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Drug and Pharmacies Regulation Act

R.S.O. 1990, CHAPTER H.4

Consolidation Period: From June 1, 2011 to the e-Laws currency date.

Last amendment: 2009, c. 33, Sched. 6, s. 51.

SKIP TABLE OF CONTENTS

CONTENTS

PART I
GENERAL

1.

Interpretation

2.

Administration of Act

PART VI
PHARMACY

118.

Application of Act

Pharmacies

139.

Certificates of accreditation

140.

Revocation of certificate and other disciplinary measures

140.1

Publication of decisions

141.

Closing of pharmacy

142.

Operation of pharmacies by corporation

143.

Where certificate of registration revoked

144.

Ownership of pharmacies

145.

Licensee bankrupt, deceased, etc.

146.

Supervision of pharmacist

147.

Designations

148.

Inspection

148.1

Entries and searches

148.2

Copying of documents and objects

148.3

Application of Public Inquiries Act, 2009

148.4

No obstruction

Drugs

149.

Dispensing of drugs

150.

Misrepresentation

152.

Mailing or delivering certain drugs

153.

Records of pharmacy

155.

Prescription drugs

156.

Prescription information

157.

Prescriptions, further requirements

158.

Prescription from outside Ontario

159.

Reports

160.

Sale of drugs by wholesale

By-laws and Regulations

160.1

By-laws

161.

Regulations

Enforcement

162.

Restraining orders

162.1

Order where public at risk

163.

Recovery of charges

164.

Surrender of cancelled accreditation certificate

165.

General offence

166.

Responsibility of owner and designated manager

167.

Evidence

PART I
GENERAL

Interpretation

1.  (1)  In this Act,

“Accreditation Committee” means the Accreditation Committee of the College; (“comité d’agrément”)

“by-laws” means the by-laws made under this Act; (“règlements administratifs”)

“certificate of accreditation” means a certificate of accreditation issued by the Registrar of the College under subsection 139 (2); (“certificat d’agrément”)

“certificate of authorization” has the same meaning as in the Regulated Health Professions Act, 1991; (“certificat d’autorisation”)

“certificate of registration” means a certificate of registration within the meaning of the Health Professions Procedural Code issued by the Registrar of the College; (“certificat d’inscription”)

“College” means the Ontario College of Pharmacists; (“Ordre”)

“Council” means the Council of the College; (“conseil”)

“designated manager” means the pharmacist designated by the owner of the pharmacy, in information provided to the College, as the pharmacist responsible for managing the pharmacy; (“gérant désigné”)

“Discipline Committee” means the Discipline Committee of the College; (“comité de discipline”)

“drug” means any substance or preparation containing any substance,

(a) manufactured, sold or represented for use in,

(i) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state or the symptoms thereof, in humans, animals or fowl, or

(ii) restoring, correcting or modifying functions in humans, animals or fowl,

(b) referred to in Schedule I, II or III,

(c) listed in a publication named by the regulations, or

(d) named in the regulations,

but does not include,

(e) any substance or preparation referred to in clause (a), (b), (c) or (d) manufactured, offered for sale or sold as, or as part of, a food, drink or cosmetic,

(f) any “natural health product” as defined from time to time by the Natural Health Products Regulations under the Food and Drugs Act (Canada), unless the product is a substance that is identified in the regulations as being a drug for the purposes of this Act despite this clause, either specifically or by its membership in a class or its listing or identification in a publication,

(g) a substance or preparation named in Schedule U,

(h) a substance or preparation listed in a publication named by the regulations, or

(i) a substance or preparation that the regulations provide is not a drug; (“médicament”)

“health profession corporation” has the same meaning as in the Regulated Health Professions Act, 1991; (“société professionnelle de la santé”)

“Health Professions Procedural Code” means the Health Professions Procedural Code set out in Schedule 2 to the Regulated Health Professions Act, 1991; (“Code des professions de la santé”)

“intern” means a person who is registered as an intern under the Pharmacy Act, 1991; (“interne”)

“member” means a member of the College; (“membre”)

“Minister” means the Minister of Health and Long-Term Care; (“ministre”)

“pharmacist” means a person registered as a pharmacist under the Pharmacy Act, 1991; (“pharmacien”)

“pharmacy” means a premises in or in part of which prescriptions are compounded or dispensed for the public or drugs are sold by retail, and includes a remote dispensing location; (“pharmacie”)

“pharmacy technician” means a person registered as a pharmacy technician under the Pharmacy Act, 1991; (“technicien en pharmacie”)

“prescriber” means a person who is authorized under the laws of a province or territory of Canada to give a prescription within the scope of his or her practice of a health discipline; (“personne autorisée à prescrire des médicaments”)

“prescription” means a direction from a prescriber directing the dispensing of any drug or mixture of drugs for a designated person or animal; (“ordonnance”)

“proprietary misconduct” means proprietary misconduct as defined in the regulations; (“faute liée à la spécialité”)

“registered pharmacy student” means a person registered as a student under the Pharmacy Act, 1991; (“étudiant en pharmacie inscrit”)

“Registrar” means the Registrar of the College; (“registrateur”)

“regulations” means the regulations made under this Act; (“règlements”)

“remote dispensing location” has the meaning provided for in the regulations. (“téléofficine”) 2007, c. 10, Sched. L, s. 1 (1, 2); 2009, c. 26, s. 8 (1, 2).

Schedules

(2)  A reference in this Act to Schedule I, II, III or U is a reference to such Schedule established by the regulations. 2007, c. 10, Sched. L, s. 1 (3).

References in other laws

(2.1)  A reference in any other Act or regulation to a term as defined in subsection 117 (1) of this Act shall be deemed to be a reference to the same term as defined in subsection (1) of this section. 2007, c. 10, Sched. L, s. 1 (1).

References to hearings

(3)  Nothing in this Act shall be construed to require a hearing to be held within the meaning of the Statutory Powers Procedure Act unless the holding of a hearing is specifically referred to. R.S.O. 1990, c. H.4, s. 1 (3).

Administration of Act

2.  The Minister is responsible for the administration of this Act. R.S.O. 1990, c. H.4, s. 2.

3.-19.  Repealed: 1991, c. 18, s. 47 (1).

PART II (ss. 20-44) Repealed: 1991, c. 18, s. 47 (1).

PART III (ss. 45-69) Repealed: 1991, c. 18, s. 47 (1).

PART IV (ss. 70-92) Repealed: 1991, c. 18, s. 47 (1).

PART V (ss. 93-116) Repealed: 1991, c. 18, s. 47 (1).

PART VI
PHARMACY

117.  Repealed: 2007, c. 10, Sched. L, s. 2.

Application of Act

118.  (1)  This Act does not apply to,

(a) drugs compounded, dispensed or supplied in and by a hospital or a health or custodial institution approved or licensed under any general or special Act under the authority of a prescriber for persons under health care provided by such hospital or health or custodial institution;

(b) the selling of,

(i) any substance registered under the Pest Control Products Act (Canada) and sold in accordance with its provisions,

(ii) any feeding stuffs registered under the Feeds Act (Canada) and sold in accordance with its provisions,

(iii) a livestock medicine within the meaning of the Livestock Medicines Act by a person licensed under that Act;

Note: On the day the Statutes of Ontario, 2009, chapter 31, section 74 comes into force, subclause (iii) is repealed and the following substituted:

(iii) a livestock medicine as defined in the Animal Health Act, 2009 by a person licensed under that Act with respect to the control and regulation of the sale of livestock medicines or by a facility licensed for the sale or offering for sale or distribution of livestock medicines;

See: 2009, c. 31, ss. 68, 75 (2).

(c) the practice of a veterinarian under the Veterinarians Act. R.S.O. 1990, c. H.4, s. 118 (1); 1991, c. 18, s. 47 (7); 2007, c. 10, Sched. L, s. 3 (1).

Same

(2)  Nothing in this Act prevents any person from selling or dispensing a drug to a person authorized under a health profession Act as defined in the Regulated Health Professions Act, 1991 to dispense, prescribe, administer, compound or sell drugs. 2009, c. 26, s. 8 (3).

Same

(3)  Nothing in this Act prevents any person from selling, to a member of the College of Chiropodists of Ontario, the College of Dental Hygienists of Ontario, the College of Midwives of Ontario or the College of Optometrists of Ontario, a drug that the member may use in the course of engaging in the practice of his or her profession. 2009, c. 26, s. 8 (3).

Same

(4)  Subject to the following, this Act does not apply to the practice of a person who is authorized under a health profession Act as defined in the Regulated Health Professions Act, 1991 to compound, dispense or sell a drug while engaging in the practice of a health profession:

1. Where that person is working in a pharmacy, this Act applies to the person’s work in the pharmacy to the same extent that it does to any other person.

2. Sections 149, 150, 152 and 160 apply to the person. 2009, c. 26, s. 8 (3).

119.-122.  Repealed: 1991, c. 18, s. 47 (1).

123.  Repealed: 1998, c. 18, Sched. G, s. 49 (4).

Note: Despite the coming into force of the Statutes of Ontario, 1998, chapter 18, Schedule G, subsection 49 (4), a regulation made under clause 123 (1) (j) respecting information to be furnished with respect to pharmacies shall be deemed to continue in force until it is revoked by the authority that made it. See: 1998, c. 18, Sched. G, s. 49 (5).

124.  Repealed: 1998, c. 18, Sched. G, s. 49 (6).

125.-138.  Repealed: 1991, c. 18, s. 47 (1).

Pharmacies

Certificates of accreditation

139.  (1)  No person shall establish or operate a pharmacy unless a certificate of accreditation has been issued in respect thereof. R.S.O. 1990, c. H.4, s. 139 (1).

Issuance

(2)  The Registrar shall issue a certificate of accreditation and renewals thereof to any applicant therefor where the applicant and the pharmacy and its proposed operation qualify under this Act and the regulations and shall refer to the Accreditation Committee every application for a certificate or renewal that the Registrar proposes to refuse or to which he or she considers terms, conditions or limitations should be attached. R.S.O. 1990, c. H.4, s. 139 (2); 2007, c. 10, Sched. L, s. 4 (1).

Accreditation Committee

(3)  The Accreditation Committee shall determine the eligibility of the applicant and the pharmacy or proposed pharmacy and its operation and may direct the Registrar to issue or refuse to issue the accreditation certificate or to issue the accreditation certificate subject to such terms, conditions or limitations as the Committee directs. R.S.O. 1990, c. H.4, s. 139 (3).

Procedure

(4)  The provisions of the Health Professions Procedural Code dealing with applications to the Registration Committee and hearings, reviews and appeals from decisions of panels of the Registration Committee apply, with necessary modifications and subject to subsection (5), to applications referred to the Accreditation Committee as though the Accreditation Committee were a panel. 1991, c. 18, s. 47 (12).

Idem

(5)  The following provisions of the Health Professions Procedural Code do not apply to applications referred to the Accreditation Committee:

1. Paragraphs 2 and 3 of subsection 18 (2).

2. Paragraph 2 of subsection 22 (6). 1991, c. 18, s. 47 (12); 2007, c. 10, Sched. L, s. 4 (2).

Revocation of certificate and other disciplinary measures

140.  (1)  Where the Accreditation Committee has reason to believe that a pharmacy or its operation fails to conform to the requirements of this Act and the regulations or to any term, condition or limitation to which its certificate of accreditation is subject, or that an act of proprietary misconduct has been committed, the Committee may refer the person who has been issued a certificate of accreditation, a designated manager of the pharmacy operated by the person who has been issued a certificate of accreditation or the directors of a corporation which has been issued a certificate of accreditation to the Discipline Committee for a hearing and determination. 2007, c. 10, Sched. L, s. 5 (1).

Procedure

(2)  The provisions of the Health Professions Procedural Code dealing with allegations of a member’s professional misconduct or incompetence referred to the Discipline Committee, interim orders where such allegations are referred to the Committee and hearings, reviews and appeals from decisions of panels of the Discipline Committee apply, with necessary modifications and subject to subsection (3), to allegations referred to the Discipline Committee under subsection (1). 1998, c. 18, Sched. G, s. 49 (7).

References in Code

(2.1)  For greater certainty, and without in any way restricting the application of subsection (2), a reference in section 37 of the Health Professions Procedural Code,

(a) to a “member” includes a person mentioned in subsection (1); and

(b) to a “certificate of registration” includes a certificate of accreditation. 2007, c. 10, Sched. L, s. 5 (2).

Idem

(3)  Subsection (3.1) applies, instead of subsections 51 (1) and (2) of the Health Professions Procedural Code, to allegations referred to the Discipline Committee under subsection (1). 1991, c. 18, s. 47 (13).

Orders

(3.1)  A panel of the Discipline Committee may make an order doing any one or more of the following if it finds that a person who has been issued a certificate of accreditation or the directors of a corporation which has been issued a certificate of accreditation have established or operated a pharmacy in contravention of this Act or the regulations, or have committed an act or acts of proprietary misconduct:

1. Directing the Registrar to revoke the certificate.

2. Directing the Registrar to suspend the certificate for a specified period of time.

3. Requiring the payment of a fine of not more than $100,000 to the Minister of Finance, and directing who shall make the payment.

4. Directing the Registrar to impose specified terms, conditions and limitations on the certificate for a specified period of time or indefinite period of time. 2007, c. 10, Sched. L, s. 5 (3).

Same, designated manager

(3.2)  Despite subsection (3), if a panel of the Discipline Committee finds that a designated manager has contravened a provision of this Act or the regulations, or has committed an act or acts of proprietary misconduct, the panel may make an order doing anything that may be done under subsection 51 (2) of the Health Professions Procedural Code, with any necessary modification. 2007, c. 10, Sched. L, s. 5 (3).

Cancellation for non-payment of fee

(4)  The Registrar may revoke or suspend a certificate of accreditation for non-payment of the fee required under the by-laws after the person operating the pharmacy has been given at least 60 days notice of default and intention to revoke or suspend. 2007, c. 10, Sched. L, s. 5 (4).

Transitional

(5)  A notice given by the Council under subsection (4) as it existed before the coming into force of subsection 5 (4) of Schedule L to the Health System Improvements Act, 2007 continues to be valid as if it had been made by the Registrar. 2007, c. 10, Sched. L, s. 5 (5).

Publication of decisions

140.1  (1)  The College shall publish a panel’s decision and its reasons, or a summary of its reasons, in its annual report and may publish the decision and reasons or summary in any other publication of the College. 2007, c. 10, Sched. L, s. 6.

Publication of name

(2)  In publishing a decision and reasons or summary under subsection (1), the College shall publish the name of the person who has been issued a certificate of accreditation, designated manager or director who was the subject of the proceeding if,

(a) the results of the proceeding may be obtained by a member of the public from the College’s register; or

(b) the person, designated manager or director requests the publication of his or her name. 2007, c. 10, Sched. L, s. 6.

Withholding of name

(3)  The College shall not publish the name of the person, designated manager or director who was the subject of the proceeding unless it is required to do so under subsection (2). 2007, c. 10, Sched. L, s. 6.

Closing of pharmacy

141.  Every person who permanently closes a pharmacy shall immediately remove all signs and symbols relating to the practice of pharmacy either within or outside the premises, shall remove and dispose of all drugs according to law and shall submit in writing to the Registrar such information and within such time as may be required by the by-laws. R.S.O. 1990, c. H.4, s. 141; 1998, c. 18, Sched. G, s. 49 (9).

Operation of pharmacies by corporation

142.  (1)  No corporation shall own or operate a pharmacy unless the majority of the directors of the corporation are pharmacists. R.S.O. 1990, c. H.4, s. 142 (1).

Same

(2)  No corporation shall own or operate a pharmacy unless a majority of each class of shares of the corporation is owned by and registered in the name of pharmacists or in the name of health profession corporations each of which holds a valid certificate of authorization issued by the College. 2000, c. 42, Sched., s. 13; 2007, c. 10, Sched. L, s. 7.

Application of subs. (2)

(3)  For the purposes of subsection (2), shares registered in the name of the personal representative of a deceased pharmacist shall, for a period not exceeding four years, be considered to be registered in the name of a pharmacist. R.S.O. 1990, c. H.4, s. 142 (3).

Idem

(4)  Subsection (2) does not apply to any corporation operating a pharmacy on the 14th day of May, 1954. R.S.O. 1990, c. H.4, s. 142 (4).

Application of section

(5)  This section does not apply to the operation of a pharmacy by a non-profit corporation having as its objects and providing health services by members of more than one health discipline. R.S.O. 1990, c. H.4, s. 142 (5).

Where certificate of registration revoked

143.  No person whose certificate of registration has been revoked for cause or while his or her licence is suspended for cause,

(a) shall be employed or work in a pharmacy; or

(b) shall act as a director or vote as a shareholder in a corporation operating a pharmacy. R.S.O. 1990, c. H.4, s. 143; 1991, c. 18, s. 47 (14); 2007, c. 10, Sched. L, s. 8.

Ownership of pharmacies

144.  (1)  No person other than a pharmacist or a corporation complying with the requirements of section 142 shall own or operate a pharmacy. R.S.O. 1990, c. H.4, s. 144 (1).

Idem

(2)  For the purposes of the ownership of a pharmacy, or for the purposes of the composition of the board of directors or ownership of shares of a corporation as required by section 142, the right to operate the pharmacy shall not be affected by,

(a) any suspension of the certificate of registration of a pharmacist; or

(b) the revocation of the certificate of registration of a pharmacist until after a period of six months has elapsed. R.S.O. 1990, c. H.4, s. 144 (2); 2007, c. 10, Sched. L, s. 9.

Licensee bankrupt, deceased, etc.

Carrying on business of bankrupt person

145.  (1)  Where a person owning and operating a pharmacy becomes bankrupt, insolvent or makes an assignment for the benefit of creditors, the person shall so notify the Registrar and the trustee in bankruptcy, liquidator or assignee, as the case may be, may own and operate the pharmacy for the purposes of the bankruptcy, insolvency or assignment. R.S.O. 1990, c. H.4, s. 145 (1).

Carrying on business of deceased person

(2)  Upon the death of a pharmacist who was owning and operating a pharmacy at the time of his or her death, the personal representative of such deceased person may own and operate the pharmacy for a period of four years or for such further period as the Council may authorize. R.S.O. 1990, c. H.4, s. 145 (2).

Notification to Registrar

(3)  Every person authorized to own and operate a pharmacy under subsection (1) or (2) shall immediately upon becoming so authorized file with the Registrar evidence of the person’s authority. R.S.O. 1990, c. H.4, s. 145 (3).

Supervision of pharmacist

146.  (1)  Subject to subsection (1.0.1), no person shall operate a pharmacy unless,

(a) it is under the supervision of a pharmacist who is physically present; and

(b) it is managed by a pharmacist who is designated as the designated manager by the owner of the pharmacy. R.S.O. 1990, c. H.4, s. 146 (1); 2007, c. 10, Sched. L, s. 10 (1); 2009, c. 26, s. 8 (4).

Remote dispensing locations

(1.0.1)  The requirement under clause (1) (a) that a pharmacist be physically present in a pharmacy does not apply with respect to a remote dispensing location, as long as,

(a) a certificate of accreditation has been issued permitting the operation of the remote dispensing location; and

(b) the remote dispensing location is operated in accordance with the regulations. 2009, c. 26, s. 8 (5).

Designated manager

(1.1)  Every owner of a pharmacy shall designate a designated manager for the pharmacy, and file notice of the designation with the College in accordance with the regulations. 2007, c. 10, Sched. L, s. 10 (2).

Exception

(2)  Where the drugs in a pharmacy are restricted to a part of the pharmacy that is not accessible to the public in accordance with the regulations, and while such part is not in operation, clause (1) (a) does not apply to the remaining premises of the pharmacy. R.S.O. 1990, c. H.4, s. 146 (2).

Display

(3)  Every designated manager shall ensure that his or her name, certificate of registration, or both, are clearly and publicly displayed in the pharmacy. 2007, c. 10, Sched. L, s. 10 (3).

Designations

147.  No person shall in connection with a retail business use any of the following designations, unless the business is an accredited pharmacy:

1. Drug store.

2. Pharmacien détaillant.

3. Pharmacy.

4. Pharmacie.

5. Drug department.

6. Service de pharmacie.

7. Drug sundries.

8. Remèdes divers.

9. Drug or Drugs.

10. Médicaments.

11. Drug mart.

12. Comptoir de médicaments.

13. Medicines.

14. Remèdes. R.S.O. 1990, c. H.4, s. 147.

Inspection

Premises

148.  (1)  An inspector appointed under a by-law may enter any pharmacy or other shop in the performance of his or her duties under this Act at all reasonable times. R.S.O. 1990, c. H.4, s. 148 (1); 2007, c. 10, Sched. L, s. 11 (1).

Documents and objects

(2)  Any document or object that is kept in a pharmacy and is relevant to pharmacy practice and to an inspection under this Act shall be open to inspection by any inspector appointed under a by-law. 2007, c. 10, Sched. L, s. 11 (2).

Entries and searches

148.1  (1)  A justice of the peace may, on the application of an inspector made without notice, issue a warrant authorizing an inspector to enter and search a place and examine any document or thing as specified in the warrant if the justice of the peace is satisfied that the inspector has been properly appointed and that there are reasonable and probable grounds established upon oath for believing that,

(a) a person has committed an act or proprietary misconduct or is in breach of this Act or the regulations; and

(b) there is something relevant to the inspection at the place. 2007, c. 10, Sched. L, s. 12.

Searches by day unless stated

(2)  A warrant issued under subsection (1) may only be executed between 8 a.m. and 8 p.m., unless the warrant specifies otherwise. 2007, c. 10, Sched. L, s. 12.

Application for dwelling

(3)  An application for a warrant under subsection (1) to enter a dwelling shall specifically indicate that the application relates to a dwelling. 2007, c. 10, Sched. L, s. 12.

Assistance and entry by force

(4)  An inspector entering and searching a place under the authority of a warrant issued under subsection (1) may be assisted by other persons and may enter a place by force. 2007, c. 10, Sched. L, s. 12.

Inspector to show identification

(5)  An inspector entering and searching a place under the authority of a warrant issued under subsection (1) shall produce his or her identification, on request, to any person at the place. 2007, c. 10, Sched. L, s. 12.

Copying of documents and objects

148.2  (1)  An inspector may copy, at the College’s expense, a document or object that an inspector may examine under subsection 148 (2) or under the authority of a warrant issued under subsection 148.1 (1). 2007, c. 10, Sched. L, s. 12.

Removal of documents and objects

(2)  An inspector may remove a document or object described in subsection (1) if,

(a) it is not practicable to copy it in the place where it is examined;

(b) a copy of it is not sufficient for the purposes of the inspection; or

(c) the object is a drug, and the inspector has provided a receipt. 2007, c. 10, Sched. L, s. 12.

Return of documents and objects or copies

(3)  If it is practicable to copy a document or object removed under subsection (2), the inspector shall,

(a) if it was removed under clause (2) (a) or (c), return the document or object within a reasonable time; or

(b) if it was removed under clause (2) (b), provide the person who was in possession of the document or object with a copy of it within a reasonable time. 2007, c. 10, Sched. L, s. 12.

Copy as evidence

(4)  A copy of a document or object certified by an inspector to be a true copy shall be received in evidence in any proceeding to the same extent and shall have the same evidentiary value as the document or object itself. 2007, c. 10, Sched. L, s. 12.

Definition

(5)  In this section, and for the purposes of subsection 148 (2),

“document” means a record of information in any form and includes any part of it. 2007, c. 10, Sched. L, s. 12.

Application of Public Inquiries Act, 2009

148.3  Section 33 of the Public Inquiries Act, 2009 applies to a determination by an inspector whether a person mentioned in subsection 140 (1) has committed an act of proprietary misconduct or is in breach of this Act or the regulations. 2009, c. 33, Sched. 6, s. 51.

No obstruction

148.4  No person shall obstruct an inspector acting under section 148, or under the authority of a warrant issued under subsection 148.1 (1), or conceal from an inspector or destroy anything that is relevant to an inspection. 2007, c. 10, Sched. L, s. 12.

Drugs

Dispensing of drugs

149.  (1)  Subject to subsections (2) and (3), no person shall compound, dispense or sell any drug in a pharmacy other than,

(a) a pharmacist;

(b) an intern acting under the supervision of a pharmacist who is physically present;

(c) a registered pharmacy student acting under the supervision of a pharmacist who is physically present; or

(d) a pharmacy technician acting under the supervision of a pharmacist who is physically present. 2007, c. 10, Sched. L, s. 13 (1); 2009, c. 26, s. 8 (6).

Exception

(2)  Where a pharmacist or an intern is present in the pharmacy and available to the purchaser for consultation, subsection (1) does not apply to the sale in a pharmacy of a drug listed in Schedule III. 2007, c. 10, Sched. L, s. 13 (2).

Remote dispensing locations

(3)  The requirement in clause (1) (d) that a pharmacist be physically present to supervise does not apply with respect to a remote dispensing location, as long as a pharmacist is actively supervising the pharmacy technician mentioned in that clause and,

(a) a certificate of accreditation has been issued permitting the operation of the remote dispensing location; and

(b) the remote dispensing location is operated in accordance with the regulations. 2009, c. 26, s. 8 (7).

Misrepresentation

150.  No person shall sell any drug under the representation or pretence that it is a particular drug when the person knows or ought to have known that it is not that drug, or does not contain any substance that the drug is meant to contain. 2007, c. 10, Sched. L, s. 14.

151.  Repealed: 2007, c. 10, Sched. L, s. 15.

Mailing or delivering certain drugs

152.  (1)  Subject to subsection (2), a drug listed in Schedule I shall, if sent through the mail, only be sent by registered mail or, if delivered by another method, shall be delivered in a method that is both traceable and auditable, with a receipt for the drug signed by the patient or the patient’s agent. 2007, c. 10, Sched. L, s. 16.

Exception, federal law

(2)  Where a law of Canada permits a method of delivery of a drug other than provided for in subsection (1), the law of Canada prevails. 2007, c. 10, Sched. L, s. 16.

Records of pharmacy

153.  The designated manager of every pharmacy shall keep or cause to be kept a record of every purchase and sale of a drug referred to in the Schedules to the Controlled Drugs and Substances Act (Canada) or the Schedule to the Narcotic Control Regulations (Canada) in such form or manner as the regulations may prescribe. 2007, c. 10, Sched. L, s. 17.

154.  Repealed: 2007, c. 10, Sched. L, s. 18.

Prescription drugs

155.  (1)  Subject to the regulations, no person shall sell by retail any drug referred to in Schedule I, except on prescription given in such form, in such manner and under such conditions as the regulations prescribe. 2007, c. 10, Sched. L, s. 19.

Exception

(2)  Subsection (1) does not apply to drugs listed in Schedule I that are sold in a container labelled by the manufacturer as for veterinary or agricultural use or sold in a form unsuitable for human use. 2007, c. 10, Sched. L, s. 19.

Prescription information

156.  (1)  Every person who dispenses a drug pursuant to a prescription shall ensure that the following information is recorded on the prescription,

(a) the name and address of the person for whom the drug is prescribed;

(b) the name, strength (where applicable) and quantity of the prescribed drug;

(c) the directions for use, as prescribed;

(d) the name and address of the prescriber;

(e) the identity of the manufacturer of the drug dispensed;

(f) an identification number or other designation;

(g) the signature of the person dispensing the drug and, where different, also the signature of the person receiving a verbal prescription;

(h) the date on which the drug is dispensed;

(i) the price charged. R.S.O. 1990, c. H.4, s. 156 (1).

Retention of records

(2)  The records required under subsection (1) shall be retained for not less than two years. R.S.O. 1990, c. H.4, s. 156 (2); 1991, c. 18, s. 47 (16).

Identification markings

(3)  The container in which the drug is dispensed shall be marked with,

(a) the identification number that is on the prescription;

(b) the name, address and telephone number of the pharmacy in which the prescription is dispensed;

(c) the identification of the drug as to its name, its strength and its manufacturer, unless directed otherwise by the prescriber;

(d) the quantity where the drug dispensed is in solid oral dosage form;

(e) the name of the owner of the pharmacy;

(f) the date the prescription is dispensed;

(g) the name of the prescriber;

(h) the name of the person for whom it is prescribed;

(i) the directions for use as prescribed. R.S.O. 1990, c. H.4, s. 156 (3).

Prescriptions, further requirements

Copy of prescription

157.  (1)  Every person in respect of whom a prescription is presented to a pharmacist to be dispensed, unless otherwise directed by the prescriber, is entitled to have a copy of it marked as such, furnished to the person, his or her agent, or a pharmacist acting on behalf of such person or agent. R.S.O. 1990, c. H.4, s. 157 (1); 2007, c. 10, Sched. L, s. 20.

Conflict

(1.1)  Subsection (1) prevails despite anything in the Personal Health Information Protection Act, 2004. 2004, c. 3, Sched. A, s. 80.

Disposal of prescriptions

(2)  Prescriptions in a pharmacy that ceases to operate as a pharmacy shall be delivered to the persons, or agents of the persons, who presented the prescription or to another pharmacy that is reasonably readily available to such person or his or her agent, or failing either, to the College. R.S.O. 1990, c. H.4, s. 157 (2).

Prescription from outside Ontario

158.  A pharmacist may dispense a drug pursuant to a prescription authorized by a prescriber licensed to practise in a province or territory of Canada other than Ontario if, in the professional judgment of the pharmacist, the patient requires the drug. 2007, c. 10, Sched. L, s. 21.

Reports

By pharmacists

159.  (1)  Every person who operates or manages a pharmacy shall provide the Minister with such information from records required to be kept under section 156 as the Minister requests. R.S.O. 1990, c. H.4, s. 159 (1).

By Registrar

(2)  The Registrar shall provide the Minister with such information respecting substances referred to in the Schedules, except Schedule U, as the Registrar possesses and the Minister requests. R.S.O. 1990, c. H.4, s. 159 (2); 2007, c. 10, Sched. L, s. 22.

Sale of drugs by wholesale

160.  (1)  No person shall sell by wholesale any drug for the purpose of sale by retail to any person who is not entitled to sell the drug by retail. R.S.O. 1990, c. H.4, s. 160 (1).

Registration by wholesalers

(2)  Every person supplying drugs by wholesale in Ontario shall register with the College as a drug wholesaler and furnish the Registrar with a signed statement showing,

(a) the person’s full name and address, or if a corporation the name of the corporation and the names and addresses of the president and directors thereof;

(b) the principal business address,

and with respect to the person’s places of business where drugs are handled,

(c) the address of each place of business, agent or representative in Ontario;

(d) the name of the manager or person responsible for each place of business in Ontario;

(e) the date on which the person proposes to commence business at each new location in Ontario. R.S.O. 1990, c. H.4, s. 160 (2).

Furnishing of information

(3)  The information required by subsection (2) shall be furnished at least seven days before commencing business and any change in the information required by subsection (2) shall be furnished to the Registrar within seven days of the change. R.S.O. 1990, c. H.4, s. 160 (3).

Location where drugs accepted

(4)  No member and no pharmacy shall receive any drug from a wholesale distributor of drugs other than at the location of a pharmacy which ordered the drugs except where appropriate in the best interest of a patient or patients. 2007, c. 10, Sched. L, s. 23.

By-laws and Regulations

By-laws

160.1  (1)  The Council may make by-laws relating to the administrative and internal affairs of the College and, without limiting the generality of the foregoing, the Council may make by-laws,

(a) requiring members or operators of pharmacies to give the College such information respecting pharmacies as may be set out in the by-laws, including the location of pharmacies, the name and address of pharmacies, the residential address of members and the name and address of owners and designated managers of pharmacies and, if the pharmacy is owned by a corporation, of the directors of the corporation, and any changes to the information;

(b) providing for the information, instruments or documents to be filed with the Registrar by persons opening, acquiring, relocating or closing a pharmacy, the form thereof and the time of filing;

(c) prescribing a fee for applying for a certificate of accreditation and for the issuance and renewal of such certificates and requiring pharmacists and operators of pharmacies to pay the fee;

(d) providing for the appointment of inspectors for the purposes of this Part. 1998, c. 18, Sched. G, s. 49 (11); 2007, c. 10, Sched. L, s. 24.

Copies of by-laws

(2)  A copy of the by-laws made by the Council shall be given to the Minister and to each member and operator of a pharmacy and shall be available for public inspection during normal business hours in the office of the College. 1998, c. 18, Sched. G, s. 49 (11).

Unanimous by-laws, etc.

(3)  A by-law or resolution signed by all the members of the Council is as valid and effective as if passed at a meeting of the Council called, constituted and held for the purpose. 1998, c. 18, Sched. G, s. 49 (11).

Regulations

161.  (1)  Subject to the approval of the Lieutenant Governor in Council, the Council may make regulations,

(a) establishing Schedules I, II, III and U for the purposes of this Act, and prescribing the substances that are to be included in those Schedules;

(b) naming or identifying substances for the purposes of the definition of “drug” in subsection 1 (1) and specifying the provisions of this Act that shall apply in respect of such substances;

(c) naming substances and preparations that are not drugs for the purposes of the definition of “drug” in subsection 1 (1);

(c.1) naming publications for the purposes of the definition of “drug” in subsection 1 (1) and specifying the provisions of this Act that shall apply in respect of substances named in those publications;

(c.2) governing matters relating to the sale in pharmacies of drugs or other specified substances or preparations;

(d) prescribing the percentage of any substance to be contained in any preparation referred to in any Schedule;

(e) prescribing the manner in which prescriptions shall be given in respect of the drugs referred to in Schedule I and the conditions under which such prescriptions may be given;

(f) authorizing the refilling of prescriptions without further prescription and prescribing the conditions under which prescriptions may be refilled without further prescription;

(g) governing the manner in which records shall be kept of the purchase and sale of drugs or of any category or class of drug;

(h) pertaining to the transfer of prescriptions and the records to be kept by the transferor and the transferee;

(i), (j) Repealed: 2007, c. 10, Sched. L, s. 25 (4).

(j.1) governing the designation of designated managers;

(k) providing for the establishment and maintenance of patient record systems;

(k.1) prescribing books and records to be kept and returns to be made and information to be furnished with respect to pharmacies and providing for the examination and audit of such books and records;

(k.2) respecting the promotion or advertising of pharmacies and respecting advertising by operators of pharmacies;

(l) prescribing the types of containers to be used for containing any drug and the designs, specifications and labelling of containers used for containing any drug;

(m) prescribing standards for accreditation of pharmacies including their operation and the maintenance, space, equipment and facilities required therefor;

(m.1) defining and governing the meaning of “remote dispensing location” for the purposes of this Act and the regulations or any provision of this Act or the regulations;

(m.2) prescribing standards for accreditation applicable to remote dispensing locations, including their operation and the maintenance, space, equipment and facilities required therefore;

(m.3) establishing requirements for and governing remote dispensing locations, their owners and operators and their operation, and clarifying the application of this Act with respect to remote dispensing locations, their owners and operators;

(n) providing for applications for certificates of accreditation of pharmacies, the issuance, suspension, revocation, expiration and renewal of such certificates, and anything ancillary to such issuance, suspension, revocation, expiration and renewal;

(o), (p) Repealed: 1998, c. 18, Sched. G, s. 49 (14).

(q) prescribing standards for the subdivision of premises so that drugs are restricted to a specified area and so that the part of the premises to which the drugs are restricted may be rendered not accessible to the public, while the other part remains open;

(r) regulating the handling, location and storage of drugs in a pharmacy;

(s) regulating the use of containers in which drugs may be dispensed;

(t) designating organizations to test, certify and designate containers that meet standards approved by the Council for such purposes as may be specified in the regulations, and requiring the use of containers that are so certified and designated except under such circumstances as are prescribed;

(u) defining “proprietary misconduct” for the purposes of this Act and governing what constitutes an act of proprietary misconduct. R.S.O. 1990, c. H.4, s. 161 (1); 1998, c. 18, Sched. G, s. 49 (12-14, 18); 2007, c. 10, Sched. L, s. 25 (1-8); 2009, c. 26, s. 8 (8).

Note: The following applies with respect to regulations respecting fees made under clause 161 (1) (n) and regulations made under clause 161 (1) (o) or (p) that are in force immediately before February 1, 1999. Despite the coming into force of the Statutes of Ontario, 1998, chapter 18, Schedule G, subsections 49 (13) and (14) (repealing the authority under which the regulations are made), the regulations shall be deemed to continue in force until they are revoked by the authority that made them. See: 1998, c. 18, Sched. G, ss. 49 (15, 16).

Note: A reference to by-laws in the Act shall be deemed to include a reference to regulations which are deemed to continue in force under the Statutes of Ontario, 1998, chapter 18, Schedule G, subsection 49 (16). See: 1998, c. 18, Sched. G, s. 49 (17).

Incorporation by reference

(2)  A regulation under subsection (1) may adopt by reference, in whole or in part and with such changes as may be necessary, any document or publication made by a body or organization independent of the College and require compliance with the document or publication adopted. 1998, c. 18, Sched. G, s. 49 (19); 2007, c. 10, Sched. L, s. 25 (9).

Note: The following applies with respect to regulations made under subsection (2) that are in force immediately before February 1, 1999. Despite the coming into force of the Statutes of Ontario, 1998, chapter 18, Schedule G, subsections 49 (13) and (14) (repealing the authority under which the regulations are made), the regulations shall be deemed to continue in force until they are revoked by the authority that made them. See: 1998, c. 18, Sched. G, ss. 49 (15, 16).

Note: A reference to by-laws in the Act shall be deemed to include a reference to regulations which are deemed to continue in force under the Statutes of Ontario, 1998, chapter 18, Schedule G, subsection 49 (16). See: 1998, c. 18, Sched. G, s. 49 (17).

Rolling incorporation

(3)  If a regulation under subsection (2) so provides, a document or publication adopted by reference shall be a reference to it, as amended from time to time, and whether the amendment was made before or after the regulation was made. 1998, c. 18, Sched. G, s. 49 (19).

Copies available for inspection

(4)  A copy of a document or publication adopted by reference under subsection (2) shall be available for public inspection during normal business hours in the office of the College and shall, if it exists in electronic format, be posted on the College’s website or made available through a hyperlink at the College’s website. 1998, c. 18, Sched. G, s. 49 (19); 2007, c. 10, Sched. L, s. 25 (10).

Enforcement

Restraining orders

162.  (1)  Where it appears to the College that any person does not comply with any provision of this Act or the regulations, despite the imposition of any penalty in respect of such non-compliance and in addition to any other rights it may have, the College may apply to a judge of the Superior Court of Justice for an order directing such person to comply with such provision, and upon the application the judge may make such order or such other order as the judge thinks fit. R.S.O. 1990, c. H.4, s. 162 (1); 2006, c. 19, Sched. C, s. 1 (1); 2007, c. 10, Sched. L, s. 26.

Appeal

(2)  An appeal lies to the Divisional Court from an order made under subsection (1). R.S.O. 1990, c. H.4, s. 162 (2).

Order where public at risk

162.1  (1)  Despite anything in the Pharmacy Act, 1991, the Regulated Health Professions Act, 1991 or the Health Professions Procedural Code, where it appears to the College that the continued operation of a pharmacy places or may place the public at risk, the College may apply to a judge of the Superior Court of Justice for an order immediately revoking or suspending the certificate of accreditation of the pharmacy. 2007, c. 10, Sched. L, s. 27.

Same

(2)  The judge of the Superior Court of Justice hearing the application may make an order revoking or suspending the certificate or placing terms, conditions or limitations on the certificate or may make such other order related to the operation of the pharmacy in the public interest as the judge sees fit. 2007, c. 10, Sched. L, s. 27.

Appeal

(3)  An appeal lies to the Divisional Court from an order made under subsection (2). 2007, c. 10, Sched. L, s. 27.

Recovery of charges

163.  A person who sells any drug in contravention of this Act, the Regulated Health Professions Act, 1991 or the Pharmacy Act, 1991 or of the regulations under this Act, the Regulated Health Professions Act, 1991 or the Pharmacy Act, 1991 is not entitled to recover any charges in respect thereof. R.S.O. 1990, c. H.4, s. 163; 1998, c. 18, Sched. G, s. 49 (20).

Surrender of cancelled accreditation certificate

164.  Where a certificate of accreditation is revoked or cancelled, the former holder thereof shall forthwith deliver the certificate to the Registrar. R.S.O. 1990, c. H.4, s. 164; 1991, c. 18, s. 47 (17).

General offence

165.  Every person who contravenes any provision of this Act or the regulations for which no penalty is otherwise provided is guilty of an offence and on conviction is liable,

(a) in the case of an individual, to a fine not exceeding $25,000 for a first offence or $50,000 for a second or subsequent offence; or

(b) in the case of a corporation, to a fine not exceeding $50,000 for a first offence or $200,000 for a second or subsequent offence. 2007, c. 10, Sched. L, s. 28.

Responsibility of owner and designated manager

166.  (1)  Every owner and designated manager of a pharmacy, or either of them, is liable for every offence against this Act committed by any person in the employ of or under the supervision of the owner or designated manager with the owner’s or designated manager’s permission, consent or approval, express or implied, and every director of a corporation operating a pharmacy is liable for every offence against this Act committed by any person in the employ of the corporation with the director’s permission, consent or approval, express or implied. 2007, c. 10, Sched. L, s. 29.

Same

(2)  Where any person operates a pharmacy contrary to this Act or the regulations, the owner and designated manager of such pharmacy, or either of them, or any director of a corporation operating a pharmacy, may be proceeded against, and prosecution or conviction of any of them is not a bar to prosecution or conviction of another. 2007, c. 10, Sched. L, s. 29.

Evidence

167.  In any prosecution under this Act, the Regulated Health Professions Act, 1991 or the Pharmacy Act, 1991,

(a) a certificate as to the analysis of any drug or poison purporting to be signed by a Food and Drug Analyst or Provincial Analyst is admissible in evidence as proof, in the absence of evidence to the contrary, of the facts stated therein without proof of the appointment or signature of the analyst;

(b) any article labelled as containing any drug is admissible in evidence as proof, in the absence of evidence to the contrary, that the article contains the drug described on the label;

(c) the label of the container of a drug dispensed pursuant to a prescription is admissible in evidence as proof, in the absence of evidence to the contrary, that the drug named in the prescription was dispensed;

(d) evidence that a drug is found in a shop or place in which business is transacted is admissible as proof, in the absence of evidence to the contrary, that it was kept for sale;

(e) evidence of the publishing of a sign, title or advertisement containing the name of an establishment or the owner thereof is admissible in evidence as proof, in the absence of evidence to the contrary, that the sign, title or advertisement was published by the owner of the establishment. R.S.O. 1990, c. H.4, s. 167; 1998, c. 18, Sched. G, s. 49 (21).

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