NEWFOUNDLAND AND LABRADOR REGULATION 12/23

NLR 94/14
as amended

1. (1) Section 2 of the Pharmacy Regulations, 2014 is amended by adding immediately after paragraph (a) the following:

(a.1) "audio-visual technology" means technology that allows persons who are not in the physical presence of one another to see, hear and communicate with each other at all times;

(2) Paragraph 2(b) of the regulations is repealed.

(3) Section 2 of the regulations is amended by adding immediately before paragraph (c) the following:

(b.1) "inspector" means a person designated under section 12.1;

(4) Section 2 of the regulations is amended by deleting the period at the end of paragraph (c) and substituting a semicolon and the word "and" and by adding immediately after paragraph (c) the following:

(d) "proposed pharmacy" means a pharmacy in respect of which an application has been made for a licence under section 23 of the Act.

2. (1) Paragraph 3(1)(a) of the regulations is amended by deleting the words "from the Royal Newfoundland Constabulary, the Royal Canadian Mounted Police or other appropriate policing agency".

(2) Paragraph 3(1)(c) of the regulations is amended by deleting the words "he or she" and substituting the words "the person has".

(3) Paragraph 3(2)(a) of the regulations is amended by deleting the word "applicants" and substituting the word "applicant's".

3. (1) Paragraph 4(1)(a) of the regulations is amended by deleting the words "from the Royal Newfoundland Constabulary, the Royal Canadian Mounted Police or other appropriate policing agency".

(2) Subsection 4(3) of the regulations is amended by deleting the words "himself or herself" and substituting the word "themself".

(3) Subsection 4(4) of the regulations is repealed and the following substituted:

(4) A pharmacy intern shall only practice pharmacy where the pharmacy intern is supervised in a manner acceptable to the board.

4. (1) Paragraph 5(1)(a) of the regulations is amended by deleting the words "from the Royal Newfoundland Constabulary, the Royal Canadian Mounted Police or other appropriate policing agency".

(2) Paragraph 5(1)(c) of the regulations is amended by deleting the words "he or she" and substituting the words "the person".

(3) Subsection 5(2) of the regulations is amended by deleting the words "himself or herself" and substituting the word "themself".

(4) Subsection 5(3) of the regulations is repealed and the following substituted:

(3) A pharmacy student shall only practice pharmacy where the pharmacy student is supervised in a manner acceptable to the board.

5. (1) Paragraph 6(1)(a) of the regulations is amended by deleting the words "from the Royal Newfoundland Constabulary, the Royal Canadian Mounted Police or other appropriate policing agency".

(2) Paragraph 6(1)(c) of the regulations is amended by deleting the words "he or she" and substituting the words "the person has".

(3) Paragraph 6(2)(a) of the regulations is amended by deleting the word "applicants" and substituting the word "applicant's".

6. Section 7 of the regulations is repealed and the following substituted:

Continuing professional development

7. Every pharmacist and pharmacy technician shall participate in continuing professional development as required by the board.

7. (1) Subsection 8(1) of the regulations is amended by

(a) deleting the words "his or her" and substituting the words "the pharmacist's";

(b) deleting the words "he or she" and substituting the words "the pharmacist"; and

(2) Subsection 8(2) of the regulations is amended by deleting the words "he or she" and substituting the words "the person".

(3) Subsection 8(3) of the regulations is amended by deleting the words "he or she" and substituting the words "the person".

8. (1) Subsection 9(1) of the regulations is amended by

(a) deleting the words "his or her" and substituting the words "the pharmacy technician's"; and

(b) deleting the words "he or she" and substituting the words "the pharmacy technician".

(2) Paragraph 9(1)(c) of the regulations is repealed and the following substituted:

(3) Subsection 9(2) of the regulations is amended by deleting the words "he or she" and substituting the words "the person".

(4) Subsection 9(3) of the regulations is amended by deleting the words "he or she" and substituting the words "the person".

9. Section 10 of the regulations is repealed and the following substituted:

Pharmacy licence renewal

10. The board may renew a pharmacy licence where the pharmacist in charge

(a) submits an application in the form approved by the board and signed by the pharmacist in charge;

(b) submits a declaration stating that the pharmacist in charge will

(i) personally manage, control and supervise the pharmacy,

(ii) comply with the Act and all regulations under the Act,

(iii) comply with the board's standards of pharmacy operation and the board's standards of pharmacy practice,

(iv) cooperate with an inspector carrying out inspections of the pharmacy under these regulations and will comply with an order of an inspector, and

(v) participate in the quality assurance program established under the Act; and

10. (1) Subsection 11(1) of the regulations is amended by

(a) deleting the word "person" and substituting the word "pharmacist";

(b) deleting the words "he or she" and substituting the words "the pharmacist"; and

(2) Subsection 11(2) of the regulations is amended by

(a) deleting the words "his or her duties" and substituting the words "the duties of a pharmacist in charge"; and

(b) deleting the word "person" and substituting the word "pharmacist".

(3) Subsection 11(4) of the regulations is amended by deleting the words "he or she" wherever they appear and substituting the words "the pharmacist".

11. (1) Paragraph 12(d) of the regulations is amended by

(a) deleting the word "a"; and

(b) deleting the words "he or she" and substituting the words "the pharmacist in charge".

(2) Section 12 of the regulations is amended by

(a) deleting the words "Standards of Pharmacy Operation" wherever they appear and substituting the words "standards of pharmacy operation"; and

(b) deleting the words "Standards of Pharmacy Practice" wherever they appear and substituting the words "standards of pharmacy practice".

(3) Paragraph 12(o) of the regulations is amended by adding immediately after the word "Act" the words "or any regulations under the Act".

(4) Paragraph 12(p) of the regulations is amended by deleting the words "these regulations" and substituting the words "all regulations under the Act".

(5) Subparagraph 12(q)(i) of the regulations is repealed.

12. The regulations are amended by adding immediately after section 12 the following:

Inspections

12.1 (1) The board or the registrar may designate persons or classes of persons to act as inspectors for the purposes of the Act and these regulations.

(2) The registrar is an inspector for the purposes of the Act and these regulations.

(3) An inspector may, at all reasonable times, inspect or examine the premises, operations, books and records of a person, licensed pharmacy or a proposed pharmacy for the purposes of determining compliance with the Act, these regulations, the by-laws or any standards of operation or pharmacy practice established by the board and the inspector may,

(a) enter any premises

(i) which is a licensed pharmacy or a proposed pharmacy,

(ii) where any property, books or records are or may be kept, or

(iii) where anything is done or is suspected by the inspector of being done in connection with a requirement of the Act or these regulations;

(b) examine, extract information from and make copies of all records, documents and other relevant information required to carry out the inspection;

(d) access patient records without the consent of that patient;

(e) inspect all facilities, equipment, drugs and supplies used or intended to be used in the practice of pharmacy;

(f) examine and conduct tests on materials or substances that the inspector considers necessary and remove the materials or substances where necessary to conduct an examination or test;

(g) interview or request information from any employee or other person providing services in the operation of the pharmacy; and

(h) require the pharmacist in charge, pharmacy owner or other person to provide the inspector all reasonable assistance, including the production of records and information respecting care administered to patients.

(4) An inspector may use audio-visual technology in conducting an inspection.

(5) A pharmacist in charge, pharmacy owner or other person shall not interfere with, obstruct, attempt to obstruct, or fail to cooperate with an inspector in carrying out duties or functions under these regulations.

Order of inspector

12.2 (1) Where an inspector finds that a person, licenced pharmacy or a proposed pharmacy is not in compliance with a provision of the Act, these regulations, the by-laws or a standard of operation or pharmacy practice established by the board, the inspector may order one or more of the following persons to take steps to ensure compliance with the provision or standard:

(a) the person;

(b) the pharmacist in charge; or

(2) An inspector may require an order under subsection (1) to be carried out immediately or within the period of time that the inspector specifies.

(3) An order under subsection (1) may include a direction that the pharmacy be closed until all persons subject to the order comply with the order to the satisfaction of the inspector.

13. Subsection 13(2) of the regulations is amended by deleting the words "he or she" and substituting the words "the pharmacist in charge".