This consolidation is unofficial and is for reference only. For the official version of the regulations, consult the original documents on file with the Registry of Regulations, or refer to the Royal Gazette Part II. Regulations are amended frequently. Please check the list of Regulations by Act to see if there are any recent amendments to these regulations filed with the Registry that are not yet included in this consolidation. Although every effort has been made to ensure the accuracy of this electronic version, the Registry of Regulations assumes no responsibility for any discrepancies that may have resulted from reformatting. This electronic version is copyright © 2009, Province of Nova Scotia, all rights reserved. It is for your personal use and may not be copied for the purposes of resale in this or any other form.
Practice of Pharmacy Regulations made under Section 77 of the
Pharmacy Act
S.N.S. 2001, c. 36
N.S. Reg. 193/2003 (November 29, 2002, effective September 1, 2003)Definitions
D1 In the Pharmacy Act and these regulations,(a) "accredited university program in pharmacy" means a university program in pharmacy accredited pursuant to clause 13(5)(a) of the Pharmacy Act or these regulations;
(b) "compound" means to cause drugs to be mixed, prepared, altered in form, mixed with non-medicinal ingredients and otherwise changed from the manufactured form;
(c) "graduate intern" means an intern who has never been licensed to practise pharmacy;
(d) "Qualifications and Professional Accountability Regulations" mean the Qualifications and Professional Accountability Regulations made by the Council pursuant to subsection 80(1) of the Pharmacy Act as approved by the Governor in Council;
(e) "qualifying intern" means an intern who is or has been licensed to practise pharmacy in another jurisdiction, or who has been licensed to practise pharmacy in Nova Scotia, but who is not currently licensed to practise pharmacy in Nova Scotia;
(f) "structured practice experience" means a course of guided practical experience approved by Council under the guidance of a preceptor in a direct patient care setting in a licensed pharmacy or hospital pharmacy, or other institution approved by the Council;
(g) "unstructured practice experience" means practical experience under the guidance of a preceptor in a direct patient care setting in a licensed pharmacy or hospital pharmacy, or other institution approved by the Council.
Part 1 - Membership, Qualifications and Licensing Members
1.1 (1) Members of the College are pharmacists, certified dispensers, registered students and interns.(2) Pharmacists may be classified as
(a) practising direct patient care;
(b) practising indirect patient care; or
(c) non-practising.
(3) A pharmacist who is not registered to practise direct patient care may be referred to as a pharmacist and may use the designation Ph. C., Reg. Pharm. or similar designation, but shall not dispense drugs or practice direct patient care pharmacy.
(4) A pharmacist in good standing leaving the practice of direct patient care pharmacy may request that the Registrar change the pharmacist’s membership classification to "practising indirect patient care".
(5) A pharmacist in good standing leaving the practice of pharmacy shall request that the Registrar either change the pharmacist’s membership to non-practising or permit the pharmacist to retire from membership.
Graduate interns - qualifying requirements
1.2 (1) The Qualifications and Professional Accountability Regulations require a qualifying intern to successfully complete the requirements of clauses 13(5)(b), (c), (d) and (e) of the Pharmacy Act.(2) For the purposes of successfully completing the requirements of clause 13(5)(b) of the Pharmacy Act, it is sufficient to have successfully completed English language proficiency assessment at a level consistent with language fluency requirements for licensure as a pharmacist in Canada, as approved by the Council.
(3) For the purposes of successfully completing the requirements of clause 13(5)(c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.
(4) For the purposes of successfully completing the requirements of clause 13(5)(d) of the Pharmacy Act, it is sufficient to have successfully completed a structured practice experience program approved by the Council consistent with the most recent framework for assessing Canadian pharmacists’ competencies at entry-to-practice through structured practical training programs as prescribed in these regulations.
(5) For the purposes of successfully completing the requirements of clause 13(5)(e) of the Pharmacy Act, it is sufficient to have successfully completed a licensing examination based on the required professional competencies for Canadian pharmacists at entry-to-practice as approved by the Council.
Mutual Recognition Agreement - registration of pharmacists
1.3 (1) The Qualifications and Professional Accountability Regulations require a pharmacist transferring to Nova Scotia from a jurisdiction that is a signatory to the "Mutual Recognition Agreement for the Profession of Pharmacy in Canada" to have successfully completed the requirement of clause 13(5)(c) of the Pharmacy Act and to provide a letter of standing from the applicant’s regulatory authority.(2) For the purposes of successfully completing the requirements of clause 13(5)(c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.
(3) A letter of standing from a regulatory authority in another jurisdiction shall
(a) confirm that the applicant was registered in that jurisdiction;
(b) set out the membership classification to which the applicant belonged and specify any limits on the applicant’s right to practice pharmacy in that jurisdiction;
(c) include a complete list of all complaints, discipline matters, discipline proceedings and penalties, warnings and cautions with respect to the applicant; and
(d) confirm whether there are any outstanding complaints or other disciplinary matters with respect to the applicant that have not been resolved.
Non-MRA registration of pharmacists
1.4 (1) The Qualifications and Professional Accountability Regulations require a pharmacist transferring to Nova Scotia from a jurisdiction that is not a signatory to the "Mutual Recognition Agreement for the Profession of Pharmacy in Canada" to have successfully completed the requirement of clause 13(5)(b), (c), (d) and (e) of the Pharmacy Act and to provide a letter of standing from the applicant’s regulatory authority.(2) For the purposes of successfully completing the requirements of clause 13(5)(b) of the Pharmacy Act, it is sufficient to have successfully completed English language proficiency assessment at a level consistent with language fluency requirements for licensure as a pharmacist in Canada, as approved by the Council.
(3) For the purposes of successfully completing the requirements of clause 13(5)(c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.
(4) For the purposes of successfully completing the requirements of clause 13(5)(d) of the Pharmacy Act, it is sufficient to have successfully completed a structured practice experience program approved by the Council consistent with the most recent framework for assessing Canadian pharmacists’ competencies at entry-to-practice through structured practical training programs as prescribed in these regulations.
(5) For the purposes of successfully completing the requirements of clause 13(5)(e) of the Pharmacy Act, it is sufficient to have successfully completed a licensing examination based on the required professional competencies for Canadian pharmacists at entry-to-practice as approved by the Council.
(6) A letter of standing from a regulatory authority in another jurisdiction shall
(a) confirm that the applicant was registered in that jurisdiction;
(b) set out the membership classification to which the applicant belonged and specify any limits on the applicant’s right to practise pharmacy in that jurisdiction;
(c) include a complete list of all complaints, discipline matters, discipline proceedings and penalties, warnings and cautions with respect to the applicant; and
(d) confirm whether there are any outstanding complaints or other disciplinary matters with respect to the applicant that have not been resolved.
Resumption of practice
1.5 (1) The Qualifications and Professional Accountability Regulations require some pharmacists resuming practice to have successfully completed the requirement of clause 13(5)(c) of the Pharmacy Act, and in some cases the requirement of clause 13(5)(d) of the Pharmacy Act.(2) For the purposes of successfully completing the requirements of clause 13(5)(c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.
(3) For the purposes of successfully completing the requirements of clause 13(5)(d) of the Pharmacy Act, it is sufficient to have successfully completed a structured practice experience program approved by the Council consistent with the most recent framework for assessing Canadian pharmacists’ competencies at entry-to-practice through structured practical training programs as prescribed in these regulations.
Registration of qualifying interns
1.6 (1) The Qualifications and Professional Accountability Regulations require an applicant for registration as a qualifying intern to have successfully completed the requirements of clauses 13(5)(b) and (c) of the Pharmacy Act and to provide a letter of standing from the applicant’s regulatory authority.(2) For the purposes of successfully completing the requirements of clause 13(5)(b) of the Pharmacy Act, it is sufficient to have successfully completed English language proficiency assessment at a level consistent with language fluency requirements for licensure as a pharmacist in Canada, as approved by the Council.
(3) For the purposes of successfully completing the requirements of clause 13(5)(c) of the Pharmacy Act, it is sufficient to have successfully completed the examination in jurisprudence approved by the Council based on pharmacy jurisprudence competencies for licensure as a pharmacist in Canada, with specific reference to Nova Scotia.
(4) A letter of standing from a regulatory authority in another jurisdiction shall
(a) confirm that the applicant was registered in that jurisdiction;
(b) set out the membership classification to which the applicant belonged and specify any limits on the applicant’s right to practise pharmacy in that jurisdiction;
(c) include a complete list of all complaints, discipline matters, discipline proceedings and penalties, warnings and cautions with respect to the applicant; and
(d) confirm whether there are any outstanding complaints or other disciplinary matters with respect to the applicant that have not been resolved.
Application forms
1.7 The application forms required pursuant to the Pharmacy Act, the Qualifications and Professional Accountability Regulations or these regulations shall be those from time to time prescribed by the Registrar.Return to direct patient care
1.8 A pharmacist practising indirect patient care may change membership classification to direct patient care by filing a notice to that effect with the College.Required practice experience
1.9 (1) No period of less than four continuous weeks working an average of at least thirty hours a week may be included in the calculation of the unstructured practice experience required by these regulations.(2) Except as hereinafter provided, no period of practice experience undertaken
(a) in the case of a registered student and an intern who was a registered student in Nova Scotia, before that person was registered as a registered student;
(b) in the case of a registered student and an intern who was a registered student in Nova Scotia, before the commencement of the second year of that person’s pharmacy program;
(c) in the case of a graduate intern who was not a registered student in Nova Scotia, before that person was registered as a graduate intern; and
(d) in the case of a qualifying intern, before that person was registered as a qualifying intern,
shall be counted towards the completion of the requirements of these regulations.
(3) Practice experience shall have been completed not more than two years prior to registration as a pharmacist.
(4) Structured or unstructured practice experience in another jurisdiction may, with the approval of the Council, be applied towards the completion of the requirements of these regulations if the Council considers that the experience is substantially similar to that which would be obtained in Nova Scotia.
(5) The Council may approve structured and unstructured practice experience in another jurisdiction as meeting the requirements of these regulations in advance of the practice experience being undertaken where Council considers that the experience is substantially similar to that which would be obtained in Nova Scotia.
(6) The Council may waive some or all of the practice experience requirements for an intern who provides evidence of active direct patient care practice in another jurisdiction with similar required standards of pharmacy practice.
(7) A preceptor shall be a pharmacist licensed for and practising direct patient care who has been registered in Canada for at least one year, who has no limitations on practice, and whose right to be a preceptor has not been revoked or suspended.
(8) A preceptor shall at all times exercise the degree of personal supervision of an intern or registered student that, in the professional judgment of the preceptor, is required to ensure safe and effective patient care given the knowledge, skills and experience of the intern or registered student and the preceptor’s responsibilities pursuant to the Pharmacy Act.
(9) In the case of unstructured practice experience, the participant shall advise the College, before commencing the practice experience, of the pharmacy, hospital or other institution approved by the Council in which the practice experience will be undertaken and provide the consent of a preceptor.
(10) A participant shall notify the College immediately if there is any change in the location in which practice experience is being undertaken or in preceptor.
(11) Structured practice experience in excess of the minimum requirement shall be counted as unstructured practice experience.
(12) The preceptor shall certify to the College the time spent in the practice experience and whether the participant was satisfactory or unsatisfactory.
(13) Practice experience for which the participant has received an unsatisfactory rating shall not be counted towards the completion of the requirements of these regulations.
Accredited university program
1.10 (1) In these regulations, an accredited university program in pharmacy includes, in addition to a university program accredited by the Canadian Council for Accreditation of Pharmacy Programs as provided by the Pharmacy Act,(a) a university program in pharmacy accredited by a body recognized as an accrediting agency by the Canadian Council for Accreditation of Pharmacy Programs;
(b) a university program in pharmacy determined by the Pharmacy Examining Board of Canada to be the equivalent of a Canadian Council for Accreditation of Pharmacy Programs accredited program; and
(c) a university program in pharmacy recognized pursuant to subsection (2).
(2) In the event a program does meet any of the requirements of subsection (1), if the Council determines that the program is the equivalent of a program accredited by the Canadian Council for Accreditation of Pharmacy Programs, the Council shall recognize the program for the purpose of these regulations.
(3) A university program in pharmacy accredited pursuant to this Section or determined to have been the equivalent of an accredited program is deemed to have been determined by the Council to be the equivalent of an accredited program pursuant to clause 13(5)(a) of the Pharmacy Act.
Time limits
1.11 (1) A person who has graduated from an accredited university pharmacy program shall qualify for and obtain a licence as a pharmacist within two years after graduation.(2) The Council may, on application, extend the period in subsection (1).
Continuing competence
1.12 Proof of completion of the requirements of the Qualifications and Professional Accountability Regulations respecting continuing competency in the twelve months preceding November 30 in any year shall be provided to the Registrar before November 30, failing which the member is suspended as provided by the Pharmacy Act and shall not practise pharmacy until reinstated.Annual renewal
1.13 (1) A licence to practise pharmacy in Nova Scotia expires December 31 in each year.(2) To renew a licence to practise pharmacy in Nova Scotia, a pharmacist or certified dispenser shall
(a) complete and submit the application form provided by the Registrar;
(b) have completed the requirements for continuing competency prescribed by the Qualifications and Professional Accountability Regulations;
(c) be insured as required by the Qualifications and Professional Accountability Regulations; and
(d) pay the fee prescribed in Schedule "A".
(3) Where a pharmacist or certified dispenser does not submit a completed application to renew a licence before November 30 in any year, the pharmacist or certified dispenser is subject to the late payment fee prescribed in Schedule "A".
(4) Where a pharmacist or certified dispenser does not submit a completed application to renew a licence before December 31 in any year, the pharmacist or certified dispenser is suspended as provided by the Pharmacy Act and shall not practise pharmacy until reinstated.
Accreditation of a new pharmacy
1.14 (1) Every person who proposes to open a new pharmacy or who proposes to acquire an existing pharmacy shall apply for a certificate of accreditation and a pharmacy licence in accordance with the Pharmacy Act not less than thirty days before the proposed opening date of the pharmacy.(2) In exceptional circumstances the Registrar may authorize a shorter notice period.
(3) A pharmacy, in order to be accredited, shall comply with the requirements of the Pharmacy Act and the regulations.
(4) An application for accreditation shall include
(a) a diagram of the pharmacy as required pursuant to Part 2 of these regulations;
(b) the name of the owner of the pharmacy and, where the owner is a body corporate, the names of the officers and directors of the body corporate;
(c) the name of the pharmacy manager;
(d) certification by the owner and the pharmacy manager that the pharmacy meets the requirements of the Pharmacy Act and the regulations; and
(e) the fee prescribed in Schedule "A".
(5) Upon accreditation, the College shall provide the pharmacy with a certificate of accreditation and a licence for the then-current year.
(6) A pharmacy licence shall be issued in the name of the manager of the pharmacy.
(7) In the event of a change in the manager of the pharmacy, the pharmacy shall obtain a replacement licence upon payment of the fee prescribed in Schedule "A".
Renewal of a pharmacy licence
1.15 (1) A pharmacy licence expires December 31 in each year.(2) A pharmacy licence is renewable on application to the College before the last day of November in the licence year.
(3) An application for renewal of a pharmacy licence shall include
(a) the name of the pharmacy manager;
(b) certification by the owner and the pharmacy manager that the pharmacy meets the requirements of the Pharmacy Act and the regulations; and
(c) the fee prescribed in Schedule "A".
(4) Where a completed application to renew a pharmacy licence is not submitted before November 30 in any year, the pharmacy is subject to the late payment fee prescribed in Schedule "A".
(5) Where a completed application to renew a pharmacy licence is not submitted before December 31 in any year, the pharmacy is suspended as provided by the Pharmacy Act.
Document replacement
1.16 (1) A pharmacist requiring replacement of a certificate of registration or licence for any of the following reasons:(a) loss or destruction of original;
(b) legal change of name; or
(c) change of name to married name,
may, on request, accompanied by the current document if it is in existence and the reason the replacement document is required, obtain a replacement copy from the Registrar upon payment of the fee specified in Schedule "A".
(2) A pharmacy requiring replacement of its licence or certificate of accreditation for any of the following reasons:
(a) change of manager;
(b) change of operating name;
(c) change of corporate name;
(d) change of location; or
(e) loss or destruction of the original,
may, on request, obtain a replacement copy from the Registrar upon payment of the fee specified in Schedule "A".
Fees
1.17 The fees set out in Schedule "A" are the fees payable in the circumstances indicated in the Schedule.Part 2 - Professional Responsibility in Community Pharmacy Responsibilities of the pharmacy manager
2.1 (1) The manager of a pharmacy is responsible for(a) the day to day management of the pharmacy;
(b) the development, maintenance and enforcement of policies and procedures to comply with the standards of practice of pharmacy as set out in an enactment or a professional standard adopted by an appropriate professional organization, or otherwise required to ensure optimal patient care;
(c) the development, maintenance and enforcement of a quality management program;
(d) ensuring that all staff members who present themselves as pharmacists or who are employed to practise as pharmacists are licensed to practise pharmacy in Nova Scotia;
(e) notifying the Registrar in writing of any changes in the pharmacy staff as they occur;
(f) responding to any questions from the Registrar respecting the practice of pharmacy in the pharmacy;
(g) advising the Registrar in writing of professional practice problems or conduct that could affect the health or safety of patients by any pharmacist, registered student, intern or certified dispenser employed in the pharmacy;
(h) cooperating fully with any inspector appointed by the Council pursuant to the Pharmacy Act;
(i) establishing a staffing plan commensurate with patient care requirements and taking reasonable steps to implement it;
(j) ensuring that information directed to the pharmacy pertaining to drugs, devices, diversion tactics and the practice of pharmacy is accessible to all staff and that any pharmacist, registered student, intern or certified dispenser is informed of its location in the pharmacy;
(k) the adoption of policies to ensure so far as possible that the pharmacy has adequate stocks of drugs and devices to meet the needs of its patients;
(l) the adoption of a policy for implementing and documenting a drug recall procedure;
(m) ensuring that all drugs in the pharmacy are secure from loss, theft or diversion;
(n) maintaining confidentiality with respect to all patient records and information;
(o) ensuring the correct and consistent use of the operating name of the pharmacy as it appears on the certificate of accreditation of the pharmacy for all pharmacy identification on labels and packaging.
(2) A pharmacist shall not act as the manager of more than one pharmacy at a time.
(3) The pharmacy manager shall report to the College any change in the ownership of the pharmacy, and, where the owner is a body corporate, any change in the names of the officers and directors of the body corporate.
Quality management
2.2 (1) Every pharmacy shall establish and maintain a continuing, documented quality assurance program that monitors staff performance, equipment, facilities and adherence to standards of practice.(2) The quality assurance program shall include a process for documenting and reporting known, alleged and suspected medication errors and discrepancies, and the steps taken to resolve the problem.
(3) The quality assurance program shall include provisions to protect the confidentiality of information relating to specific patients.
Pharmacy
2.3 (1) Every application for the accreditation of a pharmacy shall include a diagram of the pharmacy.(2) The diagram shall demonstrate compliance with the Pharmacy Act and these regulations before a certificate of accreditation is issued.
(3) The pharmacy manager shall report to the College any changes in the pharmacy, made either before or after accreditation, that would affect the diagram.
(4) The diagram shall be drawn to scale, and include
(a) all entrances, stairs or escalators, and elevators;
(b) washrooms, indicating whether for staff or the general public;
(c) an indication of whether there are additional areas of the retail premises not included in the pharmacy and the approximate size of them;
(d) storage areas;
(e) dispensary, showing the location of the counter;
(f) narcotic and controlled drug storage areas and any related equipment;
(g) areas containing scheduled drugs;
(h) patient counselling area.
(5) The diagram shall be accompanied by a description of the type of security features employed to render the dispensary and controlled drug areas secure and, where the pharmacy is part of a larger premises, the manner in which the pharmacy is secured from the larger premises when closed.
Dispensary
2.4 (1) The dispensary of a pharmacy must be a well-defined area clearly identified to the public by "Dispensary", "Prescriptions" or words of like import approved by the Registrar.(2) The dispensary staff shall be accessible to the public at the counter and by telephone.
(3) The dispensary area shall be inaccessible to the public.
(4) The dispensary shall be sufficiently large and configured to allow for safe and proper storage of medications and compounding, preparation and dispensing of medication orders, taking into account the volume of business, the nature of the patients and their particular needs, and the nature of the pharmacy’s business, and
(a) be clean, sanitary, well ventilated and well lit;
(b) contain sufficient drugs to permit the provision of a full dispensing service;
(c) have adequate shelf and storage space;
(d) include a sink with hot and cold running water;
(e) include a secure refrigerator for storing drugs;
(f) include a source of heat for compounding;
(g) include a typewriter or printer, prescription numbering system and system for filing prescriptions.
(5) A dispensary shall be adequately equipped to provide safe and proper compounding, dispensing and preparation of medication orders, and have at least
(a) an accurate prescription balance with a sensitivity reciprocal of 10 mg;
(b) glass graduates;
(c) mortars and pestles (both glass and earthenware);
(d) metallic and non-metallic spatulas;
(e) glass funnels;
(f) glass stirring rods;
(g) ointment slab or pad;
(h) counting tray;
(i) sufficient consumables such as containers and labels to permit a full dispensing service in accordance with the regulations.
Physical facilities
2.5 (1) A pharmacy shall contain an area for private patient consultation where counselling and the provision of drug information may take place without being overheard by others.(2) A pharmacy shall be of sufficient size to allow for safe and proper storage of medications, for compounding, preparation and dispensing of medication orders, and for provision of patient- oriented and administrative pharmacy services, taking into account the volume of business, the nature of the patients and their particular needs, and the nature of the pharmacy’s business.
(3) All areas of the pharmacy shall be dry, well-lighted, well-ventilated and maintained in a clean, sanitary and orderly condition.
(4) The pharmacy shall be physically separated from adjacent areas in the same premises by any means that ensures that no one has unsupervised access to any scheduled drugs when a pharmacist is not present.
(5) The current pharmacy licence shall be displayed in a conspicuous public place in the pharmacy.
Security
2.6 (1) Each pharmacist, while on duty, is responsible for the security of the pharmacy, including the enforcement of provisions to protect against unauthorized entry and theft or diversion of medication.(2) After pharmacy hours, the pharmacy premises shall be secured with suitable locks and alarms to prevent and detect unauthorized entry.
Hours
2.7 The hours of operation of the pharmacy shall be posted in a prominent place at the dispensary in the pharmacy, at the public entrances to the pharmacy, and, where the pharmacy is located in a larger premises, at the public entrances to those premises.Equipment and references
2.8 (1) The pharmacy shall be adequately equipped to provide safe and proper medication compounding, dispensing and preparation of medication orders, and patient-oriented and administrative pharmacy services.(2) The pharmacy shall be equipped with a reference library of current references relevant to medication compounding, dispensing and preparation of medication orders, and current patient- oriented references for the provision of patient-oriented pharmacy services.
(3) The pharmacy’s reference library shall at a minimum comply with "Professional Library Requirements for Community Pharmacies" (Nova Scotia College of Pharmacists) as from time to time amended or revised.
(4) The pharmacy manager may vary any specific prescribed standards for equipment and library where the pharmacy serves only a specialized clientele and does not serve the public generally, provided the pharmacy continues to provide safe and effective pharmacy services to its patients.
Practice
2.9 (1) Where sterile products are prepared, policies and procedures consistent with recognized professional standards shall be in place to ensure the sterility of the final products.(2) Every employee of the pharmacy shall wear a badge identifying the person as an employee of the pharmacy and whether that person is a pharmacist, certified dispenser, registered student, intern or other employee.
Standards of practice
2.10 A pharmacist shall comply with the Standards of Practice adopted and from time to time amended by the Nova Scotia College of Pharmacists.Expired drugs
2.11 (1) Where a drug or device is prescribed by the manufacturer to be used within a specified period of time, or before a certain date, no pharmacist shall give, sell or offer for sale the drug or device once that period of time or date has passed.(2) Any products to which subsection (1) applies shall be removed from any part of the pharmacy and the premises in which the pharmacy is located, except a clearly marked product disposal area, upon the expiration of the period of time or date.
(3) No pharmacist shall dispense any products to which subsection (1) applies if the period of time specified by the manufacturer will elapse or the expiration date specified by the manufacturer will occur during the period of use set out in the prescription.
Returned products
2.12 No pharmacist or certified dispenser shall dispense any previously dispensed product returned to the pharmacy except as provided by and in accordance with the Nova Scotia College of Pharmacists Standards of Practice as amended from time to time.Labels
2.13 (1) A pharmacist or certified dispenser shall affix an easily read label to every container of drugs dispensed.(2) A pharmacist or certified dispenser shall ensure that the prescriber’s directions for use are clearly transcribed to the label.
(3) Labels to be affixed to containers when a drug is dispensed shall contain any information that in the professional judgment of the pharmacist or certified dispenser is required for the safe and effective use of that drug by that patient, and, at a minimum, shall contain the specific information required by the Nova Scotia College of Pharmacists Standards of Practice as amended from time to time.
(4) When a medication is dispensed or sold from bulk stock bearing an expiration date that is within the time frame that a patient might reasonably be expected to store the medication, the date of expiration must appear on the label or as a supplementary label.
(5) Supplementary labels must be used when appropriate to relay information concerning the use, storage or precautions pertaining to the particular drug or medication sold or dispensed.
(6) Where a drug consists of both an inner and an outer container, a label must be affixed in a permanent fashion to the inner container.
(7) Where a drug container is too small to accommodate a full label, a label shall be affixed to the container that includes the minimum information that in the professional judgment of the pharmacist or certified dispenser is required for the safe and effective use of that drug by that patient, the full label shall be affixed to a larger container and the patient shall be counselled to keep the small container within the larger container with the full label.
(8) Notwithstanding subsections (6) and (7), a pharmacist or certified dispenser may omit the label on the inner or small container at the request of the patient where the pharmacist considers that to do so will result in better patient care.
(9) Labels must be affixed to non-prescription drugs whenever they are repackaged from the manufacturer’s original packaging in accordance with the Nova Scotia College of Pharmacists Standards of Practice as amended from time to time.
Prescriptions
2.14 (1) A pharmacist or certified dispenser is responsible for ensuring that a prescription is authentic and that the pharmacist or certified dispenser has at least the following information before the prescription is dispensed:(a) date;
(b) name and address of the patient;
(c) name of the prescribed drug or ingredients;
(d) strength, where applicable;
(e) quantity of the drug that may be dispensed;
(f) dosage instructions for use by the patient;
(g) refill authorization, where applicable;
(h) name and address of the prescriber and, in the case of a written prescription, signature of the prescriber.
(2) A pharmacist or certified dispenser shall take reasonable steps to ensure that the prescriber is licensed and practises in Canada, and belongs to a class of persons who, if licensed in Nova Scotia, would be entitled by law to prescribe that drug or device in Nova Scotia.
(3) Every pharmacist or certified dispenser who receives a verbal prescription shall reduce it to written or printed form as soon as possible, and in any event before dispensing it, and shall sign or initial it and date it.
(4) A verbal prescription shall be communicated directly from the person authorized to prescribe to a pharmacist or certified dispenser, or may be obtained from a voice message recorded by the prescriber in a manner that protects patient confidentiality.
(5) A prescription may be transmitted electronically by facsimile directly from the prescriber to the pharmacy in accordance with the Nova Scotia College of Pharmacists Standards of Practice as amended from time to time, and may be dispensed in accordance with those standards where the pharmacist or certified dispenser has verified the origin of the transmission, the authenticity of the prescription, and the prescriber’s unique identifier.
(6) The pharmacist or certified dispenser who dispenses a prescription shall sign or initial the prescription when it is dispensed and mark the date it was dispensed directly on the prescription.
(7) If a prescription is not dated, the pharmacist shall verify the date and write the verified date on the prescription before dispensing it.
(8) Every time a prescription is refilled, a record to that effect shall be signed or initialled and dated.
(9) No prescription shall be filled or refilled after one year from the date it was prescribed.
(10) Where a new prescription is presented for a previously prescribed drug, the pharmacist or certified dispenser shall cancel any unused refill authorizations remaining on any previous prescription for that drug.
Prescription copies
2.15 Every person in respect of whom a prescription is presented to a pharmacist or certified dispenser to be dispensed, and which has been dispensed, is entitled to have a copy marked "Copy for Information Only" furnished to that person or that person’s agent on request.Transfers
2.16 (1) In this Section,(a) "controlled drug" includes any drug included in the Panel of Monitored Drugs pursuant to Section 2.19 or that is a controlled drug pursuant to the Controlled Drugs and Substances Act (Canada);
(b) "pharmacist" includes a certified dispenser in Nova Scotia.
(2) Upon request, a pharmacist shall transfer a prescription to another pharmacist licensed in a Canadian jurisdiction provided that the prescription does not include a narcotic or controlled drug.
(3) When a prescription is transferred from one pharmacist to another,
(a) all remaining refills at the transferring pharmacy shall be cancelled;
(b) the transferring pharmacist shall enter on the patient record the fact that the prescription was transferred, including
(i) date of the transfer,
(ii) identity of the transferring pharmacist,
(iii) receiving pharmacist and pharmacy, and
(v)[(iv)] any other relevant information; and(c) the transfer shall comply with the Food and Drug Act (Canada), the Controlled Drugs and Substances Act (Canada), and the regulations under those Acts.
(4) A pharmacist may dispense a prescription transferred from a pharmacist licensed in another jurisdiction in Canada, including any remaining refills, if
(a) the prescription does not include a narcotic or controlled drug;
(b) the transfer complies with the Food and Drug Act (Canada), the Controlled Drugs and Substances Act (Canada), and the regulations under those Acts; and
(c) the prescriber is licensed and practises in Canada and belongs to a class of persons who, if licensed in Nova Scotia, would be entitled by law to prescribe that drug or device in Nova Scotia.
Dispensing
2.17 (1) A pharmacist may adjust the quantity of drugs dispensed from that prescribed where(a) the patient asks to purchase a smaller amount;
(b) the patient requests an early refill of the prescription for valid reasons, if the patient has a good compliance history and it is in the interest of the patient to do so, provided that to do so is permitted by law and the prescription is not for a drug listed in a schedule pursuant to the Controlled Drugs and Substances Act;
(c) the manufacturer’s unit-of-use standard package size does not exactly match the prescribed quantity;
(d) the patient has a poor compliance history as documented on the patient record;
(e) drug misuse is suspected;
(f) the quantity prescribed exceeds the amount covered by the patient’s drug plan;
(g) the patient authorizes a trial prescription quantity;
(h) in the professional opinion of the pharmacist or certified dispenser, it is necessary for the safe and effective use of that drug by that patient.
(2) A pharmacist shall not alter the quantity of drugs from that prescribed unless the alteration is for the benefit of the patient and is fully explained to the patient, including any extra cost that may be incurred by the patient.
(3) Containers meeting Canadian Standards Association standards for child-resistant containers shall be used to dispense any drug unless, in the professional opinion of the pharmacist, a child-resistant container does not meet a patient’s needs.
Counselling
2.18 (1) When a pharmacist counsels a patient, the dialogue shall be in person if practicable and shall respect the patient’s right to confidentiality.(2) A pharmacist or certified dispenser, and a student or intern under the direct supervision of a pharmacist, shall counsel a patient when a drug is dispensed to that patient, including
(a) confirmation of the identity of the patient;
(b) identification and purpose of the drug being dispensed;
(c) directions for proper use;
(d) common adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the actions required if they occur;
(e) storage requirements;
(f) prescription refill information;
(g) responses to questions and expressed needs; and
(h) such other information as the person counselling considers appropriate for the safe and effective use of that drug by that patient.
(3) Alternative forms of patient information may be used to supplement counselling.
Pharmacist not present
2.19 (1) When a pharmacist or certified dispenser is not present and the pharmacy is closed, if the pharmacy is part of a larger premises, employees in the larger premises may(a) release to patients dispensed prescriptions that have been left in a secure and private location accessible to employees outside the pharmacy; and
(b) receive orders from drug wholesalers containing scheduled drugs provided the containers are not opened and are kept in a secure location.
(2) A pharmacist or certified dispenser shall not leave a prescription to be released pursuant to clause (1)(a) unless a patient has requested the pharmacist or certified dispenser to do so, adequate steps are taken to protect the confidentiality of any information respecting the patient, and adequate steps are taken to ensure the correct identification of the patient before turning over the prescription to the patient.
(3) A pharmacist or certified dispenser who leaves a prescription to be picked up by a patient pursuant to clause (1)(a) is responsible for ensuring that the pharmacist or certified dispenser has previously counselled the patient concerning the drug.
Patient records
2.20 The pharmacy manager shall ensure that a patient record is prepared and maintained in accordance with the Standards of Practice of the Nova Scotia College of Pharmacists for each patient for whom a drug is dispensed.Advertising
2.21 (1) In this regulation, "advertising" means using space or time in a public medium or using a commercial publication to communicate to all or part of the general public for the purpose of promoting services or enhancing the image of the advertiser, but does not include communicating factual information concerning drugs or devices.(2) A pharmacist or pharmacy may make information about the pharmacy staff or professional services available to the public, subject to the following:
(a) the advertising shall not use any qualifying words such as professional, trusted, prompt, licensed, accurate, cheap, or words of similar meaning; and
(b) the advertising shall not use the words "specialist" or "expert" or words of similar meaning unless the person to whom the advertising relates possesses a specialization granted pursuant to a program approved by the Council for the purpose of granting a specialist status.
(3) A pharmacist or pharmacy may advertise those professional services that are required or mandatory only when followed by the statement, "Required by law in all Nova Scotia pharmacies", displayed in the same size and prominence as all other print in the advertising.
(4) A pharmacist or pharmacy may communicate factual and accurate information but shall not engage in advertising that
(a) is inaccurate or is otherwise capable of misleading the public by the inclusion or omission of any information;
(b) is not in keeping with the standards of good taste generally accepted in the community;
(c) misrepresents pharmaceutical knowledge or fact;
(d) compares, directly or indirectly, the pharmacist’s or pharmacy’s service or ability with that of any other pharmacist or pharmacy, or promises more effective service or better results than those already obtained;
(e) deprecates another pharmacist or pharmacy as to service, ability or fees;
(f) creates an unjustified expectation about the results the pharmacist can achieve;
(g) is made under any false or misleading guise, or takes advantage of the weakened physical or emotional state of a patient;
(h) discloses the names or identities of patients without their informed consent; or
(i) contains anything that, because of its nature, cannot be verified.
(5) A pharmacist or pharmacy shall not directly or indirectly advertise or promote Schedule I drugs.
(6) A pharmacist or pharmacy shall not directly or indirectly advertise or promote Schedule II drugs except as to the name, classification of drug, quantity or size and price.
Closing a pharmacy
2.22 Every person who permanently discontinues the operation of a pharmacy shall(a) immediately remove any signs and symbols related to the practice of pharmacy;
(b) immediately remove and dispose of all drugs and devices according to law;
(c) notify all patients as soon as possible, by newspaper advertisement or otherwise, of steps taken or proposed for the preservation of patient records and of any intended transfer of them;
(d) provide for the preservation of all patient records according to law and the return of patient records to any patient that so requests;
(e) provide for the orderly continuation of patient care; and
(f) advise the Registrar in writing of the closure prior to the closure, specifying the steps to be taken to comply with the regulations.
Part 3 - Transition and Repeal
Repeal
3.1 All regulations passed pursuant to Chapter 343 of the Revised Statutes, 1989, the Pharmacy Act, inconsistent with the provisions of these regulations, are repealed.Coming into effect
3.2 These regulations have effect on, from and after the date on which the Governor in Council approves the Qualification and Professional Accountability Regulations passed by the Council on the same date as these regulations.
Schedule "A" - Fees
Initial registration and other one-time fees
A1 The following fees are payable to the Nova Scotia College of Pharmacists:
for registration as a student or intern $100.00 to sit for the legislation examination $125.00 for a certificate of accreditation (pharmacy) $450.00 for a certificate of registration (pharmacist) $430.00 for a change in a pharmacy manage $50.00 for a replacement certificate or licence $25.00 for a certificate of standing $25.00 for reinstatement $100.00 Annual fees
A2 The following fees are payable to the Nova Scotia College of Pharmacists each year:
for an unrestricted licence to practise direct patient care pharmacy $330.00 for a licence to practise indirect patient care pharmacy $330.00 for continuance as a registered student or intern $nil for continuance as a certified dispenser $290.00 for a pharmacy licence $300.00 for non-practising membership $200.00 Late fees
A3 (1) The fee for late compliance with annual requirements including payment of fees, proof of insurance coverage and continuing education is $250.00 if full compliance is achieved by December 31 in the year in which the requirements were due.(2) If compliance is not achieved by December 31, the fee for late compliance is $500.00.
Due date
A4 (1) Annual fees are payable to the College on or before November 30 in each year, and if not paid by that date, the member or pharmacy is liable for the late payment fee provided by Section [A]3.(2) If a member or pharmacy does not pay the annual fee and any applicable late payment fee by December 31 in any year, the member or pharmacy is suspended as provided by the Pharmacy Act and shall not practise or be open as a pharmacy until the suspension is removed.
HST
A5 Harmonized Sales Tax, where applicable, is in addition to the fees specified in this Schedule.