Legalize / United Kingdom / Statutory-Instrument

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Type Statutory-Instrument

Publication 2013-02-14

Last updated 2025-10-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(b) the Local Pharmaceutical Committee for the area where the pharmacy premises are situated have been invited to be present at the inspection, where this is requested by P;

(d) X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) P must, at the request of NHS England or of X, allow it or X access to any information which it or X reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1); or

(b) in the case of NHS England, in connection with its functions that relate to pharmaceutical services.

(4) P must, at the request of NHS England, send to NHS England by means of an electronic communication of the type specified in the request any information to which a person authorised in writing by NHS England would have access during an inspection of P’s pharmacy premises pursuant to sub-paragraph (1), if—

(a) P has that information in a form which means it may be sent by that form of electronic communication; or

(b) it is reasonable for NHS England to request that P convert that information into a form which means that it may be sent by that form of electronic communication (and NHS England does so request).

(5) P must, at the request of NHS England or a person authorised in writing by NHS England to make the request, send to NHS England or that person by means of an electronic communication, a duly completed questionnaire, which is—

(a) in a format approved by NHS England; and

(b) for the purpose of enabling NHS England, or a person authorised in writing by NHS England, to determine whether or when it is necessary or expedient for a person authorised in writing by NHS England to undertake an inspection of P’s premises pursuant to sub-paragraph (1).

(6) Before information is requested pursuant to sub-paragraph (5), NHS England must consult the person who is, for the time being, the person consulted under section 165(1)(a) of the 2006 Act, in respect of pharmaceutical remuneration of NHS pharmacists on the terms of the request.

SCHEDULE 5 — Terms of service of NHS appliance contractors

Division of responsibilities between individuals and corporate bodies

1

(1) To the extent that this Schedule imposes a requirement on an NHS appliance contractor in respect of an activity which could only, or would normally, be undertaken by a natural person—

(a) if the NHS appliance contractor is a natural person—

(i) that person must comply with that requirement, or

(ii) if the NHS appliance contractor employs or engages other natural persons in connection with the provision of pharmaceutical services, the NHS appliance contractor must either comply with that requirement or secure compliance with that requirement by the other natural persons whom the NHS appliance contractor employs or engages; or

(b) if the NHS appliance contractor is not a natural person, that NHS appliance contractor must secure compliance with that requirement by the natural persons whom the NHS appliance contractor employs or engages in connection with the provision of pharmaceutical services.

(2) Where in this Schedule reference is made to an NHS appliance contractor—

(a) being the subject of any activity, and it is an activity to which a natural person could only, or would normally, be subject; or

(b) forming a view,

that reference is to be construed, as referring, as appropriate to the NHS appliance contractor (if a natural person) or to the NHS appliance contractor's staff.

(3) References in this Schedule to an NHS appliance contractor are to be construed in accordance with sub-paragraphs (1) and (2).

Breaches by directors

2

Where this Schedule imposes a requirement on the director of a body corporate that is included in a pharmaceutical list, a breach of that requirement is to be deemed to be a breach by the body corporate of its terms of service.

Dispensing services

3

An NHS appliance contractor must, to the extent that paragraphs 4 to 8 require and in the manner described in those paragraphs, provide proper and sufficient appliances to persons presenting prescriptions for appliances ordered by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service.

Dispensing of appliances

4

(1) In this Part, “signed” includes signature with a prescriber's advanced electronic signature.

(2) Subject to the following provisions of this Schedule, where—

(a) any person presents to an NHS appliance contractor (C) a non-electronic prescription form which contains—

(i) an order for an appliance, not being a restricted availability appliance, signed by a prescriber, or

(ii) an order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; ...

(b) C receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) and (ii) and—

(i) any person requests the provision of an appliance in accordance with that prescription, or

(ii) C has previously arranged with the patient that C will dispense that prescription on receipt; or

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), and

(ii) requests the provision of an appliance in accordance with the related electronic prescription form,

C must, with reasonable promptness, provide the appliance so ordered if C supplies it in the normal course of business.

(3) Subject to the following provisions of this Schedule, where—

(a) any person presents to C a non-electronic repeatable prescription which contains—

(i) an order for appliances, not being restricted availability appliances, signed by a prescriber, or

(ii) an order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”,

and also presents an associated batch issue; ...

(b) C receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) or (ii) and—

(i) any person requests the provision of appliances in accordance with that prescription, or

(ii) C has previously arranged with the patient that the supplier will dispense that prescription on receipt; or

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), and

(ii) requests the provision of appliances in accordance with the related electronic repeatable prescription,

C must, with reasonable promptness, provide such of the appliances so ordered as C supplies in the normal course of business.

(4) For the purposes of this paragraph, a non-electronic repeatable prescription for appliances shall be taken to be presented even if the person who wishes to obtain the appliances does not present that prescription, where—

(a) C has that prescription in the supplier's possession; and

(b) that person presents, or C has in C's possession, an associated batch issue.

Urgent supply without a prescription

5

(1) This paragraph applies where, in a case of urgency, a prescriber requests an NHS appliance contractor (C) to provide an appliance.

(2) C may provide the appliance requested before receiving a prescription form or repeatable prescription in respect of that appliance, provided that the prescriber undertakes to—

(a) give C a non-electronic prescription form or non-electronic repeatable prescription in respect of the appliance within 72 hours of the request being made; or

(b) transmit an electronic prescription to the Electronic Prescription Service within 72 hours of the request being made.

Preliminary matters before providing appliances

6

(1) If a person specified in sub-paragraph (2) asks an NHS appliance contractor (C) to do so—

(a) C must give an estimate of the time when the appliance will be ready; and

(b) if it is not ready by then, P must give a revised estimate of the time when it will be ready (until it is ready).

(2) A person specified in this sub-paragraph is a person—

(a) presenting a non-electronic prescription form or non-electronic repeatable prescription; or

(b) requesting the provision of appliances in accordance with an electronic prescription form or an electronic repeatable prescription.

(3) Before providing an appliance in accordance with a prescription form or repeatable prescription—

(a) C must ask any person who makes or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription that the person named on the prescription form or repeatable prescription does not have to pay the charges specified in regulation 3(1) or (2) of the Charges Regulations (supply of drugs and appliances by chemists) by virtue of either—

(i) entitlement to exemption under regulation 10(1) of the Charges Regulations (exemptions), or

(ii) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (entitlement to full remission and payment),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of regulation 10(1) of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration C already has such evidence available to C;

(b) if, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by paragraph (a), is produced to C, C must endorse the form on which the declaration is made to that effect; and

(c) in the case of an electronic prescription form or an electronic repeatable prescription, C must ensure that the following information is duly entered into the records managed by NHS England that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))—

(i) in a case where exemption from or remission of charges is claimed, a record of—

(aa) the exemption category specified in regulation 10(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case; and

(bb) whether or not satisfactory evidence was produced to C as required by sub-paragraph (a), and

(ii) in any case where a charge is due, confirmation that the relevant charge was paid.

(3A) For the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.

(3B) Sub-paragraphs (3) and (3A) apply to the provision of an appliance in accordance with a SSP as they apply to the provision of an appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes the prescription for product reimbursement purposes, as mentioned in paragraph 4A(4)(a), is treated as being the prescription in accordance with which the appliance is provided (even though the supply is not in pursuance of that prescription).

Providing appliances

7

(1) Where an NHS appliance contractor (C) is presented with, or receives from the Electronic Prescription Service, a prescription form or a repeatable prescription, C must only provide the appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 4; and

(b) in accordance with the order on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985 and the following provisions of this Schedule.

(2) If the order is for, or a product to be provided in accordance with a SSP is, an appliance of a type requiring measuring and fitting (for example a truss), C must make all necessary arrangements for—

(a) measuring the person named on the prescription form for the appliance; and

(b) fitting the appliance.

(3) If the order is for, or a product to be provided in accordance with a SSP is, an appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the appliance provided must comply with the standard or formula specified therein.

(4) Where C provides an appliance under paragraph 4A, C must include with it in a written note, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.

Refusal to provide appliances ordered

8

(1) An NHS appliance contractor (C) may refuse to provide an appliance ordered on a prescription form or repeatable prescription where—

(a) C reasonably believes that it is not a genuine order for the person named on the prescription form or repeatable prescription (for example because C reasonably believes it has been stolen or forged);

(b) it appears to C that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the appliance would be contrary to C's clinical judgement;

(c) C or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of appliances in accordance with an electronic prescription form or repeatable prescription, or by any person accompanying that person

(d) the person presenting the prescription form or requesting the provision of appliances in accordance with an electronic prescription form or repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence; or

(e) the prescription form or repeatable prescription is incomplete because it does not include information relating to the identification of the prescriber that NHS England (or a person exercising its functions) requires in order to perform its functions relating to—

(i) the remuneration of persons providing pharmaceutical services, and

(ii) any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless C (or the person who employs or engages C) is to receive no pharmaceutical remuneration of any kind in respect of the appliances.

(1A) C may refuse to provide an appliance ordered on an electronic prescription if the access that C has to the Electronic Prescription Service is not such as to enable C to dispense that prescription promptly (or at all).

(1B) C must refuse to provide an appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested appliance; or

(ii) appliances of a specified description, and the requested appliance is of that description; and

(b) alternative provision has already taken place in accordance with the SSP.

(1C) C may refuse to provide an appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested appliance, or

(ii) appliances of a specified description, and the requested appliance is of that description;

(b) C is of the opinion that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

but if C does refuse to do so, C must provide the patient or the person requesting the appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.

(2) C must refuse to provide appliances ordered on a repeatable prescription where—

(a) C has no record of that prescription (other than on the first occasion on which the prescription is presented);

(b) C does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to the supplier;

(d) to do so would not be in accordance with any intervals specified in the prescription;

(e) it would be the first time an appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;

(f) the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

(g) the expiry date on the repeatable prescription has passed; or

(h) C has been informed by the prescriber that the prescription is no longer required.

(3) Where a patient requests the supply of appliances ordered on a repeatable prescription (other than on the first occasion that the request is made), C must only provide the appliance ordered if C is satisfied that—

(a) the patient to whom the prescription relates—

(i) is using and is likely to continue to use the appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicate the need or desirability of reviewing the patient's treatment;

(b) the manner of utilisation of the appliance by the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; and

(c) there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.

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

9

(1) In connection with the services provided under paragraph 3, an NHS appliance contractor (C) must—

(a) ensure that appropriate advice is given to patients about any appliances provided to them—

(i) to enable them to utilise the appliances appropriately, and

(ii) to meet the patient's reasonable needs for general information about the appliances;

(b) provide appropriate advice to patients to whom they provide appliances on the safe keeping of the appliances;

(i) provide appropriate advice in particular on the importance of only requesting those items which they actually need, and

(ii) for those purposes, have regard to the details contained in the records maintained under paragraph (f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;

(d) provide a patient with a written note of any appliance which is owed, and inform the patient when it is expected that the appliance will become available;

(e) provide a patient with a written note of C's name, address and telephone number;

(f) keep and maintain records—

(i) of appliances provided, in order to facilitate the continued care of the patient,

(ii) in appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescription), and

(iii) of notes provided under paragraph (d);

(g) undertake appropriate training in respect of repeat dispensing having regard to any recommendations in respect of such training set out in the Drug Tariff;

(h) if C takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

(i) if C provides an appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed;

(j) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);

(k) destroy any surplus batch issues relating to appliances—

(i) which are not required, or

(ii) where a patient is refused an appliance pursuant to paragraph 8;

(l) ensure that where a person is refused appliances pursuant to paragraph 8(1)(b), (2) or (3), the patient is referred back to the prescriber for further advice;

(m) where a patient is provided with appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification;

(n) notify the prescriber of any refusal to provide appliances pursuant to paragraph 8(4); and

(o) when providing specified appliances, comply with the additional requirements set out in paragraph 11.

(2) Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing of appliances under paragraph 4, C is unable to provide an appliance, or stoma appliance customisation is required and C is unable to provide that, C must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist; or

(b) if the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to C.

Additional requirements in relation to electronic prescribing

10

(1) An NHS appliance contractor (C) must, if requested to do so by any person—

(a) explain to that person the Electronic Prescription Service, whether or not it is a service which is available through C's appliance contractor premises; and

(b) where the Electronic Prescription Service is not available through C's appliance contractor premises, provide that person with the names of at least 2 NHS appliance contractors through whom the Electronic Prescription Service is available, if these details are known to C.

(2) Where the Electronic Prescription Service is available through C's appliance contractor premises, C must, if requested to do so by any person, enter in that person's PDS patient details—

(a) where the person does not have a nominated dispensing contractor, a nominated dispensing contractor; or

(b) where the person does have a nominated dispensing contractor—

(i) a replacement dispensing contractor, or

(ii) a further dispensing contractor,

chosen by that person.

(3) Sub-paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors would thereby exceed the maximum number permitted by the Electronic Prescription Service.

(4) Regulation 116(a) to (c) applies to a request under this paragraph as it applies to an application to an NHS chemist for pharmaceutical services.

(5) If C is a nominated dispensing contractor for a person (X) but the nomination was made before C became the person listed in a pharmaceutical list in relation to the appliance contractor premises nominated in X's PDS patient details, C must within 6 months of C becoming the person so listed—

(a) explain to X that the ownership of the appliance contractor premises has changed; and

(b) ask X whether X wishes to maintain the nomination in respect of those appliance contractor premises.

(6) If C dispenses an electronic prescription or makes an urgent supply without a prescription, C must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA.

Additional requirements in relation to specified appliances

11

(1) This paragraph sets out the additional requirements referred to in paragraph 9(1)(o) relating to the provision of specified appliances.

(2) An NHS appliance contractor (C) who dispenses specified appliances in the normal course of business must provide a home delivery service in respect of those appliances and, as part of that service—

(a) C must offer to deliver the specified appliance to the patient's home;

(b) if the patient accepts that offer, the delivery must be made with reasonable promptness and at such time as is agreed with the patient;

(c) the specified appliance must be delivered in a package which displays no writing or other markings which could indicate its content; and

(d) the manner of delivery of the package and any supplementary items required by sub-paragraph (3) must not convey the type of appliance being delivered.

(3) In any case where a specified appliance is provided (whether by home delivery or otherwise), C must provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—

(a) must ensure that the patient may, if the patient wishes, consult a person to obtain expert clinical advice regarding the appliance; or

(b) if C believes it is appropriate to do so, must—

(i) refer the patient to a prescriber; or

(ii) offer the patient an appliance use review service.

(4) If C is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), C must give the patient the contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to arrange for the service to be provided, if these details are known to C.

(5) Where C provides a telephone care line in respect of the dispensing of any specified appliance, C must ensure that during out of hours periods—

(a) advice is made available to patients through that telephone care line; or

(b) telephone or website contact details for providers of NHS services that may be consulted for advice regarding specified appliances during those periods, are made available to patients through the telephone care line.

(6) For the purposes of this paragraph—

“expert clinical advice”, in relation to a specified appliance, means advice which is given by a person who is suitably trained and who has relevant experience in respect of the appliance;

“out of hours periods”, in relation to the appliance contractor premises, means the periods outside the core opening hours and any supplementary opening hours of the premises.

Signposting

12

(1) Where, on presentation of a prescription form or repeatable prescription, an NHS appliance contractor (C) is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within C's normal course of business, C must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS appliance contractor or to an NHS pharmacist; and

(b) if the patient does not consent to a referral, provide the patient with contact details of at least 2 people who are NHS pharmacists or NHS appliance contractors who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to C.

(2) C must, in appropriate cases, keep and maintain a record of any information given or referral made under sub-paragraph (1) and that record must be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by C; and

(b) follow-up care for the person who has been given the information or in respect of whom the referral has been made.

Opening hours: general

13

(1) An NHS appliance contractor (C) must ensure that pharmaceutical services are provided at or from C's appliance contractor premises—

(a) for not less than 30 hours each week;

(b) for not less than 100 hours per week, in the case of which a 100 hours condition (originally imposed under the 2005 Regulations) applies;

(c) if NHS England or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at or from the premises for fewer than 30 hours per week, provided that the person listed in relation to them provides those services at set times and on set days, at the times and on the days so set;

(d) if a Primary Care Trust, or on appeal the Secretary of State, has (under previous Regulations) directed that pharmaceutical services are to be provided at or from the premises for more than 30 hours per week, and at set times and on set days, at the times and on the days so set; or

(e) if NHS England or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at or from the premises for more than 30 hours each week, but only on set times and on set days as regards the additional opening hours—

(i) for the total number of hours each week required by virtue of that direction, and

(ii) as regards the additional opening hours for which the person listed in relation to the premises is required to provide pharmaceutical services by virtue of that direction, at the days on which and times at which that person is required to provide pharmaceutical services during those additional opening hours, as set out in that direction,

but NHS England may, in appropriate circumstances, agree a temporary suspension of services for a set period, where it has received 3 months notice of the proposed suspension.

(2) The hours during which appliance contractor premises must be open by virtue of sub-paragraph (1) are referred to in these Regulations as “core opening hours”.

(3) C must exhibit a notice specifying the days on which and times at which the appliance contractor premises are open for the provision of appliances.

(4) C must, on request, submit a return to NHS England setting out—

(a) the days on which and times at which pharmaceutical services are provided at or from C's appliance contractor premises (including times at which C is providing pharmaceutical services when C is not obliged to do so by virtue of sub-paragraph (1), which are referred to in these Regulations as “supplementary opening hours”); and

(b) the pharmaceutical services which C ordinarily provides at or from those premises.

(5) Where C changes—

(a) the supplementary opening hours of C's appliance contractor premises; or

(b) the pharmaceutical services which C is ordinarily to provide at or fromthose premises,

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

14

(1) Where NHS England issues a direction setting any days or times under this Schedule, it must in doing so seek to ensure that the hours at which premises are open for the provision of pharmaceutical services are such as to ensure that pharmaceutical services are provided on such days and at such times as are necessary to meet the needs of people in its area, or other likely users of the premises, for pharmaceutical services.

(2) In considering the matters mentioned in sub-paragraph (1), NHS England—

(a) must treat any local pharmaceutical services being provided in its area at the days and times in question as if they were pharmaceutical services being so provided; and

(b) may have regard to any pharmaceutical services that are being provided in its area in circumstances where the person providing the services is not obliged to provide those services.

(3) NHS England may only direct that an NHS appliance contractor (C) may provide pharmaceutical services at or from appliance contractor premises for less than 30 hours in any week if it is satisfied that the arrangements for the supply of appliances in its area are likely to be adequate to meet the need for such services at times when C is not providing pharmaceutical services.

(4) Except in the case of premises that have (at any time) been subject to a direction under regulation 65 or regulation 65 of the 2012 Regulations (core opening hours conditions), NHS England may only direct that C must provide pharmaceutical services at or from premises for more than 30 hours in any week if it is satisfied that C is to receive reasonable remuneration in respect of the additional opening hours for which C is required to provide pharmaceutical services (and any additional remuneration payable in accordance with a determination made as mentioned in regulation 91(6) in respect of those hours is “reasonable remuneration” for these purposes).

Determination of core opening hours instigated by the NHSCB

15

(1) Where it appears to NHS England, after consultation with or having considered the matter at the request of the Local Pharmaceutical Committee for the area in which the premises are situated, that the days on which or times at which appliance contractor premises are or are to be open for the provision of pharmaceutical services will not, or no longer, meet the needs of—

(a) people in its area; or

(b) other likely users of the appliance contractor premises,

for the pharmaceutical services available at or from those premises, it must carry out an assessment as to whether to issue a direction requiring the NHS appliance contractor (C) to provide pharmaceutical services at or from the premises at set times and on set days (which may include Christmas Day, Good Friday and bank holidays).

(2) Before concluding the assessment under sub-paragraph (1) NHS England must—

(a) give notice to C of any proposed changes to the days on which or times at which the appliance contractor premises are to be open; and

(b) allow C 30 days within which to make written representations to NHS England about the proposed changes.

(3) After considering any representations made in accordance with sub-paragraph (2)(b), NHS England must—

(a) issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4) and (5);

(b) confirm any existing direction in respect of the times at which C must provide pharmaceutical services at or from the appliance contractor premises, provided that the existing direction (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (4) and (5);

(i) revoke (without replacing it) any existing direction in respect of the times at which C must provide pharmaceutical services at or from the premises (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), or

(ii) in a case where there is no existing direction, issue no direction,

in which case, by virtue of whichever of paragraph 13(1)(a) or (b) applies, the appliance contractor premises will need to be open for not less than 30 hours each week or not less than 100 hours each week.

(4) Where NHS England issues a direction under sub-paragraph (3) in respect of appliance contractor premises that are to be required to be open—

(a) for more than 30 hours each week, it must set out in that direction—

(i) the total number of hours each week for which C must provide pharmaceutical services at or from the premises, and

(ii) as regards the additional opening hours for which C is to provide pharmaceutical services, the days on which and the times at which C is required to provide those services during those additional opening hours,

but it must not set out in that direction the days on which or times at which C is to provide pharmaceutical services during hours which are not additional opening hours; or

(b) for less than 30 hours each week, it must set out in that direction the days on which and times at which pharmaceutical services are to be provided at or from those premises.

(5) NHS England must not issue a direction under sub-paragraph (3) that has the effect simply of requiring premises to be open for 30 hours each week on set days and at set times (that is, the direction must have the effect of requiring premises to be open for either more or less than 30 hours each week).

(6) NHS England must notify C in writing of any direction issued or any other action taken under sub-paragraph (3), and where it sets new days on which or times at which the NHS appliance contractor is to provide pharmaceutical services at or from the premises, it must include with the notification a statement of—

(a) the reasons for the change; and

(b) C's right of appeal under paragraph (7).

(7) C may, within 30 days of receiving notification under sub-paragraph (6), appeal in writing to the Secretary of State against any direction issued or any other action taken under sub-paragraph (3) which sets new days on which or times at which C is to provide pharmaceutical services.

(8) The Secretary of State may, when determining an appeal, either confirm the action taken by NHS England or take any action that NHS England could have taken under paragraph (3).

(9) The Secretary of State must notify C of the determination and must in every case include with the notification a statement of the reasons for the determination.

(10) If the days on which or times at which C is to provide pharmaceutical services at or from appliance contractor premises have been changed in accordance with this paragraph, C must introduce the changes—

(a) if C has not appealed under sub-paragraph (7), not later than 8 weeks after the date on which C receives notification under sub-paragraph (6); or

(b) if C has appealed under sub-paragraph (7), not later than 8 weeks after the date on which C receives notification under sub-paragraph (9).

(11) This paragraph does not apply where regulation 65(5) to (7) applies.

Determination of core opening hours instigated by NHS England

16

(1) An NHS appliance contractor (C) may apply to NHS England for it to change the days on which or times at which C is obliged to provide pharmaceutical services at or from C's premises, in a way that—

(a) reduces the total number of hours for which C is obliged to provide pharmaceutical services each week (but not any of those required under a 100 hours condition); or

(b) keeps that total number of hours the same.

(2) Where C makes an application under sub-paragraph (1), as part of that application C must provide NHS England with such information as NHS England may reasonably request in respect of any changes to the needs of the people in its area, or other likely users of the premises, for pharmaceutical services that are material to the application.

(3) NHS England must determine an application under sub-paragraph (1) within 60 days of receiving it (including any information required of C in accordance with sub-paragraph (2)).

(4) In determining the application, NHS England must—

(a) issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (5) and (6) and which has the effect of either granting the application under this paragraph or granting it only in part;

(b) confirm any existing direction in respect of the times at which C must provide pharmaceutical services at or from the premises, provided that the existing direction (whether issued under regulation 65, this Schedule, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (5) and (6); or

(i) revoke (without replacing it) any existing direction in respect of the times at which C must provide pharmaceutical services at or from the premises (whether issued under regulation 65, this Schedule, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), where this has the effect of granting the application under this paragraph or granting it only in part, or

(ii) in a case where there is no existing direction, issue no direction,

(5) Where NHS England issues a direction under sub-paragraph (4) in respect of appliance contractor premises that are to be required to be open—

(a) for more than 30 hours each week, it must set out in that direction—

(i) the total number of hours each week for which C must provide pharmaceutical services at or from the premises, and

(ii) as regards the additional opening hours for which C is to provide pharmaceutical services, the days on which and the times at which C is required to provide those services during those additional opening hours,

but it must not set out in that direction the days on which or times at which C is to provide pharmaceutical services during hours which are not additional opening hours; or

(b) for less than 30 hours each week, it must set out in that direction the days on which and times at which pharmaceutical services are to be provided at or from those premises.

(6) NHS England must not issue a direction under sub-paragraph (4) that has the effect simply of requiring appliance contractor premises to be open for 30 hours each week on set days and at set times (that is, the direction must have the effect of requiring appliance contractor premises to be open for either more or less than 30 hours each week).

(7) Where NHS England is considering taking action under sub-paragraph (4)(a) or (c)(i), it must consult the Local Pharmaceutical Committee for the area where the premises are situated before determining the application.

(8) NHS England must notify C of any direction issued or any other action taken under sub-paragraph (4), and where this has the effect of refusing an application under this paragraph or granting it in part, it must send C a statement setting out—

(a) the reasons for the refusal or, as the case may be, for granting the application only in part; and

(b) C's right of appeal under sub-paragraph (9).

(9) C may, within 30 days of receiving a notification pursuant to sub-paragraph (8), appeal in writing to the Secretary of State against any action under sub-paragraph (4) which has the effect of refusing an application under this paragraph or granting it only in part.

(10) The Secretary of State may, when determining an appeal, either confirm the action taken by NHS England or take any action that NHS England could have taken under sub-paragraph (4).

(11) The Secretary of State must notify C of the determination and must in every case include with the notification a statement of the reasons for the determination.

(12) If the days on which or times at which C is to provide pharmaceutical services at or from appliance contractor premises have been changed in accordance with this paragraph, C must introduce the changes—

(a) if C has not appealed under sub-paragraph (9), not earlier than 30 days after the date on which C receives notification under sub-paragraph (4); or

(b) if C has appealed under sub-paragraph (9), not earlier than 30 days after the date on which C receives notification under sub-paragraph (11).

(13) This paragraph does not apply where regulation 65(5) to (7) applies.

Temporary open hours and closures during an emergency requiring the flexible provision of pharmaceutical services

17

(1) Notwithstanding the provisions of paragraphs 13 to 16, during an emergency requiring the flexible provision of pharmaceutical services, NHS England may, on application from an NHS appliance contractor (C), permit C a temporary change to the days on which or times at which C is obliged to provide pharmaceutical services at or from appliance contractor premises, or permit temporary closure of those premises, if—

(a) C gives at least 24 hours notice of the change or closure; and

(b) the reasons given by C for the request are, in the opinion of NHS England, adequate reasons.

(2) NHS England need not approve the request in advance of the change or closure, but if it does not do so and decides subsequently that C's reasons are not, in its opinion, adequate reasons, then the days on which or times at which C is obliged to provide pharmaceutical services at or from the premises are to revert to the overridden days and times, from the day after the date on which that decision is given to C.

Clinical governance

18

(1) An NHS appliance contractor (C) must, in connection with the pharmaceutical services provided by C, participate, in the manner reasonably required by NHS England, in an acceptable system of clinical governance.

(2) For these purposes a system of clinical governance is “acceptable” if it is considered acceptable by NHS England and comprises the following components—

(a) a patient and public involvement programme, which includes—

(i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii) a requirement that C publicises the NHS services that are available at or from C's appliance contractor premises,

(iii) a requirement that C undertakes an approved patient satisfaction survey annually, in an approved manner,

(iv) C's monitoring arrangements in respect of appliances owed to patients but which are out of stock,

(v) an approved complaints system (which meets the requirements of paragraph 24),

(vi) a requirement that C co-operates appropriately with visits by an authorised representative of any relevant Local Healthwatch organisation and takes appropriate action following the outcome of such visits,

(vii) a requirement that C co-operates appropriately with any reasonable inspection or review that NHS England or any relevant statutory authority wishes to undertake, and

(viii) C's monitoring arrangements in respect of C's compliance with the Equality Act 2010 ;

(b) a clinical audit programme (normally of 5 days) twice in each financial year;

(i) arrangements for ensuring that all stock is procured and handled in an appropriate way,

(ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,

(iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents,

(iv) appropriate standard operating procedures, including standard operating procedures in respect of dispensing appliances, repeatable prescriptions and providing advice and support to people caring for themselves or their families,

(v) appropriate waste disposal arrangements for clinical and confidential waste,

(vi) identifying a clinical governance lead person in respect of each of C's appliance contractor premises,

(vii) C's monitoring arrangements of C's compliance with the Health and Safety at Work etc. Act 1974 ;

(d) a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by C—

(i) in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

(ii) to people caring for themselves or their families,

and arrangements for ensuring that C, when giving advice to any patient on a matter mentioned in paragraph (d)(i), has regard to the details contained in the records maintained under paragraph 9(1)(f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;

(e) a staffing and staff management programme, which includes—

(i) arrangements for appropriate induction for staff (including locums),

(ii) appropriate training for all staff in respect of any role they are asked to perform,

(iii) arrangements for the checking of qualifications ... of all staff engaged in the provision of NHS services,

(iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of NHS services, including continuing professional development for registered pharmacists, registered nurses and registered pharmacy technicians and any necessary accreditation in respect of the provision of directed services, and

(v) arrangements for addressing poor performance (in conjunction with NHS England as appropriate); and

(f) an information governance programme, which provides for—

(i) compliance with approved procedures for information management and security, and

(ii) submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow NHS England to access that assessment.

(3) For the purposes of sub-paragraph (2), “approved” means approved by NHS England.

Professional Standards

19

An NHS appliance contractor must provide pharmaceutical services and exercise any professional judgment in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.

Inducements etc.

20

(1) An NHS appliance contractor (C) (including C's staff) must not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of the business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person (X)—

(a) presenting an order for appliances on a prescription form or repeatable prescription; or

(b) nominating C as X's dispensing contractor (or one of them) in X's PDS patient details.

(2) Promising, offering or providing a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).

(3) C (including C's staff) must not accept or receive any gift or reward in respect of only—

(a) providing contact details of alternative NHS pharmacists or NHS appliance contractors pursuant to paragraph 9(2)(b), 11(4) or 12(1)(b); or

(b) referring a prescription form or repeatable prescription to another NHS appliance contractor or NHS pharmacist pursuant to paragraph 9(2)(a) or 12(1)(a) and providing no additional service in connection with the item on that prescription.

Duty to provide information about fitness matters as they arise

21

(1) An NHS appliance contractor (C) and, where C is a body corporate every director of C must, within 7 days of its occurrence, inform NHS England in writing if they—

(a) are convicted of any criminal offence in the United Kingdom;

(b) are bound over following a criminal conviction in the United Kingdom;

(d) have, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging them absolutely (without proceeding to conviction);

(e) have accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution);

(f) have been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;

(g) are charged in the United Kingdom with a criminal offence, or are charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;

(h) are notified by any licensing, regulatory or other body of the outcome of any investigation into their professional conduct, and there is a finding against them;

(i) become the subject of any investigation into their professional conduct by any licensing, regulatory or other body;

(j) become subject to an investigation into their professional conduct in respect of any current or previous employment, or are notified of the outcome of any such investigation and any finding against them;

(k) become the subject of any investigation by NHS CFA in relation to fraud;

(l) become the subject of any investigation by another primary care organisation, which might lead to their removal from a relevant list; or

(m) are removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,

and must give details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.

(2) If a person to whom paragraph (1) applies (X) is, or was at the time of the originating events, a director of a body corporate, X must in addition inform NHS England within 7 days if any such body corporate—

(a) is convicted of any criminal offence in the United Kingdom;

(b) is convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England, could lead to a criminal conviction in England;

(c) is charged in the United Kingdom with a criminal offence, or is charged elsewhere than in the United Kingdom with an offence where the originating events, if they took place in England, could lead to a criminal conviction in England;

(d) is notified by any licensing, regulatory or other body of the outcome of any investigation into its provision of professional services, and there is a finding against the body corporate;

(e) becomes the subject of any investigation into its provision of professional services by any licensing, regulatory or other body;

(f) becomes the subject of any investigation by the NHS CFA in relation to any fraud or is notified of the outcome of such an investigation where it is adverse;

(g) becomes the subject of any investigation by another primary care organisation which might lead to its removal from any relevant list; or

(h) is removed, contingently removed or suspended from, refused inclusion in or conditionally included in any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision,

and X must give the name and registered office of the body corporate and details of any investigation or proceedings which were or are to be brought, including the nature of the investigation or proceedings, where and approximately when that investigation or those proceedings took place or are to take place, and any outcome.

(3) C or X must consent to a request being made by NHS England to any employer or former employer or licensing or regulatory body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.

Other information to be supplied

22

(1) An NHS appliance contractor (C) must give notice to NHS England within 30 days (or if this is impracticable, as soon as practicable thereafter) of—

(a) any occurrence requiring a change in the information recorded about C in the pharmaceutical list which C has not otherwise notified to NHS England in accordance with these Regulations;

(b) if C is an individual, any change of C's private address;

(c) if C is a body corporate, any change to the name, registered number, registered office, telephone number relating to that office of the body corporate; and

(d) any occurrence requiring C's addition to or removal from the EPS list or a change in the information recorded about C in that list.

(2) C must give NHS England, if it so requests, the name of any pharmacist employed or engaged by C who is responsible for dispensing a particular prescription.

(3) If C is a body corporate, it must give notice to NHS England within 30 days (or if this in impracticable, as soon as practicable thereafter) of any changes to the names and addresses of each of its directors.

(4) If C is a body corporate and appoints a director who was not listed on C's application for inclusion on a pharmaceutical list, C must, within 30 days of the person's appointment, supply to NHS England the information mentioned in paragraphs 3 and 4 of Schedule 2 about that person.

(5) If C or a director of C (if C is a body corporate) is on, or is a director of a body corporate which is on, a relevant list other than a pharmaceutical list held by NHS England, they must supply in writing to NHS England—

(a) in the case of a director of a body corporate, the name and registered office of the body corporate on the other relevant list; and

(b) particulars of the other relevant list.

(6) C or a director C (if C is a body corporate) must inform NHS England if they, or a body corporate of which they are a director, apply to be included in a relevant list other than a pharmaceutical list held by NHS England, and of the outcome of any such application.

Co-operation with Health Education England

23

An NHS appliance contractor must co-operate with NHS England in the discharge by NHS England of the duty under section 1F(1) of the 2006 Act (duty as to education and training).

Complaints

24

(1) An NHS appliance contractor must have in place arrangements, which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 , for the handling and consideration of any complaints.

(2) In this paragraph, “complaint” means a complaint about a matter connected with the provision of pharmaceutical services by the NHS appliance contractor.

Inspections and access to information

25

(1) An NHS appliance contractor (C) must allow persons authorised in writing by NHS England to enter and inspect any premises C uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

(a) ascertaining whether or not C is complying with the requirements of this Schedule;

(b) auditing, monitoring and analysing—

(i) the provision made by C, in the course of providing pharmaceutical services, for patient care and treatment, including any arrangement made with a person in respect of provision of appliances, and

(ii) the management by C of the pharmaceutical services C provides,

where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) reasonable notice of the intended entry has been given;

(b) the Local Pharmaceutical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by C;

(d) X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) C must, at the request of NHS England or of X, allow it or X access to any information which it or X reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1); or

(b) in the case of NHS England, in connection with its functions that relate to pharmaceutical services.

SCHEDULE 6 — Terms of service of dispensing doctors

Persons duly authorised to dispense on behalf of dispensing doctors

1

(1) Where this Schedule imposes a requirement on a dispensing doctor in respect of an activity which the dispensing doctor has duly authorised another person to undertake, if that other person undertakes that activity instead of the dispensing doctor—

(a) that other person must comply with that requirement; and

(b) the dispensing doctor must secure compliance with that requirement by that other person.

(2) Where reference is made in this Schedule to a dispensing doctor—

(a) being the subject of an activity, and in fact a person duly authorised by the dispensing doctor is the subject of that activity; or

(b) forming a view, and in fact a person duly authorised by the dispensing doctor is to form that view,

that reference is to be construed as referring, as appropriate, to that duly authorised person.

(3) References in this Schedule to a dispensing doctor are to be construed in accordance with sub-paragraphs (1) and (2).

Dispensing of drugs and appliances ordered by another prescriber

2

(1) In this paragraph, “signed” includes signature with a prescriber's advanced electronic signature.

(2) Subject to the following provisions of this Schedule, where—

(a) any person presents to a dispensing doctor (D) a non-electronic prescription form which contains—

(i) an order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber other than D,

(ii) an order for drugs specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber other than D, and including the reference “SLS”, or

(iii) an order for restricted availability appliances, signed by a prescriber other than D and including the reference “SLS”; ...

(b) subject to sub-paragraph (4), D receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii) and—

(i) any person requests the provision of drugs or appliances in accordance with that prescription, or

(ii) D has previously arranged with the patient that D will dispense that prescription on receipt; or

(i) presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic prescription form,

and D is authorised or required by virtue of Part 8 to provide the drugs or appliances so ordered, D must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as D supplies in the normal course of business.

(3) Subject to the following provisions of this Schedule, where—

(a) any person presents to D a non-electronic repeatable prescription which contains—

(i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971 , other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a prescriber other than D,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by a prescriber other than D and including the reference “SLS”,

(iii) an order for appliances, not being restricted availability appliances, signed by a prescriber other than D, or

(iv) an order for a restricted availability appliance, signed by a prescriber other than D, and including the reference “SLS”,

and also presents an associated batch issue; ...

(b) D receives as a nominated dispensing contractor an electronic repeatable prescription from the Electronic Prescription Service which contains an order of a kind specified in paragraph (a)(i) to (iv) and—

(i) any person requests the provision of drugs or appliances in accordance with that repeatable prescription, or

(ii) D has previously arranged with the patient that D will dispense that repeatable prescription on receipt; or

(i) presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic repeatable prescription,

(4) D must not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedules 2 to 5 to the Misuse of Drugs Regulations 2001.

(5) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances shall be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—

(a) D has that prescription in D's possession; and

(b) that person presents, or D has in D's possession, an associated batch issue.

(6) Drugs and appliances provided under this paragraph must be provided in a suitable container.

Dispensing of drugs and appliances ordered by the dispensing doctor

3

In circumstances where paragraph 2 does not apply and subject to the following provisions of this Schedule, where a dispensing doctor (D) is authorised or required by virtue of Part 8 to provide a drug or appliance to a person—

(a) D must record any order for the provision of any drugs or appliances which are needed for the treatment of the patient, before the drugs or appliances are dispensed (unless it is personally administered)—

(i) on a prescription form completed in accordance with the term of the contract under which primary medical services are provided to the patient which gives effect to paragraph 39 of Schedule 6 to the GMS Regulations (other contractual terms – prescribing) or an equivalent provision applying in relation to that contract,

(ii) if paragraph 39A of Schedule 6 to the GMS Regulations (other contractual terms – electronic prescriptions) or an equivalent provision applies in relation to the contract under which primary medical services are provided to the patient, on an electronic prescription form, or

(iii) in the case of a personally administered vaccine in respect of which the NHS BSA does not require an individual prescription form in order to process payment, on the form provided by the NHS BSA for the purposes of claiming payments for administering that vaccine (as well, potentially, as claiming other payments), and in the manner required by the NHS BSA (which may be as part of an aggregate total);

(b) D must provide those drugs or appliances in a suitable container (unless it is personally administered);

(c) D must provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances) only where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations (other contractual terms – a restrictions on prescribing by medical practitioners) are satisfied; and

(d) D must provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff.

Preliminary matters before providing ordered drugs or appliances

4

Before providing any drugs or appliances in accordance with paragraph 3 or 3A, or in the circumstances set out in paragraph 5—

(a) a dispensing doctor (D) must ask any person who makes or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription that the patient does not have to pay the charges specified in regulation 4(1) of the Charges Regulations (supply of drugs and appliances by doctors) by virtue of either—

(i) entitlement to exemption under regulation 10(1) of the Charges Regulations (exemptions), or

(ii) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (entitlement to full remission and payment),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of regulation 10 of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5 of the Remission of Charges Regulations, and at the time of the declaration D has such evidence available to D;

(b) if, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (a), is produced to D, D must endorse the form on which the declaration is made to that effect; and

(c) in the case of an electronic prescription, D must ensure that the following information is duly entered into the records managed by NHS England that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))—

(i) in a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—

(aa) the exemption category specified in regulation 10(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case, and

(bb) whether or not satisfactory evidence was produced to D as required by sub-paragraph (a),

(ii) in any case where a charge is due, confirmation that the relevant charge was paid, and

(iii) in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

Provision of Scheduled drugs

5

(1) A dispensing doctor (D) must only provide for a patient any Scheduled drug if—

(a) it is ordered as specified in sub-paragraph (2) or (4); or

(b) in the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.

(2) A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—

(a) the prescribed drug is ordered by that non-proprietary name or by its formula; and

(b) the prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically).

(3) If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (2) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.

(4) Nothing in this Schedule prevents D providing, otherwise than under pharmaceutical services, a Scheduled drug or a restricted availability appliance for a patient.

Refusal to provide drugs or appliances ordered

6

(1) A dispensing doctor (D) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a) D reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because D reasonably believes it has been stolen or forged);

(b) it appears to D that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to D's clinical judgement; or

(c) where the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that NHS England (or a person exercising its functions) requires in order to perform its functions relating to—

(i) the remuneration of persons providing pharmaceutical services, and

(ii) any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless D (or the person who employs or engages D) is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.

(1A) D may refuse to provide a drug or appliance ordered on an electronic prescription if the access that D has to the Electronic Prescription Service is not such as to enable D to dispense that prescription promptly (or at all).

(2) D must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) D has no record of that prescription;

(b) D does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to D;

(d) to do so would not be in accordance with any intervals specified in the prescription;

(e) it would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;

(f) if the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

(g) the expiry date on the repeatable prescription has passed; or

(h) D has been informed by the prescriber that the prescription is no longer required.

(3) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that the patient makes such a request), D must only provide the drugs or appliances ordered if D is satisfied—

(a) that the patient to whom the prescription relates—

(i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient's treatment;

(b) that the medication regimen of the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; and

(c) there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.

(4) D must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

(a) a SSP has effect in respect of—

(i) the requested drug or appliance; or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description; and

(b) alternative provision has already taken place in accordance with the SSP.

(5) D may refuse to fulfil an order or a request for a drug that is or is purportedly in accordance with a LPIV, a PTP or a PTPGD where—

(a) D reasonably believes it is not a genuine order or valid request for the person who requests, or on whose behalf is requested, the provision of the drug;

(b) providing it would be contrary to D’s clinical judgement;

(c) D or other persons are subjected to or threatened with violence by the person who requests the provision of the drug, or by any person accompanying that person; or

(d) the person who requests the provision of the drug, or any person accompanying that person, commits or threatens to commit a criminal offence.

(6) D must refuse to provide, pursuant to a LPIV, a PTP or a PTPGD, an order or a request for a drug that is or is purportedly in accordance with the LPIV, the PTP or PTPGD where D is not satisfied that it is in accordance with the LPIV, the PTP or PTPGD.

(7) D may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—

(a) more than one prescription item has been ordered on the prescription form or repeatable prescription;

(b) at least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; and

(c) the person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.

Dispensing doctors issuing prescription forms which may be presented to an NHS chemist

7

Notwithstanding the existence of arrangements under which a dispensing doctor (D) is to provide pharmaceutical services to a patient (P), if D determines that P requires a drug or appliance that is available on prescription at or from an NHS chemist—

(a) D may with the agreement of P issue; or

(b) if P so requests, D must not unreasonably refrain from issuing,

a prescription form that P may present to any NHS chemist instead of D supplying that drug or appliance to P.

Complaints procedures

8

Where a dispensing doctor is a provider of primary medical services, or is employed or engaged by such a provider, the complaints procedure established by—

(a) the provider or practice; or

(b) the provider or practice that employs or engages the dispensing doctor,

to deal with complaints in relation to the provision of primary medical services is also to apply in relation to a complaint about any matter reasonably connected with the provision of pharmaceutical services by that provider, practice or individual.

Inspections and access to information

9

(1) A dispensing doctor (D) must allow persons authorised in writing by NHS England to enter and inspect any premises D uses for the provision of pharmaceutical services at any reasonable time, for the purposes of—

(a) ascertaining whether or not D is complying with the requirements of this Schedule;

(b) auditing, monitoring and analysing—

(i) the provision made by D, in the course of providing pharmaceutical services, for patient care and treatment, and

(ii) the management by D of the pharmaceutical services D provides,

where the conditions in sub-paragraph (2) are satisfied.

(2) The conditions are that—

(a) reasonable notice of the intended entry has been given;

(b) the Local Medical Committee for the area where the premises are situated have been invited to be present at the inspection, where this is requested by D;

(d) X does not enter any part of the premises used solely as residential accommodation without the consent of the resident.

(3) D must, at the request of NHS England or of X, allow it or X access to any information which it or X reasonably requires—

(a) for the purposes mentioned in sub-paragraph (1); or

(b) in the case of NHS England, in connection with its functions that relate to pharmaceutical services.

Voluntary closure of premises

10

(1) Where a dispensing doctor (D) wishes—

(a) to withdraw from a dispensing doctor list, or

(b) except in the circumstances described in paragraph (2), for particular listed dispensing premises no longer to be listed in relation to D,

D must notify NHS England of D's wish at least 3 months in advance of the date on which pharmaceutical services are no longer to be provided, unless it is impracticable for D to do so, in which case D must notify NHS England as soon as it is practicable for D to do so.

(2) If particular listed dispensing premises no longer need to be listed in relation to D as a consequence of a relocation application under regulation 55, before the date on which D commences the provision of pharmaceutical services at or from the new premises, D must give notice to NHS England of when, before that date, D is to cease to provide pharmaceutical services at or from the existing premises.

SCHEDULE 7 — Mandatory terms for LPS schemes

General provisions

1

(1) The LPS contractor must comply with all relevant legislation, including—

(a) the relevant provisions of Part 13 of these Regulations; and

(b) relevant provisions that are—

(i) included in regulations under section 225 of the 2007 Act (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

(ii) made for the purpose of imposing on a services-provider (within the meaning of that section) a duty to allow authorised representatives (within the meaning of that section) to enter and view, and observe the carrying-on of activities at or from, premises owned or controlled by the services-provider.

(2) The LPS contractor must comply with the relevant provisions of the Drug Tariff.

(3) The LPS contractor must have regard to all relevant guidance issued by—

(a) NHS England; or

(b) the Secretary of State.

(4) To the extent that the provisions of the terms required by this Schedule impose a requirement on the LPS contractor (C) in respect of an activity which could only, or would normally, be undertaken by a natural person—

(a) if C is a registered pharmacist—

(i) C must comply with the requirement, or

(ii) if C employs or engages a registered pharmacist in connection with the provision of local pharmaceutical services under C's LPS scheme, C must either comply with that requirement or secure compliance with that requirement by the registered pharmacist C employs or engages; or

(b) if C is not a natural person, C must secure compliance with that requirement by the registered pharmacists C employs or engages, and references in this Schedule to an LPS contractor are to be construed accordingly.

Restrictions in an LPS scheme on supply

2

(1) Where an LPS scheme is limited to the provision of specified drugs or appliances, the LPS contractor must not provide other drugs or appliances at or from the scheme premises.

(2) An LPS scheme must contain the following terms, where applicable—

(a) where the local pharmaceutical services to be provided include the supply of appliances—

(i) the only appliances which may be supplied are appliances listed in Parts IXA, IXB, IXC or X of the Drug Tariff, and

(ii) those appliances must be supplied in accordance with the provisions of the Notes, and the List of Technical Specifications, which appear at the beginning of Part IX of the Drug Tariff, which apply at the time of supply; and

(b) where the local pharmaceutical services to be provided include the supply of chemical reagents, the only chemical reagents which may be supplied are those listed from time to time in Part IXR of the Drug Tariff.

(3) Where an LPS scheme is limited to the provision of services—

(a) to a specified class of persons (for example persons who require the provision of local pharmaceutical services for the treatment of a specified disease or condition); or

(b) to persons residing in a particular place (for example persons in a specified residential home),

the LPS contractor must not provide local pharmaceutical services to persons other than those so specified.

Dispensing

3

(1) Subject to any provisions of an LPS scheme included pursuant to paragraph 2 and the following provisions of this Schedule, where—

(a) any person presents to the LPS contractor (C) a non-electronic prescription form which contains—

(i) an order for a drug, not being a Scheduled drug, or for an appliance, not being a restricted availability appliance, signed by a prescriber,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), signed by a prescriber and including the reference “SLS”, or

(iii) an order for a restricted availability appliance, signed by a prescriber and including the reference “SLS”; ...

(b) C receives as a nominated dispensing contractor from the Electronic Prescription Service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii), and—

(i) any person requests the provision of a drug or appliance in accordance with that prescription, or

(ii) C has previously arranged with the patient that it will dispense that prescription on receipt; or

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii) requests the provision of a drug or appliance in accordance with the related electronic prescription form,

Urgent supply without a prescription

4

Where, in case of urgency, a prescriber personally known to the LPS contractor (C) requests C to provide a drug, C may provide that drug (where it would otherwise be able to provide that drug in accordance with the LPS scheme) before receiving a prescription form or repeatable prescription, provided that—

(a) the drug is not a Scheduled drug;

(b) the drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations); and

(i) give C a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug within 72 hours of the request being made, or

(ii) transmit to the Electronic Prescription Service within 72 hours of the request being made an electronic prescription.

Preliminary matters before providing ordered drugs or appliances

5

(1) If a person specified in paragraph (2) asks the LPS contractor (C) to do so—

(a) C must give an estimate of the time when the drugs or appliances will be ready; and

(b) if they are not ready by then, C must give a revised estimate of the time when they will be ready (until they are ready).

(2) A person specified in paragraph (1) is a person—

(a) presenting a non-electronic prescription form or non-electronic repeatable prescription; or

(b) requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription.

(3) Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription, C must ask any person who makes or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 3(1) or (2) of the Charges Regulations (supply of drugs and appliances by chemists) by virtue of either—

(a) entitlement to exemption under regulation 10(1) of the Charges Regulations (exemptions); or

(b) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations (entitlement to full remission and payment),

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