This is an official version.

 

Copyright © 2024: Queen’s Printer,
St. John's, Newfoundland and Labrador, Canada

Important Information
(Includes details about the availability of printed and electronic versions of the Statutes.)

 

Table of Regulations

Main Site

How current is this regulation?

 
 

NEWFOUNDLAND AND LABRADOR
REGULATION 94/14

Pharmacy Regulations, 2014
under the
Pharmacy Act, 2012

Amended by:

83/16
12/23
1/24

NEWFOUNDLAND AND LABRADOR
REGULATION 94/14

Pharmacy Regulations, 2014
under the
Pharmacy Act, 2012

(Filed November 21, 2014)

Under the authority of section 59 of the Pharmacy Act, 2012 the Newfoundland and Labrador Pharmacy Board, with the approval of the Minister of Health and Community Services, makes the following regulations.

Dated at St. John’s , November 21, 2014.

David Cramm
Chair of Newfoundland and Labrador Pharmacy Board

Steve Kent
Minister of Health and Community Services

REGULATIONS

Analysis



Short title

        1. These regulations may be cited as the Pharmacy Regulations, 2014 .

94/14 s1

Back to Top

Definitions

        2. In these regulations

             (a)  "Act" means the Pharmacy Act, 2012;

         (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;

             (b)  [Rep. by 12/23 s1]

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

             (c)  "pharmacy network" means the component of the province-wide electronic health record that allows authorized health care providers to contribute to and access patient medication profiles in real-time; and

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

94/14 s2; 83/16 s1; 12/23 s1

Back to Top

Registration of pharmacist

        3. (1) In addition to the requirements in section 14 of the Act a person applying to be registered as a pharmacist shall provide

             (a)  a current certificate of conduct satisfactory to the board;

             (b)  photo identification acceptable to the board; and

             (c)  proof satisfactory to the board that the person has completed the required period of practical training approved by the board.

             (2)  The practical training period referred to in paragraph (1)( c) shall be

             (a )  in addition to any pharmacy practical experience required as part of the applicant’s pharmacy education program;

             (b)  completed in accordance with the policies and standards developed by the board relating to practice experience requirements;

             (c )  conducted at a pharmacy or other facility approved by the board; and

             (d)  completed under the preceptorship of a pharmacist approved by the board.

94/14 s3; 12/23 s2

Back to Top

Registration of pharmacy interns

        4. (1) In addition to the requirements in section 15 of the Act a person applying to be registered as a pharmacy intern shall provide

             (a)  a current certificate of conduct satisfactory to the board; and

             (b)  photo identification acceptable to the board.

             (2)  The registration of a pharmacy intern is valid for the period of time specified in the certificate of registration and is not subject to renewal but may be extended by the board.

             (3)  A pharmacy intern shall identify themself as an intern when communicating or working with the public or members of the pharmacy profession.

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

94/14 s4; 12/23 s3

Back to Top

Registration of pharmacy students

        5. (1) In addition to the requirements in section 16 of the Act a person applying to be registered as a pharmacy student shall provide

             (a)  a current certificate of conduct satisfactory to the board;

             (b)  photo identification acceptable to the board; and

             (c)  proof that the person obtained professional liability insurance coverage in a form and amount satisfactory to the board.

             (2)  A pharmacy student shall identify themself as a student when communicating or working with the public or members of the pharmacy profession.

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

94/14 s5; 12/23 s4

Back to Top

Registration of pharmacy technicians

        6. (1) In addition to the requirements in section 17 of the Act a person applying to be registered as a pharmacy technician shall provide

             (a)  a current certificate of conduct satisfactory to the board;

             (b)  photo identification acceptable to the board; and

             (c)  proof satisfactory to the board that the person has completed the required period of practical training approved by the board.

             (2)  The practical training period referred to in subparagraph (1)( c) shall be

             (a )  in addition to any pharmacy technician practice experience required as a part of the applicant’s pharmacy technician education program;

             (b)  completed in accordance with the policies and standards developed by the board relating to practice experience requirements;

             (c )  conducted at a pharmacy or other facility approved by the board; and

             (d)  completed under the preceptorship of a pharmacist or pharmacy technician approved by the board.

94/14 s6; 12/23 s5

Back to Top

Continuing professional development

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

94/14 s7; 12/23 s6

Back to Top

Registration renewal - pharmacist

        8. (1) In addition to the requirements in section 18 of the Act a pharmacist applying to renew the pharmacist’s registration shall provide proof that the pharmacist

             (a )  continues to have professional liability insurance coverage in a form and amount satisfactory to the board;

             (b)  is not suspended or restricted with respect to the practice of pharmacy by a board or equivalent body governing the practice of pharmacy in a jurisdiction outside the province, or where suspended or restricted provide the details of the suspension or restriction; and

             (c)  completed the continuing professional development required under section 7.

             (2)  Notwithstanding subsection (1), the board may renew the registration of a person who was previously registered as a pharmacist in the province but who does not meet the requirements in paragraph 18(b) of the Act where the person

             (a)  meets the requirements in subsection (1) and paragraphs 18(a), (c) and (d) of the Act;

             (b)  completes a period of supervised practice approved by the board; and

             (c)  successfully rewrites the Newfoundland and Labrador Pharmacy Board Registration Examination for pharmacists during or after the period of supervised practice.

             (3)  Where a person referred to in subsection (2) has not practiced pharmacy in Canada for 5 years immediately before applying for renewal, the person shall, in addition to the requirements in subsection (2), successfully rewrite Part II of the Pharmacy Examining Board of Canada Qualifying Examination for pharmacists during or after the period of supervised practice.

94/14 s8; 12/23 s7

Back to Top

Registration renewal - pharmacy technician

        9. (1) In addition to the requirements in section 18 of the Act a pharmacy technician applying to renew the pharmacy technician’s registration shall provide proof that the pharmacy technician

             (a )  continues to have professional liability insurance coverage in a form and amount satisfactory to the board;

             (b)  is not suspended or restricted by a board or equivalent body governing the practice of pharmacy technicians in a jurisdiction outside the province, or where suspended or restricted provide the details of the suspension or restriction; and

             (c)  completed the continuing professional development required under section 7.

             (2)  Notwithstanding subsection (1), the board may renew the registration of a person who was previously registered as a pharmacy technician in the province but who does not meet the requirements in paragraph 18(b) of the Act where the person

             (a)  meets the requirements in subsection (1) and paragraphs 18(a), (c) and (d) of the Act;

             (b)  completes a period of supervised practice approved by the board; and

             (c)  successfully rewrites the Newfoundland and Labrador Pharmacy Board Registration Examination for pharmacy technicians during or after the period of supervised practice.

             (3)  Where a person referred to in subsection (2) has not practiced as a pharmacy technician in Canada for 5 years immediately before applying for renewal, the person shall, in addition to the requirements in subsection (2), successfully rewrite Part II of the Pharmacy Examining Board of Canada Qualifying Examination for pharmacy technicians during or after the period of supervised practice.

94/14 s9; 12/23 s8

Back to Top

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

             (c)  pays the annual licence fees set by the board.

94/14 s10; 12/23 s9

Back to Top

Connection to pharmacy network required

   10.1 A pharmacy shall be connected to the provincial electronic health record via the pharmacy network and the pharmacy network shall be fully operational within the pharmacy.

83/16 s2

Back to Top

Pharmacist in charge

      11. (1) The board may designate a pharmacist as a pharmacist in charge where the pharmacist

             (a)  applies in a manner and form prescribed by the board;

             (b)  is registered as a practicing pharmacist in the province and there are no conditions or restrictions on the pharmacist’s licence;

             (c)  has practiced pharmacy in Canada for at least 12 months immediately before the pharmacist’s application; and

             (d)  agrees to practice in the pharmacy for at least one half of the operating hours of the pharmacy, provided that this agreement does not require the pharmacist in charge to practice in the pharmacy for more than 40 hours in any week.

             (2)  Notwithstanding subsection (1), where a pharmacist in charge is unable to carry out the duties of a pharmacist in charge the board may designate a pharmacist who meets the requirements in paragraphs (1)(a), (b) and (d) as an interim pharmacist in charge for a maximum period of 60 days.

             (3)  A pharmacist may only be a pharmacist in charge of one pharmacy at a time.

             (4)  Notwithstanding subsection (3), a pharmacist may be a pharmacist in charge of more than one pharmacy where

             (a)  the pharmacist is acting as an interim pharmacist in charge;

             (b)  one of the pharmacies is a telepharmacy or satellite pharmacy; or

             (c)  the pharmacist has been given approval by the board.

94/14 s11; 83/16 s3; 12/23 s10

Back to Top

Duties of pharmacist in charge

      12. In addition to the responsibilities prescribed in the Act, a pharmacist in charge shall be responsible for the following:

             (a)  actively directing, controlling or managing the pharmacy;

             (b)  prohibiting an owner or other person who is not a pharmacist from directing, influencing, controlling or participating in the management or operation of a pharmacy;

             (c)  practicing in the pharmacy for at least one half of the operating hours of the pharmacy, provided that this paragraph does not require the pharmacist in charge to practice in the pharmacy for more than 40 hours in any week;

             (d)  ensuring that another pharmacist is designated as pharmacist in charge when the pharmacist in charge is away from the pharmacy for more than 45 days;

             (e)  developing , maintaining and enforcing written policies and procedures for pharmacy staff in accordance with applicable legislation, the board's standards of pharmacy operation and the board's standards of pharmacy practice;

             (f)  ensuring that pharmacists, pharmacy technicians, interns and students who are employed by the pharmacy are registered with the board;

             (g)  notifying the board when a person registered with the board begins or ceases employment with the pharmacy;

             (h)  notifying the board of any changes to information included on the pharmacy licence application;

              (i)  notifying the board of a contravention of the established policies and procedures;

              (j)  ensuring an adequate staffing complement for safe practice;

             (k)  ensuring that confidentiality is maintained with respect to all pharmacy and patient records in accordance with all applicable legislation and standards of practice;

              (l)  ensuring correct usage of the operating name of the pharmacy with regard to prescription labels, telephone directory listings, interior and exterior signs or media advertising;

           (m)  ensuring that the pharmacy is appropriately secured against loss, theft and diversion;

             (n)  ensuring that the pharmacy has the facilities, space, equipment, resources and systems in place to support the safe and effective provision of pharmacy services, in accordance with the board's standards of pharmacy operation;

             (o)  cooperating with any person appointed by the board in accordance with the Act or any regulations under the Act;

             (p)  ensuring compliance with all federal and provincial legislation pertaining to pharmacy practice and licensing including the Act, all regulations under the Act, the bylaws and the board's standards of pharmacy practice; and

             (q)  when a pharmacy ceases to operate

                      (i )  [Rep. by 12/23 s11]

                     (ii)  ensuring the transfer of prescription records to another pharmacy; and

                    (iii)  ensuring that all signage utilizing the words "pharmacy", "drugstore", "drugs", "prescriptions" and other words with similar meanings are removed from the premises.

94/14 s12; 83/16 s4; 12/23 s11

Back to Top

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;

             (c)  take photographs or videos the inspector considers necessary;

             (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.

12/23 s12

Back to Top

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

             (c)  the pharmacy owner.

             (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. 

12/23 s12

Back to Top

Drug schedules

      13. (1) The board may adopt the drug schedules established under the National Association of Pharmacy Regulatory Authorities National Drug Schedules System.

             (2)  Notwithstanding subsection (1), a pharmacist in charge may, where the pharmacist in charge considers it necessary, exercise a higher degree of control over a particular drug than what is contemplated in the schedules.

             (3)  Where the board adopts a drug schedule under subsection (1) that contains the drugs,

             (a)  naloxone hydrochloride injection, when indicated for emergency use for opioid overdose; and

             (b)  naloxone hydrochloride nasal spray, when indicated for emergency use for opioid overdose,

that drug schedule shall be read as not including those drugs.

94/14 s13; 12/23 s13; 1/24 s1

Back to Top

Repeal

      14. The Pharmacy Regulations , Newfoundland and Labrador Regulation 80/98, are repealed.

94/14 s14