REPUBLIC OF SOUTH AFRICA
Regulation Gazette No.7636 Vol 454 Pretoria 10 April 2003
GENERAL REGULATIONS IN TERMS OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT (101/1965), AS AMENDED
LICENCE TO COMPOUND AND DISPENSE MEDICINES
18. (1)As contemplated in section 22C(1) of the Act, a medical
practitioner, dentist or any other person registered
in terms of the Health Professions Act, 1974 (Act No. 56 of 1974), practitioner or nurse desiring to compound and dispense medicines shall apply to the Director-General for a licence to compound and dispense medicines.
(2) An application referred to in subregulation (1) shall be
accompanied by an application fee as determined by the Director- General
(3) The application shall contain at least the following information:
(i) the name and both residential and business addresses (both
physical and postal) of the applicant;
(ii) the exact location of the premises where compounding and/or
dispensing will be carried out;
(iii) proof of completion of a supplementary course contemplated
in section 22C(2) of the Act;[deleted] by amendment of 16 Oct 2003
[ Inserted ]
(iv) telephone and fax numbers of the applicant, where available;
(v) proof of registration with a statutory council;
(vi) proof of publication of the notice contemplated in subregulation (5);
(vii) motivation, as to the need for a licence in a particular
(viii) any other information that the Director-General may
(5) In considering an application referred to in subregulation (1), the
Director-General shall have regard to the following:
(a) the existence of other licensed health facilities in the vicinity
of the premises from where the compounding and dispensing of
medicines is intended to be carried out;
(b) representations, if any, by other interested persons as to whether a licence should be granted or not;
(c) the geographic area to be served by the applicant;
(d) the estimated number of health care users in the geographic area
referred to in paragraph (c);
(e) demographic considerations including disease patterns and health
status of the users to be served; and
(f) any other information that he or she deems necessary.
(6) At the same time when an application referred to in subregulation
(1) is made, the applicant must also give notice, as determined by the council, by publication in a newspaper circulating in the area where the applicant intends to conduct his or her practice of his or her intention to
apply for a licence.
(7) Any person may support or oppose an application referred to in
subregulation (1) by making written representations to the Director-General within 30 days of publication of the notice contemplated in subregulation (5).
(8) A person referred to in subregulation (1) who has been issued with
a licence shall:
(a) keep sales records either in hard copy or electronically relating
to medicines 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 compounding and dispensing in
accordance with good pharmacy practice;
(c) keep the medicines under the manufacturer's recommended storage
conditions as specified on the medicines label and or package insert;
(d) not pre-pack medicines at the premises unless authorised to do so
by the Director-General and in terms of regulation 33(a)(ii);
(e) label medicines properly with the name of the patient and a
reference number linking the patient to a patient record;
(f) not compound and dispense medicines to patients unless the sale is
preceded by proper diagnosis and prescribing for a particular
patient by the license holder;
(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 shall be destroyed in terms of
(h) secure the premises where the 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, withdraw the medicine;
(j) conspicuously display the licence in the premises
referred to in paragraph(b); and
(k) comply with the conditions of his or her licence.
(9)For the purposes of this regulation, "compounding and dispensing"
does not refer to a medicine ready for use or a medicine requiring
preparation for a once-off administration to a patient during a
PERIOD OF VALIDITY OF A LICENSE ISSUED IN TERMS OF REGULATIONS 18 AND 19 AND RENEWAL OF LICENCES
20.(1)A licence issued in terms of regulations 18 shall be valid for a period of 3 years whereas a licence issued in terms of regulations 19 shall be valid for a period of 5 years from the date of issue.
(2) A licence referred to in subregulation (1) and which has expired
may be renewed upon application to the Director-General or the Council, as the case may be.
(3) An application referred to in subregulation (2) shall -
(a) contain at least the information referred to in regulations 18(3)
and 19(3), as the case may be;
(b) be accompanied by a fee as prescribed in terms of Regulations Relating to Fees Payable to the Registrar; and
(c) be made 90 days before the expiry of the existing licence.
APPEAL AGAINST THE DECISION OF THE DIRECTOR-GENERAL OR THE COUNCIL
21.(1) An appeal in terms of Section 24(1) of the Act shall be lodged
within  30 days from the date on which the decision appealed against was communicated to the appellant.
(2) In noting the appeal, the appellant shall send a notice by
registered mail to the Minister and-
(a) in the case of a decision of the Council, to the Registrar of
Medicines, Medicines Control Council, Private Bag X828, Pretoria,
(b) in the case of a decision of the Director-General, to the
Director-General, Department of Health, Private Bag X828, Pretoria, 0001, stating the decision appealed against.
(3)The notice referred to in sub-regulation (2) shall set out clearly
and succinctly the grounds on which the appeal is based.
(4) The Minister shall within 30 days of receipt of a notice of appeal,
appoint an appeal committee to decide the appeal.
(5) The appeal committee -
(a) shall determine the procedure for its hearings;
(b) may, if it deems necessary-
(i) call for oral evidence or argument or summon any person who
(aa) in its opinion may be able to give information
concerning the subject of the appeal; or
(bb) it believes has in his or her possession or under
control any document which has a bearing on the subject of
the appeal, to appear before it at a time and place specified
in the summons, to be asked questions or to produce any
(c) shall, if it calls for oral evidence or argument,
(i) determine the date, time and place for the appeal and shall
communicate these in writing to the appellant and the Council
or the Director-General, as the case may be.
(ii) administer an oath to or accept an affirmation from any
person called as a witness at the appeal..
(7) The appeal committee shall consider the appeal and make a decision
in regard thereto within a period of 30 days from the date-
(i) on which it was appointed; or,
(ii) when the appeal hearing was completed; whichever is the