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

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 1 : Professional Standard for Premises

1.4 Minimum Standards for Community or Institutional Pharmacies providing Pharmaceutical Services from a Mobile Unit

 

1.4.1 Purpose

 

The purpose of this standard is to regulate the provision of pharmaceutical services from a mobile unit.

 

1.4.2 General considerations

 

(a) Provision of pharmaceutical services from a mobile unit must be under the direct control of a registered or licenced and recorded pharmacy, which is continuously supervised by a responsible pharmacist.
(b) A community or institutional pharmacy that offers pharmaceutical services from a mobile unit must provide these services in accordance with all relevant legislation.
(c) For purposes of this rule 'mobile' shall mean capable of moving or readily being moved.

 

1.4.3 Pre-requisites for conducting pharmaceutical services from a mobile unit

 

(a) Mobile units, from which pharmaceutical services are offered, must be under the control of a registered or licensed and recorded pharmacy.
(b) Each mobile unit, from which pharmaceutical services are provided, must be operated by and be under the direct personal supervision of a pharmacist; alternatively, where provided in law, under the indirect supervision of a pharmacist
(c) A pharmacy may only provide pharmaceutical services from a mobile unit as approved by Council.
(d) Only medicine, medical devices, products and services permitted for sale or provision from a pharmacy, may be sold and or provided from a mobile unit.
(e) A pharmacy providing pharmaceutical services from a mobile unit must, on the request of Council provide the intended route and location where the service will be stationed (where applicable), to allow for ease of inspection of the facility, specifying the following:
(i) all the areas where the services will be delivered;
(ii) the period within which those services will be provided.
(f) Mobile units providing pharmaceutical services may not be used as a basis for objection or appeal to an application for a pharmacy license.

 

1.4.4 Mobile unit, facilities and equipment within the mobile unit

 

(a) The mobile unit must be:
(i) insulated with double side panels and ceiling; and
(ii) cross-ventilated.
(b) Working surfaces, cupboards, shelves and equipment in the mobile unit must comply with the same requirements as community and institutional pharmacies.
(c) Light conditions, temperature and humidity within the mobile unit must comply with the requirements for the storage of medicine, other pharmaceutical products, raw materials and packaging materials.
(d) Separate facilities for washing hands and the cleaning of equipment must be provided.
(e) A private area/facility for the collection of samples for screening tests, where appropriate, must be available.
(f) If supplementary services such as approved screening tests are provided, suitable facilities must be available.
(g) The working surface/space within the mobile unit must be large enough to allow at least two persons to perform dispensing functions or the provision of supplementary services under safe conditions.

 

[Rule 1.4 substituted by Board Notice 193, GG 40522, dated 23 December 2016]