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Drug and Pharmacies Regulation Act

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

Historical version for the period November 1, 2001 to May 19, 2004.

Amended by: 1991, c. 18, s. 47; 1998, c. 18, Sched. G, s. 49; 2000, c. 42, Sched., ss. 12, 13.

CONTENTS

PART I
GENERAL

1.

Interpretation

2.

Administration of Act

PART VI
PHARMACY

117.

Interpretation, Part VI

118.

Application of Part

Pharmacies

139.

Certificates of accreditation

140.

Revocation of certificate and other disciplinary measures

141.

Closing of pharmacy

142.

Operation of pharmacies by corporation

143.

Where licence revoked

144.

Ownership of pharmacies

145.

Licensee bankrupt, deceased, etc.

146.

Supervision of pharmacist

147.

Designations

148.

Inspection

Drugs

149.

Dispensing of drugs

150.

Misrepresentation

151.

Sched. D drugs

152.

Mailing of drugs

153.

Records of pharmacy

154.

Sched. B drugs

155.

Prescription drugs

156.

Prescription information

157.

Prescriptions, further requirements

158.

Prescription by doctor out of Ontario

159.

Reports

160.

Sale of drugs by wholesale

By-laws and Regulations

160.1

By-laws

161.

Regulations

Enforcement

162.

Restraining orders

163.

Recovery of charges

164.

Surrender of cancelled accreditation certificate

165.

General offence

166.

Responsibility of owner and manager

167.

Evidence

PART I
GENERAL

Interpretation

1. (1) In this Act,

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

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

“Minister” means the Minister of Health. (“ministre”) R.S.O. 1990, c. H.4, s. 1 (1); 1991, c. 18, s. 47 (1, 3); 1998, c. 18, Sched. G, s. 49 (1); 2000, c. 42, Sched., s. 12.

(2) Repealed: 1991, c. 18, s. 47 (1).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. Repealed: 1991, c. 18, s. 47 (1).

4. Repealed: 1991, c. 18, s. 47 (1).

5. Repealed: 1991, c. 18, s. 47 (1).

6. Repealed: 1991, c. 18, s. 47 (1).

7. Repealed: 1991, c. 18, s. 47 (1).

8. Repealed: 1991, c. 18, s. 47 (1).

9. Repealed: 1991, c. 18, s. 47 (1).

10. Repealed: 1991, c. 18, s. 47 (1).

11. Repealed: 1991, c. 18, s. 47 (1).

12. Repealed: 1991, c. 18, s. 47 (1).

13. Repealed: 1991, c. 18, s. 47 (1).

14. Repealed: 1991, c. 18, s. 47 (1).

15. Repealed: 1991, c. 18, s. 47 (1).

16. Repealed: 1991, c. 18, s. 47 (1).

17. Repealed: 1991, c. 18, s. 47 (1).

18. Repealed: 1991, c. 18, s. 47 (1).

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

Interpretation, Part VI

117. (1) In this Part,

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

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

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

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

“Discipline Committee” means the Discipline Committee of the Council; (“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 C, D, E, F, G or N,

(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) or (c) manufactured, offered for sale or sold as, or as part of, a food, drink or cosmetic,

(f) any proprietary medicine as defined from time to time by the regulations made under the Food and Drugs Act (Canada) that does not contain any substance or preparation containing any substance referred to in Schedule C, D, E, F, G or N,

(g) a substance or preparation named in Schedule A or B; (“médicament”)

“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”)

“licence” means a certificate of registration issued under the Pharmacy Act, 1991; (“permis”)

“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 and dispensed for the public or drugs are sold by retail; (“pharmacie”)

“prescriber” means a person who is authorized to give a prescription within the scope of his or her practice of a health discipline or profession; (“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”)

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

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

“registration” means a registration as an intern or registered pharmacy student and “registered” has a corresponding meaning; (“inscription”, “inscrire”)

regulations” means the regulations made under this Part. (“règlements”) R.S.O. 1990, c. H.4, s. 117 (1); 1991, c. 18, s. 47 (1, 4-6); 1998, c. 18, Sched. G, s. 49 (2, 3).

Schedules

(2) A reference in this Part to Schedule A, B, C, D, E, F, G or N is a reference to such Schedule established by the regulations for the purposes of this Part. R.S.O. 1990, c. H.4, s. 117 (2).

(3) Repealed: 1991, c. 18, s. 47 (1).

Application of Part

118. (1) This Part 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;

(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).

Idem

(2) Nothing in this Part 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 or administer drugs. R.S.O. 1990, c. H.4, s. 118 (2); 1991, c. 18, s. 47 (8).

Idem

(3) Nothing in this Part 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. 1991, c. 18, s. 47 (9).

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

120. Repealed: 1991, c. 18, s. 47 (1).

121. Repealed: 1991, c. 18, s. 47 (1).

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. Repealed: 1991, c. 18, s. 47 (1).

126. Repealed: 1991, c. 18, s. 47 (1).

127. Repealed: 1991, c. 18, s. 47 (1).

128. Repealed: 1991, c. 18, s. 47 (1).

129. Repealed: 1991, c. 18, s. 47 (1).

130. Repealed: 1991, c. 18, s. 47 (1).

131. Repealed: 1991, c. 18, s. 47 (1).

132. Repealed: 1991, c. 18, s. 47 (1).

133. Repealed: 1991, c. 18, s. 47 (1).

134. Repealed: 1991, c. 18, s. 47 (1).

135. Repealed: 1991, c. 18, s. 47 (1).

136. Repealed: 1991, c. 18, s. 47 (1).

137. Repealed: 1991, c. 18, s. 47 (1).

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 Part 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).

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, 3 and 5 of subsection 18 (2).

2. Paragraph 2 of subsection 22 (6). 1991, c. 18, s. 47 (12).

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 Part and the regulations or to any term, condition or limitation to which its certificate of accreditation is subject, the Committee may refer the matter to the Discipline Committee for a hearing and determination. R.S.O. 1990, c. H.4, s. 140 (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).

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) If a panel of the Discipline Committee finds a person who has been issued a certificate of accreditation in respect of a pharmacy has established or operated the pharmacy in contravention of this Act or the regulations, it may make an order doing any one or more of the following:

1. Directing the Registrar to revoke the person’s certificate.

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

3. Requiring the person to pay a fine of not more than $25,000 to the Treasurer of Ontario. 1991, c. 18, s. 47 (13).

Cancellation for non-payment of fee

(4) The Council may cancel 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 two months notice of default and intention to cancel. R.S.O. 1990, c. H.4, s. 140 (4); 1998, c. 18, Sched. G, s. 49 (8).

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 Ontario College of Pharmacists. 2000, c. 42, Sched., s. 13.

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 licence revoked

143. No person whose licence 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).

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 licence of a pharmacist; or

(b) the revocation of the licence of a pharmacist until after a period of six months has elapsed. R.S.O. 1990, c. H.4, s. 144 (2).

Licensee bankrupt, deceased, etc.

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) 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 so designated by the owner of the pharmacy. R.S.O. 1990, c. H.4, s. 146 (1).

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).

Displaying licence

(3) Every manager of a pharmacy shall publicly display his or her licence in the pharmacy. 1991, c. 18, s. 47 (15).

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 Part at all reasonable times. R.S.O. 1990, c. H.4, s. 148 (1).

Records

(2) Any record required to be kept under this Part shall be open to inspection by any inspector appointed under a by-law. R.S.O. 1990, c. H.4, s. 148 (2).

Drugs

Dispensing of drugs

149. (1) Subject to section 154, no person other than a pharmacist or an intern or a registered pharmacy student acting under the supervision of a pharmacist who is physically present shall compound, dispense or sell any drug in a pharmacy. R.S.O. 1990, c. H.4, s. 149 (1).

Exception for certain drugs

(2) Where a pharmacist or an intern is present in the pharmacy and is available to the purchaser for consultation, subsection (1) does not apply to the sale in a pharmacy of a drug other than,

(a) a drug requiring a prescription for sale;

(b) a drug referred to in Part I of Schedule D; or

(c) a drug referred to in Schedule C. R.S.O. 1990, c. H.4, s. 149 (2).

Misrepresentation

150. No person shall knowingly sell any drug under the representation or pretence that it is a particular drug that it is not, or contains any substance that it does not. R.S.O. 1990, c. H.4, s. 150.

Sched. D drugs

151. (1) No person shall sell a drug listed in Schedule D unless it is labelled in accordance with the regulations. R.S.O. 1990, c. H.4, s. 151 (1).

Record of poisons

(2) No person shall sell by retail a drug listed in Part I of Schedule D unless a record of the sale is made in such manner as the regulations prescribe. R.S.O. 1990, c. H.4, s. 151 (2).

Exception

(3) Subsections (1) and (2) do not apply to a drug when it is dispensed pursuant to a prescription or forms part of the ingredients of a prescription. R.S.O. 1990, c. H.4, s. 151 (3).

Mailing of drugs

152. Drugs referred to in Schedules D, E, F, G and N shall be sent through the mail only by registered mail. R.S.O. 1990, c. H.4, s. 152.

Records of pharmacy

153. The manager of every pharmacy shall keep or cause to be kept a record of every purchase and sale of a drug referred to in Schedule G or N in such form or manner as the regulations may prescribe. R.S.O. 1990, c. H.4, s. 153.

Sched. B drugs

154. (1) No person shall sell by retail a substance listed in Schedule B unless it is labelled in accordance with the regulations. R.S.O. 1990, c. H.4, s. 154 (1).

Idem

(2) No person other than a pharmacist shall sell by retail a substance listed in Schedule B for the prevention or treatment of an ailment, disease or physical disorder, unless it is sold in the container in which it was received by the seller. R.S.O. 1990, c. H.4, s. 154 (2).

Prescription drugs

155. (1) Subject to the regulations, no person shall sell by retail any drug referred to in Schedule E, F, G or N, except on prescription given in such form, in such manner and under such conditions as the regulations prescribe. R.S.O. 1990, c. H.4, s. 155 (1).

Exception

(2) Subsection (1) does not apply to drugs referred to in Part II of Schedule F 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. R.S.O. 1990, c. H.4, s. 155 (2).

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).

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 by doctor out of Ontario

158. A pharmacist may dispense a drug pursuant to a written order signed by a physician or dentist licensed to practise in a province in Canada other than Ontario, if in the professional judgment of the pharmacist the patient requires the drug immediately, but such order shall not be refilled. R.S.O. 1990, c. H.4, s. 158.

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 A, as the Registrar possesses and the Minister requests. R.S.O. 1990, c. H.4, s. 159 (2).

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).

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 pharmacists 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 pharmacists and the name and address of owners and managers of pharmacies and, if the pharmacy is owned by a corporation, of the directors of the corporation, and any changes thereto;

(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).

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) prescribing the substances that are included in Schedules A, B, C, D, E, F, G and N for the purpose of this Part;

(b) naming substances for the purposes of the definition of “drug” in subsection 117 (1) and specifying the provisions of this Part that shall apply in respect of such substances;

(c) naming publications for the purposes of the definition of “drug” in subsection 117 (1);

(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 Schedules E, F, G and N 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) prescribing the manner in which records shall be kept of the purchase and sale of the drugs referred to in Schedules D, G and N;

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

(i) designating substances listed in Schedule D that may be sold by persons not otherwise authorized under this Part and authorizing the sale of such substances by any persons or classes of persons not otherwise authorized under this Part and prescribing the conditions under which such substances shall be sold by such persons or classes of persons;

(j) prescribing the labelling of substances listed in Schedule B for the purposes of section 154;

(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 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;

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

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

(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. R.S.O. 1990, c. H.4, s. 161 (1); 1998, c. 18, Sched. G, s. 49 (12-14, 18).

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 and require compliance with the document or publication adopted. 1998, c. 18, Sched. G, s. 49 (19).

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. 1998, c. 18, Sched. G, s. 49 (19).

Enforcement

Restraining orders

162. (1) Where it appears to the College that any person does not comply with any provision of this Part 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 Ontario Court (General Division) 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).

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).

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

(2) Repealed: 1991, c. 18, s. 47 (1).

Idem

(3) 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 to a fine not exceeding $25,000. R.S.O. 1990, c. H.4, s. 165 (3).

Responsibility of owner and manager

166. (1) Every owner or manager of a pharmacy is liable for every offence against this Part committed by any person in the employ of or under the supervision of the owner or manager with the owner’s or 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 Part committed by any person in the employ of the corporation with the director’s permission, consent or approval, express or implied. R.S.O. 1990, c. H.4, s. 166 (1).

Idem

(2) Where any person operates a pharmacy contrary to this Part or the regulations, the owner and 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. R.S.O. 1990, c. H.4, s. 166 (2).

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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