The Prescription Only Medicines (Human Use) Order 1997

This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997 and shall come into force on 18th August 1997.

In this Order, unless the context otherwise requires–

• “the Act” means the Medicines Act 1968;

• F236“additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register;

• “aerosol” means a product which is dispersed from its container by a propellent gas or liquid;

• F136“clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

  1. a

     the patient to whom the plan relates,

  2. b

     the doctor or dentist who is a party to the plan, and

  3. c

     any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan;

• F179“clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2003;

• F97...

• F53“Common Services Agency” means the Common Services Agency for the Scottish Health Service established under section 10 of the National Health Service (Scotland) Act 1978;

• F53“Community marketing authorization” means a marketing authorization granted by the European Community under Council Regulation (EEC) No. 2309/93;

• “controlled drug” has the meaning assigned to it by section 2 of the Misuse of Drugs Act 19715;

• “cyanogenetic substances” means preparations which–

  1. a

     are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17, or

  2. b

     contain more than 0.1 per cent by weight of any substance having the formula either α-Cyanobenzyl-6-O-β-d-glucopyranosyl-β-d-glucopyranoside or α-Cyanobenzyl-β-d-glucopy ranosiduronic acid;

• F187“district nurse/health visitor prescriber” means a first level nurse, or a registered midwife, against whose name in the professional register there is an annotation that he is qualified to order drugs, medicines and appliances from the Nurse Prescriber’s Formulary for District Nurses and Health Visitors Appendix in the current edition of the British National Formulary;

• “dosage unit” means–

  1. a

     where a medicinal product is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or

  2. b

     where a medicinal product is not in any such form, the unit of measurement which is used as the unit by reference to which the dose of the medicinal product is measured;

• F98“Extended Formulary” means the Nurse Prescribers’ Extended Formulary Appendix in the current edition of the British National Formulary;

• F98“extended formulary nurse prescriber” means a person—

  1. a

     F137who is a first level nurse F188or registered midwife, and

  2. b

     against whose name is recorded in F138the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Extended Formulary;

• “external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systemic absorption is unlikely to occur; and references to medicinal products for external use shall be read accordingly except that such references shall not include throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;

• F190“first level nurse” means a person registered in Sub-Part 1 of the Nurses' Part of the professional register;

• F53“Health Authority”—

  1. a

     in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;

  2. b

     in relation to Scotland, means a Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and

  3. c

     in relation to Northern Ireland, means a Health and Social Services Board established under Article 16 of the Health and Personal Social Services (Northern Ireland) Order 1972;

• F139“health care” means services for or in connection with the prevention, diagnosis or treatment of disease;

• “health prescription” means a prescription issued by a doctor, dentist F140, supplementary prescriberF99, a district nurse/health visitor prescriber or an extended formulary nurse prescriber under or by virtue of–

  1. a

     in England and Wales, the National Health Service Act 19776,

  2. b

     in Scotland, the National Health Service (Scotland) Act 19787, and

  3. c

     in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 19728;

• F141“health record” has the meaning given by section 68(2) of the Data Protection Act 19988;

• F53“homoeopathic certificate of registration” means a certificate of registration for the purposes of the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994;

• F142“independent clinic”—

  1. a

     in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 200010, and

  2. b

     in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001;

• F142“independent hospital”—

  1. a

     in relation to England and Wales, shall be construed in accordance with section 2(2), (3) and (6) of the Care Standards Act 2000, and

  2. b

     in relation to Scotland, means—

     1. i

        an independent hospital, or

     2. ii

        a private psychiatric hospital,

     as defined by section 77(1) of the Regulation of Care (Scotland) Act 2001;

• F142“independent medical agency”—

  1. a

     in relation to England and Wales, has the meaning given by section 2(5) of the Care Standards Act 2000, and

  2. b

     in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001;

• “inhaler” does not include an aerosol;

• F205“Local Health Board” has the same meaning as in the National Health Service Act 1977;

• F53“marketing authorization” includes a reference both to a United Kingdom marketing authorization and to a Community marketing authorization;

• “master” has the same meaning as in section 313(1) of the Merchant Shipping Act 19959;

• “maximum daily dose” or “MDD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered in a period of 24 hours;

• “maximum dose” or “MD” means the maximum quantity of a substance contained in the amount of a medicinal product which it is recommended should be taken or administered at any one time;

• “maximum strength” means–

  1. a

     the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;

  2. b

     the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–

     1. i

        weight in weight,

     2. ii

        weight in volume,

     3. iii

        volume in weight, or

     4. iv

        volume in volume,

     and if the maximum percentage calculated in those ways differs, the higher or highest such percentage;

• “medicinal product” includes any article or substance in respect of which section 58 of the Act has effect by virtue of an order made under section 104 of the Act, but does not include–

  1. a

     a medicinal product which is a veterinary drug as defined in section 132(1) of the Act or

  2. b

     an article or substance in respect of which section 58 has such effect where that article or substance is only to be administered to animals;

• “the Misuse of Drugs Regulations” means, in relation to England, Wales and Scotland, the Misuse of Drugs Regulations 198510 and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 198611;

• F53“NHS trust”—

  1. a

     in relation to England and Wales, has the same meaning as in the National Health Service and Community Care Act 1990;

  2. b

     in relation to Scotland, has the same meaning as in the National Health Service (Scotland) Act 1978; and

  3. c

     in relation to Northern Ireland, means a Health and Social Services trust established under article 10 of the Health and Social Services (Northern Ireland) Order 1991;

• F175“NHS foundation trust” has the same meaning as in section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003;

• F143“nursing home” has the meaning given by article 16 of the Registered Homes (Northern Ireland) Order 1992;

• “occupational health scheme” means a scheme in which a person, in the course of a business carried on by him, provides facilities for his employees for the treatment or prevention of disease;

• “offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 197112 which is within–

  1. a

     tidal waters and parts of the sea in or adjacent to the United Kingdom up to the seaward limits of territorial waters;

  2. b

     waters in any area designated under section 1(7) of the Continental Shelf Act 196413;

• “operator”, in relation to an aircraft, means the person for the time being having the management of the aircraft;

• “parenteral administration” means administration by breach of the skin or mucous membrane;

• F53“Patient Group Direction” means—

  1. a

     in connection with the supply of a prescription only medicine as referred to in article 12A(2), F16312B, 12C, 12D or 12E, a written direction relating to the supply and administration of a description or class of prescription only medicine; or

  2. b

     in connection with the administration of a prescription only medicine as referred to in article 12A(2), 12B or 12C, a written direction relating to the administration of a description or class of prescription only medicine,

  • and which, in the case of either (a) or (b)—

    1. i

       is signed by a doctor or dentist, and by a pharmacist; and

    2. ii

       relates to supply and administration, or to administration, to persons generally (subject to any exclusions which may be set out in the Direction);

• “prescription only medicine” means a medicinal product of a description or falling within a class specified in article 3 of this Order;

• F53“Primary Care Trust” has the same meaning as in the National Health Service Act 1977;

• F144“prison service” means—

  1. a

     in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952),

  2. b

     in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989), and

  3. c

     in relation to Northern Ireland, the Northern Ireland Department exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953);

• F100“professional register” means the register maintained by the Nursing and Midwifery Council F191under article 5 of the Nursing and Midwifery Order 2001;

• “prolonged release” in relation to a medicinal product means a formulation of that product which–

  1. a

     is used to reduce the rate at which the active ingredient in that product is released after administration, and

  2. b

     is sold or supplied as a prolonged, controlled or sustained release medicinal product;

• F152“registered chiropodist” means a person who is registered in Part 2 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;;

• F186“registered dietitian” means a person who is registered in Part 4 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;

• F192“registered midwife” means a person registered in the Midwives' Part of the professional register;

• F193“registered nurse” means a person registered in the Nurses' Part of the professional register;

• F186“registered occupational therapist” means a person who is registered in Part 6 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;

• F251“registered optometrist” means a person whose name is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989;

• F152“registered orthoptist” means a person who is registered in Part 7 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;;

• F186“registered orthotist and prosthetist” means a person who is registered in Part 10 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;

• F152“registered paramedic” means a person who is registered in Part 8 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;

• F152“registered physiotherapist” means a person who is registered in Part 9 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;

• F145“registered provider” means—

  1. a

     in relation to an independent hospital, an independent clinic or an independent medical agency—

     1. i

        in relation to England and Wales, the person who is registered under Part II of the Care Standards Act 2000 as the person carrying on the establishment or agency,

     2. ii

        in relation to Scotland, the person who is registered under Part 1 of the Regulation of Care (Scotland) Act 2001 as the person providing the establishment or agency, and

  2. b

     in relation to a nursing home, the person registered under Part III of the Registered Homes (Northern Ireland) Order 1992 as the person carrying on the nursing home, other than a manager who is to be treated as carrying on the home by virtue of article 17(2) of that order;

• F152“registered radiographer” means a person who is registered in Part 11 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;

• F186“registered speech and language therapist” means a person who is registered in Part 12 of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001;

• F145“relevant manager” means—

  1. a

     in relation to an independent hospital, an independent clinic or an independent medical agency—

     1. i

        in relation to England and Wales—

        1. aa

           a person who is registered under Part II of the Care Standards Act 2000 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or

        2. bb

           if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person,

     2. ii

        in relation to Scotland, a person, other than the registered provider, who was identified as an individual who is to manage the establishment or agency on the application for registration of that establishment or agency under Part 1 of Regulation of Care (Scotland) Act 2001, and

  2. b

     in relation to a nursing home, the manager of the nursing home, unless they are the registered provider for that home;

• F145“relevant register” means—

  1. a

     in relation to a first level nurse F194or registered midwife, the professional register, F208...

  2. b

     in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976; F238...

  3. c

     F209in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

     1. i

        chiropodists and podiatrists;

     2. ii

        physiotherapists; or

     3. iii

        radiographers diagnostic or therapeutic

     that register F239; and

  4. d

     F240in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989;

• “repeatable prescription” means a prescription which contains a direction that it may be dispensed more than once;

• “sell” means sell by retail as defined in section 131 of the Act and “sale” has a corresponding meaning;

• “soap” means any compound of a fatty acid with an alkali or amine;

• F53“Special Health Authority”—

  1. a

     in relation to England and Wales, has the same meaning as in the National Health Service Act 1977;

  2. b

     in relation to Scotland, means a Special Health Board constituted under section 2 of the National Health Service (Scotland) Act 1978; and

  3. c

     in relation to Northern Ireland, means a Special Health and Social Services Agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990;

• F153...

• F153...

• F111“Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977;

• F146“supplementary prescriber” means—

  1. a

     a first level nurse, F195...

  2. b

     a pharmacist, F210F196...

  3. c

     a registered midwife,F241...

  4. d

     F211a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

     1. i

        chiropodists and podiatrists;

     2. ii

        physiotherapists; or

     3. iii

        radiographers diagnostic or therapeutic F242or

  5. e

     F237a registered optometrist,

  against whose name is recorded in the relevant register an annotation F212or entry signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber;

• “supply” means supply in circumstances corresponding to retail sale as defined in section 131 of the Act;

• “unit preparation” means a preparation, including a mother tincture, prepared by a process of solution, extraction or trituration with a view to being diluted tenfold or one hundredfold, either once or repeatedly, in an inert diluent, and then used either in this diluted form or, where applicable, by impregnating tablets, granules, powders or other inert substances.

• F53“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the Medicines For Human Use (Marketing Authorisations Etc.) Regulations 1994 (including a product licence having effect as such an authorization by virtue of Schedule 6 to those Regulations).

For the purposes of this Order, the equivalence of a substance to a reference material shall be determined by calculating the amount of that reference material which is contained in that substance either by weight or, where the amount of the reference material is specified in terms of international units of activity, those units.

In Schedule 3, the abbreviation “NPF” means the Nurse Prescribers' Formulary Appendix in the British National Formulary.

In articles 12 to F14712E , a reference to a prescription only medicine being sold or supplied for the purpose of being administered in accordance with the written directions of a doctor or dentist relating to a particular person, or in accordance with a Patient Group Direction, includes a reference to it being sold or supplied in accordance with such directions or such a Direction.

In articles 12A and 12C, a reference to an arrangement for the supply or adminstration of prescription only medicines includes a reference to an arrangement which covers such supply or administration and other matters.

In Schedule 7, Part I, a reference to treatment of a clinical situation includes a reference to any form of management of that situation.

Subject to paragraph (2), the description and classes of medicinal products in relation to which extended formulary nurse prescribers are appropriate practitioners are those prescription only medicines which consist of, or contain, one or more of the substances specified in column 1 of Schedule 3A, but which do not contain any other substance or combination of substances which is a prescription only medicine not included in Schedule 3A.

If the entry in column 2 of Schedule 3A relating to a substance specifies one or more requirements as to use, route of administration or pharmaceutical form, it is a condition for the purposes of paragraph (2) that a medicinal product which consists of, or contains, that substance is administered, or is prescribed or directed for administration, in accordance with the specified requirements.

Where a maximum strength is specified in column 2 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where the maximum strength of that substance in that medicinal product, or where specified in that column the maximum strength of a medicinal product which contains that substance, does not exceed that specified maximum or, where the medicinal product consists of more than one of the substances sodium fluoride, sodium monofluorophosphate or stannous fluoride combined in a dentifrice, where the maximum strength of that combination of substances in a product does not exceed the equivalent of 0.15 per cent of fluorine.

Where a route of administration is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for administration only by that route.

Where a pharmaceutical form is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied in that pharmaceutical form.

Where a maximum dose is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use at a maximum dose which does not exceed that specified maximum dose.

Subject to paragraph (8), where a maximum daily dose is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use at a maximum daily dose which does not exceed that specified maximum daily dose.

A medicinal product which contains more than one of the substances–

• Atropine

• Atropine Methobromide

• Atropine Methonitrate

• Atropine Oxide Hydrochloride

• Atropine Sulphate

• Hyoscine

• Hyoscine Butylbromide

• Hyoscine Hydrobromide

• Hyoscine Methobromide

• Hyoscine Methonitrate

• Hyoscyamine

• Hyoscyamine Hydrobromide

• Hyoscyamine Sulphate,

satisfies the condition only where it is sold or supplied for use at a maximum daily dose which does not exceed 1 milligram in total of the alkaloids derived from belladonna, hyoscyamus, stramonium or other solanaceous plant which are contained in that medicinal product.

Where a maximum period of use or a maximum frequency of use is specified in column 4 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it is sold or supplied for use for a maximum period or frequency, as the case may be, which does not exceed the maximum period of use or the maximum frequency of use which is so specified.

Where a maximum quantity is specified in column 5 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition where it, or where so specified in that column, the medicinal product which contains that substance is sold or supplied in a quantity which does not exceed that specified maximum quantity.

In paragraphs (2) to (7) and (9) and (10) a reference to a numbered column is a reference to the column bearing that number in Schedule 1.

The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of smallpox vaccine where the conditions specified in paragraph (2) or (3) are satisfied.

The restrictions imposed by section 58(2)(a) (restriction on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (2) are satisfied.

The restrictions imposed by section 58(2)(a) shall not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business where the conditions specified in paragraph (4) are satisfied.

The conditions specified in paragraphs (2)(d) and (4)(c) shall not apply where the prescription only medicine consists of or contains phenobarbitone or phenobarbitone sodium (but no other substance specified in Schedule 4 to this Order or Schedule 1, 2 or 3 to the Misuse of Drugs Regulations) and is sold or supplied for use in the treatment of epilepsy.

The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the sale, supply or administration of a medicinal product which is not for parenteral administration and which consists of or contains solely one or more unit preparations of the following substances—

• Aconite

• Arsenic Trioxide

• Belladonna Herb

• Ignatia Bean

• Nux Vomica Seed,

if each such unit preparation has been diluted to at least one part in a million (6x)

The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration by a person listed in column 1 of Part III of Schedule 5 of the prescription only medicines for parenteral administration listed in relation to that person in column 2 of that Part where the conditions specified in the corresponding paragraphs in column 3 of that Part are satisfied.

Subject to paragraph (3), the restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine in the course of the business of a hospital where the medicine is sold or supplied for the purpose of being administered (whether in the hospital or elsewhere) to a particular person in accordance with directions satisfying the conditions specified in paragraph (2).

Such directions may be given by an extended formulary nurse prescriber or a supplementary prescriber only where he complies with any condition as to the cases or circumstances in which he may give a prescription for that medicine specified by virtue of article 3A or 3B, as if the directions are a prescription.

The exemption in paragraph (1) applies notwithstanding that the directions do not satisfy the conditions specified in article 15(2).

The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by an extended formulary nurse prescriber F124or supplementary prescriber where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the extended formulary nurse prescriber F124or supplementary prescriber has complied with any condition with which he is required to comply by virtue of F125articles 3A(2) and (3) or 3B.

For the purposes of section 58(2)(a), and subject to paragraph (3), a prescription only medicine shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless the conditions specified in paragraph (2) are fulfilled.

For the purposes of paragraph (1) the prescription may, as an alternative to fulfilling the conditions specified in paragraph (2)(a) and (b), fulfil instead the conditions specified in paragraph (4), unless the prescription is a health prescription for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations or is given by a veterinary surgeon or a veterinary practitioner.

The conditions referred to in paragraph (3) are that the prescription shall be created in electronic form and signed with an advanced electronic signature and transferred to the person by whom it is dispensed as an electronic communication (including where it is so transferred through one or more intermediaries).

In this Article—

• “advanced electronic signature” means an electronic signature which is—

  1. a

     uniquely linked to the signatory,

  2. b

     capable of identifying the signatory,

  3. c

     created using means that the signatory can maintain under his sole control, and

  4. d

     which is linked to the data to which it relates in such a manner that any subsequent change of data is detectable;

• “electronic communication” means a communication transmitted (whether from one person to another, from one device to another or from a person to a device or vice versa)—

  1. a

     by means of a telecommunication system (within the meaning of the Telecommunications Act 1984, or

  2. b

     by other means but while in an electronic form; and

• “signatory” means the appropriate practitioner giving the prescription.

The Orders specified in Schedule 6 are revoked.

In the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 198919 articles 2 to 6 and Schedules 1 and 2 are revoked.