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

Regulations

Regulations relating to the Practice of Pharmacy, 2000

Chapter VIII

24 - 28. Authorities, duties and responsibilities of the nominee, managing director or a company or manager of a close corporation entitled to carry on the business of a pharmacist

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24.

The nominee appointed as such for a company or close corporation entitled to carry on the business of a pharmacist must—

 

(1) complete and submit the application forms approved and provided by council in respect of the registration of the company or close corporation entitled to carry on the business of a pharmacist and if applicable, its pharmacy business;

 

(2) ensure that the company or close corporation which owns a pharmacy does not carry on the business of a pharmacist without a managing director or manager, as the case may be;

 

(3) pay the applicable fees as determined by council in respect of the company or the close corporation and if applicable, its pharmacy business;

 

(4) furnish the information prescribed in terms of the Regulations Relating to the Registration of Persons and the Maintenance of Registers; and

 

(5) ensure that there is compliance at all relevant times—
(a) with the requirements which entitled such company or close corporation to own a pharmacy; and
(b) with the conditions of registration of the pharmacy.

 

25.

The managing director of a company or the manager of a close corporation entitled to carry on the business of a pharmacist must—

 

(1) undertake the overall administration of the pharmacy business, which includes but is not limited to the regulation of pharmacy matters, human resources, or matters relating to processes regarding medicines or scheduled substances including procedures and record keeping and shall be responsible to council for any act performed by or on behalf of such company or close corporation, including any omission to perform an act required to be performed by or on behalf of such owner which may involve disciplinary action by council, unless he or she can satisfy council that the responsibility for such act rests upon the nominee, responsible pharmacist or a pharmacist other than him-, or herself employed by such company or close corporation;

 

(2) ensure that there is compliance with good pharmacy practice as published by council in rules;

 

(3) ensure that a responsible pharmacist is appointed for each pharmacy wherein or from which the company or close corporation conducts business;

 

(4) be part of the decision-making process affecting the pharmacy business;

 

(5) supervise every responsible pharmacist appointed by the owner of a pharmacy business, if applicable;

 

(6) ensure that the pharmacy owner complies with all the conditions of—
(a) ownership of such pharmacy business; and
(b) registration of the pharmacy; and

 

(7) ensure that no person is appointed to perform any act falling outside the scope of practice of the category in which such person is registered or which he/she is not authorised to perform in terms of the Act;

 

(8) report in writing any non-compliance with subregulations 25 (2), 25 (3), 25 (5) or 25 (6) to the management of such pharmacy business and furnish Council with a copy thereof; and

 

(9) not introduce or carry out any instruction or order from management with regard to the pharmacy business of the pharmacy owner, which could amount to a contravention of legislation applicable to such pharmacy business.

 

26.

A pharmacist who owns a pharmacy as a sole owner shall have the duties and responsibilities as set out in regulations 24 and 25 of these regulations relating to his or her pharmacy business.

 

27.

A pharmacist designated in the partnership agreement of a partnership of persons who owns a pharmacy shall have the duties and responsibilities as set out in regulations 24 and 25 of these regulations relating to such pharmacy business.

 

28.

The responsible pharmacist contemplated in regulation 25(3) must—

 

(1)ensure that he or she in fact continuously supervises the pharmacy in which he or she has been appointed;

 

(2) have appropriate qualifications and experience in the services being rendered by such pharmacy;

 

(3) ensure that persons employed in such pharmacy and who provide services forming part of the scope of practice of a pharmacist are appropriately registered with council;

 

(4) notify council immediately upon receiving knowledge that his/her services as responsible pharmacist have been or will be terminated;

 

(5) take corrective measures in respect of deficiencies with regard to inspection reports of council or in terms of the Medicines Act; and

 

(6) in addition to the general responsibilities also—
(a) ensure that unauthorised persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours;
(b) establish policies and procedures for the employees of the pharmacy with regard to the acts performed and services provided in the pharmacy;
(c) ensure the safe and effective storage and keeping of medicine or scheduled substances in the pharmacy under his or her direct personal supervision; and
(d) ensure correct and effective record-keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances.