The Misuse of Drugs Regulations 2001

Made: 13th December 2001

Laid before Parliament: 14th December 2001

Coming into force: 1st February 2002

The Secretary of State, in exercise of the powers conferred on him by sections 7, 10, 22 and 31 of the Misuse of Drugs Act 1971, after consultation with the Advisory Council on the Misuse of Drugs in accordance with section 31(3) of that Act, hereby makes the following Regulations:

Citation and commencement

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

Interpretation

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

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

• “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;

• “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 Schedule 4, or paragraph 10 of Schedule 5, applies, which—is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers);is produced for medicinal use in humans; and—is—a medicinal product, ora substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product;

• “care home” in relation to— England and Wales has the same meaning as in the Care Standards Act 2000; andScotland means the accommodation provided by a care home service;

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

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

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

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

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

• “dronabinol” does not include any substance which—has the international non-proprietary name dronabinol (recommended by the World Health Organisation); andis derived from cannabis, cannabis resin or their constituents,and stereoisomers of dronabinol are to be construed accordingly;

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

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

• ...

• “health prescription” means a prescription issued by a doctor, a dentist, a nurse independent prescriber, a pharmacist independent prescriber , 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 , the National Health Service (Scotland) Act 1978 , the Health and Personal Social Services (Northern Ireland) Order 1972 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;

• “health service” means—in England, the health service as defined by section 275(1) of the National Health Service Act 2006;in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978; andin 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 ;

• “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 ;

• ...

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

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

• “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;

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

• “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;

• “nurse independent prescriber” has the same meaning as in the 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 ;

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

• “organisation providing ambulance services” means one of the following health service organisations—an NHS trust or NHS foundation trust established under the National Health Service Act 2006 which has a function of providing ambulance services;an NHS trust established under the National Health Service (Wales) Act 2006 which has a function of providing ambulance services;the Scottish Ambulance Board;

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

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

• “pharmacist” has the same meaning as in the Human Medicines Regulations 2012;

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

• “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”;

• “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, by a nurse independent prescriber for the medical treatment of a single individual, by a pharmacist independent prescriber for the medical treatment of a single individual, a 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, by 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;

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

• ...

• “private prescribing” means issuing prescriptions other than health prescriptions or veterinary prescriptions;

• “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;

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

• “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;

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

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

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

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

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

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

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

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

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

• registered physiotherapist” has the same meaning as in the Human Medicines Regulations 2012;

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

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

• “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;

• ...

• “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;

• ...

• ...

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

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

• “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.

Specification of controlled drugs for purposes of Regulations

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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-straw

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• (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 except 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 which 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 ...;

• (b) the drugs specified in Schedule 5 except 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.

Licences to produce etc. controlled drugs

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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 possess

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• (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 , ... a registered nurse, a pharmacist independent prescriber, a physiotherapist independent prescriber, a chiropodist independent prescriber, a supplementary prescriber , a paramedic independent prescriber, a therapeutic radiographer independent prescriber or a person specified in Schedule 8 acting 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.

• (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 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 a postal operator (within the meaning of Part 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.

• (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.

Administration of drugs in Schedules 2, 3, 4 and 5

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• (1) Any person may administer to another any drug specified in Schedule 5 except nitrous oxide.

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