The Prescription Only Medicines (Human Use) Order 1997

Citation, commencement and interpretation

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

(2) In this Order, unless the context otherwise requires–

“the Act” means the Medicines Act 1968;

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

F1 ...

[F2 “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;]

[F2 “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 1971(1);

“cyanogenetic substances” means preparations which–

(a)

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

(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;

[F3 “district nurse/health visitor prescriber” means—

(a)

a person who—

(i)

is registered in Part 1 or 12 of the professional register, and

(ii)

has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 1983; or

(b)

a person who is registered in Part 11 of the professional register as a health visitor,

against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients;]

“dosage unit” means–

(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

(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;

[F4 “Extended Formulary” means the Nurse Prescribers’ Extended Formulary Appendix in the current edition of the British National Formulary;]

[F4 “extended formulary nurse prescriber” means a person—

(a)

who is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register; and

(b)

against whose name is recorded in that 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;

[F2 “Health Authority”—

(a)

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

(b)

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

(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;]

“health prescription” means a prescription issued by a doctor, dentist [F5 , a district nurse/health visitor prescriber or an extended formulary nurse prescriber] under or by virtue of–

(a)

in England and Wales, the National Health Service Act 1977(2),

(b)

in Scotland, the National Health Service (Scotland) Act 1978(3), and

(c)

in Northern Ireland, the Health and Personal Social Services (Northern Ireland) Order 1972(4);

[F2 “homoeopathic certificate of registration” means a certificate of registration for the purposes of the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994;]

“inhaler” does not include an aerosol;

[F2 “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 1995(5);

“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–

(a)

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

(b)

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

(i)

weight in weight,

(ii)

weight in volume,

(iii)

volume in weight, or

(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–

(a)

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

(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 1985(6) and in relation to Northern Ireland, the Misuse of Drugs (Northern Ireland) Regulations 1986(7);

[F2 “NHS trust”—

(a)

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

(b)

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

(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;]

“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 1971(8) which is within–

(a)

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

(b)

waters in any area designated under section 1(7) of the Continental Shelf Act 1964(9);

“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;

[F2 “Patient Group Direction” means—

(a)

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

(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)—

  (i)

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

  (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;

[F2 “Primary Care Trust” has the same meaning as in the National Health Service Act 1977;]

[F6 “professional register” means the register maintained by the Nursing and Midwifery Council pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001;]

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

(a)

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

(b)

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

“registered midwife” means a person who is registered in Part 10 of [F7 the professional register];

“registered nurse” means a person who is registered in [F8 the professional register];

“registered ophthalmic optician” means a person who is registered in either of the Registers of ophthalmic opticians maintained under section 7(a) of the Opticians Act 1989(10);

“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;

[F2 “Special Health Authority”—

(a)

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

(b)

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

(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;]

“state registered chiropodist” means a person who is registered in [F9 the register of chiropodists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001];

[F2 “state registered paramedic” means a person who is registered in [F10 the register of paramedics maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001];]

[F11 “Strategic Health Authority” means a Strategic Health Authority established under section 8 of the National Health Service Act 1977;]

“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.

[F2 “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).]

(3) 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.

(4) In this Order, unless the context otherwise requires, a reference–

(a) to a numbered section is to the section of the Act which bears that number,

(b) to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number,

(c) in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that article or Part of that Schedule which bears that number, and

(d) in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter.

(5) In [F12 Schedules 1, 2, 3A and 5]–

(a) entries specified in columns 2 to 5 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in columns 2 to 5 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;

(b) the following abbreviations are used:

• “g” for gram,

• “iu” for international unit of activity,

• “mcg” for microgram,

• “mg” for milligram,

• “ml” for millilitre.

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

[F13 (7) In articles 12 to 12C, 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.

(8) 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.

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

Textual Amendments

F1 Words in art. 1 omitted (1.4.2002) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(a)

F2 Words in art. 1(2) inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(a)

F3 Words in art. 1 inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(b)

F4 Words in art. 1 inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(c)

F5 Words in art. 1 inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(d)

F6 Words in art. 1 inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(e)

F7 Words in art. 1 substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(f)

F8 Words in art. 1 substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(g)

F9 Words in art. 1 substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(h)

F10 Words in art. 1 substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(i)

F11 Words in art. 1(2) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), regs. 1, 7, Sch. 4

F12 Words in art. 1(5) substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(3)

F13 Words in art. 1(7)-(9) inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(b)

Appropriate practitioners

2.  For the purposes of section 58 (medicinal products on prescription only), the following shall be appropriate practitioners–

(a) in relation to the descriptions and classes of medicinal products specified in article 3, doctors, dentists, veterinary surgeons and veterinary practitioners;

[F14 (b) in relation to the descriptions and classes of medicinal products specified in Schedule 3, district nurse/health visitor prescribers;

(c) in relation to the descriptions and classes of medicinal products specified in article 3A(1), extended formulary nurse prescribers.]

Textual Amendments

F14 Art. 2(b)(c) substituted for art. 2(b) (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 3

[F15 Medicinal products on prescription only

3.   The following descriptions and classes of medicinal products are specified for the purposes of section 58, namely—

(a) medicinal products in respect of which a marketing authorization has been granted, which in the marketing authorization are classified as being prescription only medicines;

(b) medicinal products in respect of which no marketing authorization has been granted consisting of or containing a substance listed in column 1 of Schedule 1;

(c) medicinal products that are for parenteral administration;

(d) medicinal products that are controlled drugs unless a marketing authorization has been granted in respect of that medicinal product in which the product is classified as being a pharmacy only or on general sale list medicine;

(e) cyanogenetic substances, other than preparations for external use;

(f) medicinal products that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used.]

Textual Amendments

F15 Art. 3 substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 4

[F16 Prescribing by extended formulary nurse prescribers

3A.— (1) 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.

(2) An extended formulary nurse prescriber may—

(a) give a prescription for a medicinal product referred to in paragraph (1); or

(b) if that medicinal product is for parenteral administration—

(i) administer that medicinal product, or

(ii) give directions for the administration of that medicinal product,

only where he complies with any condition as to the cases or circumstances in which he may do so that is specified by virtue of paragraph (3).

(3) 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.]

Textual Amendments

F16 Art. 3A inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 5

Duration of special provisions in relation to new medicinal products

F17 4.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F17 Art. 4 revoked (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 11

Exempt medicinal products

5.—(1) A medicinal product shall be exempt from the restrictions imposed by section 58(2)(a) (restrictions on sale or supply) if it, or a substance in it, is listed in column 1 of Schedule 1 and there–

(a) is an entry in column 2, 3, 4 or 5 of that Schedule which contains a condition and that condition is satisfied in accordance with the following provisions of this article; or

(b) there is more than one such condition which applies where that substance is used in that product and each of those conditions is so satisfied.

(2) 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.

(3) 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.

(4) Where a use is specified in column 3 in relation to a substance, a medicinal product which consists of or contains that substance satisfies the condition in respect of use where it is sold or supplied only for use–

(a) where a purpose for which it may be used is so specified, for that purpose;

(b) where the class of persons in whom it may be used is so specified, in persons of that class [F18 ,

provided that, where the entry in column 3 contains a condition to the effect that the product is to be wholly or mainly for use in a specified class of persons, the product satisfies that condition where it is sold or supplied wholly or mainly for use in persons of that class].

(5) 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.

(6) 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.

(7) 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.

(8) 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.

(9) 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.

(10) 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.

(11) 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.

Textual Amendments

F18 Words in art. 5(4) added (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 2

Circumstances in which controlled drugs and medicinal products authorized by the European Community are not prescription only medicines

F19 6.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F19 Art. 6 revoked (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 11

Exemption for parenteral administration in an emergency to human beings of certain prescription only medicines

7.  The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of any of the following medicinal products for parenteral administration–

• Adrenaline Injection 1 in 1000 (1 mg in 1 ml)

• Atropine Sulphate Injection

• Chlorpheniramine Injection

• Cobalt Edetate Injection

• Dextrose Injection Strong B.P.C.

• Diphenhydramine Injection

• Glucagon Injection

• Hydrocortisone Injection

• Mepyramine Injection

• Promethazine Hydrochloride Injection

• Snake Venom Antiserum

• Sodium Nitrite Injection

• Sodium Thiosulphate Injection

• Sterile Pralidoxime

where the administration is for the purpose of saving life in an emergency.

Exemptions for emergency sale or supply

8.—(1) 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.

(2) The conditions referred to in paragraph (1) are–

(a) that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied is satisfied that the sale or supply has been requested by a doctor [F20 , a district nurse/health visitor prescriber or an extended formulary nurse prescriber] who by reason of an emergency is unable to furnish a prescription immediately;

(b) that the doctor [F21 , district nurse/health visitor prescriber or extended formulary nurse prescriber] has undertaken to furnish the person lawfully conducting a retail pharmacy business with a prescription within 72 hours of the sale or supply;

(c) that the prescription only medicine is sold or supplied in accordance with the directions of the doctor [F22 , district nurse/health visitor prescriber or extended formulary nurse prescriber] requesting it;

(d) subject to paragraph (5), that the prescription only medicine is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

(e) that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(11) within the time specified in that regulation stating the particulars required under paragraph 1 of Schedule 2 to those Regulations.

(3) 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.

(4) The conditions referred to in paragraph (3) are–

(a) that the pharmacist by or under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting a prescription only medicine and has satisfied himself–

(i) that there is an immediate need for the prescription only medicine requested to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,

(ii) that treatment with the prescription only medicine requested has on a previous occasion been prescribed by a doctor [F23 , district nurse/health visitor prescriber or extended formulary nurse prescriber] for the person requesting it, and

(iii) as to the dose which in the circumstances it would be appropriate for that person to take;

(b) that no greater quantity of the prescription only medicine than will provide 5 days' treatment is sold or supplied except that where the prescription only medicine–

(i) is [F24 a preparation of insulin,] an aerosol for the relief of asthma, an ointment or cream, and has been made up for sale in a container elsewhere than at the place of sale or supply, the smallest pack that the pharmacist has available for sale or supply may be sold or supplied,

(ii) is an oral contraceptive, a quantity sufficient for a full treatment cycle may be sold or supplied,

(iii) is an antibiotic for oral administration in liquid form, the smallest quantity that will provide a full course of treatment may be sold or supplied;

(c) subject to paragraph (5), that the prescription only medicine does not consist of or contain a substance specified in Schedule 4 to this Order and is not a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations;

(d) that an entry is made in the record kept under regulation 6 of the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 within the time specified in that regulation stating the particulars required under paragraph 3 of Schedule 2 to those Regulations;

(e) that the container or package of the prescription only medicine is labelled so as to show–

(i) the date on which the prescription only medicine is sold or supplied,

(ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the prescription only medicine,

(iii) the name of the person requesting the prescription only medicine,

(iv) the name and address of the registered pharmacy from which the prescription only medicine is sold or supplied, and

(v) the words “Emergency Supply”.

(5) 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.

Textual Amendments

F20 Words in art. 8(2)(a) inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 6(a)(i)

F21 Words in art. 8(2)(b) inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 6(a)(ii)

F22 Words in art. 8(2)(c) inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 6(a)(iii)

F23 Words in art. 8(4)(a)(ii) inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 6(b)

F24 Words in art. 8(4)(b)(i) inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 2

Exemption for non-parenteral administration to human beings

9.  The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to the administration to human beings of a prescription only medicine which is not for parenteral administration.

Exemption for medicinal products at high dilutions

10.  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, any of the substances listed in column 1 of Schedule 1 or 2, only one or more unit preparation of such substances, if–

(a) each such unit preparation has been diluted to at least one part in a million (6x), and the person selling, supplying or administering the medicinal product has been requested by or on behalf of a particular person and in that person’s presence to use his own judgment as to the treatment required; or

(b) each such unit preparation has been diluted to at least one part in a million million (6c).

Exemptions for certain persons

11.—(1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply–

(a) to the sale or supply by a person listed in column 1 of Part I of Schedule 5 of the prescription only medicines 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;

(b) to the supply by a person listed in column 1 of Part II of Schedule 5 of the prescription only medicines 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.

(2) 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.

[F25 Exemption for sale or supply in hospitals

12.   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 the written directions of a doctor or dentist relating to that person notwithstanding that those directions do not satisfy the conditions specified in article 15(2).]

Textual Amendments

F25 Art. 12 substituted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(c)

[F26 Exemptions for the supply and administration of prescription only medicines by national health service bodies

12A.— (1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the supply of a prescription only medicine by—

(a) the Common Services Agency;

(b) a [F27 Strategic Health Authority,] Health Authority or Special Health Authority;

(c) an NHS trust;

(d) a Primary Care Trust; or

(e) where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply of prescription only medicines,

where the medicine is supplied for the purpose of being administered to a particular person in accordance with the written directions of a doctor or dentist relating to that person notwithstanding that those directions do not satisfy the conditions specified in article 15(2).

(2) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by—

(a) the Common Services Agency;

(b) a [F28 Strategic Health Authority,] Health Authority or Special Health Authority;

(c) an NHS trust;

(d) a Primary Care Trust; or

(e) where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply or, as the case may be, the administration of prescription only medicines,

where the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction and where the conditions specified in paragraph (3) are satisfied.

(3) The conditions referred to are that—

(a) the Patient Group Direction relates to the supply or, as the case may be, the administration, by the person who supplies or administers the medicine, of a description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

(b) the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

(c) the Patient Group Direction is signed on behalf of the person specified in column 2 of the Table in Part II of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the class of person by whom the medicine is supplied or administered;

(d) the individual who supplies or, as the case may be, administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing, on behalf of the authorising person, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and

(e) at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

(4) In this article, “excepted person” means—

(a) a doctor or dentist; or

(b) a person lawfully conducting a retail pharmacy business within the meaning of section 69.

Textual Amendments

F26 Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)

F27 Words in art. 12A(1)(b) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), reg. 1, Sch. 1 para. 73(2)(a)

F28 Words in art. 12A(2)(b) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), reg. 1, Sch. 1 para. 73(2)(b)

Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist doctors or dentists in providing national health services

12B.— (1) The restrictions imposed by section 58(2) (sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by an individual belonging to one of the classes specified in Part III of Schedule 7 to this Order where—

(a) the individual supplies or, as the case may be, administers the medicine in order to assist a doctor or dentist in the provision of, respectively, NHS primary medical services or NHS primary dental services;

(b) the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, in accordance with a Patient Group Direction; and

(c) the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to are that—

(a) the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine in order to assist the doctor or dentist in question in providing the services referred to in paragraph (1)(a) (whether or not it also relates to such supply or administration in order to assist any other doctor or dentist);

(b) the Patient Group Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

(c) the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

(d) the Patient Group Direction is signed—

(i) by the doctor or dentist in question or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and

(ii) on behalf of the health authority [F29 or Primary Care Trust]—

(a) in the case of the provision of general medical services or general dental services, with which an arrangement has been made for the provision of those services; or

(b) in the case of the performance of personal medical services or personal dental services, which is a party to the pilot scheme under which those services are provided;

(e) the individual referred to in paragraph (1) is designated in writing for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction, by the doctor or dentist in question, or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and

(f) at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.

(3) In this article—

(a) a reference to the provision of NHS primary dental services shall be construed as a reference to—

(i) in relation to England and Wales, the provision of general dental services under Part II of the National Health Service Act 1977, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997;

(ii) in relation to Scotland, the provision of general dental services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and

(iii) in relation to Northern Ireland, the provision of general dental services under the Health and Personal Social Services (Northern Ireland) Order 1972, or the performance of personal dental services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997;

(b) a reference to the provision of NHS primary medical services shall be construed as a reference to—

(i) in relation to England and Wales, the provision of general medical services under Part II of the National Health Service Act 1977, or the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997;

(ii) in relation to Scotland, the provision of general medical services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and

(iii) in relation to Northern Ireland, the provision of general medical services under the Health and Personal Social Services (Northern Ireland) Order 1972, or the performance of personal medical services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997.

Textual Amendments

F26 Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)

F29 Words in art. 12B(2)(d)(ii) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), regs. 1, 8, Sch. 5

Exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction

12C.— (1) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by a person lawfully conducting a retail pharmacy business within the meaning of section 69 where—

(a) the medicine is supplied or, as the case may be, is administered by such a person pursuant to an arrangement made with the Common Services Agency, [F30 a Strategic Health Authority,] a Health Authority, a Special Health Authority, an NHS trust or a Primary Care Trust for the supply or, as the case may be, the administration of prescription only medicines;

(b) the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction; and

(c) the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to are that—

(a) the Patient Group Direction relates to the supply or, as the case may be, the administration of a description or class of prescription only medicine by the person lawfully conducting a retail pharmacy business who supplies or, as the case may be, administers the prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

(b) the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);

(c) the Patient Group Direction is signed on behalf of the body with which an arrangement has been made as referred to in paragraph (1)(a); and

[F31 (cc) where the prescription only medicine is administered by the person lawfully conducting a retail pharmacy business within the meaning of section 69, the individual who administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing, on behalf of the body with which an arrangement has been made as referred to in paragraph (1)(a), for the purpose of the administration of prescription only medicines under the Patient Group Direction; and]

(d) at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.]

Textual Amendments

F26 Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)

F30 Words in art. 12C(1)(a) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), reg. 1, Sch. 1 para. 73(3)

F31 Art. 12C(2)(cc) inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 3(1)

Exemption in cases involving another’s default

13.  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 person who, having exercised all due diligence, believes on reasonable grounds that the product sold or supplied is not a prescription only medicine.

[F32 Exemptions relating to prescriptions given by nurses

13A.— (1) 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 a registered nurse or registered midwife who is not an appropriate practitioner in relation to that medicine where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.

(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 where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the extended formulary nurse prescriber has complied with any condition with which he is required to comply by virtue of article 3A(2) and (3).]

Textual Amendments

F32 Art. 13A inserted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 7

Exemption in the case of a forged prescription

14.  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 forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

Prescriptions

15.—(1) For the purposes of section 58(2)(a) [F33 , and subject to paragraph (2A),] 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.

(2) The conditions referred to in paragraph (1) are that the prescription–

(a) shall be signed in ink with his own name by the appropriate practitioner giving it;

(b) shall, without prejudice to sub-paragraph (a), be written in ink or otherwise so as to be indelible, unless it is a health prescription which is not for a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, in which case it may be written by means of carbon paper or similar material;

(c) shall contain the following particulars–

(i) the address of the appropriate practitioner giving it,

(ii) the appropriate date,

(iii) such particulars as indicate whether the appropriate practitioner giving it is a doctor, a dentist, [F34 a district nurse/health visitor prescriber, an extended formulary nurse prescriber], a veterinary surgeon or a veterinary practitioner,

(iv) where the appropriate practitioner giving it is a doctor, dentist [F35 , a district nurse/health visitor prescriber or an extended formulary nurse prescriber], the name, address and the age, if under 12, of the person for whose treatment it is given, and

(v) where the appropriate practitioner giving it is a veterinary surgeon or a veterinary practitioner, the name and address of the person to whom the prescription only medicine is to be delivered and a declaration by the veterinary surgeon or veterinary practitioner giving it that the prescription only medicine is prescribed for an animal or herd under his care;

(d) shall not be dispensed after the end of the period of 6 months from the appropriate date, unless it is a repeatable prescription in which case it shall not be dispensed for the first time after the end of that period nor otherwise than in accordance with the directions contained in the repeatable prescription;

(e) in the case of a repeatable prescription which does not specify the number of times it may be dispensed, shall not be dispensed on more than two occasions unless it is a prescription for an oral contraceptive in which case it may be dispensed 6 times before the end of the period of 6 months from the appropriate date.

[F36 (2A) For the purposes of paragraph (1), where a prescription is issued and dispensed in England and the conditions specified in paragraph (2C) are fulfilled, the prescription may, as an alternative to fulfilling the conditions specified in paragraph (2)(a) and (b), fulfil instead the conditions specified in paragraph (2B).

(2B) The conditions referred to are that the prescription shall be—

(a) created in an electronic form and signed with an 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); or

(b) entered on a document where—

(i) the prescription is created electronically and signed with an electronic signature and both the data and the signature are entered on the document in a non-legible manner;

(ii) the prescription is created in writing on the document, as referred to in paragraph (2)(b), and is signed with an electronic signature which is entered on the document in a non-legible manner; or

(iii) the prescription is created in an electronic form which is entered on the document in a non-legible manner, and is signed as referred to in paragraph (2)(a),

and transferred to the person by whom it is dispensed by physical means.

(2C) The conditions referred to are that—

(a) the prescription is issued by a doctor—

(i) under or by virtue of the National Health Service Act 1997; or

(ii) as part of the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1977,

and dispensed by a person lawfully conducting a retail pharmacy business within the meaning of section 69; and

(b) the Secretary of State is satisfied that—

(i) the use of electronic means in order to create, sign and transfer prescriptions (or whichever of those purposes is applicable) is appropriate for the purposes of a pilot scheme on the use of electronic prescribing, in relation to both the doctor and the person lawfully conducting a retail pharmacy business concerned, and in relation to the premises at which the prescription is dispensed; and

(ii) the particular electronic means used by both the doctor and the person lawfully conducting a retail pharmacy business concerned are suitable for the purposes of such a pilot scheme.]

(3) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to a sale or supply of a prescription only medicine which is not in accordance with a prescription given by an appropriate practitioner by reason only that a condition specified in paragraph (2) [F37 or, where applicable, paragraph (2B)] is not satisfied where the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that that condition is satisfied in relation to that sale or supply.

(4) In paragraph (2) “the appropriate date” means–

(a) in the case of a health prescription, the date on which it was signed by the appropriate practitioner giving it or a date indicated by him as being the date before which it shall not be dispensed; and

(b) in every other case, the date on which the prescription was signed by the appropriate practitioner giving it;

and, for the purposes of sub-paragraphs (d) and (e) of that paragraph, where a health prescription bears both the date on which it was signed and a date indicated as being that before which it shall not be dispensed, the appropriate date is the later of those dates.

[F38 (5) In paragraphs (2B) and (2C)—

• “doctor” has the same meaning as in section 132(1);

• “electronic communication” has the same meaning as in section 15 of the Electronic Communications Act 2000;

• “electronic signature” has the same meaning as in section 7 of the Electronic Communications Act 2000.]

Textual Amendments

F33 Words in art. 15(1) inserted (E.W.S.) (11.9.2001) by The Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 (S.I. 2001/2889), arts. 1, 2(a)

F34 Words in art. 15(2)(c)(iii) substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 8(a)

F35 Words in art. 15(2)(c)(iv) substituted (1.4.2002) by The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 8(b)

F36 Art. 15(2A)-(2C) inserted (E.W.S.) (11.9.2001) by The Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 (S.I. 2001/2889), arts. 1, 2(b)

F37 Words in art. 15(3) inserted (E.W.S.) (11.9.2001) by The Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 (S.I. 2001/2889), arts. 1, 2(c)

F38 Art. 15(5) added (E.W.S.) (11.9.2001) by The Prescription Only Medicines (Human Use) (Electronic Communications) Order 2001 (S.I. 2001/2889), arts. 1, 2(d)

Revocations

16.—(1) The Orders specified in Schedule 6 are revoked.

(2) In the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989(12) articles 2 to 6 and Schedules 1 and 2 are revoked.

Signed by authority of the Secretary of State for Health

Baroness Jay

Minister of State,

Department of Health

Win Griffiths

Parliamentary Under Secretary of State, Welsh Office

Sam Galbraith

Parliamentary Under Secretary of State, The Scottish Office

Jeff Rooker

Minister of State, Ministry of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 22nd July 1997.

D. C. Gowdy

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th July 1997.

P. Small

Permanent Secretary