Pharmacy Regulation
NHS Pharmaceutical Services Regulations (2005)
The National Health Service (Pharmaceutical Services) Regulations 2005 incorporate the Control of Entry provisions (including the four exemptions from Control of Entry), rural dispensing regulations, the Terms of Service under the new pharmacy contractual framework and Fitness to Practise provisions for pharmacy contractors.
The authoritative source is the Office of Public Sector Information, and the following are links to the Statutory Instruments. Whenever it is necessary to identify what the law requires, the original statutory instrument must be used, then check for subsequent amendment in any amending regulations.
Click on the link below to view the National Health Service (Pharmaceutical Services) Regulations 2005 Number 641 (the main regulations which came into effect on 1 April 2005):
The National Health Service (Pharmaceutical Services) Regulations 2005 Number 641
For a basic introduction to the contract Terms of Service click on the link below:
Pharmaceutical Journal article: What do the contract regulations mean?
Amendment Regulations
The Principal Regulations have been amended several times.
Click on the links below to view the amending regulations:
The National Health Service (Pharmaceutical Services) Amendment Regulations 2005 Number 1015 (effective 1 April 2005)
The National Health Service (Pharmaceutical Services) (Amendment No.2) Regulations 2005 Number 1501 (effective 5 July 2005)
The National Health Service (Primary Medical Services) (Miscellaneous Amendments) (No.2) Regulations 2005 Number 3315 (effective 6 January 2006)
The Smoking, Health and Social Care (Scotland) Act 2005 (Consequential Modifications) (England, Wales and Northern Ireland) Oreder 2006 Number 1056 (effective 31 March 2006)
The National Health Service (Performers Lists) Amendment Regulations 2005 Number 3491 (effective 1 April 2006)
The National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 Number 552 (effective 1 April 2006)
The General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions Order 2006 Number 562 (effective 1 April 2006)
The National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) Regulations 2006 Number 913 (effective 1 May 2006)
The National Health Service (Primary Medical Services and Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2006 Number 1501 (effective 24 July 2006)
The National Health Service (Pharmaceutical Services) Amendment Regulations 2006 Number 3373 (effective 19 January 2007)
The National Health Service (Pharmaceutical Services) (Remuneration for Persons providing Pharmaceutical Services) (Amendment) Regulations 2007 Number 674 (effective 1 April 2007)
The Local Involvement Networks Regulations 2008 Number 528 (effective 1 April 2008)
The National Health Service (Pharmaceutical Services) (Amendment) Regulations 2008 Number 683 (effective 21 April 2008)
The Local Involvement Networks (Miscellaneous Amendments) Regulations 2008 Number 1514 (effective 14 July 2008)
The Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 Number 309 (effective 1 April 2009)
The National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) Amendment Regulations 2009 Number 599 (effective 14 April 2009)
The National Health Service (Miscellaneous Amendments Relating to Community Pharmaceutical Services and Optometrist Prescribing) Regulations 2009 Number 2205 (effective 17 September 2009)
The above amendment regulations introduce a number of changes. PSNC has produced a briefing for pharmacy contractors that seeks to explain the amendments. This briefing can be downloaded below. However, in all cases, the legislation is contained in the Statutory Instrument published on the Office of Public Sector Information, and that is the authoritative source of law.
Secretary of State Directions
Click on the link below to view the Secretary of State Directions, which provide the regulatory framework for the Advanced Services (Medicines Use Review and Prescription Intervention Service) and the Enhanced Services.
The Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2005 (PDF Format)
The following Directions, amend the above directions. These Directions must be read in conjunction with the above Directions issued in 2005. Changes made to the Directions since they were originally published include to allow a pharmacist to provide MUR services in a consultation area away from the pharmacy, in certain circumstances where the PCT gives its consent. For MUR services arising from a prescription intervention, the requirement to have provided pharmaceutical services for a minimum of three months is removed. The numerical limit each financial year and the fee per MUR has also been changed. The December 2007 amendment introduces the new MUR form, and amends the requirements for sending copies ot the patient's GP.
Secretary of State Directions Amendment March 2006 (PDF Format)
Secretary of State Directions Amendment September 2006 (PDF Format)
Secretary of State Directions Amendment December 2007 (PDF Format)
Support on Regulatory Issues
Pharmacy contractors can obtain support on regulatory issues by contacting PSNC's Aylesbury Office
DOWNLOADS: Some documents are available in PDF format, you will require Adobe Acrobat Reader 5.0 or later for viewing which can be downloaded from the Adobe Website
DOWNLOADS: Some documents are available in ‘Microsoft Word’ format. If you do not have Microsoft Word, you can read these forms by downloading the free 'Word Viewer'. This program can be downloaded at the Microsoft website

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