| (1) | An application for a licence referred to in section 22C(1)(a) of the Act shall be made to the Director-General for a— |
| (a) | licence to dispense; or |
| (b) | licence to compound and dispense, |
medicines in accordance with the relevant scope of practice of the applicant.
| (2) | An application referred to in subregulation (1) shall be accompanied by a prescribed application fee and contain at least the following information: |
| (a) | The name and both residential and business addresses (both physical and postal) of the applicant; |
| (b) | the exact location of the premises where dispensing, or compounding and dispensing will be carried out; |
| (d) | email address, if applicable; |
| (e) | fax number, if applicable; and |
| (f) | proof of registration with the relevant statutory health council. |
| (3) | The application referred to in subregulation (1) may be submitted before a relevant supplementary course as contemplated in section 22C of the Act is completed, but may only be finally approved upon proof being furnished that such a course has been successfully completed and all other requirements have been met. |
| (4) | A person referred to in subregulation (1) who has been issued with a licence shall— |
| (a) | keep a prescription book or permanent record as contemplated in regulation 35(1) relating to medicines dispensed, or compounded and dispensed for a period of 5 years from the date of sale; |
| (b) | ensure that the dispensary and any premises where medicines are kept are suitable for— |
| (ii) | compounding and dispensing, |
in accordance with good pharmacy practice as published in rules in terms of the Pharmacy Act;
| (c) | keep the medicines under the manufacturer's recommended storage conditions as specified on the medicines label and specified in the relevant professional information; |
| (d) | not repackage medicines at the premises unless authorised to do so in terms of regulation 39; |
| (e) | label medicines in terms of Regulation 10(6) where the reference number links to a patient record; |
| (f) | dispense medicines in accordance with a prescription which complies with regulation 33 and based on a diagnosis for a particular patient; |
| (g) | not keep expired medicines on the premises other than in a demarcated area in a sealed container clearly marked: EXPIRED MEDICINES and such expired medicines must be destroyed in terms of regulation 44; |
| (h) | secure the premises where the dispensing or compounding and dispensing is carried out whenever he or she is not physically present at those premises; |
| (i) | in the event of a recall of a medicine, comply with the terms of the recall of the medicine; |
| (j) | conspicuously display the licence in the premises referred to in paragraph(b); and |
| (k) | comply with the conditions of the licence. |
| (5) | A person who has been issued with a licence referred to in subregulation (1)(b) shall compound medicines— |
| (a) | only when the sale is preceded by a proper diagnosis and in accordance with a prescription which complies with regulation 33 for a particular patient; and |
| (b) | subject to regulation 3. |
| (6) | For the purposes of this regulation, "dispensing" or "compounding and dispensing" does not refer to a medicine requiring preparation for a once -off administration to a patient during a consultation. |
