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

6. Criteria for the removal of the registration/recording of a pharmacy

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A pharmacy registration/recording may be removed from the register if any one or more of the following non-compliance to GPP or any relevant legislation is/are found:

 

(a) on the first inspection after the recording of a pharmacy (GPP, Annexure A, Rule 2.1.1):
(i) there is no pharmacist present in the pharmacy; or
(ii) there is no registered responsible pharmacist; or
(iii) there are critical GPP deficiencies resulting in a pharmacy being allocated Grade C score; or
(iv) the layout of the pharmacy is not in accordance with the floor plans and/or site plans as approved by Council and the actual layout is not compliant to GPP;

 

(b) the pharmacy has no registered responsible pharmacist for a period exceeding 3 (three) months;

 

(c) the pharmacy has obtained a Grade C score for more than two consecutive inspections;

 

(d) the pharmacy has been conducted without a pharmacist present (subject to Rule 2.1.1 of the GPP), which leaves pharmacy support personnel and/or unregistered persons to practice acts specifically relating to the scope of practice of a pharmacist without being a pharmacist, which is a criminal offence in terms of Section 29 of the Pharmacy Act;

 

(e) the pharmacy is operating from a facility/location without a valid licence;

 

(f) in terms of Regulation 8(4) and (5) of the Regulations relating to the ownership and licencing of pharmacies, a pharmacy licence has been issued by the DG, but such licence has not been recorded with the Council, and the pharmacy is operational;

 

(g) the pharmacy has failed to pay their annual fees for period exceeding 12 months; or

 

(h) the pharmacy has not been in operation for a period exceeding 6 (six) months, and the owner has failed to communicate the reason why the pharmacy is not operational to Council.