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Statutes of Newfoundland 1994


CHAPTER P-12

CHAPTER P-12.1

AN ACT TO CONTINUE THE NEWFOUNDLAND PHARMACEUTICAL ASSOCIATION

(Assented to December 16, 1994)

Analysis

1. Short title

2. Definitions

3. Non-application of Act

PART I
ASSOCIATION

4. Association to continue

5. Membership

6. Objects

7. Powers

8. Annual general meeting

9. By-laws

10. Council

11. Council members

12. Quorum

13. Committees

14. Regulations

PART II
REGISTRATION,
ADMISSION AND
EXAMINATION

15. Registers

16. Entry on register

17. Pharmacy information

18. Certificate of registration

19. Proof of registration

20. Registration of students

21. Registration of pharmacists

PART III
PRACTICE

22. Registration displayed

23. Prohibitions

24. Prohibitions

25. Pharmacy licence

26. Display of licence

27. Responsibility

28. Hospital pharmacy

29. Inspection

30. Cessation of operation

31. Prohibition

32. No action against association in certain cases

33. Liability of members is limited

34. Notices

PART IV
DISCIPLINE

35. Complaints

36. Preliminary investigation

37. Notice

38. Evidence

39. Report to discipline committee

40. Discipline committee

41. Termination of the investigation

42. Hearing by discipline committee

43. Unprofessional conduct

44. Further investigation

45. Right to counsel and appearance

46. Proceedings in private

47. Public Inquiries Act

48. Suspension pending investigation hearing

49. Powers of the discipline committee

50. Order to pay expenses

51. Suspension or cancellation pending appeal

52. Appeal

53. Trial Division

54. Fraudulent registration

55. Surrender of licence

56. Misrepresentation of status

57. Reinstatement

PART V
GENERIC DISPENSING OF PRESCRIPTION DRUGS

58. Interpretation

59. Substitute drugs

60. Price

61. Non-lowest price

62. Non-formulary

63. Formulary

64. Advisory committee

65. Unprofessional conduct

66. Actions

PART VI
PENALTY

67. Penalties and fines

68. Fines

PART VII
TRANSITIONAL AND CONSEQUENTIAL

69. Registration continued

70. Discipline continued

71. RSN 1990 cG-2
Rep.

72. RSN 1990 cP-12
Rep.

73. Commencement

Be it enacted by the Lieutenant-Governor and House of Assembly in Legislative Session convened, as follows:


Short title

1. This Act may be cited as the Pharmaceutical Association Act, 1994.

Definitions

2. In this Act

(a) "association" means the Newfoundland Pharmaceutical Association continued under section 4;

(b) "certificate" means a certificate of registration issued under section 18;

(c) "committee", with the exception of section 13, means the discipline committee established under Part IV;

(d) "council" means the council of the association established under section 11;

(e) "dispense" means to provide a substance or item ordered by prescription but does not include the administration of that substance or item to a person or animal;

(f) "drug" means a substance or combination of substances used or intended to be used to diagnose, treat, mitigate or prevent disease, disorder or an abnormal physical or mental state or a symptom of them, or to restore, correct or modify organic functions in humans or animals, including those substances or combinations of substances listed or referred to in the regulations;

(g) "former Act" means the Pharmaceutical Association Act;

(h) "hospital" means hospital as defined in the Hospitals Act;

(i) "investigated person" means a pharmacist, pharmacy student and a retail or hospital pharmacy subjected to an inquiry or investigation under Part IV and includes a person referred to in subsection 35(2);

(j) "licence" means a licence issued under section 25;

(k) "member", except in subsections 11(5) and 12(1), means a member of the association;

(l) "minister" means the Minister of Health;

(m) "pharmacist" means a person registered under section 21 of this Act;

(n) "pharmacy" means that portion of a place of business, shop, store or other location including that portion of a hospital, institution or retail operation, compounding or re-packaging facility, where drugs are prepared, compounded, dispensed or sold or where the practice of pharmacy is carried out;

(o) "practice of pharmacy" means

(i) having responsibility for preparing, distributing and controlling drugs in a pharmacy,

(ii) compounding a prescription,

(iii) dispensing a drug,

(iv) selling a drug by retail,

(v) operating a pharmacy,

(vi) disseminating information on the safe and effective use of a drug when dispensing or selling a drug, or

(vii) subdividing or breaking up a manufacturer's original package of a drug for the purpose of re-packaging the drug in larger or smaller quantities for re-distribution or retail sale;

(p) "prescription" means an instruction given orally or in writing by

(i) a medical practitioner as defined in the Medical Act,

(ii) a dentist, as defined in the Dental Act, or

(iii) a veterinarian as defined in the Veterinary Medical Act,

directing that a drug be dispensed to or for a person or animal;

(q) "secretary-registrar" means the secretary-registrar appointed under section 11; and

(r) "sell" means, directly or indirectly, upon a pretence or by any means, to barter, distribute, give or deliver, whether or not for consideration, including attempting to sell, barter, give or deliver and offering, advertising, exposing or keeping for sale.

Non-application of Act

3. (1) This Act does not apply to

(a) a medical practitioner licensed and acting under the Medical Act;

(b) a dentist or dental surgeon licensed and acting under the Dental Act;

(c) a veterinarian licensed and acting under the Veterinary Medical Act; and

(d) the sale of a proprietary medicine, as defined in Division 10 of the regulations under the Food and Drug Act (Canada).

(2) This Act shall not extend to or interfere with the dispensing of necessary drugs or medicines by registered nurses in the course of duty when practising with the approval and under the general supervision of a hospital board.

PART I
ASSOCIATION

Association to continue

4. (1) The Newfoundland Pharmaceutical Association is continued as a corporation.

(2) The head office of the association shall be situated at St. John's.

Membership

5. (1) The members of the association under the former Act shall, on the coming into force of this Act, continue as members of the association under this Act.

(2) All persons who

(a) hold a certificate of registration as a pharmacist under section 18; and

(b) have paid the annual dues fixed for membership according to the by-laws

are members of the association and have full voting rights.

(3) The council may appoint persons to associate, student, life and other types of membership in accordance with the by-laws.

Objects

6. The objects of the association are

(a) to establish and maintain standards of professional conduct, knowledge, education, qualification, skill and ethics among its members;

(b) to assure to the general public proficiency and competency regarding the practice of pharmacy;

(c) to regulate and govern members and the practice of pharmacy;

(d) to establish, maintain and develop standards for the operation of pharmacies;

(e) to administer this Act and perform duties and exercise powers which may be imposed or conferred on the association;

(f) to serve and protect the public interest in all matters relating to the sale of drugs and the practice of pharmacy;

(g) to improve pharmaceutical service and education in the province; and

(h) to advance and protect the purpose of the association and the profession of pharmacy in the province.

Powers

7. The association may

(a) acquire and hold real and personal property by way of purchase, lease, grant, hire, exchange or otherwise and dispose of that property by any means;

(b) borrow money and give security by way of mortgage, pledge, charge or otherwise for borrowed money in order to carry out the objects of the association;

(c) invest money of the association in investments that trustees are authorized to invest in the province for the benefit of the association;

(d) apply money or income of the association to carry out the objects and powers of the association;

(e) determine and collect fees, receive donations or bequests or make gifts or donations for the promotion of the association;

(f) establish and administer funds to provide scholarships, fellowships or bursaries to assist members in education and research relating to pharmacy;

(g) provide accommodation for a library, pharmaceutical museum or specimen room for use by members and other purpose of the association;

(h) in accordance with Part IV of this Act provide for the governing and discipline of persons practising pharmacy in the province;

(i) establish and maintain a register of members entitled to practise pharmacy under this Act;

(j) assess existing and develop new education standards and specify the education, training and experience required to obtain and continue registration under this Act;

(k) enter into agreements, negotiate or meet with a person, association, agency or group where it considers it is necessary for the carrying out of the objects of the association; and

(l) subject to Part IV, inquire into the practice of pharmacy by a member or student and inquire into other matters that the association considers necessary in connection with the exercise of its powers and the performance of its duties in relation to competence in the practice of pharmacy under this Act.

Annual general meeting

8. (1) The association shall hold an annual general meeting in each year and may hold other general or special meetings as are required.

(2) Ten percent of the voting membership of the association constitutes a quorum at an annual general, general or special meeting of the association.

(3) Where a quorum exists, a majority shall be sufficient to make decisions of the association and where an equality of votes exists, the chairperson of the meeting shall cast the deciding vote.

By-laws

9. (1) The association may make by-laws not inconsistent with this Act that are necessary or desirable for the proper implementation of the proceedings and powers of the association.

(2) The by-laws of the association in operation at the coming into force of this Act continue, to the extent that they are not inconsistent with this Act, to be the by-laws governing the association until revoked or amended as provided under this Act.

(3) A by-law, amendment or repeal of a by-law may be made at an annual general, general or special meeting provided that 30 days notice, in writing, of the by-law, amendment or revocation and of the meeting are given to each voting member of the association.

Council

10. (1) The association shall be governed by the council of the association which shall manage and conduct the business and affairs and exercise the powers of the association for and on behalf of the association.

(2) The members of the council of the association immediately prior to the coming into force of this Act shall continue in office under this Act until their terms of office under the former Act have expired.

Council members

11. (1) The association shall elect 7 of its members to the council.

(2) In addition to the members of the council elected under subsection (1), the minister shall appoint 5 persons to the council, 2 of whom shall be members.

(3) The council shall appoint a secretary-registrar who shall be, by virtue of the position, a non-voting member of the council, the executive and all committees of council.

(4) The council shall be elected and hold office in the manner and for the time provided for in the by-laws.

(5) The council shall elect an executive including a president from among the members of the council.

Quorum

12. (1) A majority of voting members of the council constitutes a quorum and a majority vote is sufficient for the exercise of all of the powers of the council.

(2) Where there is an equality of votes the chairperson of the meeting shall have a deciding vote.

Committees

13. The council may appoint committees from among members to carry out duties and functions directed by the council.

Regulations

14. The minister may make regulations

(a) respecting membership or other fees and levies payable to the association and the manner of collecting those fees or levies;

(b) respecting a code of ethics which may include a definition of professional misconduct and methods of advertising advisable for pharmacists and pharmacies;

(c) respecting registers of members and the information to be maintained on those registers;

(d) respecting the information to be provided and maintained on registers of corporations, partnerships or individuals carrying out a pharmacy business;

(e) respecting the registration of pharmacy students;

(f) respecting the educational, internship, practical training or other requirements necessary for registration and the standard of the practice of pharmacy in the province including provisions for mandatory continuing education of members;

(g) respecting all aspects of the dispensing, selling and handling of drugs;

(h) prescribing courses of study and examinations;

(i) respecting the appointment and definition of duties of examiners;

(j) respecting the issuance and term of certificates and licences;

(k) respecting forms and information required for registration or licensing;

(l) prescribing, with respect to drugs, drug products and substances

(i) schedules,

(ii) conditions for dispensing and sale,

(iii) concentrations and manner of preparation, and

(iv) control to be exercised by a person;

(m) respecting the adoption of schedules enacted under the Food and Drugs Act (Canada) and the Narcotic Control Act (Canada);

(n) respecting disciplinary matters, the establishment of a discipline committee and the practice of pharmacy generally;

(o) respecting information to be given to persons under subsections 39(3) and 41(2);

(p) respecting the payment of expenses under subsection 49(1);

(q) respecting the maintenance of prescriptions, prescription copies, records, the use of computers and the information to be collected and retained by computer;

(r) respecting the transfer of records, prescriptions or other information by facsimile process;

(s) respecting the destruction of drugs or medicines; and

(t) generally to give effect to the provisions of this Act.

PART II
REGISTRATION, ADMISSION AND
EXAMINATION

Registers

15. (1) The secretary-registrar shall establish and maintain those registers required by regulation to be established and maintained.

(2) The secretary-registrar shall, upon payment of the required fees, comply with a request for verification of information contained in a register established under subsection (1).

Entry on register

16. (1) An entry in a register under this Act which has been fraudulently or incorrectly made or omitted may be removed, corrected or added by the secretary-registrar upon the written direction of the council.

(2) A person who by fraudulent means obtains registration under this Act commits an offence and shall be considered to have conducted himself or herself in an unprofessional manner.

(3) A person or corporation may appeal a decision of the secretary-registrar regarding entry on a register of that person or corporation to the council in accordance with section 52.

Pharmacy information

17. (1) Not less than 30 days before opening a pharmacy for business or acquiring a pharmacy, a corporation, partnership or individual shall provide to the secretary-registrar the information required by regulation.

(2) The information provided under subsection (1) shall be confirmed and signed by the pharmacist in charge of that pharmacy.

Certificate of registration

18. (1) The secretary-registrar shall annually enter into the register the name of a pharmacist who has met the registration requirement of section 21 and the regulations and issue to that pharmacist an annual certificate of registration.

(2) A pharmacist who has not held an annual certificate of registration for 1 year immediately prior to the year in which that pharmacist seeks that certificate shall not be entitled to obtain registration and a certificate unless he or she meets additional requirements which may be prescribed by regulation.

Proof of registration

19. The production in a court or proceeding of a register or a copy of or an extract from a register under this Act, certified by the secretary-registrar is evidence of the statements on that register without proof of the fact that the signature is that of the secretary-registrar.

Registration of students

20. A person registered as a student under the former Act on the coming into force of this Act and a person who is enroled as a pharmacy student in a pharmacy program approved by the council is entitled to apply for registration as a pharmacy student under this Act.

Registration of pharmacists

21. (1) A person

(a) registered and in good standing as a pharmaceutical chemist under the former Act;

(b) who holds a Bachelor of Science Degree in Pharmacy from Memorial University of Newfoundland and possesses a certificate, gained by examination, from the Pharmacy Examining Board of Canada; or

(c) who has graduated from a Faculty of Pharmacy approved by the council and possesses a certificate, gained by examination, from the Pharmacy Examining Board of Canada

may apply for registration under this Act.

(2) An application for registration under subsection (1) shall be approved where the applicant

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

(b) pays those fees required by the regulations;

(c) has not been suspended or restricted with respect to the practice of pharmacy by a council or equivalent body governing the practice of pharmacy in a jurisdiction outside the province;

(d) is sufficiently proficient in an official language of Canada to competently discharge the duties and obligations of a pharmacist in the province;

(e) has completed a practical training period under terms and conditions prescribed by the regulations; and

(f) has paid outstanding fines, penalties or fees which are owed to the association.

PART III
PRACTICE

Registration displayed

22. A pharmacist shall display his or her certificate in a conspicuous place in full public view in a pharmacy in which that pharmacist engages in the practice of pharmacy.

Prohibitions

23. (1) A person other than a pharmacist with a certificate shall not

(a) represent or hold himself or herself out as or as being entitled to use the title or designation of pharmacist;

(b) carry on the practice of pharmacy in the province;

(c) conduct a business or operation for selling drugs except as expressly permitted under this Act; or

(d) hold himself or herself out, conduct himself or herself in a manner or wear or use clothing or a sign, emblem, title or advertisement which may reasonably lead the public to infer that he or she is registered as a pharmacist and qualified to practise pharmacy under this Act.

(2) A person other than a pharmacist, or a pharmacy student registered under this Act and acting under the direct supervision of a pharmacist who actually supervises that student in his or her presence, shall not

(a) dispense or compound a prescription or drug;

(b) sell a drug except under the provisions of this Act; or

(c) manage, control or conduct a pharmacy.

Prohibitions

24. (1) A person, corporation or business shall not

(a) display, use or permit to be displayed or used on premises owned or leased by that person, a sign, advertisement or symbol bearing the words "drugs", "medicines", "prescriptions", "pharmacy" or "pharmacist" or other words of similar meaning, unless those premises contain a pharmacy licensed under this Act and under the direct and continuous supervision and control of a pharmacist;

(b) employ a person who is not a pharmacist or a pharmacy student registered under this Act to dispense a prescription or prepare or compound drugs;

(c) sell or distribute drugs by means of mechanical vending machines;

(d) sell or distribute a substance or drug referred to in the regulations unless in full compliance with this Act; and

(e) operate a depot for the purpose of delivering to or picking up by the public, a drug, unless that place is a licensed pharmacy.

(2) A person or corporation shall not employ a person who acts in a manner which violates paragraph 23(1)(d).

Pharmacy licence

25. (1) A person or corporation shall not operate a pharmacy business and a pharmacist or pharmacy student shall not carry out the practice of pharmacy unless it is

(a) from a pharmacy registered under this Act; and

(b) in accordance with restrictions, terms or conditions in force respecting that pharmacy under this Act.

(2) The secretary-registrar shall annually register a pharmacy and issue a pharmacy licence to those pharmacies which comply with the requirements prescribed by this Act.

Display of licence

26. (1) A pharmacy licence issued under section 25 shall be displayed in a conspicuous part of a pharmacy in full public view.

(2) The word "pharmacy" shall be displayed in legible prominent letters over the door or principal entrance of a pharmacy for which a licence has been issued under section 25.

(3) A pharmacy shall not use the word "pharmacy" on that pharmacy or the premises on which the pharmacy is located unless that pharmacy has a current licence issued under section 25.

(4) A pharmacy shall display in a conspicuous place the actual name of the proprietor of that pharmacy in addition to another business name or style which is used by that pharmacy.

Responsibility

27. (1) The pharmacist in charge of a pharmacy operating under this Act shall ensure that that pharmacy is operated in compliance with this Act and failure to do so constitutes professional misconduct.

(2) A person other than a pharmacist in charge shall not direct, control or manage a pharmacy.

(3) The pharmacist in charge as referred to in subsection (2) shall be the pharmacist in charge designated upon the licence issued under section 25.

Hospital pharmacy

28. (1) A hospital with a pharmacy licensed under section 25 shall not engage or employ a person other than a pharmacist or pharmacy student registered under this Act to practise pharmacy in or from that hospital pharmacy.

(2) This section is binding on the Crown.

Inspection

29. For the purpose of ensuring compliance with this Act the secretary-registrar or a person authorized by the secretary-registrar may inspect an existing or a proposed pharmacy to determine the equipment and drugs contained or to be contained in the pharmacy.

Cessation of operation

30. (1) Where a licensed pharmacy ceases to operate as a pharmacy, the pharmacist in charge shall immediately

(a) notify the association of that cessation;

(b) return to the association the existing pharmacy licence of that pharmacy;

(c) ensure that all narcotic, controlled and other drugs are disposed of in accordance with this Act or other laws relating to that disposal;

(d) provide in writing other information requested by the association;

(e) ensure that he or she retains safe possession of files containing prescriptions for narcotic or controlled drugs;

(f) deliver all other prescription files to another licensed pharmacy or to the association; and

(g) upon request provide copies of prescriptions delivered under paragraph (f) to persons or agents of persons who presented the original prescription.

(2) Where the ownership of a pharmacy licensed under this Act changes, the pharmacist in charge shall deliver the pharmacy licence to the association by the effective date of that change and the licence of that pharmacy shall be cancelled immediately.

(3) Where a pharmacist in charge ceases his or her duties by reason of illness or death, the pharmacy formerly under his or her charge may continue to operate for not more than 60 days under the direction of another pharmacist in charge at which time a new licence shall be required for that pharmacy.

Prohibition

31. A person shall not dispense, sell, offer for sale or handle drugs or substances except in compliance with this Act.

No action against association in certain cases

32. An action shall not lie against the association, the council, the discipline committee or a member or officer of either for proceedings taken in good faith or orders made or enforced under the disciplinary provisions of this Act, the regulations or the by-laws.

Liability of members is limited

33. A member of the association shall not be personally liable for a debt of the association beyond the amount of the unpaid dues of that member, but all property, real and personal, of the association shall be held for the payment of the debts of the association.

Notices

34. (1) Notices and documents or copies of notices and documents required for the purpose of this Act to be sent to a person may be sent by mailing them to that person by registered or certified mail at his or her last known address or by personal service upon that person.

(2) Proof of receipt of the notices, documents or copies by a person referred to in subsection (1) may be proved by production of the receipt from the Canada Post Office.

PART IV
DISCIPLINE

Complaints

35. (1) A person may make a complaint respecting the conduct of a pharmacist, pharmacy student or a retail or hospital pharmacy to the secretary-registrar and that complaint shall be dealt with in accordance with this Part, the regulations and the by-laws.

(2) A complaint respecting the conduct of a person or pharmacy under subsection (1) whose certificate or licence under this Act does not exist, is invalid, revoked or suspended may be dealt with as if that person or pharmacy were registered or licensed under this Act.

Preliminary investigation

36. The secretary-registrar shall immediately upon the receipt of a complaint conduct a preliminary investigation of that complaint and may appoint a person to assist in that investigation.

Notice

37. The secretary-registrar of the association shall immediately send a notice in writing to the investigated person that a preliminary investigation is being conducted.

Evidence

38. (1) While conducting a preliminary investigation the secretary-registrar may

(a) require the investigated person to produce prescriptions, samples, drug inventory, reports, books, papers or other documents or records in the investigated person's possession or under his or her control;

(b) make copies of the documents or records that are produced;

(c) question and obtain further particulars from persons or the investigated person relating to the complaint; and

(d) enter and search a retail or hospital pharmacy, or the premises where that pharmacy is located, for the purpose of paragraphs (a), (b) and (c).

(2) The secretary-registrar conducting a preliminary investigation into the conduct of an investigated person shall report to the discipline committee on all matters regarding the professional conduct of that person in the course of the investigation.

(3) A person who fails to comply with a request made under this section commits an offence.

Report to discipline committee

39. (1) The secretary-registrar shall, on concluding a preliminary investigation or an investigation ordered under subsection (4), report his or her findings, in writing, to the discipline committee.

(2) The secretary-registrar may, before the completion of a preliminary investigation, dismiss a complaint as being frivolous or vexatious.

(3) Where a complaint has been dismissed under subsection (2) the secretary-registrar shall notify the complainant in writing of the dismissal and the reasons for that dismissal.

(4) Where a complaint has been dismissed under subsection (2), the complainant may, in writing and within 14 days of receiving notice of that dismissal under subsection (3), appeal that dismissal to the council and the council shall order the secretary-registrar to complete his or her investigation.

Discipline committee

40. The council shall establish a discipline committee in accordance with the regulations.

Termination of the investigation

41. (1) The discipline committee shall consider a report under section 39 and may terminate further proceedings if it is of the opinion that

(a) the complaint is frivolous or vexatious;

(b) there is insufficient evidence of unskilled practice of pharmacy; or

(c) there is insufficient evidence of unprofessional conduct.

(2) On terminating proceedings under subsection (1) the discipline committee shall direct the secretary-registrar to serve on the investigated person and on the complainant a written notice of that termination, including any findings and reasons.

Hearing by discipline committee

42. (1) Where the investigation or proceedings are not terminated under section 39 or 41, and following receipt and consideration of a report under subsection 39(1), the discipline committee shall immediately hold a hearing into the complaint.

(2) There shall be served on the investigated person and on the complainant a notice of hearing, stating the date, time and place at which the discipline committee will hold the hearing, and giving reasonable particulars of the conduct and complaint which has led to the hearing.

Unprofessional conduct

43. (1) Conduct of an investigated person that, in the opinion of the discipline committee,

(a) is detrimental to the best interest of the public;

(b) contravenes a code of ethics of the pharmacy profession established under the regulations; or

(c) displays a lack of knowledge, skill or judgment in the practice of pharmacy or in the carrying out of a duty or obligation undertaken in that practice

constitutes either unskilled practice of pharmacy or unprofessional conduct, whichever the discipline committee finds.

(2) Where an investigated person contravenes an Act of the Parliament of Canada relating to the sale of drugs or drug products, this Act, the regulations or the by-laws, and that contravention is, in the opinion of the discipline committee, of a serious nature, the contravention may be found by the discipline committee to be unprofessional conduct whether or not that would be found under subsection (1).

Further investigation

44. (1) The discipline committee may also hear another matter concerning the unprofessional conduct of the investigated person that arises during the hearing, but in that event the committee shall declare its intention to hear the further matter and shall permit the person sufficient opportunity to prepare an answer.

(2) Notwithstanding subsection (1), where proceedings in respect of the same circumstances or events are started against the investigated person in a court, the discipline committee may adjourn the hearing.

(3) Sections 45 to 50 shall also apply to a hearing of a further matter under subsection (1).

Right to counsel and appearance

45. The association, the investigated person and the complainant may appear and be represented by counsel at a hearing before the discipline committee.

Proceedings in private

46. All proceedings under this Part shall be held in private unless a public hearing is requested by the investigated person.

Public Inquiries Act

47. For the purpose of this Part, the discipline committee and each member of that committee has the powers that are or may be conferred on a commissioner under the Public Inquiries Act.

Suspension pending investigation hearing

48. (1) Notwithstanding section 49, where the council is of the opinion that a pharmacist may constitute a danger to the public by continuing to practice the profession of pharmacy, the council may, in order to protect the public, suspend the certificate or licence or both of that pharmacist.

(2) Where a certificate or licence has been suspended under subsection (1), within 14 days of that suspension a hearing shall be held under section 42.

Powers of the discipline committee

49. (1) Where, after an investigation and hearing under this Part, it is determined by the discipline committee that the conduct of the investigated person constitutes unprofessional conduct or unskilled practice of pharmacy or both, the discipline committee may

(a) reprimand the investigated person;

(b) suspend the certificate or licence or both of the investigated person for a specified period;

(c) suspend or further suspend the investigated person until a fine imposed under this section has been paid;

(d) suspend the certificate or licence or both of the investigated person until

(i) that person has completed a specified course of studies or obtained supervised practical experience, or

(ii) the council is satisfied as to the competence of the investigated person;

(e) accept in place of a suspension the undertaking of the investigated person to limit his or her practice of pharmacy;

(f) impose upon the investigated person a fine not to exceed a sum fixed by the regulations;

(g) impose conditions on the investigated person carrying out the practice of pharmacy, including conditions that the investigated person

(i) practise pharmacy under supervision,

(ii) not engage in a sole practice of pharmacy,

(iii) permit periodic inspections by an inspector appointed under this Act,

(iv) permit periodic audits of drugs, or

(v) report to the discipline committee, the secretary-registrar or the council on specific matters;

(h) direct the investigated person to pass a course of study or satisfy the council of his or her practical competence;

(i) cancel the certificate or licence of the investigated person;

(j) direct the investigated person to waive, reduce or repay a fee for services rendered by the investigated person that in the opinion of the council was improperly rendered;

(k) refuse an investigated person who is a student admission to examinations and registration for a fixed period or otherwise; and

(l) make another order that the council considers appropriate in the circumstances.

(2) The discipline committee shall, after conducting a hearing under section 42 and acting under subsection (1), report in writing to the council its findings and reasons for its findings and recommendations.

Order to pay expenses

50. (1) The discipline committee may, in addition to dealing with the investigated person under section 49, order that the investigated person pay the reasonable expenses of the association arising out of the investigation and hearing in accordance with the regulations and in the time fixed by the order.

(2) Where the investigated person was ordered to pay the expenses under subsection (1) and he or she fails to pay in the time ordered, the council may suspend the registration of that person until the expenses are paid.

(3) Expenses ordered to be paid to the association under this section are a debt due to the association and may be recovered by a civil action.

Suspension or cancellation pending appeal

51. Where an appeal is brought under section 52, the council may grant a stay of an order of the discipline committee until the time that the decision of the discipline committee is affirmed, varied or struck down by the Trial Division.

Appeal

52. (1) An investigated person affected by a decision under section 48, 49 or 54 may appeal to the Trial Division on an issue of law or mixed fact and law.

(2) An appeal under this section shall be started

(a) by filing a notice of appeal with the Registrar of the Supreme Court; and

(b) by serving a copy of the notice on the secretary-registrar,

within 30 days from the date the decision of the discipline committee is served on the investigated person.

(3) An appeal shall be supported by copies, certified by the secretary-registrar, of the decision of the discipline committee and the record of the hearing of that discipline committee.

(4) The secretary-registrar shall furnish the documents mentioned in subsection (3) on being requested to do so.

Trial Division

53. (1) The Trial Division on hearing the appeal may

(a) quash, confirm or vary the order or decision of the discipline committee or a part of it; and

(b) refer the matter back to the discipline committee for further consideration.

(2) The Trial Division may make an award as to the costs of an appeal that it considers appropriate.

Fraudulent registration

54. Where the discipline committee is satisfied, after considering a report under section 39 that states that a certificate or licence was issued or the corresponding registration was entered into the register by means of a false or fraudulent representation or declaration, oral or written, the discipline committee shall order that the certificate or licence be cancelled.

Surrender of licence

55. (1) Where a certificate or licence has been cancelled or suspended under this Part, the holder of that certificate or licence shall immediately give that certificate or licence to the secretary-registrar.

(2) Where a certificate or licence has been cancelled under this Part, that certificate or licence shall only be reinstated by order of the council.

Misrepresentation of status

56. It is unprofessional conduct for a person who was registered and held a certificate under this Act or whose pharmacy was licensed under this Act to represent that he or she is registered and in good standing or that the pharmacy licence is valid while that certificate or licence is expired, suspended or cancelled and that conduct may be dealt with under this Part.

Reinstatement

57. A pharmacist or pharmacy student whose certificate has been suspended or the holder of a pharmacy licence which has been suspended under this Act may apply to the secretary-registrar for reinstatement of that certificate or licence 1 year after that suspension or at a sooner date as may be ordered by the council.

PART V
GENERIC DISPENSING OF PRESCRIPTION DRUGS

Interpretation

58. (1) In this Part, "formulary" means the Interchangeable Drug Products Formulary established under section 63.

(2) Notwithstanding paragraphs 3(1)(a), (b) and (c), this Part shall apply to

(a) a medical practitioner licensed under the Medical Act;

(b) a dentist or dental surgeon licensed under the Dental Act; and

(c) a veterinarian licensed under the Veterinary Medical Act.

Substitute drugs

59. (1) Where a person authorized by law to dispense prescriptions is given a prescription directing the dispensing of a drug by its brand, chemical or generic name, that person shall dispense a substitute drug other than the drug specifically prescribed where

(a) the drug to be substituted is listed in the formulary as a drug that may be used interchangeably with the drug prescribed; and

(b) the drug to be substituted is less expensive than the drug prescribed.

(2) Subsection (1) does not apply where the prescription contains a specific written direction to the contrary in the handwriting of the person prescribing the drug.

(3) Where a drug is prescribed that must be dispensed in accordance with subsection (1) has a number of substitutes listed in the formulary, the person dispensing the drug

(a) shall dispense the lowest priced substitute drug listed in the formulary at the price listed in the formulary plus his or her normal dispensing fee; or

(b) shall, if the lowest priced drug is not available, dispense another drug listed in the formulary as a substitute for the prescribed drug,

(i) at the price of the lowest priced substitute drug listed in the formulary plus his or her normal dispensing fee where the lowest priced substitute drug is generally available within the province, or

(ii) where the lowest priced substitute drug is not generally available within the province, at the price of the lowest priced substitute drug that is so available plus his or her normal dispensing fee.

Price

60. Where a prescription contains a written direction that the prescribed drug is not to be substituted, the person dispensing the drug shall not charge more for the drug than the price listed in the formulary plus his or her normal dispensing fee, if that drug is in the formulary.

Non-lowest price

61. (1) Notwithstanding sections 59 and 60, a person may request that the prescribed drug dispensed be an equivalent drug listed in the formulary, other than the lowest priced drug listed in the formulary.

(2) Where a prescribed drug is dispensed by a person under subsection (1), that person shall inform the person requesting a specific equivalent drug of the difference in cost between the requested formulary drug and the lowest priced equivalent formulary drug.

Non-formulary

62. Where a prescribed drug not listed in the formulary is dispensed by a person authorized by law to dispense prescriptions and an equivalent drug product is listed in the formulary, that person shall charge for that dispensed drug the price of the lowest priced equivalent drug product listed in the formulary.

Formulary

63. (1) The minister may establish by regulation an Interchangeable Drug Products Formulary setting out

(a) drugs that may be used interchangeably with other drugs; and

(b) maximum prices to be charged for drugs listed in the formulary.

(2) Drugs that may be used interchangeably with other drugs in the formulary are to contain a drug or drugs in the same amounts of the same active ingredients in the same dosage form as that directed by a prescription for such a drug.

Advisory committee

64. (1) The minister shall appoint an advisory committee consisting of 2 pharmacists, 2 physicians, the Deputy Minister of Health or his or her designate and those other persons that he or she may wish to appoint, to advise on the contents of the formulary and other matters relating to drugs.

(2) The minister shall consult with the association and the Newfoundland Medical Association on the appointments to be made under subsection (1) from their respective professions.

(3) The minister shall designate one of the members to be chairperson of the advisory committee.

Unprofessional conduct

65. A pharmacist who contravenes the provisions of this Part is considered to have committed unprofessional conduct.

Actions

66. An action does not lie against a person by reason only of the prescribing or dispensing of a substitute drug in accordance with this Part.

PART VI
PENALTY

Penalties and fines

67. (1) A person, pharmacist, pharmacy student, firm, partnership, corporation or association of persons who contravenes this Act, the regulations or the by-laws commits an offence and is liable on summary conviction

(a) for the 1st offence, to a fine of not more than $2,000 or to imprisonment for a term of not more than 3 months or to both a fine and imprisonment; and

(b) for a subsequent offence to a fine of not more than $4,000 or to imprisonment for a term of not more than 6 months or to both a fine and imprisonment.

(2) A prosecution under this section shall be commenced within 2 years after the commission of the alleged offence, but not afterwards.

Fines

68. All fines imposed under this Act by the discipline committee shall be paid over to the association.

PART VII
TRANSITIONAL AND CONSEQUENTIAL

Registration continued

69. An application for registration or for a licence made but not concluded before the commencement of this Act shall be dealt with under the former Act.

Discipline continued

70. A complaint or discipline proceeding that was started but not concluded before the commencement of this Act shall be concluded under the former Act.

RSN 1990 cG-2 Rep.

71. The Generic Dispensing of Prescription Drugs Act is repealed.

RSN 1990 cP-12 Rep.

72. The Pharmaceutical Association Act is repealed.

Commencement

73. This Act comes into force on a day to be proclaimed by the Lieutenant-Governor in Council.

©Earl G. Tucker, Queen's Printer