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

Regulations

Regulations relating to the Registration of Persons and the Maintenance of Registers

1. Definitions

 

In these regulations, unless the context otherwise indicates—

 

"Act"

means the Pharmacy Act, 1974, (Act No. 53 of 1974), as amended, and regulations;

 

"assessor"

for purposes of these regulations 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 Notice No. 4734, GG50528, dated 19 April 2024]

 

"Close Corporations Act"

means the Close Corporations Act, 1984 (Act No. 69 of 1984), as amended;

 

"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;

 

"Companies Act"

means the Companies Act, 1973 (Act No. 61 of 1973), as amended;

 

"consultant pharmacy"

means a pharmacy wherein or from which some or all of the services as prescribed in regulation 19 of the Regulations Relating to the Practice of Pharmacy are provided to persons requiring pharmaceutical services;

 

"continuing professional development"

means the process by which 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 Notice No. 4734, GG50528, dated 19 April 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;

 

"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;

 

"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;

 

"manager"

means the pharmacist designated and registered as such by a close corporation entitled to carry on the business of a pharmacist in terms of the Act and who shall be responsible for performing the duties as prescribed in regulation 25 of the Regulations Relating to the Practice of Pharmacy;

 

"managing director"

means the pharmacist designated and registered as such by a company entitled to carry on the business of a pharmacist in terms of the Act and who shall be responsible for performing the duties as prescribed in regulation 25 of the Regulations Relating to the Practice of 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;

 

"Medicine Act"

means the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), as amended;

 

"nominee"

means the natural person appointed and registered as such by a company or a close corporation entitled to carry on the business of a pharmacist in terms of the Act and who shall be responsible for the duties as prescribed in regulation 24 of the Regulations Relating to the Practice of Pharmacy;

 

"pharmaceutical community service"

means the provision of services or the performance of one or more or all of the acts forming part of the scope of practice of a pharmacist in a public health facility or a complex of health facilities in accordance with the Regulations Relating to the Performance of Pharmaceutical Community Service;

 

"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(c) of Notice No. 4734, GG50528, dated 19 April 2024]

 

"pharmacy technician"

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

[Definition inserted by section 2(d) of Notice No. 4734, GG50528, dated 19 April 2024]

 

"pharmacy technician (learner)"

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

[Definition inserted by section 2(d) of Notice No. 4734, GG50528, dated 19 April 2024]

 

"pharmacy technician (student)"

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

[Definition inserted by section 2(d) of Notice No. 4734, GG50528, dated 19 April 2024]

 

"pharmacy technician (trainee)"

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

[Definition inserted by section 2(d) of Notice No. 4734, GG50528, dated 19 April 2024]

 

"pharmacy owner"

means any person who owns a pharmacy and who is registered as such in terms of the Act;

 

"pharmacy student"

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

 

"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;

 

"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;

 

"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 i n terms of the Medicines Act;

[Definition substituted by section 2(e) of Notice No. 4734, GG50528, dated 19 April 2024]

 

"qualification in pharmacy"

[Definition deleted by section 2(f) of Notice No. 4734, GG50528, dated 19 April 2024]

 

"registrar"

means the registrar of the South African Pharmacy Council;

 

"responsible pharmacist"

means a natural person who is a pharmacist and who shall be responsible to the council for complying with all the provisions of the Act and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist, and the legislation applicable to the pharmacy which is under his or her personal supervision and who is registered as such in terms of the Act;

 

"retail pharmacy"

means a community pharmacy or an institutional pharmacy in a private health facility;

 

"specialist pharmacist"

means a pharmacist who is registered as such in terms of the Act;

 

"speciality"

means a specialist qualification in one of the fields of pharmacy approved and published in rules made by council;

 

"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, for purposes of such training;

[Definition inserted by section 2(g) of Notice No. 4734, GG50528, dated 19 April 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(h) of Notice No. 4734, GG50528, dated 19 April 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(j) of Notice No. 4734, GG50528, dated 19 April 2024]