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

the Secretary of State must notify the relevant HWB (under this sub-paragraph or sub-paragraph (1)(d)), and must include with that notification a statement of the reasons for the Secretary of State’s decision and the Secretary of State’s findings of fact.

• (2) If the Secretary of State has granted or confirmed the grant of a routine or excepted application—

• (a) NHS England must send to the applicant a template of the notice of commencement referred to in paragraph 29 or a notice of consolidation referred to in paragraph 29A; and

• (b) the time periods in paragraphs 31, 32, 34 and 34A thereafter apply as if the references to the applicant being sent notices of NHS England’s decision were reference to the applicant being notified by the Secretary of State under sub-paragraph (1).

• (3) If the Secretary of State has granted or confirmed the grant of—

• (a) a routine application, NHS England must proceed as soon as is practicable to take such action under regulation 50(4) or (5) as it thinks fit, subject to any directions of the Secretary of State under paragraph 9(2)(b);

• (b) an application for outline consent, NHS England must proceed as soon as is practicable to make a determination under regulation 53(3), subject to any directions of the Secretary of State under paragraph 9(6)(a); or

• (c) an application for premises approval, NHS England must proceed as soon as is practicable take such action under regulation 57 as it thinks fit, subject to any directions of the Secretary of State under paragraph 9(6)(b).

Effect of decisions by the Secretary of State

11

For the purposes of these Regulations, the Secretary of State's decision becomes NHS England’s decision on the matter (but no further appeal to the Secretary of State on that decision is possible), unless the Secretary of State's decision is overruled by a court.

SCHEDULE 4 — NHS England’sTerms of service of NHS pharmacists

PART 1 — General

Responsibilities of NHS pharmacists and pharmacy staff

1

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

• (a) if the NHS pharmacist is a registered pharmacist—

• (i) that NHS pharmacist must comply with that requirement, or

• (ii) if the NHS pharmacist employs or engages natural persons in connection with the provision of pharmaceutical services, the NHS pharmacist must either comply with that requirement or secure compliance with that requirement by—

• (aa) where conformity with the standards generally accepted in the pharmaceutical profession so requires, a registered pharmacist (who is not suspended), or

• (bb) in other cases, by the natural persons (including registered pharmacists) whom the NHS pharmacist employs or engages in connection with the provision of pharmaceutical services; or

• (b) if the NHS pharmacist is not a natural person, that NHS pharmacist must secure compliance with that requirement by—

• (i) where conformity with the standards generally accepted in the pharmaceutical profession so requires, a registered pharmacist (who is not suspended), or

• (ii) in other cases, the natural persons (including registered pharmacists) whom the NHS pharmacist employs or engages in connection with the provision of pharmaceutical services.

• (2) Where in this Schedule reference is made to an NHS pharmacist—

• (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 a referring, as appropriate, to the NHS pharmacist (if a natural person) or to the NHS pharmacist's staff.

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

Breaches by directors and superintendents

2

Where this Schedule imposes a requirement on the director or superintendent of a body corporate that is on 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.

PART 2 — Essential services

Essential services

3

For the purposes of these Regulations, “essential services” means—

• (a) the services described in this Part; and

• (b) the activities described in this Part to be carried out in connection with those services.

Dispensing services

4

An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting prescriptions for drugs or 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 drugs and appliances

5

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

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

• (a) any person presents to an NHS Pharmacist (P) 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,

• (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) subject to sub-paragraph (4), P 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) P has previously arranged with the patient that P will dispense that prescription on receipt; or

• (c) any person—

• (i) presents P 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,

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

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

• (a) any person presents to P 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,

• (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 and including the reference “SLS”,

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

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

and also presents an associated batch issue; ...

• (b) P 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) to (iv) and—

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

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

• (c) any person—

• (i) presents P 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,

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

• (4) P 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) P has that prescription in P's possession; and

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

Urgent supply without a prescription

6

• (1) This paragraph applies where, in a case of urgency, a prescriber requests an NHS pharmacist (P) to provide a drug or appliance.

• (2) P may provide the drug or appliance requested before receiving a prescription form or repeatable prescription in respect of that drug or appliance, provided that—

• (a) in the case of a request for a drug, the drug is neither—

• (i) a Scheduled drug, nor

• (ii) 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

• (b) in the case of a request for a drug or an appliance, the prescriber undertakes to—

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

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

Preliminary matters before providing ordered drugs or appliances

7

• (1) If a person specified in sub-paragraph (2) asks an NHS pharmacist (P) to do so—

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

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

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 P already has such evidence available to P.

• (3ZA) 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.

• (3A) In any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to P, P must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—

• (a) exemption under the Charges Regulations; or

• (b) remission of charges under the Remission of Charges Regulations,

where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims.

• (4) If, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (3), is produced to P, P shall endorse the form on which the declaration is made to that effect.

• (5) In the case of an electronic prescription, P 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 (3))—

• (a) 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—

• (i) 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

• (ii) whether or not satisfactory evidence was produced to P as required by sub-paragraph (3);

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

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

• (6) Sub-paragraphs (3) to (5) apply to the provision of a drug or appliance in accordance with a SSP as they apply to the provision of a drug or 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 5A(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).

Providing ordered drugs or appliances

8

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

• (a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 5(2) or (3); 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 Part.

• (2) Drugs or appliances so ordered shall be provided either by or under the direct supervision of a registered pharmacist.

• (2A) Subject to sub-paragraphs (2B) to (2E) and without prejudice to sub-paragraphs (10) and (11), for the purposes of sub-paragraph (1)(b), a drug is provided in accordance with the order on a prescription form or repeatable prescription if (in addition to where the provision is exactly in accordance with the order)—

• (a) a different quantity is provided to that ordered on the prescription form or repeatable prescription in order to allow for the provision of the drug in its manufacturer’s original outer packaging; and

• (b) the provision is otherwise in accordance with the order.

• (2B) In the case of an order for a prescription only medicine, sub-paragraph (2A) only applies if sub-paragraph (8) applies or one of the following applies—

• (a) the provision is in accordance with regulation 217B(1) to (3) of the Human Medicines Regulations 2012 (original pack dispensing), and accordingly, regulation 217B(1) to (3) of those Regulations is expressly applied to such supplies; or

• (b) the medicine must be provided in the manufacturer’s original outer packaging in order to comply with regulation 217C of the Human Medicines Regulations 2012 (original pack dispensing: medicinal products containing a relevant substance).

• (2C) In the case of an order for a drug that is not a prescription only medicine, sub-paragraph (2A) only applies if sub-paragraph (8) applies or the provision of a different quantity to that ordered on the prescription is in circumstances where—

• (a) the different quantity is no more than 10% greater or no more than 10% less than the quantity ordered; and

• (b) the registered pharmacist carrying out or directly supervising the provision does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity to that ordered may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

• (2D) Where P may, pursuant to sub-paragraph (2A) and sub-paragraph (2B)(a) or (2C)(a) and (b), provide a different quantity of a drug to that ordered on a prescription form or a repeatable prescription, P must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to do so, having regard to the benefits to patients where they are provided with drugs in their manufacturer’s original outer packaging.

• (2E) Sub-paragraphs (2B)(a) and (2C)(a) and (b) do not apply to the provision of any drug which is—

• (a) for the time being specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain provisions under the Regulations); or

• (b) a special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (supply to fulfil special patient needs).

• (3) Where the registered pharmacist referred to in sub-paragraph (2) is employed or engaged by P, the registered pharmacist must not be someone—

• (a) who is disqualified from inclusion in a relevant list; or

• (b) who is suspended from the GPhC register.

• (4) 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), P must make all necessary arrangements for a registered pharmacist—

• (a) to measure the person named on the prescription form or repeatable prescription for the appliance; and

• (b) to fit the appliance.

• (5) If the order is for , or a product to be provided in accordance with a SSP is, a drug or 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 drug or appliance provided must comply with any relevant standard or formula specified therein.

• (6) If the order—

• (a) is an order for a drug; but

• (b) is not an order for 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 does not prescribe its quantity, strength or dosage, P (in this context, a registered pharmacist) may provide the drug in such strength and dosage as in the exercise of their professional skill, knowledge and care P considers to be appropriate and, subject to sub-paragraph (7), in such quantity as P considers to be appropriate for a course of treatment for a period not exceeding 5 days.

• (7) Where an order to which sub-paragraph (6) applies is for—

• (a) an oral contraceptive substance;

• (b) a drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs; or

• (c) an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,

which is not available for provision as part of pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, P may provide the minimum size available package.

• (8) Where any drug to which this paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by P in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—

• (a) sterile;

• (b) effervescent or hygroscopic;

• (c) a liquid preparation for addition to bath water;

• (d) a coal tar preparation;

• (e) a viscous preparation; or

• (f) packed at the time of its manufacture in a special container,

P must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

• (9) In this paragraph, “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

• (10) Subject to sub-paragraph (11), where a drug is ordered by a prescriber on a prescription form or a repeatable prescription , or is to be provided in accordance with a SSP, in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a UK marketing authorisation holder for the drug, P must provide the drug in an original pack (or in original packs) of that size which has been assembled by a manufacturer of the drug for such a UK marketing authorisation holder, unless—

• (a) it is not possible for P to obtain such a pack (or packs) with reasonable promptness in the normal course of business; or

• (b) it is not practicable for P to provide such a pack (or packs) in response to the order (for example, because of patient needs or the method of administration of the drug).

• (11) In the case of oral liquid methadone, P (in practice, a registered pharmacist) must decide whether it would be most appropriate to provide—

• (a) each dose in a separate container;

• (b) an original pack (or original packs); or

• (c) the oral liquid methadone in some other way,

and P must then provide it in packaging that accords with that decision.

• (12) P must only provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription if—

• (a) it is ordered as specified in sub-paragraph (13); 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.

• (13) 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;

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

• (c) the Scheduled drug is not in a pack which consists of a drug in more than one strength, and providing it would involve the supply of part only of the pack.

• (14) If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (13) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.

• (15) P must provide any drug which P is required to provide under paragraph 5 or 5C , or provides under paragraph 5A or 5B, in a suitable container.

• (16) Where P provides a drug or appliance under paragraph 5A, P must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.

• (17) Sub-paragraphs (5) to (10) apply to the provision of a drug in accordance with a LPIV, a PTP or a PTPGD as they apply to the provision of a drug in accordance with a prescription form or a repeatable prescription (or an associated batch issue).

• (18) Where P provides a drug under paragraph 5B, P must include a dispensing label on the packaging of the product and include in the label (in addition to the particulars required or permitted by Part 2 of Schedule 26 to the Human Medicines Regulations 2012), for the patient’s benefit, information to the effect that the product is being supplied in accordance with a PTP or a PTPGD, identifying the particular PTP or PTPGD.

Refusal to provide drugs or appliances ordered

9

• (1) An NHS pharmacist (P) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

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

• (b) it appears to P 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 P's (in practice, a registered pharmacist's) clinical judgement;

• (c) P 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 drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or by any person accompanying that person;

• (d) the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a 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 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 P (or the person who employs or engages P) is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.

• (2) P must refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe.

• (2A) P may refuse to provide a drug or appliance ordered on an electronic prescription if the access that P has to the Electronic Prescription Service is not such as to enable P to dispense that prescription promptly (or at all) , but where P does so, P must take all reasonable steps to ensure that the product ordered by the prescriber is supplied within a reasonable timescale, which may include (depending on what steps or combination of steps the circumstances require)—

• (a) providing details of other NHS pharmacists or LPS chemists whose premises are situated in the same area and who may be able to provide the product ordered by the prescriber;

• (b) urgent supply without a prescription in accordance with paragraph 6;

• (c) arranging for the urgent provision of a non-electronic prescription form by the prescriber.

• (2B) P 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.

• (2C) P may 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;

• (b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

• (c) P is unable to provide the drug or appliance within a reasonable timescale,

but if P does refuse to do so, P must provide the patient or the person requesting the drug or 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.

• (3) P must refuse to provide drugs or appliances ordered on a repeatable prescription where—

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

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

• (c) it is not signed by a prescriber;

• (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) 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) P has been informed by the prescriber that the prescription is no longer required.

• (4) 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), P must only provide the drugs or appliances ordered if P 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, or 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.

• (5) P 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) P 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 P’s clinical judgement;

• (c) P 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) P 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 P is not satisfied that it is in accordance with the LPIV, the PTP or PTPGD .

• (7) P 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.

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

10

• (1) In connection with the services provided under paragraph 4, an NHS pharmacist (P) must—

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

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

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

• (b) provide appropriate advice to patients to whom they provide drugs or appliances on—

• (i) the safe keeping of the drugs or appliances, and

• (ii) returning unwanted drugs or appliances to the pharmacy premises for safe destruction;

• (c) when providing drugs to patients in accordance with a repeatable prescription, provide appropriate advice in particular on the importance of only requesting those items which they actually need;

• (d) when providing appliances to patients in accordance with a prescription form or repeatable prescription—

• (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;

• (da) ensure that appropriate advice about the benefits of repeat dispensing is given to any patient who—

• (i) has a long term, stable medical condition (that is, a medical condition that is unlikely to change in the short to medium term), and

• (ii) requires regular medicine in respect of that medical condition,

including, where appropriate, advice that encourages the patient to discuss repeat dispensing of that medicine with a prescriber at the provider of primary medical services whose patient list the patient is on;

• (e) provide a patient with a written note (which may be in an electronic form) of any drug or appliance which is owed, and inform the patient when it is expected that the drug or appliance will become available;

• (f) keep and maintain records—

• (i) of drugs and 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 prescriptions), and

• (iii) of notes provided under sub-paragraph (e);

• (g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

• (i) if P provides a drug or appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the drugs or 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 drugs or appliances—

• (i) which are not required, or

• (ii) where a patient is refused the drugs or appliances pursuant to paragraph 9;

• (l) ensure that where a person is refused drugs or appliances pursuant to paragraphs 9(1)(b), (2), (3) or (4), the patient is referred back to the prescriber for further advice;

• (m) where a patient is provided with drugs or 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 drugs or appliances pursuant to paragraph 9(4);

• (o) when providing appliances, provide a patient with a written note of P's name, address and telephone number; and

• (p) when providing specified appliances, comply with the additional requirements set out in paragraph 12.

• (2) Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing services under paragraph 4, P is unable (having regard to any relevant SSP) to provide an appliance, or stoma appliance customisation is required and P is unable to provide that, P shall—

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

Additional requirements in relation to electronic prescribing

11

• (1) An NHS pharmacist (P) must, if requested to do so by any person—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) where the Electronic Prescription Service is temporarily unavailable through P's pharmacy premises, provide that person with contact details of at least 2 NHS pharmacists in the area at or from whose premises the service is available, if these details are known to P.

• (2) ... P 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 for that person 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 P is a nominated dispensing contractor for a person (X) but the nomination was made before P became the person listed in a pharmaceutical list in relation to the pharmacy premises nominated in X's PDS patient details, P must within 6 months of P becoming the person so listed—

• (a) explain to X that the ownership of the pharmacy premises has changed; and

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

• (6) If P dispenses an electronic prescription or makes an urgent supply without a prescription, P must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b) or (c), (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

12

• (1) This paragraph sets out the additional requirements referred to in paragraph 10(1)(p) relating to the provision of specified appliances.

• (2) An NHS pharmacist (P) 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) P 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), P 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 P 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 P is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), P 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 P.

• (5) Where P provides a telephone care line in respect of the dispensing of any specified appliance, P 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 that 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 pharmacy premises, means the periods outside the core opening hours and any supplementary opening hours of the premises.

Disposal service in respect of unwanted drugs

13

An NHS pharmacist must, to the extent paragraph 14 requires and in the manner described in that paragraph, accept and dispose of unwanted drugs presented to the NHS pharmacist for disposal.

Basic procedure in respect of unwanted drugs

14

• (1) Subject to paragraph (2), where a person presents to an NHS pharmacist (P) any drugs provided for a patient in, and which have been kept in—

• (a) a private household; or

• (b) a children's home; or

• (c) a residential care home, that is to say an establishment which exists wholly or mainly for the provision of residential accommodation, together with board and personal care, for persons in need of personal care because of—

• (i) old age,

• (ii) mental or physical disability,

• (iii) past or present dependence on alcohol or drugs,

• (iv) any past illnesses, or

• (v) past or present mental disorder,

P must accept the drugs and dispose of them in accordance with sub-paragraph (3).

• (2) P is not required to accept any drugs for disposal unless NHS England has made arrangements for the collection and disposal of drugs of that description.

• (3) On receipt of the drugs, P must—

• (a) where required to do so by NHS England or by a waste disposal contractor retained by NHS England, separate solid drugs or ampoules, liquids and aerosols from each other;

• (b) store the drugs in containers provided by NHS England, or by a waste disposal contractor retained by NHS England, for the purpose of storing drugs of that description; and

• (c) comply with any other statutory requirements in respect of storing or the disposal of drugs of that description (meeting those requirements are therefore an essential service for the purposes of these Regulations),

and shall co-operate with any suitable arrangements that NHS England has in place for regular collection of the drugs from P's pharmacy premises by or on behalf of NHS England.

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

15

In connection with the services provided under paragraph 13, an NHS pharmacist (P) must—

• (a) ensure that P (including P's staff) is aware of the risks associated with the handling of waste drugs and the correct procedures to be used to minimise those risks; and

• (b) ensure that P (including P's staff) has readily available, and close to any place where waste drugs are stored, appropriate protective equipment, including gloves, overalls and materials to deal with spillages.

Promotion of healthy lifestyles

16

An NHS pharmacist must, to the extent paragraphs 17 and 18 require, and in the manner set out in those paragraphs, promote public health messages to members of the public.

Prescription linked intervention

17

• (1) Where a person using a pharmacy—

• (a) presents a non-electronic prescription form or non-electronic repeatable prescription to an NHS pharmacist (P) or requests the provision of drugs or appliances in accordance with an electronic prescription; and

• (b) it appears to P that the person—

• (i) has diabetes,

• (ii) is at risk of coronary heart disease, especially those with high blood pressure, or

• (iii) smokes or is overweight,

P must, as appropriate, provide advice to that person with the aim of increasing that person's knowledge and understanding of the health issues which are relevant to that person's personal circumstances.

• (2) Advice given under sub-paragraph (1) may be backed up, as appropriate—

• (a) by the provision of written material (for example leaflets); and

• (b) by referring the person to other sources of information or advice.

• (3) P must, in appropriate cases, keep and maintain a record of advice given pursuant to this paragraph, and that record must be in a form that facilitates—

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

• (b) follow-up care for the person who has been given the advice.

Public health campaigns

18

An NHS pharmacist (P) must, at the request of NHS England, ensure that—

• (a) P (including P's staff) participates, in the manner reasonably requested by NHS England, in up to 6 campaigns in each financial year to promote ... health messages to users of P's pharmacy;

• (b) where requested to do so by NHS England, P records the number of people to whom P (including P's staff) has provided information as part of one of those campaigns ; and

• (c) where requested to do so by NHS England, P sends to NHS England by means of an electronic communication of the type specified in the request—

• (i) the number recorded pursuant to sub-paragraph (b), and

• (ii) information which is reasonably requested by NHS England, and which is in an anonymised form if it would otherwise identify any person to whom information was provided as part of the campaign, for the purposes of evaluating the effectiveness of the campaign and policy development.

Signposting

19

An NHS pharmacist must, to the extent paragraph 20 requires and in the manner set out in that paragraph, provide information to users of the NHS pharmacist's pharmacy about other health and social care providers and support organisations.

Service outline in respect of signposting

20

• (1) Where it appears to an NHS pharmacist (P), having regard to the need to minimise inappropriate use of health and social care services and of support services, that a person using P's pharmacy—

• (a) requires advice, treatment or support that P cannot provide; but

• (b) another provider, of which P is aware, of health or social care services or of support services is likely to be able to provide that advice, treatment or support,

P must provide contact details of that provider to that person and must, in appropriate cases, refer that person to that provider.

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

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

• (3) Where appropriate, a referral under this paragraph may be made by means of a written referral note.

• (4) P must, in appropriate cases, keep and maintain a record of any information given or referral made under this paragraph and that record must be in a form that facilitates—

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

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

Support for self-care

21

An NHS pharmacist must, to the extent paragraph 22 requires and in the manner set out in that paragraph, provide advice and support to people caring for themselves or their families.

Service outline in respect of support for self-care

22

• (1) Where it appears to an NHS pharmacist (P), having regard to the need to minimise the inappropriate use of health and social care services, that a person (X) using P's pharmacy would benefit from advice from P to help X manage a medical condition (including, in the case of a carer, to help X in assisting in the management of another person's medical condition), P must provide advice to X as regards managing the medical condition, including, as appropriate, advice—

• (a) on treatment options, including advice on the selection and use of appropriate drugs which are not prescription only medicines; and

• (b) on changes to the patient's lifestyle.

• (2) P must, in appropriate cases, keep and maintain a record of any advice given under sub-paragraph (1), and of any drugs supplied when the advice was given, and that record shall be in a form that facilitates—

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

• (b) follow-up care for the person to whom or in respect of whom the advice has been given.

PART 3 — Hours of opening

Pharmacy opening hours: general

23

• (1) Subject to paragraph 23A, an NHS pharmacist (P) must ensure that pharmaceutical services are provided at or from P's pharmacy premises—

• (a) for 40 hours each week;

• (b) for not less than 100 hours each week, in the case of premises in respect of which a 100 hours condition 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 40 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 40 hours per week, and at set times and on set days, at the times and on the days so set , subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd); 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 40 hours each week, but only on set times and on set days as regards the additional opening hours , or the core opening hours where paragraph 26(4A) applied to the issuing of the direction—

• (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 , subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd),

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 pharmacy premises must be open by virtue of sub-paragraph (1) are referred to in these Regulations as “core opening hours”.

• (3) P must notify NHS England of other hours during which P's pharmacy premises are to be open, which are hours in addition to P's core opening hours (and which are referred to in these Regulations as “supplementary opening hours”).

• (4) Unless P is a distance selling chemist, at P's pharmacy premises P must exhibit—

• (a) a notice specifying the days on which and times at which the premises are open for the provision of drugs and appliances (including times at which P is providing pharmaceutical services during supplementary opening hours); and

• (b) at times when the premises are not open, a notice based on information provided by NHS England, where practicable legible from outside the premises, specifying—

• (i) the addresses of other NHS pharmacists and the days on which and times at which drugs and appliances may be obtained from those addresses, and

• (ii) the addresses of LPS chemists in the area, the type of local pharmaceutical services which those LPS chemists provide, and the days on which and times at which their premises are open.

• (5) P 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 P's pharmacy premises (including times at which P is providing pharmaceutical services during supplementary opening hours); and

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

• (6) Where P changes—

• (a) the supplementary opening hours of P's pharmacy premises; or

• (b) the pharmaceutical services which P ordinarily provides at or from those premises,

P must supply NHS England with a return informing it of the change before the change takes place.

• (7) Where P has notified to NHS England (or, before the appointed day, a Primary Care Trust) the days on which and times at which pharmaceutical services are to be provided at or from P's pharmacy premises (for example, in a return under sub-paragraph (5) or (6) or in an application for inclusion in a pharmaceutical list)—

• (a) P must ensure that pharmaceutical services are provided at or from the premises to which the notification relates on the days and at the times set out in the notification (unless the notification has been superseded by a return, or a further return, under sub-paragraph (6)); ...

• (ba) P must not change the days on which or the times at which pharmaceutical services are to be provided at or from those premises during core opening hours, except for making a change that—

• (i) amounts to the inclusion of a rest break which is no longer than one hour, or a change to such a rest break—

• (aa) on a Monday to Saturday, which starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours, or

• (bb) on a Sunday, and

• (ii) does not change the total number of P’s core opening hours on a particular day,

otherwise than as provided for, and in accordance with the procedures set out in, paragraphs 25 and 26;

• (bb) P must not change P’s supplementary opening hours in a way that reduces the time for which P’s pharmacy is open before or after a rest break on a Monday to Saturday to less than 3 hours (if P wants to change the supplementary opening hours affected by this requirement, P must also change the time of the rest break);

• (bc) P must not change—

• (i) the total number of P’s supplementary opening hours in a way that either reduces or leaves the same the total number of P’s supplementary opening hours, or

• (ii) unless the change relates to an increase of the total number of supplementary opening hours, the days on which or the times at which pharmaceutical services are to be provided at or from P’s premises during supplementary opening hours,

for a period of at least 5 weeks after the day on which that notification was received by NHS England, unless NHS England agrees otherwise; and

• (bd) P must not change the days on which or the times at which pharmaceutical services are to be provided at or from those premises during core opening hours, in the case of making a change that—

• (i) amounts to the inclusion of a rest break which is no longer than one hour, or a change to such a rest break—

• (aa) on a Monday to Saturday, which starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours, or

• (bb) on a Sunday, and

• (ii) does not change the total number of P’s core opening hours on a particular day,

for a period of at least 5 weeks after the day on which that notification was received by NHS England, unless NHS England agrees otherwise.

• (7A) Paragraphs (ba) and (bd) of sub-paragraph (7) do not apply to changes to core opening hours of premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, and accordingly the core opening hours of such premises may only be changed in accordance with paragraph 25 or 26.

• (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (10) Where there is a temporary suspension in the provision of pharmaceutical services by P because of illness or another reason beyond the control of P, P is not in breach of sub-paragraphs (1) and (7), or of paragraph 23A(5)(a), provided that—

• (a) P notifies NHS England of that suspension as soon as practicable, in the manner required by paragraph 29D(2)(a) and wherever possible before the start of the suspension;

• (aa) P uses all reasonable endeavours to implement the business continuity plan that P is required to have by virtue of paragraph 29D; and

• (b) P uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.

• (11) Planned refurbishment of pharmacy premises is not a “reason beyond the control of P” for the purposes of sub-paragraph (10).

• (12) For the purposes of calculating the number of hours that pharmacy premises are open during a week that includes Christmas Day, Good Friday, Easter Sunday or a bank holiday, it is to be deemed that the pharmacy premises were open on that day at the times at which they would ordinarily have been open on that day of the week.

• (13) For the purposes of this Part, “additional opening hours”, where they are required, are hours during which P is required to provide pharmaceutical services pursuant to sub-paragraph (1)(e) which are in addition to the hours during which P would be required to provide pharmaceutical services, if P were subject instead to the condition set out in sub-paragraph (1)(a).

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

24

• (1) Subject to paragraph 26(2A) and except where paragraph 26(2ZB) applies, where NHS England issues a direction for setting any days or times for opening hours under this Part, or determines them without issuing a direction, it must in doing so seek to ensure that the days and times at which pharmacy premises are open for the provision of pharmaceutical services in the area in which the premises that are the subject of the direction are located are such as—

• (a) to maintain as necessary the existing level of service provision for the people in that area or other likely users of the pharmacy premises; or

• (b) to maintain a sustainable level of adequate service provision for the people in that area or other likely users of the pharmacy premises, in circumstances where maintaining the existing level of service provision is either unnecessary or not a realistically achievable outcome.

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

• (a) must treat any local pharmaceutical services being provided in its area 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 during supplementary opening hours.

• (3) NHS England may only direct that an NHS pharmacist (P) may provide pharmaceutical services at or from premises for less than 40 hours in any week if it is satisfied that the provision of pharmaceutical services in its area is likely to be adequate to meet the need for such services at times when P 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 P must provide pharmaceutical services at or from premises for more than 40 hours in any week where it is satisfied that P is to receive reasonable remuneration in respect of the additional opening hours for which P 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).

• (5) Sub-paragraph (4) does not apply in circumstances where the direction is in respect of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies.

Determination of pharmacy premises core opening hours instigated by the NHSCB

25

• (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 pharmacy 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 pharmacy 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 pharmacist (P) whose premises they are to provide pharmaceutical services at or from the pharmacy 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 P of any proposed changes to the days on which or times at which the pharmacy premises are to be open; and

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

• (3) When it determines the outcome of its assessment, 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 P must provide pharmaceutical services at or from the pharmacy premises, provided that the existing direction (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (4) and (5); or

• (c) either—

• (i) revoke, without replacing it, any existing direction in respect of the times at which P must provide pharmaceutical services at or from the pharmacy premises (whether issued under regulation 65, this Part, 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 23(1)(a) or (b) applies, the pharmacy will need to be open for 40 hours each week or for at least 100 hours each week.

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

• (a) for more than 40 hours each week, it must set out in that direction—

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

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

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

• (b) for less than 40 hours each week, it shall set out in that direction the days on which and times at which pharmaceutical services are to be provided at or from the pharmacy premises.

• (5) NHS England must not issue a direction under sub-paragraph (3) that has the effect simply of requiring pharmacy premises to be open for 40 hours each week on set days and at set times (that is, the direction must have the effect of requiring pharmacy premises to be open for either more or less than 40 hours each week).

• (6) NHS England must notify P 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 P is to provide pharmaceutical services at or from pharmacy premises, it must include with the notification a statement of—

• (a) the reasons for the change; and

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

• (7) P 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 P 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 shall notify P of the determination and shall 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 P is to provide pharmaceutical services at or from pharmacy premises have been changed in accordance with this paragraph, P must introduce the changes—

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

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

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

Determination of pharmacy premises core opening hours instigated by NHS England

26

• (1) An NHS pharmacist (P) may apply to NHS England for it to change the days on which or times at which P is obliged to provide pharmaceutical services during core opening hours at or from P's pharmacy premises in a way that—

• (a) reduces the total number of hours for which P is obliged to provide pharmaceutical services at or from those premises each week ...; or

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

• (1A) On or after 23rd June 2025, if P makes an application under paragraph (1)(b), P must state in the application whether P wishes the application to be determined on the basis of paragraph 24(1) or sub-paragraph (2ZB).

• (2) Except where sub-paragraph (2A) applies, where P makes an application under sub-paragraph (1)(a), as part of that application P must provide NHS England with such information as NHS England may reasonably request in respect of the matters that NHS England must seek to ensure pursuant to paragraph 24(1).

• (2ZA) Where P makes an application under sub-paragraph (1)(b), as part of that application P must provide NHS England with such information as NHS England may reasonably request in respect of the matters that NHS England must seek to ensure pursuant to sub-paragraph (2ZB) or paragraph or paragraph 24(1) (depending on the basis of the application).

• (2ZB) In the case of an application under sub-paragraph (1)(b) which is based on the matters that NHS England must seek to ensure pursuant to this sub-paragraph, where NHS England—

• (a) issues a direction under sub-paragraph (4) for setting any days or times for opening hours; or

• (b) determines the application under sub-paragraph (4) without issuing a direction,

it must in doing so seek to ensure that the people who are accustomed to accessing pharmaceutical services at the pharmacy premises are likely to benefit from the changes because, overall, they would be more likely to access those services at those premises during the proposed core opening hours than during the existing core opening hours.