Responsibilities of NHS pharmacists and pharmacy staff
- Ensure Schedule 4 responsibilities are met by yourself or qualified staff
UK Statutory Instrument
2013
United Kingdom
The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013
At a glance
What's here
86 compliance obligations
Who this Act binds
Plus 1 non-business duty on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Schedules
Additional requirements in relation to electronic prescribing
- Notify patients of pharmacy ownership change and confirm nomination within 6 months
Additional requirements in relation to specified appliances
- Offer home delivery for specified appliances and maintain privacy
Disposal service in respect of unwanted drugs
- Accept and dispose of unwanted drugs presented by patients
Further activities to be carried out in connection with the disposal of unwanted drugs
- Ensure staff are trained on waste drug risks and have protective equipment
Promotion of healthy lifestyles
- Promote public health messages to the public
Signposting
- Signpost pharmacy users to other health and social care providers
Service outline in respect of signposting
- Signpost patients to another provider when you cannot provide a service or product
Support for self-care
- Provide advice and support for self-care to patients
Service outline in respect of support for self-care
- Provide self-care advice to pharmacy users to reduce inappropriate NHS use
Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.
- Provide home delivery option to eligible patients during pandemic announcement
Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.
- Offer home delivery of notified items during a pandemic
Discharge medicines service
- Provide discharge medicines service to referred patients
Service outline in respect of the discharge medicines service
- Provide Discharge Medicines Service (DMS) within required timescales and procedures
Pharmacy opening hours: general
- Meet your pharmacy's required weekly opening hours
Local hours plans
Other duties (1) — Crown / regulator
- NHS England must consult local pharmaceutical committees and notify them about local hours plans Crown / Minister / Government department
Determination of pharmacy premises core opening hours instigated by NHS England
- Implement changed pharmacy opening hours within 8 weeks of NHS England notice
Determination of pharmacy premises core opening hours instigated by the NHS pharmacist
- Follow the correct process to change your pharmacy's core opening hours
Premises requirements in respect of consultation rooms
- Provide a confidential consultation room at pharmacy premises
Consultations held from distance selling premises and some small pharmacy premises
- Ensure confidential communication arrangements for distance selling pharmacy
Distance selling premises requirements in respect of websites and health promotion zones
- Maintain a website with health promotion zone for distance selling pharmacy
Professional Standards
- Provide pharmaceutical services to professional standards
Accessing summary care records
- Maintain access to and use summary care records when providing pharmaceutical services
Electronic Prescription Service access
- Maintain constant and reliable EPS access during opening hours
Contact via NHS.net Connect, pharmacy profiles and the Central Alerting System
- Maintain NHS.net Connect, pharmacy profiles, and Central Alerting System access
Business continuity plans to deal with temporary suspensions
- Maintain and implement a business continuity plan for temporary service suspensions
Inducements etc.
- Do not offer gifts or rewards to patients or prescribers for prescriptions or nominations
Duty to provide information about fitness matters as they arise
- Notify NHS England of criminal, regulatory, or professional conduct events within 7 days
Other information to be supplied
- Notify NHS England of changes to pharmacy registration and other required information
Facilitating remote access to pharmaceutical services
- Facilitate remote access to pharmaceutical services and maintain procedures
Co-operation with NHS England
- Co-operate with NHS England on education and training
Complaints
- Set up a complaints procedure that meets legal standards
Inspections and access to information
- Allow NHS England to inspect your pharmacy and provide requested information
Dispensing services
- Provide proper and sufficient drugs and appliances to NHS prescription holders
Dispensing of drugs and appliances
- Dispense prescribed drugs and appliances with reasonable promptness
Supply in accordance with a SSP
- Consider and manage dispensing under a Serious Shortage Protocol (SSP)
Preliminary matters before providing ordered drugs or appliances
- Provide time estimates and verify exemption evidence before dispensing drugs
Providing ordered drugs or appliances
- Only provide drugs or appliances as ordered on a valid prescription
Refusal to provide drugs or appliances ordered
- Know when you can or must refuse to dispense a prescription
Division of responsibilities between individuals and corporate bodies
- Ensure natural-person-only tasks are carried out by you or your staff
Additional requirements in relation to electronic prescribing
- Explain Electronic Prescription Service and offer alternatives if unavailable
Opening hours: general
- Provide pharmaceutical services for minimum weekly hours and display opening times
Clinical governance
- Participate in a clinical governance system approved by NHS England
Professional Standards
- Provide pharmaceutical services to accepted professional standards
Inducements etc.
- Do not offer gifts or rewards for prescription orders or nominations
Duty to provide information about fitness matters as they arise
- Notify NHS England of fitness matters within 7 days
Other information to be supplied
- Notify NHS England of changes to your business details and other information
Co-operation with NHS England
- Cooperate with NHS England on education and training
Complaints
- Set up complaints handling arrangements complying with the 2009 Regulations
Inspections and access to information
- Allow NHS England access for inspections and provide requested information
Dispensing services
- Provide proper and sufficient appliances on NHS prescriptions
Supply in accordance with a SSP
- Consider whether to supply under SSP and comply with endorsement/notification requirements
Preliminary matters before providing appliances
- Give time estimates and verify exemption evidence before supplying appliances
Providing appliances
- Supply NHS appliances only on valid prescriptions and meet fitting, standard and SSP notes
Refusal to provide appliances ordered
- Must refuse or restrict supply of NHS appliances in specified circumstances
Further activities to be carried out in connection with the provision of dispensing services
- Carry out all required activities when providing NHS dispensing services
Persons duly authorised to dispense on behalf of dispensing doctors
- Ensure authorised persons comply with Schedule requirements
Voluntary closure of premises
- Notify NHS England at least 3 months before voluntarily stopping dispensing services
Preliminary matters before providing ordered drugs or appliances
- Ask for exemption evidence and record prescriptions correctly
Provision of Scheduled drugs
- Only supply Scheduled drugs under authorised prescription conditions
Dispensing doctors issuing prescription forms which may be presented to an NHS chemist
- Issue a prescription form to patients who request one
Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.
- Offer home delivery to eligible patients during a pandemic
Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.
- Offer home delivery of pandemic-related medicines to eligible patients
Inspections and access to information
- Allow NHS England inspections and provide requested information
General provisions
- Comply with all relevant legislation, Drug Tariff and NHS guidance
Further activities in connection with repeat dispensing
- Fulfil duties for repeat dispensing: advice, training, audit, notifications
Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.
- Offer home delivery to eligible patients during a pandemic announcement
Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.
- Offer home delivery of pandemic-related medicines to eligible patients
Information to be provided for NHS England’s lists
- Provide up-to-date record of services and opening times to NHS England on request
Clinical governance
- Participate in a clinical governance system as required by NHS England
Professional Standards
- Provide pharmaceutical services to generally accepted professional standards
Duty to provide information about fitness to practise matters as they arise
- Report fitness-to-practise matters to NHS England within 7 days
Co-operation with NHS England
- Cooperate with NHS England on education and training duties
Refunds of prescription charges
- Repay prescription charges within three months of payment
Restrictions in an LPS scheme on supply
- Only supply authorised items and serve eligible patients under your LPS scheme
Local resolution of disputes
- Make every reasonable effort to resolve LPS disputes locally before escalating
Complaints
- Have complaints handling arrangements complying with the 2009 Complaints Regulations
Dispensing
- Dispense prescribed drugs and appliances promptly to patients
Supply in accordance with a SSP
- Consider and, if appropriate, supply in accordance with a Serious Shortage Protocol (SSP)
Providing ordered drugs or appliances
- Supply drugs or appliances only in accordance with the prescription and all applicable rules
Refusal to provide drugs or appliances ordered
- Refuse to dispense prescriptions when legally required and check patient suitability on repeat prescriptions
Further activities to be carried out in connection with the provision of dispensing services
- Provide dispensing advice, records, and written notes to patients
Additional requirements in relation to electronic prescribing
- Comply with electronic prescription service requirements
Browse 148 other Schedules — structural / supplementary
Necessary services: current provision
Necessary services: gaps in provision
Other relevant services: current provision
Improvements and better access: gaps in provision
Other NHS services
How the assessment was carried out
Map of provision
Information to be included in all routine and excepted applications
Nature of details to be supplied
Relevant information or documentation
Failure to provide undertakings or fees
Functions of NHS England in relation to fitness information relevant to applications: aggregation of information
Deferral of notifiable applications prior to notification
Refusal of notifiable applications prior to notification because of the language requirement for some NHS pharmacists
Refusal of notifiable applications on fitness grounds prior to notification
Proposed new pharmacy premises in controlled localities: refusal of routine applications because of preliminary matters prior to notification
Applications requiring notifications
Notification procedure for notifiable applications
Information to be included in all routine and excepted applications for inclusion in a pharmaceutical list
Parallel notifications
Content of notifications
Flexibility with regard to determining or deferring applications
Additional matters for consideration in relation to applications for inclusion in a pharmaceutical list
Action following deferrals
Oral hearings
Persons barred from taking part in decision making on routine and excepted applications
Timetable for determining applications
Notification of decisions on routine and excepted applications
Template notice of commencement to be included with a notice of decision
Template notice of consolidation
Fitness information about individuals: routine and excepted applications for inclusion in a pharmaceutical list
Third party rights of appeal to the Secretary of State where an application is granted
Conditional grant of applications where the address of the premises is unknown
Changes to the premises specified in an application after its grant but before the listing of the premises
Conditional grant in cases relating to future needs or future improvements or better access
Taking effect of listing decisions: general
Taking effect of decisions relating to business consolidations
Notice requiring the commencement of pharmaceutical services
Appeals to the Secretary of State by the applicant
Fitness information about corporate bodies: routine and excepted applications for inclusion in a pharmaceutical list
Fitness information that has already been provided under pharmaceutical or local pharmaceutical services
Updating of information about or relating to a superintendent
Applications seeking the listing of premises that are already, or are in close proximity to, listed chemist premises
Additional information to be included with routine applications
Additional information to be included with excepted applications
Undertakings
Determination of third party appeal rights in certain cases
Notification of decisions and subsequent action by NHS England
Effect of decisions by the Secretary of State
Misconceived appeals
Notification of appeals notices under paragraph 30, 32(5) or 36 of Schedule 2
Notification of appeals relating to notices under regulation 45
Notification of appeals relating to decisions under Part 8 of these Regulations
Non notification of appeals relating to notices under regulation 77 or 98
Flexibility with regard to the manner of determining appeals
Oral hearings
Decisions of the Secretary of State
Further activities to be carried out in connection with the provision of dispensing services
Basic procedure in respect of unwanted drugs
Prescription linked intervention
Breaches by directors and superintendents
Matters to be considered when issuing directions in respect of pharmacy premises core opening hours
Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services
Pharmacy opening hours: arrangements while a disease is or in anticipation of a disease being imminently pandemic etc.
Flexible provision of relevant immunisation services during a pandemic etc.
Clinical governance and the promotion of healthy living
Essential services
Supply in accordance with a PTP or a PTPGD
Supply in accordance with a LPIV
Urgent supply without a prescription
Sub-contracting aspects of dispensing under “hub and spoke” arrangements
Objection to and discontinuation of hub and spoke arrangements
Hub and spoke arrangements: sharing of “relevant data” between different businesses
Additional requirements in relation to specified appliances
Signposting
Matters to be considered when issuing directions in respect of core opening hours
Determination of core opening hours instigated by NHS England
Determination of core opening hours instigated by the NHS appliance contractor
Temporary open hours and closures during an emergency requiring the flexible provision of pharmaceutical services
Breaches by directors
Dispensing of appliances
Urgent supply without a prescription
Dispensing of drugs and appliances ordered by another prescriber
Dispensing of drugs and appliances ordered by the dispensing doctor
Supply in accordance with a SSP
Supply in accordance with a PTP or a PTPGD
Supply in accordance with a LPIV
Charge exemption and remission of charges: declarations and checks
Checks and records in the case of supply in accordance with a SSP
Sub-contracting aspects of dispensing under “hub and spoke” arrangements
Objection to and termination of hub and spoke arrangements
Hub and spoke arrangements: sharing of “relevant data” between different businesses
Refusal to provide drugs or appliances ordered
Complaints procedures
Accessing summary care records
Electronic Prescription Service access
Contact via NHS.net Connect and the Central Alerting System
Inducements etc
Charges for drugs, appliances and containers, and ownership of containers
Remuneration, overpayments etc
Dispute resolution: non-NHS contracts
NHS dispute resolution procedure
Determination of dispute
Disputes: supplemental
Variation of LPS schemes
Termination by agreement
Termination by serving notice
Termination of arrangements by NHS England on grounds of suitability etc
Termination by NHS England: patient safety and material financial loss
Termination and the NHS dispute resolution procedure
Third party rights
Supply in accordance with a LPIV
Urgent supply without a prescription
Preliminary matters before providing ordered drugs or appliances
Sub-contracting aspects of dispensing under “hub and spoke” arrangements
Objection to and discontinuation of hub and spoke arrangements
Hub and spoke arrangements: sharing of “relevant data” between different businesses
(1) Any fees and allowances payable to NHS pharmacists for...
(1) Any fees and allowances payable to NHS appliance contractors...
The continuity principles
Gradual introduction of the provision of pharmaceutical services by doctors
Giving effect to listing decisions: pharmaceutical lists and dispensing doctor lists
Pharmaceutical lists, EPS lists and dispensing doctor lists: continuity of entries and decisions
Service provision issues: NHS chemists
Service provision issues: dispensing doctors
LPS schemes: replacement of Primary Care Trusts with NHS England and service provision issues
Notification of LPS designations and completion of reviews
The application of Group 12 of Schedule 8 to the Value Added Tax Act 1994
Listing applications under the 2005 Regulations: NHS chemists
Listing applications under the 2012 Regulations: NHS chemists
Listing applications under the 2005 Regulations: dispensing doctors
Listing applications under the 2012 Regulations: dispensing doctors
Outstanding cases relating to dispensing contractor lists
Controlled localities
Reserved locations
Gradual discontinuation of the provision of pharmaceutical services by doctors
Amendment of the National Health Service (Charges for Drugs and Appliances) Regulations 2000
Revocation of the National Health Service (Local Pharmaceutical Services) Amendment Regulations 2012
Revocation of the National Health Service (Pharmaceutical Services) Regulations 2012 and of amendments to those Regulations
Amendment of the Local Authorities (Partnership Arrangements, Care Trusts, Public Health and Local Healthwatch Arrangements etc.) Regulations 2012
Revocation of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002
Revocation of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002
Revocation of the National Health Service (Pharmaceutical Services) Amendment Regulations 2005
Revocation of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 and amendments to those Regulations
Revocation of the National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006
Amendments to the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009
Revocation of the National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) Amendment Regulations 2009
Revocation of the National Health Service (Pharmaceutical Services and Local Pharmaceutical Services) (Amendment) Regulations 2010
sch. 4 para. 18
- Participate in NHS health promotion campaigns and report data
Discontinuation of arrangements for the provision of pharmaceutical services by doctors
- Terminate pharmaceutical services to patients when conditions change
Refunds of prescription charges
- Refund prescription charges to patients who present a valid claim within 3 months
Browse 128 other sections — procedural / definitional / commencement
Citation and commencement
Interpretation
Pharmaceutical needs assessments
Information to be contained in pharmaceutical needs assessments
Date by which the first HWB pharmaceutical needs assessments are to be published
Subsequent assessments and later first assessments
Temporary extension of earlier pharmaceutical needs assessments and access by NHS England and HWBs to pharmaceutical needs assessments
Consultation on pharmaceutical needs assessments
Matters for consideration when making assessments
Pharmaceutical lists ...
Terms of service of NHS chemists: general
Routine applications for inclusion in or amendments to a pharmaceutical list
Current needs: additional matters to which NHS England must have regard
Current needs: consequences of additional matters
Future needs: additional matters to which NHS England must have regard
Future needs: consequences of additional matters
Improvements or better access to the current service: additional matters to which NHS England must have regard
Unforeseen benefits applications: additional matters to which NHS England must have regard
Applications to which regulation 17 or 18 applies: consequences of additional matters
Future improvements or better access: additional matters to which NHS England must have regard
Future improvements or better access: consequences of additional matters
PNA based applications for new premises offering additional or different opening hours
Refusal of routine applications that are based on neither a pharmaceutical needs assessment nor unforeseen benefits
Applications from NHS chemists in respect of providing directed services
Relocations that do not result in significant change to pharmaceutical services provision
Distance selling premises applications
Transitional provision: distance selling premises applications for new inclusions made before 23rd June 2025
Change of ownership applications
Consolidation onto an existing site
Applications for temporary listings arising out of suspensions
Applications from persons exercising a right of return to a pharmaceutical list
Temporary arrangements during emergencies or because of circumstances beyond the control of NHS chemists
Refusal: language requirement for some NHS pharmacists
Refusal: same or adjacent premises
Deferrals arising out of LPS designations
Refusal of applications for inclusion in a pharmaceutical list on fitness grounds
Deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds
Granting applications for inclusion in a pharmaceutical list subject to efficiency conditions and conditions to combat fraud
Determination that an area is a controlled locality
Process for determining controlled localities: preliminary matters
Process for determining controlled localities: local notification and deferment of routine applications
Process of determining controlled localities: formulation of NHS England’s decision
Applications for new pharmacy premises in controlled localities: refusals because of preliminary matters
Applications for new pharmacy premises in controlled localities: reserved locations
Second and subsequent determinations of reserved location status
Determinations of reserved locations: supplemental matters
Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location
Appeals against decisions under Part 7
Dispensing doctor lists
Terms of service of dispensing doctors: general
Arrangements for the provision of pharmaceutical services by doctors: applications by patients
Necessary services for temporary patients
Outline consent and premises approval: applications by doctors
Notification of applications for outline consent and premises approval
Decisions on outline consent and premises approval applications and the taking effect of grants
Premises approval: relocations of practice premises which are not significant before outline consent takes effect
Premises approval: relocations of practice premises which are not significant after outline consent has taken effect
Taking effect of premises approval where there is no related application for outline consent
Gradual introduction of premises approval
Temporary provision in cases of relocations or additional premises where premises approval has not taken effect
Practice amalgamations
Lapse of outline consent and premises approval
Temporary arrangements during emergencies or circumstances beyond the control of a dispensing doctor
Persons barred from taking part in decision making with regard to applications for outline consent or premises approval
Appeals against decisions under Part 8
Distance selling premises: specific conditions
Core opening hours conditions
Continuity in respect of opening hours directions
Conditions relating to providing directed services
Conditions relating to voluntary closure of premises
Condition relating to entering administration
Conditions relating to local resolution of disputes over terms of service
Local dispute resolution before serving remedial notices or breach notices
Breaches of terms of service: remedial notices
Breaches of terms of service: breach notices
Issuing breach or remedial notices while a disease is or in anticipation of a disease being imminently pandemic etc.
Payment withholdings: supplementary matters
Removal of listings: cases relating to remedial notices and breach notices
Removal of listings: cases relating to death, incapacity or cessation of service
Voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure
Limitation on withdrawal from pharmaceutical lists while fitness investigations or proceedings are ongoing
Appeals against decisions under Part 10
Extended meaning of “health scheme” in fraud cases
Review of decisions to impose fitness conditions originally imposed on grants of applications
Removal for breach of fitness conditions imposed under regulation 35 or 79
Mandatory removal in suitability cases
Fitness cases: procedures for removal or contingent removal from pharmaceutical lists
Procedure for suspensions in fitness cases
Procedure for reviewing some suspensions and contingent removal conditions
General power to revoke suspensions in appropriate circumstances
Internal handling of fitness information by NHS England or an agent of NHS England
Review periods for national disqualifications
Wider notifications of fitness decisions
The Drug Tariff and section 164: general provisions
Data to be provided to assist Drug Tariff determinations
Remuneration of NHS chemists: instruments of appointment of NHS England
Zero or nominal product reimbursement for ... vaccines and antivirals
Dispensing doctor remuneration
The taking effect of determinations
Overpayments
Free supply of drugs, appliances and containers where the drug or appliance is supplied under pharmaceutical services
Reward scheme
Payments to suspended chemists
Designation of areas, premises or descriptions of premises
Review of designations
Cancellation of designations
Terms of service for LPS schemes: general
Suspension of terms of schemes or of enforcement of terms of schemes while a disease is or in anticipation of a disease being imminently pandemic etc.
LPS schemes: health service body status
Development of LPS schemes
Persons permitted to be parties to LPS schemes: fitness criteria
LPS proposals: fitness information to be supplied
Notification of proposals
Right of return to pharmaceutical lists: LPS contractors
LPS pilot schemes: health service body status
LPS pilot schemes: termination
Emergencies requiring the flexible provision of local pharmaceutical services
Sharing of information about LPS chemists and their employees with the General Pharmaceutical Council
Directions to the First-tier Tribunal relating to local pharmaceutical services
Lists of LPS chemists
Notification by NHS England of changes to its lists
Authorised persons to apply for services
Functions of the Secretary of State to be exercised by the NHS Litigation Authority
Proceedings relating to overridden arrangements
Transitional provisions
Transitional provisions in respect of drugs or appliances supplied in accordance with SSPs
Amendments and revocations
Review of these Regulations
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