Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 2 : Professional Standard for Services

2.31 Information relating to Compliance with Good Pharmacy Practice to be submitted in support of an Application for a Licence for Pharmacy Premises to be issued in terms of the Regulations relating to the Ownership and Licensing or Pharmacies published in terms of the Pharmacy Act 53 of 1974 as amended

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The following information must be submitted to Council as proof of compliance with Good Pharmacy Practice for purposes of recommendations made by Council to the National Department of Health for the issuing of a licence by the Director-General for a premises wherein or from which the business of a pharmacy shall be carried out in terms of the Pharmacy Act 53 of 1974 as amended:

 

2.31.1Supporting documentation

 

CRITERIA

Yes

No

1

A letter of appointment for the responsible pharmacist;

NB: No pharmacist maybe the, responsible pharmacist for more than one pharmacy

 

 

2

A letter of acceptance of the above appointment;

 

 

3

Copy of the site plan of the building indicating the location, of the pharmacy premises in relation to adjoining or surrounding businesses and access to and from the premises;

 

 

4

Copy of the professionally drawn floor plan indicating the actual layout of the pharmacy premises drawn to scale with exact measurements;

 

 

5

Signed affidavit regarding eligibility, ownership and compliance with standards (must be signed by sole proprietor, all partners of the partnership, all members of the Close Corporation, all shareholders of a Private Company and all Directors of a Public Company;

 

 

6

In case of a Close Corporation the latest CK2 as approved),

 

 

7

In case of a company a coy of the Certificate of Incorporation (Change of name if applicable) and the latest CM29;

 

 

8

If applicable, schedules from the auditors certifying the names of the directors and shareholders;

 

 

9

A bank guaranteed cheque or proof of payment of the licence application fee made payable to the SAPC.

 

 

 

2.31.2Floor plan

 

The following information must be clearly indicated in the submitted copy of the professionally drawn floor plan indicating the actual layout of the pharmacy premises drawn to scale with exact measurements:

 

 

CRITERIA

Yes

No

1

The size of the premises;

 

 

2

The size of the dispensary;

 

 

3

All entrances and exits of the pharmacy;

 

 

4

All entrances to the enclosed areas in the pharmacy e.g. admin office, manger's office, dispensary, kitchen, private area and consultation area;

 

 

5

A separate facility for washing hands;

 

 

6

A separate facility for compounding of extemporaneous preparations and cleaning of equipment;

 

 

7

Sufficient and adequate lighting;

 

 

8

A suitable waiting area;

 

 

9

A fridge for heat sensitive pharmaceuticals and vaccines;

 

 

10

A suitable separate private room for private consultation of patients;

 

 

11

 

A suitable consultation area for the provision of screening and monitoring tests, where applicable;

 

 

12

All Scheduled medicines to be stored/displayed inaccessible to the public;

 

 

13

A dispensing counter for prescriptions and pharmacist initiated prescriptions (OTC), with a suitable semi private area for each point where dispensing of medicine to the patient or the patient's agent/caregiver occurs; the dimensions of the dispensing counter and semi-private area are to be indicated on the floor plan and are to comply with the following requirements;

 

 

(i)

Height of partitioning of the semi-private area from floor - 1800 mm

 

 

(ii)

Dispensing point: 900mm deep by 1 000 mm wide

 

 

(iii)

400 mm from edge of the counter

 

 

NB:

If a counter for pharmacist initiated prescriptions (OTC) is separate from the prescription counter, the above criteria apply to both counters.

 

 

 

2.31.3Trading title(s)

 

The following criteria will be applied by Council in considering applications for the use of a title, trading title, name, description, brand name or logo (referred to as the 'name') used with respect to a community or an institutional pharmacy situated in a private or a public health facility in terms of section 35A(c) of the Pharmacy Act 53 of 1974. Council shall regard the use of following names as unacceptable—

 

 

CRITERIA

Yes

No

1

The use of the same or a similar name, including a name that sounds similar but is spelt differently, as that of another pharmacy if such pharmacies do not have the same owner;

 

 

2

Any name which is likely to be considered offensive;

 

 

3

A name that is calculated to suggest that the pharmacy in question is superior to another pharmacy or pharmacies;

 

 

4

A name which creates the impression that medicines are being sold at discounted prices;

 

 

5

A name which may be misleading to the public;

 

 

6

A name that is not associated with or does not belong to the pharmacy concerned;

 

 

7

A name that is calculated to suggest that the professional skills or ability or facilities for the rendering and supply of services which form part of the scope of practice of a pharmacist are superior or better than those of other pharmacies or pharmacists;

 

 

8

A name that is calculated to suggest that a pharmacy is associated with, belongs to or is in any way connected with a body corporate, firm or business, when not owned or part owned by that body corporate, firm or business;

 

 

9

Any name which is in contravention to the Pharmacy Act 53 of 1974.

 

 

 

2.31.4General

 

The application must be signed and sworn in the presence of a Commissioner of Oaths.