The Misuse of Drugs Regulations 2001

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

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

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

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

Licences to produce etc. controlled drugs

General authority to supply and possess

Supply of articles for administering or preparing controlled drugs

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

Production and supply of drugs in Schedules 2 and 5

Possession of drugs in Schedules 2, 3 and 4

Exemption for midwives

Cultivation under licence of cannabis plant

Approval of premises for cannabis smoking for research purposes

Documents to be obtained by supplier of controlled drugs

Form of prescriptions

Provisions as to supply on prescription

Exemption for certain prescriptions

Marking of bottles and other containers

Requirements as to registers

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

Preservation of registers, books and other documents

Preservation of records relating to drugs in Schedules 3 and 5

Exempt products

Furnishing of information with respect to controlled drugs

Destruction of controlled drugs

Revocations

Authority for Extended Formulary Nurse Prescribers to prescribe

6B

• (1) Subject to paragraph (2) of this regulation, a nurse independent prescriber or a pharmacist independent prescriber may prescribe any controlled drug specified in Schedule 2, 3, 4 or5.

• (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.

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

Production and supply of drugs in Schedules 2 and 5

Possession of drugs in Schedules 2, 3 and 4

Exemption for midwives

Cultivation under licence of cannabis plant

Approval of premises for cannabis smoking for research purposes

Documents to be obtained by supplier of controlled drugs

Form of prescriptions

Provisions as to supply on prescription

Exemption for certain prescriptions

Marking of bottles and other containers

Requirements as to registers

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

Preservation of registers, books and other documents

Preservation of records relating to drugs in Schedules 3 and 5

Preservation of records: supplementary

24A

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

Exempt products

Furnishing of information with respect to controlled drugs

Destruction of controlled drugs

Revocations

Authority for Nurse Independent Prescribers to prescribe

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Exceptions for gamma–butyrolactone and 1,4–butanediol

4B

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

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

• (a) any salt of gamma–butyrolactone; and

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

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

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

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

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

Licences to produce etc. controlled drugs

General authority to supply and possess

Supply of articles for administering or preparing controlled drugs

Authority for Nurse Independent Prescribers and Pharmacist Independent Prescribers to prescribe

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

Production and supply of drugs in Schedules 2 and 5

Possession of drugs in Schedules 2, 3 and 4

Exemption for midwives

Cultivation under licence of cannabis plant

Approval of premises for cannabis smoking for research purposes

Documents to be obtained by supplier of controlled drugs

Form of prescriptions

Provisions as to supply on prescription

Exemption for certain prescriptions

Marking of bottles and other containers

Requirements as to registers

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

Preservation of registers, books and other documents

Preservation of records relating to drugs in Schedules 3 and 5

Preservation of records: supplementary

Exempt products

Furnishing of information with respect to controlled drugs

Destruction of controlled drugs

Revocations

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.

Authority for Physiotherapist Independent Prescribers and Chiropodist Independent Prescribers to prescribe

6C

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

• (a) Diazepam by oral administration

• (b) Dihydrocodeine by oral administration

• (c) Fentanyl by transdermal administration

• (d) Lorazepam by oral administration

• (e) Morphine by oral administration or by injection

• (f) Oxycodone by oral administration

• (g) Temazepam by oral administration.

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

• (a) Diazepam by oral administration

• (b) Dihydrocodeine by oral administration

• (c) Lorazepam by oral administration

• (d) Temazepam by oral administration.

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

Production and supply of drugs in Schedules 2 and 5

Possession of drugs in Schedules 2, 3 and 4

Exemption for midwives

Cultivation under licence of cannabis plant

Approval of premises for cannabis smoking for research purposes

Documents to be obtained by supplier of controlled drugs

Form of prescriptions

Provisions as to supply on prescription

Exemption for certain prescriptions

Marking of bottles and other containers

Requirements as to registers

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

Preservation of registers, books and other documents

Preservation of records relating to drugs in Schedules 3 and 5

Preservation of records: supplementary

Exempt products

Furnishing of information with respect to controlled drugs

Destruction of controlled drugs

Revocations

Orders, supply and use of cannabis-based products for administration

16A

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

• (a) a special medicinal product that—

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

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

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

• (c) a medicinal product with a marketing authorisation.

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

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

• (b) is—

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

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

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

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

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

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

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

Exemption for certain prescriptions

Marking of bottles and other containers

Requirements as to registers

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

Preservation of registers, books and other documents

Preservation of records relating to drugs in Schedules 3 and 5

Preservation of records: supplementary

Exempt products

Furnishing of information with respect to controlled drugs

Destruction of controlled drugs

Revocations

6

But paragraphs 1 to 5 do not include a cannabis-based product for medicinal use in humans.

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.

Directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.

10A

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

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

• (i) pandemic, and

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

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

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

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

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

• (iii) during the period specified in the announcement,

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

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

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

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

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

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

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

Exemption for midwives

Cultivation under licence of cannabis plant

Approval of premises for cannabis smoking for research purposes

Documents to be obtained by supplier of controlled drugs

Form of prescriptions

Provisions as to supply on prescription

Orders, supply and use of cannabis-based products for administration

Exemption for certain prescriptions

Marking of bottles and other containers

Requirements as to registers

Record-keeping requirements in respect of drugs in Schedule 2 in particular cases

Preservation of registers, books and other documents

Preservation of records relating to drugs in Schedules 3 and 5

Preservation of records: supplementary

Exempt products

Furnishing of information with respect to controlled drugs

Destruction of controlled drugs

Revocations

10

A liquid formulation—

• (a) containing cannabidiol obtained by extraction and purification from cannabis;

• (b) where the concentration of—

• (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.

Exemptions for nitrous oxide

4C

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

• (a) intends to wrongfully inhale it; or

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

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

• (a) intends to wrongfully inhale it; or

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

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

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

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

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

• (a) intends to wrongfully inhale it; or

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

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

• (a) for medical or dental purposes; or

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

Licences to produce etc. controlled drugs

General authority to supply and possess

Supply of articles for administering or preparing controlled drugs

Authority for Nurse Independent Prescribers and Pharmacist Independent Prescribers to prescribe

Authority for Physiotherapist Independent Prescribers and Chiropodist Independent Prescribers to prescribe

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

Production and supply of drugs in Schedules 2 and 5

Possession of drugs in Schedules 2, 3 , 4 and nitrous oxide

Directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.

Exemption for midwives

Cultivation under licence of cannabis plant

Approval of premises for cannabis smoking for research purposes

Documents to be obtained by supplier of controlled drugs

Form of prescriptions

Provisions as to supply on prescription

Orders, supply and use of cannabis-based products for administration

Exemption for certain prescriptions

Marking of bottles and other containers

Requirements as to registers

Record-keeping requirements in respect of drugs in Schedule 2 in particular cases

Preservation of registers, books and other documents

Preservation of records relating to drugs in Schedules 3 and 5

Preservation of records: supplementary

Exempt products

Furnishing of information with respect to controlled drugs

Destruction of controlled drugs

Revocations

11

Nitrous oxide.

Authority for therapeutic radiographer independent prescribers and paramedic independent prescribers to prescribe

6D

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

• (a) Tramadol by oral administration;

• (b) Lorazepam by oral administration;

• (c) Diazepam by oral administration;

• (d) Morphine by oral administration or by injection;

• (e) Oxycodone by oral administration;

• (f) Codeine by oral administration.

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

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

• (b) Diazepam by oral administration or by injection;

• (c) Midazolam by oromucosal administration or by injection;

• (d) Lorazepam by injection;

• (e) Codeine phosphate by oral administration.

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

Production and supply of drugs in Schedules 3 and 4

Possession of drugs in Schedules 2, 3 , 4 and nitrous oxide

Directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.

Exemption for midwives

Cultivation under licence of cannabis plant

Approval of premises for cannabis smoking for research purposes

Documents to be obtained by supplier of controlled drugs

Form of prescriptions

Provisions as to supply on prescription

Orders, supply and use of cannabis-based products for administration

Exemption for certain prescriptions

Marking of bottles and other containers

Requirements as to registers

Record-keeping requirements in respect of drugs in Schedules 3 and 4

Preservation of registers, books and other documents

Preservation of records relating to drugs in Schedules 3 and 5

Preservation of records: supplementary

Exempt products

Furnishing of information with respect to controlled drugs

Destruction of controlled drugs

Revocations