Pharmacy Amendment Act [No. 88 of 1997]
REPUBLIC OF SOUTH AFRICA ~~~ ‘cl- -7 l.,e:~-nv
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GOVERNMENT GAZETTE
STAATSKOERANT
VAN DIE REPUBLIEK VAN SUID-AFRIKA
Re,qistered lit the Post Ojice m a Ne)vspoper
CAPE TOWN. 12 DECEJMBER 1997 VOL 390 No. 18525
KAAPSTAD. 12 DESEMBER 1997
OFFICE OF THE PRESIDENT
No. 1666. 12 December 1997
It is hereby notified that the President has assented to the following Act which is hereby published for general information:—
No, S8 of 1997: Pharmacy Amendment Act, 1997.
KANTOOR VAN DIE PRESIDENT
No. 1666. 12 Desemher 1997
H i e r b y w o r d b e k e n d gemaak M die President S? goedkeuring geheg het aan die onderstaande Wet wat hierby ter algemene inligting gepubliseer word:—
No. 88 van 1997: Wysigingswet op Aptekers, 1997.
~ No, 18525 GOVERNMENT GAZE’ITE. 12 DECEMBER 1997
Act No. 88, 1997 PHARMACY AMENDMENT ACT, 1997
GENERAL EXPLANATORY NOTE:
[ ] Words in bold type in square brackets indicate omissions from existing enactments.
Words underlined with a solid line indicate insertions in existing enactments.
ACT To amend the Pharmacy Act, 1974, so as to provide for the establishment of the new South African Pharmacy Council and for its objects and general powers; to extend the control of the council to the public sector and to amend the provisions reiating to pharmacy education and training, requirements for registration, the practice of pharmacy, the ownership of pharmacies and the investigative and disciplinary powers of the council; and to provide for matters connected therewith.
(Afrikaans text signed by the President.) (Assented to 26 November 1997.)
BE IT ENACTED by the Parliament of the Republic of South Africa, asfollows:— Amendment of section 1 of Act 53 of 1974, as amended by section 1 of Act 20 of 1979, section 1 of Act 20 of 1983, section 1 of Act 69 of 1985, section 23 of Act 94 of 1991 and section 1 of Act 6 of 1995 5
1. Section 1 of the Pharmacy Act, 1974 (hereinafter referred to as the principal Act), is hereby amended—
(a) by the insertion before the definition of “Ciskeian Medical Council” of the following definition:
“ ‘body corporate’ means any legal person registered in terms of any Act 10 in operation in the Republic.”;
(b) by the deletion of the definition of “Ciskeian Medical Council”; (c) by the deletion of the definition of “corporation”; (d) by the substitution for the definition of “pharmacist intern” of the following
definition: 15 “ ‘pharmacist intern’ means a person registered as such in terms of this Act”;
(e) by the substitution for the definition of “pharmacy” of the following definition:
‘< ‘pharmacy’ means any place wherein or from which any service 20 specially pertaining to the scope of practice of a pharmacist is provided”;
(f) by the insertion after the definition of “pharmacy” of the following
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4 No. 18525 GOVERNMENT GAZE_tTE, 12 DECEMBER 1997
Act No. 88, 1997 PHARA4ACY AMENDMENT ACT. 1997
“ ‘pharmacy practice’ means acts specially pertaining to the scope of practice of a pharmacist as prescribed in terms of section 35A of this Act;
‘pharmacy student’ means a person registered as such in terms of this Act; ‘pharmacy support personnel’ means the various categories of support 5 personnel as prescribed and registered as such in terms of this Act”;
(g) by the substitution for the definition of “registrar” of the following definition: “ ‘reuistrar’ means the reoistrar of the council appointed in te~s of section 4(u) of this Act or a person lawfully acting in that capacity”;
(h) by the insertion after the definition of “regulation” of the following definition: 10 “ ‘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 this 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 15 supervision;”;
(i) by the substitution for the definition of “scheduled substance” of the following definition:
“ ‘scheduled substance’ means a scheduled substance as referred to in the Medicines and Related Substances [Control] Act, 1965 (Act No. 101 20 of 1965);”;
(j) by the deletion of the definition of “South African Pharmacy Council°; (k) by the deletion of the definition of “Transkeian Medical Council”; and (1) by the insertion after the definition of “Transkeian Medical Council” of the
following definition: 25 “ ‘unprofessional conduct’ means improper. disgraceful or dishonora- ble or unworthy conduct or conduct which. when regard is had to the profession of a person who is registered in terms of this Act, is improper or disgraceful or dishonorable or unworthy;”,
Substitution of heading to Chapter 1 of Act 53 of 1974, as substituted by section 2 30 of Act 6 of 1995
2. The following heading is hereby substituted for the heading to Chapter 1 of the principal Act:
“ESTABLISHMENT OF THE SOUTH AFRICAN PHARMACY COUNCIL. ITS OBJECTS, GENERAL POWERS AND FUNCTIONS “. 35
Substitution of section 2 of Act 53 of 1974, as substituted by section 2 of Act 69 of 1985 and section 3 of Act 6 of 1995
3. The following section is hereby substituted for section 2 of the principal Act:
“Establishment of South African Pharmacy Council
2. (1) There is hereby established a juristic person to be known as the South African Pharmacy Council, which shall be deemed to be the successor-in-title of the Interim Pharmacy Council of South Africa, and the first meeting of the council shall be convened by the registrar.
(2) The head office of the council shall be situated in Pretoria. (3) Any reference to the Interim Pharmacy Council of South Africa in
any deed. document or Act shall be deemed to be a reference to the council established in terms of subsection ( 1 ) with effect from the date determined in accordance with section 51, and every registrar of deeds or the officer where an official record is kept shall on application by the registrar amend his or her records accordingly without it being necessary for the council to pay any transfer fees. duties or taxes.”.
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6 No. 18525 GOVERNMENT GAZETTE, 12 DECEMBER 1997
Act NO. 88, 1997 PHARMACY AMENDMENT ACT. 1997
Substitution of section 3 of Act 53 of 1974, as amended by section 4 of Act 6 of 1995
4. The following section is hereby substituted for section 3 of the principal Act:
“Objects of council
3. The oblects of the council shall be— (a) to assist in the promotion of the health of the population of the
Republic; (b) to advise the Minister or any other person on any matter relating to
pharmacy; (c) to promote the provision of pharmaceutical care which complies with
universal norms and values, in both the public and the private sector, with the goal of achieving definite therapeutic outcomes for the health and quality of life of a patient:
(d) to uphold and safeguard the rights of the general public to universally acceptable standards of pharmacy practice in both the public and the private sector:
(e) to establish, develop, maintain and control universally acceptable standards— (i) in pharmaceutical education and training; (ii) for the registration of a person who provides one or more or all of
the services which form part of the scope of practice of the category in which such person is registered;
(iii) of the practice of the various categories of persons required to be registered in terms of this Act:
(iv) of professional conduct required of persons to be registered in terms of this Act; and
(v) of control over persons registered in terms of this Act by investigating in accordance with this Act, complaints or accusa- tions relating to the conduct of registered persons;
(f) to be transparent to the profession and the general public in achieving its objects and in performing its functions and executing its powers; and
(g) to maintain and enhance the dignity of the pharmacy profession and the integrity of persons practicing that profession,”.
Amendment of section 4 of Act 53 of 1974, as amended by section 4 of Act 6 of 1995
5. Section 4 of the principal Act is hereby amended— (a) by the substitution for the heading to section 4 of the following heading:
“General powers of council”: (b) by the deletion of paragraphs (g) and (h); (c) by the deletion of the word “and’” at the end of paragraph (m); and (d) by the insertion of the following paragraphs after paragraph (m) and before the
word “generally”: “(n) to designate the office-bearers of the council and to determine the
procedure for the election of office-bearers; (o) to appoint any committee it may deem necessary and to delegate
any of its powers to any such committee and to prescribe the conditions of such delegation, including the power to subdelegate any delegated power to any member of its staff or officer duly appointed in terms of this Act;
(p) to co-opt a representative of a professional board established in terms of this Act on to the council: Provided that such a representative shall not have the right to vote;
(q) to co-opt any person on to any of its committees that it may deem necessary;
(r) to determine the number of meetings to be held by the council and
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8 No. 18525 GOVERNMENT GAZETTE. 12 DECEMBER 1997
Act No. 88, 1997 PHARMACY AMENDMENT ACT. 1997
its committees. the procedure applicable to such meetings. tht manner in which special meetings shall be convened and tht procedures applicable to such special meetings;
(s) to determine the quorum requirements for a meeting of the counci and any of its committees;
(r) to determine the manner in which decisions shall be taken at : meeting of the council or any of its committees;
(u) to appoint or dismiss a registrar or such other staff members as i may deem necessary and to determine their conditions of service Provided that the appointment or dismissal of the registrar shall bc subject to the approval of the Minister;
(v) to appoint any officer or inspector to perform any duty or act on behalf of the council in terms of this Act and to prescribe anc determine their powers and duties;
(w) to delegate any of its powers to any officer or inspector and in general to regulate the duties of any officer or inspector;
(x) to delegate to any organisation such powers as it may deem necessary from time to time;
(y) to determine the manner in which the business of the council shall be conducted and the manner in which the accounts of the council shall be kept;
(z) to purchase or in any other manner acquire property, which shall include but not be limited to the acceptance of donations. or to sell, let. mortgage or in any other manner dispose of any property of the council;
(:A ) to administer the assets of the council or any assets to be held in trust for the benefit of the council;
(W) to settle the liabilities of the council; (zC) to establish and administer a pension or a provident fund for the
employees of the council: (cD) to institute, defend and proceed with any legal action in its own
name; (:E) to borrow money on such terms and conditions as the council may
determine and to encumber any of the assets of the council as security therefor:
(zF) to pay to any members of the council. office-bearers, committee members, officers appointed in terms of this Act. or any other person or any witness subpoenaed. including persons employed by the State, such allowances as it may determine from time to time;
(rG) to determine the fees payable to the council for services performed by the council in terms of this Actor for any other reason the council may decide on;
(:H) to require any person or institution registered in terms of this Act. or involved in pharmacy practice or offering pharmaceutical education or training. to furnish the council with the information the council requires:
(:1) to establish professional boards for pharmacy support personnel registered in terms of [his Act, when the council, in consul[atlon with the Minister, deems it necessary; and
(cl) to prescribe the scope of practice of the various categories of persons registered in terms of this Act, and”.
Substitution of section 5 of Act 53 of 1974, as amended by section 2 of Act 20 of 1979, section 3 of Act 69 of 1985 and substituted by section 6 of Act 6 of 1995
6. The following section is hereby substituted for section 5 of the principal Act:
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“Constitution of council 55
5. (1) The council shall consist of 25 persons elected or appointed as follows: (a) nine pharmacists registered with the council. resident in the Republic
of South Africa and elected by pharmacists;
lo No, 18525 GoVERNMENT GAZETTE. 12 DECEMBER 1997
Act NO. 88, 1997 PHARMACY AMENDMENT ACT. 1997
(b) nine pharmacists nominated by the Members of the Executive Counci responsible for health matters in the provinces of the Republic anl appointed by the Minister;
(c) an officer of the Department appointed by the Minister; (d) two pharmacists who are members of the staff of a university at whicl
provision is made for the education and training of pharmacists nominated by such a university and appointed by the Minister Provided that such pharmacists shall not be from the same university
(e) four other persons appointed by the Minister. one of whom shall be i person appointed on account of his or her legal knowledge.
(2) The council shall have a president and vice-president. and al members of the council shall be entitled to vote during the election of tht president and the vice-president and other office-bearers of the council.
(3) Whenever the persons entitled in terms of subsection ( 1 )(a) to elec any member of the council, fail, before the expiry of the prescribed period to elect any person to till any vacancy in respect of the office of such : member, the Minister may, after consultation with the executive committet of the council, appoint a pharmacist who shall thereafter be deemed to havt been duly elected.
(4) Subject to the provisions of section 7, the members of the counci shall hold office for a period of five years, but shall be eligible fol reappointment or re-election, as the case may be, for one term only,
(5) The procedure to be followed at the election of the nine members referred to in subsection (1 )(a) shall be prescribed.
(6) If anything required to be done in terms of this Act in connection with the appointment or election or nomination of any member is omitted or not done within the time or in the manner required by this Act, the Minister may order all such steps to be taken as may be necessary to rectify the omission or error, or may validate anything done in any irregular manner, in order to give effect to the objects of this Act,
(7) The registrar shall give notice in the Gazette of the appointment or election of any member of the council, the date of such appointment or election and the period for which such member has been appointed or elected.
(8) Any person who makes or causes to be made a false declaration in connection with the election contemplated in subsection ( I )(a), shall be guilty of an offence and liable on conviction to a fine not exceeding the amount determined by the Minister from time to time by notice in the Gazette.
(9) The Minister may, in the public interest, and after consultation with a person or body responsible for the appointment or election of a member, terminate the membership of any member of the council after giving written notice to the member and affording the member an opportunity to furnish reasons to the Minister why his or her membership should not be terminated.
(10) The Minister shall notify the registrar in writing of the names of the members appointed in terms of subsection ( 1 ) of this Act.”.
Repeal of section 8 of Act 53 of 1974
7. Section 8 of the principal Act is hereby repealed.
Repeal of section 9 of Act 53 of 1974, as amended by section 3 of Act 20 of 1979 and 50 section 9 of Act 6 of 1995
8. Section 9 of the principal Act is hereby repealed.
Repeal of section 10 of Act 53 of 1974, as amended by section 4 of Act 20 of 1979
9. Section 10 of the principal Act is hereby repealed.
i2 No. 18525 GOVERNMENT GAZETTE, 12 DECEMBER 1997
Act No. 88, 1997 PHARMACY AMENDMENT ACT, 1997
Repeal of section 11 of Act 53 of 1974
10. Section 11 of the principal Act is hereby repealed.
Amendment of section 12 of Act 53 of 1974
11. Section 12 of the principal Act is hereby amended— (a) by the substitution for subsection (1) of the following subsection: 5
“Fees of council
(1) All fees payable in terms of this Act shall be paid to the council and shall be utilised as its funds for defraving expenses incurred in connection with the performance of its functions.”; and
(b) by the deletion of subsection (2). 10
Substitution of section 13 of Act 53 of 1974
12. The following section is hereby substituted for section 13 of the principal Act:
“Registration
13. ( 1 ) No person shall be entitled to provide the services which form part of the services specially pertaining to the scope of practice of a pharmacist or assist therewith. unless he or she is duly registered in one of the categories prescribed in terms of this Act.
(2) No person shall practise as a specialist pharmacist or shall conduct himself or herself as such a specialist, or shall in any other manner profess to be a person in respect of whom any such speciality has been registered. unless the speciality in question has been registered in terms of this Act in respec[ of such person.
(3) Every person who has been suspended from practicing in terms of this Act or whose name has been removed from a reg~ster, shafi be disqualified from providing any of the services or performing any act specially pertaining to the scope of practice of pharmacy as determined in the practice rules made by the council, and his or her registration certificate shall be deemed to be withdrawn until the ~enod of sus~ension has ex~ired. . or until his or her name has been restored to the register by the council.
(4) Any person who has been suspended from practicing in terms of this Act or whose name has been removed from a register in terms of subsection 45( 1)( c) and whose name has not been restored to such register shall not be entitled to remain, or be registered as the owner of a pha&acy, or hold any beneficial interest in a pharmacy.”,
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Substitution of section 14 of Act 53 of 1974, as amended by section 5 of Act 20 of 35 1974 and section 6 of Act 69 of 1985
13. The following section is hereby substituted for section 14 of the principal Act:
“Registration of persons, recording of licensed premises and mainte- nance of registers
14. With regard to the registration of persons and the recording of 40 licensed pharmacy premises in terms of this Act: (a)
(b)
(c)
the ‘various - c~tegories of persons who may be registered and pharmacies which may be recorded in terms of this Act shall be prescribed; the requirements and conditions for registration, removal, restoration 45 or reinstatement of the various categories of persons shall be prescribed; the council shall require any person who is entitled and intends to
l-l No. 18525 GOVERNMENT GAZETTE. 12 DECEMBER 1997
Act No. 88, 1997
(d)
(e)
V)
(g)
(h)
(i)
PHARMACY AMENDMENT ACT, 1997
provide one or more or all of the services which are deemed to be services specially pertaining to the scope of practice of a pharmacist. and pharmacy support personnel. or any person who assists in the provision thereof, to register with the council; the council shall keep, amend, correct and maintain such registers in the format as the council deems necessary and cause copies of such registers to be printed at the discretion of the council; the council may remove. in the prescribed manner, the name of any person from the relevant register; the council may restore, in the prescribed manner, the name of any person to the relevant register on such conditions as the council may deem fit; the council may issue, in the prescribed manner, any certificate the council may deem necessary, on such conditions as it may deem fit. and may cancel any certificate in the prescribed manner; the council may refuse. in the prescribed manner, to record any person who or a pharmacy which does not comply with the prescribed conditions; and the council may require, in the prescribed manner, all persons
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authorised in terms of section 22A to record the prescribed informs- I 20 tion with the council.”.
Repeal of section 15 of Act 53 of 1974
14. Section 15 of the principal Act is hereby repealed
Repeal of section 16 of Act 53 of 1974
15. Section 16 of the principal Act is hereby repealed, 25
Repeal of section 17 of Act 53 of 1974, as amended by section 2 of Act 20 of 1983
16. Section 17 of the principal Act is hereby repealed
Repeal of section 18 of Act 53 of 1974
17. Section 18 of the principal Act is hereby repealed.
Repeal of section 19 of Act 53 of 1974, as substituted by section 6 of Act 20 of 1979 30
18. Section 19 of the principal Act is hereby repealed
Repeal of section 20 of Act 53 of 1974, as amended by section 7 of Act 20 of 1979 and section 3 of Act 20 of 1983
19. Section 20 of the principal Act is hereby repealed.
Repeal of section 21 of Act 53 of 1974, as amended by section 8 of Act 20 of 1979, 35 section 1 of Act 39 of 1982 and section 7 of Act 69 of 1985
20. Section 21 of the principal Act is hereby repealed
Substitution of section 22 of Act 53 of 1974, as amended by section 9 of Act 36 of 1977, section 9 of Act 20 of 1979, section 2 of Act 39 of 1982 and section 8 of Act 69 of 1985 40
21. The following section is hereby substituted for section 22 of the principal Act:
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Act No. 88.1997 PHARMACY AMENDMENT ACT. 1997
“Licensing of pharmacies
22. (1) A person authorised in terms of section 22A to own a pharrnac! shall in the prescribed manner, specifying the prescribed p~iculms. appll to the Director-General for a licence for the premises wherein or frort which such business shall be carried on and the Director-General may bt entitled to issue or refuse such licence on such conditions as he or she ma~ deem fit.
(2) A person issued with a licence in terms of subsection ( 1 ) shall notif~ the council thereof in writing and on production of the said licence tht council shall record the name, address, date of Iicence, licence number anc any other particulars as prescribed.
(3) A licence issued in terms of subsection (1) may be subject tc conditions as determined by the Director-General.
(4) A pharmacy shall, subject to such conditions as may be prescribed, be conducted under the continuous personal supervision of a pharmacist, in accordance with good pharmacy practice as determined in the rules made by the council.
(5) The pharmacist referred to in subsection (4) shall be responsible tc the council for any act performed by or on behalf of the body corporate in question, including any omission to perform an act required to be performed by or on behalf of the body corporate, which may involve disciplinary action by the council, unless he or she satisfies the council that the responsibility for such act rests upon a pharmacist other than himself or herself employed by the body corporate.
(6) The council shall have the right to inspect premises in which the business of a pharmacy is carried on in terms of this Act, and the registrar shall provide the Director-General and the person who made the application in terms of subsection ( 1 ) with a written report of the findings of its inspection if it has been found that the inspected premises are not suitable for the business of a pharmacy.
(7) The Director-General may cancel or suspend any licence contem- plated in subsection (1) which does not comply with the licensing conditions as determined in terms of subsection (3). after giving notice in writing to the owner of the pharmacy or the responsible pharmacist, and affording the owner or the responsible pharmacist an opportunity to furnish reasons why the licence should not be cancelled or suspended.
(8) If a licence is suspended or cancelled. the premises shall from the date of the suspension or the cancellation be considered to be unsuitable for the carrying on of the business of a pharmacy.
(9) A person registered to carry on the business of a pharmacy at the commencement of this Act shall be deemed to be licensed in terms of subsection (1).
(10) The Director-General in consultation with the council may close a pharmacy which is being conducted in contravention of this Act and the
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Medicines and Related S~bstances [Control] Act, ] 965, or which does not 45
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comply with the licensing conditions, after giving notice to the owner or the responsible pharmacist, and aflording the owner or the responsible pharmacist an opportunity to furnish reasons to the Director-General why the pharmacy should not be closed.
(11) Any person aggrieved by a decision of the Director-General or the council, as the case may be, may within the prescribed period, in the prescribed manner appeal against such decision to an appeal committee appointed by the Minister: Provided that the chairperson of such appeal committee shall be a person appointed on account of his or her knowledge of the law.”.
Substitution of section 22A of Act 53 of 1974, as amended by section 10 of Act 36 of 1977 and section 9 of Act 69 of 1985
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22. The following section is hereby substituted for section 22A of the principal Act:
18 No. 18525 GOVERNMENT GAZETTE, 12 DECEMBER 1997
Act NO. 88, 1997 PHARM.4CY AMENDMENT ACT, 1997
“Ownership of pharmacies
22A. The Minister may prescribe who may own a pharmacy. the conditions under which such person mav own such pharmacy, and the conditions upon which such authority may be withdrawn.”.
Repeal of section 22B of Act 53 of 1974
23. Section 22B of the principal Act is hereby repealed
Amendment of section 29 of Act 53 of 1974. as amended by section 10 of Act 20 of 1979
24. Section 29 of the principal Act is hereby amended— (a) by the substitution for the words following paragraph (b) of subsection ( ] ) of
the following words: ‘“shall be guilty of an offence and on conviction liable to a fine not exceeding [five hundred rand or to imprisonment for a period not exceeding twelve months or to both such fine and such imprison- ment] the amount determined by the Minister in consultation ~’ith the Minister of Justice from time to time by notice in the Gazette.”;
(b) by the substitution for subsection (2) of the following subsection: “(2) The acts prescribed in te~s of section 35A(a)(1) shall for
purposes of subsection ( 1 ) be deemed to be acts specially pertaining to the profession of a pharmacist.”:
(() by the substitution for paragraph (a) of subsection (3) of the following paragraph:
“(a) the keeping of medicines or the supply of medicines to his or her own patients by any medical practitioner, dentist [or veterinary surgeon], practitioner or nurse in accordance with the provisions of the Medicine and Related Substances [Control] Act. 1965.”;
(d) by the substitution for subparagraph (ii) of paragraph (b) subsection (3) of the following paragraph:
“(ii) of a pharmacist’s assistant. pharmaceutical technician or other pharmaceutical [auxiliary] support personnel;”;
(e) by the substitution for paragraph @ of subsection (3) of the following paragraph:
“~) the keeping of medicine and its supply by any person or organization performing a health service and authorized in writing by the [Secretary for Health] Director-General acting after consultation with the council, to acquire medicines for the performance of such service.”;
(f) by the substitution for subsection (4) of the following subsection: “(4) The Minister may in consultation with the council grant any
person not registered in term of this Act authority to perform a service specially pertaining to the scope of practice of a pharmacist, or in writing exempt any person from the provision of this Act, on such conditions as he or she may determine.”; and
(g) by the substitution for subsection (5) of the following subsection: “(5) If he or she is of the opinion that it is in the public interest to do
so, the [Secretary for Health] Director-General may, pending the Ministers’ decision in respect of an application for a [permit] authorisation referred to in subsection (4), grant a provisional [permit] authorisation to the applicant concerned, authorizing him or her to manufacture, pack or sell any medicine or medicinal or chemical substance specified in such provisional [permit] authorisation, subject to such conditions to be determined by the said [Secretary] Director- General and set out in the provisional [permit] authorisation,”.
Amendment of section 30 of Act 53 of 1974
25. Section 30 of the principal Act is hereby amended by the substitution for the words following paragraph (e) of the following words:
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Act No. 88, 1997 PHARMACY AMENDMENT ACT, 1997
“shall be guilty of an offence and on conviction liable to a fine not exceeding [one thousand rand] the amount determined by the Minister from time to time by notice in the Gazette. ”
Repeal of section 31 of Act 53 of 1974
26. Section 31 of the principal Act is hereby repealed. 5
Substitution of section 33 of Act 53 of 1974, as amended by section 3 of Act 39 of 1982 and sections 46 and 47 of Act 97 of 1986
27. The following section is hereby substituted for section 33 of the principal Act:
“Pharmacy education and training
33. (1) The Minister may in consultation with the council make 10 regulations to- (a)
(b)
(c)
(d)
(e)
m
(g)
(h)
(i)
(j)
(k)
(1)
(m)
(n)
(0)
(P)
develop, establish, maintain and control standards of pharmacy education and training; require any institution or person intending to provide education and training to apply for the approval of such institution or person; evaluate and authorise any institution or person to offer education and training to qualify a person for registration in terms of this Act, lay down the conditions upon which such education and training may be provided and amend such conditions from time to time, or cancel or withdraw such authority; make rules regarding the evaluation of a person applying for registration in terms of this Act to ensure competence: prescribe the unit standards for pharmaceutical education and training required from a person entitled to be registered in terms of this Act; conduct a pre-registration examination or evaluation to ensure competence of a person applying for registration in terms of this Act; conduct, recognise and control supplementary training of a person registered in terms of this Act; recognise qualifications, competencies and skills for purposes of registration in terms of this Act; determine the number of pharmacy support personnel or pharmacist interns who may be trained under the supervision of a pharmacist; investigate or cause to be investigated any institution or premises recognised by the council for purposes of education and training in terms of this Act, or request such information as may be deemed necessary from such institution to enable the council to establish compliance with the requirements prescribed by the council relating to such education and training; conduct examinations or evaluations for purposes of registration or continued registration in terms of this Act; appoint or accredit examiners or moderators needed for purposes of conducting any examination or evaluation prescribed by the council; award, cancel or withdraw certificates or documents issued in respect of any examination or training provided or recognised by the council; upon notice to the institution and pharmacy students who may be afYected thereby, and after furnishing reasons, withdraw further recognition of any qualification for purposes of registration in terms of this Act on such conditions as the council may deem fit; require any person registered in terms of this Act to remain competent in the manner prescribed; make rules as to the additional qualifications, specialities or titles that may be registered in terms of this Act.”.
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Act No. X8. 1997 PHARMACY AMENDMENT ACT. 1997
Substitution of section 34 of’ Act 53 of 1974
28. The following section is hereby substituted for section 34 of the principal Act:
“Pharmacy education and training institutions
34. ( 1 ) No person shall be entitled to offer education and training for purposes of registration in terms of this Ac(, unless such institution or person and the education and training concerned have been approved by the council.
(2) Any person intending to offer education and training referred to in subsection ( 1 ) shall. before offering such education and training, apply to the council in the prescribed manner for the approval of such education and training. and of such institution or person,
(3) Any person who prevents a person authorised in terms of this Act to perform a function for or to act on behalf of the council from entering, at a reasonable time, an institution or premises offering education and training or who hinders such person in making therein or therefrom any investigation required to be done by the council, shall be guilty of an offence: Provided that the person carrying out the investigation shall produce proof of his or her identity and such authority. on request.”.
Substitution of section 35 of Act 53 of 1974
29. The following section is substituted for section 35 of the principal Act:
“Authorisation for provision and levies for services
35. ( 1 ) Except with the prior approval of the council, or authorised in terms of this Act, no person shall provide a service which pertains specially [o the scope of practice of the various categories of persons. as laid down in terms of this Act.
(2) NO person registered in terms of this Act, shall pay any person directly or indirectly or in any other manner reward him or her or it in connection with a prescription, issued by an authorised prescriber, in terms of the Medicines and Related Substances [Control] Act. 1965.”.
Insertion of section 35A of Act 53 of 1974
30. The following section is hereby inserted after section 35 of the principal Act:
“Pharmacy practice
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35A. With regard to the control of pharmacy practice— (a) the following shall be prescribed:
(i) the scope of practice of persons registered in terms of this Act, or 35 the services or acts which shall for purposes of this Act be deemed to be services or acts specially pertaining to pharmacists or pharmacy support personnel, and the conditions under which those services may be provided or the acts which may be performed; 40
(ii ) the services which may be provided in the various categories of pharmacies, and the conditions under which these services shall be provided;
(b) the council shall be entitled to make rules as to: (i) a code of conduct for pharmacists and other persons registered in 45
terms of this Act; (ii) what constitutes good pharmacy practice; (iii) the services for which a pharmacist may levy a fee and guidelines
for levying such a fee or fees;
24 No. 18525 GOVERNMENT GAZETTE, 12 DECEMBER 1997
Act No. 88.1997 PHARMACY AMENDMENT ACT. 1997
(c) the council may approve the title or name under which a pharmacy may be conducted;
(d) the council shall be entitled to investigate and inspect the practice and the conduct of the business of a pharrnacv. ”.
Amendment of section 36 of Act 53 of 1974, as amended by section 13 of Act 69 of 5 1985
31. Section 36 of the principal Act is hereby amended— (a) by the substitution for paragraph (a) of subsection (2) of the following
paragraph: “(u) the inclusion in the name. title or description of any pharmacy
business of the surname of an owner thereof [or, in the case of such a business wholly owned by a body corporate referred to in section 22 or 22B, of the surname of any director thereof or of a member of the corporation, as the case may be, who is a pharmacist];”; and
(b) by substitution for subsection (4) of the following subsection: “(4) Any person who contravenes any of the provisions of this section
shall be guilty of an offence and liable on conviction to a fine not exceeding [five hundred rand or to imprisonment not exceeding twelve months or to both such fine and such imprisonment] the amount determined by the Minister from time to time by notice in the Gazette.”.
Substitution of section 37 of Act 53 of 1974, as amended by section 12 of Act 20 of 1979 and section 4 of Act 39 of 1982
32. The following section is hereby substituted for section 37 of the principal Act:
“Continuation of pharmacy business of person registered in terms of this Act by executor, trustee, liquidator, curator, or judgment creditor
37. Notwithstanding anything to the contrary in this Act contained— (a) “’ .,, .
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(b)
(c)
(d)
me person responslDle IOr reporting me estate 01 a person who owns a pharmacy and registered in terms of this Act to the Master, or the executor of the deceased estate of such person who owns a pharmacy may. subject to the laws relating to the administration of estates, for a period not exceeding 12 months after the death of such person who owns a pharmacy. and for an additional period not exceeding 12 months. continue the pharmacy business of the deceased, and such pharmacy business shall be conducted under the continuous personal supervision of a pharmacist; the executor shall. within 30 days of his or her appointment, inform the council by registered mail of his or her appointment and of the name and registration number of the pharmacist who shall be responsible to the council in respect of the pharmacy business referred to in paragraph (a); tbe trustee in the insolvent estate of a pharmacist registered in terms of this Act or the liquidator of a body corporate entitled to carry on business as a pharmacist may, subject to applicable laws, for a period not exceeding 12 months after such a final sequestration order or final liquidation order. and for such additional period as the council may allow, continue the business of such a pharmacist or body corporate, and such business shall be conducted under the continuous personal supervision of a pharmacist; the trustee or liquidator shall. within 30 days of his or her appointment, deliver. by hand or registered mail, to the council the sequestration or liquidation order, as the case may be, referred to in paragraph (c), and the trustee or the liquidator shall inform the council, in writing, of the name and registration number of the pharmacist who shall be
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responsible to the council in respect of the business referred to in paragraph (c);
(e) the curator of the estate of a person who is carrying on business as a pharmacist but who has been declared incapable of managing his or her affairs b> an order of court. ma~’. subject to applicable laws. for a period not exceeding 12 months after the order has been given and for such additional period as the council may allow, continue such pharmacy business. and such pham~ac? business shall be conducted under the continuous personal superwslon of a pharmacist;
(f) the curator refereed to in paragraph (e) shall. within 30 days from the date on which the order was made. deliver. by hand or registered mail, such order to the council. and the curator shall inform the council. in writing, of the name and registration number of the pharmacist who shall be responsible to the council in respect of the business referred to in paragraph (e);
(,? J the judicial manage]- or a judgment creditor of a body corporate carrying on business as a pharmacist may. subject to applicable laws. for a period not exceeding the period of judicial management or six months from the date on which the attachment order was made in the case of a judgment creditor. subject to conditions determined by the council. continue such pharmacy business, and such pharmac> business shall be conducted under the continuous personal supervision of a pharmacist;
fh) the judicial mantiger or judgment creditor referred to in paragraph (g) shall. within 30 days of the granting or discharge of the order, deliver. by hand or registered mail. such order to the council, and such judicial manager or judgment creditor shall inform the council. in writing. of the name and registration number of the pharmacist who shall be responsible to the council in respect of the pharmacy business referred to in paragraph (e).”.
Amendment of section 39 of Act 53 of 1974
33. Section 39 of the principal Act is hereby amended by the substitution for subsection ( 1 ) of the following subsection:
“(1 ) The council shall have the power to enquire into any matter which is brought to the attention of the council or any complaint. charge or allegation of 35 improper or disgraceful conduct against any person registered [under] in terms of this Act and. on finding such person guilty of such conduct. to impose any of the penalties prescribed in section 45(1 ).”’.
Amendment of section 40 of Act 53 of 1974
34. Section 40 of the principal Act is hereby amended— 40 (a) by the substitution for the words following upon subparagraph (iv) of
paragraph (c) of subsection (1) of the following words: “shall be guilty of an offence and liable on conviction to a fine not exceeding [one hundred rand] the amount to be determined by the Minister from time to time by notice in the Ga~ette: Provided that every 45 person so summoned shall be entitled to all tbe privileges to which a witness subpoenaed to give evidence before a provincial division of the Supreme Court is entitled.”: and
(b) by the addition of subsection 3: “(3) The council shall be entitled to make an order as regards the costs 50
incurred in an inquiry or investigation relating to the conduct of a registered person. of an amount not exceedin,~ the amount determined b}’ the Minister from time to time by notice in the Gazetre. ”.
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28 No. 18525 GOVERNMENT GAZEITE, 12 DECEMBER 1997
Act No. 88, 1997 PHARMACY AMENDMENT ACT, 1997
Amendment of section 44 of Act 53 of 1974, as amended by section 15 of Act 20 of 1979
35. Section 44 of the principal Act is hereby amended by the insertion of the following subsection:
“(4) When it appears— 5 (a) from any disciplinary proceedings held by an employer into the conduct of a
person registered in terms of this Actor any institution at which education and training in pharmacy is offered, that there is prima facie evidence of unprofessional conduct on the part of such employee or a student being trained as a pharmacist; 10
(b) that the registration of a pharmacy student with an education and training institution has been suspended or cancelled,
then the employer or the institution shall furnish the council with a copy of the record of such proceedings, or such portion thereof that is material to the issue, or notify in writing the cou~cil of such suspension or cancellation.”.
Amendment of Section 45 of Act 53 of 1974, as amended by section 16 of Act 20 of 1979
36. Section 45 of the principal Act is hereby amended— (u) by the substitution for paragraph (b) of subsection ( 1 ) of the following
paragraph: “(b) Suspension for a specified period from practicing or performing
any acts forming part of his or her [profession or if he is a pharmacist intern or pharmacist assistant, from performing such acts as he may perform] scope of practice as prescribed in terms of this Act:”; or
(b) by the insertion of the following paragraph after paragraph (c) of subsection (1):
“(d) A fine not exceeding the amount determined by the Minister from time to time by notice in the Gazetre. ”.
Insertion of section 45B to Act 53 of 1974
37. The principal Act is amended by the insertion of the following section after section 45A:
“Recovery of fines and cost orders
45B. ( 1 ) Any fine imposed in terms of this Act shall. unless an appeal has been noted against such penalty, be paid to the council within 14 days after the imposition thereof, or within such extended period and in such installments as the council may in its discretion determine.
(2) Any cost order made in terms of this Act shall— (a) in the event of such order being made against the pro forma
complainant or against the council be paid by the council within 14 days after the amount thereof has been fixed;
(b) in the event of such order being made against any other person be paid to the council within 14 days after the amount thereof has been fixed, or within such extended period and in such installments as the council may in its discretion determine.
(3) The imposition of a fine or the making of a cost order in terms of this Act shall have the effect of a judgment in civil proceedings in the magistrate’s court of the district in which the person liable to pay such fine resides or has his or her registered address or main place of business.”.
Substitution of section 48 of Act 53 of 1974, as substituted by section 52 of Act 88 of 1996
38. The following section is hereby substituted for section 48 of the principal Act:
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30 No. 18525 GOVERNMENT GAZETTE. 12 DECEMBER 1997
Act No. 88, 1997 PHARMACY AMENDMENT ACT. 1997
“Limitation of liability
48. Subject k) the provisions of this Act Lhe council or any member or officer of the council shall not be liable in respect of any act done in good faith or duty performed in accordance with this Act.”.
Amendment of section 49 of Act 53 of 1974, as amended by section 11 of Act 36 of 5 1977. section 18 of Act 20 of 1979, section 5 of Act 39 of 1982, section 5 of Act 20 of 1983 and section 14 of Act 69 of 1985
39. Section 49 of the principal Act. is hereby amended— (a) by the substitution for the words preceding subsection ( 1 ) of the following
words: 10 “The Minister ma). [on the recommendation ofl in consultation with the council. make regulations relating to—:”:
(b) by the substitution for paragraph (d) of subsection (1) of the following paragraph:
“(d) an} fees payable under this Act [(including annual fees in respect 15 of any pharmacy or fees in respect of the registration of any pharmacy or any person as a pharmacist intern, pharmacy student. pharmaceutical technician. pharmacist assistant, or pharmaceutical auxiliary personnel member or, of a body corporate carrying on business as a pharmacist or of a 20 managing director of any such body corporate or of a manager of a corporation) and exemption from the payment of any such fees]:”:
(c) by the substitution for subparagraph (i) of paragraph (k) of subsection ( 1 ) of the following subparagraph: 25
(i) the syllabuses for the various subjects included in the curriculum for the diploma in pharmacy [awarded by the council in terms of section 33(2)]:”:
~ d) b~ the substitution for subparagraph (i) of paragraph (n) of subsection ( I ) of the following subparagraph: 30
(i) the eleclion of members of the council required to be elected in terms of section [5(l)(b) or 7(2)] 5( I ):”: and
(e) by (he insertion of the following subsections after subsection (3): “(4) The council shall. not less than two months before any rule is
made in terms of this Act, cause the text of such rule to be published in 35 the Ga:ette together with a notice declaring the council’s intention to make such a rule and inviting interested persons to furnish the council with comments thereon or any representations they may wish to make in regard thereto.
(5) The Minister shall, not less than three months before any 40 regulation is made in terms of this Act. cause the text of such draft regulation to be published in the Gazette together with a notice declaring the Minister’s intention to make such a regulation and inviting interested persons to furnish the Minister with comments thereon or any represen- tations they may wish to make in regard thereto: Provided that if the 45 Minister thereafter decides to alter the draft regulations as a result of any objections or representations so submitted. it shall not be necessary to publish such alterations before making the re~ulations. ”.
Insertion of section 49A in Act 53 of 1974
40. The following section is hereby inserted after section 49 of the principal Act: 50
“Delegation of powers
49A. ( 1 ) The Minister may delegate or authorise in writing the Director-General or any officer of the Department or the council to exercise any of the powers conferred upon him or her by this Act, other than the powers referred to in section 49. 55
(2) The Director-General may delegate or authorise in writing any officer of the Department or the council to exercise any of the powers conferred upon him or her bv this Act.”.
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Act NO. 88, 1997 PHARMACY AMENDMENT ACT, 1997
Substitution of section 50 of Act 53 of 1974
41. The following section is hereby substituted for section 50 of the principal Act:
“Penalty where not expressly provided
50. Any person who contravenes any provision of this Act in respect of the contravention of which no penalty is expressly provided shall on conviction be liable to a fine not exceeding [five hundred rand] the amount determined by the Minister from time to time by notice in the Gazette.”.
Substitution of section 51 of Act 53 of 1974, as amended by section 11 of Act 6 of 1995
42. The following section is hereby substituted for section 51 of the principal Act:
“Abolition of Interim Pharmacy Council of South Africa, and transitional provisions
51. The [South African] Interim Pharmacy Council of South Africa shall cease to exist on the day immediately preceding the date of the first meeting of the council. and all rights, obligations, assets and liabilities acquired or incurred, as the case may be, by the [South African] Interim Pharmacy Council of South Africa, shall immediately vest in the council and the council shall be deemed to have acquired or incurred such rights. obligations, assets and liabilities in terms of this Act.”.
Substitution of section 52 of Act 53 of 1974
43. The following section is hereby substituted for section 52 of the principal Act:
“Savings
52. (1) Any proclamation. notice, regulation. authorisation or order
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issued, made or granted or any registration, removal from a register. 25 appointment or any other thing done in terms of a provision of arty law repealed, shall, except in so far as may be otherwise required by this Act. be deemed to have been issued, made, granted or done under the provisions of this Act,
(2) The members of the council as constituted immediately prior to the 30 commencement of this Act shall continue to be members. and the council shall be deemed to be validly constituted in terms of this Act, until a date determined by the Minister and published in the Gazette.
(3) If any of the members referred to in subsection (2) vacates his or her office, the council shall, until the date referred to in that subsection, consist 35 of the remaining members.”.
Insertion of section 52A in Act 53 of 1974
44. The following section is hereby inserted in the principal Act, after section 52:
“Act binding on State
52A. This Act is binding on the State.”. 40
Substitution of long title of Act 53 of 1974
45. The following long title is hereby substituted for the long title of the principal Act:
“Act
To provide for the establishment of the South African Pharmacy Council and for its objects and general powers; to extend the control of the council to the 45
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Act No. 88.1997 PH.4RMACY AMENDMENT ACT. 1997
public sector; and to provide for pharmacy education and training, require- ments for registration, the practice of pharmacy, the ownership of pharmacies and the investigative and disciplinary powers of the council; and to provide for matters connected therewith.”,
Short title and commencement
46. ( 1 ) This Act shall be called the Pharmacy Amendment Act, 1997, and shall come into operation on a date fixed by the President by proclamation in the Gamme.
(2) Different dates may be fixed in terms of subsection (1) in respect of the different provisions of this Act.
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