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  • reg. 19(1)(c) inserted by S.I. 2006/1450 reg. 7(1) (This amendment not applied to legislation.gov.uk. The commencement date of regs. 7(1), 10 was changed to 1.1.2008 by S.I. 2006/2178, regs. 1(1), 7 and then regs. 7(1), 10 were omitted on 16.8.2007 before they came into force by virtue of S.I. 2007/2154, regs. 2(1), 5(3))

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Citation and commencementU.K.

1.  These Regulations may be cited as the Misuse of Drugs Regulations 2001 and shall come into force on 1st February 2002.

InterpretationU.K.

2.—(1) In these Regulations, unless the context otherwise requires—

  • “the Act” means the Misuse of Drugs Act 1971;

  • [F1“accountable officer” has the same meaning as in the Health Act 2006;]

  • “authorised as a member of a group” means authorised by virtue of being a member of a class as respects which the Secretary of State has granted an authority under and for the purposes of regulation 8(3), 9(3) or 10(3) which is in force, and “his group authority”, in relation to a person who is a member of such a class, means the authority so granted to that class;

  • [F2“cannabis-based product for medicinal use in humans” means a preparation or other product, other than one to which paragraph 5 of part 1 of [F3Schedule 4, or paragraph 10 of Schedule 5, applies], which—

    (a)

    is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers);

    (b)

    is produced for medicinal use in humans; and—

    (c)

    is—

    (i)

    a medicinal product, or

    (ii)

    a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product;]

  • [F4“care home” in relation to—

    (a)

    England and Wales has the same meaning as in the Care Standards Act 2000; and

    (b)

    Scotland means the accommodation provided by a care home service;]

  • [F5“care home service” has the same meaning as in the Public Services Reform (Scotland) Act 2010;]

  • [F6“clinical management plan” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F2“clinical trial” has the same meaning as in the Medicines for Human Use (Clinical Trials) Regulations 2004;]

  • [F8“the Common Services Agency for the health service” means the body established under section 10 of the National Health Service (Scotland) Act 1978;]

  • “document” [F9means anything in which information of any description is recorded (within the meaning of the Civil Evidence Act 1995];

  • [F2“dronabinol” does not include any substance which—

    (a)

    has the international non-proprietary name dronabinol (recommended by the World Health Organisation); and

    (b)

    is derived from cannabis, cannabis resin or their constituents,

    and stereoisomers of dronabinol are to be construed accordingly;]

  • [F10“equivalent body” means a Local Health Board in Wales, a Health Board in Scotland or the Northern Ireland Central Services Agency for the Health and Social Services in Northern Ireland;]

  • “exempt product” means a preparation or other product consisting of one or more component parts, any of which contains a controlled drug, where—

    (a)

    the preparation or other product is not designed for administration of the controlled drug to a human being or animal;

    (b)

    the controlled drug in any component part is packaged in such a form, or in combination with other active or inert substances in such a manner, that it cannot be recovered by readily applicable means or in a yield which constitutes a risk to health; and

    (c)

    no one component part of the product or preparation contains more than one milligram of the controlled drug or one microgram in the case of lysergide or any otherN-alkyl derivative of lysergamide;

  • [F11“Health Board” means a board constituted under section 2 of the National Health Service (Scotland) Act 1978;]

  • F12...

  • “health prescription” means a prescription issued by [F13a doctor, a dentist, a nurse independent prescriber, a pharmacist independent prescriber [F14, a podiatrist independent prescriber, a physiotherapist independent prescriber, a paramedic independent prescriber, a therapeutic radiographer independent prescriber] or a supplementary prescriber] under the National Health Service Act 1977 M1, the National Health Service (Scotland) Act 1978 M2, the Health and Personal Social Services (Northern Ireland) Order 1972 M3 or the National Health Service (Isle of Man) Acts 1948 to 1979 (Acts of Tynwald) or upon a form issued by a local authority for use in connection with the health service of that authority;

  • [F15“health service” means—

    (a)

    in England, the health service as defined by section 275(1) of the National Health Service Act 2006;

    (b)

    in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978; and

    (c)

    in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 2006;]

  • “installation manager” and “offshore installation” have the same meanings as in the Mineral Workings (Offshore Installations) Act 1971 M4;

  • [F16“Local Health Board” means a Local Health Board established in accordance with section 16BA of the National Health Service Act 1977;]

  • “master” and “seamen” have the same meanings as in the Merchant Shipping Act 1995 M5;

  • F17...

  • [F18“medical purposes” means the purposes of preventative medicine, medical diagnosis, medical research or the provision of medical care and treatment;]

  • [F2“medicinal product” has the same meaning as in the Human Medicines Regulations 2012;]

  • [F19“NHS Business Services Authority” means the special health authority established under Article 2 of the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) (Establishment and Constitution) Order 2005;]

  • [F18“nitrous oxide” includes any preparation or other product containing nitrous oxide;]

  • [F19“the Northern Ireland Central Services Agency for the Health and Social Services” means the body established under Article 26 of the Health and Personal Social Services (Northern Ireland) Order 1972;]

  • [F20“nurse independent prescriber” has the same meaning as in [F7the Human Medicines Regulations 2012], and such a person may only prescribe controlled drugs in accordance with regulation 6B;]

  • “officer of customs and excise” means an officer within the meaning of the Customs and Excise Management Act 1979 M6;

  • [F21“operating department practitioner” means a person who is registered under the [F22Health Professions Order 2001] as an operating department practitioner;]

  • [F23“organisation providing ambulance services” means one of the following health service organisations—

    (a)

    an NHS trust or NHS foundation trust established under the National Health Service Act 2006 which has a function of providing ambulance services;

    (b)

    an NHS trust established under the National Health Service (Wales) Act 2006 which has a function of providing ambulance services;

    (c)

    the Scottish Ambulance Board;]

  • [F24“paramedic independent prescriber” has the same meaning as in the Human Medicines Regulations 2012;]

  • [F25“patient group direction” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F26“pharmacist” has the same meaning as in [F27the Human Medicines Regulations 2012];]

  • [F28“pharmacist independent prescriber” has the same meaning as in [F7the Human Medicines Regulations 2012], and such a person may only prescribe controlled drugs in accordance with regulation 6B;]

  • [F29“physiotherapist independent prescriber” has the same meaning as in the Human Medicines Regulations 2012;

  • “podiatrist independent prescriber” has the same meaning as in the Human Medicines Regulations 2012”;]

  • [F26“prescriber identification number” means the number recorded against a person’s name by the relevant National Health Service agency for the purposes of that person’s private prescribing;]

  • “prescription” means a prescription issued by a doctor for the medical treatment of a single individual, [F30by [F31a nurse independent prescriber] for the medical treatment of a single individual,] [F32by a pharmacist independent prescriber for the medical treatment of a single individual,] [F33a podiatrist independent prescriber for the medical treatment of a single individual, a physiotherapist independent prescriber for the medical treatment of a single individual, a paramedic independent prescriber for the medical treatment of a single individual, a therapeutic radiographer independent prescriber for the medical treatment of a single individual,] [F34by a supplementary prescriber for the medical treatment of a single individual,] by a dentist for the dental treatment of a single individual or by a veterinary surgeon or veterinary practitioner for the purposes of animal treatment;

  • [F35“prison” has the same meaning as in [F36section 49(3) of the Investigatory Powers Act 2016];]

  • F37...

  • [F38“private prescribing” means issuing prescriptions other than health prescriptions [F39or veterinary prescriptions;]]

  • [F38“professional registration number” means the number recorded against a person’s name in the register of any body that licenses or regulates any profession of which that person is a member;]

  • [F40“professional register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001;]

  • [F41“register” means either a bound book, which does not include any form of loose leaf register or card index, or a computerised system which is in accordance with best practice guidance endorsed by the Secretary of State under section 2 of the National Health Service Act 1977;]

  • [F42“registered chiropodist” has the same meaning as in [F7the Human Medicines Regulations 2012] [F43(but see regulation 8(8A) of these Regulations)];]

  • [F44“registered midwife” has the same meaning as in [F7the Human Medicines Regulations 2012];

  • “registered nurse” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F45“registered occupational therapist” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F46“registered optometrist” has the same meaning as in [F7the Human Medicines Regulations 2012];

  • “registered orthoptist” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F47“registered orthotist and prosthetist” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F48“registered paramedic” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • “registered pharmacy” has the same meaning as in [F27the Human Medicines Regulations 2012];

  • [F49registered physiotherapist” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F50“registered podiatrist” has the same meaning as in the Human Medicines Regulations 2012 (but see regulation 8(8A) of these Regulations);]

  • [F49“registered radiographer” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F51“relevant National Health Service agency” means, for England and Wales, the NHS Business Services Authority; for Scotland, the Common Services Agency for the health service; and for Northern Ireland, the Northern Ireland Central Services Agency for the Health and Social Services;]

  • “retail dealer” means a person lawfully conducting a retail pharmacy business or a pharmacist engaged in supplying drugs to the public at a health centre within the meaning of the Medicines Act 1968;

  • F52...

  • [F53“specialist community public health nurse” means a registered nurse or midwife who is also registered in the Specialist Community Public Health Nurses' Part of the professional register and against whose name in that Part of the register there is an annotation that she has a qualification in health visiting;]

  • F52...

  • F52...

  • [F54“supplementary prescriber” has the same meaning as in [F7the Human Medicines Regulations 2012];]

  • [F55“therapeutic radiographer independent prescriber” has the same meaning as in the Human Medicines Regulations 2012;]

  • [F56“veterinary prescription” means a prescription issued by a veterinary surgeon or veterinary practitioner for the purposes of animal treatment;]

  • “wholesale dealer” means a person who carries on the business of selling drugs to persons who buy to sell again.

(2) In these Regulations any reference to a regulation or schedule shall be construed as a reference to a regulation contained in these Regulations or, as the case may be, to a schedule to these Regulations, and any reference in a regulation or schedule to a paragraph shall be construed as a reference to a paragraph of that regulation or schedule.

(3) Nothing in these Regulations shall be construed as derogating from any power or immunity of the Crown, its servants or agents.

Textual Amendments

Marginal Citations

Specification of controlled drugs for purposes of RegulationsU.K.

3.  Schedules 1 to 5 shall have effect for the purpose of specifying the controlled drugs to which certain provisions of these Regulations apply.

Exceptions for drugs in Schedules 4 and 5 and poppy-strawU.K.

4.—(1) Section 3(1) of the Act (which prohibits the importation and exportation of controlled drugs) shall not have effect in relation to the drugs specified in Schedule 5 [F57except nitrous oxide].

(2) The application of section 3(1) of the Act, in so far as it creates an offence, and the application of sections 50(1) to (4), 68(2) and (3) or 170 of the Customs and Excise Management Act 1979, in so far as they apply in relation to a prohibition or restriction on importation or exportation having effect by virtue of section 3 of the Act, are hereby excluded in the case of importation or exportation [F58which is carried out in person for administration to that person of any drug specified in Part II of Schedule 4].

(3) Section 5(1) of the Act (which prohibits the possession of controlled drugs) shall not have effect in relation to—

(a)any drug specified in Part II of Schedule 4 F59...;

(b)the drugs specified in Schedule 5 [F60except nitrous oxide].

(4) Sections 4(1) (which prohibits the production and supply of controlled drugs) and 5(1) of the Act shall not have effect in relation to poppy-straw.

(5) Sections 3(1), 4(1) and 5(1) of the Act shall not have effect in relation to any exempt product.

Textual Amendments

[F61Exceptions for drugs in Schedule 1U.K.

4A.—(1) Section 5(1) of the Act (which prohibits the possession of controlled drugs) shall not have effect in relation to a fungus (of any kind) which contains psilocin or an ester of psilocin where that fungus—

(a)is growing uncultivated;

(b)is picked by a person already in lawful possession of it for the purpose of delivering it as soon as is reasonably practicable into the custody of a person lawfully entitled to take custody of it and it remains in that person’s possession for and in accordance with that purpose;

(c)is picked for either of the purposes specified in paragraph (2) and is held for and in accordance with the purpose specified in paragraph (2)(b), either by the person who picked it or by another person; or

(d)is picked for the purpose specified in paragraph (2)(b) and is held for and in accordance with the purpose in paragraph (2)(a), either by the person who picked it or by another person.

(2) The purposes specified for the purposes of this paragraph are—

(a)the purpose of delivering the fungus as soon as is reasonably practicable into the custody of a person lawfully entitled to take custody of it; and

(b)the purpose of destroying the fungus as soon as is reasonably practicable.]

Textual Amendments

[F62Exceptions for gamma–butyrolactone and 1,4–butanediolU.K.

4B—(1) Gamma–butyrolactone and 1,4–butanediol are excepted from sections 3(1) (import and export), 4(1) (production and supply) and 5(1) (possession) of the Act save where a person imports, exports, produces, supplies or offers to supply either substance, or has either substance in his possession, knowing or believing that it will be used for the purpose of human ingestion whether by himself or another person other than as a flavouring in food.

(2) In this regulation references to gamma–butyrolactone include—

(a)any salt of gamma–butyrolactone; and

(b)any preparation or other product containing gamma–butyrolactone or a substance specified in sub–paragraph (a) of this paragraph.

(3) In this regulation references to 1,4-butanediol include—

(a)any substance which is an ester or ether or both an ester and ether of 1,4‑butanediol;

(b)any salt of 1,4–butanediol or of a substance specified in sub–paragraph (a) of this paragraph; and

(c)any preparation or other product containing 1,4–butanediol or a substance specified in sub–paragraph (a) or (b) of this paragraph.]

Textual Amendments

[F63Exemptions for nitrous oxide U.K.

4C.—(1) The application of section 3(1) (which prohibits the importation and exportation of controlled drugs) of the Act, in so far as it creates an offence, and the application of sections 50(1) to (4), 68(2) and (3) or 170 of the Customs and Excise Management Act 1979, in so far as they apply in relation to a prohibition or restriction on importation or exportation having effect by virtue of section 3 of the Act, are hereby excluded in the cases of importation or exportation of nitrous oxide except where a person imports or exports the substance and—

(a)intends to wrongfully inhale it; or

(b)knows, or is reckless as to whether, it is likely to be wrongfully inhaled by some other person.

(2) Notwithstanding the provisions of section 4(1)(a) (which prohibits the production of controlled drugs) of the Act, any person may produce nitrous oxide except where the person—

(a)intends to wrongfully inhale it; or

(b)knows, or is reckless as to whether, it is likely to be wrongfully inhaled by some other person.

(3) Notwithstanding the provisions of section 4(1)(b) (which prohibits the supply of controlled drugs) of the Act any person may—

(a)supply, including by way of administration, nitrous oxide, except where the person knows, or is reckless as to whether, it is likely to be wrongfully inhaled by a person; or

(b)offer to supply nitrous oxide, except where the person knows, or is reckless as to whether, if the substance were supplied in accordance with the offer, it would be likely to be wrongfully inhaled by any person.

(4) Notwithstanding the provisions of section 5(1) (which prohibits the possession of controlled drugs) of the Act any person may possess nitrous oxide except where the person—

(a)intends to wrongfully inhale it; or

(b)intends to supply it to another person for its wrongful inhalation by any person.

(5) In this regulation references to wrongful inhalation mean any inhalation other than—

(a)for medical or dental purposes; or

(b)of nitrous oxide which has been released into the atmosphere.]

Textual Amendments

Licences to produce etc. controlled drugsU.K.

5.  Where any person is authorised by a licence of the Secretary of State issued under this regulation and for the time being in force to produce, supply, offer to supply or have in his possession any controlled drug, it shall not by virtue of section 4(1) or 5(1) of the Act be unlawful for that person to produce, supply, offer to supply or have in his possession that drug in accordance with the terms of the licence and in compliance with any conditions attached to the licence.

General authority to supply and possessU.K.

6.—(1) Notwithstanding the provisions of section 4(1)(b) of the Act, any person who is lawfully in possession of a controlled drug may supply that drug to the person from whom he obtained it.

(2) Notwithstanding the provisions of section 4(1)(b) of the Act, any person who has in his possession a drug specified in Schedule 2, 3, 4 or 5 which has been supplied by or on the prescription of a practitioner [F64, F65... a registered nurse, [F66a pharmacist independent prescriber,] [F67a physiotherapist independent prescriber, a chiropodist independent prescriber,] [F68a supplementary prescriber] [F69, a paramedic independent prescriber, a therapeutic radiographer independent prescriber] or a person specified in Schedule 8] [F70acting in accordance with a patient group direction] for the treatment of that person, or of a person whom he represents, may supply that drug to any doctor, dentist or pharmacist for the purpose of destruction.

[F71(2A) Notwithstanding the provisions of section 4(1)(b) of the Act, a person who is in possession of a drug specified in Schedule 5 and who has been supplied that drug by a registered chiropodist or registered podiatrist, may supply that drug to any doctor, dentist or pharmacist for the purpose of destruction.]

(3) Notwithstanding the provisions of section 4(1)(b) of the Act, any person who is lawfully in possession of a drug specified in Schedule 2, 3, 4 or 5 which has been supplied by or on the prescription of a veterinary practitioner or veterinary surgeon for the treatment of animals may supply that drug to any veterinary practitioner, veterinary surgeon or pharmacist for the purpose of destruction.

(4) It shall not by virtue of section 4(1)(b) or 5(1) of the Act be unlawful for any person in respect of whom a licence has been granted and is in force under section 16(1) of the Wildlife and Countryside Act 1981 M7 to supply, offer to supply or have in his possession any drug specified in Schedule 2 or 3 for the purposes for which that licence was granted.

(5) Notwithstanding the provisions of section 4(1)(b) of the Act, any of the persons specified in paragraph (7) may supply any controlled drug to any person who may lawfully have that drug in his possession.

(6) Notwithstanding the provisions of section 5(1) of the Act, any of the persons so specified may have any controlled drug in his possession.

(7) The persons referred to in paragraphs (5) and (6) are

(a)a constable when acting in the course of his duty as such;

(b)a person engaged in the business of a carrier when acting in the course of that business;

(c)a person engaged in the business of [F72a postal operator (within the meaning of [F73Part 3 of the Postal Services Act 2011])] when acting in the course of that business;

(d)an officer of customs and excise when acting in the course of his duty as such;

(e)a person engaged in the work of any laboratory to which the drug has been sent for forensic examination when acting in the course of his duty as a person so engaged;

(f)a person engaged in conveying the drug to a person who may lawfully have that drug in his possession.

[F74(8) Notwithstanding the provisions of section 4(1)(b) of the Act, a person lawfully conducting a retail pharmacy business may supply or offer to supply medicines containing phenobarbital or phenobarbital sodium provided that the medicine is supplied (or in the case of an offer to supply would be supplied) in accordance with conditions A to E of regulation 224 or 225 of the Human Medicines Regulations 2012.]

Textual Amendments

Marginal Citations

[F75Supply of articles for administering or preparing controlled drugsU.K.

6A.—(1) Notwithstanding the provisions of section 9A(1) and (3) of the Act, any of the persons specified in paragraph (2) may, when acting in their capacity as such, supply or offer to supply the following articles—

(a)a swab;

(b)utensils for the preparation of a controlled drug;

(c)citric acid;

(d)a filter;

(e)ampoules of water for injection, only when supplied or offered for supply in accordance with the Medicines Act 1968 and of any instrument which is in force thereunder

[F76(f)ascorbic acid].

(2) The persons referred to in paragraph (1) are—

(a)a practitioner;

(b)a pharmacist;

(c)a person employed or engaged in the lawful provision of drug treatment services

[F77(d)a supplementary prescriber acting under and in accordance with the terms of a clinical management plan] [F78; and

(e)a nurse independent prescriber].

[F79(3) Despite the provisions of section 9A(1) and (3) of the Act, a person employed or engaged in the lawful provision of drug treatment services may, when acting in that capacity, supply or offer to supply aluminium foil in the context of structured steps—

(a)to engage a patient in a drug treatment plan, or

(b)which form part of a patient’s drug treatment plan.

(4) In this regulation “drug treatment plan” means a written plan, relating to the treatment of an individual patient, and agreed by the patient and the person employed in the lawful provision of drug treatment services.]]

Textual Amendments

[F80Authority for Nurse Independent Prescribers and Pharmacist Independent Prescribers to prescribeU.K.

6B.—(1) Subject to paragraph (2) of this regulation, a nurse independent prescriber or a pharmacist independent prescriber may prescribe any controlled drug specified in Schedule 2, 3, 4 or 5.

(2) Neither a nurse independent prescriber nor a pharmacist independent prescriber may prescribe any of the following substances to a person he considers, or has reasonable grounds to suspect, is addicted to any controlled drug listed in the Schedule to the Misuse of Drugs (Supply to Addicts) Regulations 1997 save for the purpose of treating organic disease or injury:

(a)cocaine, any salt of cocaine, and any preparation or other product containing cocaine or any salt of cocaine;

(b)diamorphine, any salt of diamorphine, and any preparation or other product containing diamorphine or any salt of diamorphine;

(c)dipipanone, any salt of dipipanone, and any preparation or other product containing dipipanone or any salt of dipipanone.

(3) For the purposes of paragraph (2) a person is addicted to a controlled drug if, and only if, he has as a result of repeated administration become so dependent upon that controlled drug that he has an overpowering desire for the administration of it to be continued.]

Textual Amendments

[F81Authority for Physiotherapist Independent Prescribers and Chiropodist Independent Prescribers to prescribeU.K.

6C.—(1) A registered physiotherapist independent prescriber may prescribe any of the following controlled drugs for the treatment of organic disease or injury provided that the controlled drug is prescribed to be administered by the specified method—

(a)Diazepam by oral administration

(b)Dihydrocodeine by oral administration

(c)Fentanyl by transdermal administration

(d)Lorazepam by oral administration

(e)Morphine by oral administration or by injection

(f)Oxycodone by oral administration

(g)Temazepam by oral administration.

(2) A registered chiropodist independent prescriber may prescribe any of the following controlled drugs for the treatment of organic disease or injury provided that the controlled drug is prescribed to be administered by the specified method—

(a)Diazepam by oral administration

(b)Dihydrocodeine by oral administration

(c)Lorazepam by oral administration

(d)Temazepam by oral administration.]

Textual Amendments

[F82Authority for therapeutic radiographer independent prescribers and paramedic independent prescribers to prescribeU.K.

6D.—(1) A therapeutic radiographer independent prescriber may prescribe any of the following controlled drugs for the treatment of organic disease or injury provided that the controlled drug is prescribed to be administered by the specified method—

(a)Tramadol by oral administration;

(b)Lorazepam by oral administration;

(c)Diazepam by oral administration;

(d)Morphine by oral administration or by injection;

(e)Oxycodone by oral administration;

(f)Codeine by oral administration.

(2) A paramedic independent prescriber may prescribe any of the following controlled drugs for the treatment of organic disease or injury provided the controlled drug is prescribed to be administered by the specified method—

(a)Morphine sulphate by oral administration or by injection;

(b)Diazepam by oral administration or by injection;

(c)Midazolam by oromucosal administration or by injection;

(d)Lorazepam by injection;

(e)Codeine phosphate by oral administration.]

Textual Amendments

Administration of drugs in Schedules 2, 3, 4 and 5U.K.

7.—(1) Any person may administer to another any drug specified in Schedule 5 [F83except nitrous oxide].

(2) A doctor or dentist may administer to a patient any drug specified in Schedule 2, 3 or 4.

(3) Any person other than a doctor or dentist may administer to a patient, in accordance with the directions of a doctor or dentist, any drug specified in Schedule 2, 3 or 4 [F84, and for these purposes the circumstances in which a person is to be regarded as administering in accordance with the directions of a doctor or dentist include where that person is acting in accordance with a patient group direction].

[F85(4) Notwithstanding the provisions of paragraph (3), a nurse independent prescriber or a pharmacist independent prescriber may administer to a patient, without the directions of a doctor or dentist, any controlled drug which such nurse independent prescriber or such pharmacist independent prescriber respectively may prescribe under regulation 6B provided it is administered for a purpose for which it may be prescribed under that regulation.]

[F86(5) Notwithstanding the provisions of paragraph (3), any person may administer to a patient in accordance with the specific directions of a nurse independent prescriber or a pharmacist independent prescriber any controlled drug which such nurse independent prescriber or such pharmacist independent prescriber respectively may prescribe under regulation 6B provided it is administered for a purpose for which it may be prescribed under that regulation.]

[F87(6) Notwithstanding the provisions of paragraph (3), a supplementary prescriber acting under and in accordance with the terms of a clinical management plan may administer to a patient, without the directions of a doctor or dentist, any drug specified in Schedule 2, 3 or 4.

(7) Notwithstanding the provisions of paragraph (3), any person may administer to a patient, in accordance with the directions of a supplementary prescriber acting under and in accordance with the terms of a clinical management plan, any drug specified in Schedule 2, 3 or 4.]

[F88(8) Notwithstanding the provisions of paragraph (3), a registered physiotherapist independent prescriber or registered chiropodist independent prescriber may administer to a patient without the directions of a doctor or a dentist, any controlled drug which such registered physiotherapist independent prescriber or registered chiropodist independent prescriber respectively may prescribe under regulation 6C provided it is administered for a purpose for which it may be prescribed under that regulation and by the method by which it was prescribed to be administered.

(9) Notwithstanding the provisions of paragraph (3), any person may administer to a patient, in accordance with the specific instructions of a registered physiotherapist independent prescriber or registered chiropodist independent prescriber, any controlled drug which such registered physiotherapist independent prescriber or registered chiropodist independent prescriber may prescribe under regulation 6C, provided it is administered for a purpose for which it may be prescribed under that regulation and by the method by which it was prescribed to be administered.]

[F89(10) Notwithstanding the provisions of paragraph (3), a paramedic independent prescriber or a therapeutic radiographer independent prescriber may administer to a patient without the directions of a doctor or a dentist, any controlled drug which such paramedic independent prescriber or such therapeutic radiographer independent prescriber may prescribe under regulation 6D provided it is administered for a purpose for which it may be prescribed under that regulation and by the method by which it was prescribed to be administered.

(11) Notwithstanding the provisions of paragraph (3), any person may administer to a patient in accordance with the specific instructions of a paramedic independent prescriber or a therapeutic radiographer independent prescriber, any controlled drug which such paramedic independent prescriber or such therapeutic radiographer independent prescriber may prescribe under regulation 6D, provided it is administered for a purpose for which it may be prescribed under that regulation and by the method by which it was prescribed to be administered.]

Textual Amendments

Production and supply of drugs in Schedules 2 and 5U.K.

8.—(1) Notwithstanding the provisions of section 4(1)(a) of the Act—

(a)a practitioner or pharmacist, acting in his capacity as such, may manufacture or compound any drug specified in Schedule 2 or 5;

(b)a person lawfully conducting a retail pharmacy business and acting in his capacity as such may, at the registered pharmacy at which he carries on that business, manufacture or compound any drug specified in Schedule 2 or 5;

[F90(c)a nurse independent prescriber acting in her capacity as such, or a supplementary prescriber acting under and in accordance with the terms of a clinical management plan, may compound any drug specified in Schedule 2 or 5 for the purposes of administration in accordance with regulation 7;

(d)any person acting in accordance with the written directions of a doctor, a dentist, a nurse independent prescriber, a pharmacist independent prescriber, [F91paramedic independent prescriber, therapeutic radiographer independent prescriber] or a supplementary prescriber acting under and in accordance with the terms of a clinical management plan, may compound any drug specified in Schedule 2 or 5 for the purposes of administration in accordance with regulation 7]

(2) Notwithstanding the provisions of section 4(1)(b) of the Act, any of the following persons, that is to say—

(a)a practitioner;

(b)a pharmacist;

(c)a person lawfully conducting a retail pharmacy business;

(d)the person in charge or acting person in charge of a hospital or [F92care home] which is wholly or mainly maintained by a public authority out of public funds or by a charity or by voluntary subscriptions;

[F93(da)the person in charge or acting person in charge of an organisation providing ambulance services;]

[F94(e)in the case of such a drug supplied to her by a person responsible for the dispensing and supply of medicines at a hospital, care home or prison, the senior registered nurse, acting senior registered nurse, or registered midwife, for the time being in charge of a ward, theatre or other department in the hospital, care home or prison.]

[F95(ea)in the case of such a drug supplied to him by a person responsible for the dispensing and supply of medicines at a hospital, an operating department practitioner practising in that hospital;]

(f)a person who is in charge of a laboratory the recognised activities of which consist in, or include, the conduct of scientific education or research and which is attached to a university, university college or such a hospital as aforesaid or to any other institution approved for the purpose under this sub-paragraph by the Secretary of State;

(g)a public analyst appointed under section 27 of the Food Safety Act 1990 M8;

(h)a sampling officer within the meaning of Schedule 3 to the Medicines Act 1968;

(i)a person employed or engaged in connection with a scheme for testing the quality or amount of the drugs, preparations and appliances supplied under the National Health Service Act 1977 or the National Health Service (Scotland) Act 1978 and the regulations made thereunder;

(j)[F96a person authorised by the General Pharmaceutical Council] for the purposes of section 108 or 109 of the Medicines Act 1968,

[F97(k)a supplementary prescriber acting under and in accordance with the terms of a clinical management plan,]

may, when acting in his capacity as such, supply or offer to supply any drug specified in Schedule 2 or 5 to any person who may lawfully have that drug in his possession, except that nothing in this paragraph authorises—

(i)the person in charge or acting person in charge of [F98a hospital, organisation providing ambulance services] or [F92care home], having a pharmacist responsible for the dispensing and supply of medicines, to supply or offer to supply any drug; F99...

(ii)a [F100senior registered nurse, acting senior registered nurse or registered midwife] for the time being in charge of a ward, theatre or other department to supply any drug otherwise than for administration to a patient in that ward, theatre or department in accordance with the directions of a [F101doctor, dentist, supplementary prescriber acting under and in accordance with the terms of a clinical management plan or, subject to paragraph (2A), a nurse independent prescriber [F102or a pharmacist independent prescriber]; or]

[F103(iii)an operating department practitioner to supply any drug otherwise than for administration to a patient in a ward, theatre or other department in accordance with the directions of a doctor, dentist, supplementary prescriber acting under and in accordance with the terms of a clinical management plan or, subject to paragraph (2A), a nurse independent prescriber [F104or a pharmacist independent prescriber].]

[F105(iv)the person in charge or acting person in charge of an organisation providing ambulance services to supply any drugs other than directly to employees of the organisation for the immediate treatment of sick or injured persons.]

[F106(2A) The directions given by a nurse independent prescriber or a pharmacist independent prescriber referred to in paragraph (2)(k)(ii) and (iii) shall relate only to a controlled drug which such nurse independent prescriber or such pharmacist independent prescriber respectively may prescribe under regulation 6B and a purpose for which it may be prescribed under that regulation.]

(3) Notwithstanding the provisions of section 4(1)(b) of the Act, a person who is authorised as a member of a group may, under and in accordance with the terms of his group authority and in compliance with any conditions attached thereto, supply or offer to supply any drug specified in Schedule 2 or 5 to any person who may lawfully have that drug in his possession.

(4) Notwithstanding the provisions of section 4(1)(b) of the Act, a person who is authorised by a written authority issued by the Secretary of State under and for the purposes of this paragraph and for the time being in force may, at the premises specified in that authority and in compliance with any conditions so specified, supply or offer to supply any drug specified in Schedule 5 to any person who may lawfully have that drug in his possession.

(5) Notwithstanding the provisions of section 4(1)(b) of the Act—

(a)the owner of a ship, or the master of a ship which does not carry a doctor among the seamen employed in it; or

(b)the installation manager of an offshore installation,

may supply or offer to supply any drug specified in Schedule 2 or 5—

(i)for the purpose of compliance with any of the provisions specified in paragraph (6), to any person on that ship or installation;

(ii)to any person who may lawfully supply that drug to him;

(iii)to any constable for the purpose of the destruction of that drug.

(6) The provisions referred to in paragraph (5) are any provision of, or of any instrument which is in force under—

(a)the Mineral Workings (Offshore Installations) Act 1971;

(b)the Health and Safety at Work etc. Act 1974 M9 or

(c)the Merchant Shipping Act 1995.

[F107[F108(7) Notwithstanding the provisions of section 4(1)(b) of the Act, a nurse independent prescriber may, when acting in her capacity as such, supply or offer to supply any controlled drug specified in Schedule 2 or 5 to any person who may lawfully have any of those drugs in his possession provided it is supplied or offered in circumstances where she may prescribe it under regulation 6B.]

[F109(7A) Notwithstanding the provisions of section 4(1)(b) of the Act, a paramedic independent prescriber or a therapeutic radiographer independent prescriber may, when acting in their capacity as such, supply or offer to supply any controlled drug specified in Schedule 2 or 5 to any person who may lawfully have any of those drugs in their possession provided it is supplied or offered in circumstances where they may prescribe it under regulation 6D.]

(8) Notwithstanding the provisions of section 4(1)(b) of the Act—

(a)a registered nurse [F110or a pharmacist], when acting in her capacity as such, may supply or offer to supply, under and in accordance with the terms of a patient group direction, diamorphine [F111or morphine where administration of such drugs is required for the immediate, necessary treatment of sick or injured persons];

[F112(b)a registered nurse or a person specified in Schedule 8 may, when acting in their capacity as such, supply or offer to supply, under and in accordance with the terms of a patient group direction, any drug specified in Schedule 5 or ketamine to any person who may lawfully have that drug in his possession, except that this paragraph shall not have effect in the case of ketamine or any preparation of ketamine which is designed for administration by injection and which is to be used for the purpose of treating a person who is addicted to a drug;]]

[F113(c)Notwithstanding the provisions of section 4(1)(b) of the Act, a specified registered chiropodist or specified registered podiatrist may, when acting in such capacity, supply or offer to supply the following controlled drugs—

(i)co-codamol 8/500, 15/500 and 30/500,

(ii)co-dydramol 10/500, and

(iii)codeine phosphate.]

[F114(8A) In paragraph (8)(c) “specified registered chiropodist” and “specified registered podiatrist” mean the registered chiropodists and registered podiatrists specified in paragraph 11 of Part 1 and paragraph 2 of Part 4 of Schedule 17 to the Human Medicines Regulations 2012 (against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicine specified).]

[F115(9) For the purposes of paragraph (8)(b) above, a person shall be regarded as being addicted to a drug if, and only if, he has as a result of repeated administration become so dependent upon the drug that he has an overpowering desire for the administration of it to be continued.]

Textual Amendments

Marginal Citations

Production and supply of drugs in Schedules 3 and 4U.K.

9.—(1) Notwithstanding the provisions of section 4(1)(a) of the Act—

(a)a practitioner or pharmacist, acting in his capacity as such, may manufacture or compound any drug specified in Schedule 3 or 4;

(b)a person lawfully conducting a retail pharmacy business and acting in his capacity as such may, at the registered pharmacy at which he carries on that business, manufacture or compound any drug specified in Schedule 3 or 4;

(c)a person who is authorised by a written authority issued by the Secretary of State under and for the purposes of this sub-paragraph and for the time being in force may, at the premises specified in that authority and in compliance with any conditions so specified, produce any drug specified in Schedule 3 or 4;

[F116(d)a nurse independent prescriber acting in her capacity as such, or a supplementary prescriber acting under and in accordance with the terms of a clinical management plan, may compound any drug specified in Schedule 3 or 4 for the purposes of administration in accordance with regulation 7;

(e)any person acting in accordance with the written directions of a doctor, a dentist, a nurse independent prescriber, a pharmacist independent prescriber, [F117paramedic independent prescriber, therapeutic radiographer independent prescriber] or a supplementary prescriber acting under and in accordance with the terms of a clinical management plan, may compound any drug specified in Schedule 3 or 4 for the purposes of administration in accordance with regulation 7.]

(2) Notwithstanding the provisions of section 4(1)(b) of the Act, any of the following persons, that is to say—

(a)a practitioner;

(b)a pharmacist;

(c)a person lawfully conducting a retail pharmacy business;

(d)a person in charge of a laboratory the recognised activities of which consist in, or include, the conduct of scientific education or research;

(e)a public analyst appointed under section 27 of the Food Safety Act 1990;

(f)a sampling officer within the meaning of Schedule 3 to the Medicines Act 1968;

(g)a person employed or engaged in connection with a scheme for testing the quality or amount of the drugs, preparations and appliances supplied under the National Health Service Act 1977 or the National Health Service (Scotland) Act 1978 and the regulations made thereunder;

(h)[F118a person authorised by the General Pharmaceutical Council] for the purposes of section 108 or 109 of the Medicines Act 1968,

[F119(i)a supplementary prescriber acting under and in accordance with the terms of a clinical management plan,]

may, when acting in his capacity as such, supply or offer to supply any drug specified in Schedule 3 or 4 to any person who may lawfully have that drug in his possession.

(3) Notwithstanding the provisions of section 4(1)(b) of the Act—

(a)a person who is authorised as a member of a group, under and in accordance with the terms of his group authority and in compliance with any conditions attached thereto;

(b)the person in charge or acting person in charge of [F120a hospital, organisation providing ambulance services] or [F121care home];

[F122(c)in the case of such a drug supplied to her by a person responsible for the dispensing and supply of medicines at that hospital, care home or prison, the senior registered nurse, acting senior registered nurse or registered midwife, for the time being in charge of a ward, theatre or other department in the hospital, care home or prison.]

[F123(d)in the case of such a drug supplied to him by a person responsible for the dispensing and supply of medicines at a hospital, an operating department practitioner practising in that hospital;]

may, when acting in his capacity as such, supply or offer to supply any drug specified in Schedule 3, or any drug specified in Schedule 4 F124..., to any person who may lawfully have that drug in his possession, except that nothing in this paragraph authorises—

(i)the person in charge or acting person in charge of [F125a hospital, organisation providing ambulance services] or [F126care home], having a pharmacist responsible for the dispensing and supply of medicines, to supply or offer to supply any drug;

(ii)a [F127senior registered nurse, acting senior registered nurse or registered midwife] for the time being in charge of a ward, theatre or other department to supply any drug otherwise than for administration to a patient in that ward, theatre or department in accordance with the directions of a [F128doctor, dentist, supplementary prescriber acting under and in accordance with the terms of a clinical management plan or, subject to paragraph (3A), a nurse independent prescriber [F129or a pharmacist independent prescriber]; or]

[F130(iii)an operating department practitioner to supply any drug otherwise than for administration to a patient in a ward, theatre or other department in accordance with the directions of a doctor, dentist, supplementary prescriber acting under and in accordance with the terms of a clinical management plan or, subject to paragraph (3A), a nurse independent prescriber [F131or a pharmacist independent prescriber].]

[F132(iv)the person in charge or acting person in charge of an organisation providing ambulance services to supply any drugs other than directly to employees of the organisation for the immediate treatment of sick or injured persons.]

[F133(3A) The directions given by a nurse independent prescriber or a pharmacist independent prescriber referred to in paragraph (3)(d)(ii) and (iii) shall relate only to a controlled drug which such nurse independent prescriber or such pharmacist independent prescriber respectively may prescribe under regulation 6B and a purpose for which it may be prescribed under that regulation.]

(4) Notwithstanding the provisions of section 4(1)(b) of the Act—

(a)a person who is authorised by a written authority issued by the Secretary of State under and for the purposes of this sub-paragraph and for the time being in force may, at the premises specified in that authority and in compliance with any conditions so specified, supply or offer to supply any drug specified in Schedule 3 or 4 to any person who may lawfully have that drug in his possession;

(b)a person who is authorised under paragraph (1)(c ) may supply or offer to supply any drug which he may, by virtue of being so authorised, lawfully produce to any person who may lawfully have that drug in his possession.

(5) Notwithstanding the provisions of section 4(1)(b) of the Act—

(a)the owner of a ship, or the master of a ship which does not carry a doctor among the seamen employed in it;

(b)the installation manager of an offshore installation,

may supply or offer to supply any drug specified in Schedule 3, or any drug specified in Schedule 4 F134...—

(i)for the purpose of compliance with any of the provisions specified in regulation 8(6), to any person on that ship or installation; or

(ii)to any person who may lawfully supply that drug to him.

(6) Notwithstanding the provisions of section 4(1)(b) of the Act, a person in charge of a laboratory may, when acting in his capacity as such, supply or offer to supply any drug specified in Schedule 3 which is required for use as a buffering agent in chemical analysis to any person who may lawfully have that drug in his possession.

[F135[F136(7) Notwithstanding the provisions of section 4(1)(b) of the Act, a nurse independent prescriber may, when acting in her capacity as such, supply or offer to supply any controlled drug specified in Schedule 3 or 4 to any person who may lawfully have any of those drugs in his possession provided it is supplied or offered in circumstances where she may prescribe it under regulation 6B.]

[F137(7A) Notwithstanding the provisions of section 4(1)(b) of the Act, a paramedic independent prescriber or a therapeutic radiographer independent prescriber may, when acting in their capacity as such, supply or offer to supply any controlled drug specified in Schedule 3 or 4 to any person who may lawfully have any of those drugs in their possession provided it is supplied or offered in circumstance where they may prescribe it under regulation 6D.]

(8) Notwithstanding the provisions of section 4(1)(b) of the Act, a registered nurse or a person specified in Schedule 8, when acting in their capacity as such, may supply or offer to supply, under and in accordance with the terms of a patient group direction, any drug specified in Schedule 4 [F138or Midazolam] to any person who may lawfully have that drug in his possession, except that this paragraph shall not have effect in the case of—

(a)the supply or offer to supply of any of the anabolic steroid drugs specified in Part II of Schedule 4; and

(b)any drug or preparation which is designed for administration by injection and which is to be used for the purpose of treating a person who is addicted to a drug;

(c)for the purposes of paragraph (b) above, a person shall be regarded as being addicted to a drug if, and only if, he has as a result of repeated administration become so dependent upon the drug that he has an overpowering desire for the administration of it to be continued.]

Textual Amendments

Possession of drugs in Schedules 2, 3 [F139, 4 and nitrous oxide] U.K.

10.—(1) Notwithstanding the provisions of section 5(1) of the Act—

(a)a person specified in one of sub-paragraphs (a) to [F140(k)] of regulation 8(2) may have in his possession any drug specified in Schedule 2;

(b)a person specified in one of sub-paragraphs (a) to [F141(i)] of regulation 9(2) may have in his possession any drug specified in Schedule 3 or 4;

(c)a person specified in [F142regulation 9(3)(b) to (d)] or (6) may have in his possession any drug specified in Schedule 3,

[F143(d)a person specified in [F142regulation 9(3)(b) to (d)] may have in his possession any drug specified in Part I of Schedule 4 F144...;

[F145(e)a person specified in [F146regulation 8(7) or (7A), regulation 8(8)(a), or regulation 9(7), (7A) or (8)] may have in her possession any drug specified in those regulations in accordance with the conditions specified in those regulations,]]

[F147(f)a person specified in sub-paragraph (f) of regulation 8(2) may have nitrous oxide in his possession,]

[F148(g)a person specified in regulation 8(8)(b) may have possession of ketamine in accordance with that provision.]

for the purpose of acting in his capacity as such a person, except that nothing in this paragraph authorises—

(i)a person specified in sub-paragraph (e) [F149or (ea)] of regulation 8(2);

(ii)a person specified in sub-paragraph (c) [F150or (d)] of regulation 9(3); or

(iii)a person specified in regulation 9(6),

to have in his possession any drug other than such a drug as is mentioned in the paragraph or sub-paragraph in question specifying him.

(2) Notwithstanding the provisions of section 5(1) of the Act, a person may have in his possession any drug specified in Schedule 2, 3 or Part I of Schedule 4 for administration for medical, dental or veterinary purposes in accordance with the directions of a practitioner [F151, a supplementary prescriber acting under and in accordance with the terms of a clinical management plan] [F152, a nurse independent prescriber [F153a podiatrist independent prescriber, a physiotherapist independent prescriber, a paramedic independent prescriber, a therapeutic radiographer independent prescriber] or a pharmacist independent prescriber, except that this paragraph shall not have effect in the case of a person to whom the drug has been supplied by or on the prescription of a doctor, a supplementary prescriber, a nurse independent prescriber, [F153a podiatrist independent prescriber, a physiotherapist independent prescriber, a paramedic independent prescriber, a therapeutic radiographer independent prescriber] a pharmacist independent prescriber or a person specified in Schedule 8 acting in accordance with a patient group direction], if—

(a)that person was then being supplied with any controlled drug by or on the prescription of another doctor [F154, another supplementary prescriber] [F155, another nurse independent prescriber, another pharmacist independent prescriber [F156, another podiatrist independent prescriber, another physiotherapist independent prescriber, another paramedic independent prescriber, another therapeutic radiographer independent prescriber] or another person specified in Schedule 8 acting in accordance with a patient group direction and failed to disclose that fact to the first mentioned doctor, supplementary prescriber, nurse independent prescriber, pharmacist independent prescriber [F157, podiatrist independent prescriber, physiotherapist independent prescriber, paramedic independent prescriber, therapeutic radiographer independent prescriber] or person specified in Schedule 8 acting in accordance with a patient group direction] before the supply by him or on his prescription; or

(b)that or any other person on his behalf made a declaration or statement, which was false in any particular, for the purpose of obtaining the supply or prescription.

(3) Notwithstanding the provisions of section 5(1) of the Act, a person who is authorised as a member of a group may, under and in accordance with the terms of his group authority and in compliance with any conditions attached thereto, have [F158nitrous oxide or] any drug specified in Schedule 2, 3 or Part I of Schedule 4 in his possession.

(4) Notwithstanding the provisions of section 5(1) of the Act—

(a)a person who is authorised by a written authority issued by the Secretary of State under and for the purposes of this sub-paragraph and for the time being in force may, at the premises specified in that authority and in compliance with any conditions so specified, have in his possession [F159nitrous oxide or] any drug specified in Schedule 3 or 4;

(b)a person who is authorised under regulation 9(1)(c ) may have in his possession any drug which he may, by virtue of being so authorised, lawfully produce;

(c)a person who is authorised under regulation 9(4)(a) may have in his possession any drug which he may, by virtue of being so authorised, lawfully supply or offer to supply.

(5) Notwithstanding the provisions of section 5(1) of the Act—

(a)any person may have in his possession any drug specified in Schedule 2, 3 or Part I of Schedule 4 for the purpose of compliance with any of the provisions specified in regulation 8(6);

(b)the master of a foreign ship which is in a port in Great Britain may have in his possession any drug specified in Schedule 2, 3 or Part I of Schedule 4 so far as necessary for the equipment of the ship.

(6) The foregoing provisions of this regulation are without prejudice to the provisions of regulation 4(3)(a).

Textual Amendments

[F160Directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.U.K.

10A.—(1) For the purposes of regulation 10(2), the directions of a practitioner may be the directions of a pharmacist, which do not require a prescription, in the following circumstances—

(a)as a consequence of a disease being, or in anticipation of a disease being imminently—

(i)pandemic, and

(ii)a serious risk or potentially a serious risk to human health,

in order to assist in the management of the serious risk or potentially serious risk to human health, the Secretary of State has made an announcement in respect of the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4 as part of the health service;

(b)as part of the announcement, the Secretary of State has issued advice to the effect that—

(i)in the area to which the announcement relates,

(ii)in the particular circumstances specified in the announcement, and

(iii)during the period specified in the announcement,

arrangements for the provision of services as part of the health service (“NHS arrangements”) with a person lawfully conducting a retail pharmacy business may include provisions permitting the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4 in accordance with the directions of a pharmacist, provided that the supply is in accordance with regulation 226 or 226A of the Human Medicines Regulations 2012;

(c)the person lawfully conducting a retail pharmacy business with whom the NHS arrangements are made complies with the requirements of the arrangements in respect of the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4; and

(d)the period specified in the announcement (taking into account any extension) has not ended and the announcement has not been withdrawn or amended in a way that means that the relevant provisions in the NHS arrangements are no longer permitted by the announcement.

(2) The period specified in the announcement, as mentioned in paragraph (1)(b)(iii), must initially not be for more than three months, but it may be extended for further periods of not more than three months at a time.

(3) Before making, amending (including by way of extension) or withdrawing an announcement under paragraph (1) which relates to—

(a)all or any area of Scotland, the Secretary of State must consult the Scottish Ministers;

(b)all or any area of Wales, the Secretary of State must consult the Welsh Ministers.]

Textual Amendments

Exemption for midwivesU.K.

11.—(1) Notwithstanding the provisions of sections 4(1)(b) and 5(1) of the Act, a registered midwife who has, in accordance with the provisions of rules made under [F161article 42 of the Order], notified to the local supervising authority her intention to practise may, subject to the provisions of this regulation—

(a)so far as necessary to her professional practice, have in her possession;

(b)so far as necessary as aforesaid, administer [F162or supply]; and

(c)surrender to the appropriate medical officer such stocks in her possession as are no longer required by her of,

any controlled drug which she may, under and in accordance with the provisions of the Medicines Act 1968 and of any instrument which is in force thereunder, lawfully administer.

(2) Nothing in paragraph (1) authorises a midwife to have in her possession any drug which has been obtained otherwise than on a midwife’s supply order signed by the appropriate medical officer.

(3) In this regulation—

  • F163...

  • “appropriate medical officer” means—

    (a)

    a doctor who is for the time being authorised in writing for the purposes of this regulation by the local supervising authority for the region or area in which the drug was, or is to be, obtained; or

    (b)

    for the purposes of paragraph (2), a person appointed under and in accordance with [F164article 43 of the Order] by that authority to exercise supervision over registered midwives within their area, who is for the time being authorised as aforesaid;

  • “local supervising authority” has the meaning it is given by [F165Schedule 4 of the Order];

  • “midwife’s supply order” means an order in writing specifying the name and occupation of the midwife [F166obtaining the drug, the name of the person to whom it is to be administered or supplied,] the purpose for which it is required and the total quantity to be obtained.

  • [F167“the Order” means the Nursing and Midwifery Order 2001;]

Textual Amendments

Cultivation under licence of cannabis plantU.K.

12.  Where any person is authorised by a licence of the Secretary of State issued under this regulation and for the time being in force to cultivate plants of the genus Cannabis, it shall not by virtue of section 6 of the Act be unlawful for that person to cultivate any such plant in accordance with the terms of the licence and in compliance with any conditions attached to the licence.

Approval of premises for cannabis smoking for research purposesU.K.

13.  Section 8 of the Act (which makes it an offence for the occupier of premises to permit certain activities there) shall not have effect in relation to the smoking of cannabis or cannabis resin for the purposes of research on any premises for the time being approved for the purpose under this regulation by the Secretary of State.

Documents to be obtained by supplier of controlled drugsU.K.

14.—(1) Where a person (hereafter in this paragraph referred to as “the supplier”), not being a practitioner, supplies a controlled drug otherwise than on a prescription, the supplier shall not deliver the drug to a person who—

(a)purports to be sent by or on behalf of the person to whom it is supplied (hereafter in this paragraph referred to as “the recipient”); and

(b)is not authorised by any provision of these Regulations other than the provisions of regulation 6(6) and (7)(f) to have that drug in his possession,

unless that person produces to the supplier a statement in writing signed by the recipient to the effect that he is empowered by the recipient to receive that drug on behalf of the recipient, and the supplier is reasonably satisfied that the document is a genuine document.

(2) Where a person (hereafter in this [F168regulation] referred to as “the supplier”) supplies a controlled drug, otherwise than on a prescription or by way of administration, to any of the persons specified in paragraph (4), the supplier shall not deliver the drug—

(a)until he has obtained a requisition in writing which—

(i)is signed by the person to whom the drug is supplied (hereafter in this paragraph referred to as “the recipient”);

(ii)states the name, address and profession or occupation of the recipient;

(iii)specifies the purpose for which the drug supplied is required and the total quantity to be supplied; and

(iv)where appropriate, satisfies the requirements of paragraph (5);

[F169(v)is in the form approved by the Secretary of State, the Welsh Ministers or the Scottish Ministers, for the purposes of requisitioning Schedule 2 and 3 controlled drugs;]

(b)unless he is reasonably satisfied that the signature is that of the person purporting to have signed the requisition and that that person is engaged in the profession or occupation specified in the requisition,

except that where the recipient is a practitioner and he represents that he urgently requires a controlled drug for the purpose of his profession, the supplier may, if he is reasonably satisfied that the recipient so requires the drug and is, by reason of some emergency, unable before delivery to furnish to the supplier a requisition in writing duly signed, deliver the drug to the recipient on an undertaking by the recipient to furnish such a requisition within the twenty-four hours next following.

(3) A person who has given such an undertaking as aforesaid shall deliver to the person by whom the controlled drug was supplied a signed requisition in accordance with the undertaking.

(4) The persons referred to in paragraph (2) are—

(a)a practitioner;

(b)the person in charge or acting person in charge of [F170a hospital, organisation providing ambulance services] or [F171care home];

(c)a person who is in charge of a laboratory;

(d)the owner of a ship, or the master of a ship which does not carry a doctor among the seamen employed in it;

(e)the master of a foreign ship in a port in Great Britain;

(f)the installation manager of an offshore installation.

[F172(g)a supplementary prescriber];

[F173(h)a nurse independent prescriber;

(i)a pharmacist independent prescriber]

[F174(j)a person who holds a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State, or a person who is a registered paramedic]

(5) A requisition furnished for the purposes of paragraph (2) shall—

[F175(a)where furnished by the person in charge or acting person in charge of a hospital, organisation providing ambulance services or care home, be signed by a doctor or dentist employed or engaged in that hospital, organisation or care home;]

(b)where furnished by the master of a foreign ship, contain a statement, signed by the proper officer of the port health authority, or, in Scotland, [F176a health board competent person designated under section 3 of the Public Health etc. (Scotland) Act 2008 by the health board] by the Health Board, within whose jurisdiction the ship is, that the quantity of the drug to be supplied is the quantity necessary for the equipment of the ship.

[F177(5A) Subject to paragraph (5B), on receipt of a requisition (other than a veterinary requisition) mentioned in paragraph (2), the supplier shall—

(a)mark on the requisition in ink or otherwise indelibly his name and address; and

(b)send the requisition to the relevant National Health Service agency in accordance with arrangements specified by that agency.

(5B) Paragraph (5A) shall not apply where the supplier is—

(a)a wholesale dealer; or

(b)a person responsible for the dispensing and supply of medicines at a [F178hospital, organisation providing ambulance services, care home or prison].]

(6) Where the person responsible for the dispensing and supply of medicines at [F179any hospital, care home or prison supplies a controlled drug to an operating department practitioner, senior registered nurse, acting senior registered nurse, or registered midwife, for the time being in charge of any ward, theatre or department in that hospital, care home or prison] (hereafter in this paragraph referred to as “the recipient”) he shall—

(a)obtain a requisition in writing, signed by the recipient, which specifies the total quantity of the drug to be supplied; and

(b)mark the requisition in such manner as to show that it has been complied with,

and any requisition obtained for the purposes of this paragraph shall be retained in the dispensary at which the drug was supplied and a copy of the requisition or a note of it shall be retained or kept by the recipient.

(7) Nothing in this regulation shall have effect in relation to—

(a)the drugs specified in Schedules 4 and 5 or poppy-straw;

(b)any drug specified in Schedule 3 contained in or comprising a preparation which—

(i)is required for use as a buffering agent in chemical analysis;

(ii)has present in it both a substance specified in paragraph 1 or 2 of that Schedule and a salt of that substance; and

(iii)is pre-mixed in a kit;

(c)any exempt product.

[F180(d)subject to paragraph (6) any drug which is required—

(i)for use in a prison; or

(ii)for use in a care home, which as its whole or main purpose provides palliative care for persons resident there who are suffering from a progressive disease in its final stages.]

[F181(8) In this regulation, “veterinary requisition” means a requisition which states, in accordance with paragraph (2)(ii), that the recipient is a veterinary surgeon or veterinary practitioner.]

Textual Amendments

Form of prescriptionsU.K.

15.—(1) Subject to the provisions of this regulation, a person shall not issue a prescription containing a controlled drug other than a drug specified in Schedule 4 or 5 F182... unless the prescription complies with the following requirements, that is to say, it shall—

[F183(a)be written so as to be indelible, be dated and be signed by the person issuing it with his usual signature [F184or be prescribed on an electronic prescription form];]

[F185(aa)except in the case of a health prescription [F186or a veterinary prescription], be written on a prescription form provided by [F187[F188NHS England] or an] equivalent body for the purposes of private prescribing [F189unless prescribed on an electronic prescription form];]

[F190(ab)except in the case of a health prescription or a veterinary prescription, specify the prescriber identification number of the person issuing it;]

F191(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)except in the case of a health prescription, specify the F192... address of the person issuing it;

(d)if issued by a dentist, have the words “for dental treatment only” written on it and, if issued by a veterinary surgeon or a veterinary practitioner, have a declaration written on it that the controlled drug is prescribed for an animal or herd under his care [F193and specify the Royal College of Veterinary Surgeons registration number of the veterinary surgeon or veterinary practitioner issuing it];

(e)specify the name and address of the person for whose treatment it is issued or, if it is issued by a veterinary surgeon or veterinary practitioner, of the person to whom the controlled drug prescribed is to be delivered;

(f)specify the dose to be taken and—

(i)in the case of a prescription containing a controlled drug which is a preparation, the form and, where appropriate, the strength of the preparation, and either the total quantity (in both words and figures) of the preparation or the number (in both words and figures) of dosage units, as appropriate, to be supplied;

(ii)in any other case, the total quantity (in both words and figures ) of the controlled drug to be supplied;

(g)in the case of a prescription for a total quantity intended to be supplied by instalments, contain a direction specifying the amount of the instalments of the total amount which may be supplied and the intervals to be observed when supplying.

[F194(1A) F195. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(1B) Nothing in this regulation prevents the issue of a prescription, other than a health prescription, which is not written on a prescription form provided by [F196[F188NHS England] or an] equivalent body for the purposes of private prescribing, containing a controlled drug other than a drug specified in Schedule 4 or 5, where the person issuing the prescription believes on reasonable grounds that the drug will be supplied by a pharmacist in a hospital.]

F197(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) In the case of a prescription issued for the treatment of a patient in a [F198hospital, care home or prison], it shall be a sufficient compliance with paragraph (1)(e) if the prescription is written on the patient’s bed card or case sheet.

[F199(4) In this regulation, “electronic prescription form” has the same meaning as in the National Health Service (Pharmaceutical and Local Pharmaceutical) Regulations 2013.]

[F200(5) For the purposes of paragraph (1)(g), if the intervals to be observed when supplying are changed by a pharmacist in the following circumstances, the changed intervals are treated as the intervals specified by the prescriber—

(a)as a consequence of a disease being, or in anticipation of a disease being imminently—

(i)pandemic, and

(ii)a serious risk or potentially a serious risk to human health,

in order to assist in the management of the serious risk or potentially serious risk to human health, the Secretary of State has made an announcement in respect of the supply of drugs specified in Schedule 2 or 3 as part of the health service;

(b)as part of the announcement, the Secretary of State has issued advice to the effect that—

(i)in the area to which the announcement relates,

(ii)in the particular circumstances specified in the announcement, and

(iii)during the period specified in the announcement,

arrangements for the provision of services as part of the health service (“NHS arrangements”) with a person lawfully conducting a retail pharmacy business may include provisions permitting pharmacists to change the intervals in prescriptions for drugs specified in Schedule 2 or 3 supplied under NHS arrangements;

(c)the pharmacist who changes the intervals—

(i)is the person who is, for the purposes of regulation 16(1), the person who supplies the drug on the prescription;

(ii)does so as part of and in accordance with NHS arrangements to which the announcement relates; and

(iii)does so with the agreement of the prescriber or, if the prescriber is unavailable, a person who is part of the same team responsible for treating the patient for whom the drug is prescribed as the prescriber, and who has been designated by the prescriber as a person who is able to agree this type of change if the prescriber is unavailable; and

(d)the period specified in the announcement (taking into account any extension) has not ended and the announcement has not been withdrawn or amended in a way that means that the relevant provisions in the NHS arrangements are no longer permitted by the announcement.

(6) The period specified in the announcement, as mentioned in paragraph (5)(b)(iii), must initially not be for more than three months, but it may be extended for further periods of not more than three months at a time.

(7) Before making, amending (including by way of extension) or withdrawing an announcement under paragraph (5) which relates to—

(a)all or any area of Scotland, the Secretary of State must consult the Scottish Ministers;

(b)all or any area of Wales, the Secretary of State must consult the Welsh Ministers.]

Textual Amendments

F185Reg. 15(1)(aa) inserted (7.7.2006 for E.S., 1.1.2007 in so far as not already in force) by The Misuse of Drugs (Amendment No. 2) Regulations 2006 (S.I. 2006/1450), regs. 2(1)(3), 5(1)(a) (with regs. 12, 13)

F186Words in reg. 15(1)(aa) inserted (1.9.2006 for E.S., 1.1.2007 in so far as not already in force) by The Misuse of Drugs (Amendment No. 3) Regulations 2006 (S.I. 2006/2178), regs. 1(1)(2), 4(1)(a)

F190Reg. 15(1)(ab) inserted (1.9.2006 for E.S., 1.1.2007 in so far as not already in force) by The Misuse of Drugs (Amendment No. 3) Regulations 2006 (S.I. 2006/2178), regs. 1(1)(2), 4(1)(b)

F192Words in reg. 15(1)(c) inserted and simultaneously revoked (1.9.2006 for E.S., 1.1.2007 in so far as not already in force) by The Misuse of Drugs (Amendment No. 2) Regulations 2006 (S.I. 2006/1450), regs. 2(1)(3), 5(1)(b) (with regs. 12, 13) and The Misuse of Drugs (Amendment No. 3) Regulations 2006 (S.I. 2006/2178), regs. 1(1)(2), 4(1)(c)

F194Reg. 15(1A)(1B) inserted (7.7.2006 for E.S., 1.1.2007 in so far as not already in force) by The Misuse of Drugs (Amendment No. 2) Regulations 2006 (S.I. 2006/1450), regs. 2(1)(3), 5(2) (with regs. 12, 13)

Provisions as to supply on prescriptionU.K.

16.—(1) [F201Subject to paragraph (5),] a person shall not supply a controlled drug other than a drug specified in Schedule 4 or 5 on a prescription—

(a)[F202subject to paragraphs (1A) and (1C),] unless the prescription complies with the provisions of regulation 15;

(b)unless the address specified in the prescription as the address of the person issuing it is an address within the United Kingdom;

(c)unless he either is acquainted with the signature of the person by whom it purports to be issued and has no reason to suppose that it is not genuine, or has taken reasonably sufficient steps to satisfy himself that it is genuine;

(d)before the [F203appropriate date];

(e)subject to paragraph [F204(4)], later than [F205twenty-eight days] after the [F203appropriate date].

[F206(1A) A pharmacist may supply a controlled drug other than a drug specified in Schedule 4 or 5 F207... if the prescription contains minor typographical errors or spelling mistakes or if it does not comply with the provisions of regulation 15 in the way specified in paragraph (1B), provided that—

(a)having exercised all due diligence, he is satisfied on reasonable grounds that the prescription is genuine;

(b)having exercised all due diligence, he is satisfied on reasonable grounds that he is supplying the drug in accordance with the intention of the person issuing the prescription;

(c)he amends the prescription in ink or otherwise indelibly to correct the minor typographical errors or spelling mistakes or so that the prescription complies with the requirements of regulation 15 as the case may be; and

(d)he marks the prescription so that the amendment he has made under sub-paragraph (c) is attributable to him.

(1B) The way specified in paragraph (1A) is that, in relation to regulation 15(1)(f), the total quantity of the preparation or of the controlled drug or the number of dosage units as the case may be is specified in either words or figures but not both.

(1C) A pharmacist may supply a controlled drug other than a drug specified in Schedule 4 or 5 on a prescription other than a health prescription in a hospital if it does not comply with regulation 15 in the ways specified in paragraph (1D).

(1D) The ways specified in paragraph (1C) are—

(a)the prescription is not written on a prescription form provided by [F208[F188NHS England] or an] equivalent body for the purposes of private prescribing;

(b)the prescription does not specify the prescriber identification number of the person issuing it.]

(2) Subject to paragraphs (3) and (4), a person supplying on prescription a controlled drug other than a drug specified in Schedule 4 or 5 shall, at the time of the supply, mark on the prescription the date on which the drug is supplied and, [F209if it is a veterinary prescription,] shall retain the prescription on the premises from which the drug was supplied.

(3) A person supplying temazepam on prescription in accordance with a prescription form of a kind specified in regulation 2A(1)(a)(i) of the National Health Service (Pharmaceutical Services) Regulations 1992 shall, at the time of the supply, enter on the form by electronic means the date on which the drug is supplied.

(4) In the case of a prescription containing a controlled drug other than a drug specified in Schedule 4 or 5, which contains a direction that specified instalments of the total amount may be supplied at stated intervals, the person supplying the drug shall not do so otherwise than in accordance with that direction, and—

(a)paragraph (1) shall have effect as if for the requirement contained in sub-paragraph (e) thereof there were substituted a requirement that the occasion on which the first instalment is supplied shall not be later than [F210twenty-eight days] after the [F211appropriate date];

(b)paragraph (2) shall have effect as if for the words “at the time of the supply” there were substituted the words “ on each occasion on which an instalment is supplied ”.

[F212(5) A person shall not supply a controlled drug specified in Schedule 4 on a prescription later than twenty-eight days after the appropriate date.

(6) A person who is asked to supply on prescription a controlled drug specified in Schedule 2 must first ascertain whether the person collecting the drug is the patient, the patient’s representative or a healthcare professional acting in his professional capacity on behalf of the patient; and—

(a)where that person is the patient or the patient’s representative, he may—

(i)request evidence of that person’s identity; and

(ii)refuse to supply the drug if he is not satisfied as to the identity of that person;

(b)where that person is a healthcare professional acting in his professional capacity on behalf of the patient, he—

(i)must obtain that person’s name and address;

(ii)must, unless he is acquainted with that person, request evidence of that person’s identity; but

(iii)may supply the drug even if he is not satisfied as to the identity of that person.

(7) In this regulation—

“appropriate date” means the later of the date on which it was signed by the person issuing it or the date indicated by him as being the date before which it shall not be supplied;

“healthcare professional” has the same meaning as in the National Health Service Act 1977;

“patient” means the person named in the prescription as the person to whom the drug is to be supplied;

“patient’s representative” means a person sent by or on behalf of the patient (other than a healthcare representative acting in his professional capacity).]

Textual Amendments

F203Words in reg. 16(1)(d)(e) substituted (7.7.2006) by The Misuse of Drugs (Amendment No. 2) Regulations 2006 (S.I. 2006/1450), regs. 2(1), 6(3) (with regs. 12, 13)

F206Reg. 16(1A)-(1D) inserted (7.7.2006 for E.S. and for W. in so far as inserting reg. 16(1A)(1B), 1.1.2007 in so far as not already in force) by The Misuse of Drugs (Amendment No. 2) Regulations 2006 (S.I. 2006/1450), regs. 2(1)(3), 6(5) (with regs. 12, 13)

[F213Orders, supply and use of cannabis-based products for administrationU.K.

16A—(1) Subject to paragraph (4), a person shall not order (whether by issuing a prescription or otherwise) a cannabis-based product for medicinal use in humans for administration, unless that product is—

(a)a special medicinal product that—

(i)is not also an investigational medicinal product, but

(ii)is for use in accordance with a prescription or direction of a specialist medical practitioner;

(b)an investigational medicinal product without a marketing authorisation that is for use in a clinical trial; or

(c)a medicinal product with a marketing authorisation.

(2) Subject to paragraph (4), a person shall not supply a cannabis-based product for medicinal use in humans by way of or for the purpose of the administration of that product, unless the supply—

(a)is pursuant to an order that complies with paragraph (1); and

(b)is—

(i)in the case of a product that is a special medicinal product but is not also an investigational medicinal product, for use in accordance with a prescription or direction of a specialist medical practitioner,

(ii)in the case of a product that is an investigational medicinal product without a marketing authorisation, for use in a clinical trial, or

(iii)of a medicinal product with a marketing authorisation.

(3) A person shall not self-administer a cannabis-based product for medicinal use in humans by the smoking of the product (other than for research purposes in accordance with regulation 13);

(4) Nothing in this regulation shall have effect in relation to the order or supply of a cannabis-based product for medicinal use in humans for administration to animals for research purposes.

(5) In this regulation, “investigational medicinal product”, “marketing authorisation”, and “special medicinal product” have the same meanings as in the Human Medicines Regulations 2012.

(6) In this regulation, “specialist medical practitioner” means a doctor included in the register of specialist medical practitioners kept under section 34D of the Medical Act 1983 (the Specialist Register).]

Textual Amendments

Exemption for certain prescriptionsU.K.

17.  Nothing in regulations 15 and 16 shall have effect in relation to a prescription issued for the purposes of a scheme for testing the quality or amount of the drugs, preparations and appliances supplied under the National Health Service Act 1977 or the National Health Service (Scotland) Act 1978 and the regulations made thereunder or to any prescriptions issued for the purposes of the Medicines Act 1968 to a sampling officer within the meaning of that Act.

Marking of bottles and other containersU.K.

18.—(1) Subject to paragraph (2), no person shall supply a controlled drug otherwise than in a bottle, package or other container which is plainly marked—

(a)in the case of a controlled drug other than a preparation, with the amount of the drug contained therein;

(b)in the case of a controlled drug which is a preparation—

(i)made up into tablets, capsules or other dosage units, with the amount of each component (being a controlled drug) of the preparation in each dosage unit and the number of dosage units in the bottle, package or other container;

(ii)not made up as aforesaid, with the total amount of the preparation in the bottle, package or other container and the percentage of each of its components which is a controlled drug.

(2) Nothing in this regulation shall have effect in relation to—

(a)the drugs specified in Schedules 4 and 5 or poppy-straw;

(b)any drug specified in Schedule 3 contained in or comprising a preparation which—

(i)is required for use as a buffering agent in chemical analysis;

(ii)has present in it both a substance specified in paragraph 1 or 2 of that Schedule and a salt of that substance; and

(iii)is premixed in a kit;

(c)any exempt product;

[F214(d)the supply of a controlled drug by or on the prescription of a practitioner, a supplementary prescriber, a nurse independent prescriber [F215, registered chiropodist or registered podiatrist, paramedic independent prescriber, therapeutic radiographer independent prescriber] or a pharmacist independent prescriber;]

(e)the supply of a controlled drug for administration in a clinical trial or a medicinal test on animals.

[F216(3) In this regulation—

  • F217...

  • “medicinal test on animals” has the same meaning as in the Medicines Act 1968.]

Textual Amendments

Record-keeping requirements in respect of drugs in Schedules 1 and 2U.K.

19.—(1) Subject to paragraph (3) and regulation 21, every person authorised by or under regulation 5 or 8 to supply any drug specified in Schedule 1 or 2 shall comply with the following requirements, that is to say—

(a)he shall, in accordance with the provisions of this regulation and of regulation 20, keep a register and shall enter therein in chronological sequence [F218subject to subparagraph (f), using the headings specified in subparagraphs (d) and (e),] particulars of every quantity of a drug specified in Schedule 1 or 2 obtained by him and of every quantity of such a drug supplied (whether by way of administration or otherwise) by him whether to persons within or outside Great Britain;

(b)he shall use a separate register or separate part of the register for entries made in respect of each class of drugs, and each of the drugs specified in paragraphs 1 and 3 of Schedule 1 and paragraphs 1, 3 and 6 of Schedule 2 together with its salts and any preparation or other product containing it or any of its salts shall be treated as a separate class, so however that any stereoisomeric form of a drug or its salts shall be classed with that drug.

[F219(d)The headings in respect of entries made for drugs obtained are—

(i)Date supply received;

(ii)Name and address from whom received;

(iii)Quantity received.

(e)The headings in respect of entries made for drugs supplied are—

(i)Date supplied;

(ii)Name/Address of person or firm supplied;

(iii)Details of authority to possess – prescriber or licence holder’s details;

(iv)Quantity supplied;

(v)Person collecting Schedule 2 controlled drug (patient/ patient’s rep/ healthcare professional) and if healthcare professional, name and address;

(vi)Was proof of identity requested of patient/ patient’s rep (Yes/No);

(vii)Was proof of identity of person collecting provided (Yes/No).

(f)The headings at subparagraph (e)(v) to (vii) apply only in respect of drugs specified in Schedule 2.]

[F220(2) Entries made in respect of drugs obtained and drugs supplied may be made on the same page or on separate pages in the register.]

[F221(2A) Subject to regulation 20(e), nothing in [F222paragraph (1)] shall prevent the use of a register to record additional information to that required or allowed under those provisions.]

(3) The foregoing provisions of this regulation shall not have effect in relation to—

(a)in the case of a drug supplied to him for the purpose of destruction in pursuance of regulation 6(2) or (3), a practitioner or pharmacist;

(b)a person licensed under regulation 5 to supply any drug, where the licence so directs; or

[F223(c)the senior registered nurse, acting senior registered nurse or registered midwife, for the time being in charge of a ward, theatre or other department in a hospital, care home or prison.]

Textual Amendments

Requirements as to registersU.K.

20.  Any person required to keep a register under regulation 19 shall comply with the following requirements, that is to say—

[F224(a)in the separate register or separate part of the register used for each class of drug, a separate page shall be used in respect of each strength and form of that drug and the head of each such page shall specify the class of the drug, its strength and form;]

(b)every entry required to be made under regulation 19 in such a register shall be made on the day on which the drug is obtained or, as the case may be, on which the transaction in respect of the supply of the drug by the person required to make the entry takes place or, if that is not reasonably practicable, on the day next following that day;

(c)no cancellation, obliteration or alteration of any such entry shall be made, and a correction of such an entry shall be made only by way of marginal note or footnote which shall specify the date on which the correction is made;

[F225(d)every such entry and every correction of such an entry shall be made in ink or otherwise so as to be indelible or shall be in a computerised form in which every such entry is attributable and capable of being audited and which is in accordance with best practice guidance endorsed by the Secretary of State under section 2 of the National Health Service Act 1977;]

(e)such a register shall not be used for any purpose other than [F226purposes related to] these Regulations;

(f)a separate register shall be kept in respect of each premises at which the person required to keep the register carries on his business or occupation, but subject to that not more than one register shall be kept at one time in respect of each class of drugs in respect of which he is required to keep a separate register, so, however, that a separate register may, with the approval of the Secretary of State, be kept in respect of each department of the business carried on by him;

(g)every such register in which entries are currently being made shall be kept at the premises to which it relates [F227and, where the register is in computerised form, be accessible from those premises].

Textual Amendments

Record-keeping requirements in respect of drugs in Schedule 2 in particular casesU.K.

21.—(1) Where a drug specified in Schedule 2 is supplied in accordance with regulation 8(5)(a)(i) to any person on a ship, an entry in the official log book required to be kept under the Merchant Shipping Act 1995 or, in the case of a ship which is not required to carry such an official logbook, a report signed by the master of the ship, shall, notwithstanding anything in these Regulations, be a sufficient record of the supply if the entry or report specifies the drug supplied and, in the case of a report, it is delivered as soon as may be to a superintendent at a Marine Office established and maintained under the Merchant Shipping Act 1995.

(2) Where a drug specified in Schedule 2 is supplied in accordance with regulation 8(5)(b)(i) to a person on an offshore installation, an entry in the installation logbook required to be maintained under the Offshore Installations (Logbooks and Registration of Death) Regulations 1972 M10 which specifies the drug supplied shall, notwithstanding anything in these Regulations, be a sufficient record of the supply.

(3) A midwife authorised by regulation 11(1) to have any drug specified in Schedule 2 in her possession shall—

(a)on each occasion on which she obtains a supply of such a drug, enter in a book kept by her and used solely for the purposes of this paragraph the date, the name and address of the person from whom the drug was obtained, [F228the name of the person to whom it is to be administered or supplied, the amount] obtained and the form in which it was obtained; and

(b)on administering [F229or supplying] such a drug to a patient, enter in the said book as soon as practicable the name and address of the patient, [F230the name of the person to whom it was administered or supplied, the amount] administered and the form in which it was administered.

Textual Amendments

Marginal Citations

[F231Record-keeping requirements in respect of drugs in Schedules 3 and 4]U.K.

22.—(1) Every person who is authorised under regulation 5 or 9(1)(c ) to produce any drug specified in Schedule 3 or 4 shall make a record of each quantity of such a drug produced by him.

(2) Every person who is authorised by or under any provision of the Act to import or export any drug specified in Schedule 3 shall make a record of each quantity of such a drug imported or exported by him.

(3) Every person who is authorised under regulation 9(4) to supply any drug specified in Schedule 4 shall make a record of each quantity of such a drug imported or exported by him.

(4) Paragraph (2) shall not have effect in relation to a person licensed under the Act to import or export any drug where the licence so directs.

[F232(5) Every person who is authorised by or under any provision of the Act to have in his possession or to destroy, or cause to be destroyed, the substance specified in paragraph 5 of Part 1 of Schedule 4 shall make a record of each quantity of such drug possessed or destroyed.

(6) Paragraph (5) shall not have effect in relation to—

(a)a patient to whom the substance specified in paragraph 5 of Part 1 of Schedule 4 has been prescribed;

(b)a constable when acting in the course of his duty as such;

(c)a person engaged in the business of a carrier when acting in the course of that business;

(d)a person engaged in the business of a postal operator (within the meaning of Part 3 of the Postal Services Act 2011) when acting in the course of that business;

(e)an officer of customs and excise when acting in the course of his duty as such;

(f)a person engaged in the work of any laboratory to which the substance specified in paragraph 5 of Part 1 of Schedule 4 has been sent for forensic examination when acting in the course of his duty as a person so engaged; and

(g)a person engaged in conveying the substance specified in paragraph 5 of Part 1 of Schedule 4 to a person who may lawfully have that substance in his possession.]

Textual Amendments

Preservation of registers, books and other documentsU.K.

23.—(1) All registers and books kept in pursuance of regulation 19 or 21(3) shall be preserved for a period of two years from the date on which the last entry therein is made.

(2) Every record made in pursuance of regulation 22 shall be preserved for a period of two years from the date on which the record was made.

(3) Every F233... [F234 ... veterinary prescription] on which a controlled drug is supplied in pursuance of these [F235Regulations] [F236, and every prescription (other than a health prescription) on which a controlled drug specified in Schedules 4 or 5 is so supplied,] shall be preserved for a period of two years from the date on which the last delivery under it was made.

[F237(4) Every prescription (other than a health prescription [F238or a veterinary prescription]) on which a controlled drug other than a drug specified in Schedule 4 or 5 is supplied [F239shall] be sent to the relevant National Health Service agency in accordance with arrangements specified by that agency.]

Textual Amendments

Preservation of records relating to drugs in Schedules 3 and 5U.K.

24.—(1) A producer of any drug specified in Schedule 3 or 5 and a wholesale dealer in any such drug shall keep every invoice or other like record issued in respect of each quantity of such a drug obtained by him and in respect of each quantity of such a drug supplied by him.

(2) A person who is authorised under regulation 9(4)(a) to supply any drug specified in Schedule 3 shall keep every invoice or other like record issued in respect of each quantity of such a drug obtained by him and in respect of each quantity of such a drug supplied by him.

(3) A retail dealer in any drug specified in Schedule 3, a person in charge or acting person in charge of [F240a hospital, organisation providing ambulance services] or [F241care home] and a person in charge of a laboratory shall keep every invoice or other like record issued in respect of each quantity of such a drug obtained by him and in respect of each quantity of such a drug supplied by him.

(4) A retail dealer in any drug specified in Schedule 5 shall keep every invoice or other like record issued in respect of each quantity of such a drug obtained by him.

(5) Every invoice or other record which is required by this regulation to be kept in respect of a drug specified in Schedule 3 shall contain information sufficient to identify the date of the transaction and the person by whom or to whom the drug was supplied.

(6) Every document kept in pursuance of this regulation (other than a health prescription) shall be preserved for a period of two years from the date on which it is issued, except that the keeping of a copy of the document made at any time during the said period of two years shall be treated for the purposes of this paragraph as if it were the keeping of the original document.

Textual Amendments

[F242Preservation of records: supplementaryU.K.

24A.  For the purposes of regulations 23 and 24(6), “preserved” means kept in its original form, or copied and kept in a computerised form which is in accordance with best practice guidance endorsed by the Secretary of State under section 2 of the National Health Service Act 1977.]

Textual Amendments

Exempt productsU.K.

25.  Nothing in regulations 19 to 24 shall have effect in relation to any exempt product.

Furnishing of information with respect to controlled drugsU.K.

26.—(1) The persons specified in paragraph (2) shall on demand made by the Secretary of State or by any person authorised in writing by the Secretary of State in that behalf—

(a)furnish such particulars as may be requested in respect of the producing, obtaining or supplying by him of any controlled drug or in respect of any stock of such drugs in his possession;

(b)for the purpose of confirming any such particulars, produce any stock of such drugs in his possession;

(c)produce any register, book or document required to be kept under these Regulations relating to any dealings in controlled drugs which is in his possession.

[F243(1A) For the purposes of paragraph (1)(c), the Secretary of State or any person authorised in writing by the Secretary of State in that behalf may request that a register which is kept in computerised form be produced by sending a copy of it, in computerised or other form, to the appropriate person.]

(2) The persons referred to in paragraph (1) are—

(a)any person authorised by or under these Regulations to produce any controlled drug;

(b)any person authorised by or under any provision of the Act to import or export any controlled drug;

(c)a wholesale dealer;

(d)a retail dealer;

(e)a practitioner;

(f)the person in charge or acting person in charge of [F244a hospital, organisation providing ambulance services] or [F245care home];

(g)a person who is in charge of a laboratory;

(h)a person who is authorised under regulation 9(4)(a) to supply any controlled drug.

[F246(i)a supplementary prescriber];

[F247(j)a nurse independent prescriber]

[F248(k)a registered chiropodist or registered podiatrist;

(l)a paramedic independent prescriber;

(m)a therapeutic radiographer independent prescriber.]

(3) Nothing in this regulation shall require the furnishing of personal records which a person has acquired or created in the course of his profession or occupation and which he holds in confidence; and in this paragraph “personal records” means documentary and other records concerning an individual (whether living or dead) who can be identified from them and relating to his physical or mental health.

Textual Amendments

Destruction of controlled drugsU.K.

27.—(1) No person who is required by any provision of, or by any term or condition of a licence having effect under, these Regulations to keep records with respect to a drug specified in Schedule 1, 2, 3 or 4 shall destroy such a drug or cause such a drug to be destroyed except in the presence of and in accordance with any directions given by a person authorised (whether personally or as a member of a class) for the purposes of this paragraph by the Secretary of State [F249or, subject to paragraph (1A), an accountable officer] (hereafter in this regulation referred to as an “authorised person”).

[F250(1A) An accountable officer shall not be an authorised person.]

(2) An authorised person may, for the purposes of analysis, take a sample of a drug specified in Schedule 1, 2, 3 or 4 which is to be destroyed.

(3) Where a drug specified in Schedule 1, 2, 3 or 4 is destroyed in pursuance of paragraph (1) by or at the instance of a person who is required by any provision of, or by any term or condition of a licence having effect under, these Regulations to keep a record in respect of the obtaining or supply of that drug, that record shall include particulars of the date of destruction and the quantity destroyed and shall be signed by the authorised person in whose presence the drug is destroyed.

(4) Where the master or owner of a ship or installation manager of an offshore installation has in his possession a drug specified in Schedule 2 which he no longer requires, he shall not destroy the drug or cause it to be destroyed but shall dispose of it to a constable, or to a person who may lawfully supply that drug to him.

(5) Nothing in paragraph (1) or (3) shall apply to any person who is required to keep records only by virtue of [F251regulation 22(2), (3) or (5) or 24(3)].

(6) Nothing in paragraph (1) or (3) shall apply to the destruction of a drug which has been supplied to a practitioner or pharmacist for that purpose in pursuance of regulation 6(2) or (3).

Textual Amendments

RevocationsU.K.

28.—(1) The regulations specified in Schedule 7 are hereby revoked.

(2) Notwithstanding paragraph (1), any register, record, book, prescription or other document required to be preserved under regulation 23 or 24 of the Misuse of Drugs Regulations 1985 M11 shall be preserved for the same period of time as if these Regulations had not been made.

(3) In the case of a prescription issued before the coming into force of these Regulations, regulation 16(1) shall have effect as if—

(a)in the case of a prescription containing a controlled drug other than a drug to which the provisions of regulation 15 of the Misuse of Drugs Regulations 1985 applied at the time the prescription was issued, sub-paragraphs (a) and (b) of that paragraph were omitted; and

(b)in any other case, for the said sub-paragraphs (a) and (b) there were substituted the words “ unless the prescription complies with the provisions of the Misuse of Drugs Regulations 1985 relating to prescriptions ”.

Marginal Citations

Bob Ainsworth

Parliamentary Under-Secretary of State

Home Office

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