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

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 1 : Professional Standard for Premises

1.1 Introduction
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The keeping, compounding, dispensing or supply of any medicine or scheduled substance by a pharmacist, pharmacist intern or pharmacist's assistant or the provision of services which form part of the scope of practice of a pharmacist, may only take place in or from a pharmacy if the pharmacy complies with minimum standards relating to premises, facilities and equipment and is duly licensed by the Department of Health and recorded in terms of the Pharmacy Act.

 

In adhering to minimum standards of good pharmacy practice it must also be taken into consideration that pharmacists are obliged to exercise proper and/or reasonable care in respect of and control over—

(a) the acquisition, storage, manufacture, dispensing, sale, supply or disposal of medicines, or of raw materials for the manufacture of medicines, for human or veterinary use;
(b) chemical and hazardous substances;
(c) access of the public to medicines and scheduled substances;
(d) the hygiene, cleanliness and neatness of a pharmacy;
(e) the appearance of a pharmacy.

 

Each section sets out minimum standards for premises, facilities and equipment for community, institutional, and mobile pharmacies as well as primary health care facilities, which must be met. Failure to meet the standards could form the basis of a complaint of misconduct and in some instances even the withdrawal of a licence to own a pharmacy in terms of the Pharmacy Act.

 

Manufacturing pharmacies, wholesale pharmacies and distributors must comply with standards as prescribed in the Guidance Document: Good Manufacturing Practice published by the Medicines Control Council (MCC) (GN R7659 of 2 May 2003) and Good Wholesale Practice for Wholesalers, Distributors and Bonded Warehouses (MCC 6 June 2003).

 

Good pharmacy practice standards for persons licensed to dispense in terms of the Medicines Act are provided in section 1.7 of this chapter.