section. O. Reg. 451/10, s. 1.
7. An applicant is deemed to have met the requirements in paragraph 1 of subsection 6 (1) if the applicant meets all the following non-exemptible requirements:
1. The applicant must,
i. hold a non-restricted registration in at least one jurisdiction at the time of application and have held that registration continuously for at least two years, and
ii. satisfy the Registrar or a panel of the Registration Committee that the applicant engaged in the full scope of practice as a pharmacist in that jurisdiction for at least 600 hours.
2. The applicant must,
i. satisfy the Registrar or a panel of the Registration Committee that the applicant has practised pharmacy within the scope of practice of the profession as set out in section 3 of the Act for at least 600 hours during the three years before the date on which the applicant met all of the other requirements for the issuance of a certificate of registration as a pharmacist in the course of providing patient care while practising as a pharmacist in one or more of the jurisdictions where he or she held the non-restricted registration,
ii. undergo a review of his or her practice conducted in a manner approved by the Registration Committee, meet any requirements regarding continuing education or remediation set by a panel of the Registration Committee within the time set by the panel, and pay the required fees, or
iii. successfully complete the examination referred to in paragraph 4 of subsection 6 (1) within three years of the date on which he or she meets all of the other requirements for the issuance of a certificate of registration as a pharmacist. O. Reg. 451/10, s. 1.
8. (1) Where section 22.18 of the Health Professions Procedural Code applies to an applicant the requirements of paragraphs 1, 3 and 4 of subsection 6 (1) are deemed to have been met by the applicant if he or she provides, for each jurisdiction where the applicant holds an out-of-province certificate, a certificate, letter or other evidence satisfactory to the Registrar or a panel of the Registration Committee confirming that the applicant is in good standing as a pharmacist in that jurisdiction. O. Reg. 451/10, s. 1.
(2) Without in any way limiting the generality of subsection (1), “good standing” shall include the fact that,
(a) the applicant is not the subject of any discipline or fitness to practise order or of any proceeding or ongoing investigation or of any interim order or agreement as a result of a complaint, investigation or proceeding; and
(b) the applicant has complied with the continuing competency and quality assurance requirements of the regulatory authority that issued the applicant that out-of-province certificate as a pharmacist. O. Reg. 451/10, s. 1.
(3) An applicant referred to in subsection (1) is deemed to have met the requirements of paragraph 1 of subsection 4 (1) where the requirements for the issuance of the applicant’s out-of-province certificate included language proficiency requirements equivalent to those required by that paragraph. O. Reg. 451/10, s. 1.
(4) Despite subsection (1), an applicant is not deemed to have met a requirement if that requirement is described in subsection 22.18 (3) of the Health Professions Procedural Code. O. Reg. 451/10, s. 1.
Terms, Conditions and Limitations, Part B Pharmacist
9. (1) Every certificate of registration of a pharmacist listed in Part B of the register is subject to the following terms, conditions and limitations:
1. The member shall not provide any care to a patient, whether direct or indirect.
2. The member shall not dispense, sell or compound drugs.
3. The member shall not supervise that part of the pharmacy where drugs are kept.
4. The member shall not be the designated manager of a pharmacy within the meaning of the Drug and Pharmacies Regulation Act.
5. The member shall not supervise the practice of pharmacy of an intern, registered pharmacy student or pharmacy technician.
6. The member shall, when working in a pharmacy or any other environment where patient care is being provided, clearly identify him or herself as a non-practising pharmacist. O. Reg. 451/10, s. 1.
(2) With the prior written approval of the Registrar, and despite paragraphs 1 and 2 of subsection (1), a pharmacist listed in Part B of the register may dispense, sell or compound a drug and provide care to a patient under the direct supervision of a pharmacist who is registered in Part A of the register where the sole purpose is to assist the member in preparing to meet the requirements specified in subsection 46 (3) to transfer a member holding a certificate of registration as a pharmacist who is registered in Part B of the register to Part A of the register. O. Reg. 451/10, s. 1.
(3) Where a member wishes to seek the approval of the Registrar under subsection (2), the member shall provide to the Registrar, in writing, the name of the pharmacist or pharmacists who will be providing the required supervision, the name and address of the pharmacy or pharmacies at which the member proposes to practise under that supervision and the proposed date upon which the member wishes to commence practice. O. Reg. 451/10, s. 1.
(4) Any approval provided by the Registrar under subsection (2) must specify,
(a) the name of the pharmacist or pharmacists who will be required to supervise the member;
(b) the name and address of the pharmacy or pharmacies where the member will be practising; and
(c) the term of the approval, which must not exceed six months. O. Reg. 451/10, s. 1.
(5) Where the Registrar is satisfied that it is appropriate to do so the Registrar may extend the term of the approval provided under subsection (2) but in no case may the combined term exceed one year unless a panel of the Quality Assurance Committee approves of a further extension. O. Reg. 451/10, s. 1.
PART IV
REGISTRATION — REGISTERED PHARMACY STUDENTS
10. (1) It is an additional requirement for the issuance of a certificate of registration as a registered pharmacy student that the applicant must,
(a) have been accepted as a student in a university program referred to in subparagraph 1 i of subsection 6 (1) or in an approved program referred to in sub-subparagraph 1 ii A of that subsection;
(b) be engaged in attaining any education or training referred to in sub-subparagraph 1 ii B of subsection 6 (1); or
(c) be engaged in attaining any education or training specified by a panel of the Registration Committee as a condition for the issuance of another certificate of registration, other than a certificate of registration as a pharmacy technician. O. Reg. 451/10, s. 2.
(2) Subject to section 11, the requirement in subsection (1) is non-exemptible. O. Reg. 451/10, s. 2.
11. (1) Where section 22.18 of the Health Professions Procedural Code applies to an applicant the requirements of subsection 10 (1) are deemed to have been met by the applicant if he or she provides, for each jurisdiction where the applicant holds an out-of-province certificate, a certificate, letter or other evidence satisfactory to the Registrar or a panel of the Registration Committee confirming that the applicant is in good standing as a pharmacy student in that jurisdiction. O. Reg. 451/10, s. 2.
(2) Without in any way limiting the generality of subsection (1), “good standing” shall include the fact that,
(a) the applicant is not the subject of any discipline or fitness to practise order or of any proceeding or ongoing investigation or of any interim order or agreement as a result of a complaint, investigation or proceeding; and
(b) the applicant has complied with the continuing competency and quality assurance requirements of the regulatory authority that issued the applicant that out-of-province certificate as a registered pharmacy student. O. Reg. 451/10, s. 2.
(3) An applicant referred to in subsection (1) is deemed to have met the requirements of paragraph 1 of subsection 4 (1) where the requirements for the issuance of the applicant’s out-of-province certificate included language proficiency requirements equivalent to those required by that paragraph. O. Reg. 451/10, s. 2.
(4) Despite subsection (1), an applicant is not deemed to have met a requirement if that requirement is described in subsection 22.18 (3) of the Health Professions Procedural Code. O. Reg. 451/10, s. 2.
Terms, Conditions and Limitations
12. (1) Every certificate of registration as a registered pharmacy student is subject to the following terms, conditions and limitations:
1. The member,
i. in the case of a member to whom subsection 11 (1) does not apply, shall only engage in the practice of pharmacy while enrolled in and actively participating in a program provided for in subsection 10 (1) or while actively engaged in any education or training specified in that subsection, and
ii. in the case of a member to whom subsection 11 (1) applies, shall only engage in the practice of pharmacy while enrolled in and actively participating in an educational program that is a requirement for the issuance of an applicable out-of-province certificate authorizing practice as an intern or pharmacist.
2. The member may only engage in the practice of pharmacy,
i. while under the direct supervision of a member who holds a certificate of registration as a pharmacist, or
ii. where a program or any education or training provided for in subsection 10 (1) includes a clinical component in a premises that is not a pharmacy but at which drugs may be prescribed or dispensed, while under the direct supervision of a member of a College within the meaning of the Regulated Health Professions Act, 1991 who has been approved for this purpose by the faculty that provides the program, education or training.
3. Despite subparagraph 2 ii, the member shall not dispense, compound or sell a drug unless under the direct supervision of a member holding a certificate of registration as a pharmacist.
4. Despite subparagraph 2 ii, the member may not supervise that part of the pharmacy where drugs are kept.
5. The member may neither delegate a controlled act nor accept the delegation of a controlled act. O. Reg. 451/10, s. 2.
(2) A certificate of registration as a registered pharmacy student automatically expires when the member is issued a certificate of registration as a pharmacist or an intern. O. Reg. 451/10, s. 2.
(3) A certificate of registration as a registered pharmacy student automatically expires,
(a) in the case of a member engaged in a program referred to in subparagraph 1 i of subsection 6 (1), when the member is refused readmission to the program, ceases to be enrolled in the program or ceases to actively participate in the program;
(b) in the case of a member engaged in an approved program referred to in sub-subparagraph 1 ii A of subsection 6 (1), two years after registration as a registered pharmacy student unless that period of time is extended by a panel of the Registration Committee;
(c) in the case of a member engaged in attaining any education or training or combination of education and training referred to in sub-subparagraph 1 ii B of subsection 6 (1) or in attaining any education or training or combination of education and training required by a panel of the Registration Committee as a condition for the issuance of another class of certificate of registration, on the date specified by the panel in its decision or, if no date was specified, one year from that decision, unless extended by a panel of the Registration Committee; and
(d) in the case of a member whose application for a certificate of registration as a registered pharmacy student was considered under subsection 11 (1), on the date on which the member ceases to hold an out-of-province certificate that is equivalent to a certificate of registration as a registered pharmacy student. O. Reg. 451/10, s. 2.
13. (1) The following are additional requirements for the issuance of a certificate of registration as an intern:
1. The applicant must,
i. have a minimum of a baccalaureate degree in pharmacy evidencing the successful completion of a program designed to educate and train persons to be practising pharmacists which was,
A. awarded on or before December 31, 1993 by a constituent faculty of the Association of Faculties of Pharmacy of Canada, or
B. awarded by a university as a result of successful completion of a program which was, at the time of the award, accredited by the Canadian Council for Accreditation of Pharmacy Programs or by another accrediting body approved by the Council for that purpose, or
ii. have a university degree in pharmacy that does not meet the requirements of subparagraph i but that evidences the successful completion of a program designed to educate and train persons to be practising pharmacists, and,
A. have successfully completed a program that, at the time the applicant commenced it, was approved by the Council as one whose graduates should possess knowledge, skill and judgment at least equal to those of current graduates of a program mentioned in sub-subparagraph i B, or
B. have successfully completed the examination provided for in paragraph 4 of subsection 6 (1) on the applicant’s first attempt and have successfully completed any further education or training or combination of education and training that was specified by a panel of the Registration Committee to evidence that the applicant possesses knowledge, skill and judgment at least equal to those of current graduates of a program mentioned in sub-subparagraph i B.
2. Subject to subsections (3) and (4), the applicant must have successfully completed a structured practical training program approved by the Council while holding a certificate of registration as a registered pharmacy student and while under the direct supervision of a preceptor approved by the Registration Committee. O. Reg. 451/10, s. 3.
(2) Subject to subsections (3) and (4) and section 14, the requirements in subsection (1) are non-exemptible. O. Reg. 451/10, s. 3.
(3) With the approval of the Council, all or any part of a structured practical training program referred to in paragraph 2 of subsection (1) may be completed as part of a program referred to in paragraph 1 of subsection (1), even if the applicant did not hold a certificate of registration as a registered pharmacy student at the time. O. Reg. 451/10, s. 3.
(4) An applicant shall be deemed to have met the requirement in paragraph 2 of subsection (1) if, at the time of application, the applicant holds a non-restricted registration as a pharmacist, has held that registration for at least two years and the applicant,
(a) satisfies the Registrar or a panel of the Registration Committee that the applicant engaged in the full scope of practice as a pharmacist in that jurisdiction for at least 600 hours;
(b) successfully completed a structured practical training program which is, in the opinion of a panel of the Registration Committee at least equivalent to a program mentioned in paragraph 2 of subsection (1), or has other education, training or experience that, in the opinion of a panel of the Registration Committee is at least equivalent to the program mentioned in paragraph 2 of subsection (1); or
(c) successfully completed the education and obtained the additional training or experience that a panel of the Registration Committee has specified. O. Reg. 451/10, s. 3.
(5) The requirement of paragraph 2 of subsection (1) shall not be considered to have been met unless the applicant is issued a certificate of registration as an intern within one year of meeting that requirement or within such greater time as is specified by a panel of the Registration Committee. O. Reg. 451/10, s. 3.
(6) An applicant who has a university degree in pharmacy mentioned in subparagraph 1 ii of subsection (1), and who successfully completes any further education or training or combination of education and training specified by a panel of the Registration Committee shall be deemed to have met the requirement in paragraph 1 of subsection (1) if the applicant,
(a) was registered as a registered pharmacy student on December 3, 2010; or
(b) becomes registered as a registered pharmacy student after December 3, 2010 but before December 3, 2011. O. Reg. 451/10, s. 3.
14. (1) Where section 22.18 of the Health Professions Procedural Code applies to an applicant the requirements of subsection 13 (1) are deemed to have been met by the applicant if he or she provides, for each jurisdiction where the applicant holds an out-of-province certificate, a certificate, letter or other evidence satisfactory to the Registrar or a panel of the Registration Committee confirming that the applicant is in good standing as an intern in that jurisdiction. O. Reg. 451/10, s. 3.
(2) Without in any way limiting the generality of subsection (1), “good standing” shall include the fact that,
(a) the applicant is not the subject of any discipline or fitness to practise order or of any proceeding or ongoing investigation or of any interim order or agreement as a result of a complaint, investigation or proceeding; and
(b) the applicant has complied with the continuing competency and quality assurance requirements of the regulatory authority that issued the applicant that out-of-province certificate as an intern. O. Reg. 451/10, s. 3.
(3) An applicant referred to in subsection (1) is deemed to meet the requirements of paragraph 1 of subsection 4 (1) where the requirements for the issuance of the applicant’s out-of-province certificate included language proficiency requirements equivalent to those required by that paragraph. O. Reg. 451/10, s. 3.
(4) Despite subsection (1), an applicant is not deemed to have met a requirement if that requirement is described in subsection 22.18 (3) of the Health Professions Procedural Code. O. Reg. 451/10, s. 3.
Terms, Conditions and Limitations
15. (1) Every certificate of registration as an intern is subject to the following terms, conditions and limitations:
1. The member shall only engage in the practice of pharmacy,
i. when practising in a pharmacy to which the Drug and Pharmacies Regulation Act applies, while under the direct supervision of a member holding a certificate of registration as a pharmacist, or
ii. in all other cases, while under the supervision of a member holding a certificate of registration as a pharmacist.
2. The member shall not supervise that part of the pharmacy where drugs are kept.
3. The member shall not delegate a controlled act. O. Reg. 451/10, s. 3.
(2) A certificate of registration as an intern automatically expires,
(a) when the member is issued a certificate of registration as a pharmacist; or
(b) one year from the date on which it was issued unless a panel of the Registration Committee specifies otherwise. O. Reg. 451/10, s. 3.
PART VI
REGISTRATION — PHARMACY TECHNICIANS
16. (1) The following are additional requirements for the issuance of a certificate of registration as a pharmacy technician:
1. The applicant must,
i. have successfully completed a pharmacy technician program designed to educate and train persons to be pharmacy technicians which was, at the time the applicant graduated, accredited by the Canadian Council for Accreditation of Pharmacy Programs or such other accrediting body approved by the Council for that purpose,
ii. have successfully completed a pharmacy technician program designed to educate and train persons to be pharmacy technicians other than one referred to in subparagraph i or have a university degree or university diploma in pharmacy and, in either case,
A. must have successfully completed a program that, at the time the applicant commenced was approved by the Council as one whose graduates should possess knowledge, skill and judgment at least equivalent to a current graduate of a program referred to in subparagraph i, or
B. must have successfully completed the examination referred to in paragraph 4 on the applicant’s first attempt, and have successfully completed any further education or training or combination of education and training that was specified by a panel of the Registration Committee to evidence that the applicant possesses knowledge, skill and judgment at least equivalent to a current graduate of a program referred to in subparagraph i,
iii. have successfully completed a program before January 1, 2015 that, at the time the applicant commenced was approved by the Council as one whose graduates should possess knowledge, skill and judgment at least equivalent to a current graduate of a program referred to in subparagraph i, or
iv. have met the requirements of paragraph 1 of subsection 6 (1).
2. The applicant must have successfully completed an examination in pharmaceutical jurisprudence approved by the Council for applicants for a certificate of registration as a pharmacy technician.
3. The applicant must have successfully completed a structured practical training program approved by the Council and must have done so under the direct supervision of a preceptor approved by the Registration Committee.
4. The applicant must have successfully completed the qualifying examination of the Pharmacy Examining Board of Canada for pharmacy technicians or successfully completed another examination that has been approved by the Council for that purpose. O. Reg. 451/10, s. 4.
(2) With the approval of the Council, all or any part of a structured practical training program referred to in paragraph 3 of subsection (1) may be completed as part of a program referred to in subparagraph 1i of subsection (1) or sub-subparagraph 1 ii A of subsection (1). O. Reg. 451/10, s. 4.
(3) The requirement in paragraph 1 of subsection (1) must be met within two years before the date on which the applicant met all of the other requirements for the issuance of a certificate of registration as a pharmacy technician unless the applicant,
(a) satisfies the Registrar or a panel of the Registration Committee that the applicant has practised pharmacy within the scope of practice of the profession as set out in section 3 of the Act under the supervision or direction of a pharmacist for at least 600 hours during the three years before the date on which the applicant met all the other requirements for the issuance of a certificate of registration as a pharmacy technician and did so while practising as a pharmacy technician in Canada or in another jurisdiction approved by the Council;
(b) meets any requirements regarding any further education or training or a combination of education or training, if any, set by a panel of the Registration Committee within the time set by the panel; or
(c) successfully completes the examination referred to in paragraph 4 of subsection (1) within three years of the date on which he or she meets all of the other requirements for the issuance of a certificate of registration as a pharmacy technician. O. Reg. 451/10, s. 4.
(4) The requirement of paragraph 2 of subsection (1) shall not be considered to have been met unless the applicant is issued a certificate of registration as a pharmacy technician within three years of meeting that requirement. O. Reg. 451/10, s. 4.
(5) An applicant is only eligible to take the examination referred to in paragraph 2 of subsection (1) three times in any 24-month period. O. Reg. 451/10, s. 4.
(6) The requirement in paragraph 3 of subsection (1) shall not be considered to have been met unless the applicant,
(a) is issued a certificate of registration as a pharmacy technician within two years of meeting that requirement;
(b) satisfies the Registrar or a panel of the Registration Committee that the applicant has practised pharmacy within the scope of practice of the profession as set out in section 3 of the Act under the supervision or direction of a pharmacist for at least 600 hours during the three years before the date on which the applicant met all the other requirements for the issuance of a certificate of registration as a pharmacy technician and did so while practising as a pharmacy technician in Canada or in another jurisdiction approved by the Council; or
(c) meets any requirements regarding any further education or training or a combination of education or training, if any, set by a panel of the Registration Committee within the time set by the panel. O. Reg. 451/10, s. 4.
(7) Subject to subsection (8), paragraph 4 of subsection (1) is not considered to have been met unless the applicant,
(a) successfully completed the examination within three attempts; or
(b) successfully completed the examination on the applicant’s fourth attempt having first successfully completed the further education or training or combination of education and training required by the examining body responsible for the administration of the examination or, if no further education or training was required by that body, the further education or training or combination of education and training, if any, that was specified by a panel of the Registration Committee. O. Reg. 451/10, s. 4.
(8) Where, by virtue of subsection (7), an applicant is not considered to have met the requirement in paragraph 4 of subsection (1), the applicant may not attempt the examination again until the applicant successfully completes a new program mentioned in subparagraph 1 i of subsection (1). O. Reg. 451/10, s. 4.
(9) An applicant shall be deemed not to have met the requirement of subparagraph 1 iii of subsection (1) unless, before January 1, 2012 and before commencing the program referred to in that subparagraph, the applicant successfully completed,
(a) the College’s Pharmacy Technician Certification Examination;
(b) the Pharmacy Technician Evaluating Examination of the Pharmacy Examining Board of Canada; or
(c) another examination approved by the Council. O. Reg. 451/10, s. 4.
(10) Subject to subsection (2) and section 17, the requirements in subsection (1) are non-exemptible. O. Reg. 451/10, s. 4.
(11) A reference in this section to “all of the other requirements for the issuance of a certificate of registration” includes, without being limited to, a requirement set out in subsection 4 (1) or subsection (1) of this section. O. Reg. 451/10, s. 4.
17. (1) Where section 22.18 of the Health Professions Procedural Code applies to an applicant the requirements of paragraphs 1, 3 and 4 of subsection 16 (1) are deemed to have been met by the applicant if he or she provides, for each jurisdiction where the applicant holds an out-of-province certificate, a certificate, letter or other evidence satisfactory to the Registrar or a panel of the Registration Committee confirming that the applicant is in good standing as a pharmacy technician in that jurisdiction. O. Reg. 451/10, s. 4.
(2) Without in any way limiting the generality of subsection (1), “good standing” shall include the fact that,
(a) the applicant is not the subject of any discipline or fitness to practise order or of any proceeding or ongoing investigation or of any interim order or agreement as a result of a complaint, investigation or proceeding; and
(b) the applicant has complied with the continuing competency and quality assurance requirements of the regulatory authority in that issued the applicant that out-of-province certificate as a pharmacy technician. O. Reg. 451/10, s. 4.
(3) An applicant referred to in subsection (1) is deemed to meet the requirements of paragraph 1 of subsection 4 (1) where the requirements for the issuance of the applicant’s out-of-province certificate included language proficiency requirements equivalent to those required by that paragraph. O. Reg. 451/10, s. 4.
(4) Despite subsection (1), an applicant is not deemed to have met a requirement if that requirement is described in subsection 22.18 (3) of the Health Professions Procedural Code. O. Reg. 451/10, s. 4.
Terms, Conditions and Limitations
18. Every certificate of registration as a pharmacy technician is subject to the following terms, conditions and limitations:
1. The member shall only engage in the practice of pharmacy,
i. when practising in a pharmacy to which the Drug and Pharmacies Regulation Act applies, other than a remote dispensing location, while under the direct supervision of a member holding a certificate of registration as a pharmacist, or
ii. in all other cases, while under the supervision or direction of a member holding a certificate of registration as a pharmacist.
2. When practising in a pharmacy to which the Drug and Pharmacies Regulation Act applies the member shall not supervise that part of a pharmacy where drugs are kept.
3. The member shall not delegate a controlled act.
4. The member shall not provide information or education relating to drug use, either to or for a patient, where the provision of the information requires therapeutic knowledge, clinical analysis or clinical assessment. O. Reg. 451/10, ss. 4, 6 (2).
PART VII
SUSPENSIONS, RESIGNATIONS, REINSTATEMENTS, ETC.
19. (1) If a member fails to provide information about the member in the manner and in the form as required under the by-laws, the Registrar may give the member notice of intention to suspend the member and may suspend the member’s certificate of registration for failure to provide the information 60 days after notice is given. O. Reg. 451/10, s. 5.
(2) Where the Registrar suspends a member’s certificate of registration under subsection (1), the Registrar shall lift the suspension upon being satisfied that the required information has been filed with the College and that any fees required for the lifting of that suspension has been paid. O. Reg. 451/10, s. 5.
20. (1) If, pursuant to the by-laws, the College requests evidence that the member holds professional liability insurance in the amount and in the form as required by the by-laws and the member fails to provide that evidence within 14 days of having been requested to do so, the Registrar shall immediately give the member notice of intention to suspend the member and may suspend the member’s certificate of registration for failure to provide the evidence 30 days after notice is given. O. Reg. 451/10, s. 5.
(2) Where the Registrar suspends the member’s certificate of registration under subsection (1), the Registrar shall lift that suspension upon being satisfied that the member holds professional liability insurance in the amount and in the form required by the by-laws and that any fee required for the lifting of that suspension has been paid. O. Reg. 451/10, s. 5.
21. Where the Registrar suspends a member’s certificate of registration under section 24 of the Health Professions Procedural Code for failure to pay a fee, the Registrar shall lift the suspension upon being satisfied that the member,
(a) has paid all amounts owed to the College;
(b) holds professional liability insurance in the amount and in the form required by the by-laws; and
(c) pays any fees required for the lifting of that suspension. O. Reg. 451/10, s. 5.
22. (1) A member shall be deemed to have resigned where,
(a) the member’s certificate of registration was suspended for failure to pay a fee that the member was required to pay in accordance with the regulations or by-laws and that suspension continued for 120 days; or
(b) the member’s certificate of registration was suspended pursuant to subsection 19 (1) or subsection 20 (1) and the suspension continued for 60 days. O. Reg. 451/10, s. 5.
(2) The resignation is effective,
(a) in the case of a resignation under clause (1) (a), on the 121st day following the commencement of that suspension;
(b) in the case of a suspension under clause (1) (b), on the 61st day following the commencement of the suspension. O. Reg. 451/10, s. 5.
23. A member who resigns, or whose certificate of registration is suspended or revoked shall, if so requested, immediately return to the College,
(a) his or her certificate of registration; and
(b) any card or other form of identification issued to him or her by the College for the purpose of identifying him or her as a member of the College. O. Reg. 451/10, s. 5.
24. (1) A former member who held a certificate of registration as a pharmacist or pharmacy technician and who resigned as a member of the College may apply for the reinstatement of his or her certificate of registration by submitting a completed application to the Registrar in the form provided by the Registrar. O. Reg. 451/10, s. 5.
(2) Subject to subsections (3), (4) and (6), the Registrar may reinstate the former members certificate of registration if,
(a) the former member has paid,
(i) the required reinstatement fee,
(ii) the annual fee for the year in which the certificate of registration is to be reinstated, if not previously paid,
(iii) the annual fee for the year in which the former member resigned or was deemed to have resigned, if not previously paid unless the Registrar is satisfied that the former member did not engage in the practice of pharmacy in Ontario during that year, and
(iv) any other money owed by the former member to the College at the date the application for reinstatement is submitted, including, without being limited to, any penalty fees that were due at the time that he or she ceased to be a member and any costs or expenses ordered to be paid under section 53.1 of the Health Professions Procedural Code, any costs awarded to the College by a Court and any amount owing to the College under a by-law or former regulation made under the Act;
(b) the application for reinstatement was submitted to the Registrar within three years of the date on which the former member resigned or in the case of a former member who was deemed to have resigned under subsection 22 (1), three years from the date on which the former member was suspended where that suspension resulted in a deemed resignation; and
(c) the application meets the requirement set out in paragraph 7 of subsection 4 (1) with necessary modifications. O. Reg. 451/10, s. 5.
(3) A former member is ineligible for reinstatement under subsection (2) if he or she,
(a) is the subject of a proceeding for professional misconduct, incompetence or incapacity in Ontario or any like proceeding in any other jurisdiction in relation to the practice of pharmacy or another profession, or was the subject of such a proceeding, other than a proceeding that was completed on its merits;
(b) was, at the time he or she ceased to be a member or at any time since, the subject of a proceeding in respect of,
(i) any criminal offence in any jurisdiction,
(ii) any offence relating to the use, possession or sale of drugs in any jurisdiction,
(iii) any offence arising in any jurisdiction relating to the practice of pharmacy or any other profession or occupation, or
(iv) any offence under the Controlled Drugs and Substances Act (Canada);
(c) was, after he or she ceased to be a member, found guilty of,
(i) any criminal offence in any jurisdiction,
(ii) any offence relating to the use, possession or sale of drugs in any jurisdiction,
(iii) any offence arising in any jurisdiction relating to the practice of pharmacy or any other profession or occupation, or
(iv) any offence under the Controlled Drugs and Substances Act (Canada);
(d) is the subject of an inquiry or investigation by the Registrar, a committee, a panel of a committee or a board of inquiry of the College, or was the subject of such an inquiry or investigation, that was not completed on its merits or which resulted in the member’s resignation;
(e) was, at the time he or she ceased to be a member, the subject of an outstanding order or requirement of a committee, a panel of a committee, or a board of inquiry of the College;
(f) was, at the time he or she ceased to be a member, in breach of an order or requirement of a committee, a panel of a committee, or a board of inquiry of the College;
(g) was, at the time he or she ceased to be a member, in violation of a decision of a panel of the Inquiries, Complaints and Reports Committee or of any predecessor committee, including a decision requiring the member to attend to be cautioned;
(h) was, at the time he or she ceased to be a member, in breach of any written agreement with or undertaking provided to the College; or
(i) had, at the time he or she ceased to be a member, terms, conditions or limitations on his or her certificate of registration, other than those applicable to all members of the class of certificate of registration he or she previously held. O. Reg. 451/10, s. 5.
(4) A former member must meet all of the requirements set out in subsection (2) within one year of submitting his or her application for reinstatement. O. Reg. 451/10, s. 5.
(5) Nothing in this section prevents a former member from making any number of applications for reinstatement or from making an application for a new certificate of registration. O. Reg. 451/10, s. 5.
(6) A former member who is seeking reinstatement of a certificate of registration as a pharmacist and who is otherwise eligible for the reinstatement shall be reinstated into Part B of the register unless the former member satisfies the Registrar that,
(a) the former member did not resign at a time when the member had been selected for but had not successfully completed a practice review under the College’s Quality Assurance Program; and
(b) the member had performed at least 600 hours of patient care in Canada, the United States of America or another jurisdiction approved by the Council during the period of three years commencing immediately before the date of the member’s resignation. O. Reg. 451/10, s. 5.
Reinstatement, Pursuant to Order
25. If a former member’s certificate of registration is ordered to be reinstated by a panel of the Discipline Committee or of the Fitness to Practise Committee, the Registrar shall reinstate the certificate of registration upon payment of,
(a) the required reinstatement fee; and
(b) the annual fee for the year in which the certificate of registration is to be reinstated, if not previously paid. O. Reg. 451/10, s. 5.
PART VII.1
NOTICES OF MEETINGS AND HEARINGS
26. (1) The Registrar shall ensure that notice of every Council meeting that is required to be open to the public under the Act is given in accordance with this section. O. Reg. 451/10, s. 5.
(2) The notice must be published at least 14 days before the date of the meeting in a daily newspaper of general circulation throughout Ontario. O. Reg. 451/10, s. 5.
(3) The notice must be in English and French. O. Reg. 451/10, s. 5.
(4) The notice must contain the following information:
1. The date, time and place of the meeting.
2. A statement of the purpose of the meeting. O. Reg. 451/10, s. 5.
(5) The Registrar shall provide the information contained in the notice to every person who requests it by telephone. O. Reg. 451/10, s. 5.
27. (1) The Registrar shall ensure that the information concerning an impending hearing by a panel of the Discipline Committee to deal with allegations of professional misconduct or incompetence made against a member is given, in accordance with this section, to a person who requests the information. O. Reg. 451/10, s. 5.
(2) The information shall be given,
(a) at least 14 days before the date of the hearing, if the request is received 14 days before the date of the hearing; or
(b) as soon as possible after the request is made, if the request is received after that time but before the date of the hearing. O. Reg. 451/10, s. 5.
(3) The information given shall be as follows:
1. The name of the member against whom the allegations have been made.
2. The member’s principal place of practice.
3. The date, time and place of the hearing.
4. A statement of the purpose of the hearing. O. Reg. 451/10, s. 5.
(4) The Registrar shall provide the information in French to a person who requests that the information be provided in French, wherever reasonably possible. O. Reg. 451/10, s. 5.
28. (1) In this section,
“advertisement” includes an announcement, directory listing or other form of communication similar to an advertisement;
“drug services” means one or more of the compounding, dispensing or sale by retail of drugs or the provision of information or advice with respect to drugs. O. Reg. 451/10, s. 5; O. Reg. 59/11, s. 1 (1, 2).
(2) A member shall not, through any medium, publish, display, distribute or use, or permit, directly or indirectly, the publication, display, distribution or use through any medium of, an advertisement relating to drug services that,
(a) is false, misleading or deceptive, whether as a result of the inclusion of information or the omission of information;
(b) is not readily comprehensible to the persons to whom it is directed;
(c) is not dignified and in good taste;
(d) contains anything that cannot be verified;
(e) contains testimonials, comparative statements or endorsements;
(f) contains a reference to a member’s area of practice or to a procedure or treatment available from a member practising in the pharmacy, unless the advertisement discloses whether or not the member has an area of expertise and, if the member does have such an area of expertise, the particular expertise;
(g) contains references to a particular brand of equipment used to assist in providing drug services;
(h) contains information that is not relevant to the choice of a pharmacist; or
(i) contains any representations as to the safety or effectiveness or an indication for use of any drug referred to in Schedule I established by the regulations under the Drug and Pharmacies Regulation Act.
(j) Revoked: O. Reg. 59/11, s. 1 (4).
O. Reg. 451/10, s. 5; O. Reg. 59/11, s. 1 (3, 4).
(3) An advertisement by a member that includes price information relating to drugs referred to in Schedule I established by the regulations under the Drug and Pharmacies Regulation Act shall include the price information for at least 15 different drugs, 10 of which each belong to a different one of the following drug classifications:
1. Anti-infective agents.
2. Antineoplastic agents.
3. Autonomic agents.
4. Blood formation and coagulation drugs.
5. Cardiovascular drugs.
6. Central nervous system drugs.
7. Diagnostic agents.
8. Electrolytic, caloric and water balance drugs.
9. Cough preparations.
10. Eye, ear, nose and throat preparations.
11. Gastrointestinal drugs.
12. Gold compounds.
13. Heavy metal antagonists.
14. Hormones and substitutes.
15. Oxytocics.
16. Skin and mucous membrane preparations.
17. Spasmolytics.
18. Unclassified therapeutic agents.
19. Vitamins. O. Reg. 451/10, s. 5; O. Reg. 59/11, s. 1 (5).
(4) Where an advertisement by a member includes price information relating to drugs referred to in Schedule I established by the regulations under the Drug and Pharmacies Regulation Act, the advertisement shall include at a minimum the following information with respect to each drug:
1. The quantity of the drug being advertised at the advertised price.
2. The total cost for the drug to the purchaser including any dispensing fee.
3. The time period during which the advertised price will be available. O. Reg. 59/11, s. 1 (6).
(5) An advertisement by a member that includes price information relating to drugs referred to in Schedule I established by the regulations under the Drug and Pharmacies Regulation Act shall include, in addition to the price information referred to in subsection (4), the following information with respect to each advertised drug:
1. The strength of the drug.
2. The brand name of the drug.
3. The dosage form of the drug. O. Reg. 59/11, s. 1 (6).
(6) Where an advertisement by a member includes price information relating to drugs referred to in Schedule I established by the regulations under the Drug and Pharmacies Regulation Act, equal prominence shall be given to each drug and, for each of those drugs, equal prominence shall be given to all the information required under subsections (4) and (5). O. Reg. 59/11, s. 1 (6).
(7), (8) Revoked: O. Reg. 59/11, s. 1 (6).
Professional Misconduct re Advertising
29. It is professional misconduct for the purposes of clause 51 (1) (c) of the Health Professions Procedural Code for a member who advertises price information with respect to a drug referred to in Schedule I established by the regulations under the Drug and Pharmacies Regulation Act to charge any purchaser, including the executive officer under the Ontario Drug Benefit Act more for the drug than the member has advertised, pursuant to paragraph 2 of subsection 28 (4), as the total cost for the drug to the purchaser including any dispensing fee. O. Reg. 59/11, s. 2.
Clarification re Application of Part
30. Nothing in this Part prohibits a member from publishing, displaying, distributing or using, or permitting directly or indirectly the publication, display, distribution or use of, an advertisement that relates solely to the co-payment or dispensing fee charged by the member for supplying a drug that is a listed drug product under the Ontario Drug Benefit Act to an eligible person under that Act. O. Reg. 451/10, s. 5.
31. In this Part,
“adapt” means to change a patient’s prescription respecting,
(a) the dose of the prescribed drug,
(b) the dosage form of the prescribed drug,
(c) the directions for use of the prescribed drug, or
(d) the route of administration for taking the prescribed drug,
but does not include therapeutic substitution;
“Part A pharmacist” means a member who holds a certificate of registration as a pharmacist and who is listed in Part A of the register;
“prescriber” means a person who is authorized under the laws of a province or territory of Canada to give a prescription within the scope of his or her practice of a health profession;
“prescription” means a direction from a prescriber directing the dispensing of a drug or mixture of drugs for a specific patient;
“renew” means to provide a patient with a prescription that repeats a prescription previously provided to that patient;
“therapeutic substitution” means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent. O. Reg. 302/12, s. 1.
32. (1) Where the provisions of this Part are inconsistent with a law of Canada respecting prescriptions, including those related to a targeted substance, the law of Canada shall prevail and the provisions of this Part to the extent they are inconsistent with that law shall not apply. O. Reg. 302/12, s. 1.
(2) Where the provisions of this Part are inconsistent with the provisions of the Narcotics Safety and Awareness Act, 2010, the provisions of that Act shall prevail and the provisions of this Part, to the extent they are inconsistent with that Act, shall not apply. O. Reg. 302/12, s. 1.
33. A member shall not perform a controlled act under paragraph 2, 3, 4 or 5 of subsection 4 (1) of the Act except in accordance with this Part. O. Reg. 302/12, s. 1.
34. (1) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a member referred to in subsection (2) who meets all the requirements in subsection (3) is authorized to perform the following acts:
1. Administering a substance specified in Table 1 to this Regulation by injection to a patient.
2. Administering a substance specified in Table 2 to this Regulation by inhalation to a patient. O. Reg. 302/12, s. 1.
(2) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration. O. Reg. 302/12, s. 1.
(3) A member may only perform an act provided for in subsection (1) if he or she complies with the following:
1. The member may only perform the act for the purpose of patient education and demonstration, and before performing the act,
i. must explain that purpose to the patient or his or her authorized agent, and
ii. must receive an informed consent from the patient or his or her authorized agent.
2. The member shall ensure that he or she only performs the act in an environment that is clean, safe, private and comfortable for the patient.
3. The member shall ensure that appropriate infection control procedures are in place.
4. The member must possess sufficient knowledge, skill and judgment respecting the substance to be administered, and sufficient understanding of the condition of the patient, to be able to administer the substance safely.
5. The member must consider whether administering a substance by injection or inhalation to the patient is appropriate, given the known risks and benefits to the patient and the safeguards and resources available to safely manage the outcome after administration and any other relevant circumstances.
6. The member must maintain a patient record that includes,
i. the name and address of the patient,
ii. the name and address of the member,
iii. the date the act was performed,
iv. the name, strength (where applicable) and quantity of the substance that the member administered to the patient,
v. the circumstances relating to the administration of the substance to the patient and any adverse reaction experienced by the patient, and
vi. confirmation that an informed consent was given by the patient or his or her authorized agent. O. Reg. 302/12, s. 1.
(4) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a Part A pharmacist is authorized to administer influenza vaccine by injection to a patient who is five years of age or older, if the Part A pharmacist,
(a) administers the vaccine in accordance with Ontario’s Universal Influenza Immunization Program as described on the Ministry’s website;
(b) receives an informed consent from the patient or his or her authorized agent; and
(c) meets all the requirements in paragraphs 2 to 6 of subsection (3). O. Reg. 302/12, s. 1.
35. (1) For the purposes of paragraph 3 of subsection 4 (1) of the Act, a member referred to in subsection (3) who complies with the other requirements of this section is authorized to prescribe the following specified drugs:
1. Varenicline Tartrate.
2. Bupropion Hydrochloride. O. Reg. 302/12, s. 1.
(2) A drug mentioned in subsection (1) may only be prescribed by a member for the sole purpose of smoking cessation. O. Reg. 302/12, s. 1.
(3) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform the act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration. O. Reg. 302/12, s. 1.
(4) A member may only prescribe a drug under this section if he or she,
(a) possesses sufficient knowledge, skill and judgment respecting the drug and the patient’s condition to prescribe the drug for the patient;
(b) has considered whether prescribing the drug for the patient is appropriate, given the known risks and benefits of prescribing the drug for the patient and other relevant factors respecting the patient;
(c) gives the prescription to the patient or his or her authorized agent;
(d) advises the patient or his or her authorized agent, at the time of giving the prescription, that he or she may elect to take it to a pharmacy of his or her choosing for dispensing;
(e) notifies the patient’s primary care provider (if any) within a reasonable time, that the member prescribed a drug for the patient and provides details respecting the prescription; and
(f) complies with the additional requirements under sections 37 and 38. O. Reg. 302/12, s. 1.
36. (1) For the purposes of paragraph 4 of subsection 4 (1) of the Act, a member referred to in subsection (3) who complies with the other provisions of this section is authorized to perform the following acts:
1. Adapting a patient’s prescription.
2. Renewing a patient’s prescription for the purpose of continuity of care. O. Reg. 302/12, s. 1.
(2) Subsection (1) does not authorize a member referred to in subsection (3) to adapt or renew a prescription for a controlled substance as defined in the Controlled Drugs and Substances Act (Canada) or a drug designated as a monitored drug by the regulations under the Narcotics Safety and Awareness Act, 2010. O. Reg. 302/12, s. 1.
(3) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration. O. Reg. 302/12, s. 1.
(4) A member may only perform an act provided for in subsection (1) if he or she complies with the following:
1. The member must either possess the patient’s prescription to be adapted or renewed or,
i. receive a copy of the prescription directly from the pharmacy where the prescription was dispensed to the patient,
ii. be satisfied based on verbal confirmation from a pharmacist at the pharmacy where the prescription was dispensed to the patient as to the existence and details of the prescription, or
iii. have access to the medical record that contains information about the prescription.
2. If the member is renewing a prescription, he or she must not prescribe a quantity of the drug that exceeds the lesser of,
i. the quantity that was originally prescribed, including any refills that were authorized by the prescriber, and
ii. a six months’ supply.
3. The member must, within a reasonable time, notify the prescriber identified on the prescription adapted or renewed by the member, as well as the patient’s primary care provider if the member knows that the patient has such a care provider other than the prescriber, providing details about the patient’s prescription, when the member,
i. renews a patient’s prescription, or
ii. adapts a patient’s prescription, if, in the member’s opinion,
A. adapting the prescription is clinically significant in relation to the patient, or
B. the notification is necessary to support the patient’s care.
4. At the time that the member adapts or renews the patient’s prescription, the member must advise the patient or his or her authorized agent,
i. that he or she is entitled to the prescription, and
ii. that he or she may take the prescription to a pharmacy of his or her choosing for dispensing.
5. The member must comply with the additional requirements under sections 37 and 38. O. Reg. 302/12, s. 1.
37. A member who performs an act provided for in section 35 or 36 must ensure that the following information is recorded on the prescription:
1. The name and address of the patient for whom the drug is prescribed.
2. The name, strength (where applicable) and quantity of the prescribed drug.
3. Directions for the use of the drug, including its dose, frequency, route of administration and any special instructions.
4. The name, address, telephone number and College registration number of the member issuing the prescription.
5. The date the prescription was issued by the member.
6. If applicable, reference to the prescription that the member adapted or renewed, including the name and contact details of the original prescriber.
7. The number of refills that the member authorized, if applicable.
8. Any other information required by law. O. Reg. 302/12, s. 1.
38. A member who performs an act under section 35 or 36 must maintain a patient record that includes details of the member’s rationale for his or her decision to act under section 35 or 36 and the following information, if applicable:
1. Reference to, or a copy of, the patient’s prescription that the member renewed or adapted, including the name and contact information of the prescriber.
2. A copy of the prescription that the member gave to the patient or his or her authorized agent under clause 35 (4) (c) or that the member gave to the patient or his or her authorized agent to take to a pharmacy of their choosing under paragraph 4 of subsection 36 (4).
3. A record of the results of laboratory or other tests that the member considered in making the decision to act under section 35 or 36.
4. The date on which the member notified the following persons, as applicable, and the method by which the notification occurred:
i. The patient’s primary care provider notified under clause 35 (4) (e) or paragraph 3 of subsection 36 (4).
ii. The patient’s prescriber notified under paragraph 3 of subsection 36 (4). O. Reg. 302/12, s. 1.
39. (1) For the purposes of paragraph 5 of subsection 4 (1) of the Act, a member referred to in subsection (2) who meets all the requirements in subsection (4) is authorized to perform the act of piercing a patient’s dermis with a lancet-type device to obtain blood. O. Reg. 302/12, s. 1.
(2) A member who is a Part A pharmacist, an intern, a registered pharmacy student or a pharmacy technician is authorized to perform the act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration. O. Reg. 302/12, s. 1.
(3) A pharmacy technician shall not perform the act provided for in subsection (1) unless,
(a) a Part A pharmacist is physically present on the premises at the time when the pharmacy technician performs the act; and
(b) the pharmacy technician is under the direction of a Part A pharmacist at the time when the pharmacy technician performs the act. O. Reg. 302/12, s. 1.
(4) A member may only perform the act provided for in subsection (1) if he or she complies with the following:
1. The member may only perform the act for the purpose of demonstrating the appropriate use of lancet-type devices for the patient’s self care and education or for the patient’s self monitoring of his or her chronic disease, and before performing the act,
i. shall explain that purpose to the patient or his or her authorized agent, and
ii. shall receive an informed consent from the patient or his or her authorized agent.
2. The member shall ensure that he or she only performs the act in an environment that is clean, safe, private and comfortable for the patient.
3. The member shall ensure that appropriate infection control procedures are in place.
4. The member must possess the knowledge, skill and judgment respecting the performance of the act and understand the condition of the patient, to perform it safely and effectively.
5. The member must consider whether performing the act on the patient is appropriate, given the known risks and benefits to the patient and the safeguards and resources available to safely manage the outcome and any other relevant circumstances.
6. The member must maintain a patient record that includes,
i. the name and address of the patient and the member,
ii. the date the act was performed, and
iii. confirmation that an informed consent was given by the patient or his or her authorized agent. O. Reg. 302/12, s. 1.
40. Revoked: O. Reg. 451/10, s. 5.
41. In this Part,
“assessor” means an assessor appointed under section 81 of the Health Professions Procedural Code;
“Committee” means the Quality Assurance Committee. O. Reg. 98/98, s. 2.
42. The Committee shall administer the quality assurance program, which shall include the following components:
1. Maintenance of a portfolio of continuous learning.
2. Maintenance of a two-part register for pharmacist members.
3. Practice review and remediation.
4. Remediation of behaviour and remarks of a sexual nature. O. Reg. 98/98, s. 2.
43. (1) A pharmacist shall maintain a portfolio of continuous learning activities in accordance with guidelines on such activities published by the College and distributed to the members.
(2) A pharmacist shall submit the portfolio to the College on request. O. Reg. 98/98, s. 2.
Two-Part Register for Pharmacists
44. (1) The part of the College’s register that lists pharmacists shall have a Part A (patient care) and a Part B (no patient care). O. Reg. 451/10, s. 7.
(2) Every pharmacist shall be listed in either Part A or Part B. O. Reg. 451/10, s. 7.
45. (1) Upon being issued a certificate of registration as a pharmacist for the first time, the member shall ask to be listed in Part A or Part B of the register by completing and submitting the form provided by the Registrar. O. Reg. 451/10, s. 7.
(2) Every year at the time of paying the annual membership fee, a pharmacist shall ask for a renewal of his or her listing in Part A or Part B or for a transfer to the other Part. O. Reg. 451/10, s. 7.
(3) A member who asks for a renewal of a listing in Part A after the third anniversary of being issued a certificate of registration as a pharmacist for the first time shall not be listed in that Part unless he or she has dispensed, sold or compounded drugs, provided non-prescription drugs, health care aids and devices or information related to drug use for at least 600 hours during the preceding three years in the course of providing patient care while practising the profession in Canada. O. Reg. 451/10, s. 7.
46. (1) A pharmacist may ask for a transfer from Part A of the register to Part B or from Part B to Part A at any time. O. Reg. 451/10, s. 7.
(2) If a member listed in Part A asks for a transfer to Part B, the member shall be transferred to Part B. O. Reg. 451/10, s. 7.
(3) If a member listed in Part B asks for a transfer to Part A, the member shall be transferred to Part A if he or she,
(a) undergoes a practice review in accordance with section 47; and
(b) satisfies the educational and practice requirements that may be specified by the Quality Assurance Committee. O. Reg. 451/10, s. 7.
(4) If the Registrar proposes to reject a request for a transfer to Part A, the request shall be referred to a panel of the Quality Assurance Committee. O. Reg. 451/10, s. 7.
(5) The member shall be given a reasonable opportunity to make written submissions to the panel before it makes a decision. O. Reg. 451/10, s. 7.
(6) A member whose request to be listed in Part A is rejected by the panel may appeal to another panel of the Quality Assurance Committee. O. Reg. 451/10, s. 7.
(7) No member of a panel that rejects a request to be listed in Part A shall sit on a panel hearing an appeal of that decision. O. Reg. 451/10, s. 7.
(8) On an appeal, the member shall be given a reasonable opportunity to make written submissions to the panel before it makes a decision. O. Reg. 451/10, s. 7.
Practice Review and Remediation
47. (1) Each year the College shall select at random the names of pharmacists required to undergo a practice review.
(2) A pharmacist listed in Part A is required to undergo a practice review if his or her name is selected at random or the member is referred to the Committee by the Complaints Committee or Executive Committee.
(3) If a pharmacist listed in Part A fails to undergo a required practice review, the Committee may transfer the pharmacist to Part B after giving him or her a reasonable opportunity to make written submissions.
(4) A pharmacist listed in Part B is required to undergo a practice review if he or she is referred to the Committee by the Complaints Committee or Executive Committee or if the pharmacist has asked to be listed in Part A under subsection 46 (3).
(5) The Committee shall appoint an assessor to conduct a practice review.
(6) The assessor shall prepare a written report on the review and submit it to the Committee.
(7) After considering the report, the Committee may decide,
(a) that no further action is required;
(b) that the pharmacist is required to undertake the remediation specified by the Committee to correct any deficiency in his or knowledge, skills or judgment identified by the review; or
(c) that the pharmacist is to be listed in Part A where the review took place pursuant to a request to be listed in Part A.
(8) If the Committee proposes to require a pharmacist to undertake remediation under clause (7) (b), it shall not do so unless,
(a) the pharmacist has been given a report of the results of the review;
(b) the pharmacist has been given written notice of the Committee’s intention to require him or her to undertake remediation;
(c) the pharmacist has been given at least 14 days from receipt of the notice to make written submissions to the Committee; and
(d) the Committee has considered any such submissions.
(9) After the pharmacist undertakes the specified remediation, the Committee may require him or her to undergo another practice review by an assessor, and subsections (6), (7) and (8) apply to that review. O. Reg. 98/98, s. 2.
48. (1) If the Committee requires a pharmacist to undertake remediation under section 47 and the pharmacist either fails to do so or fails to successfully complete the remediation, the Committee may direct the Registrar to impose terms, conditions or limitations on the pharmacist’s certificate of registration for a specified period not exceeding six months.
(2) If the Committee proposes to make a direction under subsection (1), it shall not do so unless,
(a) the pharmacist has been given written notice of its intention;
(b) the pharmacist has been given at least 14 days from receipt of the notice to make written submissions to the Committee or to request an appearance before the Committee in order to make oral submissions; and
(c) the Committee has considered any such submissions.
(3) A pharmacist who requests an appearance under clause (2) (b) shall be given a reasonable opportunity to appear but the Committee may dispose of the matter if he or she has been given a reasonable opportunity to appear and does not.
(4) If the period specified under subsection (1) expires and the pharmacist still has not undertaken or successfully completed the remediation, the Committee may report him or her to the Executive Committee and provide it with such information as it considers appropriate, except information that may not be disclosed under section 83 of the Health Professions Procedural Code.
(5) If the Registrar imposes terms, conditions or limitations on a pharmacist’s certificate of registration for a specified period pursuant to a direction given by the Committee under subsection (1), the Committee may direct the Registrar to remove the terms, conditions or limitations before the end of the specified period if the Committee is satisfied that they are no longer needed.
(6) After directing the imposition of terms, conditions or limitations on a pharmacist’s certificate of registration for a specified period not exceeding six months under subsection (1), the Committee may direct the imposition of terms, conditions or limitation on the pharmacist’s certificate of registration for a second specified period not exceeding six months under subsection (1) but, after having done so, the Committee shall not direct the imposition of terms, conditions or limitations on the pharmacist’s certificate of registration for any further specified period.
(7) If the Committee directs a second imposition of terms, conditions or limitations on the pharmacist’s certificate, subsections (2), (3), (4) and (5) apply with respect to the second imposition. O. Reg. 98/98, s. 2.
Remediation of Behaviour and Remarks of a Sexual Nature
49. (1) This section applies to matters referred to the Committee by,
(a) a panel of the Complaints Committee under subsection 26 (3) of the Health Professions Procedural Code; and
(b) the Executive Committee under section 79.1 of the Code.
(2) The chair of the Committee shall establish a panel from among the members of the Committee for the purpose of considering a matter referred to in subsection (1).
(3) The chair of the Committee shall appoint a mediator to attempt to resolve the matter.
(4) If the mediator is unable to resolve the matter within 90 days after being appointed, the mediator shall report the failure to the chair without delay and provide the chair with a written report on the mediation.
(5) The chair shall give the member complained against a copy of the mediator’s report and a notice advising him or her of the right to make written submissions to the panel.
(6) The member shall be given at least 14 days after receipt of the mediator’s report and recommendations to make written submissions to the panel or to request an appearance before the panel to make oral submissions, or to do both.
(7) A member who requests an appearance shall be given a reasonable opportunity to make an appearance, but the panel may dispose of the matter without such appearance if the member has been given a reasonable opportunity to appear.
(8) If the mediation concerns a matter referred by the Complaints Committee, the chair shall give the complainant a copy of the mediator’s report.
(9) A mediator’s proposed resolution of a matter referred to the Committee by the Complaints Committee must be acceptable to the complainant, the member complained against and the panel.
(10) A mediator’s proposed resolution of a matter referred to the Committee by the Executive Committee must be acceptable to the member complained against and the panel.
(11) After considering the mediator’s report and any written or oral submissions, the panel may require the member to undergo an assessment for the purpose of establishing if he or she requires education with respect to sexual abuse.
(12) The assessment shall be carried out by an assessor appointed by the Committee.
(13) The assessor shall provide a written report to the panel and shall make such recommendations as the assessor considers appropriate about the member’s need for education with respect to sexual abuse.
(14) A copy of the report and recommendations, and a notice informing him or her of the right to make submissions in accordance with subsections (6) and (7), shall be provided to the member.
(15) After considering the assessor’s report and recommendations and the member’s submissions, if any, the panel may require the member to attend or participate in a sexual abuse education program.
(16) If the panel proposes to take action under subsection (15), the member has the right to make submissions in accordance with subsections (6) and (7). O. Reg. 98/98, s. 2.
50. (1) If a member refuses to undergo an assessment under subsection 49 (11) or to attend or participate in a program under subsection 49 (15), the panel may direct the Registrar to impose terms, conditions or limitations on the member’s certificate of registration for a specified period not exceeding six months.
(2) If the panel proposes to take action under subsection (1), the member has the right to make submissions in accordance with subsections 49 (6) and (7).
(3) If the panel is satisfied that the terms, conditions and limitations imposed on a member’s certificate or registration are no longer needed, it shall direct the Registrar to remove them before the end of the specified period.
(4) If, at the end of the specified period, the member continues to refuse to undergo the required assessment or to attend or participate in the program, the panel shall refer the matter to the Executive Committee. O. Reg. 98/98, s. 2.
51. (1) The Committee may sit as a panel to consider a report on a practice review or any matter arising out of a practice review, a matter relating to the imposition of terms, conditions or limitations on a member’s registration under section 48 or a matter under section 49.
(2) A panel shall have at least three members appointed by the chair of the Committee from among the Committee members; at least one member of the panel shall be a member appointed to the Committee by the Lieutenant Governor in Council.
(3) Three members of a panel constitute a quorum. O. Reg. 98/98, s. 2.
PART IX
INSPECTION OF DRUG PREPARATION PREMISES
52. This Part applies to the College and members as of the day that it comes into force, except that,
(a) sections 54, 55, 56, 59 and 60 apply as of 90 days from the day that this Part comes into force; and
(b) the requirements in subsection 57 (1) and section 58 apply as of 30 days from the day that this Part comes into force. O. Reg. 154/13, s. 1.
53. (1) In this Part,
“designated member” means,
(a) the member designated for a drug preparation premises in accordance with section 58, or
(b) where only one member engages in or supervises drug preparation activities at or in connection with a drug preparation premises, that member;
“drug” means a substance or a preparation containing a substance referred to in clauses (a) to (d) of the definition of “drug” in subsection 1 (1) of the Drug and Pharmacies Regulation Act, but does not include,
(a) a substance or preparation referred to in those clauses that is manufactured, sold or represented for use in animals or fowl, or
(b) a substance or preparation referred to in clause (e), (f), (g), (h) or (i) of that definition;
“drug preparation activities” means reconstituting, diluting or otherwise preparing a drug or combining, admixing or mixing together two or more substances, at least one of which is a drug, to create a final product for the purposes of the sale or provision to another person, other than pursuant to or in anticipation of a prescription;
“drug preparation premises” means any place where a member engages in drug preparation activities, or where drug preparation activities take place that a member supervises, but does not include,
(a) a pharmacy in respect of which a valid certificate of accreditation has been issued under the Drug and Pharmacies Regulation Act,
(b) a premises in respect of which a valid establishment licence has been issued under the Food and Drugs Act (Canada), or
(c) a hospital or a health or custodial institution approved or licensed under any general or special Act;
“inspector” means a person appointed by the College to carry out an inspection on behalf of the College;
“supervise” means to supervise either directly or indirectly. O. Reg. 154/13, s. 1.
(2) Anything that may be done by the College under this Part may be done by the Council or by a committee established under clause 94 (1) (i) of the Health Professions Procedural Code. O. Reg. 154/13, s. 1.
54. (1) All drug preparation premises are subject to inspection by the College in accordance with this Part. O. Reg. 154/13, s. 1.
(2) In carrying out an inspection of a drug preparation premises under subsection (1), the College may also require any or all of the following:
1. Inspection, examination or testing regarding any equipment, instrument, materials or any other thing that may be used in the drug preparation premises.
2. Examination and copying of books, accounts, reports, records or similar documents that are, in the opinion of the College, relevant to the member’s practice with respect to the drug preparation activities at or in connection with the drug preparation premises.
3. Inquiries or questions to be answered by the member that are relevant to the member’s practice with respect to the drug preparation activities at or in connection with the drug preparation premises.
4. Direct observation of a member in his or her practice with respect to drug preparation activities at or in connection with the drug preparation premises. O. Reg. 154/13, s. 1.
55. An inspector may, on the production of information identifying him or her as an inspector, enter and have access to any drug preparation premises at reasonable times and may inspect the drug preparation premises and do any of the things mentioned in subsection 54 (2) on behalf of the College. O. Reg. 154/13, s. 1.
56. (1) It is the duty of every member engaging in or supervising drug preparation activities at or in connection with drug preparation premises that are subject to an inspection to,
(a) submit to an inspection of the drug preparation premises in accordance with this Part;
(b) promptly answer a question or comply with a requirement of the inspector that is relevant to an inspection under this Part; and
(c) co-operate fully with the College and the inspector who is conducting an inspection of a drug preparation premises in accordance with this Part. O. Reg. 154/13, s. 1.
(2) A member shall not engage in or supervise drug preparation activities at or in connection with a drug preparation premises where an inspector has been denied entry or access. O. Reg. 154/13, s. 1.
57. (1) No member shall commence engaging in or supervising drug preparation activities at or in connection with drug preparation premises unless the member has previously given notice in writing to the College in accordance with subsection (5) of the member’s intention to do so. O. Reg. 154/13, s. 1.
(2) Where a member has provided notice in writing to the College in accordance with subsection (1) and the drug preparation premises have not passed an inspection or passed an inspection with conditions within the previous five years, the College shall ensure that an inspection of the drug preparation premises is performed within 60 days from the day that the College receives the member’s notice or 150 days from the day this Part comes into force, whichever is later. O. Reg. 154/13, s. 1.
(3) A member who engages in or supervises drug preparation activities at or in connection with a drug preparation premises as of the day that is 30 days from the day this Part comes into force shall give notice in writing to the College in accordance with subsection (5) within 90 days from the day this Part comes into force. O. Reg. 154/13, s. 1.
(4) The College shall ensure that an inspection of the drug preparation premises with respect to which a member gives notice under subsection (3) is performed within 150 days from the day this Part comes into force. O. Reg. 154/13, s. 1.
(5) The notice required in subsections (1) and (3) shall include the following information, submitted in the form and manner required by the College:
1. The full name of the member giving the notice and the full name of the individual or corporation who is the owner or occupier of the drug preparation premises, if he or she is not the member who is required to give notice under this section.
2. The full address of the drug preparation premises.
3. The date when the member first began engaging in or supervising drug preparation activities at or in connection with the drug preparation premises or the proposed date when the member intends to begin engaging in or supervising drug preparation activities at or in connection with the drug preparation premises.
4. Any other information the College requires that is relevant to an inspection of the drug preparation premises conducted under this Part. O. Reg. 154/13, s. 1.
58. Where two or more members engage in or supervise drug preparation activities at or in connection with a drug preparation premises, the members shall designate a member as the designated member for the drug preparation premises, and shall immediately notify the College of the designated member’s identity. O. Reg. 154/13, s. 1.
59. All drug preparation premises are subject to an inspection by the College once every five years after the initial inspection of the premises or more often if, in the opinion of the College, it is necessary or advisable to do so. O. Reg. 154/13, s. 1.
60. (1) After an inspection of a drug preparation premises, the College shall determine, in accordance with the accepted standards of practice, whether the drug preparation premises pass, pass with conditions or fail. O. Reg. 154/13, s. 1.
(2) In determining whether drug preparation premises pass, pass with conditions or fail an inspection, the College may consider,
(a) the inspection results provided to the College by the inspector;
(b) information provided by one or more members engaging in or supervising drug preparation activities at or in connection with the drug preparation premises respecting the inspection, including the answers given by them in response to inquiries or questions asked by the inspector;
(c) the information contained in a notice given by a member under subsection 57 (1) or (3);
(d) any submissions made by the member or members engaging in or supervising drug preparation activities at or in connection with the drug preparation premises that are relevant to the inspection; and
(e) any other information that is directly relevant to the inspection of the drug preparation premises conducted under this Part. O. Reg. 154/13, s. 1.
(3) The College shall deliver a report, in writing and in accordance with section 39 of the Regulated Health Professions Act, 1991, to the individual or corporation that is the owner or occupier of the drug preparation premises and to the designated member for the drug preparation premises, within a reasonable time after the inspection is completed. O. Reg. 154/13, s. 1.
(4) Any report made by the College respecting an inspection of drug preparation premises where a member is engaging in or in respect of which the member is supervising drug preparation activities shall make a finding that the drug preparation premises passed, passed with conditions or failed the inspection and shall provide reasons where the drug preparation premises passed with conditions or failed the inspection. O. Reg. 154/13, s. 1.
(5) Any report made by the College that finds that drug preparation premises failed an inspection or passed with conditions is effective on the day that it is received, in accordance with section 39 of the Regulated Health Professions Act, 1991, by the designated member for the drug preparation premises. O. Reg. 154/13, s. 1.
(6) The designated member who receives a report made by the College that finds that a drug preparation premises failed an inspection or passed with conditions shall promptly provide copies of the report to all members engaging in or supervising drug preparation activities at or in connection with the drug preparation premises. O. Reg. 154/13, s. 1.
(7) A member shall not engage in or supervise drug preparation activities at or in connection with a drug preparation premises that fail an inspection until,
(a) the College delivers a report indicating that the drug preparation premises passed a subsequent inspection, or passed with conditions; or
(b) after considering submissions under subsection (9), the College substitutes a finding that the drug preparation premises pass or pass with conditions. O. Reg. 154/13, s. 1.
(8) A member shall not engage in or supervise drug preparation activities at or in connection with drug preparation premises that pass an inspection with conditions except in accordance with the conditions set out in the report until,
(a) the College delivers a report indicating that the drug preparation premises passed a subsequent inspection; or
(b) after considering submissions under subsection (9), the College substitutes a finding that the drug preparation premises pass. O. Reg. 154/13, s. 1.
(9) A member may make submissions in writing to the College within 14 days from the date on which a report made by the College that finds that the drug preparation premises passed with conditions or failed the inspection becomes effective in accordance with subsection (5). O. Reg. 154/13, s. 1.
(10) The College may or may not elect to reinspect the drug preparation premises after receiving a member’s submissions, but no more than 60 days after a member provides his or her submissions, the College shall do one or more of the following:
1. Confirm its finding that the drug preparation premises failed the inspection or passed with conditions.
2. Make a report and find that the drug preparation premises passed with conditions.
3. Make a report and find that the drug preparation premises passed the inspection. O. Reg. 154/13, s. 1.
(11) Drug preparation premises that fail an inspection or pass with conditions may be subject to one or more further inspections within a reasonable time after the College delivers its report, at the request of a member, any other person to whom the College gave the report, or at any time at the discretion of the College. O. Reg. 154/13, s. 1.
(12) Where, as a result of an inspection carried out under this Part, a report made by the College finds that a member’s knowledge, skill or judgment is unsatisfactory, the College may direct the Registrar to refer the report to the Quality Assurance Committee. O. Reg. 154/13, s. 1.
(13) Where, as a result of an inspection carried out under this Part, a report made by the College finds that a member may have committed an act of professional misconduct or may be incompetent or incapacitated, the College may direct the Registrar to refer the report to the Inquiries, Complaints and Reports Committee. O. Reg. 154/13, s. 1.
Column 1 |
Column 2 |
Column 3 |
Column 4 |
American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classification |
Substance | ||
8:00 Anti-infective Agents |
8:18 Antivirals |
8:18.08.04 HIV Entry and Fusion Inhibitors |
Enfuvirtide |
8:18.20 Interferons |
Interferon Alfa-2b | ||
Peginterferon alfa-2a | |||
Peginterferon alfa-2b | |||
10:00 Antineoplastic Agents |
Goserelin | ||
Leuprolide | |||
Methotrexate | |||
12:00 Autonomic Drugs |
12:12 Sympathomimetic (Adrenergic) Agents |
12:12.12 Alpha- and Beta-Adrenergic Agonists |
Scopolamine |
Hyoscine | |||
Glycopyrrolate | |||
Epinephrine | |||
20:00 Blood Formation and Coagulation |
20:04 Antianemia Drugs |
20:04.04 Iron Preparations |
Iron |
20:12 Coagulants and Anticoagulants |
20:12.04 Anticoagulants |
Dalteparin | |
Danaparoid | |||
Enoxaparin | |||
Fondaparinux | |||
Heparin | |||
Nadroparin | |||
Tinazaparin | |||
20:16 Hematopoietic Agents |
Ancestim | ||
Darbepoetin alfa | |||
Epoetin alfa | |||
Filgrastim | |||
Pegfilgrastim | |||
Romiplostim | |||
28:00 Central Nervous System Agents |
28:08 Analgesics and Antipyretics |
28:08.08 Opiate Agonists |
Codeine |
Hydromorphone | |||
Meperidine | |||
Morphine | |||
28:08.12 Opiate Partial Agonists |
Nalbuphine | ||
Pentazocine | |||
28:16 Psychotherapeutic Agents |
28:16.08 Antipsychotics |
Haloperidol | |
Methotrimeprazine | |||
28:32 Antimigraine Agents |
28:32.28 Selective Serotonin Agonists |
Sumatriptan | |
40:00 Electrolytic, Caloric, and Water Balance |
40:12 Replacement Preparations |
Normal saline | |
48:00 Respiratory Tract Agents |
48:92 Respiratory Tract Agents, Miscellaneous |
Omalizumab | |
56:00 Gastrointestinal Drugs |
56:22 Antiemetics |
56:22.08 Antihistamines |
Dimenhydrinate |
Prochlorperazine | |||
56:32 Prokinetic Agents |
Metoclopropamide | ||
56:92 GI Drugs, Miscellaneous |
Certolizumab Pegol | ||
Methylnaltrexone | |||
64:00 Heavy Metal Antagonists |
Deferoxamine | ||
68:00 Hormones and Synthetic Substitutes |
68:18 Gonadotropins |
Follitropin-alpha | |
Follitropin-beta | |||
Gonadotropin-chorionic | |||
Gonadotropin-chorionic-alfa | |||
Gonadotropin-human | |||
Lutropin-alfa | |||
Menotropins | |||
Urofollitropin | |||
68:20 Antidiabetic Agents |
Exenatide | ||
Insulins | |||
Liraglutide | |||
68:22 Antihypoglycemic Agents |
68:22:12 Glycogenolytic Agents |
Glucagon | |
68:24 Parathyroid |
Calcitonin Salmon | ||
Teriparatide | |||
68:28 Pituitary |
Desmopressin | ||
Vasopressin | |||
68:30 Somatotropin Agonists and Antagonists |
68:30.04 Somatotropin Agonists |
Somatropin | |
68:30.08 Somatotropin Antagonists |
Pegvisomant | ||
68:32 Progestins |
Medroxyprogesterone | ||
88:00 Vitamins |
88:08 Vitamin B Complex |
Cyanocobalamin | |
Folic Acid | |||
Methylcobalamin | |||
Pyridoxine | |||
Thiamine | |||
88:12 Vitamin C |
Ascorbic Acid | ||
88:24 Vitamin K Activity |
Vitamin K | ||
92:00 Miscellaneous Therapeutic Agents |
92:12 Antidotes |
Leucovorin | |
92:20 Biologic Response Modifiers |
Denosumab | ||
Glatiramer | |||
Interferon-Beta-1A | |||
Interferon-Beta-1B | |||
Natalizumab | |||
92:36 Disease-modifying Antirheumatic Drugs |
Abatacept | ||
Adalimumab | |||
Anakinra | |||
Etanercept | |||
Gold Sodium Thiomalate | |||
Golimumab | |||
Ustekinumab | |||
92:40 Gonadotropin- releasing Hormone Antagonists |
Cetrorelix | ||
Ganirelix | |||
92:92 Other Miscellaneous Therapeutic Agents |
Octreotide | ||
Miscellaneous |
Sterile Water for Injection (Diluent) |
O. Reg. 302/12, s. 2.
Column 1 |
Column 2 |
Column 3 |
Column 4 |
American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classification |
Substance | ||
8:00 Anti-infective Agents |
8:18 Antivirals |
8:18.28 Neuraminidase Inhibitors |
Zanamivir |
8:12 Antibacterials |
8:12.07.16 Monobactams |
Tobramycin | |
Aztreonam | |||
12:00 Autonomic Drugs |
12:08 Anticholinergic Agents |
12:12.08 Antimuscarinics/Antispasmodics |
Ipratropium |
Tiotropium | |||
12:12 Sympathomimetic (Adrenergic) Agents |
12:12.08.12 Selective Beta2- Adrenergic Agonists |
Fenoterol | |
Formoterol | |||
Salbutamol | |||
Salmeterol | |||
Terbutaline | |||
12:16 Sympatholytic (Adrenergic Blocking) Agents |
12:16.04.04 Non-Selective alpha-Adrenergic Blocking Agents |
Dihyroergotamine | |
12:92 Autonomic Drugs, Miscellaneous |
Nicotine | ||
28:00 Central Nervous System Agents |
28:08 Analgesics and Antipyretics |
28:08.12 Opiate Partial Agonists |
Butorphanol |
28:32 Antimigraine Agents |
28:32.28 Selective Serotonin Agonists |
Sumatriptan | |
Zolmitriptan | |||
40:00 Electrolytic, Caloric, and Water Balance |
40:12 Replacement Preparations |
Sodium chloride | |
48:00 Respiratory Tract Agents |
48:24 Mucolytic Agents |
Dornase alfa | |
52:00 Eye, Ear, Nose and Throat (EENT) Preparations |
52:02 Antiallergic Agents |
Sodium Cromoglycate | |
Levocabastine | |||
52:08 Anti-inflammatory Agents |
52:08.08 Corticosteroids |
Beclomethasone | |
Budesonide | |||
Ciclesonide | |||
Flunisolide | |||
Fluticasone | |||
Mometasone | |||
Triamcinolone | |||
52:32 Vasoconstrictors |
Oxymetazoline | ||
Phenylephrine | |||
Xylometazoline | |||
68:00 Hormones and Synthetic Substitutes |
68:18 Gonadotropins |
Buserelin | |
Nafarelin | |||
68:24 Parathyroid |
Calcitonin Salmon | ||
68:28 Pituitary |
Desmopressin | ||
Vasopressin | |||
92:00 Miscellaneous Therapeutic Agents |
92:12 Antidotes |
Acetylcysteine |
O. Reg. 302/12, s. 2.