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

Board Notices

Guideline for the Removal of Pharmacy registration/recording as a result of non-compliance with good pharmacy practice and other pharmacy legislation

2. Background

 

The South African Pharmacy Council (the Council) in terms of Section 35A of the Pharmacy Act, 53 of 1974 has the legislative mandate to control pharmacy practice within South Africa. In this regard the Council has published good pharmacy practice standards as contained in the Rules relating to good pharmacy practice (GPP). In doing so the Council requires that all responsible pharmacists, pharmacists, pharmacy support personnel and pharmacy owners ensure that the pharmaceutical services they provide are of the highest quality and comply with such good pharmacy practice standards.

 

The Council has, in terms of Section 38A of the Pharmacy Act, appointed inspection officers to inspect pharmacies for the purpose of monitoring compliance with GPP, the approval of pharmacy premises for the training of pharmacy support personnel and pharmacist interns and for purposes of investigation of complaints received alleging misconduct or unprofessional conduct.

 

Applications for pharmacy premises licences are made to the Director-General: Health (DG), in line with Section 22 of the Pharmacy Act. The Council conducts a desktop evaluation for compliance with GPP and then informs the DG whether the application is deemed to be compliant or non-compliant to GPP. It has been established that some pharmacies, at the first inspection after the recording of a new pharmacy licence, are non-compliant to critical non-negotiable questions and/or have critical GPP deficiencies. There are also pharmacies which continuously fail to comply with GPP and/or fail to comply with the requirement that, in terms of Section 22 of the Pharmacy Act, the pharmacy must have a registered responsible pharmacist and must be under the continuous supervision of a pharmacist.

 

In such cases the public is exposed to the risk of compromised, and/or poor-quality pharmaceutical services. It is the duty of the Council to protect, promote and maintain the health, safety and well-being of patients and the public and to ensure that where such services are compromised, such pharmacies are restricted from providing pharmaceutical services.