ontario regulation 154/13

made under the

Pharmacy Act, 1991

Made: May 10, 2013
Approved: May 14, 2013
Filed: May 15, 2013
Published on e-Laws: May 15, 2013
Printed in The Ontario Gazette: June 1, 2013

Amending O. Reg. 202/94

(GENERAL)

1. Ontario Regulation 202/94 is amended by adding the following Part:

Part IX
INSPECTION OF DRUG PREPARATION PREMISES

Temporal Application

52. This Part applies to the College and members as of the day that it comes into force, except that,

(a) sections 54, 55, 56, 59 and 60 apply as of 90 days from the day that this Part comes into force; and

(b) the requirements in subsection 57 (1) and section 58 apply as of 30 days from the day that this Part comes into force.

Interpretation

53. (1) In this Part,

“designated member” means,

(a) the member designated for a drug preparation premises in accordance with section 58, or

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

“drug” means a substance or a preparation containing a substance referred to in clauses (a) to (d) of the definition of “drug” in subsection 1 (1) of the Drug and Pharmacies Regulation Act, but does not include,

(a) a substance or preparation referred to in those clauses that is manufactured, sold or represented for use in animals or fowl, or

(b) a substance or preparation referred to in clause (e), (f), (g), (h) or (i) of that definition;

“drug preparation activities” means reconstituting, diluting or otherwise preparing a drug or combining, admixing or mixing together two or more substances, at least one of which is a drug, to create a final product for the purposes of the sale or provision to another person, other than pursuant to or in anticipation of a prescription;

“drug preparation premises” means any place where a member engages in drug preparation activities, or where drug preparation activities take place that a member supervises, but does not include,

(a) a pharmacy in respect of which a valid certificate of accreditation has been issued under the Drug and Pharmacies Regulation Act,

(b) a premises in respect of which a valid establishment licence has been issued under the Food and Drugs Act (Canada), or

(c) a hospital or a health or custodial institution approved or licensed under any general or special Act;

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

“supervise” means to supervise either directly or indirectly.

(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

54. (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 his or her practice with respect to drug preparation activities at or in connection with the drug preparation premises.

55. An inspector may, on the production of information identifying him or her as an inspector, enter and have access to any drug preparation premises at reasonable times and may inspect the drug preparation premises and do any of the things mentioned in subsection 54 (2) on behalf of the College.

56. (1) It is the duty of every member engaging in or supervising drug preparation activities at or in connection with drug preparation premises that are subject to an inspection to,

(a) submit to an inspection of the drug preparation premises in accordance with this Part;

(b) promptly answer a question or comply with a requirement of the inspector that is relevant to an inspection under this Part; and

(c) co-operate fully with the College and the inspector who is conducting an inspection of a drug preparation premises in accordance with this Part.

(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.

57. (1) No member shall commence engaging in or supervising drug preparation activities at or in connection with drug preparation premises unless the member has previously given notice in writing to the College in accordance with subsection (5) of the member’s intention to do so.

(2) Where a member has provided notice in writing to the College in accordance with subsection (1) and the drug preparation premises have not passed an inspection or passed an inspection with conditions within the previous five years, the College shall ensure that an inspection of the drug preparation premises is performed within 60 days from the day that the College receives the member’s notice or 150 days from the day this Part comes into force, whichever is later.

(3) A member who engages in or supervises drug preparation activities at or in connection with a drug preparation premises as of the day that is 30 days from the day this Part comes into force shall give notice in writing to the College in accordance with subsection (5) within 90 days from the day this Part comes into force.

(4) The College shall ensure that an inspection of the drug preparation premises with respect to which a member gives notice under subsection (3) is performed within 150 days from the day this Part comes into force.

(5) The notice required in subsections (1) and (3) shall include the following information, submitted in the form and manner required by the College:

1. The full name of the member giving the notice and the full name of the individual or corporation who is the owner or occupier of the drug preparation premises, if he or she is not the member who is required to give notice under this section.

2. The full address of the drug preparation premises.

3. The date when the member first began engaging in or supervising drug preparation activities at or in connection with the drug preparation premises or the proposed date when the member intends to begin engaging in or supervising drug preparation activities at or in connection with the drug preparation premises.

4. Any other information the College requires that is relevant to an inspection of the drug preparation premises conducted under this Part.

58. Where two or more members engage in or supervise drug preparation activities at or in connection with a drug preparation premises, the members shall designate a member as the designated member for the drug preparation premises, and shall immediately notify the College of the designated member’s identity.

59. All drug preparation premises are subject to an inspection by the College once every five years after the initial inspection of the premises or more often if, in the opinion of the College, it is necessary or advisable to do so.

60. (1) After an inspection of a drug preparation premises, the College shall determine, in accordance with the accepted standards of practice, whether the drug preparation premises pass, pass with conditions or fail.

(2) In determining whether drug preparation premises pass, pass with conditions or fail an inspection, the College may consider,

(a) the inspection results provided to the College by the inspector;

(b) information provided by one or more members engaging in or supervising drug preparation activities at or in connection with the drug preparation premises respecting the inspection, including the answers given by them in response to inquiries or questions asked by the inspector;

(c) the information contained in a notice given by a member under subsection 57 (1) or (3);

(d) any submissions made by the member or members engaging in or supervising drug preparation activities at or in connection with the drug preparation premises that are relevant to the inspection; and

(e) any other information that is directly relevant to the inspection of the drug preparation premises conducted under this Part.

(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 his or her submissions, the College shall do one or more of the following:

1. Confirm its finding that the drug preparation premises failed the inspection or passed with conditions.

2. Make a report and find that the drug preparation premises passed with conditions.

3. Make a report and find that the drug preparation premises passed the inspection.

(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.

Commencement

2. This Regulation comes into force on the day it is filed.

Made by:

The Ontario College of Pharmacists:

Christopher Leung

President

Marshall Moleschi

Registrar

Date made: May 10, 2013.