Regulations, Directions and Guidance

This page contains links to all the relevant pharmaceutical regulations, directions issued by the Secretary of State, and subsequent guidance issued by the DH, PCC, or other bodies.

You may also wish to look at the Pharmacy Regulations & Guidance User Group page, which contains the minutes of past meetings, as well as good practice documents and models/tools developed by the NHS.  Click here to go to the group's page.

• Control of Entry
  • 100 hour pharmacies
  • Internet pharmacies
  • One-stop-shop pharmacies 

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Regulations

NHS (Pharmaceutical Services) Regulations 2005

The National Health Service (Pharmaceutical Services) Regulations 2005. These regulations came into force on 1st April 2005 and replace the NHS (Pharmaceutical Services) Regulations 1992 which were revoked by the 2005 regulations. However, the 1992 Regulations remain in force in relation to any applications for inclusion in a pharmaceutical list made before 1 April 2005.

The regulations include:

• Control of Entry provisions (including the four exemptions from Control of Entry)
• Rural dispensing regulations
• Terms of Service under the new pharmacy contractual framework
• Fitness to Practise provisions for pharmacy contractors

Download the National Health Service (Pharmaceutical Services) Regulations 2005

Amendments

National Health Service (Pharmaceutical Services) Amendment Regulations 2005 Number 1015 (which amended the main regulations, which also came into effect on 1 April 2005): 

National Health Service (Pharmaceutical Services) (Amendment No. 2) Regulations 2005 number 1051 (which also amended the main regulations, and came into effect on 5 July)

Amendment Directions (mainly dealing with MURs)

Disability Discrimination Act

Download a copy of the Disability Discrimination Act
Access our resource toolkit on the Disability Discrimination Act.

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Directions

(21st April 08) NHS Pharmaceutical Services (Fees for Applications) in effect from 21st April 2008

Click here to access the directions

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Secretary of State Directions to PCTs

Download the Pharmaceutical Services (Advanced and Enhanced Services) (England) (Amendment) Directions 2005 (for PCTs and coming into force on 1st January 2006)

Download the National Health Service (Pharmaceutical Services) Directions 2005

• The Directions amend the NHS (Pharmaceutical Services) Regulations 2005 to include a provision which was previously in the NHS (Pharmaceutical Services) Regulations 1992. The amendment enables chemists to request copies of their scripts and the calculations made on them so that they can check their remuneration. It also enables LPCs or the PSNC to request copies of these so that they can check them on behalf of any of the chemists they represent.

Download the Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2005

• 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.

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Guidance

Delivering quality in primary care: Primary Care Trust management of primary care practitioners' lists - community chemist contractors / bodies corporate

This guidance is primarily for Primary Care Trusts on managing fitness to practise requirements in respect of either applicants to be admitted to pharmaceutical lists or existing chemists on these lists under the NHS (Pharmaceutical Services) Regulations 2005. This guidance is now in its final version.

Download the guidance
Download annexes to the guidelines

Fitness to practise and bodies corporate

List of Home PCTs for Pharmacy bodies corporate (Updated June 2009)

A revised list of the home PCTs for pharmacy bodies corporate can be found here.

Download the NHS (Pharmaceutical Services) Regulations 2005 - Information for Primary Care Trusts (control of entry)

• This Guidance has been produced to assist Primary Care Trusts in the assessment and determination of applications to provide NHS pharmaceutical services. There are two versions of the guidance. One shows where the guidance has been revised (in tracked changes), the other incorporates the changes.

Department of Health Link to NHS Pharmaceutical Regulations 2005

View NHS Pharmaceutical regulations, guidance on implementation and other useful documents on the Department of Health website.

DH Guidance: Part XIX amended

Click here to download guidance from the DH on payments to chemists suspended by a Primary Care Trust or by direction of the FHSAA.