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O. Reg. 256/24: GENERAL

filed June 19, 2024 under Pharmacy Act, 1991, S.O. 1991, c. 36

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ontario regulation 256/24

made under the

Pharmacy Act, 1991

Made: April 30, 2024
Approved: May 30, 2024
Filed: June 19, 2024
Published on e-Laws: June 19, 2024
Published in The Ontario Gazette: July 6, 2024

General

CONTENTS

PART I
INTERPRETATION

1.

Definitions

PART II
GENERAL PROVISIONS RE CERTIFICATES OF REGISTRATION

2.

Classes of certificates of registration

3.

Two part register

4.

Mandatory Part A

5.

Pharmacists and technicians

6.

Transfer

7.

Application for certificate of registration

8.

Requirements for issuance of certificate of registration, any class

9.

Terms, etc., of every certificate

PART III
REGISTRATION — PHARMACISTS

10.

Additional requirements

11.

Terms, conditions and limitations, Part B pharmacists

PART IV
REGISTRATION — INTERNS

12.

Additional requirements

13.

Terms, conditions and limitations, interns

PART V
REGISTRATION — PHARMACY TECHNICIANS

14.

Additional requirements

15.

Terms, conditions and limitations, pharmacy technicians

16.

Terms, conditions and limitations, Part B pharmacy technicians

PART VI
REGISTRATION — INTERN TECHNICIANS

17.

Additional requirements

18.

Terms, conditions and limitations, intern technician

PART VII
REGISTRATION — PHARMACISTS (EMERGENCY ASSIGNMENT)

19.

Additional requirements

20.

Terms, conditions and limitations, pharmacists (emergency assignment)

21.

Transfer to other class of registration

PART VIII
REGISTRATION — PHARMACY TECHNICIANS (EMERGENCY ASSIGNMENT)

22.

Additional requirements

23.

Terms, conditions and limitations, pharmacy technician (emergency assignment)

24.

Transfer to other class of registration

PART IX
MOBILITY WITHIN CANADA

25.

Mobility within Canada

PART X
QUALITY ASSURANCE

26.

Definitions

27.

Application

28.

Administration

29.

Continuing professional development

30.

Self-assessments

31.

Practice and peer assessments

32.

Panel requirements

PART XI
SUSPENSIONS, RESIGNATIONS, REINSTATEMENTS, ETC.

33.

Failure to provide information

34.

Liability insurance

35.

Lifting of suspensions

36.

Deemed resignations

37.

Return of certificate, etc.

38.

Reinstatement

39.

Ineligibility for reinstatement

40.

Reinstatement to Part A or B

41.

Reinstatement pursuant to order

PART XII
NOTICES OF MEETINGS AND HEARINGS

42.

Notice of meetings

43.

Notice of hearings

PART XIII
ADVERTISING

44.

Advertising

45.

Professional misconduct re advertising

46.

Clarification re application of Part

PART XIV
CONTROLLED ACTS

47.

Interpretation

48.

Inconsistencies

49.

Controlled acts

50.

Substances

51.

Prescribing

52.

Adapting and renewing prescriptions

53.

Recording information

54.

Patient record

55.

Piercing dermis

PART XV
INSPECTION OF DRUG PREPARATION PREMISES

56.

Interpretation

57.

Inspection

58.

Entrance by inspector

59.

Duties of members

60.

Notice

61.

Designated member

62.

Intervals for inspections

63.

Determination of pass

PART XVI
FUNDING FOR THERAPY AND COUNSELLING

64.

Definition

65.

Alternative requirements

PART XVII
TRANSITIONAL

66.

Transitional

PART XVIII
AMENDMENTS TO THIS REGULATION

67.

Amendments to this Regulation

PART XIX
REVOCATION

68.

Revocation

PART XX
COMMENCMENT

69.

Commencement

Schedule 1

Injected substances

Schedule 2

Inhaled substances

Schedule 3

Vaccines

Schedule 4

Drugs — minor ailments

 

Part I
Interpretation

Definitions

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; (“surveillance directe”)

“Part A” means Part A of the register of members; (“partie A”)

“Part B” means Part B of the register of members; (“partie B”)

“Part A pharmacist” means a member who holds a certificate of registration as a pharmacist listed in Part A; (“pharmacien inscrit à la partie A”)

“Part A pharmacy technician” means a member who holds a certificate of registration as a pharmacy technician listed in Part A; (“technicien en pharmacie inscrit à la Partie A”)

“pharmacy” has the same meaning as in subsection 1 (1) of the Drug and Pharmacies Regulation Act and includes a hospital pharmacy and an institutional pharmacy within the meaning of that Act; (“pharmacie”)

“pharmacy accredited as a community pharmacy” means a pharmacy for which a certificate of accreditation of the community pharmacy class has been issued under the Drug and Pharmacies Regulation Act; (“pharmacie agréée à titre de pharmacie communautaire”)

“remote dispensing location” has the same meaning as in subsection 1 (1) of the Drug and Pharmacies Regulation Act. (“téléofficine”)

Part II
general provisions re certificates of registration

Classes of certificates of registration

2. The following are prescribed as classes of certificates of registration:

1.  Pharmacist.

2.  Intern.

3.  Pharmacy technician.

4.  Intern technician.

5.  Pharmacist (emergency assignment).

6.  Pharmacy technician (emergency assignment).

Two part register

3. For the purposes of this Regulation, the College’s register of members shall have a Part A (patient care) and a Part B (no patient care).

Mandatory Part A

4. Every intern, intern technician, pharmacist (emergency assignment) and pharmacy technician (emergency assignment) shall be listed in Part A.

Pharmacists and technicians

5. (1) Every pharmacist and pharmacy technician shall be listed in either Part A or Part B.

(2) Every member holding a certificate of registration as a pharmacy technician as of the day this subsection comes into force shall initially be listed in Part A.

(3) Upon being issued a certificate of registration, a pharmacist or a pharmacy technician shall ask to be listed in Part A or Part B by completing and submitting the form provided by the Registrar.

(4) Every year at the time of paying the annual membership fee, a pharmacist or a pharmacy technician shall ask to renew their listing in Part A or Part B or for a transfer to Part A or Part B.

(5) A pharmacist or a pharmacy technician who asks to renew a listing in Part A must provide to the Registrar a declaration of competence to provide patient care in the form approved by the Council.

(6) If a pharmacist or a pharmacy technician fails to submit the declaration referred to in subsection (5), the Registrar may,

(a)  give the member a notice of intention to transfer the member to Part B; and

(b)  transfer the member to Part B, if the member fails to provide the declaration within 30 days from the date the notice was given.

Transfer

6. (1) A pharmacist or a pharmacy technician may ask for a transfer between Parts A and B at any time by completing and submitting the form provided by the Registrar.

(2) If a pharmacist or a pharmacy technician asks for a transfer from Part A to Part B, the Registrar shall transfer the member to Part B.

(3) If a pharmacist or a pharmacy technician asks for a transfer from Part B to Part A, the Registrar may transfer the member to Part A if the member successfully completes a practice assessment of competence.

(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 Registration Committee.

(5) If the panel rejects a request to be transferred to Part A, the member may appeal to another panel of the Registration Committee.

(6) A panel referred to in subsections (4) and (5) shall be composed of at least three members appointed by the chair of the Registration Committee from among members of that committee, at least one of whom shall be a member of the Council who was appointed by the Lieutenant Governor in Council.

(7) Three members of a panel referred to in subsections (4) and (5) constitute a quorum.

(8) 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.

(9) A member whose request for a transfer is referred to a panel of the Registration Committee under subsection (4) or who makes an appeal under subsection (5) shall be given a reasonable opportunity to make written submissions to the panel before the panel makes a decision.

Application for certificate of registration

7. 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.

Requirements for issuance of certificate of registration, any class

8. (1) The following are requirements for the issuance of a certificate of registration of any class:

1.  The applicant must be able to speak, read, write and comprehend English or French with sufficient fluency to practise the profession.

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 similar 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 the profession in Ontario.

6.  The applicant’s past and present conduct must afford reasonable grounds for the belief that the applicant,

i.  will practise the profession 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 their ability to practise the profession in a safe manner,

iii.  has sufficient knowledge, skill, ability and judgment to engage competently in the practice of the profession 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 their certificate of registration.

8.  The applicant must pay any fees required under the by-laws for the issuance of the certificate of registration for which the applicant applied.

(2) Subject to sections 21 and 24, the requirement under paragraph 8 of subsection (1) of this section is non-exemptible.

(3) An applicant must meet all of the requirements for registration within one year following the filing of their application, but this does not prevent the applicant from filing a new application.

(4) Despite subsection (3), an applicant for a certificate in the pharmacist (emergency assignment) or pharmacy technician (emergency assignment) class must meet all the requirements for registration at the time the application is filed.

(5) 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 their application or supporting documentation.

Terms, etc., of every certificate

9. Every certificate of registration is subject to the following terms, conditions and limitations:

1.  The member must continue to satisfy the requirements of subsection 8 (1).

2.  The member shall notify the Registrar in writing if the member no longer satisfies any of the requirements of subsection 8 (1).

3.  A member who fails to maintain professional liability insurance in the amount and in the form required by the by-laws shall immediately cease to engage in the practice of the profession until such time as the member obtains professional liability insurance.

PART III
REGISTRATION — PHARMACISTS

Additional requirements

10. (1) In addition to the requirements in section 8, the following requirements apply to the issuance of a certificate of registration as a pharmacist:

1.  The applicant must, have obtained a minimum of a baccalaureate degree in pharmacy,

i.  from a Canadian program accredited by the Canadian Council for Accreditation of Pharmacy Programs, or from another program that is accredited by another accrediting body approved by the Council, or

ii.  from a program that does not meet the requirements of subparagraph i, if the applicant passes an evaluation approved by the Council, and

A.  successfully completes a bridging program or another program approved by the Council, or

B.  successfully completes the qualifying examination of the Pharmacy Examining Board of Canada for pharmacists, or another examination approved by Council, on the applicant’s first attempt.

2.  The applicant must have obtained the degree referred to in paragraph 1 no more than two years prior to submitting an application for the issuance of a certificate of registration as a pharmacist, but this time limit does not apply if the applicant,

i.  undergoes a review of their 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 and pays the required fees, or

ii.  successfully completed the qualifying examination of the Pharmacy Examining Board of Canada for pharmacists, or another examination approved by Council, within two years prior to submitting an application for the issuance of a certificate of registration as a pharmacist.

3.  No more than two years prior to submitting an application for the issuance of a certificate of registration as a pharmacist, the applicant must have successfully completed an assessment in pharmaceutical jurisprudence, ethics and professionalism approved by the Council.

4.  No more than two years prior to submitting an application for the issuance of a certificate of registration as a pharmacist, the applicant must have successfully completed a practice assessment of competence approved by the Council.

5.  The applicant must, have successfully completed the qualifying examination of the Pharmacy Examining Board of Canada for pharmacists, or another examination approved by Council,

i.  within the first three attempts,

ii.  on the fourth attempt, if the applicant first successfully completes any further education or training required by the examining body responsible for the administration of the examination or by a panel of the Registration Committee, or

iii.  on a fifth or subsequent attempt, if the applicant first obtains a new degree that meets the requirements of subparagraph 1 i.

(2) In addition to the requirements in section 8, the following are additional requirements for the issuance of a certificate of registration as a pharmacist to an applicant who previously held a certificate of registration as a pharmacist in Ontario:

1.  The applicant must successfully complete the assessment in pharmaceutical jurisprudence, ethics and professionalism referred to in paragraph 3 of subsection (1).

2.  The applicant must undergo a review of their 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 and pay the required fees.

(3) An applicant to whom subsection (2) applies is not required to satisfy the requirements of subsection (1), except as required by subsection (2).

(4) The requirements of subsections (1) and (2) are non-exemptible, except as provided under subsection (3).

Terms, conditions and limitations, Part B pharmacists

11. (1) Every certificate of registration of a pharmacist listed in Part B 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 perform any controlled act.

3.  The member shall not supervise any 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 the profession by another person.

6.  The member shall, while working in a pharmacy or any other environment where patient care is being provided, clearly identify themself as a non-patient care pharmacist.

(2) Despite subsection (1), a pharmacist listed in Part B may perform a controlled act and provide care to a patient with the prior written approval of the Registrar where,

(a)  the sole purpose of doing so is to assist the member in preparing to meet the requirements specified in subsection 6 (3); and

(b)  the member is under the direct supervision of a Part A pharmacist or a member holding a certificate of registration as a pharmacist (emergency assignment).

(3) Subject to subsection (4), an approval provided by the Registrar under subsection (2) must not be for a period exceeding six months.

(4) 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 Registration Committee approves of a further extension.

Part iv
REgistration — Interns

Additional requirements

12. (1) In addition to the requirements in section 8, the following requirements apply to the issuance of a certificate of registration as an intern:

1.  The applicant must satisfy the educational requirements of paragraph 1 of subsection 10 (1).

2.  The applicant must have obtained the degree referred to in paragraph 1 of subsection 10 (1) no more than two years prior to submitting an application for the issuance of a certificate of registration as an intern, but this time limit does not apply if the applicant successfully completed the qualifying examination of the Pharmacy Examining Board of Canada for pharmacists, or another examination approved by Council, within two years prior to submitting an application for the issuance of a certificate of registration as an intern.

(2) The requirements in subsection (1) are non-exemptible.

Terms, conditions and limitations, interns

13. (1) Every certificate of registration as an intern is subject to the following terms, conditions and limitations:

1.  When practising in a pharmacy accredited as a community pharmacy, other than a remote dispensing location, the member shall only engage in the practice of the profession while under the direct supervision of a Part A pharmacist or a member holding a certificate of registration as a pharmacist (emergency assignment).

2.  When practising in any location other than the one described in paragraph 1, the member shall only engage in the practice of the profession while under the supervision of a Part A pharmacist or a member holding a certificate of registration as a pharmacist (emergency assignment).

3.  The member shall not supervise any part of the pharmacy where drugs are kept.

4.  The member shall not delegate a controlled act.

(2) A certificate of registration as an intern automatically expires on the earlier of the following:

1.  The date on which the member is issued a certificate of registration as a pharmacist.

2.  One year after the date on which the member’s certificate of registration as an intern was issued, unless a panel of the Registration Committee specifies otherwise.

Part v
REGISTRATION — pharmacy technicians

Additional requirements

14. (1) In addition to the requirements in section 8, the following requirements apply to the issuance of a certificate of registration as a pharmacy technician:

1.  The applicant must have obtained a pharmacy technician certificate or diploma, or a university degree in pharmacy,

i.  from a Canadian program accredited by the Canadian Council for Accreditation of Pharmacy Programs, or a program that is accredited by another accrediting body approved by Council, or

ii.  from a program that does not meet the requirements of subparagraph i, if the applicant passes an evaluation approved by the Council and,

A.  successfully completes a bridging program or another program approved by the Council, or

B.  successfully completes the qualifying examination of the Pharmacy Examining Board of Canada for pharmacy technicians or another examination approved by Council on the applicant’s first attempt.

2.  The applicant must have obtained the certificate, degree or diploma referred to in paragraph 1 no more than two years prior to submitting an application for the issuance of a certificate of registration as a pharmacy technician, but this time limit does not apply if the applicant,

i.  undergoes a review of their 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, and pays the required fees, or

ii.  successfully completed the qualifying examination of the Pharmacy Examining Board of Canada for pharmacy technicians, or another examination approved by Council, within two years prior to submitting an application for the issuance of a certificate of registration as a pharmacy technician.

3.  No more than two years prior to submitting an application for the issuance of a certificate of registration as a pharmacy technician, the applicant must have successfully completed an assessment in pharmaceutical jurisprudence, ethics and professionalism approved by the Council.

4.  No more than two years prior to submitting an application for the issuance of a certificate of registration as a pharmacy technician, the applicant must have successfully completed a practice assessment of competence approved by the Council.

5.  The applicant must have successfully completed the qualifying examination of the Pharmacy Examining Board of Canada for pharmacy technicians, or another examination approved by the Council,

i.  within the first three attempts,

ii.  on the fourth attempt, if the applicant successfully completes any further education or training required by the examining body responsible for the administration of the examination or by a panel of the Registration Committee, or

iii.  on any subsequent attempt, if the applicant first obtains a new certificate, diploma or degree that meets the requirements of subparagraph 1 i.

(2) In addition to the requirements in section 8, the following additional requirements apply to an applicant who previously held a certificate of registration as a pharmacy technician in Ontario:

1.  The applicant must successfully complete the assessment in pharmaceutical jurisprudence, ethics and professionalism referred to in paragraph 3 of subsection (1).

2.  The applicant must undergo a review of their 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, and pay the required fees.

(3) An applicant to whom subsection (2) applies is not required to satisfy the requirements of subsection (1), except as required by subsection (2).

(4) The requirements of subsections (1) and (2) are non-exemptible, except as provided under subsection (3).

Terms, conditions and limitations, pharmacy technicians

15. Every certificate of registration as a pharmacy technician is subject to the following terms, conditions and limitations:

1.  When practising in a pharmacy accredited as a community pharmacy, other than a remote dispensing location, the member shall only engage in the practice of the profession while under the direct supervision of a Part A pharmacist or a member holding a certificate of registration as a pharmacist (emergency assignment).

2.  When practising in any location other than the one described in paragraph 1, the member shall only engage in the practice of the profession while under the supervision of a Part A pharmacist or a member holding a certificate of registration as a pharmacist (emergency assignment).

3.  In a pharmacy accredited as a community pharmacy, the member shall not supervise any part of the pharmacy where drugs are kept.

4.  The member shall not delegate a controlled act.

5.  The member shall not provide information or education relating to drug use, either to or for a patient, where the provision of the information or education requires therapeutic knowledge, clinical analysis or clinical assessment.

Terms, conditions and limitations, Part B pharmacy technicians

16. (1) Every certificate of registration as a pharmacy technician listed in Part B is subject to the following additional terms, conditions and limitations:

1.  The member shall not provide any care to a patient, whether direct or indirect.

2.  The member shall not perform any controlled act.

3.  The member shall not supervise the practice of the profession by another person.

4.  The member shall, while working in a pharmacy or any other environment where patient care is being provided, clearly identify themself as a non-patient care pharmacy technician.

(2) Despite paragraphs 1 and 2 of subsection (1), a pharmacy technician listed in Part B may perform a controlled act and provide care to a patient with the prior written approval of the Registrar as long as,

(a)  the sole purpose of doing so is to assist the member in preparing to meet the requirements specified in subsection 6 (3); and

(b)  the member is under the direct supervision of a Part A pharmacy technician or a Part A pharmacist or a member holding a certificate of registration as a pharmacist (emergency assignment).

(3) Subject to subsection (4), an approval provided by the Registrar under subsection (2) must not exceed six months.

(4) 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 Registration Committee approves a further extension.

PART VI
REGISTRATION — Intern Technicians

Additional requirements

17. (1) In addition to the requirements in section 8, the following additional requirements apply for the issuance of a certificate of registration as an intern technician:

1.  The applicant must satisfy the educational requirements of paragraph 1 of subsection 14 (1).

2.  The applicant must have obtained the certificate, diploma or degree referred to in paragraph 1 of subsection 14 (1) no more than two years prior to submitting an application for the issuance of a certificate of registration as an intern technician, but this time limit does not apply if the applicant successfully completed the qualifying examination of the Pharmacy Examining Board of Canada for pharmacy technicians, or another examination approved by Council, within two years prior to submitting an application for the issuance of a certificate of registration as an intern technician.

(2) The requirements of subsection (1) are non-exemptible.

Terms, conditions and limitations, intern technician

18. (1) Every certificate of registration as an intern technician is subject to the following terms, conditions and limitations:

1.  The member shall only engage in the practice of the profession while under the direct supervision of a Part A pharmacist, a pharmacist (emergency assignment), a Part A pharmacy technician, or a pharmacy technician (emergency assignment).

2.  The member shall not supervise any 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.

(2) A certificate of registration as an intern technician automatically expires on the earlier of the following:

1.  The date on which the member is issued a certificate of registration as a pharmacy technician.

2.  One year after the date on which the member’s certificate of registration as an intern technician was issued unless a panel of the Registration Committee specifies otherwise.

PART VII
REGISTRATION — PHARMACISTS (EMERGENCY ASSIGNMENT)

Additional requirements

19. (1) In addition to the requirements in section 8, the following additional requirements apply for the issuance of a certificate of registration as a pharmacist (emergency assignment):

1.  The Minister must have requested that the College initiate registrations under this class based on the Minister’s opinion that emergency circumstances call for it or the Council must have determined, after taking into account all of the relevant circumstances that impact the ability of applicants to meet the ordinary registration requirements, that there are emergency circumstances, and that it is in the public interest that the College issue emergency certificates of registration.

2.  The applicant must,

i.  have satisfied the educational requirements of paragraph 1 of subsection 10 (1) no more than two years prior to submitting an application for the issuance of a certificate of registration as a pharmacist (emergency assignment),

ii.  currently be practising as a pharmacist in a jurisdiction approved by the Council, and provide, for each jurisdiction where the applicant holds a certificate, a letter, certificate 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, or

iii.  have practised as a pharmacist in a jurisdiction approved by the Council within three years prior to the day on which the applicant met all other requirements for the issuance of a certificate of registration as a pharmacist (emergency assignment), and provide, for each jurisdiction where the applicant held a certificate, a letter, certificate or other evidence satisfactory to the Registrar or a panel of the Registration Committee confirming that the applicant was in good standing as a pharmacist in that jurisdiction.

(2) Without in any way limiting the generality of subparagraphs 2 ii and iii 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’s certificate as a pharmacist.

Terms, conditions and limitations, pharmacists (emergency assignment)

20. (1) Every certificate of registration as a pharmacist (emergency assignment) is subject to the following terms, conditions and limitations:

1.  The member shall, while working in a pharmacy or any other environment where patient care is being provided, clearly identify themself as a pharmacist (emergency assignment).

2.  The member shall only engage in the practice of the profession while under the supervision of a Part A pharmacist.

3.  The member shall not be the designated manager of a pharmacy for the purposes of the Drugs and Pharmacies Regulation Act.

(2) A certificate of registration as a pharmacist (emergency assignment) expires on the later of,

(a)  60 days after the date on which the certificate was issued, or extended under subsection (3); and

(b)  three months after either the Minister or the Council declares that the emergency circumstances that gave rise to the issuance of certificates of registration in the pharmacist (emergency assignment) class have ended.

(3) The Registrar may extend a certificate of registration as a pharmacist (emergency assignment) for one or more periods of 60 days as long as emergency circumstances persist.

(4) The Registrar may revoke a certificate of registration as a pharmacist (emergency assignment) prior to the expiry of the certificate if, in the opinion of the Registrar, it is advisable to do so.

(5) Where a member listed in Part B of the register also holds a certificate of registration as a pharmacist (emergency assignment), the terms, conditions and limitations listed in section 11 shall not apply to the member during the time that the member holds the emergency assignment certificate.

(6) Where a member who holds a certificate of registration as an intern also holds a certificate of registration as a pharmacist (emergency assignment), the terms, conditions and limitations listed in subsection 13 (1) shall not apply to the member during the time that the member holds the emergency assignment certificate.

Transfer to other class of registration

21. A member who holds a certificate of registration as a pharmacist (emergency assignment) may apply for a certificate of registration in another class, and a member who does so is exempt from the requirement to pay the fee set out in paragraph 8 of subsection 8 (1).

PART VIII
REGISTRATION — PHARMACY TECHNICIANS (EMERGENCY ASSIGNMENT)

Additional requirements

22. (1) In addition to the requirements in section 8, the following additional requirements apply for the issuance of a certificate of registration as a as a pharmacy technician (emergency assignment):

1.  The Minister must have requested that the College initiate registrations under this class based on the Minister’s opinion that emergency circumstances call for it or the Council must have determined, after taking into account all of the relevant circumstances that impact the ability of applicants to meet the ordinary registration requirements, that there are emergency circumstances, and that it is in the public interest that the College issue emergency certificates of registration.

2.  The applicant must,

i.  have satisfied the educational requirements of paragraph 1 of subsection 14 (1) no more than two years prior to submitting an application for the issuance of a certificate of registration as a pharmacy technician (emergency assignment),

ii.  currently be practising as a pharmacy technician in a jurisdiction approved by the Council, and provide, for each jurisdiction where the applicant holds a certificate, a letter, certificate 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, or

iii.  have practised as a pharmacy technician in a jurisdiction approved by the Council within three years prior to the day on which the applicant met all other requirements for the issuance of a certificate of registration as a pharmacy technician (emergency assignment), and provide, for each jurisdiction where the applicant held a certificate, a letter, certificate or other evidence satisfactory to the Registrar or a panel of the Registration Committee confirming that the applicant was in good standing as a pharmacy technician in that jurisdiction.

(2) Without in any way limiting the generality of subparagraphs 2 ii and iii 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 the certificate as a pharmacy technician.

(3) Where a member listed in Part B of the register also holds a certificate of registration as a pharmacy technician (emergency assignment), the terms, conditions and limitations listed in section 16 do not apply to the member during the time that the member holds the emergency assignment certificate.

(4) Where a member who holds a certificate of registration as an intern technician also holds a certificate of registration as a pharmacy technician (emergency assignment), the terms, conditions and limitations listed in subsection 18 (1) do not apply to the member during the time that the member holds the emergency assignment certificate.

Terms, conditions and limitations, pharmacy technician (emergency assignment)

23. (1) Every certificate of registration as a pharmacy technician (emergency assignment) is subject to the following terms, conditions and limitations:

1.  The member shall, while working in a pharmacy or any other environment where patient care is being provided, clearly identify themselves as a pharmacy technician (emergency assignment).

2.  The member shall only engage in the practice of the profession,

i.  when practising in a pharmacy accredited as a community pharmacy, other than a remote dispensing location, while under the direct supervision of a member holding a certificate of registration as a pharmacist or as a pharmacist (emergency assignment), or

ii.  in all other cases, while under the supervision or direction of a member holding a certificate of registration as a pharmacist listed in Part A or as a pharmacist (emergency assignment).

3.  In a pharmacy accredited as a community pharmacy, the member shall not supervise any part of the pharmacy where drugs are kept.

4.  The member shall not delegate a controlled act.

5.  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.

(2) A certificate of registration as a pharmacy technician (emergency assignment) expires on the later of,

(a)  60 days after the date on which the certificate was issued or extended under subsection (3); and

(b)  12 months after either the Minister or the Council declares that the emergency circumstances that gave rise to the issuance of certificates of registration in the pharmacy technician (emergency assignment) class have ended.

(3) The Registrar may extend a certificate of registration as a pharmacy technician (emergency assignment) for one or more periods of 60 days as long as emergency circumstances persist.

(4) The Registrar may revoke a certificate of registration as a pharmacy technician (emergency assignment) prior to the expiry of the certificate if, in the opinion of the Registrar, it is advisable to do so.

Transfer to other class of registration

24. A member who holds a certificate of registration as a pharmacy technician (emergency assignment) may apply for a certificate of registration in the pharmacy technician class, and a member who does so is exempt from the requirement to pay the fee set out in paragraph 8 of subsection 8 (1).

PART IX
MOBILITY WITHIN CANADA

Mobility within Canada

25. (1) Subject to subsection 22.18 (3) of the Health Professions Procedural Code, an applicant to whom section 22.18 of the Health Professions Procedural Code applies will be deemed to have satisfied the following requirements if, for each jurisdiction where the applicant holds an out-of-province certificate, the applicant provides 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 in that jurisdiction:

1.  The requirements of paragraphs 1, 2, 4, and 5 of subsection 10 (1), where the applicant applies for a certificate of registration as a pharmacist.

2.  The requirements of section 12, where the applicant applies for a certificate of registration as an intern.

3.  The requirements of paragraphs 1, 2, 4 and 5 of subsection 14 (1), where the applicant applies for a certificate of registration as a pharmacy technician.

4.  The requirements of section 17, where the applicant applies for a certificate of registration as an intern technician.

(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 out-of-province certificate to the applicant.

(3) An applicant referred to in subsection (1) shall be deemed to have met the requirements of paragraph 1 of subsection 8 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.

PART X
QUALITY ASSURANCE

Definitions

26. In this Part,

“assessment” means an assessment carried out under section 82 of the Health Professions Procedural Code and includes a practice or peer assessment and reassessment, as applicable; (“évaluation”)

“assessor” means an assessor appointed by the Committee under section 81 of the Health Professions Procedural Code; (“évaluateur”)

“Committee” means the Quality Assurance Committee. (“comité”)

Application

27. This Part only applies to,

(a)  a member who holds a certificate of registration as a pharmacist and is listed in Part A; and

(b)  a member who hold a certificate of registration as a pharmacy technician and is listed in Part A.

Administration

28. The Committee shall administer the quality assurance program.

Continuing professional development

29. A member shall,

(a)  participate in continuing professional development activities, and maintain a portfolio of such activities in the form and manner approved by the Council; and

(b)  submit a copy of the portfolio to the College or to an assessor on request.

Self-assessments

30. A member shall,

(a)  participate in self-assessment activities, and keep a record of such activities in the form and manner approved by the Council; and

(b)  submit a copy of the records to the College or to an assessor on request.

Practice and peer assessments

31. (1) A member shall be required to undergo a practice or peer assessment or both if,

(a)  in response to a request made under clause 29 (b) or 30 (b), the member does not provide the requested information, or the portfolio or records provided do not demonstrate that the member has engaged in adequate continuing professional development or self-assessment activities, or

(b)  the member is directed by the Council to undergo an assessment on the basis of other criteria specified by the Council and published on the College’s website at least three months before the member is directed to undergo an assessment.

(2) If a member fails to undergo a required assessment, the Committee may direct the Registrar to transfer the member to Part B after giving the member a reasonable opportunity to make written submissions.

Panel requirements

32. (1) A panel of the Committee may exercise any of the powers of the Committee under this Part or section 80.2 of the Health Professions Procedural Code.

(2) A panel of the Committee shall be composed of at least three members appointed by the chair of the Committee from among the Committee members, at least one of whom shall be a member of the Council who was appointed by the Lieutenant Governor in Council.

(3) Three members of a panel constitute a quorum.

PART XI
SUSPENSIONS, RESIGNATIONS, REINSTATEMENTS, ETC.

Failure to provide information

33. If a member fails to provide the College with information about the member in the manner and form required under the by-laws, the Registrar may,

(a)  give the member a notice of intention to suspend the member’s certificate of registration; and

(b)  suspend the member’s certificate of registration, if the member fails to provide the information within the 30 days following the day the notice was given.

Liability insurance

34. If a member fails to provide the College with evidence that the member holds professional liability insurance in the amount and form required under the by-laws within the 14 days following the day a notice was given that the evidence is required, the Registrar shall,

(a)  immediately give the member a notice of intention to suspend the member’s certificate of registration; and

(b)  suspend the member’s certificate of registration, if the member fails to provide the evidence within the 30 days following the day the notice under clause (a) was given.

Lifting of suspensions

35. (1) The Registrar shall lift a suspension under section 33 or 34 upon being satisfied that the member,

(a)  has filed the required information or evidence, as the case may be, with the College in accordance with the requirements of the by-laws; and

(b)  has paid any fees required for lifting the suspension.

(2) If the Registrar suspends a member’s certificate of registration under section 24 of the Health Professions Procedural Code for failing 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)  has paid fees required for the lifting of the suspension.

Deemed resignations

36. If a member’s certificate of registration is suspended, the member shall be deemed to have resigned immediately following the last day of the following periods:

1.  If the suspension is for failure to pay fees required by the regulations or the by-laws, when the suspension has continued for 120 days.

2.  If the suspension is under section 33 or 34, when the suspension has continued for 60 days.

Return of certificate, etc.

37. A member who resigns, or whose certificate of registration is suspended or revoked shall, if so requested, immediately return their certificate of registration to the College.

Reinstatement

38. (1) Subject to subsections (2) and (3), a former member who resigned or was deemed to have resigned may apply to have their certificate of registration reinstated by,

(a)  submitting a completed application to the Registrar in the form provided by the Registrar;

(b)  paying,

(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, if not previously paid, unless the Registrar is satisfied that the former member did not engage in the practice of the profession in Ontario during that year, and

(iv)  any other amount owed by the former member to the College, including but not limited to, any penalty or late fees that were due at the time that they ceased to be a member, 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; and

(c)  providing evidence satisfactory to the Registrar that the applicant will have professional liability insurance in the amount and in the form specified by the by-laws as of the anticipated date of reinstatement of the certificate of registration.

(2) It is a condition of reinstatement that the Registrar be satisfied that,

(a)  the applicant is not ineligible for any reason set out in section 39; and

(b)  the applicant meets the requirements of section 8.

(3) An application for reinstatement under subsection (1) may not be submitted more than three years after,

(a)  the date on which the former member resigned; or

(b)  in the case of a former member who was deemed to have resigned under section 36, the date on which the former member was suspended and that suspension resulted in the deemed resignation.

Ineligibility for reinstatement

39. (1) A former member is ineligible for reinstatement if the former member,

(a)  held a certificate of registration as an intern or intern technician at the time they ceased to be a member;

(b)  was, at the time they ceased to be a member, or at any time since then, the subject of,

(i)  a proceeding for professional misconduct, incompetence or incapacity in Ontario or any similar proceeding in any other jurisdiction in relation to the practice the profession or another profession, other than a proceeding that was completed on its merits in which the allegations were found not to have been proven,

(ii)  an inquiry or investigation by the Registrar, a committee or a panel of a committee of the College, which resulted in the member’s resignation or an inquiry or investigation that was not completed on its merits, other than an inquiry or investigation the result of which was a determination that no further action should be taken against the member, or

(iii)  a proceeding in respect of,

(A)  any criminal offence in any jurisdiction,

(B)  any offence relating to the use, possession or sale of drugs in any jurisdiction,

(C)  any offence arising in any jurisdiction relating to the practice of the profession or any other profession or occupation, or

(D)  any offence under the Controlled Drugs and Substances Act (Canada);

(c)  was, at the time they ceased to be a member,

(i)  the subject of, or in breach of, an outstanding order or requirement of a committee or a panel of a committee of the College,

(ii)  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, or

(iii)  in breach of any written agreement with or undertaking provided to the College; or

(d)  had, at the time they ceased to be a member, terms, conditions or limitations on their certificate of registration, other than those applicable to all members of the class of certificate of registration they previously held and those applicable to all members of the part of the register of members in which they were previously listed.

(2) Nothing in this Part prevents a former member who resigned or was deemed to have resigned from making any number of applications for reinstatement or from making an application for a new certificate of registration.

Reinstatement to Part A or B

40. (1) Subject to subsections (2) and (3), a former member who satisfies the conditions for reinstatement in section 38 may be reinstated in Part A if the former member,

(a)  was previously listed in Part A at the time of their resignation;

(b)  asks to be listed in Part A in their application for reinstatement; and

(c)  provides to the Registrar a declaration of competence to provide patient care in the form approved by the Council.

(2) A former member shall not be reinstated in Part A if, at the time of their resignation, the former member had been selected for but had not yet taken part in an assessment under the College’s Quality Assurance Program or had failed to successfully complete such an assessment.

(3) A former member who meets the conditions for reinstatement in section 38,

(a)  may be reinstated in Part B if former member asks to be listed in Part B in their application for reinstatement; or

(b)  shall be reinstated in Part B if the Registrar determines that the former member does not qualify for reinstatement in Part A pursuant to subsection (1) or (2).

Reinstatement pursuant to order

41. 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.

PART xII
NOTICES OF MEETINGS AND HEARINGS

Notice of meetings

42. (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.

(2) The notice must be published at least 14 days before the date of the meeting on the College’s website.

(3) The notice must be in English and French.

(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.

(5) The Registrar shall provide the information contained in the notice to every person who requests it.

Notice of hearings

43. (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.

(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.

(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.

(4) The Registrar shall provide the information in French to a person who requests that the information be provided in French, wherever reasonably possible.

PART XIII
ADVERTISING

Advertising

44. (1) In this section,

“advertisement” includes an announcement, directory listing or other form of communication similar to an advertisement; (“publicité”)

“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. (“services pharmaceutiques”)

(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.

(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.  Cough preparations.

8.  Diagnostic agents.

9.  Electrolytic, caloric and water balance drugs.

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.

(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.

(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.

(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).

Professional misconduct re advertising

45. 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 44 (4) of this Regulation, as the total cost for the drug to the purchaser including any dispensing fee.

Clarification re application of Part

46. 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.

part xiv
controlled acts

Interpretation

47. (1) In this Part,

“adapt” means, subject to subsection (2), to change a patient’s prescription by changing any of the following, but does not include therapeutic substitution,

(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; (“adapter”)

“coronavirus exemption” means the exemption issued by the Minister of Health for Canada on March 19, 2020 under subsection 56 (1) of the Controlled Drugs and Substances Act (Canada) entitled “Subsection 56 (1) Class Exemption for Patients, Practitioners and Pharmacists Prescribing and Providing Controlled Substances in Canada During the Coronavirus Pandemic”, available on a website of the Government of Ontario, including any renewal or replacement of the exemption; (“exemption applicable au coronavirus”)

“point-of-care test” means a test that employs a medical device authorized by the Minister of Health for Canada for point-of-care use; (“analyse hors laboratoire”)

“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 their practice of a health profession; (“prescripteur”)

“prescription” means a direction from a prescriber directing the dispensing of a drug or mixture of drugs for a specific patient; (“ordonnance”)

“renew” means to provide a patient with a prescription that repeats a prescription previously provided to that patient; (“renouveler”)

“therapeutic substitution” means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent. (“substitution thérapeutique”)

(2) While the coronavirus exemption is in effect, in this Part,

“adapt” in relation to the adaptation of a prescription for a controlled substance under the Controlled Drugs and Substances Act (Canada), means to change the prescription by changing any of the following, but does not include therapeutic substitution,

(a)  the dose and regime of the prescribed drug,

(b)  the dosage form of the prescribed drug,

(c)  the de-prescribing of the prescribed drug, or

(d)  the part-filling of the prescription.

(3) In this Part,

(a)  a reference to a Part A pharmacist includes a member who holds a certificate of registration as a pharmacist (emergency assignment); and

(b)  a reference to a Part A pharmacy technician includes a member who holds a certificate of registration as a pharmacy technician (emergency assignment).

Inconsistencies

48. (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.

(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.

Controlled acts

49. 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.

Substances

50. (1) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a member referred to in subsection (2) of this section who meets all the requirements in subsection (4) is authorized to perform the following acts:

1.  Administering a substance specified in Schedule 1 by injection.

2.  Administering a substance specified in Schedule 2 by inhalation.

3.  Administering a vaccine specified in Schedule 3 by injection.

(2) A Part A pharmacist or an intern is authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on their certificate of registration.

(3) A pharmacy technician who meets all the requirements in subsection (6) is authorized to perform an act provided for in paragraph 3 of subsection (1), but only with respect to the influenza vaccine, respiratory syncytial virus vaccine and Coronavirus (COVID-19) vaccines and subject to the terms, conditions and limitations imposed on their certificate of registration.

(4) A member referred to in subsection (2) may only perform an act provided for in subsection (1) if the member complies with the following:

1.  Before performing the act, the member must explain the purpose of the act to the patient or the patient’s authorized agent and receive an informed consent from the patient or the patient’s authorized agent.

2.  The member shall ensure that the member 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 their authorized agent.

7.  Where administering a substance specified in Schedule 1 by injection to a patient through an established central or peripheral venous access device, the member must only do so in collaboration with a member of the College of Nurses of Ontario who is a registered nurse in the extended class or a member of the College of Physicians and Surgeons of Ontario.

8.  Where the act is performed for a purpose other than that of patient education or demonstration the member must, within a reasonable time after performing the act, notify the following persons that the member performed the act, and provide details respecting the act:

i.  The prescriber, if any, of the substance that was administered.

ii.  The patient’s primary care provider, where the member knows that the patient has such a care provider other than the prescriber.

9.  Where administering an influenza vaccine by injection, the member must administer the vaccine in accordance with Ontario’s Universal Influenza Immunization Program as described on the Ministry’s website.

10.  The member may only administer a vaccine to patients who are two years of age or older in the case of the influenza vaccine, six months of age and older in the case of the COVID-19 vaccines and five years of age or older in the case of every other vaccine.

(5) Where a limitation or a route of administration is indicated with respect to a substance listed in Schedule 1, a member shall only administer the substance in compliance with the limitation and in accordance with the route of administration specified.

(6) A member referred to in subsection (3) may only perform the act of administering the vaccine by injection provided for in paragraph 3 of subsection (1) if the patient is two years of age or older in the case of the influenza vaccine, five years of age or older in the case of respiratory syncytial virus vaccine or six months of age or older in the case of Coronavirus (COVID-19) vaccines and if the member,

(a)  possesses sufficient knowledge, skill and judgment to be able to administer the vaccine safely;

(b)  meets all the requirements in paragraphs 2, 3 and 6 of subsection (4);

(c)  meets the requirement in paragraph 9 of subsection (4), when administering an influenza vaccine by injection; and

(d)  has confirmed that a member referred to in subsection (2), or another regulated health professional authorized to administer the vaccine by injection, has,

(i)  received an informed consent from the patient or the patient’s authorized agent,

(ii)  a sufficient understanding of the vaccine and condition of the patient for the vaccine to be administered safely, and

(iii)  considered whether administering the vaccine by injection 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 and any other relevant circumstances.

Prescribing

51. (1) For the purposes of paragraph 3 of subsection 4 (1) of the Act, a Part A pharmacist is authorized to prescribe the following drugs, subject to subsections (2) and (4) of this section and to the terms, conditions and limitations imposed on their certificate of registration:

1.  For the sole purpose of smoking cessation, the following specified drugs:

i.  Bupropion Hydrochloride.

ii.  Varenicline Tartrate.

2.  For the sole purpose of treating a minor ailment listed in Column 1 of the Table to Schedule 4, a drug opposite the minor ailment in Column 3 of that Table.

3.  For the sole purpose of treating COVID-19, Nirmatrelvir/Ritonavir.

4.  For the sole purpose of treating influenza, Oseltamivir.

(2) In the case of drug referred to in paragraph 3 of subsection (1),

(a)  the Part A pharmacist shall make a determination as to the patient’s risk for any drug interactions that cannot be properly managed or that prevent Nirmatrelvir/Ritonavir from being prescribed and shall not prescribe the drug if such an interaction exists; and

(b)  the Part A pharmacist shall notify the patient’s primary care provider, if any, within a reasonable time that the pharmacist prescribed Nirmatrelvir/Ritonavir to the patient and provide details respecting the prescription.

(3) For the purposes of paragraph 3 of subsection 4 (1) of the Act, an intern is authorized to prescribe the following drugs, subject to subsection (4) of this section and to the terms, conditions and limitations imposed on their certificate of registration:

1.  For the sole purpose of smoking cessation, the following specified drugs:

i.  Bupropion Hydrochloride.

ii.  Varenicline Tartrate.

2.  For the sole purpose of treating a minor ailment listed in Column 1 of the Table to Schedule 4, a drug opposite the minor ailment in Column 3 of that Table.

(4) A Part A pharmacist or an intern may only prescribe a drug under this section if they,

(a)  possess sufficient knowledge, skill and judgment respecting the drug and the patient’s condition to prescribe the drug for the patient;

(b)  have 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)  give the prescription to the patient or the patient’s authorized agent;

(d)  advise the patient or the patient’s authorized agent, at the time of giving the prescription, that they may elect to take it to a pharmacy of their choosing for dispensing;

(e)  notify the patient’s primary care provider, if any, within a reasonable time, that the Part A pharmacist or intern prescribed a drug for the patient and provide details respecting the prescription;

(f)  comply with the additional requirements under sections 53 and 54; and

(g)  have determined, through a therapeutic assessment, that the drug is the most appropriate treatment for the patient’s condition.

Adapting and renewing prescriptions

52. (1) For the purposes of paragraph 4 of subsection 4 (1) of the Act, a member referred to in subsection (4) 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.

(2) Subject to subsection (3), 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.

(3) During the period of time in which the coronavirus exemption is in effect, subsection (2) does not apply to the extent that the coronavirus exemption or the Controlled Drugs and Substances Act (Canada) authorizes the member to adapt or renew a prescription for a controlled substance under that Act.

(4) A Part A pharmacist and an intern are authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on their certificate of registration.

(5) A member may only perform an act provided for in subsection (1) if the member 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,

iii.  have access to the medical record that contains information about the prescription, or

iv.  during the period of time in which the coronavirus exemption is in effect, if the criteria set out in subparagraphs i, ii and iii cannot be met, be satisfied as to the existence and details of the prescription from an alternative source, including, but not limited to, the prescription label, the prescription receipt with medication history, a photograph of the prescription or a facsimile of the prescription.

2.  If the member is renewing a prescription, the member 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 12 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 the patient’s authorized agent,

i.  that they are entitled to the prescription, and

ii.  that they may take the prescription to a pharmacy of their choosing for dispensing.

5.  The member must comply with the additional requirements under sections 53 and 54.

Recording information

53. A member who performs an act provided for in section 51 or 52 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.

Patient record

54. A member who performs an act under section 51 or 52 must maintain a patient record that includes details of the member’s rationale for their decision to act under section 51 or 52 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 their authorized agent under clause 51 (4) (c) or that the member gave to the patient or their authorized agent to take to a pharmacy of their choosing under clause 51 (4) (d) or paragraph 4 of subsection 52 (5).

3.  A record of the results of laboratory or other tests that the member considered in making the decision to act under section 51 or 52.

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 51 (4) (e) or paragraph 3 of subsection 52 (5).

ii.  The patient’s prescriber notified under paragraph 3 of subsection 52 (5).

Piercing dermis

55. (1) For the purposes of paragraph 5 of subsection 4 (1) of the Act, a member referred to in subsection (2) of this section who meets all the requirements of subsection (4) is authorized to perform the act of piercing a patient’s dermis with a lancet-type device to obtain blood.

(2) A Part A pharmacist, an intern, a Part A pharmacy technician and an intern technician are authorized to perform the act provided for in subsection (1), subject to the terms, conditions and limitations imposed on their certificate of registration.

(3) A Part A pharmacy technician and an intern 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 the act is performed;

(b)  they are under the direction of a Part A pharmacist at the time the act is performed; and

(c)  if the act is performed to administer a point-of-care test, a Part A pharmacist interprets the results of the test and makes any professional decision arising from those results.

(4) A member may only perform the act provided for in subsection (1) if the member 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 their chronic disease, unless the act is performed to administer a point-of-care test.

2.  The member may only perform the act to administer a point-of-care test if the test is listed in subsection 28 (2) of Ontario Regulation 45/22 (General) made under the Laboratory and Specimen Collection Centre Licensing Act and if it is administered for the purpose of assisting patients with the management of their medication to treat chronic disease.

3.  Before performing an act described in paragraphs 1 or 2 the member must,

i.  explain the purpose to the patient or their authorized agent, and

ii.  receive an informed consent from the patient or their authorized agent.

4.  The member shall ensure that the member only performs the act in an environment that is clean, safe, private and comfortable for the patient.

5.  The member shall ensure that appropriate infection control procedures are in place.

6.  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.

7.  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.

8.  The member must maintain a patient record that includes,

i.  the name and address of the patient,

ii.  the name and work address of the member,

iii.  the date the act was performed,

iv.  the circumstances relating to the performance of the act and any adverse reaction experienced by the patient,

v.  confirmation that an informed consent was given by the patient or their agent, and

vi.  if the act was performed to administer a point-of-care test,

A.  the results of the test, and

B.  the professional decision arising from the results of the test and the rationale for the decision.

9.  If the act is performed to administer a point-of-care test, the member must notify the patient’s primary care provider, if any, within a reasonable time that the member performed the act and provide details respecting the act.

Part Xv
INSPECTION OF DRUG PREPARATION PREMISES

Interpretation

56. (1) In this Part,

“designated member” means,

(a)  the member designated for a drug preparation premises in accordance with section 61, or

(b)  where only one member engages in or supervises drug preparation activities at or in connection with a drug preparation premises, that member; (“membre désigné”)

“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; (“médicament”)

“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; (“activités de préparation de médicaments”)

“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; (“locaux de préparation de médicaments”)

“inspector” means a person appointed by the College to carry out an inspection on behalf of the College; (“inspecteur”)

“supervise” means to supervise either directly or indirectly. (“surveiller”)

(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.

Inspection

57. (1) All drug preparation premises are subject to inspection by the College in accordance with this Part.

(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 their practice with respect to drug preparation activities at or in connection with the drug preparation premises.

Entrance by inspector

58. An inspector may, on the production of information identifying them 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 57 (2) on behalf of the College.

Duties of members

59. (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.

(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.

Notice

60. (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 (3) of the member’s intention to do so.

(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.

(3) The notice required in subsection (1) must 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 they are 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.

Designated member

61. 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.

Intervals for inspections

62. 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.

Determination of pass

63. (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.

(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 60 (1);

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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).

(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 their 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.

(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.

(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.

(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.

PART Xvi
FUNDING FOR THERAPY AND COUNSELLING

Definition

64. In this Part,

“member” includes a former member.

Alternative requirements

65. (1) The alternative requirements that must be satisfied in order for a person to be eligible for funding under clause 85.7 (4) (b) of the Health Professions Procedural Code are prescribed in this section.

(2) A person is eligible for funding for therapy or counselling if,

(a)  there is an admission made by a member in a statement to the College or in an agreement with the College that the member sexually abused the person while the person was a patient of the member;

(b)  a member has been found guilty under the Criminal Code (Canada) of sexually assaulting the person while the person was a patient of the member;

(c)  there is a statement, contained in the written reasons of a committee of the College given after a hearing, that the person, while a patient, was sexually abused by a member; or

(d)  there is sufficient evidence presented to the Patient Relations Committee to support a reasonable belief that the person, while a patient, was sexually abused by a member.

(3) For the purposes of clause (2) (d), and without limiting the generality of that clause, the following kinds of evidence may support a reasonable belief that a person, while a patient, was sexually abused by a member:

1.  Evidence of reports made with respect to the member under subsection 85.1 (1) or 85.2 (1) of the Health Professions Procedural Code.

2.  Evidence that corroborates the person’s allegations of sexual abuse by the member.

(4) A person is not eligible under subsection (2) unless, at the time the sexual abuse occurred, the person was a patient of the member and the member was practising in Ontario.

(5) Despite subsections (2), (3) and (4), a person is eligible for funding for therapy or counselling under this Part only if,

(a)  the person submits an application for funding to the Patient Relations Committee in the form provided by the College and, in the application, the person names the member who is alleged to have sexually abused the person;

(b)  the person adheres to the procedures followed by the Patient Relations Committee when determining whether the person has satisfied the requirements for eligibility for funding; and

(c)  the person provides such other information as is required by the Patient Relations Committee.

(6) A decision by the Patient Relations Committee that a person is eligible for funding for therapy or counselling does not constitute a finding against the member and shall not be considered by any other committee of the College dealing with the member.

Part XVII
transitional

Transitional

66. (1) Subject to subsections (2) and (3), every certificate of registration that was in existence under Ontario Regulation 202/94 (General) made under the Act immediately before section 68 came into force 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.

(2) Subject to subsection (3), every certificate of registration as a registered pharmacy student that was in existence immediately before section 68 came into force shall be deemed to have expired on the day that section came into force.

(3) A certificate of registration as a registered pharmacy student shall be continued as a certificate of registration as an intern if, at the time section 68 came into force the member,

(a)  satisfied the requirements of section 8;

(b)  satisfied the requirements of subsection 10 (1); and

(c)  was in the process of completing a practice assessment of competence.

(4) Where an applicant has completed any of the requirements for the issuance of a certificate of registration as they existed immediately before section 68 came into force, the applicant shall be deemed to have satisfied the equivalent requirement or requirements for the issuance of a certificate of registration of that class under this Regulation, and in all other respects the application shall be dealt with pursuant to this Regulation.

Part XVIIi
amendments to this Regulation

Amendments to this Regulation

67. (1) The definition of “adapt” in subsection 47 (1) of this Regulation is amended by striking out “subject to subsection (2)” in the portion before clause (a).

(2) The definition of “coronavirus exemption” in subsection 47 (1) of this Regulation is revoked.

(3) Subsection 47 (2) of this Regulation is revoked.

(4) Subsection 52 (2) of this Regulation is amended by striking out “Subject to subsection (3)” at the beginning.

(5) Subsection 52 (3) of this Regulation is revoked.

(6) Paragraph 1 of subsection 52 (5) of this Regulation is amended by adding “or” at the end of subparagraph ii, by striking out “or” at the end of subparagraph iii and by revoking subparagraph iv.

Part XIX
Revocation

Revocation

68. Ontario Regulation 202/94 is revoked.

Part XX
commencment

Commencement

69. (1) Except as otherwise provided in this section, this Regulation comes into force on the later of October 1, 2024 and the day this Regulation is filed.

(2) Section 67 comes into force on September 30, 2026.

Schedule 1
Injected Substances

Analgesics and Antipyretics

  Codeine — For patient education and demonstration only

Hydromorphone — For patient education and demonstration only

Morphine — For patient education and demonstration only

Nalbuphine — For patient education and demonstration only

Antibacterials

Amikacin

Ampicillin

Cefazolin

Cefepime

Cefotaxime

Cefoxitin

Ceftazidime

Ceftriaxone

Clindamycin

Cloxacillin

Ertapenem

Gentamicin

Penicillin G

Anticholinergic Agents

Glycopyrrolate — Must not be administered intravenously

Hyoscine — Must not be administered intravenously

Scopolamine — Must not be administered intravenously

Anticoagulants

Dalteparin — Must not be administered intravenously

Danaparoid — Must not be administered intravenously

Enoxaparin — Must not be administered intravenously

Fondaparinux — Must not be administered intravenously

Heparin — For patient education and demonstration only

Nadroparin — Must not be administered intravenously

Tinazaparin

Antidiabetic Agents

Dulaglutide

Exenatide

Insulins

Liraglutide

Lixisenatide

Semaglutide

Tirzepatide

Antihemorrhagic Agents

Emicizumab

Antihistamines

  Dimenhydrinate — Must not be administered intravenously

Diphenhydramine — Only for monitoring and management of allergic reactions

Antimigraine Agents

Erenumab

Sumatriptan

Antiparkinsonian Agents

Apomorphine

Benztropine

Antivirals

Enfuvirtide

Interferons

Peginterferon alfa-2a

Central Nervous System Agents, Miscellaneous

Inotersen

Complement Inhibitors

Icatibant

Lanadelumab

Disease-modifying Antirheumatic Drugs

Abatacept

Adalimumab

Anakinra

Etanercept

Golimumab — Must not be administered intravenously

Methotrexate — Must not be administered intravenously

Sarilumab

Tocilizumab — Must not be administered intravenously

Ustekinumab — Must not be administered intravenously

Enzymes

Asfotase Alfa

GI Drugs, Miscellaneous

Certolizumab Pegol

Methylnaltrexone

Gonadotropins and Antigonadotropins

Follitropin-alpha

Follitropin-beta

Follitropin-delta

Gonadotropin-chorionic

Gonadotropin-chorionic-alfa

Goserelin — For patient education and demonstration only

Leuprolide — For patient education and demonstration only

Lutropin-alfa

Menotropins

Triptorelin acetate

Gonadotropin-releasing Hormone Antagonists

Cetrorelix

Ganirelix

Heavy Metal Antagonists

Deferoxamine — For patient education and demonstration only

Hematopoietic Agents

Darbepoetin alfa — Must not be administered intravenously

Epoetin alfa — Must not be administered intravenously

Filgrastim — Must not be administered intravenously

Pegfilgrastim

Romiplostim — For patient education and demonstration only

Immunomodulatory Agents

Denosumab

Glatiramer

Interferon-Beta-1A

Interferon-Beta-1B

Natalizumab

Immunosuppressive Agents

Belimumab — Must not be administered intravenously

Mepolizumab

Miscellaneous Agents

Sodium Chloride

Sterile Water for Injection (Diluent)

Parathyroid

Calcitonin Salmon — For patient education and demonstration only

Teriparatide

Pituitary

Desmopressin — For patient education and demonstration only

Vasopressin — For patient education and demonstration only

Progestins

Medroxyprogesterone

Progesterone

Prokinetic Agents

  Metoclopramide

Proprotein Convertase Subtilisin Kexin Type 9 (Pcsk9) Inhibitors

Alirocumab

Evolocuma

Psychotherapeutic Agents

Haloperidol — For patient education and demonstration only

Methotrimeprazine — For patient education and demonstration only

Respiratory Tract Agents

Omalizumab

Skin And Mucous Membrane Agents

Brodalumab

Dupilumab

Guselkumab

Ixekizumab

Risankizumab — Must not be administered intravenously

Secukinumab

Somatostatin Agonists and Antagonists

Lanreotide

Octreotide — Must not be administered intravenously

Pasireotide

Somatotropin Agonists and Antagonists

Pegvisomant

Somatropin

Tesamorelin

Sympatholytic (Adrenergic Blocking) Agents

Dihydroergotamine — Must not be administered intravenously

Vitamins

Ascorbic Acid — Must not be administered intravenously

Cyanocobalamin

Folic Acid — Must not be administered intravenously

Pyridoxine — Must not be administered intravenously

Thiamine — Must not be administered intravenously

Vitamin K

Schedule 2
Inhaled Substances

Anticholinergic Agents

Aclidinium

Glycopyrronium

Ipratropium

  Tiotropium

Umeclidinium

Sympathomimetic (Adrenergic) Agents

Formoterol

Indacaterol

Olodaterol

  Salbutamol

Salmeterol

Terbutaline

Vilanterol

Anti-infective Agents

Aztreonam

Levofloxacin

Tobramycin

Zanamivir

Autonomic Drugs, Miscellaneous

Nicotine

Antiallergic Agents

Sodium Cromoglycate

Anti-inflammatory Agents

Beclomethasone

Budesonide

Ciclesonide

Fluticasone

Mometasone

Triamcinolone

Miscellaneous Agents

Sodium chloride

Sterile water for inhalation

Respiratory Tract Agents

Acetylcysteine

Dornase alfa

Schedule 3
Vaccines

1.  Bacille Calmette-Guerin (BCG) Vaccines

2.  Haemophilus Influenzae type b (Hib) Vaccines

3.  Meningococcal Vaccines

4.  Pneumococcal Vaccines

5.  Typhoid Vaccines

6.  Combined Typhoid and Hepatitis A Vaccines

7.  Hepatitis A Vaccines

8.  Hepatitis B Vaccines

9.  Hepatitis A and B combined Vaccines

10.  Herpes Zoster Vaccines

11.  Human Papillomavirus (HPV) Vaccines

12.  Japanese Encephalitis Vaccines

13.  Rabies Vaccines

14.  Varicella Vaccines

15.  Yellow Fever Vaccines

16.  Respiratory Syncytial Virus (RSV) Vaccines

17.  Influenza Vaccines

18.  Coronavirus (COVID-19) Vaccines

Schedule 4
DrugS — Minor Ailments

Item

Column 1
Minor Ailment

Column 2
Drug Classes

Column 3
Specified Drugs

1.

Acne (mild)

Skin and Mucous Membrane Agents

Adapalene

Azelaic acid

Benzoyl peroxide

Clindamycin

Dapsone

Erythromycin

Glycolic acid

Salicylic acid

Tazarotene

Tretinoin

Trifarotene

2a.

Allergic rhinitis

Antihistamines

Azelastine

Bilastine

Cetirizine

Cyproheptadine

Desloratadine

Fexofenadine

Loratadine

Olopatadine

Rupatadine

2b.

Allergic rhinitis

Corticosteroids

Beclomethasone

Budesonide

Ciclesonide

Fluticasone

Mometasone

Triamcinolone

3.

Candidal stomatitis

Antifungals

Nystatin

4a.

Conjunctivitis (bacterial, allergic or viral)

Antiallergic Agents

Antazoline

Bepotastine

Cromolyn sodium (Sodium cromoglycate)

Ketotifen

Lodoxamide

Olopatadine

Pheniramine

4b.

Conjunctivitis (bacterial, allergic or viral)

Antibacterials

Erythromycin

Fusidic acid

Gramicidin

Polymyxin B

Tobramycin

Trimethoprim

4c.

Conjunctivitis (bacterial, allergic or viral)

Vasoconstrictors

Naphazoline

Oxymetazoline

Phenylephrine

Tetrahydrozoline

5.

Dermatitis (atopic/eczema, allergic or contact)

Anti-inflammatory Agents

Beclomethasone

Betamethasone valerate

Clobetasone

Crisaborole

Desonide

Fluocinolone

Hydrocortisone

Prednicarbate

Triamcinolone

6a.

Dermatitis (diaper)

Antifungals

Ciclopirox

Clotrimazole

Ketoconazole

Miconazole

Nystatin

6b.

Dermatitis (diaper)

Anti-inflammatory Agents

Desonide

Hydrocortisone

7.

Dysmenorrhea

Nonsteroidal Anti-inflammatory Agents

Acetylsalicylic acid (ASA)

Celecoxib

Diclofenac

Flurbiprofen

Ibuprofen

Ketoprofen

Mefenamic acid

Naproxen

8a.

Gastroesophageal reflux disease (GERD)

Antacids and Adsorbents

Alginic acid

Aluminum hydroxide

Calcium carbonate

Magnesium salts

8b.

Gastroesophageal reflux disease (GERD)

Histamine H2-Antagonists

Cimetidine

Famotidine

Nizatidine

Ranitidine

8c.

Gastroesophageal reflux disease (GERD)

Proton-Pump Inhibitors

Dexlansoprazole

Esomeprazole

Lansoprazole

Omeprazole

Pantoprazole

Rabeprazole

9.

Hemorrhoids

Skin and Mucous Membrane Agents

Dibucaine (Cinchocaine)

Esculin (Aesculin)

Framycetin (Neomycin B)

Hydrocortisone

Phenylephrine

Pramoxine

Zinc sulfate

10a.

Herpes labialis

Anti-inflammatory Agents

Hydrocortisone

10b.

Herpes labialis

Antivirals

Acyclovir

Docosanol

Famciclovir

Valacyclovir

11.

Impetigo

Antibacterials

Bacitracin

Fusidic acid (Sodium fusidate)

Gramicidin

Mupirocin

Ozenoxacin

Polymyxin B

12a.

Insect bites and urticaria

Antihistamines

Bilastine

Cetirizine

Chlorpheniramine

Cyproheptadine

Desloratadine

Diphenhydramine

Fexofenadine

Hydroxyzine

Loratadine

Rupatadine

12b.

Insect bites and urticaria

Antipruritics and Anti-inflammatory Agents

Benzocaine

Calamine

Camphor

Desonide

Hydrocortisone

Lidocaine

Menthol

Pramoxine

Zinc oxide

13a.

Musculoskeletal sprains and strains

Analgesics

Acetaminophen

13b.

Musculoskeletal sprains and strains

Nonsteroidal Anti-inflammatory Agents

Acetylsalicylic acid (ASA)

Celecoxib

Diclofenac

Flurbiprofen

Ibuprofen

Ketoprofen

Mefenamic acid

Naproxen

14.

Nausea and vomiting of pregnancy

Antiemetics and Antinauseants

Dimenhydrinate

Diphenhydramine

Doxylamine

Promethazine

Pyridoxine

15.

Oral aphthae

Anti-inflammatory Agents

Triamcinolone

16.

Pinworms/Threadworms

Anthelmintics

Mebendazole

Pyrantel pamoate

17.

Tick bites, post-exposure prophylaxis to prevent Lyme disease

Antibacterials

Doxycycline

18.

Urinary tract infection (uncomplicated)

Urinary Anti-infectives

Fosfomycin

Nitrofurantoin

Sulfamethoxazole

Trimethoprim

19.

Vulvovaginal candidiasis

Antifungals

Clotrimazole

Fluconazole

Miconazole

Terconazole

 

Made by:
Pris par :

Council of the Ontario College of Pharmacists:
Le Conseil de l’Ordre des pharmaciens de l’Ontario :

Shenda Tanchak

Registrar & CEO / Registraire et chef de la direction

James Morrison

Board Chair / Président du Conseil D’administration

Date made: April 30, 2024
Pris le : 30 avril 2024

 

 

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