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Pharmacy Act, 1974 (Act No. 53 of 1974)

Regulations

Regulations relating to Pharmacy Education and Training

1. Definitions

 

In these Regulations, unless the context otherwise indicates—

 

“Act”

means the Pharmacy Act, 1974, (Act 53 of 1974), as amended, and regulations;

 

“additional qualification”

means a qualification obtained as part of continuing professional development which is recognised by council for purposes of registration;

 

“assessor”

means any pharmacist registered by council in accordance with criteria determined and published for this purpose by council to measure outcomes of pharmacy education and training;

 

“certificate of approval”

means a certificate issued by council to a person or institution that complies with the criteria determined and published by council for the approval of providers;

 

“certificate of qualification”

[Definition deleted by section 2(a) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“community pharmacy”

means a pharmacy wherein or from which some or all of the services as prescribed in regulation 18 of the Regulations Relating to the Practice of Pharmacy are provided to persons requiring pharmaceutical services, but excludes an institutional pharmacy;

 

“continuing professional development”

means the process by which natural persons registered under this Act maintain and enhance  their competence throughout their professional careers, and encompasses a range of activities including continuing education and supplementary training;

[Definition substituted by section 2(b) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“contract”

means a written contract approved by the Council which lays down the conditions of the—

(a) internship of a pharmacist intern;
(b) in-service training of a pharmacist's assistant (learner basic) or pharmacist's assistant (learner post-basic); or
(c) traineeship of a pharmacy technician (trainee);

[Definition substituted by section 2(c) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“direct personal supervision”

means guidance and support provided by a pharmacist whilst physically present in a pharmacy and in accordance with rules relating to good pharmacy practice published in terms of the Act;

[Definition substituted by section 2(d) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“in-service training”

means the training undertaken by a pharmacist’s assistant (learner basic) or pharmacist’s assistant (learner post-basic) under the direct personal supervision of a tutor at a pharmacy approved by council for purposes of such training;

 

“internship”

means the practical training undertaken by a pharmacist intern in terms of a contract under the direct personal supervision of a tutor in a pharmacy approved by council for purposes of such training or at an institution registered as a provider of a qualification in pharmacy;

 

“institutional pharmacy”

means a pharmacy situated in—

(a) a public health facility wherein or from which some or all of the services as prescribed in regulation 18 of the Regulations Relating to the Practice of Pharmacy are provided to persons requiring pharmaceutical services, from or at that public health facility; or
(b) a private health facility wherein or from which some or all of the services as prescribed in regulation 18 of the Regulations Relating to the Practice of Pharmacy are provided to persons requiring pharmaceutical services from or at that private health facility,

but excludes a community pharmacy;

 

“manufacturing pharmacy”

means a pharmacy wherein or from which some or all of the services as prescribed in regulation 16 of the Regulations Relating to the Practice of Pharmacy are provided and which shall sell medicine only to a wholesale pharmacy or a community pharmacy or an institutional pharmacy or to persons who are authorised to purchase medicines in terms of the Medicines Act or to an organ of State;

 

“Medicines Act”

the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965), as amended;

 

“pharmacist’s assistant”

means a natural person registered in one of the following categories—

(a) pharmacist’s assistant (learner basic);
(b) pharmacist’s assistant (basic);
(c) pharmacist ’s assistant (learner post-basic);
(d) pharmacist’s assistant (post-basic);
(e) pharmacy technician (learner);
(f) pharmacy technician (student);
(g) pharmacy technician (trainee);
(h) pharmacy technician; or
(i) pharmacy student;

which constitute the various categories of pharmacy support personnel registered as such in terms of the Act;

[Definition substituted by section 2(e) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

"pharmacy technician"

means a natural person registered as such in terms of the Act;

[Definition inserted by section 2(f) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

"pharmacy technician (learner)"

means a natural person registered as such in terms of the Act;

[Definition inserted by section 2(f) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

"pharmacy technician (student)"

means a natural person registered as such in terms of the Act;

[Definition inserted by section 2(f) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

"pharmacy technician (trainee)"

means a natural person registered as such in terms of the Act;

[Definition inserted by section 2(f) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“pharmacist intern"

means a person registered as such and who is undergoing an internship;

 

“primary care drug therapy”

means diagnosing a health need, prescribing and supplying of medicine to meet the health needs of a patient or group of patients or, where necessary, the referral to another health care provider by a pharmacist who has received the necessary authorisation from the council;

 

“private health facility

means any hospital, institution or facility at which provision is made for diagnostic interventions, medical or surgical treatment, and nursing or other health care which is not owned or controlled by an organ of State;

 

“provider”

means any person or institution approved by and registered with the  Council in terms of the Act to provide education and training approved by the Council for purposes of:

(a) registration as a pharmacist;
(b) registration as a pharmacist's assistant (basic), pharmacist's assistant (post-basic) or pharmacy technician;
(c) registration of a speciality;
(d) continuing professional development;
(e) supplementary training; or
(f) a course determined by the Council in terms of the Medicines Act;

[Definition substituted by section 2(g) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“public health facility”

means any hospital, institution or facility at which provision is made for diagnostic interventions, medical or surgical treatment and nursing or other health care which is owned or controlled by an organ of State;

 

“qualification in pharmacy”

[Definition deleted by section 2(h) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“supplementary training”

means training approved by council which empowers a registered person to perform acts or provide services, in terms of the Act or any other law, which fall outside the scope of practice of the category in which he or she is registered;

 

"traineeship"

means practical training, as determined by the Council from time to time, undertaken by a pharmacy technician (trainee) in terms of a contract, under the direct personal supervision of a tutor in a pharmacy approved by the Council in terms of the Act for purposes of such training;

[Definition inserted by section 2(i) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“tutor”

means a pharmacist registered with the Council as a tutor, to supervise the internship of a pharmacist intern, the traineeship of a pharmacy technician (trainee) or the in-service training of a pharmacist's assistant (learner basic) or pharmacist's assistant (learner post-basic);

[Definition substituted by section 2(j) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“unit standards”

[Definition deleted by section 2(k) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]

 

“wholesale pharmacy”

means a pharmacy wherein or from which some or all of the services as prescribed in regulation 17 of the Regulations Relating to the Practice of Pharmacy are provided and which shall sell medicine only to a wholesale pharmacy or a community pharmacy or an institutional pharmacy or to persons who are authorised to purchase medicines in terms of the Medicines Act or to an organ of State.

 

"work-based  training"

means education and training undertaken by a pharmacist's assistant (learner basic); pharmacist's assistant (learner post-basic), or pharmacy technician (learner) in a pharmacy under the auspices of a provider, as  part of an education and training programme approved by the Council for purposes of registration as a pharmacist's assistant (basic); pharmacist's assistant (post-basic), or pharmacy technician.

[Definition inserted by section 2(l) of Regulations relating to Pharmacy Education and Training: Amendment, 2024, Notice No. 4937, GG50766, dated 7 June 2024]