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Pharmacy Practice Regulations

made under Section 80 of the

Pharmacy Act

S.N.S. 2011, c. 11

N.S. Reg. 258/2013 (effective August 6, 2013)

amended to N.S. Reg. 98/2023 (effective June 6, 2023)



Table of Contents


Please note: this table of contents is provided for convenience of reference and does not form part of the regulations.
Click here to go to the text of the regulations.

 


Part 1: General

Short title

Definitions


Part 2: Registration and Licensing

Registrants

Pharmacist candidate preceptors

Pharmacy technician candidate preceptors

Time limits

Insurance coverage

Classification of practice

Continuing education


Part 3: Pharmacy Technicians

Delegation to technician


Part 4: Pharmacy Practice

Dispensing

Assessment of drug therapy

Counselling

                   Monitoring  

Prescriptions

Product integrity

Pharmacist not present

Delegation of drug therapy by injection

Delegation of tests and services


Part 5: Pharmacies

Changes

Reinspection

Qualifications of pharmacy manager

Responsibilities of the pharmacy manager

Quality assurance

Persons permitted in dispensary and pharmacy

Dispensary

Physical facilities

Security

Advertising

Closing a pharmacy

Provision of pharmacy services outside licensed pharmacy



 

Part 1: General


Short title

1        These regulations may be cited as the Pharmacy Practice Regulations.


Definitions

2        (1)    Words and phrases defined in the Pharmacy Act have the same meanings in these regulations.

 

          (2)    The definitions contained in the Pharmacy Act and Regulations Definitions Regulations made under the Act apply to these regulations unless the context otherwise requires.



Part 2: Registration and Licensing


Registrants

3        (1)    Registrants of the College are pharmacists, registered students, interns, pharmacy technicians and pharmacy technician candidates.

 

          (2)    Pharmacists may be classified as

 

                   (a)      practising direct patient care;

 

                   (b)     practising indirect patient care; or

 

                   (c)      non-practising.

 

          (3)    Pharmacy technicians may be classified as

 

                   (a)      practising direct patient care; or

 

                   (b)     non-practising.

 

          (4)    A pharmacist or pharmacy technician who is not registered to practise direct patient care shall not dispense drugs or practise direct patient care pharmacy.

 

          (5)    A pharmacist or pharmacy technician in good standing leaving the practice of pharmacy shall apply to the Registrar to resign or shall change classification to non-practising.

 

          (6)    A pharmacist or pharmacy technician who is non-practising may only describe themselves as a “pharmacist (non-practising)” or “pharmacy technician (non-practising)”.


Pharmacist candidate preceptors

4        (1)    A preceptor is responsible for the oversight of a registered student or intern engaged in practice experience, and must

 

                   (a)      provide reasonable instruction to the registered student or intern;

 

                   (b)     confirm to the Registrar that the registered student or intern completed a certain period of practice experience while under the preceptor’s oversight;

 

                   (c)      confirm to the Registrar that the registered student or intern completed the requirements of the period of practice experience undertaken under the preceptor’s oversight;

 

                   (d)     confirm to the Registrar that the registered student or intern met or failed to meet the requirements of the period of practice experience; and

 

                   (e)      confirm to the Registrar that the registered student or intern has satisfactory language skills and is a fit and proper person to practise pharmacy competently, safely and ethically.

 

          (2)    A preceptor must be a licensed pharmacist practising direct patient care in a Canadian jurisdiction.

 

          (3)    A preceptor must have been licensed to practise in Canada for at least one year.

 

          (4)    A preceptor must have no limitations on practice but need not have certification authorizing extended practice.

 

          (5)    A preceptor’s right to be a preceptor must not have been revoked or suspended.

 

          (6)    A preceptor is required to ensure that any intern or registered student engaged in practice experience has the level of personal supervision or direction, 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.


Pharmacy technician candidate preceptors

5        (1)    A preceptor for a pharmacy technician candidate is responsible for the oversight of a pharmacy technician candidate engaged in practice experience, and must

 

                   (a)      provide reasonable instruction to the pharmacy technician candidate;

 

                   (b)     confirm to the Registrar that the pharmacy technician candidate completed a certain period of practice experience while under the preceptor’s oversight;

 

                   (c)      confirm to the Registrar that the pharmacy technician candidate completed the requirements of the period of practice experience undertaken under the preceptor’s oversight;

 

                   (d)     confirm to the Registrar that the pharmacy technician candidate met or failed to meet the requirements of the period of practice experience; and

 

                   (e)      confirm to the Registrar that the pharmacy technician candidate has satisfactory language skills and is a fit and proper person to practise pharmacy competently, safely and ethically.

 

          (2)    A preceptor must be a licensed pharmacy technician practising direct patient care or a licensed pharmacist practising direct patient care in a Canadian jurisdiction.

 

          (3)    A preceptor must have been licensed to practise in Canada for at least one year.

 

          (4)    A preceptor must have no limitations on practice.

 

          (5)    A preceptor’s right to be a preceptor must not have been revoked or suspended.

 

          (6)    A preceptor is required to ensure that any pharmacy technician candidate engaged in practice experience has the level of personal supervision, 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 pharmacy technician candidate.


Time limits

6        (1)    A person who has graduated from an accredited degree program in pharmacy must qualify for and obtain a licence as a pharmacist within two years after the successful completion of all required parts of the examination to assess required professional competencies.

 

          (2)    A person who has graduated from an accredited pharmacy technician training program must qualify for and obtain a licence as a pharmacy technician within two years after the successful completion of all required parts of the examination to assess required professional competencies.

 

          (3)    The Council may, on application, extend the period in subsection (1) or subsection (2), subject to such conditions as the Council determines are appropriate.


Insurance coverage

7        (1)    Every pharmacist practising direct or indirect patient care, every pharmacy technician practising direct patient care, every pharmacy technician candidate, every intern and every registered student must obtain and maintain professional liability insurance in an amount not less than $2,000,000.00.

 

          (2)    The professional liability insurance policy must

 

                   (a)      be issued by an insurer authorized to conduct business in Nova Scotia;

 

                   (b)     be issued in the name of the individual insured;

 

                   (c)      apply to any practice setting in Nova Scotia;

 

                   (d)     have a policy limit of not less than $2,000,000 per claim or occurrence and an aggregate limit of not less than $2,000,000, excluding legal or court costs;

 

                   (e)      cover liability for any professional service the registrant may be authorized to provide under the Act;

 

                   (f)      allow an extended reporting period for at least three years in the case of a claims-based policy and have a minimum retroactive date of five years in the case of an occurrence-based policy;

 

                   (g)     have a maximum deductible of $5,000 per claim;

 

                   (h)     include a term to the effect that the insurer will notify the College if the policy is cancelled, expires or ceases to meet the requirements of this regulation; and

 

                   (i)      include a term to the effect that the policy continues in force in conformity with this regulation until the notice required by clause (h) is received by the College.

 

          (3)    Legal defence payments for regulatory proceedings or other legal proceedings shall not erode the minimum limit of liability required to be available to satisfy claims.

 

          (4)    The registrant must ensure that the Registrar is provided with the most current certificate of professional liability insurance from the registrant’s insurer that confirms that the registrant is insured and that the insurance complies with the regulations.


Classification of practice

8        (1)    A pharmacist must at all times be able to certify that the pharmacist has practised sufficient direct patient care pharmacy in the two previous years to maintain the competence to practise direct patient care pharmacy, if the pharmacist is to continue to be eligible to practise direct patient care pharmacy.

 

          (2)    A pharmacist practising direct patient care may change classification to indirect patient care or to non-practising by filing a notice to that effect with the College.

 

          (3)    A non-practising pharmacist or a pharmacist practising indirect patient care may change classification to direct patient care by complying with the requirements of the Registration, Licensing and Professional Accountability Regulations.

 

          (4)    A non-practising pharmacist may change classification to practising indirect patient care by filing a notice to that effect with the College and complying with the provisions of the Registration, Licensing and Professional Accountability Regulations.

 

          (5)    A pharmacy technician must at all times be able to certify that the pharmacy technician has practised sufficient direct patient care pharmacy as a pharmacy technician in the two previous years to maintain the competence to practise direct patient care pharmacy, if the pharmacy technician is to continue to be eligible to practise.

 

          (6)    A practising pharmacy technician may change classification to non-practising by filing a notice to that effect with the College.

 

          (7)    A non-practising pharmacy technician may change classification to practising by complying with the requirements of the Registration, Licensing and Professional Accountability Regulations.


Continuing education

9        (1)    Continuing education for a pharmacist, certified dispenser or pharmacy technician must be accredited by the Canadian Council for Continuing Education in Pharmacy or an equivalent body accepted by the Council, by Dalhousie University, or by another pharmacy regulatory authority.

 

          (2)    A pharmacist or pharmacy technician transferring from another jurisdiction in Canada may apply to the Registrar for credit for any continuing education completed in the other jurisdiction, and the Registrar will allow credit for any continuing education credits that meet the criteria established for continuing education in the other jurisdiction.



Part 3: Pharmacy Technicians


Delegation to technician

10      A pharmacist may delegate to a pharmacy technician the responsibility to check prescriptions prepared for release for technical accuracy and compliance with the Act, the regulations and the standards of practice and confirm the accuracy and completeness of compounds prepared for release, provided the pharmacist

 

                   (a)      evaluates the prescription;

 

                   (b)     assesses the patient and the patient’s health history and medication record;

 

                   (c)      determines that the proposed therapy is appropriate for the patient;

 

                   (d)     fulfills the pharmacist’s responsibilities to counsel the patient and to monitor the patient’s drug therapy;

 

                   (e)      complies with any conditions prescribed by an enactment or the standards of practice; and

 

                   (f)      is satisfied that the delegation is appropriate.



Part 4: Pharmacy Practice


Dispensing

11      (1)    A drug shall not be dispensed unless a pharmacist or certified dispenser is satisfied that the drug therapy is appropriate and that the patient has sufficient information for the safe and effective use of that drug by that patient.

 

          (2)    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 insurance 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,

 

but 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.

 

          (4)    All steps in the dispensing process must occur within the pharmacy from which a prescription is released unless otherwise provided in the standards of practice.


Assessment of drug therapy

12      (1)    A pharmacist or certified dispenser must communicate, directly or indirectly, with a patient to assess the patient and to obtain sufficient information to determine if a proposed drug therapy is appropriate.

 

          (2)    The pharmacist or certified dispenser is responsible for the appropriateness of drug therapy for a patient.

 

          (3)    A pharmacist or certified dispenser must communicate with the patient’s primary health care provider if the pharmacist or certified dispenser determines the drug therapy may not be appropriate.


Counselling

13      (1)    A pharmacist or certified dispenser must provide counselling to a patient before releasing the first fill of each prescription to the patient to ensure that the patient has sufficient information for the safe and effective use of that particular drug by that individual patient.

 

          (2)    Patient counselling must involve an exchange of information with the patient.

 

          (3)    When a pharmacist or certified dispenser counsels a patient, the dialogue shall be in person unless it is not practicable for the patient.

 

          (4)    Patient counselling must respect the patient’s right to confidentiality.

 

Monitoring          

14      (1)    A pharmacist or certified dispenser is responsible for monitoring the ongoing appropriateness of drug therapy, including refills.

 

          (2)    A pharmacist or certified dispenser must communicate with the patient as appropriate to ensure the drug therapy continues to be appropriate, including reviewing dosage regimen, adherence to prescription therapy, adherence to prescription instructions, efficacy and side effects.

 

          (3)    A pharmacist or certified dispenser must communicate with the patient’s primary health care provider if the pharmacist or certified dispenser determines the drug therapy may not be appropriate.


Prescriptions

15      (1)    Reasonable steps must be taken before dispensing a prescription to determine that an out-of-province prescriber is licensed to practise in Canada, and belongs to a class of persons who, if licensed in Nova Scotia, would be entitled by law to prescribe the drug or device in Nova Scotia.

 

          (2)    The creation of a written record of a prescription as set out in the Food and Drug Regulations (Canada) must be carried out before the prescription is dispensed.

 

          (3)    The person who receives a verbal prescription shall sign or initial it and date it.

 

          (4)    A verbal prescription shall be communicated directly from the person authorized to prescribe to a registrant authorized to receive a prescription, or may be obtained from a voice message recorded by the prescriber that is retrieved in a manner that protects patient confidentiality.

 

          (5)    A prescription transmitted electronically directly from the prescriber to the pharmacy may not be dispensed unless the registrant authorized to receive the prescription has verified the validity and authenticity of the prescription and its compliance with the requirements of the standards of practice respecting electronic prescriptions.

 

          (6)    When a prescription is first dispensed, the pharmacist responsible shall sign or initial and date the prescription, and any person involved in the dispensing must also sign or initial.

 

          (7)    If a prescription is not dated, the person dispensing shall verify the date and document the verified date on the prescription before dispensing it.

 

          (8)    Every time a prescription is refilled or part filled, a record to that effect shall be signed or initialled and dated by the pharmacist responsible and by any person involved in the dispensing.

 

          (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, any unused refill authorizations remaining on any previous prescription for that drug must be cancelled.


Product integrity

16      (1)    No registrant may dispense any previously dispensed product returned to the pharmacy except as provided by and in accordance with the standards of practice.

 

          (2)    Where the manufacturer of a drug or device directs that it be used within a specified period of time, or before a certain date, a registrant must not dispense or provide the product after the expiry date.

 

          (3)    Expired products must be removed from the general stock of drugs to be dispensed but must be kept in the pharmacy in a clearly marked secure product disposal area.

 

          (4)    A registrant must not dispense any products to which subsection (2) 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.

 

          (5)    A registrant must take reasonable steps to ensure the integrity of a drug or device at the time it is dispensed or provided, and its ongoing integrity during the period of use set out in the prescription.


Pharmacist not present

17      (1)    When

 

                   (a)      a pharmacist or certified dispenser is not present;

 

                   (b)     the pharmacy is closed; and

 

                   (c)      the pharmacy is part of a larger premises,

 

employees in the larger premises may

 

                   (d)     allow patients to pick up dispensed prescriptions that have been left in a secure and private location accessible to employees outside the pharmacy; and

 

                   (e)      receive deliveries 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 picked up according to subsection (1) unless

 

                   (a)      a patient has requested the pharmacist or certified dispenser to do so;

 

                   (b)     adequate steps are taken to protect the confidentiality of any information respecting the patient; and

 

                   (c)      adequate steps are taken to ensure the correct identification of the patient before releasing the prescription to the patient.

 

          (3)    Nothing in this Section reduces the obligations of a pharmacist or certified dispenser to counsel the patient or to monitor the ongoing appropriateness of the patient’s drug therapy.


Delegation of drug therapy by injection

17A   (1)    A pharmacist who is authorized to administer drug therapy by injection may delegate the authority to administer drug therapy by injection to a pharmacy technician, a pharmacy technician candidate, an intern or a student.

 

          (2)    The delegating pharmacist must ensure that the delegating pharmacist and the registrant to whom the authority to administer drug therapy by injection is delegated comply with all of the requirements of Section 6 of the Pharmacist Extended Practice Regulations.

 

          (3)    A registrant other than a pharmacist may only administer drug therapy by injection if

 

                   (a)      a pharmacist has delegated the authority to administer drug therapy by injection to the registrant; and

 

                   (b)     the registrant holds a valid permit to administer drug therapy by injection issued in accordance with the standards of practice.

 

          (4)    The registrant to whom the authority to administer drug therapy by injection is delegated must administer the drug therapy safely and appropriately in accordance with the standards of practice.

 

          (5)    The requirements for the issuance and renewal of a valid permit to administer drug therapy by injection for a pharmacist in Section 7 of the Pharmacist Extended Practice Regulations apply to all registrants to whom a valid permit to administer drug therapy is issued.


Delegation of tests and services

17B    (1)    A pharmacist who is authorized to order, receive, conduct and interpret tests and services needed to properly manage drug therapy may delegate the authority to conduct tests and services needed to properly manage drug therapy to a pharmacy technician, a pharmacy technician candidate, an intern or a student.

 

          (2)    The delegating pharmacist must ensure that the delegating pharmacist and the registrant to whom the authority to conduct tests and services needed to properly manage drug therapy is delegated comply with all of the requirements of Section 9 of the Pharmacist Extended Practice Regulations.

 

          (3)    The delegating pharmacist is responsible for ensuring that the test or service is in the best interests of the patient.

 

          (4)    A pharmacist must only delegate the authority to conduct tests and services needed to properly manage drug therapy to a registrant who has the knowledge and training to exercise the authority safely and in the best interests of the patient.

 

          (5)    The registrant to whom the authority to conduct tests and services needed to properly manage drug therapy is delegated must have and maintain the knowledge and training to conduct tests and services needed to properly manage drug therapy safely, appropriately and in accordance with the standards of practice.



Part 5: Pharmacies


Changes

18      (1)    A pharmacy manager or the pharmacy owner must advise the College in the form provided by the Registrar as soon as possible of any change

 

                   (a)      in the ownership of the pharmacy;

 

                   (b)     in the pharmacy manager;

 

                   (c)      in the operating name of the pharmacy;

 

                   (d)     in the corporate name of the owner;

 

                   (e)      in the location of the pharmacy; and

 

                   (f)      that will result in changes to the diagram submitted as part of the application for accreditation.

 

          (2)    A pharmacy must obtain a new certificate of accreditation if the ownership of the pharmacy changes.

 

          (3)    A pharmacy must obtain a new licence if:

 

                   (a)      the pharmacy manager changes;

 

                   (b)     the operating name or the corporate name of the owner changes; or

 

                   (c)      the location is changed.

 

          (4)    An alternate pharmacy manager must advise the College if the alternate pharmacy manager ceases to be qualified to be an alternate pharmacy manager or withdraws consent to be an alternate pharmacy manager.


Reinspection

19      A pharmacy must be reinspected at its own cost:

 

                   (a)      when a certificate of accreditation is issued after a change in ownership;

 

                   (b)     when a pharmacy changes its location; and

 

                   (c)      when changes are made to the pharmacy that result in changes to the diagram submitted as part of the application for accreditation.


Qualifications of pharmacy manager

20      (1)    A pharmacy manager must

 

                   (a)      be registered and licensed as a pharmacist in Nova Scotia practising direct patient care;

 

                   (b)     have been practising direct patient care pharmacy in Canada for a total of 12 months in the past five years;

 

                   (c)      practice pharmacy in that pharmacy location;

 

                   (d)     have no limitations on practice, but the person need not have certification authorizing extended practice; and

 

                   (e)      not be disqualified or suspended from acting as a pharmacist or as a pharmacy manager.

 

          (2)    An alternate pharmacy manager, emergency pharmacy manager and interim pharmacy manager must meet the requirements of clauses (a), (d) and (e) of subsection (1).

 

          (3)    A pharmacist shall not be the manager of more than one pharmacy at a time except as an alternate pharmacy manager, emergency pharmacy manager or interim pharmacy manager.


Responsibilities of the pharmacy manager

21      (1)    A pharmacy manager is responsible for the operation of the pharmacy in accordance with the principle of optimal patient care and adherence to the Act, the regulations and the standards of practice.

 

          (2)    The manager of a pharmacy is responsible for

 

                   (a)      the compliance by the pharmacy with the Act, the regulations and the standards of practice;

 

                   (b)     the day-to-day management of the pharmacy;

 

                   (c)      the development, maintenance and enforcement of policies and procedures to comply with the standards of practice, or otherwise required to ensure optimal patient care;

 

                   (d)     the development, maintenance and enforcement of a quality assurance program;

 

                   (e)      continuing quality improvement of the pharmacy;

 

                   (f)      ensuring that all staff members who present themselves as registrants are registered and licensed in Nova Scotia;

 

                   (g)     notifying the College of any changes in the registrants employed by the pharmacy;

 

                   (h)     notifying the College of any change in the ownership of the pharmacy and, in the case of a corporate owner, any change in the directors or registered agent of the corporate owner;

 

                   (i)      notifying the College of any changes in the pharmacy that would affect the information provided to the College in the application for accreditation or a renewal;

 

                   (j)      responding to any questions from the Registrar respecting the practice of pharmacy in the pharmacy;

 

                   (k)     advising the Registrar in writing of professional practice problems or conduct by any registrant employed in the pharmacy that could affect the health or safety of patients;

 

                   (l)      co-operating with any inspector appointed by the Council pursuant to the Act;

 

                   (m)    establishing a staffing plan commensurate with patient care requirements and taking reasonable steps to implement it;

 

                   (n)     implementing policies that set out the practice roles and responsibilities of all registrants, consistent with the Act, the regulations and the standards of practice;

 

                   (o)     implementing policies that set out the practice roles and responsibilities of all non-registrant dispensary employees, consistent with the Act, the regulations and the standards of practice;

 

                   (p)     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;

 

                   (q)     adopting, implementing and enforcing policies for the security of the pharmacy and the dispensary and for maintaining security and confidentiality of personal information;

 

                   (r)      ensuring that a patient record is prepared and maintained in accordance with the standards of practice for each patient for whom a drug is dispensed;

 

                   (s)      taking steps to ensure that all alerts, advisories and recalls respecting drugs and drug therapy are promptly implemented and are provided to all registrants employed by the pharmacy;

 

                   (t)      ensuring that information directed to the pharmacy pertaining to drugs, devices, diversion tactics and the practice of pharmacy is provided to all staff and that any registrant employed by the pharmacy is informed of its availability;

 

                   (u)     the adoption of policies for expired drugs and devices and for returned drugs;

 

                   (v)     ensuring that all drugs in the pharmacy are secure from loss, theft or diversion;

 

                   (w)    maintaining confidentiality with respect to all personal information;

 

                   (x)     posting and adhering to the hours of operation of the pharmacy; and

 

                   (y)     ensuring the correct and consistent use of the operating name of the pharmacy as it appears on the pharmacy licence for all pharmacy identification including labels and packaging.

 

          (3)    A pharmacy manager shall report to the College any information that calls into question the conduct, capacity, practice or professional competence of a registrant or the pharmacy, including

 

                   (a)      any breach of the Act;

 

                   (b)     any breach of the regulations; and

 

                   (c)      any breach of the standards of practice.


Quality assurance

22      (1)    Every pharmacy manager shall establish and maintain a continuous, documented quality assurance program according to the standards of practice that monitors staff performance; adequacy of staff levels; equipment and facilities; and adherence to standards of practice.

 

          (2)    The quality assurance program shall include a process for documenting, reporting and analyzing known, suspected, intercepted and corrected medication errors and discrepancies, and the steps taken to resolve the problems and prevent their recurrence.

 

          (3)    The quality assurance program must demonstrate how the analysis of known, suspected, intercepted and corrected medication errors and discrepancies and regular pharmacy self-assessment has been acted upon to improve the quality of patient care.

 

          (4)    The quality assurance program shall include provisions to protect the confidentiality of information relating to specific patients.


Persons permitted in dispensary and pharmacy

23      (1)    No person other than a registrant and a person specifically authorized by the pharmacy manager may be present in the dispensary.

 

          (2)    Any pharmacist working in the dispensary is responsible for any person in the dispensary.

 

          (3)    Anyone is permitted to be in the pharmacy when a pharmacist is present in the pharmacy unless prohibited by the pharmacy manager or a pharmacist who is present.

 

          (4)    Only a person specifically authorized by the pharmacy manager may be in the pharmacy when a pharmacist is not present in the pharmacy.

 

          (5)    The pharmacy manager is responsible for any person in the pharmacy.


Dispensary

24      (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 patients of the pharmacy, taking into account the nature of the patients and their particular needs.

 

          (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)      contain adequate stocks of drugs and devices to meet the needs of its patients;

 

                   (b)     have adequate shelf and storage space;

 

                   (c)      include a sink with hot and cold running water;

 

                   (d)     include a secure refrigerator for storing drugs;

 

                   (e)      in pharmacies that have not been issued a limited-service pharmacy licence, include a source of heat for compounding, an accurate prescription balance, and adequate equipment for compounding common dosage forms; and

 

                   (f)      in pharmacies that have been issued a limited-service pharmacy licence, include a source of heat for compounding, an accurate prescription balance and adequate equipment for compounding as necessary to adequately serve the pharmacy’s clientele.

 

          (5)    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.

 

          (6)    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 pharmacy services that meet the requirements of the standards of practice.

 

          (7)    The pharmacy must have unrestricted Internet access so as to permit pharmacy staff to effectively research questions related to patient care and to respond to patient inquiries, with effective security systems including firewalls to protect personal information.


Physical facilities

25      (1)    A pharmacy shall contain an area for patient consultation where counselling and the provision of drug information may take place without being overheard by others and which respects the privacy needs of every patient.

 

          (2)    A pharmacy shall be of sufficient size to allow for safe and proper storage of medications 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, adequately lit, adequately ventilated and maintained in a clean, sanitary and orderly condition.

 

          (4)    If the pharmacy is not physically separated from adjacent areas in the same premises by any means that ensures that no one has access to any scheduled drugs or patient information, the entire premises must be closed to the public when a pharmacist or certified dispenser is not present.

 

          (5)    The current pharmacy licence shall be displayed conspicuously in the pharmacy.

 

          (6)    The current licence of every registrant employed in the pharmacy and any permit for extended practice must be displayed in a conspicuous place in a pharmacy.

 

          (7)    Every employee of the pharmacy must wear a badge identifying whether the person is a pharmacist, certified dispenser, pharmacy technician, registered student, intern or other employee.


Security

26      (1)    Each pharmacist present 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)    Every pharmacist is responsible for the security and confidentiality of patient information.

 

          (3)    When the pharmacy is closed, the pharmacy premises must be secured to prevent and detect unauthorized entry.


Advertising

27      (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)    Advertising by registrants and pharmacies about pharmacy services must be directed to optimal patient care consistent with the standards of practice and the professional responsibilities of a pharmacist.

 

          (3)    A registrant or pharmacy may make information about the pharmacy staff or professional services available to the public, but advertising relating to pharmacy services:

 

                   (a)      shall not use any qualifying words such as professional, trusted, prompt, licensed, accurate, cheap, or words of similar meaning; and

 

                   (b)     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.

 

          (4)    A registrant 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”.

 

          (5)    A registrant or pharmacy may communicate factual and accurate information about pharmacy services 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)     misrepresents pharmaceutical knowledge or fact;

 

                   (c)      compares, directly or indirectly, the registrant’s or pharmacy’s service or ability with that of any other registrant or pharmacy, or promises more effective service or better results than those already obtained;

 

                   (d)     deprecates another registrant or pharmacy as to service, ability or fees;

 

                   (e)      creates an unjustified expectation about the results the registrant can achieve;

 

                   (f)      is made under any false or misleading guise, or takes advantage of the weakened physical or emotional state of a patient;

 

                   (g)     discloses personal information or identifies patients; or

 

                   (h)     contains anything that, because of its nature, cannot be verified.

 

          (6)    A registrant or pharmacy shall not directly or indirectly advertise or promote Schedule I drugs.

 

          (7)    A registrant 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.

 

          (8)    A registrant or pharmacy may not offer inducements or bonus programs that are limited to new patients.


Closing a pharmacy

28      When a pharmacy ceases to provide pharmacy services to its patients or to the public it serves, the pharmacy manager must:

 

                   (a)      provide for the orderly continuation of patient care;

 

                   (b)     remove any signs and symbols related to the practice of pharmacy;

 

                   (c)      immediately remove and dispose of all drugs and devices according to law;

 

                   (d)     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;

 

                   (e)      provide for the preservation of all patient records according to law and the return of patient records to any patient that so requests; 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.


Provision of pharmacy services outside licensed pharmacy

29      A pharmacist who provides pharmacy services outside the jurisdiction of a licensed pharmacy must submit a completed annual registration form as supplied by the Registrar, describing the pharmacy services that will be provided and all related information.

 

 


 

Legislative History
Reference Tables

Pharmacy Practice Regulations

N.S. Reg. 258/2013

Pharmacy Act

Note:  The information in these tables does not form part of the regulations and is compiled by the Office of the Registrar of Regulations for reference only.

Source Law

The current consolidation of the Pharmacy Practice Regulations made under the Pharmacy Act includes all of the following regulations:

N.S.
Regulation

In force
date*

How in force

Royal Gazette
Part II Issue

258/2013

Aug 6, 2013

date specified

Jul 26, 2013

15/2017

Mar 1, 2017

date specified

Feb 17, 2017

140/2020

Oct 5, 2020

date filed

Oct 23, 2020

98/2023

Jun 6, 2023

date filed

Jun 16, 2023

 

 

 

 

 

 

 

 

The following regulations are not yet in force and are not included in the current consolidation:

N.S.
Regulation

In force
date*

How in force

Royal Gazette
Part II Issue

 

 

 

 

 

 

 

 

 

 

 

 

*See subsection 3(6) of the Regulations Act for rules about in force dates of regulations.

Amendments by Provision

ad. = added
am. = amended

fc. = fee change
ra. = reassigned

rep. = repealed
rs. = repealed and substituted

Provision affected

How affected

3(1)...................................................

rs. 140/2020

6(1)-(2).............................................

am. 140/2020

7(1)...................................................

am. 140/2020

8(3)...................................................

am. 15/2017

8(4)...................................................

am. 15/2017

8(7)...................................................

am. 15/2017

11(4).................................................

ad. 98/2023

15(2) ................................................

rs. 15/2017

15(3) ................................................

rep. 15/2017

15(3) ................................................

ra. from 15(4) 15/2017

15(4) ................................................

am. and ra. as 15(3) 15/2017

15(4) ................................................

ra. from 15(5) 15/2017

15(5) ................................................

ra. as 15(4) 15/2017

15(5).................................................

ra. from 15(6) 15/2017

15(6).................................................

ra. as 15(5) 15/2017

15(6) ................................................

ra. from 15(7) 15/2017

15(7) ................................................

am. and ra. as 15(6) 15/2017

15(7).................................................

ra. from 15(8) 15/2017

15(8) ................................................

ra. as 15(7) 15/2017

15(8) ................................................

ra. from 15(9) 15/2017

15(9) ................................................

am. and ra. as 15(8) 15/2017

15(9).................................................

ra. from 15(10) 15/2017

15(10) ..............................................

ra. as 15(9) 15/2017

15(10)...............................................

ra. from 15(11) 15/2017

15(11)...............................................

ra. as 15(10) 15/2017

17A-B...............................................

ad. 140/2020

20(1)(b) ............................................

rs. 15/2017

29......................................................

ad. 98/2023

Note that changes to headings are not included in the above table.

Editorial Notes and Corrections

 

Note

Effective
date

1

The second instances of clauses 17(1)(a) and (b) of original text relettered as clauses 17(1)(d) and (e) for the purposes of this consolidation.

 

 

 

 

 

 

 

Repealed and Superseded

N.S.
Regulation

Title

In force
date

Repealed
date

 

 

 

 

Note:  Only regulations that are specifically repealed and replaced appear in this table.  It may not reflect the entire history of regulations on this subject matter.

 

 


Webpage last updated: 19-06-2023