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NEWFOUNDLAND AND LABRADOR
REGULATION 94/14

Pharmacy Regulations, 2014
under the
Pharmacy Act, 2012

Amended by:

83/16

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

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Definitions

        2. In these regulations

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

             (b)  "continuing education unit" means one hour of continuing pharmacy education; and

             (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.

94/14 s2; 83/16 s1

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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 from the Royal Newfoundland Constabulary, the Royal Canadian Mounted Police or other appropriate policing agency;

             (b)  photo identification acceptable to the board; and

             (c)  proof satisfactory to the board that he or she 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

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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 from the Royal Newfoundland Constabulary, the Royal Canadian Mounted Police or other appropriate policing agency; 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 himself or herself 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 he or she is supervised in a manner acceptable to the board by a registered pharmacist whose registration is not subject to conditions or restrictions.

94/14 s4

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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 from the Royal Newfoundland Constabulary, the Royal Canadian Mounted Police or other appropriate policing agency;

             (b)  photo identification acceptable to the board; and

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

             (2)  A pharmacy student shall identify himself or herself 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 he or she is supervised, in a manner acceptable to the board, by a registered pharmacist whose registration is not subject to conditions or restrictions.

94/14 s5

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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 from the Royal Newfoundland Constabulary, the Royal Canadian Mounted Police or other appropriate policing agency;

             (b)  photo identification acceptable to the board; and

             (c)  proof satisfactory to the board that he or she 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

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Continuing education and professional development

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

             (a)  completing a minimum of 15 continuing education units per calendar year of which at least half shall be from accredited programs;

             (b)  submitting a professional development log containing information required by the board; and

             (c)  maintaining a learning portfolio that contains the information required by the board.

94/14 s7

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Registration renewal - pharmacist

        8. (1) In addition to the requirements in section 18 of the Act a pharmacist applying to renew his or her registration shall provide proof that he or she

             (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 education and 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 he or she

             (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, he or she 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

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Registration renewal - pharmacy technician

        9. (1) In addition to the requirements in section 18 of the Act a pharmacy technician applying to renew his or her registration shall provide proof that he or she

             (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 education and professional development as 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 he or she

             (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, he or she 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

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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 him or her;

             (b)  submits a declaration stating that he or she will

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

                     (ii)  comply with the Act and these regulations, and

                    (iii)  comply with the board's Standards of Pharmacy Operation and the board's Standards of Pharmacy Practice; and

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

94/14 s10

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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

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Pharmacist in charge

      11. (1) The board may designate a person as a pharmacist in charge where he or she

             (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 his or her licence;

             (c)  has practiced pharmacy in Canada for at least 12 months immediately before his or her 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 his or her duties the board may designate a person 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)  he or she is acting as an interim pharmacist in charge;

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

             (c)  he or she has been given approval by the board.

94/14 s11; 83/16 s3

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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 a pharmacist in charge when he or she 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;

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

             (q)  when a pharmacy ceases to operate

                      (i)  returning the existing pharmacy licence,

                     (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

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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 he or she considers it necessary, exercise a higher degree of control over a particular drug than what is contemplated in the schedules.

94/14 s13

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Repeal

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

94/14 s14