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The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009

Type Scottish-Statutory-Instrument

Publication 2009-05-14

Last updated 2023-11-06

State In force

Jurisdiction Scotland

Department King's Printer for Scotland

Source legislation.gov.uk

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Made: 14th May 2009

Laid before the Scottish Parliament: 18th May 2009

Coming into force: 1st July 2009

In accordance with paragraph 24(1) and (3) of Schedule 7 to the Tribunals Courts and Enforcement Act 2007[^f00002] they have consulted the Administrative Justice and Tribunals Council and its Scottish Committee.

Citation and commencement

1

These Regulations may be cited as the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009 and come into force on 1st July 2009.

Interpretation and application

2

(1) In these Regulations unless the context otherwise requires–

“the Act” means the National Health Service (Scotland) Act 1978;

“the 1968 Act” means the Medicines Act 1968[^f00003];

“additional professional services” has the meaning assigned to it in regulation 4;

“advanced electronic signature” means an advanced electronic signature within the meaning given in Article 3(11) of Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC;

“the Agency” means the Common Services Agency for the Scottish Health Service constituted under section 10 of the Act[^f00005];

“appliance” means an appliance which is a listed appliance within the meaning of section 27(1) of the Act;

“appropriate non-proprietary name” means a non-proprietary name which is not mentioned in any directions given by the Scottish Ministers under section 17N(6) of the Act (other mandatory contract terms)[^f00006] as to the drugs or other substances–which may not be ordered for patients in the provision of primary medical services under a general medical services contract;except where the conditions in paragraph 40(2) of schedule 6 of the GMS Contracts Regulations[^f00007] are satisfied, which can only be ordered for specified patients and specified purposes;

“Area Medical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act[^f00008];

“Area Pharmaceutical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act;

“Board” means a Health Board within the meaning of section 2(1)(a) of the Act[^f00009];

“chemical reagent” means a chemical reagent included in a list for the time being approved by the Scottish Ministers for the purposes of section 27 of the Act;

“clinical management plan” has the meaning ascribed in regulation 8(1) of the Human Medicines Regulations 2012;

“collection and delivery arrangement” means an arrangement within the meaning of regulation 248(2) of the Human Medicines Regulations 2012,

“controlled locality” is to be construed in accordance with paragraph 1A of Schedule 3;

“corresponding decision” has the same meaning as in section 32D of the Act[^f00011];

“dentist” means a dental practitioner;

“directed services” means additional pharmaceutical services within the meaning of section 27A of the Act;

“dispensing doctor” means a medical practitioner who provides services corresponding to pharmaceutical services—under the terms of a general medical services contract which gives effect to paragraph 44 of schedule 6 of the GMS Contracts Regulations; orunder the terms of a section 17C agreement which gives effect to paragraph 16 of schedule 1 of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018;

“doctor” means a fully registered medical practitioner within the meaning of Schedule 1 to the Interpretation Act 1978[^f00012];

“drugs” includes medicines and chemical reagents;

“Drug Tariff” has the meaning assigned to it in regulation 12;

“electronic communication” has the same meaning as in section 15 of the Electronic Communications Act 2000[^f00013];

“electronic prescription form” means a prescription form as defined in paragraph (b) of the definition of “prescription form”;

“electronic signature” has the meaning given to it by section 7(2) of the Electronic Communications Act 2000;

“emergency requiring the flexible provision of pharmaceutical services” means an emergency declared by means of a direction to Boards under section 2(5) of the Act to the effect that, as a result of the threatened damage to human welfare caused or which may be caused by the illness designated in the direction, Boards must for a specified period exercise one or more of their functions under regulation 6 or regulation 11(5), subject to any conditions or limitations set out in the direction;

“ePharmacy service” means the electronic system provided by the Agency by which electronic messages are transmitted between pharmacy contractors, doctors and the Agency;

“equivalent body” means–in England, NHS England , or in relation to any time prior to 1st April 2013 and after 30th September 2002 a Primary Care Trust, or in relation to any time prior to 1st October 2002 a Health Authority;in Wales, a Local Health Board or in relation to any time prior to 1st April 2003 a Health Authority;in Northern Ireland, a Health and Social Services Board;or any successor body;

“equivalent list” means a list kept by an equivalent body;

“GMS Contracts Regulations” means the National Health Service (General Medical Services Contracts) (Scotland) Regulations 2018;

“health centre” means premises provided by the Scottish Ministers in accordance with the provisions of section 36(1)(b) of the Act;

“hypodermic needle exchange services” has the meaning assigned to it in regulation 3(3);

“independent nurse prescriber” means a person—who is registered in the Nursing and Midwifery Register; andagainst whose name is recorded in that register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a community practitioner nurse prescriber, a nurse independent prescriber or a nurse independent/supplementary prescriber;

“joint discipline committee” has the same meaning as in the National Health Service (Discipline Committees) (Scotland) Regulations 2006[^f00015];

“listed drugs” means such drugs and medicines as are included in a list for the time being approved by the Scottish Ministers for the purposes of section 27(1) of the Act;

“medicinal product” means–a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC[^f00016]; orany product which is not a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, but which is a medicinal product within the meaning ascribed to it in section 130 of the 1968 Act[^f00017];

“minor relocation” has the meaning assigned to it in regulation 5;

“National Appeal Panel” means the panel constituted under Part II of Schedule 4;

“NHS funded services” means—primary medical services provided by a person under arrangements with a Health Board for the purpose of meeting that Health Board’s duty to provide or secure the provision of primary medical services as respects their area; andpharmaceutical services provided by a person on a Board’s pharmaceutical or provisional pharmaceutical list;

“nominated community representative” means a person nominated by one or more Community Councils from amongst their elected members for the purpose of making representations in accordance with the procedures set out in Schedule 3;

“non-electronic prescription form” means a prescription form as defined in paragraph (a) of the definition of “prescription form”;

“non-proprietary name” in relation to a drug means–where the drug is described in a monograph in the current edition in force at the time of the supply of the drug, (as defined in regulation 321(3) of the Human Medicines Regulations 2012), of the European Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary, the International Pharmacopoeia, the Cumulative List of Recommended International Non-proprietary Names or the Dental Practitioners' Formulary, any name, or abbreviation of the name, at the head of that monograph or, where the name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that publication; orwhere the drug is not so described but has an approved name, being the name which appears in the current edition in force at the time of the supply of the drug, (as defined in the said regulation 321(3) of the Human Medicines Regulations 2012) of the list of names prepared and published under regulation 318 of those Regulations, its approved name;

“Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001[^f00019];

“optometrist independent prescriber” means a person–who is a registered in the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989[^f00020]...; andagainst whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;

“pandemic treatment protocol” means a protocol that—relates to the supply of a prescription only medicine to be used for the prevention of or as a treatment for a disease that is, or in anticipation of a disease being imminently, pandemic and a serious risk, or potentially a serious risk, to human health, andis approved in accordance with regulation 247 of the Human Medicines Regulations 2012 (exemption for supply in the event or anticipation of pandemic disease),

“paramedic independent prescriber” means a person—registered in Part 8 of the register maintained under article 5 of the Health Professions Order 2001; andagainst whose name in that register is recorded an annotation signifying that the person is qualified to order drugs, medicines and appliances as a paramedic independent prescriber;

“Patient Group Direction” has the meaning ascribed in regulation 213 of the Human Medicines Regulations 2012;

“pharmaceutical care services plan” means a document prepared by the Board annually, comprising a summary of the pharmaceutical services provided in the area of the Board together with an analysis by the Board of where in its area it believes there is a lack of adequate provision of pharmaceutical services;

“pharmaceutical discipline committee” has the same meaning as in the National Health Service (Discipline Committees) (Scotland) Regulations 2006;

“pharmaceutical list” has the meaning assigned to it in regulation 5;

“pharmaceutical services” means those services as defined by section 27 of the Act and includes the provision to persons who are in a Board’s area of listed drugs and medicines which are ordered for those persons by a dental practitioner in pursuance by such dental practitioner of the performance of personal dental services within the meaning of section 1(8) of the National Health Service (Primary Care) Act 1997[^f00023] but not including directed services;

“pharmacist” means a person who is registered as a pharmacist in Part 1 ... of the register maintained under article 19 of the Pharmacy Order 2010 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 [^f00025];

“pharmacy contractor” means a contractor who provides pharmaceutical services, or a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act[^f00026], who provides pharmaceutical services in terms of arrangements made by a Board under section 27 of the Act;

“pharmacist independent prescriber” means a pharmacist against whose name in the relevant register is recorded an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;

“physiotherapist independent prescriber” means a physiotherapist who is registered in Part 9 of the register maintained under article 5 of the Health Professions Order 2001, and against whose name in that register is recorded an annotation signifying that the physiotherapist is qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;

“podiatrist or chiropodist independent prescriber” means a podiatrist or chiropodist who is registered in Part 2 of the register maintained under article 5 of the Health Professions Order 2001, and against whose name in that register is recorded an annotation signifying that the podiatrist or chiropodist is qualified to order drugs, medicines and appliances as a podiatrist or chiropodist independent prescriber;

“prescriber” means—a doctor,a pharmacist independent prescriber,a independent nurse prescriber,an optometrist independent prescriber,a physiotherapist independent prescriber,a podiatrist or chiropodist independent prescriber, ... a therapeutic radiographer independent prescriber, ... a paramedic independent prescriber, or a supplementary prescriber under an agreed clinical management plan;

“prescription form” means–a form provided by the Board or the Agency–on which the provision of pharmaceutical services may be ordered by–a Board;a dentist pursuant to the provisions of his or her terms of service;a dentist performing personal dental services in accordance with a pilot under Part I of the National Health Service (Primary Care) Act 1997; ora prescriber; ......and includes a prescription form provided and issued under equivalent arrangements having effect in England, Wales or Northern Ireland; ordata that are created in an electronic form for the provision of pharmaceutical services ordered by–a dentist pursuant to the provisions of his or her terms of service;a dentist performing personal dental services in accordance with a pilot under Part I of the National Health Service (Primary Care) Act 1997; ora prescriber,and signed with such a person’s advanced electronic signature and transmitted as an electronic communication through the ePharmacy service; ora form on which domiciliary oxygen has been ordered–by a prescriber in England or Wales for a patient normally resident in England or Wales; andin relation to a form which contains an order by a prescriber in England, the patient named on the form (or a person on the patient’s behalf) completes and signs a declaration of entitlement to exemption or a statement that a charge has been paid;

“prescription only medicine” has the meaning given in regulation 5 of the Human Medicines Regulations 2012,

“provisional pharmaceutical list” has the meaning assigned to it in regulation 8;

“PTP” means a pandemic treatment protocol,

“registered pharmacy” means a registered pharmacy within the meaning of section 74 of the 1968 Act[^f00027];

“relevant service” means whole-time service in the armed forces of the Crown in a national emergency or otherwise, or compulsory whole-time service in those forces, including service resulting from any reserve liability, or any equivalent service by a person liable for compulsory whole-time service in those forces;

“restricted availability appliance” means an appliance which is approved for particular categories of persons or for particular purposes only;

“scheduled drug” means–a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug or other substance which may not be ordered in the provision of primary medical services under a general medical services contract; orexcept where the conditions in paragraph 40(2) of schedule 6 of the GMS Contracts Regulations[^f00028] are satisfied, a drug, medicine or other substance which is specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug or other substance which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract;

“Scottish SSP” means a Scottish serious shortage protocol which is a written protocol in respect of any drug or appliance which is not a prescription only medicine that—is issued by the Scottish Ministers in circumstances where Scotland or any part of Scotland is, in the opinion of the Scottish Ministers, experiencing or may experience a serious shortage of—a specified drug or appliance, ordrugs or appliances of a specified description,provides for the supply by a pharmacist or dispensing doctor, where there is an order on a prescription form or serial prescription for—the specified drug or appliance, ora drug or appliance of the specified description,of a different drug or appliance or quantity or strength of a drug or appliance to that ordered by the prescriber or dentist, subject to such conditions as may be specified in the Scottish SSP, andspecifies the period for which, and the parts of Scotland (which may be all of Scotland) for which the Scottish SSP is to have effect,

“serious shortage protocol” means, in respect of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226A of the Human Medicines Regulations 2012,

“SSP” means a serious shortage protocol,

“supplementary prescriber” means a person whose name is registered in–the Nursing and Midwifery Register; Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010; the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to–chiropodists and podiatrists;physiotherapists; ...diagnostic or therapeutic radiographers; ... dietitians; or the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989,and against whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a supplementary prescriber or, in the case of the Nursing and Midwifery Register, a nurse independent/supplementary prescriber;

“supply form” means a form issued by a Board to record a supply of pharmaceutical services under the terms of a Patient Group Direction issued by a Health Board in accordance with regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012;

“suspended by direction of the Tribunal” means suspended as respects the provision of pharmaceutical services by a direction of the Tribunal made pursuant to section 32A(2) or section 32B(1) of the Act[^f00031] or to any provisions in force in England and Wales or Northern Ireland corresponding to those provisions;

“terms of service” means the terms of service for pharmacists and pharmacy contractors contained or referred to in Schedule 1;

“therapeutic radiographer independent prescriber” means a person—registered in Part 11 of the register maintained under article 5 of the Health Professions Order 2001; andagainst whose name in that register is recorded—an entitlement to use the title “therapeutic radiographer”; andan annotation signifying that the person is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;

“the Tribunal” means the Tribunal constituted under section 29 of the Act[^f00032].

(2) These Regulations shall apply to a person, firm or body corporate (other than a dental practitioner) providing pharmaceutical services (which includes the supply of appliances by appliance suppliers) as they apply to a pharmacist.

(3) Unless the context otherwise requires–

(a) any reference in these Regulations–

(i) to a numbered regulation is a reference to the regulation bearing that number in these Regulations,

(ii) to a numbered Part or Schedule is a reference to the Part of, or Schedule to, these Regulations bearing that number,

(iii) to a form thereby prescribed includes a form substantially the same; and

(b) any reference in a regulation or in a Schedule to these Regulations to a numbered paragraph is a reference to the paragraph bearing that number in that regulation or Schedule.

Pharmaceutical services

3

(1) The arrangements for the provision of pharmaceutical services shall include arrangements for–

(a) the supply of contraceptive substances and appliances;

(b) subject to paragraph (6) the provision of hypodermic needle exchange services.

(2) The arrangements referred to in paragraph (1) shall incorporate the terms of service for pharmacists and pharmacy contractors set out in Schedule 1 to these Regulations.

(3) In these Regulations “hypodermic needle exchange services” means–

(a) the supply, free of charge, by a pharmacy contractor to a person reasonably believed by that pharmacy contractor (if a pharmacist), or a pharmacist employed by that pharmacy contractor, to be a drug misuser, of–

(i) hypodermic needles and syringes;

(ii) equipment for the safe disposal of such needles and syringes; and

(iii) other equipment associated with self-injection.

(b) the receipt by a pharmacy contractor from such a person and the subsequent safe disposal, both free of charge, of any used hypodermic needle or syringe;

(4) In paragraph (3) “drug misuser” means a person who is misusing drugs by self-injection.

(5) A pharmacy contractor may at any time give notice in writing to the Board that such pharmacy contractor wishes to be–

(a) included in or excluded from any arrangements for the supply of contraceptive services and appliances; or

(b) included in any arrangements for the provision of hypodermic needle exchange services.

(6) A Board shall agree to a pharmacy contractor providing hypodermic needle exchange services only–

(a) after consulting its most senior pharmaceutical and medical advisers and the Director of Public Health; and

(b) if it is satisfied that such services are necessary or desirable in the area of the premises specified in the application.

(7) A pharmacy contractor participating in arrangements for the provision of hypodermic needle exchange services shall maintain records in relation to those services which shall include–

(a) the number of hypodermic needles and syringes issued by such pharmacy contractor;

(b) an estimate of the number of used hypodermic needles and syringes received by such pharmacy contractor for disposal; and

(8) A pharmacy contractor may at any time give notice in writing to the Board that such pharmacy contractor wishes to cease to be included in arrangements for the provision of hypodermic needle exchange services either immediately or at such time as may be specified in the notice.

(9) The Board may at any time, by giving notice in writing to a pharmacy contractor, terminate such pharmacy contractor’s involvement in arrangements for the provision of hypodermic needle exchange services either immediately or with effect from such date as may be specified in the notice.

Additional professional services

4

(1) A pharmacy contractor may undertake to provide additional professional services.

(2) In these Regulations “additional professional services” means–

(a) the setting aside in a pharmacy of an area for the display of health education material;

(b) the provision to the public of advice and counselling on medicines and appliances;

(c) the undertaking of clinical audits where clinical audit means the systematic and critical analysis of the quality of clinical care; and

(d) the publication by a pharmacy contractor of a practice leaflet which shall–

(i) include the name, address and telephone number of the pharmacy and the hours in each day of the week during which that pharmacy contractor provides pharmaceutical services from those premises;

(ii) detail the arrangements for dealing with after-hours and other urgent requirements from or in relation to that pharmacy;

(iii) state that National Health Service prescriptions are dispensed and which other National Health Service pharmaceutical services are provided; and

(iv) state that a pharmacist is available to advise and answer questions about medicines and the treatment of common ailments.

Pharmaceutical list

5

(1) The Board shall prepare a list to be called “the pharmaceutical list” of, subject to the provisions of regulation 26 (practitioners subject to inquiry) of the National Health Service (Tribunal) (Scotland) Regulations 2004[^f00033], the names of persons, other than doctors and dentists, who undertake to provide pharmaceutical services and of the addresses of the premises within the Board’s area from which these persons undertake to provide such services. The said list shall also state the nature of the pharmaceutical services to be provided, and the days and hours during which the premises are open, and show pharmacists as a separate category of persons within that list.

(2) A person (hereinafter referred to in this regulation as an “applicant”)–

(a) who wishes to be included in the pharmaceutical list for the provision of pharmaceutical services; or

(b) whose name is already included in the pharmaceutical list, but who intends–

(i) to open within the Board’s area additional premises from which to provide pharmaceutical services, or

(ii) to relocate within the Board’s area the premises from which the applicant provides pharmaceutical services

shall (except in the instance of an application to which paragraph (3) or (4) applies) complete a pre-application and joint consultation in accordance with regulation 5A before making an application, and an application in every instance shall be in accordance with whichever version of Form A set out in Schedule 2 is appropriate.

(2A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2B) Subject to paragraph (2E), an application made in any case other than one to which paragraph (3) or (4) applies shall be summarily refused (without being subject to the procedures in Schedule 3) by the Board unless it includes an applicant’s assessment which meets the requirements set out in paragraph (2C).

(2C) An applicant’s assessment in terms of Form A must include—

(a) a written statement from the person who may grant possession of the premises that (without prejudice to any negotiation in relation to any such grant) the premises may be used for the provision of pharmaceutical services;

(b) a description of any adjustments the applicant intends to make to the premises to ensure that the applicant will comply with the duties incumbent upon a provider of pharmaceutical services under section 29 of the Equality Act 2010;

(c) a description of the boundaries of the neighbourhood within which the applicant intends to provide pharmaceutical services;

(d) an assessment (in sufficient detail so as to assist the Board to make a determination) of the current provision in the neighbourhood described by the applicant of services for which the applicant believes there is not adequate provision by persons on the pharmaceutical list and evidence in support of that belief;

(e) a description of the pharmaceutical services which the applicant will provide;

(f) the date by which the applicant intends to commence the provision of such services;

(g) the hours in each day that the applicant intends to provide such services;

(h) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(i) (where the provisions of paragraph (2D) apply) evidence of the significant change that has occurred (which evidence will be of sufficient detail so as to assist the Board to make a determination) that means in the applicant’s view that it is now necessary or desirable that an application be granted in order to secure adequate provision, by persons on the pharmaceutical list, of pharmaceutical services by the applicant in the neighbourhood in which the premises are to be located;

(j) (where the provisions of paragraph (10B) apply) evidence of the significant change that has occurred (which evidence will be of sufficient detail so as to assist the Board to make a determination) that means in the applicant’s view that the granting of the application will now not prejudice the provision of NHS funded services in the controlled locality.

(2D) The provisions of this paragraph apply where—

(a) an application for the provision of pharmaceutical services was refused by—

(i) the Board (and not overturned by the National Appeal Panel); or

(ii) the National Appeal Panel,

in the previous 12 months;

(b) that application was in relation to a neighbourhood that encompassed the same, or substantially the same, area encompassed by the neighbourhood to which the application that is now being submitted relates; and

(2E) If, in the opinion of the Board, the applicant’s assessment submitted with the application does not comply with the requirements of paragraph (2C), the Board is not bound to refuse the application if the applicant within 5 working days of being asked by the Board provides further information that in the opinion of the Board meets the requirements set out in paragraph (2C).

(3) Where an application is made and–

(a) the applicant intends to provide the same pharmaceutical services from premises from which, at the time of the application, another person whose name is included in the pharmaceutical list provides those services, in place of that person; and

(b) the condition specified in paragraph (5) is fulfilled,

the Board shall grant the application.

(4) Where an application is made and–

(a) the applicant intends to relocate to new premises, within the neighbourhood in which the applicant provides pharmaceutical services, from the premises already listed in relation to such applicant, and to provide from those new premises the same pharmaceutical services which such applicant is listed as providing from the applicant’s existing premises;

(b) the Board is satisfied that the relocation is a minor relocation; and

the Board shall grant the application.

(5) The condition referred to in paragraphs (3)(b) and (4)(c) is that in either case the provision of the particular pharmaceutical services by the applicant will not be interrupted, except for any period during which, in terms of any scheme made under regulation 11(1) that applies to the applicant, or any such longer period as the Board may for good cause allow, the provision of such services is not required.

(6) In this regulation the reference to a minor relocation is to one where there will be no significant change in the neighbourhood population in respect of which pharmaceutical services are provided by the applicant and other circumstances are such that there will be no significant effect on the pharmaceutical services provided by the applicant or any other person whose name is included in the pharmaceutical list of the Board.

(7) Before satisfying itself that a relocation is a minor relocation the Board shall seek and take into account the views of the Area Pharmaceutical Committee and of the most senior pharmaceutical adviser, or equivalent, of the Board.

(8) In the case of an application to which paragraph (4)(a) applies, where the Board is not satisfied that the relocation is a minor relocation, it shall not grant the application but shall notify the applicant in writing of its decision and of its reasons.

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

(10) An application made in any case other than one to which paragraph (3) or (4) applies shall be assessed in accordance with the procedures set out in Schedule 3, and shall be granted by the Board—

(a) only if it is satisfied that the provision of pharmaceutical services at the premises named in the application is necessary or desirable in order to secure adequate provision of pharmaceutical services in the neighbourhood in which the premises are located by persons whose names are included in the pharmaceutical list; and

(b) if the boundaries of the neighbourhood within which the applicant intends to provide pharmaceutical services falls within any part of a controlled locality, only if it is satisfied that the granting of such an application, in its opinion, would not prejudice the provision of NHS funded services in the controlled locality.

(10A) When considering an application to which paragraph (10) applies, which is of the type described in paragraph (2)(b)(ii), the Board shall disregard premises already listed in relation to such applicant.

(10B) The provisions of this paragraph apply where—

(a) an application for the provision of pharmaceutical services to which regulation 5(10)(b) applies was refused by—

(i) the Board (and not overturned by the National Appeal Panel); or

(ii) the National Appeal Panel,

in the previous 3 years;

(b) that application was in relation to a neighbourhood that encompassed the same, or substantially the same, area encompassed by the neighbourhood to which the application that is now being submitted relates; and

(11) Where an application is granted it shall be notified on Form C set out in Schedule 2.

(12) Where an application is granted in accordance with paragraph (10), it shall be competent for the Board to grant it only in respect of some of the pharmaceutical services specified in that application.

(13) An application, in any case other than one to which paragraph (4) applies, which is made by a person who qualified as a pharmacist in an EEA State other than the United Kingdom, or in Switzerland, shall not be granted unless the applicant satisfies the Board that the applicant has the knowledge of English, which, in the interests of the applicant and persons making use of the services to which the application relates, is necessary for the provision of pharmaceutical services in the Board’s area.

(14) Where an application is granted, the Board shall make the relevant entries in the pharmaceutical list only after the expiry of the period within which an appeal against the decision to grant the application might be intimated or the conclusion of all the appeal procedures, whichever is appropriate.

Temporary relocations and additional premises

6

(1) Regulation 5(2)(b), (4), (6), (7), (8), (10), (11) and (14) shall not apply to an application for a temporary amendment to the pharmaceutical list which the Board is satisfied is necessary or desirable because of an emergency requiring the flexible provision of pharmaceutical services.

(2) In the circumstances described in paragraph (1), the Board may make a temporary amendment to an entry in the pharmaceutical list, but–

(a) only for a specified period (which shall not be for longer than the specified period for the duration of the emergency given by the Scottish Ministers) which the Board may extend or curtail in appropriate circumstances; and

(b) the applicant may revert to the applicant’s original entry in the pharmaceutical list before the end of the specified period, on giving the Board at least 24 hours notice.

(3) Where–

(a) a direction is given under section 2(5) of the Act which contains a declaration of an emergency requiring the flexible provision of pharmaceutical services; and

(b) the Scottish Ministers issue a further direction under that section changing the specified period of the duration of the emergency,

for the purposes of these Regulations, the duration of the emergency is to be construed in accordance with the specified period as revised by the Scottish Ministers.

Effect to be given to corresponding decisions in England, Wales and Northern Ireland

7

(1) A Health Board shall not include the name of any person in its pharmaceutical list, and shall remove the name of any person from its pharmaceutical list, if any decision has been made in England, Wales or Northern Ireland to deal with that person in any way which corresponds (whether or not exactly) with a way in which a person may be dealt with under section 29B(2)[^f00034] , 30(2) or (5)[^f00035] (except a decision to remove a disqualification or conditional disqualification) or 32B(1)[^f00036] of the Act, for so long as that decision is in force.

(2) Where any corresponding decision is made in England, Wales or Northern Ireland by an equivalent body that–

(a) a person is to be included in an equivalent list subject to conditions;

(b) a person is to be removed from an equivalent list contingent on conditions;

(d) any conditions so imposed are varied,

a Health Board shall impose those conditions in relation to the provision by that person of pharmaceutical services in the area of the Health Board.

(3) The Health Board may make such modifications of the conditions referred to in paragraph (2) as it considers necessary for them to have the like effect in relation to Scotland as they do in relation to England, Wales or (as the case may be) Northern Ireland, but only if the Health Board has previously given the person concerned written notice of the proposed modifications and an opportunity to make representations about them.

Provisional pharmaceutical list

8

(1) The Board may also in accordance with this regulation prepare a list, to be called “the provisional pharmaceutical list” in which there shall be included, subject to the provisions of regulation 26 (practitioners subject to inquiry) of the National Health Service (Tribunal) (Scotland) Regulations 2004, the name of any person, other than a doctor or dentist, who undertakes provisionally to provide pharmaceutical services. The provisional pharmaceutical list shall state the particulars required under regulation 5(1) in relation to any such person and also the date (“the provisional date”) from which such person undertakes to provide pharmaceutical services at the premises specified in an application under regulation 5(2).

(2) Where in any application under paragraph (2) of regulation 5 to which paragraph (4) or (10) of that regulation applies–

(a) any one or more of the statements in paragraph 2(b) of Form A (application for inclusion in the pharmaceutical list to provide pharmaceutical services – relocation or new application) is negative; or

(ab) the information required in paragraph 2(b) of Form A(2) (application for inclusion in the pharmaceutical list to provide pharmaceutical services – change of provider) is not provided; and

(b) the Board is satisfied on the basis of such information as may be submitted with the application that the applicant intends to commence business at the premises specified in the application in the event of the applicant’s name being included in the pharmaceutical list,

the Board, in the case of an application to which paragraph (10) of regulation 5 applies, shall notify and otherwise deal with the application in accordance with that paragraph and Schedule 3 or, in the case of an application to which paragraph (4) of that regulation applies, shall deal with it in accordance with that paragraph and in either case where the Board grants the application the Board may include the name of the applicant in the provisional pharmaceutical list for its area.

(3) Where an application is determined by the inclusion of the name of the applicant in the provisional pharmaceutical list, the Board shall give notification of the decision to the applicant in Form D set out in Schedule 2, and in this regulation any reference to “the date of inclusion” is to the date of inclusion in the provisional pharmaceutical list as stated in Form D.

(4) Subject to paragraph (5) the applicant shall, as soon as reasonably practicable after the date of inclusion and in any event not later than either–

(a) the date six months after the date of inclusion, or

(b) if earlier, the provisional date,

submit Form B set out in Schedule 2 with any information required but not given in paragraph 2(b) of Form A(1) or A(2) and on receipt of such information the Board shall include the name of the applicant in the pharmaceutical list and remove it from the provisional pharmaceutical list.

(5) Where a person whose name has been included in the provisional pharmaceutical list applies in writing to the Board not later than twenty eight days before the date by which, in terms of paragraph (4) above, the applicant is required to submit Form B, that the applicant wishes the Board to extend the period for submission of that Form and the Board is satisfied that, due to circumstances outwith that person’s control and which could not reasonably have been anticipated at the date of the application, there is no reasonable prospect of such person being able to submit that Form by that date, the Board may extend the period for submission of Form B by a further period not exceeding nine months.

(6) Where an applicant, whose name is included in the provisional pharmaceutical list, has not submitted Form B in accordance with paragraphs (4) or (5), the applicant’s name shall be removed from the provisional pharmaceutical list.

Removal from and amendment to pharmaceutical list

9

(1) Where the Board determines in accordance with paragraph (4) that a person whose name has been included for the preceding six months in the pharmaceutical list has not during that period provided pharmaceutical services the Board shall remove that person’s name from the said list.

(2) A period during which the person was suspended by direction of the Tribunal does not count towards the period of six months referred to in paragraph (1).

(3) Where a Board determines in accordance with paragraph (4) that the supply of equipment necessary to provide domiciliary oxygen therapy service is no longer required, either in total or in part, and this service or part thereof has not been provided for the preceding six months the Board may cancel or amend the contract to provide the domiciliary oxygen therapy service contracted for.

(4) Before making a determination under paragraphs (1) or (3), the Board shall–

(a) give the person not less than 28 days' notice in writing of its intention so to do;

(b) afford the person an opportunity of making written representations to the Board; and

(5) Nothing in paragraphs (1) and (3) shall–

(a) prejudice the right of a person to apply to be included again in the pharmaceutical list; or

(b) prevent a person from applying to increase the supply of equipment for domiciliary oxygen therapy service already provided; or

(c) affect a person who is performing a period of relevant service and in such a case no removal under paragraphs (1) or (3) shall be effected in respect of any such person until six months after such person has completed that service.

Transitional Arrangements

10

Where, before the date these Regulations come into force any application is made, any action is commenced or any decision is pending by a Board, the Agency or the National Appeal Panel under the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995[^f00037], the provisions of those Regulations shall, notwithstanding regulation 17 (revocations) continue to apply on or after that date in respect of any such action or decision.

Schemes for securing proper pharmaceutical service

11

(1) The Board, after consultation with the Area Pharmaceutical Committee, shall prepare a scheme for securing that one or more places of business on the pharmaceutical list in the area of the Board shall at all reasonable times be open. The scheme shall specify the days and hours during which such places shall be open, and the arrangements for the dispensing of medicines required urgently at other times.

(2) The provisions of schemes prepared under paragraph (1) shall be subject to the approval of the Scottish Ministers.

(3) In the event of the Board and the Area Pharmaceutical Committee failing to agree on any provision of a scheme to be prepared under paragraph (1), the matter shall be referred to the Scottish Ministers, whose determination shall be final.

(4) Where the Board after consultation with the Area Pharmaceutical Committee, amends the provisions of a scheme approved under paragraph (2), the Area Pharmaceutical Committee or any person whose name is included in the pharmaceutical list may appeal in respect of any such amendment, and any such appeal–

(a) shall be made in writing and received by the Board within 21 days from the date on which notification of that amendment was published; and

(b) may be determined by the Scottish Ministers; or

(c) if the Scottish Ministers so decide, be determined in accordance with the procedures set out in paragraph 5(3) to (5) of Schedule 3 and paragraphs 9 to 15 of Schedule 4.

(5) During an emergency requiring the flexible provision of pharmaceutical services, a Board may agree with any person whose name is included in a pharmaceutical list that the provisions of a scheme prepared under paragraph (1) shall not apply to that person for the duration of the emergency.

Payments to pharmacy contractors and standards of drugs and appliances

12

(1) The Scottish Ministers shall after consultation with an organisation which is, in their opinion, representative of the general body of pharmacy contractors cause to be prepared a statement (in these Regulations referred to as “the Drug Tariff”) which they may after such consultation amend from time to time and which (subject to paragraph (2)) shall include–

(a) the prices on the basis of which the payment for specified drugs (being drugs commonly prescribed) and appliances is to be calculated;

(b) the method of calculating the payment for drugs not specified in the Drug Tariff;

(c) the dispensing fees or other sums payable in respect of the supply of drugs and appliances and of additional professional services;

(d) arrangements for claiming fees, allowances and remuneration in connection with the making and implementation of arrangements for the provision of pharmaceutical services;

(e) the standards of quality for drugs;

(f) the list of appliances approved by the Scottish Ministers for the purposes of section 27 of the Act, the specifications for such appliances and, in the case of a restricted availability appliance, the categories of persons for whom or the purposes for which the appliance is approved;

(g) the method by which a claim may be made for compensation for financial loss in respect of oxygen equipment;

(h) the list of chemical reagents approved by the Scottish Ministers for the purpose of section 27 of the Act and the specification for such chemical reagents; and

(i) the fees, allowances and remuneration payable for the provision of such directed services as may be specified.

(2) The Drug Tariff may state in respect of any specified fee falling within paragraph (1)(c) or (i), or any other specified fee, allowance or other remuneration in respect of the provision of pharmaceutical services by pharmacy contractors included in the pharmaceutical list of a Board, that the determining authority for that fee, allowance or other remuneration for those pharmacy contractors is the Board, and in such a case paragraphs (3), (4) and (5) shall apply[^f00038].

(3) The Board shall consult such body as it considers representative of pharmacy contractors in its area before making any determination by virtue of paragraph (2).

(4) A determination made by the Board by virtue of paragraph (2) shall include the arrangements for claiming the specified fees, allowances or other remuneration and may provide that the pharmacy contractor requires to have prior authority from the Board to provide a specified service and associated drugs.

(5) A determination made by the Board by virtue of paragraph (2) shall be notified in writing to all pharmacy contractors included in its pharmaceutical list.

Payments to pharmacy contractors in respect of suspended pharmacists

13

(1) The Board shall make payments to a pharmacy contractor (if a pharmacist), or to a pharmacy contractor in respect of a pharmacist engaged by that pharmacy contractor, who is suspended by direction of the Tribunal in accordance with the determination of the Scottish Ministers in relation to such payments.

(2) The Scottish Ministers shall make the determination in accordance with paragraph (1) after consultation with the organisation referred to in regulation 12(1), and it shall be published with the Drug Tariff.

(3) The determination may be amended from time to time by the Scottish Ministers, after consultation with the organisation referred to in paragraph (2), and any amendments shall also be published with the Drug Tariff.

(4) Subject to paragraph (5), the determination of the Scottish Ministers shall be such as to secure that, as far as reasonably practicable, and after making adjustments for any reduction in expenses, the suspended pharmacist receives payments at a rate corresponding to the suspended pharmacist’s remuneration under the Drug Tariff (but excluding any payments made by virtue of regulation 12(1)(g)) during the 12 months ending with the direction for suspension by the Tribunal.

(5) The determination of the Scottish Ministers may include provision that payments in accordance with the determination are not to exceed a specified amount in any specified period.

Application for pharmaceutical services

14

An application to a pharmacy contractor for pharmaceutical services may be made (other than by the pharmacist concerned) on behalf of any person who is incapable of requesting pharmaceutical services themself on account of sickness or infirmity by any duly authorised person.

Publication of particulars

15

(1) The Board shall make available for inspection at its offices copies of–

(a) the pharmaceutical list;

(b) the terms of service for pharmacists and pharmacy contractors;

(ba) its pharmaceutical care services plan;

(d) any schemes made under regulation 11 and shall keep them revised and up-to-date; ...

(e) determinations made by the Board by virtue of regulation 12(2); and

(f) details of any controlled locality identified by the Board under paragraph 1A of Schedule 3.

(2) The Board may make any of the documents described in paragraph (1) of this regulation available for inspection at such other places in its area as appear convenient for informing all persons interested, or may publish at such places a notice of the places and times at which copies of any of those documents may be inspected.

(3) The Board shall send a copy of the pharmaceutical list to the area medical, dental and pharmaceutical committees, and shall within fourteen days of any alteration in the pharmaceutical list inform each of them of such alteration.

(4) The Board shall send a copy of the pharmaceutical list to all pharmacy contractors on the list.

(5) Paragraph (3) shall not apply to alterations in a pharmaceutical list made by a Board in terms of regulation 6(2).

Service of documents

16

Except where expressly provided to the contrary, any document which is required or authorised to be given or sent to a person or body under these Regulations (including the terms of service) may be given or sent by delivering it to that person, or in the case of a body, to the secretary or general manager of that body or by sending it to that person, or in the case of a body, to the secretary or general manager of that body at that person’s usual or last known address.

Revocations

17

The Regulations specified in column (1) of Schedule 5 are revoked to the extent specified in column (3) of that Schedule.

Consequential amendments

18

The provisions listed in Schedule 6 are amended as specified in that Schedule.

SCHEDULE 1 — TERMS OF SERVICE FOR PHARMACISTS AND PHARMACY CONTRACTORS

Interpretation

1

In these terms of service unless the context otherwise requires–

(a) except in relation to a pharmacy contractor who has notified the Board under regulation 3(5) that such pharmacy contractor wishes to be excluded from the arrangements for the supply of contraceptive substances and appliances referred to in regulation 3, “drugs” includes contraceptive substances and “appliances” includes contraceptive appliances;

(b) any reference to a numbered paragraph is a reference to the paragraph bearing that number in these terms of service and any reference to a numbered sub-paragraph is a reference to the sub-paragraph bearing that number in that paragraph.

Division of responsibilities between individuals and corporate bodies

2

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

(a) if the pharmacy contractor is a pharmacist–

(i) that pharmacy contractor must comply with that requirement; and

(ii) if such pharmacy contractor employs or engages a pharmacist in connection with the provision of pharmaceutical services, that pharmacy contractor must secure compliance with that requirement by such pharmacists, and such pharmacists must also comply with that requirement; and

(b) if the pharmacy contractor is not a natural person, that pharmacy contractor must secure compliance with that requirement by the pharmacists whom it employs or engages, and those pharmacists must comply with that requirement,

and references in this Schedule must be construed accordingly.

(2) Where this Schedule imposes a requirement on the director or superintendent of a body corporate that is on the pharmaceutical list, breach of that requirement shall be deemed to be a breach by the body corporate of its terms of service.

Incorporation of provisions of regulations, etc.

3

Any provisions of the following affecting the rights and obligations of pharmacists and pharmacy contractors shall be deemed to form part of the terms of service:–

(a) these Regulations;

(b) the Drug Tariff;

(d) so much of the National Health Service (Discipline Committees) (Scotland) Regulations 2006 as relates to–

(i) the investigation of disciplinary matters relating to pharmacists and pharmacy contractors and other investigations to be made by the pharmaceutical discipline committee and the joint discipline committee and the action which may be taken by the Board as a result of such investigations, including the withholding of remuneration from pharmacists and pharmacy contractors where there has been a breach of the terms of service;

(ii) appeals to the Scottish Ministers from decisions of the Board; ...

(e) the National Health Service (Tribunal) (Scotland) Regulations 2004 ; and

(f) the Patient Rights (Scotland) Act 2011 and any regulations or directions made under that Act, so far as relevant to pharmacists and pharmacy contractors as providers of services under the health service.

Provision of pharmaceutical services

4

(1) Subject to the other provisions of these Regulations where–

(a) any person presents 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; or

(ii) an order for a drug specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract signed by and endorsed on its face with the reference “SLS” by a prescriber; or

(iii) an order for a restricted availability appliance, signed by and endorsed on its face with the reference “SLS” by a prescriber; or

(iv) an order for listed drugs signed by a dentist; or

(b) subject to sub-paragraphs (4) and (9), the pharmacist receives from the ePharmacy service an electronic prescription form which contains an order of a kind specified in sub sub-paragraph (a)(i)-(iv);

and the patient named on the form or a person on the patient’s behalf, requests the provision of drugs and appliances in accordance with that prescription and, in the case of a form provided and issued under arrangements having effect in England, completes and signs a declaration of entitlement to exemption or a statement that a charge has been paid, a pharmacist shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as the pharmacist supplies in the normal course of business and any drugs so specified shall be in a suitable container.

(1A) In furtherance of the obligations in sub-paragraphs (1) and (3), a pharmacist, when providing drugs or appliances ordered in accordance with those sub-paragraphs must—

(a) use all reasonable endeavours to provide those drugs or appliances with reasonable promptness;

(b) refrain from taking any action which may delay or prevent the dispensing of those drugs or appliances; and

(c) contact the prescriber or dentist to discuss alternative arrangements where there is likely to be, in that pharmacist’s opinion, a clinically significant delay in the dispensing of those drugs or appliances.

(1B) A pharmacist is under no obligation to provide pharmaceutical services in respect of a prescription form issued under arrangements having effect in England unless the patient has paid any charge due to be paid by virtue of the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Scotland) Regulations 2011.

(2) In this paragraph–

(a) “Medicines: Care and Review Service” means a directed service provided by a pharmacy contractor with whom a Health Board has made arrangements in accordance with directions issued by the Scottish Ministers relating to the provision of a service to assist patients with drugs, medicines and appliances and the management of long term illnesses, diseases or health conditions;

(aa) “prison” means—

(i) a prison within the meaning of section 43 of the Prisons (Scotland) Act 1989,

(ii) a remand centre within the meaning of section 19(1)(a) of that Act, or

(iii) a young offenders institution within the meaning of section 19(1)(b) of that Act,

(b) “serial prescriber” means a doctor , pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber who in the course of the provision of primary medical services in terms of the Act orders drugs, medicines or listed appliances for–

(i) a registered patient within the meaning of regulation 3(1) of the GMS Contracts Regulations where the doctor , pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber is providing primary medical services in terms of a general medical services contract under section 17J of the Act;

(ii) a registered patient within the meaning of regulation 3 of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018 where the doctor , pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber is providing primary medical services in terms of an agreement under section 17C of the Act; or

(iii) a patient registered to receive those primary medical services in terms of the Act, other than as in (i) and (ii), except where that patient is a temporary resident, being a person who is resident in Scotland for more than 24 hours and less than 3 months, or where that patient receives primary medical services in prison,

and such patient has a long-term illness, disease or health condition that requires ongoing management over a period of a year or longer,

(i) a non-electronic prescription form generated by a computer and signed in ink by a serial prescriber containing the following information:

(aa) the drugs, medicines or listed appliances ordered for a patient;

(bb) the total quantity or period for which the drugs, medicines or listed appliances are ordered, which period shall not exceed 56 weeks from the date of issue of the prescription;

(cc) the quantity of the drugs, medicines or listed appliances which are to be dispensed to the patient at any one time; and

(dd) the instructions for use of the drugs, medicines or listed appliances; and

(ii) an electronic copy of that prescription form transmitted through the ePharmacy service to a pharmacy contractor ....

(d) “relevant pharmacist” means:

(i) the pharmacy contractor, where the pharmacy contractor is a pharmacist; or

(ii) any pharmacist employed or engaged by, that pharmacy contractor; and

(iii) where the pharmacy contractor is not a pharmacist, any pharmacist employed or engaged by that pharmacy contractor.

(2A) A pharmacy contractor must ensure that drugs or appliances ordered on a serial prescription are not supplied to a patient unless the patient has registered with that pharmacy contractor for the provision of the Medicines: Care and Review Service.

(3) Where a person is registered with a pharmacy contractor for the provision of the Medicines: Care and Review Service, that pharmacy contractor shall ensure that a relevant pharmacist, with reasonable promptness, shall provide the drugs, medicines or listed appliances ordered on a serial prescription in the quantities and at the intervals specified on the serial prescription in accordance with the provisions in sub-paragraph (2)(c)(i)(aa) to (dd).

(4) The patient or a person acting on behalf of the patient shall present the non-electronic copy of the serial prescription to the relevant pharmacist on the first occasion that the patient asks to be supplied with drugs, medicines or listed appliances ordered for the patient on a serial prescription.

(5) When the patient or a person acting on behalf of the patient asks to be supplied with drugs, medicines or listed appliances ordered for the patient on a serial prescription at any subsequent interval specified on the serial prescription, the relevant pharmacist shall supply the drugs, medicines or appliances in accordance with the serial prescription in accordance with the provisions in sub-paragraph (2)(c)(i)(aa) to (dd) only after drawing down the electronic copy of that serial prescription from the ePharmacy service to check that the serial prescriber has not cancelled that serial prescription.

(6) A relevant pharmacist shall not provide under a serial prescription a controlled drug within the meaning of the Misuse of Drugs Act 1971[^f00040], other than a drug which is for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001[^f00041].

(7) A relevant pharmacist shall not supply any drugs, medicines or listed appliances ordered on a serial prescription if–

(a) the serial prescription was presented for dispensing for the first time more than 24 weeks after the date the serial prescription was signed by the serial prescriber;

(b) in the pharmacist’s professional judgement the supply is not appropriate for the patient;

(d) the pharmacist has been informed by the serial prescriber that the serial prescription has been cancelled.

(8) A relevant pharmacist shall ensure on each occasion that drugs, medicines or appliances are supplied on a serial prescription that such supply is appropriate for the patient.

(9) Where a relevant pharmacist reasonably believes that a form presented as a prescription form under sub-paragraph (1) or a form presented as serial prescription under sub-paragraph (4) is not a genuine order for the person named on the form the pharmacist shall refuse to supply the order for drugs or appliances on the form.

(10) A relevant pharmacist shall 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 4 or 5 to the Misuse of Drugs Regulations 2001[^f00042].

(11) A relevant pharmacist may refuse to supply drugs or appliances in accordance with these Regulations where–

(a) the pharmacist or other person is subjected to or threatened with violence by the person ... requesting the provision of drugs or appliances in accordance with these Regulations, or by any person accompanying that person; or

(b) the person ... requesting the provision of drugs or appliances in accordance with these Regulations, or any other person accompanying that person, commits or threatens to commit a criminal offence.

(12) Subject to sub-paragraph (13A), a relevant pharmacist shall not, except for the duration of an emergency requiring the flexible provision of pharmaceutical services, accept for dispensing any prescription form or serial prescription transmitted from or received at a registered pharmacy which is not included in the pharmaceutical list.

(13) Subject to sub-paragraph (13A), a relevant pharmacist shall not, except for the duration of an emergency requiring the flexible provision of pharmaceutical services, supply any drugs or listed appliances ordered on a prescription form or serial prescription other than at a registered pharmacy which is included in the pharmaceutical list.

(13A) Sub-paragraphs (12) and (13) do not apply to the acceptance of a prescription form or serial prescription, or to the supply of medicinal products ordered on such a form or serial prescription, which form part of a collection and delivery arrangement.

(14)

(a) For the purposes of this sub-paragraph—

“prescription form” is limited to a prescription form provided and issued under arrangements having effect in England;

“2011 Regulations” means the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Scotland) Regulations 2011;

“2003 Regulations” means the National Health Service (Travelling Expenses and Remission of Charges) (Scotland) (No. 2) Regulations 2003.Subject to paragraphs (c) and (d), a pharmacist before supplying a prescribed item to any person presenting a prescription form which—has a declaration in terms of regulation 4(2)(a) of the 2011 Regulations claiming charge exemption; orhas a declaration claiming charge remission under the 2003 Regulations,shall request evidence of a patients entitlement to such exemption or remission.Paragraph (b) shall not apply in respect of claims for exemption under regulation 4(1)(a) or (c) of the 2011 Regulations where the person’s date of birth has been printed by means of a computer on the prescription form.Paragraph (b) shall not apply in respect of a declaration relating to a claim for exemption under regulation 4(1)(a)-(h) of the 2011 Regulations where the pharmacist has information in the pharmacist’s possession at the time of supplying the item which confirms the patient is entitled to the exemption claimed.Where the person presenting the prescription form does not show evidence of entitlement and the pharmacist, in respect of a declaration relating to a claim for exemption made under regulation 4(1)(a)-(h) of the 2011 Regulations does not have evidence in the pharmacist’s possession to confirm that the patient is entitled to make that claim, the pharmacist shall mark that patient’s prescription form accordingly before supplying the prescribed item.

(15)

(a) A pharmacist independent prescriber shall not supply any item ordered on a prescription form by that pharmacist independent prescriber unless the conditions specified in paragraph (b) are met.

(b) The conditions referred to in paragraph (a) are–

(i) the item has been ordered in accordance with the arrangements which a Health Board has made pursuant to Directions issued by the Scottish Ministers in respect of pharmacist independent prescribers; and

(ii) the pharmacist independent prescriber reasonably considers that either–

(aa) exceptional circumstances exist whereby it is in the best interests of the patient to whom the item is to be supplied that the pharmacist independent prescriber who orders the item should supply it; or

(bb) the patient to whom the item is to be supplied, or the patient’s representative, is otherwise unlikely to be able to obtain the item without suffering excessive inconvenience or delay.

(c) A pharmacist independent prescriber who supplies an item which such pharmacist independent prescriber has ordered must endorse the prescription form for that item with the words “self-dispensed”.

(16) Where an order, not being an order to which ... the Misuse of Drugs Regulations 2001, except Schedules 4 and 5 to those regulations, apply, issued by a prescriber or a dentist on a prescription form for drugs or listed drugs does not prescribe the quantity, strength or dosage thereof, a pharmacist may supply such strength and dosage of drugs or listed drugs so ordered as the pharmacist shall consider to be appropriate, and, subject to the provisions of sub-paragraph (23), in such quantity as the pharmacist considers to be appropriate for a course of treatment of the patient to whom the order relates, for a period not exceeding five days.

(17) Where an order to which sub-paragraph (16) applies is for–

(a) an oral contraceptive; or

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

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

which is not available for supply as part of pharmaceutical services except in such packages that the minimum available package contains a quantity appropriate to a course of treatment for a patient for a period of more than five days, the pharmacist may supply for the patient to whom the order relates, such minimum available package.

(18) Where any drug, not being one to which the Misuse of Drugs Regulations 2001, except Schedule 5 to those regulations, apply, ordered by a prescriber or a dentist on a prescription form, or a by a serial prescriber on a serial prescription, is available for provision by a pharmacist 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;

(d) a coal tar preparation;

(e) a viscous preparation; or

(f) packed at the time of its manufacture in a calendar pack or special container,

the pharmacist shall, subject to sub-paragraph (19), provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(19) A pharmacist shall not provide, pursuant to sub-paragraph (18), a drug in a calendar pack where in the pharmacist’s professional judgement, it was the intention of the prescriber or dentist who ordered the drug that it should be provided only in the exact quantity ordered.

(20) In this paragraph–

(a) “calendar pack” means a blister or strip pack showing the days of the week or month against each of the several units in the pack; and

(b) “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(21) All drugs and preparations supplied by pharmacists shall, where a standard or formula is specified in the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary (including any Appendix published as part of that Formulary), or the Drug Tariff, conform to the standard or formula so specified, and in any other case shall be of a grade or quality not lower than the grade or quality ordinarily used for medicinal purposes.

(22) All appliances supplied by pharmacists shall conform to the specifications included in the Drug Tariff.

(23) Subject to any regulations in force under the Weights and Measures Act 1985[^f00046], a pharmacist shall provide pharmaceutical services only in response to and, subject to sub-paragraphs (16), (17), (18) and (29) to (43), in accordance with an order on a non-electronic prescription form signed as specified in sub-paragraph (1)(a), or in accordance with an electronic prescription form received in accordance with sub-paragraph (1)(b), or in accordance with a serial prescription in accordance with the provisions in sub-paragraph (2)(c) or in accordance with the terms of a Patient Group Direction issued by a Board in accordance with regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012, except that in a case of urgency where a prescriber personally known to a pharmacist requests that pharmacist to dispense a drug or appliance the pharmacist may supply that drug or appliance before receiving such a prescription form, only if–

(a) that drug is not a scheduled drug;

(b) that 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;

(d) in any case the prescriber undertakes to furnish the pharmacist, within 72 hours, with such a prescription form.

(24) Except as provided in sub-paragraph (25), a pharmacist shall not supply, by way of pharmaceutical services under the Act or otherwise, any scheduled drug which is ordered by name, formula or other description on a prescription form or a serial prescription.

(25) Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form or a serial prescription either by that name or by its formula, a pharmacist may supply a drug which has the same specification notwithstanding that it is a scheduled drug.

(26) Where a drug which is ordered as specified in sub-paragraph (23) combines more than one drug, that sub-paragraph shall apply only if the combination has an appropriate non-proprietary name, whether the individual drugs which it combines do so or not.

(27) A pharmacist or pharmacy contractor shall 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 presenting an order for drugs or appliances on a prescription form or serial prescription.

(28) A pharmacist or pharmacy contractor shall not, except with the consent of the Scottish Ministers, provide at a health centre services other than pharmaceutical services in accordance with section 27 of the Act.

(29) A pharmacist may dispense a drug where the conditions for urgent supply specified in regulation 225 (emergency sale etc by pharmacist: at patient's request) of the Human Medicines Regulations 2012 are satisfied, before receiving a prescription form, if the pharmacist is satisfied that it is appropriate to do so.

(30) This sub-paragraph applies where—

(a) a person requests a prescription only medicine—

(i) from a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, and

(ii) in accordance with a prescription form or serial prescription, and

(b) a SSP has effect in respect of—

(i) the requested prescription only medicine, or

(ii) prescription only medicines of a specified description, and the requested prescription only medicine is of that description.

(31) Where sub-paragraph (30) applies, a pharmacist may supply a prescription only medicine in accordance with a SSP where—

(a) the conditions specified in regulation 226A of the Human Medicines Regulations 2012 are satisfied, and

(b) the pharmacist is able to do so with reasonable promptness.

(32) This sub-paragraph applies where—

(a) a person requests a drug or appliance—

(i) from a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, and

(ii) in accordance with a prescription form or serial prescription, and

(b) a Scottish 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.

(33) Where sub-paragraph (32) applies, a pharmacist may supply a different drug or appliance or quantity or strength of a drug or appliance to that ordered on the prescription form or serial prescription where—

(a) the pharmacist is able to do so with reasonable promptness,

(b) to do so is in accordance with the Scottish SSP, and

(c) the pharmacist is of the opinion, in the exercise of their professional skill and judgement, that the supply of a different drug or appliance or quantity or strength of a drug or appliance to that ordered by the prescriber or dentist is reasonable and appropriate.

(34) Where sub-paragraph (30) or (32) applies—

(a) a pharmacist is of the opinion, in the exercise of their professional skill and judgement, that it is unreasonable or inappropriate to supply in accordance with the SSP or the Scottish SSP, and

(b) the pharmacist is able to supply the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale, but not with reasonable promptness,

the requirements to act with reasonable promptness in sub-paragraphs (1), (1A)(a) and (3) are to be read as requirements to act within a reasonable timescale.

(35) A pharmacist must refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription where—

(a) sub-paragraph (30) or (32) applies, and

(b) alternative supply has already taken place in accordance with the SSP or the Scottish SSP.

(36) A pharmacist may refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription where—

(a) sub-paragraph (30) or (32) applies,

(b) the pharmacist is of the opinion, in the exercise of their professional skill and judgement, that it is unreasonable or inappropriate to supply in accordance with the SSP or the Scottish SSP, and

(c) the pharmacist is unable to provide the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale.

(37) Where a pharmacist refuses to supply a prescription only medicine or other drug or appliance under sub-paragraph (36), the pharmacist must contact the prescriber or dentist to discuss alternative arrangements.

(38) Where a pharmacist supplies a prescription only medicine in accordance with a SSP or other drug or appliance in accordance with a Scottish SSP the pharmacist must—

(a) include in the dispensing label on the packaging of the prescription only medicine or other drug or appliance, for the patient’s benefit, information to the effect that the prescription only medicine or other drug or appliance is being supplied in accordance with a SSP or a Scottish SSP, identifying the particular SSP or Scottish SSP, and

(b) supply the prescription only medicine or other drug or appliance in a suitable container.

(39) A pharmacist may supply a prescription only medicine in accordance with a PTP where—

(a) a PTP has effect in respect of the prescription only medicine,

(b) the requirements specified in the PTP are satisfied, and

(40) A pharmacist may refuse to supply a prescription only medicine in accordance with a PTP where in the pharmacist’s professional judgement it is unreasonable or inappropriate to do so.

(41) Where a pharmacist supplies a prescription only medicine in accordance with a PTP the pharmacist must—

(a) include in the dispensing label on the packaging of the prescription only medicine, for the patient’s benefit, information to the effect that the prescription only medicine is being supplied in accordance with a PTP, identifying the particular PTP, and

(b) supply the prescription only medicine in a suitable container.

(42) A pharmacist may provide pharmaceutical services in accordance with the terms of a protocol approved by the Scottish Ministers under regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations) of the Human Medicines Regulations 2012 where the conditions specified in that regulation are satisfied.

(43) A pharmacist may provide pharmaceutical services in response to an announcement of the Secretary of State and arrangements made in accordance with regulation 10A (directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.) or 15(5) (form of prescriptions) of the Misuse of Drugs Regulations 2001.

Directed services

5

A pharmacy contractor with whom a Health Board makes an arrangement for the provision of any directed service shall comply with the terms and conditions of the arrangement and any terms contained in the relevant Directions.

Premises and hours of business

6

(1) Subject to regulation 11(5), pharmaceutical services shall be provided from the premises specified in the application made by the pharmacy contractor for inclusion in the Board’s list, and the premises shall be open for the supply of pharmaceutical services during the hours specified in the scheme to be made by the Board for that purpose under the Regulations.

(2) At every premises from which pharmaceutical services are provided there shall be exhibited a notice to be provided by the Board in the form prescribed in Schedule 2. There shall also be exhibited at such premises, at times when those premises are not open, and in such a manner as to be visible at such times, a notice in a form approved by the Board, indicating the facilities available for securing the dispensing of medicines urgently required.

(3) Pharmaceutical services shall not, except with the consent of the Board, or on appeal, of the Scottish Ministers, be provided by a pharmacy contractor in premises occupied by a doctor other than at a health centre.

(4) Subject to regulation 6 and sub-paragraph (4A), no pharmacy contractor shall provide pharmaceutical services from any pharmacy or other premises which are not included in the pharmaceutical list in respect of that pharmacy contractor.

(4A) Sub-paragraph (4) does not apply to the provision of pharmaceutical services which form part of a collection and delivery arrangement.

Dispensing of medicines

7

(1) The dispensing of medicines shall be performed either by or under the direct supervision of a pharmacist.

(2) Where the pharmacist referred to in sub-paragraph (1) is employed, the pharmacist must not be one–

(a) who has been disqualified under sections 29B(2) or 30(2) or (5) of the Act (or under any corresponding provision in force in England and Wales or Northern Ireland) from inclusion in the pharmaceutical list of any Board or any equivalent body while the disqualification remains in force; or

(b) who is suspended by direction of the Tribunal or any corresponding decision in England, Wales or Northern Ireland while the suspension remains in force.

Names of pharmacists

8

A pharmacy contractor shall, if so required by the Board, furnish to the Board the name or names of pharmacists employed by that pharmacy contractor in providing pharmaceutical services and directed services.

Drugs, etc. to be supplied without charge

9

(1) Subject to the provisions of any Regulations made under section 69 of the Act all drugs, containers and appliances supplied under these terms of service shall be supplied free of charge.

(2) Where a pharmacy contractor supplies an oxygen container or oxygen equipment, other than equipment specified in the Drug Tariff as not returnable to the pharmacy contractor, the container and equipment shall remain the property of the pharmacy contractor who shall have no claim against the Board in the event of the loss of, or damage to, such container or equipment except as may be provided in the Drug Tariff.

Method of payment

10

(1) A pharmacy contractor is required to furnish to the Board or Agency or to such other person or body as it may direct, on dates to be appointed by the Scottish Ministers after consultation with an organisation which is in their opinion representative of the general body of pharmacy contractors, the prescription forms, serial prescription forms, supply forms and other forms (including electronic copies and electronic claim messages) upon which the orders for drugs and appliances supplied by or on behalf of such pharmacy contractor were given, arranged in such manner as the Board or Agency may direct, together with a statement of accounts containing such particulars relating to the provision by the pharmacy contractor of pharmaceutical services as the Board, with the approval of the Scottish Ministers, may from time to time require.

(2) A pharmacy contractor whose name is included in the pharmaceutical list shall supply, in response to a request from the Scottish Ministers and within one month of the notification of the request, any information which the Scottish Ministers may require for the purpose of conducting any inquiry into the prices, payments, fees, allowances and remuneration specified in these Regulations or the Drug Tariff.

(3) The Board or Agency shall, if any pharmacy contractor so requires, afford the pharmacy contractor reasonable facilities for examining all or any of the forms on which the drugs or appliances supplied by such pharmacy contractor were ordered, together with particulars of the amounts calculated to be payable in respect of such drugs and appliances and if the pharmacy contractor takes objection thereto, the Board or Agency shall take such objection into consideration.

(4) The Board or Agency shall, if so required by an organisation which is recognised by the Scottish Ministers as representative of the general body of pharmacy contractors, afford the said organisation similar facilities for examining such forms and particulars relating to all or any of the pharmacy contractors and shall take into consideration any objection made thereto by the said organisation.

(5) Payment will be made for drugs and appliances in the Drug Tariff at the prices specified therein and for drugs or appliances not in the Drug Tariff in the manner set forth therein subject in either case to any deduction required to be made by regulations made under section 69 of the Act.

(6) Where the Board or Agency is satisfied that adequate reasons have been given, payment may be made to a pharmacy contractor in respect of forms submitted by such pharmacy contractor outwith any set time-limits.

(7) If the Scottish Ministers, after consultation with such organisation as is mentioned in sub-paragraph (4), is satisfied at any time that the method of payment herein before provided for in this paragraph is such that undue delay in payment may be caused thereby, they may direct that the amounts to be payable to a pharmacy contractor shall be calculated by such other method, whether by averaging the amounts payable to a pharmacy contractor or otherwise, as appears to them designed to secure that–

(a) payment may be made within a reasonable time; and

(b) payments to a pharmacy contractor shall, as nearly as may be, remain the same as if the payments had been calculated in accordance with the first mentioned method of payment,

and payments calculated by any such other method shall be deemed for all purposes to be payments made in accordance with these Regulations.

(8) No pharmacy contractor will be paid in respect of the supply of drugs or appliances—

(a) indicated on a prescription form or serial prescription,

(b) in terms of regulation 225 (emergency sale etc by pharmacist: at patient’s request) of the Human Medicines Regulations 2012,

(c) in terms of a Patient Group Direction issued by a Health Board in accordance with regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012,

(d) in accordance with the terms of a protocol approved by the Scottish Ministers under regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations) of the Human Medicines Regulations 2012,

(e) in accordance with a SSP or a Scottish SSP,

(f) in accordance with a PTP, or

(g) in response to an announcement by the Secretary of State and arrangements made in accordance with regulation 10A (directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.) or 15(5) (form or prescriptions) of the Misuse of Drugs Regulations 2001,

unless that supply takes place at a registered pharmacy included in the pharmaceutical list in respect of that pharmacy contractor or takes place in accordance with a collection and delivery arrangement.

(9) Where a payment had been made to a pharmacy contractor to which such pharmacy contractor was not due, the Agency or Board shall draw that over-payment to the attention of such pharmacy contractor and unless the Scottish Ministers direct otherwise the amount overpaid shall be repaid by the pharmacy contractor to the Board or Agency.

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