The National Health Service (Pharmaceutical Services) Regulations 2005

1. Introductory Text

2. PART 1 General

   1. 1. Citation, commencement and extent

   2. 2. Interpretation

   3. 3. Terms of service

3. PART 2 Pharmaceutical Lists and Applications for Admission to a Pharmaceutical List

   1. 4. Preparation of lists

   2. 5. Applications for inclusion in or amendment to a pharmaceutical list

   3. 6. Applications involving a minor relocation within a Primary Care Trust’s area

   4. 7. Applications involving a minor relocation between neighbouring Primary Care Trusts

   5. 8. Applications involving a change of ownership

   6. 9. Applications following suspension from the list

   7. 10. Right of return to pharmaceutical lists

   8. 11. Refusal: general provisions

   9. 12. Necessary or desirable test

   10. 13. Exemption from the necessary or desirable test

   11. 14. Variation of directed services in respect of exempted premises

   12. 15. Approved retail areas

   13. 16. New one-stop primary care centres

   14. 17. Refusal: distance selling premises

   15. 18. Refusal: premises which are in a controlled locality but not in a reserved location

   16. 19. Refusal: fitness to practise grounds

   17. 20. Imposition of conditions

   18. 21. Conditional inclusion relating to fitness to practise matters

   19. 22. Relevant procedures for applications

   20. 23. Notification of applications

   21. 24. Determination of applications

   22. 25. Deferral of consideration of certain applications

   23. 26. Deferral of consideration of applications on fitness to practise grounds

   24. 27. Notification of decision

   25. 28. Notifications by Primary Care Trusts to other persons

   26. 29. Appeals

   27. 30. Appeals against imposition of conditions and related decisions

   28. 31. Determination that an area is a controlled locality

   29. 32. Appeals relating to rurality of an area

   30. 33. Notification of an application in respect of premises in a controlled locality

   31. 34. Decision not to consider an application in respect of premises in a controlled locality

   32. 35. Pharmaceutical services in reserved locations

   33. 36. Determination of applications in respect of controlled localities

   34. 37. Notification of decision in respect of applications in controlled localities

   35. 38. Appeals in connection with determinations in respect of controlled localities etc

   36. 39. Procedure after grant of application

   37. 40. Preliminary consent to be included in a pharmaceutical list

   38. 41. Effect of preliminary consent

4. PART 3 Conditional inclusion, suspension and removal from pharmaceutical lists

   1. 42. Review of decision to impose conditions

   2. 43. Appeals following a review

   3. 44. Removal for breach of conditions

   4. 45. Removal from pharmaceutical lists

   5. 46. Criteria for decisions on removal

   6. 47. Cases where the Primary Care Trust must remove a chemist

   7. 48. Procedure on removal

   8. 49. Supplementary matters relating to removal

   9. 50. Procedure on suspension

   10. 51. Procedure on review of Primary Care Trust decision

   11. 52. Review periods on national disqualification

   12. 53. Withdrawals from the list

   13. 54. Temporary provision of services during a period of suspension

   14. 55. Notifications

5. PART 4 Payments to chemists

   1. 56. Standards of, and payments for, drugs and appliances

   2. 57. Claims and overpayments

   3. 58. Payments to suspended chemists

   4. 59. Reward Scheme

6. PART 5 Provision of Pharmaceutical Services by Doctors

   1. 60. Arrangements for provision of pharmaceutical services by doctors

   2. 61. Outline consent and premises approval

   3. 62. Taking effect of outline consent and premises approval

   4. 63. Lapse of outline consent and premises approval

   5. 64. Premises approval: change of premises before outline consent takes effect

   6. 65. Premises approval: additional and new premises after outline consent has taken effect

   7. 66. Premises approval: practice amalgamations

   8. 67. Premises approval – transitional provisions

   9. 68. Dispensing doctor lists

   10. 69. Removal of entries from dispensing doctor lists

7. PART 6 Miscellaneous

   1. 70. Publication of particulars

   2. 71. List of chemists providing an ETP service

   3. 72. Exercise of choice of chemist in certain cases

   4. 73. Transitional provisions

   5. 74. Transitional arrangements in respect of terms of service

   6. 75. Minor and consequential amendments and revocations

8. Signature

9. 1. SCHEDULE 1

      TERMS OF SERVICE OF PHARMACISTS

      1. PART 1 GENERAL

         1. 1. Incorporation of provisions

         2. 2. Division of responsibilities between individuals and corporate bodies

      2. PART 2 ESSENTIAL SERVICES

         1. 3. Essential services

         2. 4. Dispensing services

         3. 5. Dispensing of drugs and appliances

         4. 6. Urgent supply without a prescription

         5. 7. Preliminary matters before providing ordered drugs or appliances

         6. 8. Providing ordered drugs or appliances

         7. 9. Refusal to provide drugs or appliances ordered

         8. 10. Further activities to be carried out in connection with the provision of dispensing services

         9. 11. Additional requirements in relation to electronic prescribing

         10. 12. Disposal service in respect of unwanted drugs

         11. 13. Basic procedure in respect of unwanted drugs

         12. 14. Further activities to be carried out in connection with the disposal of unwanted drugs

         13. 15. Promotion of healthy lifestyles

         14. 16. Prescription linked intervention

         15. 17. Public health campaigns

         16. 18. Signposting

         17. 19. Service outline in respect of signposting

         18. 20. Support for self-care

         19. 21. Service outline in respect of support for self-care

      3. PART 3 HOURS OF OPENING

         1. 22. Pharmacy opening hours: general

         2. 23. Matters to be considered when issuing directions in respect of pharmacy opening hours

         3. 24. Determination of pharmacy opening hours instigated by the Primary Care Trust

         4. 25. Determination of pharmacy opening hours instigated by the pharmacist

      4. PART 4 CLINICAL GOVERNANCE, FITNESS TO PRACTISE AND COMPLAINTS

         1. 26. Clinical governance

         2. 27. Professional Standards

         3. 28. Inducements etc.

         4. 29. Duty to provide information about fitness to practise matters: pharmacists on pharmaceutical lists on 1st April 2005

         5. 30. Duty to provide information about fitness to practise matters as they arise

         6. 31. Home Primary Care Trust of bodies corporate

         7. 32. Complaints

      5. PART 5 OTHER TERMS OF SERVICE

         1. 33. Directed Services

         2. 34. Information to be supplied

         3. 35. Withdrawal from pharmaceutical lists

         4. 36. Charges for drugs and refunds

         5. 37. Inspections and access to information

   2. SCHEDULE 2

      TERMS OF SERVICE OF DISPENSING DOCTORS

      1. 1. Incorporation of provisions

      2. 2. Persons duly authorised to dispense on behalf of dispensing doctors

      3. 3. Dispensing of drugs and appliances ordered by another prescriber

      4. 4. Dispensing of drugs and appliances ordered by the dispensing doctor

      5. 5. Preliminary matters before providing ordered drugs or appliances

      6. 6. Provision of Scheduled drugs

      7. 7. Refusal to provide drugs or appliances ordered

      8. 8. Fees and charges

      9. 9. Complaints procedures

      10. 10. Inspections and access to information

   3. SCHEDULE 3

      TERMS OF SERVICE OF SUPPLIERS OF APPLIANCES

      1. 1. Incorporation of provisions

      2. 2. Division of responsibilities between individuals and corporate bodies

      3. 3. Dispensing services

      4. 4. Dispensing of appliances

      5. 5. Preliminary matters before providing appliances

      6. 6. Providing appliances

      7. 7. Refusal to provide appliances ordered

      8. 8. Further activities to be carried out in connection with the provision of dispensing services

      9. 9. Additional requirements in relation to electronic prescribing

      10. 10. Opening hours: general

      11. 11. Matters to be considered when issuing directions in respect of opening hours

      12. 12. Determination of opening hours instigated by the Primary Care Trust

      13. 13. Determination of opening hours instigated by the supplier of appliances

      14. 14. Professional Standards

      15. 15. Inducements etc.

      16. 16. Duty to provide information about fitness to practise matters: suppliers of appliances on pharmaceutical lists on 1st April 2005

      17. 17. Duty to provide information about fitness to practise matters as they arise

      18. 18. Home Primary Care Trust of bodies corporate

      19. 19. Complaints

      20. 20. Directed Services

      21. 21. Information to be supplied

      22. 22. Withdrawal from pharmaceutical lists

      23. 23. Charges for appliances

      24. 24. Inspections and access to information

   4. SCHEDULE 4

      1. Part 1 INFORMATION TO BE INCLUDED IN AN APPLICATION FOR INCLUSION IN A PHARMACEUTICAL LIST OR INCLUSION IN A LIST IN RESPECT OF DIFFERENT SERVICES OR PREMISES

         1. 1. APPLICATION

         2. 2. DETAILS OF APPLICANT

         3. 3. DETAILS OF PREMISES AND OPENING HOURS

         4. 4. PHARMACEUTICAL SERVICES TO BE PROVIDED

         5. 5. NECESSARY OR DESIRABLE TEST

         6. 6. APPLICATIONS MADE UNDER REGULATION 5(1)(b)(ii) OR 5(1)(c)

         7. 7. APPLICATIONS MADE UNDER REGULATION 5(1)(b)(iii)

         8. 8. APPLICATIONS MADE IN ACCORDANCE WITH REGULATION 8

      2. Part 2 NOTIFICATION OF COMMENCEMENT DATE

      3. Part 3 INFORMATION AND UNDERTAKINGS TO BE GIVEN BY AN APPLICANT IN CONNECTION WITH AN APPLICATION FOR INCLUSION (OR TEMPORARY INCLUSION) IN A PHARMACEUTICAL LIST

         1. 1. An applicant (other than an applicant which is a body...

         2. 2. An applicant which is a body corporate shall provide the...

         3. 3. An applicant shall provide the following undertakings—

         4. 4. An applicant shall supply in writing information as to whether...

         5. 5. If the applicant (and where the applicant is a body...

         6. 6. Where the applicant (or where the applicant is a body...

         7. 7. Where the applicant (or where the applicant is a body...

         8. 8. Where the applicant is a body corporate, the name and...

         9. 9. The applicant shall supply the name of any Primary Care...

         10. 10. If the applicant is the director or superintendent of a...

         11. 11. If, in the case of any application, the Primary Care...

         12. 12. The applicant shall give a written undertaking to notify the...

   5. SCHEDULE 5

      MINOR AND CONSEQUENTIAL AMENDMENTS

      1. 1. The National Health Service (General Medical Services Contracts) (Personal Medical Services Agreements) and (Pharmaceutical Services) (Amendment) Regulations 2005

      2. 2. The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004

      3. 3. The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004

      4. 4. The Nurses and Midwives (Parts of and Entries in the Register) Order of Council 2004

      5. 5. The National Health Service (General Medical Services etc) (Patients' Forums) Amendment Regulations 2003

      6. 6. The National Health Service (Pharmaceutical Services) (General Medical Services) and (Charges for Drugs and Appliances) Amendment Regulations 2003

      7. 7. The National Health Service (Amendments Relating to Prescribing by Nurses and Pharmacists etc) (England) Regulations 2003

      8. 8. The National Health Service (Local Pharmaceutical Services Etc) Regulations 2002

      9. 9. The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc Provisions) Regulations 2002

      10. 10. The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002

      11. 11. The National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002

      12. 12. The National Health Service (Pharmaceutical Services) and (Misuse of Drugs) (Electronic Communications) Order 2001

      13. 13. The National Health Service (Charges for Drugs and Appliances) Regulations 2000

      14. 14. The National Health Service (Payments by Local Authorities to NHS Bodies) (Prescribed Functions) Regulations 2000

      15. 15. The National Health Service (Pilot Schemes for Personal Dental Services: Miscellaneous Provisions and Consequential Amendments) Regulations 1998

      16. 16. The National Health Service (Indicative Amounts) Regulations 1997

      17. 17. The National Health Service (Service Committees and Tribunal) Regulations 1992

      18. 18. The National Health Service (General Dental Services) Regulations 1992

   6. SCHEDULE 6

      REVOCATIONS

10. Explanatory Note