Statistics Act, 1999
R 385
Pharmacy Act, 1974 (Act No. 53 of 1974)Board NoticesGuideline for the Removal of Pharmacy registration/recording as a result of non-compliance with good pharmacy practice and other pharmacy legislation6. Criteria for the removal of the registration/recording of a pharmacy |
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. |