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Table of Contents
Pharmacy Act, 1974 (Act No. 53 of 1974)
Notice No. 1871 of 1974
Act
1. Definitions
Chapter I : Establishment of The South African Pharmacy Council, its objects, General Powers And Functions
2. Establishment of South African Pharmacy Council
3. Objects of council
4. General powers of council
5. Constitution of council
6. [Repealed]
7. Vacation of office and the filling of vacancies
8. [Repealed]
9. [Repealed]
10 [Repealed]
11. [Repealed]
12. Fees of council
13. Registration
Chapter II : Registration of Pharmacists and Bodies Corporate carrying on Business as a Pharmacist and Maintenance of Registers
14. Registration of persons, recording of licensed premises and maintenance of registers
14A Community service
15. [Repealed]
16. [Repealed]
17. [Repealed]
18. [Repealed]
19 [Repealed]
20. [Repealed]
21. [Repealed]
22. Body corporate carrying on business as pharmacist
22A. Prohibition of opening, purchase or acquisition of certain pharmacies by certain bodies corporate
22B Corporation carrying on business as pharmacist
23. Removal of name from, and restoration to register
24. Appeal against refusal to register or against removal of name from register
25. Publication of registers
26. Register as proof
27. Issue of duplicate registration certificate, extract from register or certificate by registrar
28. Registration of additional qualifications and of specialities
29. Penalties for professing to be or practising as pharmacist while unregistered
30. Penalty for false representation inducing registration, for false entry in register and for impersonation
31. [Repealed]
32. Limitations in respect of unregistered persons and proof required for the issue of licences
Chapter III : Control of Pharmaceutical Education
33. Pharmacy education and training
34. Pharmacy education and training institutions
Chapter IV : Conduct of Pharmaceutical Practice
35. Authorisation for provision and levies for services
35A. Pharmacy practice
36. Restriction in respect of business names
37. Continuation of pharmacy business of person registered in terms of this Act by executor
38. Restriction in, or suspension from, practice of registered person
Chapter V : Disciplinary Powers of the Council
38A. Powers of officers and other persons
39. Inquiry by the council into charges of misconduct
40. Procedure for the conduct of an inquiry
41. Council to make rules relating to offences under this Chapter
42. Charges by pharmacists
43. Commission on prescription
44. Cognizance by council of conduct of registered persons under certain circumstances
45. Penalties the council may impose
45A. Postponement of imposition, and suspension of operation, of penalty
45B. Recovery of fines and cost orders
46. Penalty for false evidence
47. Effect of suspension or removal from register
48. Limitation of liability
Chapter VI : General and Supplementary Provisions
49. Regulations
49A. Delegation of powers
50. Penalty where not expressly provided
51. Abolition of Interim Pharmacy Council of South Africa, and transitional provisions
52. Savings
53. Short title and commencement
Regulations
Regulations relating to Pharmacy Education and Training
Notice No. R. 1156 of 2000
1. Definitions
Chapter l: Standards of education and training of pharmacists
2 - 3. Minimum curriculum
4. Course for a qualification in pharmacy
5 - 13. Requirements and conditions for pharmacy internship
14. Cession of contract of pharmacy internship
15. Approval of the contract of cession
16. Delegation of training by tutor
17. Assessment and completion of pharmacist internship
18. Pre-registration evaluations
19. [Deleted] Qualification in pharmacy entitling pharmacists to registration
Chapter ll: Standards of education and training of pharmacists' assistants (basic) and pharmacist's assistants (post-basic)
20 - 22. Standards of education and training of pharmacists' assistants
23 - 25. Entry assumptions for a pharmacist's assistant in the categories pharmacist's assistant (learner basic) and pharmacist's assistant (learner post-basic)
26 - 27. General requirements and conditions for in-service training
28 - 29. Delegation of in-service training
30 - 31. Supervision of pharmacy support personnel undergoing in-service training
32 - 33. Evaluation prior to registration of a person in the category pharmacist's assistant (basic) or pharmacist's assistant (post basic)
Chapter III : Standards of education and training of pharmacy technicians
34. [Deleted] Certificate of qualification entitling pharmacists' assistants to registration
34A - 34F. Standards of education and training of pharmacy technicians
34G. Cession of contract of traineeship
34H - 34I. Approval of contract of cession
34J. Assessment and completion of pharmacy technician traineeship
34K. Pre-registration evaluations
34L. Evaluation of prior learning
Chapter IV : Registration of Tutors and Approval of Premises for purpose of Education and Training
35. Approval of a tutor
36 - 40. Approval of premises
Chapter V : Approval of providers of pharmacy education and training
41. Approval of providers
42. Conditions for approval
42A. Appointment and duties of designated pharmacist
43 - 48. Inspection of providers
Repeal
Annexures
[Deleted] Annexure A : Unit standards for pharmacists
[Deleted] Annexure B : Unit standards for pharmacist's assistants in the category pharmacist's assistant (basic) and pharmacist's assistant (post-basic)
[Deleted] Annexure C
Regulations relating to the Registration of Persons and the Maintenance of Registers
Notice No. R. 1160 of 2000
1. Definitions
Chapter I
Chapter II
Chapter III
Chapter IV
Chapter V
Chapter VI
Chapter VII
Chapter VIII
Chapter IX
Chapter IXA
Chapter X
Chapter XI
Chapter XII
Chapter XIII
Chapter XIV
Chapter XV
Regulations Relating to Continuing Professional Development, 2019
Notice No. 668 of 2019
1. Definitions
2. Participation in Continuing Professional Development
3. Annual Declaration
4. Designation on registers kept in terms of section 14
5. Assessment
6. Non-Compliance
7. Appeals
8. Deferment
9. Short title and Commencement
Regulations Relating to Fees Payable to the South African Pharmacy Council, 2022
Notice No. R. 2827 of 2022
1. Definitions
2. Fees payable to Council
3. Determination of Fees
4. Short title
Schedule of Fees as at 1 January 2023
Notices
Application Fee: Application for a Licence for Pharmacy Premises
Notice No. 760 of 2003
List of Approved Facilities for the Purposes of performing Community Service by Pharmacists in the year 2016
Notice No. 691 of 2015
Guidance for the issuing of Licences for Pharmacy Premises
Notice No. 1476 of 2017
1. Introduction
2. Definitions
3. Purpose
4. General principles
5. Information to be submitted with the pharmacy premises licence application
6. Norms for granting of licences for pharmacy premises
7. Basis for evaluation of applications
8. Title
Board Notices
Rules Relating to the Services for which a Pharmacist may Levy a Fee and Guidelines for Levying such a Fee or Fees 2004
Board Notice 106 of 2004
Annexure A : Guidelines for Levying a Fee or Fees
Rules Relating to Good Pharmacy Practice, 2004
Board Notice 129 of 2004
Introduction
The underlying philosophy
The scope of practice of pharmacists
Good pharmacy practice requirements
General objectives and requirements of pharmaceutical services
Chapter 1 : Professional Standard for Premises
1.1 Introduction
1.2 Minimum Standards for Pharmacy Premises, Facilities and Equipment
1.3 Minimum Standards Relating Specifically to Institutional Pharmacies
1.4 Minimum Standards for Community or Institutional Pharmacies providing Pharmaceutical Services from a Mobile Unit
1.5 Minimum Standards for Community or Institutional Pharmacies Operating Websites
1.6 Minimum Standards for the Supply of Medicines in a Primary Health Care Clinic
1.7 Minimum Standards Specifically Relating to the Medicine Room of a Person Licenced to Dispense Medicine in terms of the Medicines Act
1.8 Minimum Standards Specifically Relating to a Storage Area for Pharmaceuticals Outside the Physical Premises of a Pharmacy
1.9 Minimum Standards Relating to Automated Dispensing Units for the Purpose of Dispensing Medicines and Medical Devices
1.10 Minimum Standard for a Drive-Through Facility in a Pharmacy
1.11 Minimum Standards for Institutional Public Pharmacy Operating a Remote Automated Dispensing Unit (RADU)
Chapter 2 : Professional Standards for Services
2.1 Introduction
2.2 Minimum Standards for Manufacturing of any Medicine or Scheduled Substance
2.3 Minimum Standards for Procurement, Storage and Distribution
2.4 Minimum Standards Relating Specifically to Institutional Pharmacies
2.5 Minimum Standards Relating Specifically to Mobile Pharmaceutical Services
2.6 Minimum Standards Relating Specifically to Wholesale Pharmacies
2.7 Minimum Standards for the Dispensing of Medicine or Scheduled Substances on the Prescription of an Authorised Prescriber
2.8 Minimum Standards for Patient Information and Advice
2.9 Minimum Standards for Record Keeping Procedures
2.10 Minimum Standards for Dispensing Specifically in Institutional Pharmacies
2.11 Minimum Standards for Clinical Pharmaceutical Services in Institutional Pharmacies
2.12 Minimum Standards for Pharmacist -Initiated Therapy
2.13 Minimum Standards for Screening and Monitoring Services in Pharmacies
2.14 Minimum Standards for Immunisation Services
2.15 Minimum Standards for Reproductive Health Services
2.16 Minimum Standards for other Health Care Services
2.17 Minimum Standards for Aseptic Dispensing Service
2.18 Compounding
2.19 Pre-packing
2.20 Minimum Standards for a total Parenteral Nutrition (TPN) Consultation Service
2.21 Minimum Standards for therapeutic medicine monitoring scheme
2.22 Minimum Standards for the Provision of Complementary Medicine
2.23 Minimum Standards for Animal Health Care Services
2.24 Minimum Standards for Aids Resource Centres in a Pharmacy
2.25 Review of the overall Medication Requirements of a Patient
2.26 Minimum Standards for Emergency Postcoital Contraception (EPC) (SAPC GPP 2010)
2.27 Control of Schedule 6 Medicines or Substances
2.28 Approval of Tutors and Premises for Training of Pharmacist Interns and Pharmacist's Assistants
2.29 Products which may not be sold in a Pharmacy
2.30 Minimum Standards regarding Maintenance and Disposal of Confidential Information relating to Patients
2.31 Information relating to Compliance with Good Pharmacy Practice to be submitted in support of an Application for a Licence for Pharmacy Premises to be issued in terms of the Regulations relating to the Ownership and Licensing or Pharmacies published i
2.32 Minimum Standards regarding Destruction and Disposal of Medicines and Scheduled Substances
2.33 Minimum Standard for the Sale of HIV Self-Screening Test Kits
Chapter 3 : Professional Standards for Pharmacy Human Resources
3.1 Scope of Practice of Pharmacy Personnel
3.2 Recommended Standards regarding Staff Selection, Appraisal and Training
3.3 Legislative Requirements regarding the Training of Pharmacist Interns and Pharmacist's Assistants
3.4 Minimum Standards for Pharmaceutical Human Resource Development
3.5 Professional Indemnity
3.6 Minimum Standards for Locum/Relief Pharmacists
3.7 Minimum Standards for the Management of Human Resources in Wholesale and Manufacturing Pharmacies
3.8 Minimum Standard relating to the Supervision of Pharmacy Support Personnel
3.9 Scope of Practice of Pharmacy Personnel
Chapter 4 : Professional Standards for Pharmacy Management
4.1 Introduction
4.2 Minimum Standards for Pharmacy Administration and Management
4.3 Minimum Standards for Quality Management in a Institutional Pharmacy
Annexure A : Scope of Practice of Pharmacy Personnel
Minimum Standard for Sexual and Reproductive Health Services provided by Pharmacists
Rules Relating to the Code of Conduct, 2008
Board Notice 108 of 2008
Introduction
1.1 Wellbeing of the Patient
1.2 Honour and Dignity of the Profession
1.3 Confidentiality
1.4 Continuing Professional Development (CPD)
1.5 Co-operation with Health Care Professionals
1.6 Professional Independence
1.7 Advertising
1.8 Professional Appearance and Nature of Pharmacy
1.9 Control over Medicines
1.10 Chemicals sold/provided in a Pharmacy
1.11 Dual Registration
1.12 The Use of Trading Titles, Brand Names and Logos
Rules Relating to the Services for which a Pharmacist may Levy a Fee and Guidelines for Levying such a Fee or Fees 2009
Board Notice 65 of 2009
Annexure A : Guidelines for Levying a Fee or Fees
Fees Payable to the Council under The Pharmacy Act 53 of 1974
Board Notice 150 of 2010
Board Notice 841 of 2017
Board Notice 170 of 2018
Board Notice 188 of 2019
Board Notice 83 of 2021
Board Notice 133 of 2021
Board Notice 185 of 2021
Board Notice 526 of 2023
[Replaced] Rules Relating to the Services for which a Pharmacist may Levy a Fee and Guidelines for Levying such a Fee or Fees 2010
Board Notice 193 of 2010
Annexure A : Guidelines for Levying a Fee or Fees
Rules Relating to Good Pharmacy Practice
1. Introduction
2. Purpose
3. General Considerations
4. Legislative Requirements
5. Minimum Requirements for the Destruction of Medicines
6. Disposal of Medicines
Rules Relating to Good Pharmacy Practice, 2017
Board Notice 184 of 2017
Minimum Standard for the Sale of HIV Self-Screening Test Kits
2017 Good Pharmacy Education Standards
Board Notice 183 of 2017
Preamble and Principles
Definition and Abbreviations of Terms
1. Minimum Standards for Vision, Mission and Planning
2. Minimum Standards for Organisation and Administration
3. Minimum Standards for Work-Based Learning
4. Minimum Standards for Facilities and Financial, Human and Physical Resources
5. Minimum Standards for Delivery of Programmes
6. Minimum Standards for Student Matters
7. Minimum Standards for Quality Assurance
8. Minimum Standards for Short Courses registered with Council
Bibliography
Addendums
Addendum 1 : An Example of Space Requirements for a BPHARM Programme
Addendum 2 : Criteria for the Evaluation of Foreign Qualifications
Addendum 3 : Exit Level Outcomes for the Qualifications in Pharmacy Higher Certificate in Pharmacy Technical Support
Addendum 4 : Requirements and Procedures of Council for Accreditation of Prospective Providers and Reaccreditation and Monitoring of Current Providers
2018 Competency Standards for Pharmacists in South Africa: Board Notice 59 of 2018
Board Notice 59 of 2018
Acronyms
Acknowledgements
Definitions
1. Introduction
2. Background
3. The Competency Standard Development Team
4. Competence Standards vs Competency Standards
5. Development Process
6. Development of the Competency Standards
7. Structure of the Competency Standards and Domains
8. Competency Standards for Pharmacists in South Africa
9. Levels of Practice for Pharmacists
10. The 2018 Competency Standards for Pharmacists in South Africa
Domain 1: Public Health
Domain 2: Safe and Rational Use of Medicines and Medical Devices
Domain 3: Supply of Medicines and Medical Devices
Domain 4: Organisation and Management Skills
Domain 5: Professional and Personal Practice
Domain 6: Education, Critical Analysis and Research
References
Election/Appointment of Members of Council
Board Notice 184 of 2018
Rules relating to the Services for which a Pharmacist may levy a fee and Guidelines for levying such a fee or fees 2019
Board Notice 35 of 2019
Annexures
Annexure A : Guidelines for Levying a Fee or Fees
Annexure B : Guidelines for Levying a Fee for Fees
Additional Fees Payable to the Council under the Pharmacy Act 53 of 1974 (2019)
Board Notice 41 of 2019
Regulations Relating to Continuing Professional Development (CPD)
Board Notice 174 of 2019
Rules relating to the Services for which a Pharmacist may levy a fee and Guidelines for levying such a fee or fees, 2020
Board Notice 27 of 2020
Annexures
Annexure A : Guidelines for Levying a Fee or Fees
Annexure B : Services for which a Pharmacist may levy a Fee or Fees
Guideline for the Removal of Pharmacy registration/recording as a result of non-compliance with good pharmacy practice and other pharmacy legislation
Board Notice 63 of 2020
1. Title
2. Background
3. Purpose of the guideline
4. Definitions and abbreviations
5. Legal framework
6. Criteria for the removal of the registration/recording of a pharmacy
7. Process for the removal of the registration/recording of a pharmacy
8. Restoration of the registration/recording of a pharmacy
9. Appeal process
10. Annexures
The Restoration Requirements and Process for Pharmacists who have been Removed from the Register
Board Notice 80 of 2020
Restoration Process for Pharmacists who have been removed from the Register of Pharmacists for a specified period
Guidelines for Registration of Persons who hold a Bachelor of Pharmacy Degree, as Pharmacist's Assistant Post-Basic
Board Notice 138 of 2020
[Replaced] Rules relating to the Services for which a Pharmacist may levy a fee and Guidelines for levying such a fee or fees, 2021
Board Notice 69 of 2021
Annexures
Annexure A : Guidelines for Levying a Fee or Fees
Annexure B : Services for which a Pharmacist may levy a Fee of Fees
A Pharmacist who provides Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART) services in South Africa: Scope of Practice, Competency Standards and the Criteria for Accreditation of a Pharmacist Initiated Management of Antiretroviral Therap
Board Notice 101 of 2021
Part 1: The Scope of Practice for a PIMART Pharmacist
Part 2: Competency Standards for a Pharmacist who provides Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART) Services
Acronyms
Definitions
Summary of PIMART Competency Standards
Domain 1: Conduct Testing and Diagnosis of HIV
Domain 2: Initiate Pre-Exposure Prophylasis (PrEP), Post-Exposure Prophylaxis (PEP) and 1st Line Antiretroviral Therapy (ART) plus initiation of TB-Preventative Therapy (TPT) where appropriate and apply protocol adherence measures
Domain 3: Implement Processes for the prevention of HIV transmission and infection via PrEP, safer conception and contraception, and prevention of mother to child transmission
Domain 4: Implement processes to identify and manage co-morbidities and opportunistic infections related to HIV
Domain 5: Implement processes to prevent and manage drug interactions, adverse drug reactions and drug resistance
Domain 6: Handle ART data responsibly and use Disease Management Systems appropriately
References
Part 3: Criteria for Accreditation/Approval by the South African Pharmacy Council of a curriculum leading to the awarding of a Pharmacist Initiated Management of Antiretroviral Therapy course
A. Introduction
B. Principles
C: Criteria for Accreditation/Approval of a curriculum leading to the awarding of a PIMART course
1. Criteria for entry to the course
2. Criteria for compliance with the requirements of the course
3. Requirements for pharmacists who want to provide PIMART services
4. Criteria for compliance with the outcomes
5. Criteria for compliance with requirements relating to qualifications and experience of course presenters
6. Criteria for compliance with requirement for prior approval by the relevant structures of the institution
7. Criteria for compliance with requirements relating to mode of delivery
8. Criteria for compliance with requirements relating to assessment and moderation
9. Criteria for compliance with the process of appeal
10. Criteria for compliance with the dishonesty and plagiarism policy
11. Criteria for compliance with the certification methods and procedures
12. Criteria for compliance with facilities and equipment
13. Criteria for compliance with standards for administration and record keeping
A Pharmacist who offers Immunisation Services in South Africa: Scope of Practice, Competency Standards and the Criteria to Accredit a Generic Short Course for Pharmacists in Immunisation and Injection Technique, and delivering Immunisation Services
Board Notice 241 of 2022
Part 1: Scope of Practice for a Pharmacist offering Immunisation Services
Part 2: Competency Standards for a Pharmacist who provides Immunisation Services
1. Introduction
2. Background
3. Summary of Competency Standards for Pharmacists providing Immunisation Services
Domain 1: Public Health
Domain 2: Safe and Rational use of Vaccine and Administration Device
Domain 3: Supply of Vaccines
Domain 4: Organisational and Management Skills
Domain 5: Professional and Personal Practice
4. References
Part 3: Criteria to Accredit a Generic Short Course for Pharmacists in Immunisation and Injection Technique, and delivering Immunisation Services
1. Rationale for training on Immunisation and Injection Technique
2. Purpose of the Immunisation and Injection Technique training
3. Target group for Immunisation and Injection Technique training
4. Minimum entrance criteria to the Immunisation and Injection Technique training
5. Duration of the Immunisation and Injection Technique training
6. Immunisation and Injection Technique training rules
7. Recognition of prior learning
8. Outcomes and associated Assessment Criteria
9. Critical cross-field outcomes
10. Qualifications and experience of presenters/facilitators
11. Standards for presentation of the Immunisation and Injection Technique training
12. Mode of Delivery
13. Assessment of the Immunisation and Injection Technique training
14. Process of Appeal
15. Process in case of Dishonesty and Plagiarism
16. Standards for administration and record keeping
17. Certification methods and procedures
18. Facilities, Equipment and Consumables
19. Appendix A - Medicine List
Rules Relating to the Services for which a Pharmacist may Levy a Fee and Guidelines for Levying such a Fee or Fees
Board Notice 287 of 2022
Annexures
Annexure A : Guideline for Levying a Fee or Fees
Annexure B
Pharmacists providing Family Planning Services (Reproductive Health Services)
Board Notice 314 of 2022
Part 1: Scope of Practice for a Pharmacist who provides Family Planning Services (Reproductive Health Services)
Part 2: Competency Standards for Pharmacists who provides Family Planning Services (Reproductive Health Services)
Acronyms
Definitions
1. Introduction
2. Background
3. Development of Competency Standards for Pharmacists providing Family Planning Services
4. Summary of Competency Standards for a Pharmacist providing Family Planning Services
Domain 1: Public Health
Domain 2: Safe and rational use of medicines and medical devices
Domain 3: Supply of medicines and medical devices
Domain 4: Organisational and management skills
Domain 5: Professional and personal practice
5. References
Part 3: Criteria for Accreditation of Family Planning (Reproductive Heath) Learning Programme
List of Abbreviations
Rationale for training on Family Planning (Reproductive Health)
Purpose of the Family Planning (Reproductive Health) Training
Target group for Family Planning (Reproductive Health) Training
Minimum entrance criteria to the Family Planning Training (Reproductive Health)
Duration of the Family Planning Training (Reproductive Health)
Family Planning (Reproductive Health) Training Rules
Recognition of prior learning
Outcomes and the associated Assessment Criteria
Critical Cross-field Outcomes
Qualifications and Experience of Presenters/Facilitators
Standards for presentation of the Family Planning Training (Reproductive Health)
Mode of delivery
Assessment of the Family Planning (Reproductive Health) Training
Process of Appeal
Process in case of dishonesty and plagiarism
Standards for administration and record keeping
Certification methods and procedures
Facilities and Equipment
Appendix A- Medicine List
Standard for Tutor Training Programmes
Board Notice 318 of 2022
1. Definitions
2. Purpose and Rationale of the Programme
3. Learning assumed to be in place
4. Programme Rules
5. Exit Level Outcomes
6. Associated Assessment Criteria
7. Critical Cross-Field Outcomes
8. International Comparability
9. Moderation Options
10. Qualifications and Experience of Presenters/Facilitators
11. Criteria for the Registration of Assessors and Moderators
12. Notes
Primary Care Drug Therapy Pharmacist (PCDT)
Board Notice 384 of 2023
Part 1 : The Scope of Practice for a Pharmacist providing Primary Care Drug Therapy (PCDT)
Part 2 : Competency Standards for a Pharmacist providing Primary Care Drug Therapy
Part 3 : Criteria for Accreditation : Primary Care Drug Therapy
[Replaced] Rules Relating to the Services for which a Pharmacist may Levy a Fee and Guidelines for Levying such a Fee or Fees
Board Notice 385 of 2023
Annexures
Annexure A : Guidelines for Levying a Fee of Fees
Annexure B
Rules Relating to the Services for which a Pharmacist may Levy a Fee and Guidelines for Levying such a Fee or Fees
Board Notice 539 of 2023
Annexures
Annexure A : Guidelines for Levying a Fee or Fees
Annexure B
Minister
means the Minister of Health;
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