4 Annual
certificate
5 Appeal
6 Limitation on
practice
7 Restricted
practitioner
8 Academic
practitioner
9 Pharmacy intern
10 Military
practitioner
11 Other classes
of members
12 Honorary and
honorary life members
13 Registration to
include photograph
14 Registers
15 Dispensing of
drug by prescription
16 Keeping records
17 Electronic
technology
18 Auxiliary
system
19 Packaging of
drug
20 Labelling of
drug
21 Complaint in
writing
22 Voluntary
withdrawals
23 Appeals
Committee
24 Costs
25 Adjournments by
Investigating Committee
26 Rehearing by
Investigating Committee
27 Practice review
28 Reinstatement
after non‑payment of fees, etc.
29 Reinstatement
following discipline
30 Notice of
findings
31 Costs
32 Advertising
33 Misleading
practices
34 Pharmacy licence
and pharmacy certificate
35 Declaration re
licensed pharmacy
36 Business hours
37 Operation
without licence or certificate
38 Suspension or
cancellation
39 Closure of
pharmacy
40 Absence of
pharmacist from pharmacy
41 Ineligibility
for pharmacy licence
42 Business
address
43 Professional
products department
44 Prescription
department
45 Requirements of
licensed and certified pharmacies
46 Certified
pharmacies
47 Development of
standards
48 Right to enter
pharmacy
49 Repeal
50 Coming into
force
Definitions
1 In this Regulation,
(a) “Act”
means the Pharmaceutical Profession Act;
(b) “premises”
means a building in which a pharmacy and any commercial enterprise that is
related to or associated with the pharmacy is located, but where the pharmacy
and the related or associated commercial enterprise are not the only occupants
of a building, means the part of the building in which the pharmacy and the
related or associated commercial enterprise are located.
Continuing education
2(1) In
this section, “continuing education committee” means the continuing education
committee established by the Council in accordance with the by‑laws.
(2) A
member may earn continuing education units by completing programs that are
approved by the continuing education committee.
(3) The continuing education committee
may assign up to one continuing education unit for each hour of a program
approved by it that is completed by a member.
Application for
registration as a pharmacist
3(1) A person may apply to the Registrar to be
registered as a pharmacist.
(2) An
application under subsection (1) must
(a) contain
the information prescribed by the Council, and
(b) be
made in person.
(3) An
application for registration as a pharmacist may not be approved by the Registration
Committee unless the applicant
(a) provides
proof to the Registration Committee that the applicant
(i) has complied with the requirements of section 13(a) to (d) of the
Act,
(ii) is of good character and reputation, and
(iii) is at least 18 years of age,
(b) provides
a statutory declaration stating that the applicant has not been convicted of an
indictable offence under the Criminal Code (Canada) or similar legislation
outside Canada or, if the applicant has been so convicted, evidence satisfactory
to the Registration Committee showing effective rehabilitation, and
(c) pays
the fees established under the by‑laws.
(4) An
applicant for registration as a pharmacist must have complied with section
13(a) of the Act within the one‑year period preceding the date of the
application.
(5) The
time period set out in subsection (4) does not apply if
(a) on
the date of the application, the applicant is registered
(i) in the register of non‑practising members, or
(ii) as a practising member in good standing of an association
governing the practice of pharmacy in a Canadian jurisdiction outside Alberta,
or
(b) the
applicant has met the requirements of section 13(a) of the Act, has not been
registered as a pharmacist and has, within the 2 years preceding the date of
the application,
(i) earned the number of continuing education units prescribed by the
Registration Committee or completed any refresher course prescribed by the
Registration Committee,
(ii) practised as a pharmacy intern in accordance with section 9, and
(iii) passed the internship examination administered by the Internship
Committee.
Annual certificate
4(1) A pharmacist may apply to the Registrar for an
annual certificate.
(2) The
Registrar may not issue an annual certificate unless the applicant has, in each
2‑year period following his initial registration, earned a minimum of 30
continuing education units.
Appeal
5(1) A person who is not satisfied with a decision
(a) of
the continuing education committee under section 2,
(b) of
the Registrar under section 4, or
(c) of
the Registration Committee under section 3(5)(b)(i)
may, by notice in
writing within 30 days of receiving notice of the decision, appeal the decision
to the Council.
(2) On
reviewing a decision under this section, the Council may confirm or vary the
decision.
(3) The
Council must forthwith notify
(a) the
applicant, and
(b) the
continuing education committee, the Registrar or the Registration Committee, as
the case may be,
of its decision.
Limitation on practice
6(1) For the purposes of section 2(4)(e) of the Act,
“under the direct supervision of a pharmacist” means that the pharmacist must
exercise direct authority over and assume responsibility for the practice of
pharmacy by the person.
(2) A
person, other than a restricted practitioner, who engages in the practice of
pharmacy under section 2(4)(e) of the Act is limited to performing the
following duties:
(a) processing
a prescription by
(i) transcribing information to a manual patient medication profile,
or
(ii) adding information to a computerized patient medication profile;
(b) generating
and affixing a prescription label;
(c) counting
and pouring drugs, including obtaining a drug from shelf stock;
(d) preparing
a prescription receipt;
(e) preparing
billings;
(f) physically
preparing compounded drugs;
(g) preparing
alternate drug delivery systems including, without limitation, IV additives and
total parenteral nutrition;
(h) repackaging
drugs;
(i) preparing
reports required by the Food and Drugs Act (Canada) and the Narcotic
Control Act (Canada) in respect of the drugs listed in Schedule 1 to the
Act;
(j) placing
and receiving orders for drugs, except drugs set out in the Schedule to the Narcotic
Control Act (Canada).
Restricted
practitioner
7 There shall be the following categories of restricted
practitioner:
(a) academic
practitioner;
(b) pharmacy
intern;
(c) military
practitioner.
Academic practitioner
8(1) A person may apply to the Registrar to be
registered as an academic practitioner.
(2) An
application under subsection (1) must
(a) contain
the information prescribed by the Council, and
(b) be
made in person.
(3) An
application under subsection (1) may not be approved by the Registration
Committee unless the applicant
(a) provides
proof to the Registration Committee that the applicant
(i) is an instructor at an approved faculty of pharmacy, and
(ii) possesses qualifications that, at the time they were awarded,
would have enabled the applicant to engage in the practice of pharmacy,
and
(b) pays
the fee established under the by‑laws.
(4) On
entering a person’s name in the register of restricted practitioners the
Registrar shall issue a certificate of status to that person.
(5) A
certificate of status expires
(a) when
the academic practitioner ceases to meet the requirements of subsection (3)(a),
or
(b) at
the end of June in each year,
whichever occurs
first.
(6) On
application, the Registrar shall renew the certificate of status of an academic
practitioner who
(a) continues
to meet the requirements of subsection (3)(a),
(b) meets
the continuing education requirements set out in subsection (7), and
(c) pays
the annual fee established under the by‑laws.
(7) An
academic practitioner must earn at least 30 continuing education units in each
2‑year period in which he is registered as an academic practitioner.
(8) An academic practitioner who holds a current
certificate of status may engage in the practice of pharmacy only to the extent
that is necessary to enable the practitioner to carry out duties as an
instructor at an approved faculty of pharmacy.
AR 322/94 s8;169/96
Pharmacy intern
9(1) In this section, “Committee” means the
Internship Committee appointed by the Council to administer the internship
program.
(2) A
person may apply to the Registrar to be registered as a pharmacy intern.
(3) An
application under subsection (2) must
(a) contain
the information prescribed by the Council, and
(b) be
made in person.
(4) An
application under subsection (2) may not be approved by the Registration
Committee unless the applicant
(a) is
a person who
(i) is currently registered in or within the previous 12 months has
graduated from an approved faculty of pharmacy,
(ii) has complied with the requirements of section 13(a)(i) and (ii)
of the Act but is ineligible for registration as a pharmacist because of
section 3(4) of this Regulation, or
(iii) has been directed by the Registration Committee under section
28(2)(c) to meet an internship requirement,
(b) provides
proof to the Registration Committee
(i) that the applicant is of good character and reputation,
(ii) that the applicant is at least 18 years of age,
(iii) that the applicant is a Canadian citizen, has been lawfully
admitted to Canada for permanent residence or resides in Canada temporarily
pursuant to an international agreement,
(iv) by means of a statutory declaration that the applicant has not
been convicted of an indictable offence under the Criminal Code (Canada)
or similar legislation outside Canada or, if the applicant has been so
convicted, establishes to the Registration Committee that the applicant has
been effectively rehabilitated,
(v) that the applicant is not and has not been suspended as a result
of professional misconduct by an association of persons governing the practice
of pharmacy in Canada or elsewhere, and
(vi) that English is the applicant’s first language, that the
applicant has graduated from a training program in pharmacy that was offered in
an English‑speaking institution or that the applicant is sufficiently
fluent in spoken and written English to carry on practice as a pharmacy intern,
and
(c) pays
the fee established under the by‑laws.
(5) Proof
by an applicant of a score of 250 or greater on the Test of Spoken English is
conclusive proof of sufficient fluency in spoken English for the purposes of
subsection (4)(b)(vi).
(6) The
period of internship
(a) for
an applicant referred to in subsection (4)(a)(i) shall be 500 practice hours,
or
(b) for
an applicant referred to in subsection (4)(a)(ii) or (iii) shall be set by the
Registration Committee but shall not exceed 500 practice hours.
(7) Notwithstanding
subsection (6) the Committee may, where it considers appropriate to do so,
(a) direct
a pharmacy intern to complete an extended period of internship, not to exceed
500 hours, where the pharmacy intern does not successfully pass the internship
examination administered by the Committee, and
(b) extend
the period of internship where a pharmacy intern referred to in subsection (4)(a)(i)
applies to the Committee to have the period of internship extended.
(8) Internships
may be undertaken
(a) in
a licensed pharmacy or a publicly funded pharmacy,
(b) in
a certified pharmacy with the approval of the Committee, or
(c) in
a facility approved by the Committee that is not a pharmacy but in which drug
research or other scientific or pharmaceutical activity in respect of drugs
takes place.
(9) During
a period of internship, a pharmacy intern must be assigned to a pharmacist who,
as the intern’s preceptor, must ensure that the intern is exposed to at least
the following areas of the practice of pharmacy:
(a) evaluation
of prescription drug orders;
(b) communication
with other health professionals;
(c) dispensing
of drugs;
(d) patient
medication profile update and review;
(e) drug
use review;
(f) patient
counselling;
(g) proper
and safe storage of drugs;
(h) any
other areas established by the Committee.
(10) Unless
authorized by the Council, a person is not eligible to be a preceptor under
this section if his right to practise has at any time been cancelled or
suspended in any jurisdiction for discipline reasons.
(11) A
preceptor must comply with the preceptor’s responsibilities as set out in the
internship manual published by the Association.
(12) Notwithstanding
subsection (8), an intern may, with the consent of the Committee, undertake an
internship under the supervision of a pharmacist registered in a jurisdiction
outside Alberta.
(13) The
Committee may not approve an internship under subsection (12) unless
(a) the
applicant clearly identifies the pharmacy where the internship is to be
completed by address and by provincial, territorial or state licensure number,
(b) a
practising pharmacist in good standing who is confirmed by the appropriate
provincial, territorial or state licensing body and is engaged in the practice
of pharmacy in the pharmacy referred to in clause (a) agrees to serve as a
preceptor for the applicant,
(c) the
preceptor submits to the Committee an outline of the curriculum to be followed
by the intern, and
(d) the
Committee is satisfied that the curriculum submitted by the preceptor meets the
requirements of an internship in Alberta.
(14) Where
an applicant has undertaken an internship in whole or in part in other than a
licensed pharmacy, or in a pharmacy in a jurisdiction outside Alberta, credit
for the internship may not be given until a report has been submitted by the
intern and co‑signed by the preceptor outlining the curriculum and hours
of actual participation completed by the intern.
(15) A
pharmacy intern who undertakes a period of internship in a jurisdiction outside
Alberta must comply with the rules governing the practice of pharmacy in that
jurisdiction.
(16) A
person who provides proof that he has, in a Canadian jurisdiction outside
Alberta while registered as a pharmacist in that jurisdiction, engaged in the
practice of pharmacy on a full‑time basis for one year immediately prior
to application for registration as a pharmacy intern must register as a
pharmacy intern but may be permitted to take the internship examination
administered by the Committee without serving a period of internship.
(17) The
Council may direct the Registrar to cancel the registration of a pharmacy
intern who ceases to be an undergraduate student in good standing at an
approved faculty of pharmacy.
(18) A
registration as a pharmacy intern terminates when the pharmacy intern has
served the period of internship required under subsection (6) or (7) and
successfully passes the internship examination administered by the Committee.
Military practitioner
10(1) A
person may apply to the Registrar to be registered as a military practitioner.
(2) An
application under subsection (1) must
(a) contain
the information prescribed by the Council, and
(b) be
made in person.
(3) An
application under subsection (1) may not be approved by the Registration
Committee unless the applicant
(a) provides
proof to the Registration Committee that the applicant
(i) is a member of the Canadian Armed Forces on full‑time
service, and
(ii) is a practising member of a pharmaceutical association or society
or college of pharmacy in Canada,
and
(b) pays
the fees established under the by‑laws.
(4) On
entering a person’s name in the register of military practitioners, the
Registrar shall issue a certificate of status to that person.
(5) A
certificate of status expires
(a) when
the military practitioner ceases to meet the requirements of subsection (3)(a),
or
(b) at
the end of June in each year,
whichever occurs
first.
(6) On
application, the Registrar shall renew the certificate of status of a military
practitioner who
(a) continues
to meet the requirements of subsection (3)(a),
(b) meets
the continuing education requirements set out in subsection (7), and
(c) pays
the annual fee established under the by‑laws.
(7) A
military practitioner must earn at least 30 continuing education units in each
2‑year period in which he is registered as a military practitioner.
(8) A military practitioner may engage in the
practice of pharmacy only to the extent that is necessary to enable the
practitioner to carry out duties as required by the Canadian Armed Forces.
AR 322/94 s10;169/96
Other classes of
members
11(1) A
pharmacist may apply to the Registrar to be registered as a non‑practising
member and the Registrar may approve the application if the applicant pays the
fee established under the by‑laws.
(2) A
member who is 55 years of age or older and has retired from the practice of
pharmacy may apply to the Registrar to be registered as a retired member and
the Registrar may approve the application if the applicant pays the fee
established under the by‑laws.
(3) A
person who is not qualified to be registered as a pharmacist but is interested
in the aims and objectives of the Association may apply to the Registrar to be
registered as an associate member and the Registrar may approve the application
if the applicant pays the fee established under the by‑laws.
(4) An
application under subsection (1), (2) or (3) must contain the information
prescribed by the Council.
(5) A
person registered under this section is entitled to attend and participate at
meetings of the Association and to receive the official newsletter of the
Association.
(6) A
person registered under this section is not entitled
(a) to
engage in the practice of pharmacy,
(b) to
hold any office in the Association, or
(c) to
vote on matters relating to the business and affairs of the Association.
Honorary and honorary
life members
12(1) The
Council may select as an honorary member a person who
(a) is
not and has never been a pharmacist, and
(b) has
rendered distinguished service to the pharmaceutical profession.
(2) The
Council may select as an honorary life member a person who
(a) is
or has been a pharmacist, and
(b) has
rendered distinguished service to the pharmaceutical profession.
(3) An
honorary member has the rights and privileges of a member referred to in
section 11.
(4) An
honorary life member has the rights and privileges of a member referred to in
section 11 and may vote on matters relating to the business and affairs of the
Association.
(5) No
registration fees are payable in respect of an honorary member or honorary life
member.
Registration to
include photograph
13 The registration of an applicant under this Regulation must
include the taking of a photograph of the applicant for inclusion in the
applicant’s file.
Registers
14(1) The
Registrar shall establish the registers referred to in section 11(1) of the
Act.
(2) Each
register must contain
(a) the
registrant’s name and business address, and
(b) any
other information that the Council determines should be entered in the
register.
(3) A
person whose name is registered in a register must inform the Registrar forthwith
in writing of any change in the person’s business address.
(4) The
Registrar must keep the registers current.
(5) The
Registrar may not remove or re‑enter a name or memorandum in a register
except on the direction of the Council.
Dispensing of drug by
prescription
15(1) A
pharmacist who dispenses a drug pursuant to a prescription must ensure that the
drug is dispensed in accordance with the directions of the prescriber.
(2) No
pharmacist shall dispense a drug pursuant to a prescription unless he has
determined, directly or through consultation, that the prescription is
authentic, accurate, complete and appropriate.
(3) A
pharmacist shall maintain patient medication profiles as required by the
standards of practice established under section 90 of the Act.
(4) If
a pharmacist has reason to believe that a drug that has been prescribed is not
appropriate for the patient, the pharmacist may not dispense the drug without
consulting the prescriber, and even after such consultation may refuse to dispense
the drug where the pharmacist considers that the drug is not appropriate for
the patient.
(5) A
pharmacist who dispenses a drug pursuant to a prescription must evaluate the
patient’s medication profile and must, orally or in writing, counsel the patient
or the patient’s agent appropriately with respect to the use of the drug, or be
satisfied that the patient or the patient’s agent has already been so
counselled.
(6) A
pharmacist who dispenses a drug must ensure that a record containing the
following information is created for each transaction:
(a) the
name of the patient for whom the drug was prescribed;
(b) the
name of the prescriber of the drug;
(c) the
date the drug was dispensed;
(d) the
name, strength and dosage form of the drug dispensed;
(e) the
DIN of the drug dispensed;
(f) the
quantity of the drug dispensed;
(g) a
unique prescription number;
(h) the
name of the dispensing pharmacist;
(i) the
price of the prescription, if applicable;
(j) any
other information required in the standards of practice referred to in section
47.
(7) A
pharmacist referred to in subsection (6) shall create a paper copy of a record
referred to in subsection (6) for each prescription the pharmacist receives,
and shall put his handwritten initials on each record.
(8) The
licensee and proprietor of a licensed pharmacy shall ensure
(a) that
the records referred to in subsection (6) are kept in an electronic storage
system in accordance with section 17, and
(b) generally that records that are required to
be kept by this Regulation, including records that are stored electronically,
are kept in a form and manner that is acceptable to the Council.
AR 322/94 s15;251/2001
Keeping records
16 The licensee and proprietor of a licensed
pharmacy shall ensure that the records referred to in section 15(6) and (7) are
kept for at least 2 years after the last change to any information in the
record occurs.
Electronic technology
17(1) The
licensee and the proprietor of a licensed pharmacy shall ensure that the
licensed pharmacy is equipped with an electronic storage system that complies
with this section and that the electronic storage system is maintained in
accordance with this section.
(2) An
electronic prescription system that is part of an electronic storage system must
meet the following requirements:
(a) it
must incorporate a security system that ensures that only persons who are
authorized by the licensee have access to the system and that creates an
accurate audit trail of persons using the electronic prescription system;
(b) it
must be designed so as to require a deliberate procedure to be carried out by
the licensee or a person under the direct supervision of a pharmacist before
any information can be purged from the system;
(c) it
must be capable of providing information in a form that is acceptable to the
Council;
(d) it
must be capable of storing and reporting the information referred to in section
15(6);
(e) it
must be capable of collating and generating reports of prescription information
chronologically and by drug name and strength, patient name and prescriber
name.
(3) Electronically
stored data must
(a) be
backed up at least daily,
(b) be
stored safely,
(c) be
stored so that it is retrievable in the event that the system malfunctions, and
(d) be
stored and handled so that patient confidentiality is maintained.
Auxiliary system
18 A licensed pharmacy must be equipped with
an auxiliary record keeping system acceptable to the Registrar, and that system
must be used when the electronic storage system is not operating.
Packaging of drug
19(1) In
this section, “child resistant package” means a container for a drug that meets
the requirements for a child resistant package under Part C of the Food and Drug Regulations, C.R.C.,
chapter 870.
(2) A
pharmacist who dispenses a drug pursuant to a prescription must provide the
drug in a child‑resistant package.
(3)
Subsection (2) does not apply if
(a) the
prescriber or the person who presents the prescription to a pharmacist directs
otherwise,
(b) in
the professional judgment of the pharmacist, it is advisable not to use a child‑resistant
package,
(c) a
child‑resistant package is not suitable because of the physical form of
the drug, or
(d) the pharmacist is unable to obtain a child‑resistant
package because supplies of those packages are not reasonably available.
AR 322/94 s19;138/98
Labelling of drug
20(1) A pharmacist who dispenses a drug must ensure
that the label affixed to the drug container is legible and explicitly
identifies the following:
(a) the
name, address and telephone number of the pharmacy;
(b) the
name of the patient for whom the drug was dispensed;
(c) the
name of the prescriber of the drug;
(d) the
name, strength and dosage form of the drug;
(e) instructions
for the use of the drug;
(f) the
dispensing pharmacist;
(g) a
unique prescription number;
(h) the
date the drug was dispensed;
(i) any
other information required by the standards of practice referred to in section
47.
(2) Notwithstanding
subsection (1),
(a) if
a label referred to in subsection (1) cannot be affixed to a drug container,
the pharmacist shall ensure that the container has a label with the patient’s
name, the name of the drug and the drug strength on it, that the container is
put into another package and that the label referred to in subsection (1) is
affixed to the package, and
(b) if
a drug is dispensed as part of an official scientific or medical investigation,
the drug container may be labelled in a manner appropriate to the investigation
as long as the label ensures that the contents can be identified in an
emergency.
(3) Where
the by‑laws prescribe a standard form of label for the purposes of
subsection (1), the pharmacist must use that label.
Complaint in writing
21 The Registrar may require a complaint under
section 48 of the Act to be in writing and signed by the complainant.
Voluntary withdrawals
22(1) In the event that a member wishes to submit a
voluntary withdrawal under section 51(1)(b) of the Act, the Infringement
Committee may require the member to attend before it to answer questions as to
the basis for the voluntary withdrawal so that the Infringement Committee can
determine what directions, if any, to make regarding counselling or treatment
under section 52 of the Act.
(2) A
member whose voluntary withdrawal has been accepted by the Infringement
Committee, may make application in writing to the Infringement Committee
requesting that he be permitted to resume practice, and must specify in the
application the basis for the request and the facts supporting it.
(3) The
Infringement Committee may, in determining an application under subsection (2),
and generally for the purposes of section 52(2) of the Act, require the member
to appear before it to answer questions regarding the member’s resumption of
practice.
(4) The
Infringement Committee must give the member at least 7 days’ notice of the date
on which the member is to attend before the Committee under subsection (1) or
(3).
(5) The
member and the Association may be represented by counsel at a hearing under
subsection (1) or (3).
Appeals Committee
23(1) The Appeals Committee under section 53(1) of
the Act, in considering an appeal under 54(1) of the Act,
(a) must
review the preliminary investigation report and any written arguments or documentation
provided by the complainant or investigated person,
(b) may
request additional information or documentation from the complainant or
investigated person, and
(c) may
request that the complainant or the investigated person appear before the
Committee.
(2) The
Appeals Committee must give at least 15 days’ notice of the appearance date
where it makes a request under subsection (1)(c).
(3) If
a complainant fails to comply with a request of the Appeals Committee under
subsection (1)(b) or (c), the Appeals Committee shall dismiss the appeal.
Costs
24(1) If the Appeals Committee intends to make an
order for costs under section 54(4) of the Act, it must serve the complainant
with a notice setting out the particulars of the costs.
(2) A
complainant who is served with a notice under subsection (1) may contest
(a) the
making of the order for costs, or
(b) the
particulars or amount of the costs,
by serving a written
submission on the Association’s office not later than 30 days after receiving
the notice under subsection (1).
(3) The
Appeals Committee must consider the submissions made under subsection (2), if
any, before making a final order under section 54(4) of the Act.
Adjournments by
Investigating Committee
25(1) The Investigating Committee, on notice to the
member, may adjourn any hearing of the Committee from time to time, whether or
not the hearing has been commenced, and on such terms as it may direct.
(2) Prior
to the commencement of a hearing or the resumption of an adjourned hearing, the
Chair of the Investigating Committee may, on the written application of the
investigated person or the Association made no later than 7 days before the
scheduled date of the hearing or resumption, adjourn the hearing for a period
not exceeding 60 days.
Rehearing by
Investigating Committee
26 An investigated person or the Association
may apply for a rehearing under section 72 of the Act by serving a written
notice on the Registrar that sets out
(a) the
decision in respect of which a rehearing is sought,
(b) the
grounds for the request for the rehearing, and
(c) a
summary of the new evidence the person wishes to put before the Committee.
Practice review
27(1) The Practice Review Committee must conduct a
review of the practice of a member on being requested to do so by an
Investigating Committee or by the Council.
(2) The
Practice Review Committee must give reasonable notice to the member and the
member’s employer, if any, of the Committee’s intention to conduct a review of
the practice of the member.
(3) The
Practice Review Committee or a person authorized by it may, on reasonable
notice, at a reasonable time and on communicating to the member the purpose and
authority for the entry, enter any premises where a member carries out the
practice of pharmacy, other than a private dwelling, for the purpose of
carrying out its duties under the Act and this Regulation.
(4) The
Practice Review Committee or a person authorized by it may require a member to
provide to the Committee any records or copies of records in the member’s
possession or under the member’s control that relate to the review and may
require the attendance of the member during the review.
(5) The
Practice Review Committee or authorized person may make copies of the records
and must return the records to the member who provided them within a reasonable
time after removing them.
(6) The
Practice Review Committee, while conducting a review of the practice of a
member, may review any other matter related to the practice of the member that
arises in the course of the review.
Reinstatement after
non-payment of fees, etc.
28(1) A person
(a) whose
certificate of registration, annual certificate, pharmacy licence or pharmacy
certificate has been suspended for failure to pay annual fees, penalties or
costs or any other fees, dues or levies payable under the Act, this Regulation
or the by‑laws,
(b) whose
certificate of registration, annual certificate, pharmacy licence or pharmacy
certificate was cancelled at his request,
(c) whose
certificate of registration, annual certificate, pharmacy licence or pharmacy
certificate was suspended for failure to acquire the minimum number of
continuing education units prescribed in this Regulation, or
(d) who
is registered as a non‑practising or retired member
may apply to the
Registrar to be reinstated in the appropriate register.
(2) No
person shall be reinstated under subsection (1) until the person has
(a) paid
(i) the arrears of the fees, penalties, costs, dues or levies,
(ii) the reinstatement fee established under the by‑laws, and
(iii) the penalty established under the by‑laws,
(b) provided
to the Registrar a statutory declaration stating that he has not knowingly
engaged in the exclusive scope areas of the practice of pharmacy in Alberta
during the period of suspension or non‑registration or while registered
as a non‑practising or retired member, as the case may be, and
(c) met
any other requirements prescribed by the Registration Committee relating to
internship or continuing education.
Reinstatement following
discipline
29(1) A person whose certificate of registration,
annual certificate, pharmacy licence or pharmacy certificate has been cancelled
under Part 7 of the Act may apply in writing to the Council for an order
reinstating the certificate, annual certificate, pharmacy licence or annual
certificate.
(2) The
application must set out the grounds on which reinstatement is sought.
(3) The
Council may establish a Committee of Inquiry consisting of not fewer than 3
members of the Council to consider the application and make recommendations to
the Council.
(4) The
following applies to an inquiry by the Council or a Committee of Inquiry:
(a) the
applicant must appear before the Council or Committee at the time and place set
by the Council or Committee;
(b) any
person may appear before the Council or Committee to show cause why the
applicant should not be granted reinstatement;
(c) the
applicant and the Association may be represented by counsel and may give
evidence and present any evidence that the Council or Committee considers
relevant;
(d) the
Council or Committee is not bound by the rules of law concerning evidence
applicable to judicial proceedings, but may proceed to ascertain the facts in
any manner it considers appropriate.
(5) Where
a Committee of Inquiry is established, it must file a report in writing with
the Registrar stating whether or not, in its opinion, the registration of the
applicant should be reinstated and recommending any conditions that should be
imposed on the reinstatement.
(6) The
Registrar must provide copies of the report to the Council and the applicant.
(7) The
Council must consider the report of the Committee of Inquiry
(a) at
the next regular meeting of the Council, or
(b) before
the expiry of 4 months after the report is received by the Registrar,
whichever occurs
first.
(8) After
considering the report of the Committee of Inquiry or conducting its own
inquiry, as the case may be, the Council may reinstate the registration of the
applicant subject to any terms and conditions it considers appropriate.
(9) No
person shall be reinstated under this section until the person has
(a) paid
(i) any arrears of fees, penalties, costs, dues or levies,
(ii) the reinstatement fee established under the by‑laws, and
(iii) the penalty established under the by‑laws,
and
(b) provided
to the Registrar a statutory declaration stating that he has not knowingly
engaged in the exclusive scope areas of the practice of pharmacy in Alberta
during the period of suspension.
(10) The
Registrar must notify the applicant of the Council’s decision forthwith.
Notice of findings
30 If an Investigating Committee or the Council finds that the
conduct of an investigated person constitutes unskilled practice of pharmacy,
professional misconduct or proprietary misconduct pursuant to Part 7 of the
Act, the Registrar, after any appeal or right to appeal has expired,
(a) shall
promptly give a notice of the findings
(i) to the investigated person’s employer, if any, and
(ii) to any other person who requests it,
(b) shall
promptly publish notice of the findings to the members, unless the
Investigating Committee or the Council directs otherwise, and
(c) may
give a notice of the findings to any other person the Registrar considers
should receive the notice.
Costs
31 If an Investigating Committee, the
Council or the Appeals Committee orders a member, proprietor or complainant to
pay the costs of an investigation or appeal, the Registrar must, as soon as
possible after the hearing or the appeal and in accordance with the
instructions of the Investigating Committee, the Council or the Appeals
Committee, compute the expenses incurred in connection with the proceedings,
which must include the following:
(a) the
expenses of the members of the Investigating Committee or the Appeals
Committee;
(b) the
cost of transcripts;
(c) witness
fees;
(d) the
fee of the lawyer acting on behalf of the Association;
(e) any
other expenses incurred by the Association incidental to or prerequisite to the
proceedings.
Advertising
32(1) No pharmacist or proprietor may hold himself
out as a representative of the Association without prior authorization from the
President of the Association or from the Council, and a pharmacist’s or
proprietor’s personal statements, comments and opinions about matters of
interest to the Association must be clearly identified as personal.
(2) No
pharmacist or proprietor may be a party to any arrangement or agreement with a
manufacturer or other supplier of drugs or medicines for the purpose of
promoting the sale and use of prescription drugs or drugs listed in Schedule 2
of the Act in a manner that may exploit a patient.
(3) No
pharmacist or proprietor may supply or permit any other person to supply to a
prescriber prescription blanks which bear either the name or address of the
pharmacist or proprietor or a pharmacy with which the pharmacist or proprietor
is associated or any message or slogan
calculated to identify any particular pharmacist, proprietor or pharmacy.
(4) No
pharmacist or proprietor may promote a pharmacist’s services or the services of
a pharmacy in a manner that encourages or may reasonably be perceived to
encourage the improper use of medications.
(5) No
pharmacist or proprietor may support the promotion or sale of objectionable or
unworthy products that are not conducive to maintaining the honour and dignity
of the profession or are not capable of providing the quality of care
reasonably expected of a pharmacist.
(6) A
pharmacist or proprietor may make information about himself or his pharmacy
services available to any person or the public generally, subject to the
following:
(a) the
advertising may use the following terms but may not use any qualifying words:
(i) pharmaceutical chemist, dispensing chemist or chemist;
(ii) dispensing druggist or druggist;
(iii) pharmacist or apothecary;
(iv) pharmacy or drugstore;
(v) drug dispensary or pharmaceutical dispensary;
(vi) prescription service;
(b) the
advertising may not use the words “specialist” or “expert” or other similar
expressions unless the person to whom the advertising relates possesses a
specialization granted pursuant to a program approved by the Council.
(7) No
pharmacist or proprietor may engage in advertising that
(a) is
not in good taste,
(b) is
inaccurate or is otherwise capable of misleading the public,
(c) misrepresents
pharmaceutical knowledge or fact,
(d) compares,
directly or indirectly, the pharmacist’s or pharmacy’s services 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 or uses coercion, duress or
harassment,
(h) is
undignified or otherwise offensive so as to be incompatible with the best
interests of the public,
(i) tends
to lower the honour and dignity of the pharmaceutical profession generally, or
(j) discloses
the names or identities of patients without their informed consent.
(8) No
pharmacist or proprietor may give anything of value to another person for recommending
the pharmacist’s or pharmacy’s services.
(9) Subsection
(8) does not apply to the payment of the costs of advertising.
(10) The
licensee and the proprietor of a licensed pharmacy shall ensure that any sign
provided to the licensee or proprietor by the Association is posted in
accordance with the instructions of the Association.
(11) A
licensee and a proprietor must be able to produce a copy of any advertisement
the licensee or proprietor has published in the preceding 12‑month
period.
Misleading practices
33 No pharmacist or proprietor may label,
package, treat, process, sell or advertise any drug or medicine in a manner
that is false, misleading or deceptive or is likely to create an erroneous
impression regarding its character, value, quantity, composition, merit or
safety.
Pharmacy licence and
pharmacy certificate
34(1) An
initial application under section 19(1) of the Act must be made in person.
(2) An
application under section 19(1) of the Act subsequent to the initial
application must be in writing and must contain the information prescribed by
the Council.
(3) Unless it is previously suspended or cancelled,
a pharmacy licence or a pharmacy certificate remains in force until its expiry,
which is at the end of June in each year.
AR 322/94 s34;169/96
Declaration re
licensed pharmacy
35 A firm, partnership or person who intends
to open a new licensed pharmacy or who acquires an existing licensed pharmacy
must, not less than 30 days before the date of the opening or acquisition of
the pharmacy, provide to the Registrar a written declaration setting out
(a) the
name and address of the licensee,
(b) the
name and address of the firm, partnership or proprietor,
(c) the
names and addresses of the directors or partners, if applicable,
(d) the
proposed date of the opening or acquisition of the pharmacy,
(e) the
business address of the pharmacy, and
(f) any
other information required by the Council.
Business hours
36(1) A licensee must inform the Registrar, when
applying for a pharmacy licence or certificate, of the regular hours of
operation of the pharmacy in respect of which the application is made.
(2) The
licensee of a licensed or certified pharmacy shall
(a) inform
the Registrar of any change in the regular hours of operation of the pharmacy,
not less than 30 days before the change occurs,
(b) ensure
that the regular hours of operation of the pharmacy are posted at all public
entrances to the premises in which it is located, and
(c) ensure
that the pharmacy remains open during its regular hours of operation posted
under clause (b).
Operation without
licence or certificate
37 A pharmacy that has hired a pharmacist under section 24(1)
or 25(2) of the Act may continue to operate without a pharmacy licence or
pharmacy certificate, as the case may be, for not more than 30 days.
Suspension or
cancellation
38 On the suspension or cancellation of a pharmacy licence or
pharmacy certificate, a pharmacist hired under section 24(1) of the Act must
prepare an inventory, in triplicate, of drugs in the pharmacy and must
(a) retain
one copy for the pharmacist whose pharmacy licence or pharmacy certificate has
been suspended or cancelled,
(b) retain
one copy to be filed in the pharmacy, and
(c) provide
one copy to the Association.
Closure of pharmacy
39(1) If a licensed or certified pharmacy closes as a
result of a pharmacist not being hired under section 24(1) or 25(2) of the Act,
the proprietor or the proprietor’s agent or the other person in charge of the
affairs of the pharmacy must, within 5 working days,
(a) place
all drugs in the pharmacy in sealed containers and ensure that the containers
remain sealed until a new pharmacy licence or pharmacy certificate has been
issued and responsibility for the containers has been handed over to the new
licensee of the pharmacy, and
(b) advise
the Association in writing as to the disposition of the records of patients of
the pharmacy and the drugs in the pharmacy.
(2) When
a licensed or certified pharmacy closes permanently, the licensee, the proprietor
or the proprietor’s agent must arrange for the disposition of the drugs in the
pharmacy in a manner that complies with the Narcotic Control Act (Canada)
and the Food and Drugs Act (Canada).
(3) When
a licensed or certified pharmacy closes temporarily or permanently, the
licensee, the proprietor or the proprietor’s agent must advise the Association
in writing of the closure within 5 working days.
Absence of pharmacist
from pharmacy
40(1) The licensee of a licensed or certified
pharmacy must ensure that a pharmacist is in attendance at the pharmacy at all
times during the hours of operation of the pharmacy.
(2) Notwithstanding
subsection (1), a pharmacist may be away from the pharmacy for short periods if
(a) he
is accessible in person or by telephone and can return to the pharmacy
immediately,
(b) he
can ensure that the practice of pharmacy is not carried on in his absence by a
person who is not a pharmacist, and
(c) the
practice of pharmacy is not compromised by his absence.
Ineligibility for pharmacy
licence
41 The Registrar may not issue a pharmacy licence in respect
of a pharmacy that is intended to be operated in conjunction with or in a
premises that would, in the opinion of the Council, tend to lower the honour
and dignity of the pharmaceutical profession.
Business address
42 A proprietor and a licensee must maintain
a separate business address in Alberta for each pharmacy the proprietor or
licensee owns in Alberta and must inform the Registrar in writing of any change
in that address within 14 days after the change occurs.
Professional products
department
43(1) If a licensed pharmacy contains a professional
products department, the licensee must ensure that the professional products
department meets the requirements of this section.
(2) If
a licensed pharmacy contains a professional products department that does not
comprise at least 85% of the public area of the premises,
(a) the
professional products department must be identified by a sign reading
“Pharmacy”, “Professional Products” or “Professional Products Department”, and
(b) the
professional products department must be physically separated from the
remaining public area of the premises by the use of contrasting colours,
physical separation, elevated or lowered floors, canopies or other similar
devices.
(3) All
products in the professional products department must be labelled in accordance
with any drug information program approved by the Council.
(4) Only
the following health related products may be displayed for sale in the professional
products department:
(a) drugs
listed in Schedule 3 to the Act;
(b) substances
or combinations of substances not listed in Schedule 3 to the Act that bear a
Drug Identification Number (DIN);
(c) substances
or combinations of substances that bear a “GP” designation;
(d) medical
and surgical supplies and other health aids, including health monitoring
devices and diabetes supplies.
Prescription
department
44(1) The licensee and the proprietor of a licensed
pharmacy must ensure that the prescription department meets the requirements of
this section.
(2) The
prescription department must be comprised of
(a) a
dispensary, where drugs listed in Schedules 1 and 2 to the Act must be stored,
and
(b) a
patient services area, where drugs listed in Schedule 3 to the Act must be
stored.
(3) The
prescription department must have an area of at least 33 m2, at
least 18 m2 of which must be dispensary area.
(4) The
dispensary area of a prescription department must be equipped with the
following:
(a) a
counter with at least 1.5 m2 of continuous unrestricted work
area excluding the sink and receiving area;
(b) working
aisles that are not less than one metre wide;
(c) adequate
shelf and storage space;
(d) a
refrigerator or suitably controlled temperature area;
(e) a
lockable drug locker or cupboard;
(f) a
sink that is easily accessible to the prescription counter and that is equipped
with hot and cold running water;
(g) a
container for waste disposal;
(h) a
heat source for extemporaneous compounding;
(i) a
prescription indexing and filing system;
(j) a
patient medication profile recording system;
(k) a
private telephone line for pharmacy use only.
(5) The
Council may authorize a prescription department that does not meet the
requirements of subsection (3) if the applicant or licence holder can satisfy
the Council that
(a) it
is not reasonably practicable to meet those requirements,
(b) the
presence of a pharmacy with a prescription department that does not meet those
requirements is in the public interest, and
(c) the
fact that the prescription department does not meet those requirements will not
compromise the standards required under the Act for the practice of pharmacy.
(6) If
a licensed pharmacy is located in a premises over which the licensee does not
exercise complete control, the prescription department must be separated from
the remainder of the premises by a permanent or sliding wall that extends from
the floor to the ceiling or otherwise prevents access to the prescription
department and is suitable to the Registrar.
(7) Only
the health related products referred to in section 43(4) may be stored or
displayed for sale in the patient services area.
Requirements of
licensed and certified pharmacies
45(1) The licensee and the proprietor of a licensed
pharmacy and the licensee of a certified pharmacy must ensure that this section
is complied with.
(2) A
sign that indicates the presence of the pharmacy and is of a design and
dimensions acceptable to the Registrar must be posted at the pharmacy and on
the exterior of the premises in which the pharmacy is located.
(3) The
premises in which the pharmacy is located must
(a) be
kept in a clean and orderly condition,
(b) have
adequate lighting and ventilation and adequate humidity and temperature control,
(c) have
a quarantine area for the storage of drugs that are outdated, damaged,
deteriorated, misbranded or adulterated or that are in immediate or sealed
outer or secondary containers that have been opened,
(d) be
physically separate and clearly delineated from other parts of the building,
(e) be
equipped with
(i) a security system that will provide suitable protection against
theft or diversion that is facilitated or hidden by tampering with computers or
electronic records, and
(ii) an alarm system to detect entry after hours,
and
(f) be
accessible only to personnel approved by the licensee.
(4) The
purchasing or procurement of drugs for a licensed or certified pharmacy must be
carried out under the direction of a pharmacist.
(5) Licensed
pharmacies and certified pharmacies must contain sufficient drugs, equipment
and supplies to permit the efficient provision of effective pharmacy
services.
(6) Drugs
in licensed pharmacies and certified pharmacies must be stored and handled in a
safe and secure manner.
(7) A
facility in which drugs are stored, warehoused, handled, held, offered,
marketed or displayed must
(a) be
of suitable size and construction to facilitate proper operation, cleaning and
maintenance, and
(b) have
a lockable drug locker or cupboard.
(8) All
drugs must be stored at appropriate temperatures and under appropriate
conditions in accordance with the manufacturer’s requirements, as indicated on
the label of the drugs or in accordance with requirements in the current edition
of an official compendium.
(9) All
incoming and outgoing drug shipments must be visually examined to confirm the
identity of the drugs and to ensure that there has been no contamination or
damage to the drugs.
(10) Drugs
that are outdated, damaged, deteriorated, misbranded or adulterated, including
any drug whose immediate or sealed outer or sealed secondary containers have
been opened, must be quarantined and physically separated from other drugs
until they are destroyed or returned to their supplier.
(11) Licensed
pharmacies and certified pharmacies must contain current editions of the
pharmaceutical references prescribed by Council.
(12) Licensed
pharmacies and certified pharmacies must be equipped with the following
compounding and dispensing equipment:
(a) a
prescription balance with a sensitivity reciprocal or accuracy of 200 mg
or less;
(b) 10 mg
through to 50 g metric weights;
(c) at
least one each of 10 ml, 50 ml, 150 ml, 250 ml and
500 ml metric graduates;
(d) a
small glass mortar and pestle that is between 50 ml and 100 ml in size and a
large glass mortar and pestle that is between 250 ml and 500 ml in size;
(e) at
least one each of a small, medium and large stainless steel spatula and at
least one non‑metal spatula;
(f) at
least one small glass or plastic funnel approximately 7.5 mm in diameter
and at least one large glass or plastic funnel approximately 15 mm in
diameter;
(g) at
least 2 glass or rubber stirring rods;
(h) an
ointment slab or parchment paper;
(i) a
counting tray;
(j) a
sufficient quantity and assortment of clear, amber and child resistant vials,
ointment jars, prescription bottles and caps;
(k) a
sufficient quantity of auxiliary prescription labels, filter papers, empty
capsules, distilled or deionized water and other consumable materials;
(l) a
typewriter or computer operated prescription labelling device;
(m) a
manual or computer operated prescription numbering device.
Certified pharmacies
46(1) The licensee of a certified pharmacy must
ensure that this section is complied with.
(2) A
certified pharmacy may distribute drugs or compounded preparations only to a
licensed pharmacy, another certified pharmacy or a publicly funded pharmacy.
(3) Where
a certified pharmacy is located in a repackaging facility or a compounding
centre, repackaged drugs must have attached to them a label showing the
following:
(a) the
name of the certified pharmacy repackaging the drugs;
(b) the
address and telephone number of the certified pharmacy repackaging the drugs;
(c) the
date of repackaging;
(d) the
drug name, strength and dosage form;
(e) the
manufacturer’s lot number or a unique pharmacy control number;
(f) the
expiry date of the drug;
(g) the
initials of the pharmacist performing or supervising the repackaging.
(4) Records
of all transactions regarding the receipt, storage and distribution or other
disposition of drugs must be kept, and such records must show the following
information:
(a) the
source of the drugs, including the name and principal addresses of the seller
or transferor and the address of the location from which the drugs were shipped
to the certified pharmacy;
(b) the
identity and quantity of the drugs received and distributed or disposed of;
(c) the
dates of receipt and distribution or other disposition of the drugs;
(d) the
name and address of the pharmacy to which the drugs were distributed or
disposed of and, where applicable, the name of the licensee of that pharmacy.
(5) Where
a certified pharmacy is engaged in repackaging drugs, records must be kept that
show the following information for each drug that is repackaged:
(a) the
name of the client or customer;
(b) the
drug name and strength;
(c) the
manufacturer’s name;
(d) the
date of repackaging;
(e) the
quantity repackaged;
(f) the
manufacturer’s lot number;
(g) the
manufacturer’s expiry date;
(h) the
initials or signature of the packaging personnel;
(i) the
initials or signature of the supervising pharmacist;
(j) the
date of verification.
(6) Information
in an inventory or record kept under subsection (4) or (5) must be kept for a
period of at least 2 years after the date the drug to which the information
relates was disposed of.
(7) Written
policies and procedures respecting the receipt, security, storage, inventory
and distribution of drugs must be established and must meet the following
requirements:
(a) provide
for the identification, recording and reporting of all losses or thefts of
drugs;
(b) provide
for the distribution of approved drug stocks on an “oldest” first basis unless
circumstances specifically warrant otherwise;
(c) provide
for the correction of errors or inaccuracies in inventories;
(d) implement
a system of address recalls and withdrawals of drugs pursuant to action
(i) by any department or agency of the Government of Canada or a
provincial government, a municipal police service or the Alberta Pharmaceutical
Association, or
(ii) by the manufacturer to promote public health and safety by
replacing existing merchandise with improved products or package design;
(e) implement
procedures to ensure security and operation of facilities during periods of
national, provincial or local emergency, including strikes and fires, floods
and other natural disasters;
(f) provide
for the segregation of all out‑dated drugs and their destruction or
return to the manufacturers.
Development of
standards
47(1) The Council must develop standards for the
practice of pharmacy respecting competency, ethical conduct and the application
of pharmaceutical knowledge and skills.
(2) Standards
of practice developed by the Council do not come into effect unless
(a) a
draft of the proposed standards with a proposed effective date has been
(i) published in or circulated with the official newsletter of the
Association, and
(ii) provided to the Minister,
(b) the
pharmacists have had at least 60 days from the date of publication of the
proposed standards to respond in writing to the Council regarding the
standards,
(c) the
Minister has had at least 60 days from the date he received the proposed
standards to respond in writing to the Council regarding the standards,
(d) the
Council, having reviewed and considered all comments, has prepared a final
draft of the standards that specifies the effective date, and
(e) a
copy of the final draft of the standards is
(i) published in or is circulated with the official newsletter of the
Association, and
(ii) provided to the Minister.
Right to enter
pharmacy
48(1) An inspector appointed under section 44 of the
Act or the Registrar may
(a) enter
any premises of a licensed or certified pharmacy, other than a private
dwelling, and inspect the land or premises for the purpose of ascertaining
whether the Act, this Regulation, the by‑laws and the standards of
practice referred to in section 47 are being complied with,
(b) demand
the production for examination of any records that are or may be relevant to
the purpose of the inspection, and
(c) on
giving a receipt for them, remove any records for the purpose of making copies
of them.
(2) A
person who removes any records under subsection (1) may make copies of the
records and must return the records to the premises from which they were
removed within a reasonable time after removing them.
(3) If
a person
(a) refuses
or fails to permit entry on any land or premises under subsection (1)(a) or,
after permitting entry, obstructs an inspector or the Registrar in the exercise
of authority under this section,
(b) refuses
or fails to comply with a demand under subsection (1)(b), or
(c) refuses
or fails to permit the removal of any records under subsection (1)(c),
the inspector or the
Registrar may apply to the Court of Queen’s Bench by originating notice for an
order under subsection (4).
(4) If,
on application under subsection (3), a judge is satisfied that there are
reasonable and probable grounds to believe that access to land or premises or
the production or removal of records is necessary for the purpose of
ascertaining whether the Act, this Regulation, the by‑laws or the
standards of practice referred to in section 47 are being complied with, the
judge may make any order he considers necessary to enforce compliance with this
section.
Repeal
49 The Rules, Regulations and By‑laws
of the Alberta Pharmaceutical Association (Alta. Reg. 453/65) are repealed.
Coming into force
50(1) This Regulation, except sections 15(8)(a), 17
and 44(2) and (3), comes into force on the date the Pharmaceutical
Profession Act comes into force.
(2) Sections
15(8)(a), 17 and 44(2) and (3) come into force on a date that is 2 years after
the date the Pharmaceutical Profession Act comes into force.
