Statutory Instruments
2001 No. 3998
DANGEROUS DRUGS
The Misuse of Drugs Regulations 2001cross-notes
Made
13th December 2001
Laid before Parliament
14th December 2001
Coming into force
1st February 2002
M1 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
1. These Regulations may be cited as the Misuse of Drugs Regulations 2001 and shall come into force on 1st February 2002.
Interpretation
2. β(1) In these Regulations, unless the context otherwise requiresβ
βthe Actβ means the Misuse of Drugs Act 1971;
[F1 βaccountable officerβ has the same meaning as in the Health Act 2006; F1]
βauthorised as a member of a groupβ 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 βhis group authorityβ, in relation to a person who is a member of such a class, means the authority so granted to that class;
[F2 βcannabis-based product for medicinal use in humansβ means a preparation or other product, other than one to which paragraph 5 of part 1 of [F3 Schedule 4, or paragraph 10 of Schedule 5, applies F3] , whichβ
(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; andβ
(c)isβ
(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; F2]
[F4 βcare homeβ in relation toβ
(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; F4]
[F5 βcare home serviceβ has the same meaning as in the Public Services Reform (Scotland) Act 2010; F5]
[F6 βclinical management planβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F6]
[F2 βclinical trialβ has the same meaning as in the Medicines for Human Use (Clinical Trials) Regulations 2004; F2]
[F8 βthe Common Services Agency for the health serviceβ means the body established under section 10 of the National Health Service (Scotland) Act 1978; F8]
βdocumentβ [F9 means anything in which information of any description is recorded (within the meaning of the Civil Evidence Act 1995F9] ;
[F2 βdronabinolβ does not include any substance whichβ
(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; F2]
[F10 βequivalent bodyβ 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; F10]
βexempt productβ means a preparation or other product consisting of one or more component parts, any of which contains a controlled drug, whereβ
(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 other N -alkyl derivative of lysergamide;
[F11 βHealth Boardβ means a board constituted under section 2 of the National Health Service (Scotland) Act 1978; F11]
F12 ...
M2,M3,M4 βhealth prescriptionβ means a prescription issued by [F13 a 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 prescriberF14] or a supplementary prescriberF13] 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;
[F15 βhealth serviceβ meansβ
(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; F15]
M5 βinstallation managerβ and βoffshore installationβ have the same meanings as in the Mineral Workings (Offshore Installations) Act 1971 ;
[F16 βLocal Health Boardβ means a Local Health Board established in accordance with section 16BA of the National Health Service Act 1977; F16]
M6 βmasterβ and βseamenβ have the same meanings as in the Merchant Shipping Act 1995 ;
F17 ...
[F18 β medical purposes β means the purposes of preventative medicine, medical diagnosis, medical research or the provision of medical care and treatment; F18]
[F2 βmedicinal productβ has the same meaning as in the Human Medicines Regulations 2012; F2]
[F19 β NHS Business Services Authorityβ 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; F19]
[F18 β nitrous oxide β includes any preparation or other product containing nitrous oxide; F18]
[F19 βthe Northern Ireland Central Services Agency for the Health and Social Servicesβ means the body established under Article 26 of the Health and Personal Social Services (Northern Ireland) Order 1972; F19]
[F20 βnurse independent prescriberβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] , and such a person may only prescribe controlled drugs in accordance with regulation 6B; F20]
M7 βofficer of customs and exciseβ means an officer within the meaning of the Customs and Excise Management Act 1979 ;
[F21 βoperating department practitionerβ means a person who is registered under the [F22 Health Professions Order 2001 F22] as an operating department practitioner; F21]
[F23 βorganisation providing ambulance servicesβ means one of the following health service organisationsβ
(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; F23]
[F24 β paramedic independent prescriber β has the same meaning as in the Human Medicines Regulations 2012; F24]
[F25 βpatient group directionβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F25]
[F26 βpharmacistβ has the same meaning as in [F27the Human Medicines Regulations 2012F27] ; F26]
[F28 βpharmacist independent prescriberβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] , and such a person may only prescribe controlled drugs in accordance with regulation 6B; F28]
[F29 β physiotherapist independent prescriber β has the same meaning as in the Human Medicines Regulations 2012;
β podiatrist independent prescriber β has the same meaning as in the Human Medicines Regulations 2012β; F29]
[F26 βprescriber identification numberβ means the number recorded against a personβs name by the relevant National Health Service agency for the purposes of that personβs private prescribing; F26]
βprescriptionβ means a prescription issued by a doctor for the medical treatment of a single individual, [F30 by [F31 a nurse independent prescriberF31] for the medical treatment of a single individual, F30][F32 by a pharmacist independent prescriber for the medical treatment of a single individual, F32][F33 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, F33][F34 by a supplementary prescriber for the medical treatment of a single individual, F34] 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 βprisonβ has the same meaning as in [F36section 49(3) of the Investigatory Powers Act 2016F36] ; F35]
F37 ...
[F38 βprivate prescribingβ means issuing prescriptions other than health prescriptions[F39 or veterinary prescriptions; F39,F38]]
[F38 βprofessional registration numberβ means the number recorded against a personβs name in the register of any body that licenses or regulates any profession of which that person is a member; F38]
[F40 βprofessional registerβ means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001; F40]
[F41 βregisterβ 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; F41]
[F42 βregistered chiropodistβ has the same meaning as in [F7the Human Medicines Regulations 2012F7][F43 (but see regulation 8(8A) of these Regulations) F43] ; F42]
[F44 βregistered midwifeβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ;
βregistered nurseβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F44]
[F45 βregistered occupational therapistβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F45]
[F46 βregistered optometristβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ;
βregistered orthoptistβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F46]
[F47 βregistered orthotist and prosthetistβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F47]
[F48 βregistered paramedicβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F48]
βregistered pharmacyβ has the same meaning as in [F27the Human Medicines Regulations 2012F27] ;
[F49 registered physiotherapistβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F49]
[F50 β registered podiatrist β has the same meaning as in the Human Medicines Regulations 2012 (but see regulation 8(8A) of these Regulations); F50]
[F49 βregistered radiographerβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F49]
[F51 βrelevant National Health Service agencyβ 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; F51]
βretail dealerβ 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 βspecialist community public health nurseβ 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; F53]
F52 ...
F52 ...
[F54 βsupplementary prescriberβ has the same meaning as in [F7the Human Medicines Regulations 2012F7] ; F54]
[F55 β therapeutic radiographer independent prescriber β has the same meaning as in the Human Medicines Regulations 2012; F55]
[F56 βveterinary prescriptionβ means a prescription issued by a veterinary surgeon or veterinary practitioner for the purposes of animal treatment; F56]
βwholesale dealerβ 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
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-straw
4. β(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 [F57 except nitrous oxideF57] .
(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 [F58 which is carried out in person for administration to that person of any drug specified in Part II of Schedule 4 F58] .
(3) Section 5(1) of the Act (which prohibits the possession of controlled drugs) shall not have effect in relation toβ
(a) F59 any drug specified in Part II of Schedule 4 ...;
(b) the drugs specified in Schedule 5 [F60 except nitrous oxideF60] .
(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.
[F61 Exceptions for drugs in Schedule 1
4A.β(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 fungusβ
(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 personβs 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 areβ
(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. F61]
[F62 Exceptions for gammaβbutyrolactone and 1,4βbutanediol
4Bβ(1) Gammaβbutyrolactone and 1,4βbutanediol 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 gammaβbutyrolactone includeβ
(a) any salt of gammaβbutyrolactone; and
(b) any preparation or other product containing gammaβbutyrolactone or a substance specified in subβparagraph (a) of this paragraph.
(3) In this regulation references to 1,4-butanediol includeβ
(a) any substance which is an ester or ether or both an ester and ether of 1,4βbutanediol;
(b) any salt of 1,4βbutanediol or of a substance specified in subβparagraph (a) of this paragraph; and
(c) any preparation or other product containing 1,4βbutanediol or a substance specified in subβparagraph (a) or (b) of this paragraph. F62]
[F63 Exemptions for nitrous oxide
4C.β(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 andβ
(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 producenitrous oxide except where the personβ
(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 mayβ
(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 personβ
(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 thanβ
(a) for medical or dental purposes; or
(b) of nitrous oxide which has been released into the atmosphere. F63]
Licences to produce etc. controlled drugs
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 possess
6. β(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, [F66 a pharmacist independent prescriber, F66][F67 a physiotherapist independent prescriber, a chiropodist independent prescriber, F67][F68 a supplementary prescriberF68][F69 , a paramedic independent prescriber, a therapeutic radiographer independent prescriberF69] or a person specified in Schedule 8 F64][F70 acting in accordance with a patient group directionF70] 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. F71]
(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.
M8 (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 [F72 a postal operator (within the meaning of [F73Part 3 of the Postal Services Act 2011F73] ) F72] 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. F74]
[F75 Supply of articles for administering or preparing controlled drugs
6A.β(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 articlesβ
(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 F76] .
(2) The persons referred to in paragraph (1) areβ
(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 planF77][F78 ; and
(e) a nurse independent prescriberF78] .
[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 stepsβ
(a) to engage a patient in a drug treatment plan, or
(b) which form part of a patientβs drug treatment plan.
(4) In this regulation βdrug treatment planβ 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. F79,F75]]
[F80 Authority for Nurse Independent Prescribers and Pharmacist Independent Prescribers to prescribe
6B.β(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. F80]
[F81 Authority for Physiotherapist Independent Prescribers and Chiropodist Independent Prescribers to prescribe
6C.β(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 methodβ
(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 methodβ
(a) Diazepam by oral administration
(b) Dihydrocodeine by oral administration
(c) Lorazepam by oral administration
(d) Temazepam by oral administration. F81]
[F82 Authority for therapeutic radiographer independent prescribers and paramedic independent prescribers to prescribe
6D.β(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 methodβ
(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 methodβ
(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. F82]
Administration of drugs in Schedules 2, 3, 4 and 5
7. β(1) Any person may administer to another any drug specified in Schedule 5 [F83 except nitrous oxideF83] .
(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 directionF84] .
[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. F85]
[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. F86]
[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. F87]
[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. F88]
[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. F89]
Production and supply of drugs in Schedules 2 and 5
8. β(1) Notwithstanding the provisions of section 4(1)(a) of the Actβ
(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 prescriberF91] 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 F90]
(2) Notwithstanding the provisions of section 4(1)(b) of the Act, any of the following persons, that is to sayβ
(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 homeF92] 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; F93]
[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. F94]
[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; F95]
(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) M9 a public analyst appointed under section 27 of the Food Safety Act 1990 ;
(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) [F96 a person authorised by the General Pharmaceutical Council F96] 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, F97]
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 authorisesβ
(i) F99 the person in charge or acting person in charge of [F98 a hospital, organisation providing ambulance servicesF98] or [F92care homeF92] , having a pharmacist responsible for the dispensing and supply of medicines, to supply or offer to supply any drug; ...
(ii) a [F100 senior registered nurse, acting senior registered nurse or registered midwifeF100] 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[F102 or a pharmacist independent prescriberF102] ; or F101]
[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[F104 or a pharmacist independent prescriberF104] . F103]
[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. F105]
[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. F106]
(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 Actβ
(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 5β
(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 underβ
(a) the Mineral Workings (Offshore Installations) Act 1971;
(b) M10the Health and Safety at Work etc. Act 1974 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. F108]
[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. F109]
(8) Notwithstanding the provisions of section 4(1)(b) of the Actβ
(a) a registered nurse[F110 or a pharmacistF110] , 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 [F111 or morphine where administration of such drugs is required for the immediate, necessary treatment of sick or injured persons F111] ;
[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; F112,F107]]
[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 drugsβ
(i) co-codamol 8/500, 15/500 and 30/500,
(ii) co-dydramol 10/500, and
(iii) codeine phosphate. F113]
[F114 (8A) In paragraph (8)(c) βspecified registered chiropodistβ and βspecified registered podiatristβ 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). F114]
[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. F115]
Production and supply of drugs in Schedules 3 and 4
9. β(1) Notwithstanding the provisions of section 4(1)(a) of the Actβ
(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 prescriberF117] 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. F116]
(2) Notwithstanding the provisions of section 4(1)(b) of the Act, any of the following persons, that is to sayβ
(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) [F118 a person authorised by the General Pharmaceutical Council F118] 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, F119]
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 Actβ
(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 [F120 a hospital, organisation providing ambulance servicesF120] or [F121care homeF121] ;
[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. F122]
[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; F123]
F124 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 ..., to any person who may lawfully have that drug in his possession, except that nothing in this paragraph authorisesβ
(i) the person in charge or acting person in charge of [F125 a hospital, organisation providing ambulance servicesF125] or [F126care homeF126] , having a pharmacist responsible for the dispensing and supply of medicines, to supply or offer to supply any drug;
(ii) a [F127 senior registered nurse, acting senior registered nurse or registered midwifeF127] 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[F129 or a pharmacist independent prescriberF129] ; or F128]
[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[F131 or a pharmacist independent prescriberF131] . F130]
[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. F132]
[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. F133]
(4) Notwithstanding the provisions of section 4(1)(b) of the Actβ
(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 Actβ
(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,
F134 may supply or offer to supply any drug specified in Schedule 3, or any drug specified in Schedule 4 ...β
(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. F136]
[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. F137]
(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 [F138 or Midazolam F138] to any person who may lawfully have that drug in his possession, except that this paragraph shall not have effect in the case ofβ
(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. F135]
Possession of drugs in Schedules 2, 3 [F139 , 4 and nitrous oxide F139]
10. β(1) Notwithstanding the provisions of section 5(1) of the Actβ
(a) a person specified in one of sub-paragraphs (a) to [F140 (k) F140] 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) F141] of regulation 9(2) may have in his possession any drug specified in Schedule 3 or 4;
(c) a person specified in [F142 regulation 9(3)(b) to (d) F142] or (6) may have in his possession any drug specified in Schedule 3,
[F143 (d) a person specified in [F142 regulation 9(3)(b) to (d) F142] may have in his possession any drug specified in Part I of Schedule 4 F144 ...;
[F145 (e) a person specified in [F146 regulation 8(7) or (7A), regulation 8(8)(a), or regulation 9(7), (7A) or (8) F146] may have in her possession any drug specified in those regulations in accordance with the conditions specified in those regulations, F145,F143]]
[F147 (f) a person specified in sub-paragraph (f) of regulation 8(2) may have nitrous oxide in his possession, F147]
[F148 (g) a person specified in regulation 8(8)(b) may have possession of ketamine in accordance with that provision. F148]
for the purpose of acting in his capacity as such a person, except that nothing in this paragraph authorisesβ
(i) a person specified in sub-paragraph (e) [F149 or (ea) F149] of regulation 8(2);
(ii) a person specified in sub-paragraph (c) [F150 or (d) F150] 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 planF151][F152 , a nurse independent prescriber[F153 a podiatrist independent prescriber, a physiotherapist independent prescriber, a paramedic independent prescriber, a therapeutic radiographer independent prescriberF153] 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, [F153 a podiatrist independent prescriber, a physiotherapist independent prescriber, a paramedic independent prescriber, a therapeutic radiographer independent prescriberF153] a pharmacist independent prescriber or a person specified in Schedule 8 acting in accordance with a patient group directionF152] , ifβ
(a) that person was then being supplied with any controlled drug by or on the prescription of another doctor[F154 , another supplementary prescriberF154][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 prescriberF156] 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 prescriberF157] or person specified in Schedule 8 acting in accordance with a patient group directionF155] 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 F158] 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 Actβ
(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 F159] 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 Actβ
(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).
[F160 Directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.
10A.β(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 circumstancesβ
(a) as a consequence of a disease being, or in anticipation of a disease being imminentlyβ
(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 thatβ
(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 (βNHS arrangementsβ) 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 toβ
(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. F160]
Exemption for midwives
11. β(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 [F161 article 42 of the Order F161] , notified to the local supervising authority her intention to practise may, subject to the provisions of this regulationβ
(a) so far as necessary to her professional practice, have in her possession;
(b) so far as necessary as aforesaid, administer [F162 or supply F162] ; 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 midwifeβs supply order signed by the appropriate medical officer.
(3) In this regulationβ
F163 ...
βappropriate medical officerβ meansβ
(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 [F164 article 43 of the Order F164] by that authority to exercise supervision over registered midwives within their area, who is for the time being authorised as aforesaid;
βlocal supervising authorityβ has the meaning it is given by [F165 Schedule 4 of the Order F165] ;
βmidwifeβs supply orderβ means an order in writing specifying the name and occupation of the midwife [F166 obtaining the drug, the name of the person to whom it is to be administered or supplied, F166] the purpose for which it is required and the total quantity to be obtained.
[F167 β the Order β means the Nursing and Midwifery Order 2001; F167]
Cultivation under licence of cannabis plant
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 purposes
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 drugs
14. β(1) Where a person (hereafter in this paragraph referred to as βthe supplierβ), not being a practitioner, supplies a controlled drug otherwise than on a prescription, the supplier shall not deliver the drug to a person whoβ
(a) purports to be sent by or on behalf of the person to whom it is supplied (hereafter in this paragraph referred to as βthe recipientβ); 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 [F168 regulation F168] referred to as βthe supplierβ) 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 drugβ
(a) until he has obtained a requisition in writing whichβ
(i) is signed by the person to whom the drug is supplied (hereafter in this paragraph referred to as βthe recipientβ);
(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; F169]
(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) areβ
(a) a practitioner;
(b) the person in charge or acting person in charge of [F170 a hospital, organisation providing ambulance servicesF170] or [F171care homeF171] ;
(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 prescriberF172] ;
[F173 (h) a nurse independent prescriber;
(i) a pharmacist independent prescriberF173]
[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 paramedicF174]
(5) A requisition furnished for the purposes of paragraph (2) shallβ
[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; F175]
(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, [F176 a health board competent person designated under section 3 of the Public Health etc. (Scotland) Act 2008 by the health boardF176] 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 shallβ
(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 isβ
(a) a wholesale dealer; or
(b) a person responsible for the dispensing and supply of medicines at a [F178 hospital, organisation providing ambulance services, care home or prisonF178] . F177]
(6) Where the person responsible for the dispensing and supply of medicines at [F179 any 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 prisonF179] (hereafter in this paragraph referred to as βthe recipientβ) he shallβ
(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 toβ
(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 whichβ
(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 requiredβ
(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. F180]
[F181 (8) In this regulation, βveterinary requisitionβ means a requisition which states, in accordance with paragraph (2)(ii), that the recipient is a veterinary surgeon or veterinary practitioner. F181]
Form of prescriptions
F18215. β(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 ... unless the prescription complies with the following requirements, that is to say, it shallβ
[F183 (a) be written so as to be indelible, be dated and be signed by the person issuing it with his usual signature [F184 or be prescribed on an electronic prescription formF184] ; F183]
[F185 (aa) except in the case of a health prescription[F186 or a veterinary prescriptionF186] , be written on a prescription form provided by [[F187,F188 NHS England F188] or an F187]equivalent body for the purposes of private prescribing[F189 unless prescribed on an electronic prescription formF189] ; F185]
[F190 (ab) except in the case of a health prescription or a veterinary prescription, specify the prescriber identification number of the person issuing it; F190]
F191 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) F192 except in the case of a health prescription, specify the ... address of the person issuing it;
(d) if issued by a dentist, have the words βfor dental treatment onlyβ 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 [F193 and specify the Royal College of Veterinary Surgeons registration number of the veterinary surgeon or veterinary practitioner issuing it F193] ;
(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 drugprescribed is to be delivered;
(f) specify the dose to be taken andβ
(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,F188 NHS England F188] or an F196]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. F194]
F197 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3) In the case of a prescription issued for the treatment of a patient in a [F198 hospital, care home or prisonF198] , it shall be a sufficient compliance with paragraph (1)(e) if the prescription is written on the patientβs bed card or case sheet.
[F199 (4) In this regulation, βelectronic prescription formβ has the same meaning as in the National Health Service (Pharmaceutical and Local Pharmaceutical) Regulations 2013. F199]
[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 prescriberβ
(a) as a consequence of a disease being, or in anticipation of a disease being imminentlyβ
(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 thatβ
(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 (βNHS arrangementsβ) 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 intervalsβ
(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 toβ
(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. F200]
Provisions as to supply on prescription
16. β(1)[F201 Subject to paragraph (5), F201] a person shall not supply a controlled drug other than a drug specified in Schedule 4 or 5 on a prescriptionβ
(a) [F202 subject to paragraphs (1A) and (1C), F202] 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 dateF203] ;
(e) subject to paragraph [F204 (4) F204] , later than [F205 twenty-eight days F205] after the [F203appropriate dateF203] .
[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 thatβ
(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) areβ
(a) the prescription is not written on a prescription form provided by [[F208,F188 NHS England F188] or an F208]equivalent body for the purposes of private prescribing;
(b) the prescription does not specify the prescriber identification number of the person issuing it. F206]
(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, [F209 if it is a veterinary prescription, F209] 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, andβ
(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 [F210 twenty-eight days F210] after the [F211appropriate dateF211] ;
(b) paragraph (2) shall have effect as if for the words βat the time of the supplyβ there were substituted the words β on each occasion on which an instalment is supplied β .
[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 patientβs representative or a healthcare professional acting in his professional capacity on behalf of the patient; andβ
(a) where that person is the patient or the patientβs representative, he mayβ
(i) request evidence of that personβs 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, heβ
(i) must obtain that personβs name and address;
(ii) must, unless he is acquainted with that person, request evidence of that personβs identity; but
(iii) may supply the drug even if he is not satisfied as to the identity of that person.
(7) In this regulationβ
βappropriate dateβ 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;
βhealthcare professionalβ has the same meaning as in the National Health Service Act 1977;
βpatientβ means the person named in the prescription as the person to whom the drug is to be supplied;
βpatientβs representativeβ means a person sent by or on behalf of the patient (other than a healthcare representative acting in his professional capacity). F212]
[F213 Orders, supply and use of cannabis-based products for administration
16Aβ(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 isβ
(a) a special medicinal product thatβ
(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 supplyβ
(a) is pursuant to an order that complies with paragraph (1); and
(b) isβ
(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, βinvestigational medicinal productβ, βmarketing authorisationβ, and βspecial medicinal productβ have the same meanings as in the Human Medicines Regulations 2012.
(6) In this regulation, βspecialist medical practitionerβ means a doctor included in the register of specialist medical practitioners kept under section 34D of the Medical Act 1983 (the Specialist Register). F213]
Exemption for certain prescriptions
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 containers
18. β(1) Subject to paragraph (2), no person shall supply a controlled drug otherwise than in a bottle, package or other container which is plainly markedβ
(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 preparationβ
(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 toβ
(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 whichβ
(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 prescriberF215] or a pharmacist independent prescriber; F214]
(e) the supply of a controlled drug for administration in a clinical trial or a medicinal test on animals.
[F216 (3) In this regulationβ
F217 ...
βmedicinal test on animalsβ has the same meaning as in the Medicines Act 1968. F216]
Record-keeping requirements in respect of drugs in Schedules 1 and 2
19. β(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 sayβ
(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 [F218 subject to subparagraph (f), using the headings specified in subparagraphs (d) and (e), F218] 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 areβ
(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 areβ
(i) Date supplied;
(ii) Name/Address of person or firm supplied;
(iii) Details of authority to possess β prescriber or licence holderβs details;
(iv) Quantity supplied;
(v) Person collecting Schedule 2 controlled drug (patient/ patientβs rep/ healthcare professional) and if healthcare professional, name and address;
(vi) Was proof of identity requested of patient/ patientβs 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. F219]
[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. F220]
[F221 (2A) Subject to regulation 20(e), nothing in [F222 paragraph (1) F222] shall prevent the use of a register to record additional information to that required or allowed under those provisions. F221]
(3) The foregoing provisions of this regulation shall not have effect in relation toβ
(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. F223]
Requirements as to registers
20. Any person required to keep a register under regulation 19 shall comply with the following requirements, that is to sayβ
[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; F224]
(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; F225]
(e) such a register shall not be used for any purpose other than [F226 purposes related to F226] 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 [F227 and, where the register is in computerised form, be accessible from those premises F227] .
Record-keeping requirements in respect of drugs in Schedule 2 in particular cases
21. β(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.
M11 (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 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 shallβ
(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, [F228 the name of the person to whom it is to be administered or supplied, the amount F228] obtained and the form in which it was obtained; and
(b) on administering [F229 or supplying F229] such a drug to a patient, enter in the said book as soon as practicable the name and address of the patient, [F230 the name of the person to whom it was administered or supplied, the amount F230] administered and the form in which it was administered.
[F231 Record-keeping requirements in respect of drugs in Schedules 3 and 4 F231]
22. β(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 toβ
(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. F232]
Preservation of registers, books and other documents
23. β(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.
F233 (3) Every ... [F234 ... veterinary prescriptionF234] on which a controlled drug is supplied in pursuance of these [F235 Regulations F235][F236 , and every prescription (other than a health prescription) on which a controlled drug specified in Schedules 4 or 5 is so supplied, F236] 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[F238 or a veterinary prescriptionF238] ) on which a controlled drug other than a drug specified in Schedule 4 or 5 is supplied [F239 shall F239] be sent to the relevant National Health Service agency in accordance with arrangements specified by that agency. F237]
Preservation of records relating to drugs in Schedules 3 and 5
24. β(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 [F240 a hospital, organisation providing ambulance servicesF240] or [F241care homeF241] 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.
[F242 Preservation of records: supplementary
24A. For the purposes of regulations 23 and 24(6), βpreservedβ 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. F242]
Exempt products
25. Nothing in regulations 19 to 24 shall have effect in relation to any exempt product.
Furnishing of information with respect to controlled drugs
26. β(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 behalfβ
(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. F243]
(2) The persons referred to in paragraph (1) areβ
(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 [F244 a hospital, organisation providing ambulance servicesF244] or [F245care homeF245] ;
(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 prescriberF246] ;
[F247 (j) a nurse independent prescriberF247]
[F248 (k) a registered chiropodist or registered podiatrist;
(l) a paramedic independent prescriber;
(m) a therapeutic radiographer independent prescriber. F248]
(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 βpersonal recordsβ 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.
Destruction of controlled drugs
27. β(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 [F249 or, subject to paragraph (1A), an accountable officerF249] (hereafter in this regulation referred to as an βauthorised personβ).
[F250 (1A) An accountable officer shall not be an authorised person. F250]
(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 [F251 regulation 22(2), (3) or (5) or 24(3) F251] .
(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).
Revocations
28. β(1) The regulations specified in Schedule 7 are hereby revoked.
M12 (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 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 ifβ
(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 β unless the prescription complies with the provisions of the Misuse of Drugs Regulations 1985 relating to prescriptions β .
Bob Ainsworth
Parliamentary Under-Secretary of State
Home Office
Regulation 3
SCHEDULE 1 CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 14, 15, 16, 18, 19, 20, 23, 26 AND 27
1. The following substances and products, namely -
[F252 Adinazolam (1-(8-Chloro-6-phenyl-4 H -[1,2,4]triazolo[4,3-a][1,4]benzodiazepin-1-yl)- N,N -dimethylmethanamine) F252]
[F253 AP-237 (1-[4-([2E]-3-phenyl-2-propen-1-yl)-1-piperazinyl]-1-butanone) (bucinnazine)
AP-238 (1-[2,6-dimethyl-4-[2E]-3-phenyl-2-propen-1-yl]-1-piperazinyl-1-propanone)
Azaprocin (1-[3-[(E)-3-phenyl-2-propen-1-yl]-3,8-diazabicyclo[3.2.1]octan-8-yl]propan-1-one)
Bentazepam (5-phenyl-1,3,6,7,8,9-hexahydro-2 H -[1]benzothieno[2,3-e][1,4]diazepin-2-one) F253]
[F252 N -Benzyl-ethylphenidate F252]
[F253 Bretazenil ( tert -butyl-8-bromo-11,12,13,13a-tetrahydro-9-oxo-9 H -imidazo[1,5-a]-pyrrolo[2,1-c][1,4]benzodiazepine-1-carboxylate) F253]
[F252 Bromazolam (8-bromo-1-methyl-6-phenyl-4 H -[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) F252]
[F254 Brorphine F254]
Bufotenine
[F255 Butonitazene F255]
Cannabinol
[F256 Cannabinol derivatives not beingβ
(i)dronabinol or its stereoisomers; or
(ii)the substance specified in paragraph 10 of Schedule 5 F256]
Cannabis[F257 (not being the substance specified in paragraph 5 of Part 1 of Schedule 4) F257] and cannabis resin
Cathinone
[F258 4β-Chlorodiazepam (7-Chloro-5-(4-chlorophenyl)-1-methyl-1,3-dihydro-2 H -1,4-benzodiazepin-2-one) F258]
[F253 Clobromazolam (8-bromo-6-(2-chlorophenyl)-1-methyl-4 H -[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) F253]
[F258 Clonazolam (6-(2-Chlorophenyl)-1-methyl-8-nitro-4 H -[1,2,4]triazolo[4,3-a][1,4] benzodiazepine) F258]
[F253 Cloniprazepam (5-(2-chlorophenyl)-1-(cyclopropylmethyl)-7-nitro-1,3-dihydro-2 H -1,4-benzodiazepin-2-one) F253]
[F259 Clonitazene F259]
Coca leaf
Concentrate of poppy-straw
[F260 Cumyl-PeGaClone F260]
[F253 Desalkylgidazepam (7-bromo-5-phenyl-1,3-dihydro-2 H -1,4-benzodiazepin-2-one)
Deschloroclotizolam (2-chloro-9-methyl-4-phenyl-6 H -thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine) F253]
[F261 Deschloroetizolam (2-Ethyl-9-methyl-4-phenyl-6 H -thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4] diazepine) F261]
[F261 3,4-Dichloroethylphenidate F261]
[F261 3,4-Dichloromethylphenidate (3,4-DCMP) F261]
[F261 Diclazepam (7-Chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2 H -1,4-benzodiazepin-2-one) F261]
[F253 Difludiazepam (7-chloro-5-(2,6-difluorophenyl)-1-methyl-3 H -1,4-benzodiazepin-2-one) F253]
[F262 [2,3βDihydroβ5βmethylβ3β(4βmorpholinylmethyl)pyrrolo[1, 2, 3β de ]β1,4βbenzoxazinβ6βyl]β1βnaphthalenylmethanone F262]
[F262 3βDimethylheptylβ11βhydroxyhexahydrocannabinol F262]
[F263 Diphenidine F263]
[F263 Ephenidine F263]
[F263 Ethyleneoxynitazene F263]
[F264 Ethylnaphthidate F264]
[F264 Ethylphenidate F264]
Eticyclidine
[F265 Etizolam F265]
[F266 Etodesnitazene (etazene) F266]
[F266 Etonitazene F266]
Etryptamine
[F267 Flualprazolam (8-chloro-6-(2-fluorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) F267]
[F268 Flubromazepam (7-Bromo-5-(2-fluorophenyl)-1,3-dihydro-2 H -1,4-benzodiazepin-2-one) F268]
[F268 Flubromazolam (8-Bromo-6-(2-fluorophenyl)-1-methyl-4 H -[1,2,4]triazolo[4,3-a][1,4] benzodiazepine) F268]
[F253 Flubrotizolam (2-bromo-4-(2-fluorophenyl)-9-methyl-6 H -thieno[3,2f][1,2,4]triazolo[4,3a][1,4]diazepine)
Fluclotizolam (2-chloro-4-(2-fluorophenyl)-9-methyl-6 H -thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine)
Fluetizolam (2-ethyl-4-(2-fluorophenyl)-9-methyl-6 H -thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine) F253]
[F269 Flunitazene F269]
[F270 Flunitrazolam (6-(2-fluorophenyl)-1-methyl-8-nitro-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) F270]
[F268 4-Fluoroethylphenidate F268]
[F268 4-Fluoromethylphenidate F268]
[F268 Fonazepam (5-(2-Fluorophenyl)-7-nitro-1,3-dihydro-2 H -1,4-benzodiazepin-2-one) F268]
[F271 Fungus (of any kind) which contains psilocin or an ester of psilocin F271]
[F253 Gidazepam (7-bromo-2,3-dihydro-2-oxo-5-phenyl-1 H -1,4-benzodiazepine-1-acetic acid hydrazide) F253]
[F272 [9βHydroxyβ6βmethylβ3β[5βphenylpentanβ2βyl] oxyβ5, 6, 6a, 7, 8, 9, 10, 10aβoctahydrophenanthridinβ1βyl] acetate F272]
[F272 9-(Hydroxymethyl)β6, 6βdimethylβ3β(2βmethyloctanβ2βyl)β6a, 7, 10, 10aβtetrahydrobenzo[ c ]chromenβ1βol F272]
[F273 3-Hydroxyphenazepam (7-Bromo-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-2 H -1,4-benzodiazepin-2-one) F273]
[F273 Isopropylphenidate (IPP or IPPD) F273]
[F274 Isotonitazene F274]
[F275 Khat F275]
Lysergamide
Lysergide and other N -alkyl derivatives of lysergamide
[F276 Meclonazepam (5-(2-Chlorophenyl)-3-methyl-7-nitro-1,3-dihydro-2 H -1,4-benzodiazepin-2-one) F276]
Mescaline
Methcathinone
[F277 Methoxyphenidine F277][F278 (1-[1-(2-methoxyphenyl)-2-phenylethyl]piperidine) (methoxphenidine) F278]
[F253 Methylclonazepam (5-(2-chlorophenyl)-1-methyl-7-nitro-3 H -1,4-benzodiazepin-2-one) F253]
[F279 4-Methylmethylphenidate F279]
[F279 Methylmorphenate F279]
[F279 Methylnaphthidate (HDMP-28) F279]
[F280 N -methyl-1-(thiophen-2-yl)propan-2-amine (methiopropamine or MPA) F280]
[F279 Metizolam (4-(2-Chlorophenyl)-2-ethyl-6 H -thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4] diazepine) F279]
[F281 Metodesnitazene (metazene) F281]
[F281 Metonitazene F281]
[F279 Nifoxipam (5-(2-Fluorophenyl)-3-hydroxy-7-nitro-1,3-dihydro-2 H -1,4-benzodiazepin-2- one) F279]
[F279 Nitrazolam (1-Methyl-8-nitro-6-phenyl-4 H -[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) F279]
[F282 Norfludiazepam (7-chloro-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one) F282]
[F253 para-methyl-AP-237 (1-[4-[2E]-3-(4-methylphenyl)-2-propen-1-yl]-1-piperazinyl-1-butanone)
para-nitroazaprocin (1-[3-[(E)-3-(4-nitrophenyl)-2-propen-1-yl]-3,8-diazabicyclo[3.2.1]octan-8-yl)propan-1-one) F253]
[F279 Propylphenidate F279]
[F283 Protonitazene F283]
F284 ...
Psilocin
[F285 Pyrazolam (8-Bromo-1-methyl-6-(2-pyridinyl)-4 H -[1,2,4]triazolo[4,3-a][1,4] benzodiazepine) F285]
Raw opium
[F253 Rilmazafone (5-([(2-aminoacetyl)amino]methyl)-1-[4-chloro-2-(2-chlorobenzoyl)phenyl]- N , N -dimethyl-1 H -1,2,4-triazole-3-carboxamide) F253]
Rolicyclidine
Tenocyclidine
[F253 Thionordazepam (7-chloro-5-phenyl-1,3-dihydro-2 H -1,4-benzodiazepin-2-thione) F253]
[F286 (6a R ,9 R )-4-acetyl- N , N -diethyl-7-methyl-4,6,6a,7,8,9-hexahydroindolo[4,3- fg ]quinoline-9-carboxamide (ALD-52) F286]
4-Bromo-2,5-dimethoxy-a-methylphenethylamine
[F253 4β-Chloro-deschloroalprazolam (6-(4-chlorophenyl)-1-methyl-4 H -[1,2,4]triazolo[4,3-a][1,4]benzodiazepine) F253]
[F287 1-Cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45) F287]
[F288 N -Desethyl etonitazene F288]
[F288 N -Desethylisotonitazene F288]
[F288 N -Desethyl protonitazene F288]
[F289 3,4-dichloro- N -[[1-(dimethylamino)cyclohexyl]methyl]benzamide (AH-7921) F289]
[F290 3,4-dichloro- N -[2-(dimethylamino)cyclohexyl]- N -methylbenzamide (U-47,700) F290]
[F289 (6a R, 9 R )- N,N- diethyl-7-allyl-4,6,6a,7,8,9-hexahydroindolo[4,3- fg ]quinoline-9-carboxamide (AL-LAD) F289]
[F289 (6a R, 9 R ) -N,N- diethyl-7-ethyl-4,6,6a,7,8,9-hexahydroindolo[4,3 -fg ]quinoline-9-carboxamide (ETH-LAD) F289]
[F289 (6a R, 9 R )- N,N- diethyl-7-propyl-4,6,6a,7,8,9-hexahydroindolo[4,3- fg ]quinoline-9-carboxamide (PRO-LAD) F289]
N,N -Diethyltryptamine
[F291 2-((Dimethylamino)methyl)-1-(3-hydroxyphenyl)cyclohexanol F291]
[F292 2,4-dimethylazetidinyl{(6a R, 9 R )-7-methyl-4,6,6a,7,8,9-hexahydroindolo[4,3- fg ]quinolin-9-yl}methanone (LSZ) F292]
N,N -Dimethyltryptamine
2,5-Dimethoxy-a,4-dimethylphenethylamine
N -Hydroxy-tenamphetamine
4-Methyl-aminorex
[F253 2-Methyl-AP-237 (1-[2-methyl-4-[2E]-3-phenyl-2-propen-1-yl]-1-piperazinyl-1-butanone) F253]
[F293 4-Methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (4,4β-DMAR) F293]
[F294 N -Piperidinyl-etonitazene (etonitazepipne) F294]
[F294 N -Pyrrolidino-etonitazene (etoniazepyne) F294]
[F294 N -Pyrrolidino protonitazene F294]
[F295 (b) any compound (not being a compound for the time being specified in sub-paragraph (a) above) structurally derived from tryptamine or from a ring-hydroxy tryptamine by modification in any of the following ways, that is to sayβ
(i) by substitution at the nitrogen atom of the sidechain to any extent with alkyl or alkenyl substituents, or by inclusion of the nitrogen atom of the side chain (and no other atoms of the side chain) in a cyclic structure;
(ii) by substitution at the carbon atom adjacent to the nitrogen atom of the side chain with alkyl or alkenyl substituents;
(iii) by substitution in the 6-membered ring to any extent with alkyl, alkoxy, haloalkyl, thioalkyl, alkylenedioxy, or halide substituents;
(iv) by substitution at the 2-position of the tryptamine ring system with an alkyl substituent; F295]
(c) the following phenethylamine derivatives, namelyβ
Allyl(a-methyl-3,4-methylenedioxyphenethyl)amine
2-Amino-1-(2,5-dimethoxy-4-methylphenyl)ethanol
2-Amino-1-(3,4-dimethoxyphenyl)ethanol
Benzyl(a-methyl-3,4-methylenedioxyphenethyl)amine
4-Bromo- b ,2,5-trimethoxyphenethylamine
N -(4- sec -Butylthio-2,5-dimethoxyphenethyl)hydroxylamine
Cyclopropylmethyl(a-methyl-3,4-methylenedioxyphenethyl)amine
2-(4,7-Dimethoxy-2,3-dihydro-1H-indan-5-yl)ethylamine
2-(4,7-Dimethoxy-2,3-dihydro-1H-indan-5-yl)-1-methylethylamine
2-(2,5-Dimethoxy-4-methylphenyl)cyclopropylamine
2-(1,4-Dimethoxy-2-naphthyl)ethylamine
2-(1,4-Dimethoxy-2-naphthyl)-1-methylethylamine
N -(2,5-Dimethoxy-4-propylthiophenethyl)hydroxylamine
2-(1,4-Dimethoxy-5,6,7,8-tetrahydro-2-naphthyl)ethylamine
2-(1,4-Dimethoxy-5,6,7,8-tetrahydro-2-naphthyl)-1-methylethylamine
a,a-Dimethyl-3,4-methylenedioxyphenethylamine
a,a-Dimethyl-3,4-methylenedioxyphenethyl(methyl)amine
Dimethyl(a-methyl-3,4-methylenedioxyphenethyl)amine
N -(4-Ethylthio-2,5-dimethoxyphenethyl)hydroxylamine
4-Iodo-2,5-dimethoxy-a-methylphenethyl(dimethyl)amine
2-(1,4-Methano-5,8-dimethoxy-1,2,3,4-tetrahydro-6-naphthyl)ethylamine
2-(1,4-Methano-5,8-dimethoxy-1,2,3,4-tetrahydro-6-naphthyl)-1-methylethylamine
2-(5-Methoxy-2,2-dimethyl-2,3-dihydrobenzo[ b ]furan-6-yl)-1-methylethylamine
2-Methoxyethyl(a-methyl-3,4-methylenedioxyphenethyl)amine
2-(5-Methoxy-2-methyl-2,3-dihydrobenzo[ b ]furan-6-yl)-1-methylethylamine
b-Methoxy-3,4-methylenedioxyphenethylamine
1-(3,4-Methylenedioxybenzyl)butyl(ethyl)amine
1-(3,4-Methylenedioxybenzyl)butyl(methyl)amine
2-(a-Methyl-3,4-methylenedioxyphenethylamino)ethanol
a-Methyl-3,4-methylenedioxyphenethyl(prop-2-ynyl)amine
N -Methyl- N -(a-methyl-3,4-methylenedioxyphenethyl)hydroxylamine
O -Methyl- N -(a-methyl-3,4-methylenedioxyphenethyl)hydroxylamine
a-Methyl-4-(methylthio)phenethylamine
b,3,4,5-Tetramethoxyphenethylamine
b,2,5-Trimethoxy-4-methylphenethylamine
(d) any compound (not being methoxyphenamine or a compound for the time being specified in sub-paragraph (a) above) structurally derived from phenethylamine, an N -alkylphenethylamine,a-methylphenethylamine, an N -alkyl-a-methylphenethylamine,a-ethylphenethylamine, or an N -alkyl-a-ethylphenethylamine by substitution in the ring to any extent with alkyl, alkoxy, alkylenedioxy or halide substitutents, whether or not further substituted in the ring by one or more other univalent substituents;
(e) any compound (not being a compound for the time being specified in Schedule 2) structurally derived from fentanyl by modification in any of the following ways, that is to say -
(i) by replacement of the phenyl portion of the phenethyl group by any heteromonocycle whether or not further substituted in the heterocycle;
(ii) by substitution in the phenethyl group with alkyl, alkenyl, alkoxy, hydroxy, halogeno, haloalkyl, amino or nitro groups;
(iii) by substitution in the piperidine ring with alkyl or alkenyl groups;
(iv) by substitution in the aniline ring with alkyl, alkoxy, alkylenedioxy, halogeno or haloalkyl groups;
(v) by substitution at the 4-position of the piperidine ring with any alkoxycarbonyl or alkoxyalkyl or acyloxy group;
(vi) by replacement of the N -propionyl group by another acyl group;
(f) any compound (not being a compound for the time being specified in Schedule 2) structurally derived from pethidine by modification in any of the following ways, that is to sayβ
(i) by replacement of the l-methyl group by an acyl, alkyl whether or not unsaturated, benzyl or phenethyl group, whether or not further substituted;
(ii) by substitution in the piperidine ring with alkyl or alkenyl groups or with a propano bridge, whether or not further substituted;
(iii) by substitution in the 4-phenyl ring with alkyl, alkoxy, aryloxy, halogeno or haloalkyl groups;
(iv) by replacement of the 4-ethoxycarbonyl by any other alkoxycarbonyl or any alkoxyalkyl or acyloxy group;
(v) by formation of an N-oxide or of a quaternary base.
[F296 (g) 1βbenzylpiperazine or any compound (not being a compound for the time being specified in Schedule 4) structurally derived from 1βbenzylpiperazine or 1βphenylpiperazine by modification in any of the following waysβ
(i) by substitution at the second nitrogen atom of the piperazine ring with alkyl, benzyl, haloalkyl or phenyl groups;
(ii) by substitution in the aromatic ring to any extent with alkyl, alkoxy, alkylenedioxy, halide or haloalkyl groups;
[F297 (h) Any compound structurally derived from 3β(1βnaphthoyl)indole, 3-(2-naphthoyl)indole, 1Hβindolβ3βylβ(1βnaphthyl)methane or 1H-indol-3-yl-(2-naphthyl)methane by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, ( N -methylpiperidin-2-yl)methyl or 2β(4βmorpholinyl)ethyl, whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent.
(i) Any compound structurally derived from 3β(1βnaphthoyl)pyrrole or 3-(2-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, ( N -methylpiperidin-2-yl)methyl or 2β(4βmorpholinyl)ethyl, whether or not further substituted in the pyrrole ring to any extent and whether or not substituted in the naphthyl ring to any extent.
(j) Any compound structurally derived from 1β(1βnaphthylmethylene)indene or 1-(2-naphthylmethylene)indene by substitution at the 3βposition of the indene ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, ( N -methylpiperidin-2-yl)methyl or 2β(4βmorpholinyl)ethyl, whether or not further substituted in the indene ring to any extent and whether or not substituted in the naphthyl ring to any extent.
(k) Any compound structurally derived from 3βphenylacetylindole by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, ( N -methylpiperidin-2-yl)methyl or 2β(4βmorpholinyl)ethyl, whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent. F297]
(l) any compound structurally derived from 2β(3βhydroxycyclohexyl)phenol by substitution at the 5βposition of the phenolic ring by alkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl or 2β(4βmorpholinyl)ethyl, whether or not further substituted in the cyclohexyl ring to any extent. F296]
[F298 (la) Any compound structurally derived from 3-benzoylindole by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, ( N -methylpiperidin-2-yl)methyl or 2β(4βmorpholinyl)ethyl, whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent.
(lb) Any compound structurally derived from 3-(1-adamantoyl)indole or 3-(2-adamantoyl)indole by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, ( N -methylpiperidin-2-yl)methyl or 2β(4βmorpholinyl)ethyl, whether or not further substituted in the indole ring to any extent and whether or not substituted in the adamantyl ring to any extent.
(lc) Any compound structurally derived from 3-(2,2,3,3-tetramethylcyclopropylcarbonyl)indole by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, ( N -methylpiperidin-2-yl)methyl or 2β(4βmorpholinyl)ethyl, whether or not further substituted in the indole ring to any extent. F298]
[F299 (ld) [F300 Any compound (not being a compound for the time being specified in sub-paragraphs (h) to (lc) above) structurally related to 1-pentyl-3-(1-naphthoyl)indole (JWH-018), in that the four sub-structures, that is to say the indole ring, the pentyl substituent, the methanone linking group and the naphthyl ring, are linked together in a similar manner, whether or not any of the sub-structures have been modified, and whether or not substituted in any of the linked sub-structures with a benzyl or phenyl group and whether or not such compound is further substituted to any extent with alkyl, alkenyl, alkoxy, halide, haloalkyl or cyano substituents and, where any of the sub-structures have been modified, the modifications of the sub-structures are limited to any of the following, that is to sayβ F300]
(i) replacement of the indole ring with indane, indene, indazole, pyrrole, pyrazole, imidazole, benzimidazole, pyrrolo[2,3-b]pyridine, pyrrolo[3,2-c]pyridine or pyrazolo[3,4-b]pyridine;
(ii) replacement of the pentyl substituent with alkyl, alkenyl, benzyl, cycloalkylmethyl, cycloalkylethyl, ( N -methylpiperidin-2-yl)methyl, 2-(4-morpholinyl)ethyl or (tetrahydropyran-4-yl)methyl;
(iii) replacement of the methanone linking group with an ethanone, carboxamide, carboxylate, methylene bridge or methine group;
(iv) replacement of the 1-naphthyl ring with 2-naphthyl, phenyl, benzyl, adamantyl, cycloalkyl, cycloalkylmethyl, cycloalkylethyl, bicyclo[2.2.1]heptanyl, 1,2,3,4-tetrahydronaphthyl, quinolinyl, isoquinolinyl, 1-amino-1-oxopropan-2-yl, 1-hydroxy-1-oxopropan-2-yl, piperidinyl, morpholinyl, pyrrolidinyl, tetrahydropyranyl or piperazinyl; F299]
[F301 (m) Any compound (not being bupropion, diethylpropion, pyrovalerone or a compound for the time being specified in subβparagraph (a) above) structurally derived from 2βaminoβ1βphenylβ1βpropanone by modification in any of the following ways, that is to sayβ
(i) by substitution in the phenyl ring to any extent with alkyl, alkoxy, alkylenedioxy, haloalkyl or halide substituents, whether or not further substituted in the phenyl ring by one or more other univalent substituents;
(ii) by substitution at the 3βposition with an alkyl substituent;
(iii) by substitution at the nitrogen atom with alkyl or dialkyl groups, or by inclusion of the nitrogen atom in a cyclic structure. F301]
[F302 (n) Any compound structurally derived from 2βaminopropanβ1βone by substitution at the 1-position with any monocyclic, or fusedβpolycyclic ring system (not being a phenyl ring or alkylenedioxyphenyl ring system), whether or not the compound is further modified in any of the following ways, that is to sayβ
(i) by substitution in the ring system to any extent with alkyl, alkoxy, haloalkyl or halide substituents, whether or not further substituted in the ring system by one or more other univalent substituents;
(ii) by substitution at the 3βposition with an alkyl substituent;
(iii) by substitution at the 2-amino nitrogen atom with alkyl or dialkyl groups, or by inclusion of the 2-amino nitrogen atom in a cyclic structure. F302]
[F303 (o) Any compound (not being pipradrol) structurally derived from piperidine, pyrrolidine, azepane, morpholine or pyridine by substitution at a ring carbon atom with a diphenylmethyl group, whether or not the compound is further modified in any of the following ways, that is to say,
(i) by substitution in any of the phenyl rings to any extent with alkyl, alkoxy, haloalkyl or halide groups;
(ii) by substitution at the methyl carbon atom with an alkyl, hydroxyalkyl or hydroxy group;
(iii) by substitution at the ring nitrogen atom with an alkyl, alkenyl, haloalkyl or hydroxyalkyl group. F303]
[F304 (p) 1-Phenylcyclohexylamine or any compound (not being eticyclidine, ketamine, phencyclidine, rolicyclidine, tenocyclidine or tiletamine) structurally derived from 1-phenylcyclohexylamine or 2-amino-2-phenylcyclohexanone by modification in any of the following ways, that is to say,
(i) by substitution at the nitrogen atom to any extent by alkyl, alkenyl or hydroxyalkyl groups, or replacement of the amino group with a 1-piperidyl, 1-pyrrolidyl or 1-azepyl group, whether or not the nitrogen containing ring is further substituted by one or more alkyl groups;
(ii) by substitution in the phenyl ring to any extent by amino, alkyl, hydroxy, alkoxy or halide substituents, whether or not further substituted in the phenyl ring to any extent;
(iii) by substitution in the cyclohexyl or cyclohexanone ring by one or more alkyl substituents;
(iv) by replacement of the phenyl ring with a thienyl ring. F304]
[F305 (q) Any compound (not being benzyl(Ξ±-methyl-3,4-methylenedioxyphenethyl)amine) structurally derived from mescaline, 4-bromo-2,5-dimethoxy-Ξ±-methylphenethylamine, 2,5-dimethoxy-Ξ±,4-dimethylphenethylamine, N -hydroxytenamphetamine, or a compound specified in sub-paragraph (c) or (d) above, by substitution at the nitrogen atom of the amino group with a benzyl substituent, whether or not substituted in the phenyl ring of the benzyl group to any extent;
(r) Any compound (not being a compound for the time being specified in sub- paragraph (c) above) structurally derived from 1-benzofuran, 2,3-dihydro-1-benzofuran, 1H-indole, indoline, 1H-indene, or indane by substitution in the 6-membered ring with a 2-ethylamino substituent whether or not further substituted in the ring system to any extent with alkyl, alkoxy, halide or haloalkyl substituents and whether or not substituted in the ethylamino side-chain with one or more alkyl substituents. F305]
[F306 (s) any compound (not being a compound for the time being specified in sub-paragraph (a) above) with a maximum molecular mass of 500 atomic mass units and structurally derived from 2-(2-benzyl-benzimidazol-1-yl)ethanamine by modification in any of the following ways, that is to sayβ
(i) by substitution at the nitrogen of the ethanamine to any extent by alkyl substituents containing up to three carbon atoms or alkenyl substituents containing up to three carbon atoms or by inclusion of the nitrogen atom (and no other atoms of the side chain) in a cyclic structure;
(ii) by substitution in the phenyl ring of the benzyl system to any extent by alkyl or haloalkyl containing up to six carbon atoms, alkoxy or haloalkoxy containing up to five carbon atoms, acetyloxy, hydroxy, cyano, halogen, thioalkyl containing up to five carbon atoms or alkylsulphonyl containing up to five carbon atoms;
(iii) by substitution at the 5- or 6- positions of the benzimidazole system by nitro, acetyl, cyano, methoxy, trifluoromethyl, trifluoromethoxy or halogen substituents;
(iv) by substitution at the benzylic carbon by a methyl group;
(v) by replacement of the benzylic carbon by a nitrogen, oxygen or sulphur atom;
(vi) by substitution in the phenyl ring of the benzyl system by an ethoxy group linked back to the phenyl ring to form a dihydrobenzofuran structure;
(vii) by replacement of the phenyl ring of the benzyl system by methylenedioxyphenyl. F306]
2. Any stereoisomeric form of a substance specified in paragraph 1.
[F307 3. Any ester or ether of a substance specified in paragraph 1 (not being 2-((dimethylamino)methyl)-1-(3-hydroxyphenyl)cyclohexanol) or paragraph 2. F307]
4. Any salt of a substance specified in any of paragraphs 1 to 3.
5. Any preparation or other product containing a substance or product specified in any of paragraphs 1 to 4, not being a preparation specified in Schedule 5.
[F308 6. But paragraphs 1 to 5 do not include a cannabis-based product for medicinal use in humans. F308]
Regulation 3
SCHEDULE 2 CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 14, 15, 16, [F309 16A, F309] 18, 19, 20, 21, 23, 26 AND 27
1. The following substances and products, namelyβ
Acetorphine
Alfentanil
Allylprodine
Alphacetylmethadol
Alphameprodine
Alphamethadol
Alphaprodine
[F310 Amineptine F310]
Anileridine
Benzethidine
Benzylmorphine (3-benzylmorphine)
Betacetylmethadol
Betameprodine
Betamethadol
Betaprodine
Bezitramide
[F311Cannabis-based product for medicinal use in humansF311]
Carfentanil
F312 ...
Cocaine
Desomorphine
Dextromoramide
Diamorphine
Diampromide
Diethylthiambutene
Difenoxin
Dihydrocodeinone O -carboxymethyloxime
[F313 Dihydroetorphine F313]
Dihydromorphine
Dimenoxadole
Dimepheptanol
Dimethylthiambutene
Dioxaphetyl butyrate
Diphenoxylate
Dipipanone
Dronabinol
Drotebanol
Ecgonine, and any derivative of ecgonine which is convertible to ecgonine or to cocaine
Ethylmethylthiambutene
F312 ...
Etorphine
Etoxeridine
Fentanyl
Furethidine
Hydrocodone
Hydromorphinol
Hydromorphone
[F314 4-Hydroxy-n-butyric acid F314]
Hydroxypethidine
Isomethadone
[F315 Ketamine F315]
Ketobemidone
Levomethorphan
Levomoramide
Levophenacylmorphan
Levorphanol
[F316 Lisdexamphetamine F316]
Lofentanil
Medicinal opium
Metazocine
Methadone
Methadyl acetate
Methyldesorphine
Methyldihydromorphine (6-methyldihydromorphine)
Metopon
Morpheridine
Morphine
Morphine methobromide, morphine N-oxide and other pentavalent nitrogen morphine derivatives
Myrophine
[F317 Nabilone F317]
Nicomorphine
Noracymethadol
Norlevorphanol
Normethadone
Normorphine
Norpipanone
[F318 Oripavine F318]
Oxycodone
Oxymorphone
Pethidine
Phenadoxone
Phenampromide
Phenazocine
Phencyclidine
Phenomorphan
Phenoperidine
Piminodine
Piritramide
Proheptazine
Properidine
Racemethorphan
Racemoramide
Racemorphan
[F319 Remifentanil F319]
Sufentanil
[F320 Tapentadol F320]
Thebacon
Thebaine
Tilidate
Trimeperidine
Zipeprol
4-Cyano-2-dimethylamino-4,4-diphenylbutane
4-Cyano-1-methyl-4-phenylpiperidine
2-Methyl-3-morpholino-1,1-diphenylpropane-carboxylic acid
a-Methylphenethylhydroxylamine
1-Methyl-4-phenylpiperidine-4-carboxylic acid
4-Phenylpiperidine-4-carboxylic acid ethyl ester
2. Any stereoisomeric form of a substance specified in paragraph 1 not being dextromethorphan or dextrorphan.
3. Any ester or ether of a substance specified in paragraph 1 or 2, not being a substance specified in paragraph 6.
4. Any salt of a substance specified in any of paragraphs 1 to 3.
5. Any preparation or other product containing a substance or product specified in any of paragraphs 1 to 4, not being a preparation specified in Schedule 5.
[F321 5A. But paragraphs 2 to 5 only apply in respect of a cannabis-based product for medicinal use in humans if the cannabis-based product that would, as a consequence of paragraphs 2 to 5, be specified in this Schedule but for the operation of this paragraph, is produced for medicinal use in humans. F321]
6. The following substances and products, namelyβ
Acetyldihydrocodeine | Methaqualone |
Amphetamine | Methylamphetamine |
Codeine | Methylphenidate |
Dextropropoxyphene | Nicocodine |
Dihydrocodeine | Nicodicodine (6-nicotinoyldihydrocodeine) |
Ethylmorphine (3-ethylmorphine) | Norcodeine |
Fenethylline | Phenmetrazine |
Glutethimide | Pholcodine |
Lefetamine | Propiram |
Mecloqualone | Quinalbarbitone |
7. Any stereoisomeric form of a substance specified in paragraph 6.
8. Any salt of a substance specified in paragraph 6 or 7.
9. Any preparation or other product containing a substance or product specified in any of paragraphs 6 to 8, not being a preparation specified in Schedule 5.
Regulation 3
SCHEDULE 3 F322 CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 14, 15 ..., 16, 18, 22, 23, 24, 26 AND 27
1. The following substances, namelyβ
(a)
Benzphetamine
[F323 7-bromo-5-(2-chlorophenyl)-1,3-dihydro-2 H -1,4-benzodiazepin-2-one F323]
Buprenorphine
Cathine
Chlorphentermine
Diethylpropion
Ethchlorvynol
Ethinamate
Flunitrazepam
[F324 Gabapentin (1β(aminomethyl)cyclohexaneacetic acid) F324]
Mazindol
Mephentermine
Meprobamate
Methylphenobarbitone
Methyprylone
[F325 Midazolam F325]
Pentazocine
Phendimetrazine
Phentermine
Pipradrol
[F326 Pregabalin (( S ) β 3β(aminomethyl)-5-methylhexanoic acid) F326]
Temazepam
[F327 Tramadol F327]
(b) any 5, 5 disubstituted barbituric acid not being quinalbarbitone.
[F328 2. Any stereoisomeric form of a substance specified in paragraph 1 or 3 not being phenylpropanolamine.
3. [F329 Anyβ
(a) ester or ether of pipradrol; or
(b) ester of gabapentin (1β(aminomethyl)cyclohexaneacetic acid) or pregabalin (( S ) β 3β(aminomethyl)-5-methylhexanoic acid). F329]
4. Any salt of a substance specified in any of paragraphs 1 to 3.
5. Any preparation or other product containing a substance specified in any of paragraphs 1 to 4, not being a preparation specified in Schedule 5. F328]
Regulation 3
SCHEDULE 4
PART I CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 22, 23, 26 AND 27
1. The following substances and products, namelyβ
Alprazolam
Aminorex
Bromazepam
Brotizolam
Camazepam
Chlordiazepoxide
[F330 1β(3βchlorophenyl)piperazine F330]
[F330 1β(3βchlorophenyl)β4β(3βchloropropyl)piperazine F330]
Clobazam
Clonazepam
Clorazepic acid
Clotiazepam
Cloxazolam
Delorazepam
Diazepam
Estazolam
Ethyl loflazepate
Fencamfamin
Fenproporex
Fludiazepam
Flurazepam
Halazepam
Haloxazolam
F331 ...
F332 ...
Ketazolam
Loprazolam
Lorazepam
Lormetazepam
Medazepam
Mefenorex
Mesocarb
F333 ...
Nimetazepam
Nitrazepam
Nordazepam
Oxazepam
Oxazolam
Pemoline
Pinazepam
Prazepam
Pyrovalerone
[F334 Remimazolam F334]
Tetrazepam
Triazolam
[F335 Xylazine F335]
N -Ethylamphetamine
[F336 Zaleplon F336]
[F337 Zolpidem F337]
[F338 Zopiclone F338]
2. Any stereoisomeric form of a substance specified in paragraph 1.
3. Any salt of a substance specified in paragraph 1 or 2.
4. Any preparation or other product containing a substance or product specified in any of paragraphs 1 to 3, not being a preparation specified in Schedule 5.
[F339 5. A liquid formulationβ
(a) containing a botanical extract of cannabisβ
(i) with a concentration of not more than 30 milligrams of cannabidiol per millilitre, and not more than 30 milligrams of delta-9-tetrahydrocannabinol per millilitre, and
(ii) where the ratio of cannabidiol to delta-9-tetrahydrocannabinol is between 0.7 and 1.3,
(b) which is dispensed through a metered dose pump as a mucosal mouth spray, and
(c) which was approved for marketing by the Medicines and Healthcare Products Regulatory Agency on 16 th June 2010 F339]
PART II [F340 Controlled Drugs Excepted From the Prohibition on Possession; Excluded from the Application of Offences Arising from the Prohibition on Importation and Exportation when Carried Out in Person for Administration to That Person; and Subject to the Requirements of Regulations 22, 23, 26 and 27 F340]
1. The following substances, namelyβ
[F341 5Ξ±βAndrostaneβ3,17βdiol F341]
[F341 Androst-4-ene-3,17-diol F341]
[F341 1βAndrostenediol F341]
[F341 1βAndrostenedione F341]
[F342 4-Androstene-3, 17-dione F342]
[F343 5βAndrostenedione F343]
[F342 5-Androstene-3, 17 diol F342]
Atamestane
Bolandiol
Bolasterone
Bolazine
Boldenone
[F344 Boldione F344]
Bolenol
Bolmantalate
Calusterone
4-Chloromethandienone
Clostebol
[F345 Danazol F345]
[F345 Desoxymethyltestosterone F345]
[F346 Dienedione (estra-4, 9-diene-3,17-dione) F346]
Drostanolone
Enestebol
Epitiostanol
Ethyloestrenol
Fluoxymesterone
Formebolone
Furazabol
[F347 Gestrinone F347]
[F347 3βHydroxyβ5Ξ±βandrostanβ17βone F347]
Mebolazine
Mepitiostane
Mesabolone
Mestanolone
Mesterolone
Methandienone
Methandriol
Methenolone
Methyltestosterone
Metribolone
Mibolerone
Nandrolone
[F348 19βNorandrostenedione F348]
[F349 19-Nor-4-Androstene-3, 17-dione F349]
[F349 19-Nor-5-Androstene-3, 17 diol F349]
[F350 19βNorandrosterone F350]
Norboletone
Norclostebol
Norethandrolone
[F351 19βNoretiocholanolone F351]
Ovandrotone
Oxabolone
Oxandrolone
Oxymesterone
Oxymetholone
Prasterone
Propetandrol
[F352 Prostanozol F352]
Quinbolone
Roxibolone
Silandrone
Stanolone
Stanozolol
Stenbolone
Testosterone
[F353 Tetrahydrogestrinone F353]
Thiomesterone
Trenbolone
2. Any compound (not being Trilostane or a compound for the time being specified in paragraph 1 of this Part of this Schedule) structurally derived from 17-hydroxyandrostan-3-one or from 17-hydroxyestran-3-one by modification in any of the following ways, that is to say -
(a) by further substitution at position 17 by a methyl or ethyl group;
(b) by substitution to any extent at one or more of positions 1, 2, 4, 6, 7, 9, 11 or 16, but at no other position;
(c) by unsaturation in the carbocyclic ring system to any extent, provided that there are no more than two ethylenic bonds in any one carbocyclic ring;
(d) by fusion of ring A with a heterocyclic system.
3. Any substance which is an ester or ether (or, where more than one hydroxyl function is available, both an ester and an ether) of a substance specified in paragraph 1 or described in paragraph 2 of this Part of this Schedule.
4. The following substances, namelyβ
Chorionic Gonadotrophin (HCG)
Clenbuterol
Non-human chorionic gonadotrophin
Somatotropin
Somatrem
Somatropin
[F354 Zeranol F354]
[F354 Zilpaterol F354]
5. Any stereoisomeric form of a substance specified or described in any of paragraphs 1 to 4 of this Part of this Schedule.
6. Any salt of a substance specified or described in any of paragraphs 1 to 5 of this Part of this Schedule.
7. Any preparation or other product containing a substance or product specified or described in any of paragraphs 1 to 6 of this Part of this Schedule, not being a preparation specified in Schedule 5.
Regulation 3
SCHEDULE 5 CONTROLLED DRUGS EXCEPTED FROM THE PROHIBITION ON IMPORTATION, EXPORTATION AND POSSESSION [F355 (APART FROM NITROUS OXIDE) F355] AND SUBJECT TO THE REQUIREMENTS OF REGULATIONS 24 AND 26
1. β(1) Any preparation of one or more of the substances to which this paragraph applies, not being a preparation designed for administration by injection, when compounded with one or more other active or inert ingredients and containing a total of not more than 100 milligrams of the substance or substances (calculated as base) per dosage unit or with a total concentration of not more than 2.5% (calculated as base) in undivided preparations.
(2) The substances to which this paragraph applies are acetyldihydrocodeine, codeine, dihydrocodeine, ethylmorphine, nicocodine, nicodicodine (6-nicotinoyldihydrocodeine), norcodeine and pholcodine and their respective salts.
F356 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3. Any preparation of medicinal opium or of morphine containing (in either case) not more than 0.2% of morphine calculated as anhydrous morphine base, being a preparation compounded with one or more other active or inert ingredients in such a way that the opium or, as the case may be, the morphine cannot be recovered by readily applicable means or in a yield which would constitute a risk to health.
4. Any preparation of dextropropoxyphene, being a preparation designed for oral administration, containing not more than 135 milligrams of dextropropoxyphene (calculated as base) per dosage unit or with a total concentration of not more than 2.5% (calculated as base) in undivided preparations.
5. Any preparation of difenoxin containing, per dosage unit, not more than 0.5 milligrams of difenoxin and a quantity of atropine sulphate equivalent to at least 5% of the dose of difenoxin.
6. Any preparation of diphenoxylate containing, per dosage unit, not more than 2.5 milligrams of diphenoxylate calculated as base, and a quantity of atropine sulphate equivalent to at least 1% of the dose of diphenoxylate.
7. Any preparation of propiram containing, per dosage unit, not more than 100 milligrams of propiram calculated as base and compounded with at least the same amount (by weight) of methylcellulose.
8. Any powder of ipecacuanha and opium comprisingβ
10% opium, in powder,
10% ipecacuanha root, in powder, well mixed with
80% of any other powdered ingredient containing no controlled drug.
9. Any mixture containing one or more of the preparations specified in paragraphs 1 to 8, being a mixture of which none of the other ingredients is a controlled drug.
[F357 10. A liquid formulationβ
(a) containing cannabidiol obtained by extraction and purification from cannabis;
(b) where the concentration ofβ
(i) delta-9-tetrahydrocannabinol is not more than 0.1 milligram per millilitre; and
(ii) cannabidiol is 95-105 milligrams per millilitre;
(c) which is presented in a bottle, as an oral solution for oral administration; and
(d) which was approved for marketing by the European Commission on 19th September 2019. F357]
[F358 11. Nitrous oxide. F358]
Regulation 19
F359 SCHEDULE 6 FORM OF REGISTER
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 28
SCHEDULE 7 REGULATIONS REVOKED
Regulations revoked | References |
---|---|
The Misuse of Drugs Regulations 1985 | S.I. 1985/2066 |
The Misuse of Drugs (Amendment) Regulations 1986 | S.I. 1986/2330 |
The Misuse of Drugs (Amendment) Regulations 1988 | S.I. 1988/916 |
The Misuse of Drugs (Amendment) Regulations 1989 | S.I. 1989/1460 |
The Misuse of Drugs (Amendment) Regulations 1990 | S.I. 1990/2630 |
The Misuse of Drugs (Amendment) Regulations 1995 | S.I. 1995/2048 |
The Misuse of Drugs (Amendment No. 2) Regulations 1995 | S.I. 1995/3244 |
The Misuse of Drugs (Amendment) Regulations 1996 | S.I. 1996/1597 |
The Misuse of Drugs (Amendment) Regulations 1998 | S.I. 1998/882 |
The Misuse of Drugs (Amendment) Regulations 1999 | S.I. 1999/1404 |
[F361 Regulations 6(2), 8(8), 9(8) and 10(2) F361]
[F360 SCHEDULE 8
1. Any of the following persons may supply or administer a specified controlled drug under a patient group direction, namelyβ
(a) 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 F362 ... registered paramedic;
F363 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) a registered midwife;
[F364 (d) a registered optometrist;
(e) a registered chiropodist;
(f) a registered orthoptist;
(g) a registered physiotherapist;
(h) a registered radiographer; F364]
[F365 (i) a registered occupational therapist;
(j) a registered orthotist and prosthetist; F365]
[F366 (k) a pharmacistF366,F360]] ;