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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

General Regulations

Permits, Licensing and Authorisation

22. Licence to dispense or compound and dispense medicines

 

(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;
(c) telephone number;
(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—
(i) dispensing; or
(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.

 

 


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