The National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995

law://uk/uksi/1995/414@2026-11-12

Contents

1Citation and commencement#

These Regulations may be cited as the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995 and shall come into force on 31st March 1995.

2Interpretation and application#

(1)In these Regulations unless the context otherwise requires—• “the Act” means the National Health Service (Scotland) Act 1978;• “additional professional services” has the meaning assigned to it in regulation 4;• “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 Schedule 10 to the National Health Service (General Medical Services) (Scotland) Regulations 1995 or, except where the conditions in paragraph 31(2) of the doctors' terms of service are satisfied, in Schedule 11 to those Regulations;• “Area Medical Committee” means the committee of that name for the area of a Board recognised under section 9 of the Act;• “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 the Act;• “chemical reagent” means a chemical reagent included in a list for the time being approved by the Secretary of State for the purposes of section 27 of the Act;• “dentist” means a dental practitioner;• “doctor” means a fully registered medical practitioner;• “drugs” includes medicines and chemical reagents;• “Drug Tariff” has the meaning assigned to it in regulation 9;• “hypodermic needle exchange services” has the meaning assigned to it in regulation 3(5);• “listed drugs” means such drugs and medicines as are included in a list for the time being approved by the Secretary of State for the purposes of section 27(1) of the Act;• “medical list” means a list prepared under section 19 of the Act of medical practitioners who have undertaken to provide general medical services;• “medicinal products” are products defined under section 130 of the Medicines Act 1968;• “minor relocation” has the meaning assigned to it in regulation 5;• “National Appeal Panel” means the panel constituted under Part II of Schedule 4;• “non-proprietary name” in relation to a drug means (a) where the drug is described in a monograph in the current edition (as defined in section 103(5) of the Medicines Act 1968), as in force at the time of the supply of the drug, of the European Pharmacopoeia, the British Practitioners' Formulary, any name, or abbreviation of such name, at the head of that monograph or, where such name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that publication; or (b) where the drug is not so described but has an approved name, being the name which appears in the current edition (as defined in the said section 103(5)) of the list of names prepared and published under section 100 of that Act, as in force at the time of the supply of the drug, such approved name;• “pharmaceutical list” has the meaning assigned to it in regulation 5;• “pharmaceutical services” means those services as defined by section 27 of the Act;• “pharmacist” means a pharmacist within the meaning of section 132(1) of the Medicines Act 1968;• “pharmacist contractor” means a contractor who provides pharmaceutical services, or a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968;• “provisional pharmaceutical list” has the meaning assigned to it in regulation 6;• “registered pharmacy” means a registered pharmacy within the meaning of section 74 of the Medicines Act 1968;• “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;• “scheduled drug” means a drug or other substance specified in Schedule 10 to the National Health Service (General Medical Services) (Scotland) Regulations 1995, or except where the conditions in paragraph 31(2) of the doctors' terms of service are satisfied, in Schedule 11 to those Regulations.• “supplemental services” has the meaning assigned to it in regulation 3(3);• “terms of service” means the terms of service for pharmacists contained or referred to in Schedule 1.

(2)These Regulations shall apply to a person, firm or body corporate (other than a doctor or 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.

3Pharmaceutical services#

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

(a)the supply of contraceptive substances and appliances;

(b)the provision of supplemental services;

(c)subject to paragraph (8) the provision of hypodermic needle exchange services.

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

(3)In these Regulations “supplemental services” means—

(a)where a registered pharmacy regularly supplies drugs and medicines to be taken by persons resident in a home, the giving of advice by him, or by a pharmacist employed by him, following a visit to that home in connection with procedures there for the safe keeping and correct administration of those drugs and medicines;

(b)the keeping of records of such visits as are referred to in sub-paragraph (a);

(c)the keeping of records in connection with drugs and medicines supplied to or to be taken by any person—

(i)who claims exemption under regulation 7(1)(c) of the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 1989 (exemption from charges for drugs and appliances), or

(ii)who, in the opinion of the pharmacist dispensing the drug or medicine, is likely to have difficulty understanding the nature and dosage of the drug or medicine dispensed and the times at which it is to be taken,

in circumstances where the nature of the drug or medicine is such that, in the opinion of the pharmacist who dispenses it, the same or a similar drug or medicine is likely to be prescribed for that person regularly on future occasions.

(4)In paragraph (3)—

(a)“home” means any one of—

(i)a nursing home within the meaning of the Nursing Homes Registration (Scotland) Act 1938, or

(ii)a residential or other establishment within the meaning of Part IV of Social Work (Scotland) Act 1968, or

(iii)a private hospital within the meaning of Part IV of the Mental Health (Scotland) Act 1984;

(b)“records” shall include—

(i)in the case of those kept pursuant to paragraph (3)(b), a record of the name and address of the home, of the date of each visit and of the nature of any advice given in the course of or following each such visit and to whom it was given, and

(ii)in the case of those kept pursuant to paragraph (3)(c), a record of the name and address of the person to or for whom the drug or medicine is supplied, of the name, quantity, and dosage and of the date on which the supply was made and any advice given in relation to the use of the drugs and medicines supplied.

(5)In these Regulations “hypodermic needle exchange services” means—

(a)the supply, free of charge, by a pharmacist to a person reasonably believed by that pharmacist to be a drug misuser of—

(i)hypodermic needles and syringes; and

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

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

(c)the provision of counselling to such a person by a trained pharmacist.

(6)In paragraph (5)—

(a)“drug misuser” means a person who is misusing drugs by self-injection;

(b)“trained pharmacist” means a pharmacist who has received relevant training prepared by the Post Qualification Education Board for Pharmacists in Scotland.

(7)A pharmacist may at any time give notice in writing to the Board that he 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 “supplemental services”; or

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

(8)A Board shall agree to a pharmacist providing hypodermic needle exchange services only—

(a)after consulting its Chief Administrative Pharmaceutical Officer and its Chief Administrative Medical Officer and 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.

(9)A pharmacist 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 him;

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

(c)the number of persons to whom he has supplied hypodermic needles and syringes.

(10)A pharmacist may at any time give notice in writing to the Board that he 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.

(11)The Board may at any time, by giving notice in writing to a pharmacist, terminate his 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.

4Additional professional services#

(1)A pharmacist 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; and

(d)the publication by a pharmacist 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 pharmacist 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.

(3)In paragraph (2)(c) “clinical audit” means the systematic and critical analysis of the quality of clinical care.

5Pharmaceutical list#

(1)The Board shall prepare a list to be called “the pharmaceutical list” of 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 he provides pharmaceutical services, or

(iii)to provide pharmaceutical services other than those already listed in relation to him from premises which are already included in the pharmaceutical list,

shall apply to the Board in accordance with whichever version of Form A set out in of Schedule 2 is appropriate or, in the case of an application to which the applicant proposes that paragraph (4) should apply, Form A(MR) set out in that Schedule.

(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 he provides pharmaceutical services, from the premises already listed in relation to him, and to provide from those new premises the same pharmaceutical services which he is listed as providing from his existing premises,

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

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

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 8(3) that applies to him, 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 appreciable 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 Chief Administrative Pharmaceutical Officer of the Board.

(8)In the case of an application to which paragraph (4)(a) applies, where the Board is not satisfied that the relation 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)Nothing in this regulation shall preclude or prevent an applicant from making an application in accordance with Form A or Form A(MR) in circumstances where the applicant considers that paragraph (4) may apply to such an application.

(10)An application made in any case other than one to which paragraph (3) or (4) applies shall be granted by the Board, after the procedures set out in Schedule 3 have been followed, 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.

(11)Where an application is granted, it shall be notified in accordance with whichever version of Form C set out in Schedule 2 is appropriate.

(12)Where an application is granted in accordance with paragraph (10), it shall be competent for the Board to grant it in respect of some only 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 to have his name registered under the Pharmacy Act 1954 by virtue of section 4A of that Act (qualification by European diploma) shall not be granted unless the applicant satisfies the Board that he has the knowledge of English, which, in the interests of himself 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.

6Provisional pharmaceutical list#

(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 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 or, as the case may be, Form A(MR), is negative, 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 his 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 or, as the case may be, Form A(MR), 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, he is required to submit Form B, that he 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 his 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), his name shall be removed from the provisional pharmaceutical list.

7Removal from and amendment to pharmaceutical list#

(1)Where the Board determines in accordance with paragraph (3) 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)Where a Board determines in accordance with paragraph (3) 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.

(3)Before making a determination under paragraphs (1) or (2), the Board shall—

(a)give the person 28 days' notice of its intention so to do,

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

(c)consult the Area Pharmaceutical Committee.

(4)Nothing in paragraphs (1) and (2) 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 (2) shall be effected in respect of any such person until six months after he has completed that service.

8Schemes for securing proper pharmaceutical service#

(1)The Board after consultation with the Area Pharmaceutical Committee shall prepare a scheme for testing the quality and checking the amounts of drugs and appliances supplied, and where appropriate the directions for use. The minimum number of tests to be made annually shall be specified in the scheme.

(2)For the purposes of a scheme prepared in accordance with paragraph (1), a drug or appliance dispensed and awaiting collection shall be deemed to be supplied.

(3)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.

(4)The provisions of schemes prepared under paragraph (3) shall be subject to the approval of the Secretary of State.

(5)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 (3), the matter shall be referred to the Secretary of State, whose determination shall be final.

(6)Where the Board after consultation with the Area Pharmaceutical Committee, amends the provisions of a scheme approved under paragraph (4), 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 Secretary of State, or

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

9Payments to pharmacists and standards of drugs and appliances#

The Secretary of State shall after consultation with an organisation which is, in his opinion, representative of the general body of pharmacists cause to be prepared a statement (in these Regulations referred to as “the Drug Tariff”) which he may after such consultation amend from time to time and which 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 supplemental services and 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 Secretary of State for the purposes of section 27 of the Act and the specifications for such appliances;

(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 Secretary of State for the purpose of section 27 of the Act and the specification for such chemical reagents.

10Exercise of choice of pharmacist in certain cases#

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

11Publication of particulars#

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

(a)the pharmaceutical list,

(b)the terms of service for pharmacists,

(c)the Drug Tariff,

(d)any schemes made under regulation 8,

and shall keep them revised and up-to-date.

(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)Subject to paragraph (4) the Board shall send a copy of the medical list to all pharmacists providing pharmaceutical services in the area; and at intervals of not more than three months shall notify them of any alteration therein.

(4)If the Board considers that only portions of the medical list, or only some of the alterations thereto, are likely to concern any persons providing pharmaceutical services, it may send to such persons a copy of only those portions, or those alterations.

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

12Service of documents#

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 that person, or in the case of a body, to the secretary or general manager of that body or by sending it in a prepaid envelope addressed to him, or in the case of a body, to the secretary or general manager of that body at his usual or last known address.

13Revocations#

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

Schedule 1 · terms of service for pharmacists

(1)In these terms of service unless the context otherwise requires—

(a)“prescription form” means a form provided by the Board or, where the doctor is on the medical list of more than one Board, by the Board which is responsible for the supply of that form, for issue by a doctor or dentist to enable a person to obtain pharmaceutical services as defined by section 27 of the Act;

(b)except in relation to a pharmacist who has notified the Board under regulation 3(7) that he 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;

(c)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.

(2)Any provisions of the following affecting the rights and obligations of pharmacists shall be deemed to form part of the terms of service:—

(a)these Regulations;

(b)the Drug Tariff;

(c)any scheme made under regulation 8;

(d)so much of Part II of the National Health Service (Service Committees and Tribunal) (Scotland) Regulations 1992 as relates to—

(i)the investigation of complaints made by or on behalf of persons against pharmacists and other investigations to be made by the pharmaceutical service committee and the joint services committee and the action which may be taken by the Board as a result of such investigations, including the withholding of remuneration from pharmacists where there has been a breach of the terms of service;

(ii)appeals to the Secretary of State from decisions of the Board.

(3)

(1)Subject to sub-paragraphs (2) and (3) a pharmacist shall supply, with reasonable promptness, to any person who presents on a prescription form—

(a)an order for drugs, not being scheduled drugs, or for appliances, signed by a doctor;

(b)an order for a drug specified in Schedule 11 to the National Health Service (General Medical Services) (Scotland) Regulations 1995, signed by, and endorsed on its face with the reference “SLS”, by a doctor;

(c)an order for listed drugs, or for drugs, not being scheduled drugs, signed by a dentist,

such drugs and appliances as may be so ordered, and any drugs so supplied shall be in a suitable container.

(2)A pharmacist shall not accept for dispensing any prescription form transmitted from or received at a registered pharmacy which is not included in the pharmaceutical list.

(3)A pharmacist shall not supply any drugs or listed appliances ordered on a prescription form other than at a registered pharmacy which is included in the pharmaceutical list.

(4)Where an order, not being an order to which the Poisons Rules 1982 or the Misuse of Drugs Regulations 1985 apply, issued by a doctor 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 he shall consider to be appropriate, and, subject to the provisions of sub-paragraph (5), in such quantity as he considers to be appropriate for a course of treatment of the patient to whom the order relates, for a period not exceeding five days.

(5)Where an order to which sub-paragraph (4) 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.

(6)Where any drug, not being one to which the Misuse of Drugs Regulations 1985 apply, ordered by a doctor or dentist on a prescription form, 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;

(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 calendar pack or special container,

the pharmacist shall, subject to sub-paragraph (7), provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(7)A pharmacist shall not provide, pursuant to sub-paragraph (6), a drug in a calendar pack where in his opinion, it was the intention of the doctor or dentist who ordered the drug that it should be provided only in the exact quantity ordered.

(8)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.

(9)All drugs and preparations supplied by pharmacists shall, where a standard or formula is specified in the British Pharmacopoeia, the British Pharmaceutical Codex, 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.

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

(11)Subject to any regulations in force under the Weights and Measures Act 1985, a pharmacist shall provide pharmaceutical services only in response to and, subject to sub-paragraphs (4), (5) and (6), in accordance with an order on a prescription form signed as specified in sub-paragraph (1), except that in a case of urgency where a doctor personally known to a pharmacist requests him 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; and

(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 5 to the Misuse of Drugs Regulations 1985; and

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

(12)Except as provided in sub-paragraph (13), 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.

(13)Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form 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.

(14)Where a drug which is ordered as specified in sub-paragraph (12) 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.

(15)A pharmacist 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 his presenting an order for drugs or appliances on a prescription form.

(16)A pharmacist shall not, except with the consent of the Secretary of State, provide at a health centre services other than pharmaceutical services in accordance with section 27 of the Act.

(4)

(1)Pharmaceutical services shall be provided from the premises specified in the application made by the pharmacist 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 Secretary of State, be provided by a pharmacist in premises occupied by a doctor other than at a health centre.

(4)No pharmacist shall provide pharmaceutical services from any pharmacy or other premises which are not included in the pharmaceutical list in respect of that pharmacist.

(5)The dispensing of medicines shall be performed either by or under the direct supervision of a pharmacist who shall not, unless the Secretary of State otherwise consents, be a person disqualified under section 29 of the Act for inclusion in a pharmaceutical list.

(6)A pharmacist contractor shall, if so required by the Board, furnish to the Board the name or names of pharmacists employed by him in dispensing medicines.

(7)

(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 pharmacist supplies an oxygen container or oxygen equipment, other than equipment specified in the Drug Tariff as not returnable to the pharmacist, the container and equipment shall remain the property of the pharmacist 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.

(8)

(1)A pharmacist is required to furnish to the Board or to such other person or body as it may direct, on dates to be appointed by the Secretary of State after consultation with an organisation which is in his opinion representative of the general body of pharmacists, the prescription forms and other forms upon which the orders for drugs and appliances supplied by him were given, arranged in such manner as the Board may direct, together with a statement of accounts containing such particulars relating to the provision by him of pharmaceutical services as the Board, with the approval of the Secretary of State, may from time to time require.

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

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

(4)The Board shall, if so required by any organisation which is, in the opinion of the Secretary of State, representative of the general body of pharmacists, afford the said organisation similar facilities for examining such forms and particulars relating to all or any of the pharmacists 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)If the Secretary of State, after consultation with such organisation as is mentioned in sub-paragraph (1), is satisfied at any time that the method of payment hereinbefore provided for in this paragraph is such that undue delay in payment may be caused thereby, he may direct that the amounts to be payable to a pharmacist shall be calculated by such other method, whether by averaging the amounts payable to a pharmacist or otherwise, as appears to him designed to secure that—

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

(b)payments to a pharmacist 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.

(7)No pharmacist shall be paid in respect of the supply of drugs or listed appliances indicated on a prescription form unless that supply takes place at a registered pharmacy included in the pharmaceutical list in respect of that pharmacist.

(9)

(1)Subject to sub-paragraph (2) a pharmacist may at any time give notice in writing to the Board that he desires to withdraw his name from the pharmaceutical list and his name shall be removed therefrom at the expiration of three months from the date of such notice or of such shorter period as the Board may agree.

(2)Where representations are made to the Tribunal under the provisions of section 29 of the Act (disqualification of persons providing services) that the continued inclusion of a pharmacist in the pharmaceutical list would be prejudicial to the efficiency of the service, he shall not, except with the consent of the Secretary of State and subject to such conditions as the Secretary of State may impose, be entitled to withdraw his name from the list pending the termination of the proceedings on such representations.

(3)The name of any pharmacist whose business is carried on by representatives in accordance with the provisions of the Medicines Act 1968, shall not be removed from the list so long as the business is carried on by them in accordance with the provisions of that Act, and the representatives agree to be bound by the terms of service of the pharmacist.

(10)Without prejudice to any rule or implication of law to that effect, a pharmacist who provides pharmaceutical services in accordance with arrangements made in these Regulations shall do so in conformity with standards generally accepted in the pharmaceutical profession.

(11)A pharmacist who has undertaken to provide supplemental services within the meaning of paragraph (3) of regulation 3 shall on request make available to the Board all records kept in accordance with sub-paragraphs (b) and (c) of that paragraph.

Schedule 2

Schedule 3 · procedure on applications to the board under regulation 5(10) Receipt and notification of applications

(1)

(1)The Board shall, within five working days of receiving an application to which regulation 5(10) applies, give written notice of the application to—

(a)the Area Pharmaceutical Committee;

(b)the Area Medical Committee;

(c)any person whose name is included in the pharmaceutical list or the provisional pharmaceutical list and whose interests may, in the opinion of the Board, be significantly affected if the application were granted;

(d)any Board whose boundary is within two kilometres of the proposed premises;

(e)any local health council whose area is affected by the application,

and any person or body so notified may, within 30 days from the date on which the notification was sent to him, make written representations about the application to the Board.

(2)Any Board which is notified under sub-paragraph (1)(d) above shall, within 5 working days, give written notice of the application to—

(a)its Area Pharmaceutical Committee;

(b)its Area Medical Committee;

(c)any person whose name is included in its pharmaceutical list or the provisional pharmaceutical list and whose interests may, in the opinion of the said Board, be significantly affected if the application were granted;

(d)every local health council serving its area,

and any person so notified may, within 30 days from the date on which the notification was sent to the said Board, make written representations to the Board to whom the application was made.

(3)Any notice given under sub-paragraph (1) or (2) above shall include a statement of the right to make representations in accordance with that sub-paragraph.

(2)

(1)In considering an application to which regulation 5(10) applies, the Board shall have regard to—

(a)the pharmaceutical services already provided in the neighbourhood of the premises named in the application by persons whose names are included in a pharmaceutical list;

(b)pharmaceutical services to be provided in the neighbourhood at these premises by any person whose name is included in the provisional pharmaceutical list;

(c)any representations received by the Board under paragraph 1; and

(d)any information available to the Board which, in its opinion, is relevant to the consideration of the application.

(2)The Board may, in accordance with this Schedule, determine any application in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the application without hearing any oral representations.

(3)In any case in which the Board decides to hear oral representations, it shall give the applicant and any person from whom it received representations under paragraph 1 reasonable notice of the meeting at which such representations are to be heard.

(4)The applicant and any person mentioned in sub-paragraph (3) shall be permitted to be assisted in making representations at any such meeting by some other person, but that other person shall not appear in the capacity of counsel, solicitor or paid advocate, nor shall he be entitled to speak on behalf of the applicant or any person mentioned in sub-paragraph (3).

(5)The procedure by which representations are heard shall be such as the Board may determine.

(6)The functions of the Board under this paragraph shall be exercised by the Pharmacy Practices Committee on behalf of the Board.

(3)The Board shall, within 5 working days of having been notified in accordance with paragraph 6 of Part I of Schedule 4, intimate to the applicant and the persons mentioned in paragraph 1 the decision on the application, the reasons for it, and of any right of appeal applicable under paragraph 4.

(4)

(1)Subject to sub-paragraph (2) the applicant or any person mentioned in paragraph 1, except the local health council, may appeal against the decision of the Board on the application, and notice of any such appeal given to the Board within 21 days from the date on which notification of the Board’s decision was sent to him.

(2)Any person mentioned in paragraph 1 who was notified of an application under that paragraph but made no written representations to the Board about it shall not be entitled to appeal against a decision of the Board in relation to that application.

(3)Any notice of appeal under this paragraph shall contain a concise statement of the facts and contentions upon which the appellant intends to rely.

(4)The Board shall refer a notice of appeal under this paragraph to the chairman of the National Appeal Panel appointed in accordance with Schedule 4.

(5)If the chairman, after considering the notice of appeal, is of the opinion that the notice discloses no reasonable grounds of appeal, or that the appeal is otherwise frivolous or vexatious, he may determine the appeal by dismissing it forthwith, in which case he shall inform the Board accordingly. The chairman’s decision in such cases shall be final.

(6)In any other case the National Appeal Panel shall be convened in accordance with Schedule 4 and the said Panel shall thereafter determine the appeal.

(7)The Council on Tribunals or the Scottish Committee thereof shall be given 14 days notice of any Panel hearing, and a member of the Council or its Scottish Committee shall be entitled to be present at any such hearing.

(8)The appellant, applicant and any person mentioned in paragraph 1(1)(c), except the local health council, who made written representation to the Board about the application shall be permitted to be assisted in making representations at any Panel hearing by some other person, but that other person shall not appear in the capacity of counsel, solicitor or paid advocate, nor shall he be entitled to speak on behalf of the person being assisted.

Schedule 4

Part I · pharmacy practices committee

(1)

(1)The Board shall, in accordance with regulation 7 of the Health Boards (Membership and Procedure) (No.2) Regulations 1991 and the provisions of this Schedule establish a committee (to be known as “the Pharmacy Practices Committee”).

(2)The Pharmacy Practices Committee shall on behalf of the Board exercise the functions of the Board in terms of regulation 5(10) and paragraph 2 of Schedule 3.

(3)

(1)The Pharmacy Practices Committee shall consist of seven members of whom—

(a)one shall be the chairman appointed as such by the Board; the chairman shall be a member of the Board but shall not be an officer of the Board nor shall he be, nor previously have been, a doctor, dentist, ophthalmic optician or pharmacist or the employee of a person who is a doctor, dentist, ophthalmic optician or pharmacist;

(b)three shall be pharmacists of whom—

(i)one shall be a pharmacist whose name is not included in any pharmaceutical list and who is not the employee of a person whose name is so listed; and he shall be appointed by the Board from persons nominated by the Royal Pharmaceutical Society of Great Britain; and

(ii)two shall be pharmacists each of whom is included in a pharmaceutical list or is an employee of a person whose name is so listed; and each shall be appointed by the Board from persons nominated by the Area Pharmaceutical Committee; and

(c)three shall be persons appointed by the Board otherwise than from the members of the Board but none shall be nor previously have been a doctor, dentist, ophthalmic optician or a pharmacist, or an employee of a person who is a doctor, dentist, ophthalmic optician or pharmacist.

(2)Persons to act as deputies for, and corresponding in number to, each of those categories of person appointed pursuant to sub-paragraph (1) shall, provided they satisfy the criteria specified in that sub-paragraph, be appointed by the Board and in the absence of any of those persons a deputy from the appropriate category shall be entitled to act in his place.

(3)If a nomination sought for the purposes of sub-paragraph (1)(b)(i) or (ii) above is not made before such date as the Board may determine, the Board may appoint as a member a person who satisfies the criteria specified in the relevant sub-paragraph.

(4)The Board shall prepare and maintain lists of the persons who have been appointed, in accordance with paragraph 3(1)(a), (b)(i) or (b)(ii), or (c), as the case might be, and who currently serve as members of the Pharmacy Practices Committee, and shall provide the Secretary of State with a copy of such lists from time to time.

(4)

(1)Before any meeting of the Pharmacy Practices Committee begins the chairman, or in his absence, the person acting as chairman, shall ask the members intending to be present whether, in respect of any matter to be considered at the meeting, any of them—

(a)has an interest to declare; or

(b)is associated with a person who has any personal interest,

and any such member who has or, as the case may be, is associated with a person who has, any such interest shall disclose it accordingly.

(2)Any member who has, pursuant to the provisions of sub-paragraph (1) above, disclosed an interest or who, in the opinion, expressed to the meeting, of the chairman or in his absence, the person acting as chairman as the case may be, should have disclosed such an interest, shall not be present at the consideration or discussion of that matter or the voting on it, and a deputy who has no such interest may act in his place.

(5)No business shall be transacted at a meeting of the Pharmacy Practices Committee unless the chairman or in his absence, the person acting as chairman, one member appointed under each of paragraph 3(1)(b)(i) and (ii), and two other members appointed under paragraph 3(1)(c) are present.

(6)

(1)Subject to sub-paragraphs (2), (3) and (4) below, every application considered by the Pharmacy Practices Committee shall be considered by all members present, but shall be determined only by a majority of votes of the members present who are entitled to vote.

(2)A member appointed by virtue of paragraph 3(1)(b)(i) is entitled to vote.

(3)A member appointed by virtue of paragraph 3(1)(b)(ii) is not entitled to vote and shall withdraw immediately before a decision on an application by voting takes place.

(4)The chairman, or in his absence the person acting as chairman, shall not be entitled to vote at any meeting except in the case of an equality of votes of the other persons present and voting, in which case he shall have a casting vote.

(5)The Pharmacy Practices Committee shall within ten working days of taking its decision give written notification of it to the Board with reasons for that decision.

(7)Subject to the provisions of these Regulations, the Board may make, vary or revoke standing orders with respect to the terms of office of members of the Pharmacy Practices Committee, the procedure of that committee and the making of reports of its proceedings to the Board.

(8)The proceedings of the Pharmacy Practices Committee shall not be invalidated by any vacancy in its membership, or any defect in a member’s appointment.

Part II · national appeal panel

(9)

(1)The Board shall submit the names of its nominees for the National Appeal Panel to the Secretary of State and shall advise him from time to time of any changes in such nominees.

(2)At the request of the Secretary of State, the Scottish Department of the Royal Pharmaceutical Society of Great Britain and the Scottish Pharmaceutical General Council shall submit the names of their nominees for the National Appeal Panel.

(10)

(1)After consultation with all Health Boards, the Scottish Department of the Royal Pharmaceutical Society of Great Britain and the Scottish Pharmaceutical General Council the Secretary of State shall appoint a person as chairman of the National Appeal Panel.

(2)The person so appointed shall not be a doctor, dentist, ophthalmic optician, pharmacist, or person, or employee of a person, whose name is on any pharmaceutical list.

(11)

(1)In any case in which paragraph 4(6) of Schedule 3 falls to be applied, the Secretary of State shall arrange to convene in accordance with this paragraph the National Appeal Panel, the members of which shall be drawn from—

(a)the lists maintained in accordance with paragraph 3(4) and

(b)the nominees proposed in accordance with paragraph 9.

(2)No member of the National Appeal Panel shall be a member of—

(a)the Board or the Pharmacy Practices Committee of the Board which considered the application or

(b)any Board which was notified in terms of paragraph 1(1)(d) of Schedule 3 and which submitted representations in accordance with that paragraph.

(3)The National Appeal Panel shall consist of nine members of whom—

(a)one shall be chairman appointed as provided for in paragraph 10;

(b)one shall be vice chairman and likewise be appointed as such in accordance with the terms of paragraph 10;

(c)four shall be pharmacists, one of whom has been nominated by the Scottish Department of Royal Pharmaceutical Society of Great Britain and the other three by the Scottish Pharmaceutical General Council; and of the said four members two shall be persons whose names are, or who are employees of persons whose names are, included in a pharmaceutical list;

(d)three shall be persons nominated by a Board none of whom is, or has been previously, a doctor, dentist, ophthalmic optician or a pharmacist nor a person employed by a doctor, dentist, ophthalmic optician or pharmacist.

(12)

(1)Before the start of any meeting of the National Appeal Panel the chairman, or vice chairman if acting as chairman, shall ask the members intending to be present whether, in respect of the appeal to be considered at the meeting, any of them—

(a)has an interest to declare;

(b)is associated with a person who has any personal interest,

and any such member who has or, as the case may be, is associated with the person who has, any such interest shall disclose it accordingly.

(2)Any member who has, pursuant to the provisions of sub-paragraph (1) disclosed an interest or who, in the opinion, expressed to the meeting, of the chairman or vice chairman as the case may be, should have disclosed such an interest, shall not be present at the consideration or discussion of that appeal or the voting on it.

(13)No business of the National Appeal Panel shall be transacted unless the chairman, or vice chairman if acting as chairman, and two members who are appointed under sub-paragraph (3)(c) of paragraph 11 and are in terms of paragraph 14 entitled to vote, and two members appointed under sub-paragraph (3)(d) of paragraph 11, are present.

(14)

(1)Subject to sub-paragraphs (2), (3) and (4), every appeal considered by the National Appeal Panel shall be considered by all members present, but be determined only by a majority of votes of the members present who are entitled to vote.

(2)A member appointed by virtue of paragraph 11(3)(c) and whose name is not included in any pharmaceutical list, or who is not an employee of a person who is so listed, and the vice chairman provided he is not acting as chairman are entitled to vote.

(3)A member appointed by virtue of paragraph 11(3)(c) and whose name is included in any pharmaceutical list, or who is an employee of a person so listed, is not entitled to vote and shall withdraw immediately before a decision on an appeal by voting takes place.

(4)The chairman, or vice chairman if acting as chairman, shall not be entitled to vote at any meeting except in the case of an equality of votes of the other persons present and voting, in which case he shall have a casting vote.

(15)

(1)The National Appeal Panel shall determine an appeal in such manner as it thinks fit and its decision in respect of that appeal shall be final.

(2)The National Appeal Panel shall within 5 working days of taking its decision, give written notification of that decision with reasons for it to the Board to whom the original application was made.

(3)The Board shall, within 5 working days, of receipt of such notification, intimate to the applicant and all persons mentioned in paragraph 1 of Schedule 3 that decision and the reasons for it.

Schedule 5 · Revocations

Contains public sector information licensed under the Open Government Licence v3.0.

1Citation and commencement#

2Interpretation and application#

3Pharmaceutical services#

4Additional professional services#

5Pharmaceutical list#

6Provisional pharmaceutical list#

7Removal from and amendment to pharmaceutical list#

8Schemes for securing proper pharmaceutical service#

9Payments to pharmacists and standards of drugs and appliances#

10Exercise of choice of pharmacist in certain cases#

11Publication of particulars#

12Service of documents#

13Revocations#

Connections

Defined terms · 35

History · 1 version

Key facts

1Citation and commencement#

2Interpretation and application#

3Pharmaceutical services#

4Additional professional services#

5Pharmaceutical list#

6Provisional pharmaceutical list#

7Removal from and amendment to pharmaceutical list#

8Schemes for securing proper pharmaceutical service#

9Payments to pharmacists and standards of drugs and appliances#

10Exercise of choice of pharmacist in certain cases#

11Publication of particulars#

12Service of documents#

13Revocations#