Correspondence

The Misuse of Drugs Act 1971 (Amendment) (No. 2) Order 2024 and The Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) (No. 2) Regulations 2024

Published 15 January 2025

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This publication is available at https://www.gov.uk/government/publications/circular-0022025-the-misuse-of-drugs-act-1971-order-2024/the-misuse-of-drugs-act-1971-amendment-no-2-order-2024-and-the-misuse-of-drugs-and-misuse-of-drugs-designation-england-and-wales-and-scotland

Changes to the Misuse of Drugs Act 1971 (“the MDA 1971”) to control 22 substances, along with 2-benzyl benzimidazole variants (nitazenes) falling under a new generic definition, under that Act. Further changes to also schedule those substances under the Misuse of Drugs Regulations 2001 (SI 2001/3998) (“the MDR 2001”) and, where appropriate, designate them under the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 (SI 2015/704) (“the 2015 Order”).

Introduction

This circular draws attention to the contents of the below Statutory Instruments, which will come into force at 00.01 on 15 January 2025:

  • The Misuse of Drugs Act 1971 (Amendment) (No. 2) Order 2024 (SI 2024/1361) (“the 2024 Order (No. 2)”)
  • The Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) (No. 2) Regulations 2024 (SI 2024/1369) (“the 2024 Regulations (No. 2)”)

The 2024 Order (No. 2) amends the MDA 1971 to control six substances and introduce a generic definition of nitazenes as Class A drugs and to control 16 substances as Class C drugs.

The 2024 Regulations (No. 2) complement the 2024 Order (No. 2) by amending the MDR 2001 and the 2015 Order, where appropriate, to:

  • add 21 substances controlled by the 2024 Order (No. 2) to Schedule 1 to the MDR 2001 and designate them under the 2015 Order, owing to their lack of recognised medicinal value in the UK;
  • add the generic definition of nitazenes controlled by the 2024 Order (No. 2) to Schedule 1 to the MDR 2001 and designate that definition under the 2015 Order, owing to the lack of recognised medicinal value in the UK of those nitazenes; and
  • add one substance (xylazine) controlled by the 2024 Order (No. 2) to Part 1 of Schedule 4 to the MDR 2001 to enable access for legitimate use in veterinary care as a veterinary medicine.

The SIs are available at www.legislation.gov.uk, at the following links:

SIs are also published by the Stationery Office. Telephone orders and general enquiries: 0330 202 5070.

Background

The MDA 1971 controls drugs that are “dangerous or otherwise harmful”. Schedule 2 to the MDA 1971 specifies these drugs and groups them in three categories – Part 1 lists drugs known as Class A drugs, Part 2 lists Class B drugs and Part 3 lists Class C drugs. The three-tier system of classification (A, B and C) provides a framework within which criminal penalties are set with reference to the harm that a drug has, or is capable of having, when misused, and the type of illegal activity undertaken with regards to that drug. Control under the MDA 1971 also brings those substances previously captured by the Psychoactive Substances Act 2016 outside the ambit of that Act.

The MDR 2001 regulate legitimate access to drugs controlled under the MDA 1971. Controlled drugs are placed in one of five Schedules to the MDR 2001. The Schedule into which a drug is placed is based on an assessment of its medicinal or therapeutic value in the UK, the need for legitimate access and the potential for harm when misused. The Schedule in which a controlled drug is placed primarily dictates the extent to which it is lawful to import, export, produce, possess, supply and administer the controlled drug, and imposes requirements around prescribing, record-keeping, labelling, destruction, disposal and safe custody.

Controlled drugs placed into Schedule 1 of the MDR 2001 are considered to have no known medicinal value in the UK and are subject to the greatest restrictions, requiring a Home Office licence for access to these drugs. Controlled drugs are designated under the 2015 Order where the Secretary of State is of the opinion that it is in the public interest for the production, supply and possession of that drug is either wholly unlawful or unlawful except for research or other special purposes, or for medicinal use of that drug to be unlawful except under licence.

Controlled drugs placed in the other Schedules (2 to 5) to the MDR 2001 are also subject to requirements (albeit less strict than those for controlled drugs placed in Schedule 1). For controlled drugs placed in Part 1 of Schedule 4, those requirements are related to record-keeping, labelling, furnishing of information and destruction.

All amendments made by these instruments follow recommendations from and / or consultation with the Advisory Council on the Misuse of Drugs (ACMD), as is statutorily required by sections 2(5), 7(7) and 31(3) of the MDA 1971.

The Misuse of Drugs Act 1971 (Amendment) (No. 2) Order 2024 and Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) (No. 2) Regulations 2024

Acyl piperazine opioids

In March 2023, the acyl piperazine opioid 2-methyl-AP-237, a type of synthetic opioid, was added to Schedule 1 of the United Nations Single Convention on Narcotic Drugs 1961, to which the UK is a signatory. Following this, the previous Government requested advice from the ACMD on appropriate control under the MDA 1971 and scheduling under associated Regulations. In addition to the review of 2-methyl-AP-237, the ACMD’s report also considered other acyl piperazine opioids, including AP-238, and para-methyl-AP-237, that have been detected in the UK or elsewhere.

The ACMD published its report on 27 March 2024, in which it assessed there to be serious acute health risks associated with these synthetic opioids, such as respiratory depression, which in overdose can lead to death. Though detection of these synthetic opioids was reportedly low at the time in which the ACMD was carrying out its research, the report still deemed them a significant potential threat to public health due to the likelihood of further increases in their prevalence and the potential health and social harms associated with their use.

The ACMD recommended control of four acyl piperazine opioids and two chemically bridged acyl piperazine derivatives as Class A drugs under the MDA 1971 and placement of those substances in Schedule 1 to the MDR 2001 and designation under the 2015 Order. The Government accepted this recommendation. The report is available at the following link: ACMD advice on acyl piperazine opioids, including 2-methyl-AP-237 (accessible) - GOV.UK (www.gov.uk).

The 2024 Order (No. 2) therefore controls the following six synthetic opioids as Class A drugs under the MDA 1971:

  • AP-237;
  • AP-238;
  • Azaprocin;
  • para-methyl-AP-237;
  • para-nitroazaprocin;
  • 2-Methyl-AP-237.

Possession of a Class A drug carries a maximum penalty of up to 7 years in prison, an unlimited fine or both, whilst production and supply carries a maximum penalty of up to life imprisonment, an unlimited fine or both.

The 2024 Regulations (No. 2) complement the 2024 Order (No. 2) by placing these substances in Schedule 1 to the MDR 2001. They also designate them under the 2015 Order as they have no known medicinal value in the UK. This means that they can only be accessed for research, or other special purposes, under a Home Office controlled drug licence issued by the Drugs and Firearms Licensing Unit (DFLU). It is therefore only possible for an authority to lawfully import, export, produce, possess, supply and administer these substances under the aforementioned licence.

A generic definition for 2-benzyl benzimidazole variants (nitazenes)

Following the reported involvement of nitazenes, a type of synthetic opioid, in a number of drug-related deaths and near-fatal overdoses in the UK and elsewhere, the ACMD published a report on 18 July 2022 and several subsequent addenda up to 6 October 2023 that deemed their availability to present a significant potential threat to public health. The ACMD recommended control of a number of nitazenes and the previous Government accepted these recommendations, proceeding to control 15 synthetic opioids, including 14 nitazenes on 20 March 2024. The report also recommended a consultation with relevant stakeholders on, followed by the introduction of a generic definition for, nitazenes, which was further developed through the subsequent addenda discussed below.

On 15 December 2023 and 5 April 2024, the ACMD went on to publish two further addenda to their report, in which they highlighted the emergence of new nitazenes not captured by the generic definition developed through the previous consultation. The relevant ACMD report and addenda are available at the following link: ACMD advice on 2-benzyl benzimidazole and piperidine benzimidazolone opioids - GOV.UK (www.gov.uk). These addenda therefore recommended further consultation on these additional substances, in order to update the generic definition accordingly. Subject to the outcomes of this consultation, the ACMD recommended control, scheduling and designation of all substances falling under this updated generic definition and the Government accepted this recommendation.

The 2024 Order (No. 2) controls all substances falling under the generic definition for nitazenes as Class A drugs under the MDA 1971.

Possession of a Class A drug carries a maximum penalty of up to 7 years in prison, an unlimited fine or both, whilst production and supply carries a maximum penalty of up to life imprisonment, an unlimited fine or both.

The 2024 Regulations (No. 2) complement the 2024 Order (No. 2) by placing substances that fall under the new generic definition for nitazenes in Schedule 1 to the MDR 2001. They also designate them under the 2015 Order as they have no known medicinal value in the UK. This means that they can only be accessed for research, or other special purposes, under a Home Office controlled drug licence issued by the DFLU. It is therefore only possible for an authority to lawfully import, export, produce, possess, supply and administer these substances under the aforementioned licence.

Due to the detection of a number of new benzodiazepines and related compounds in Europe and the UK since the ACMD’s report of 29 April 2020 on novel benzodiazepines, the ACMD provided updated advice on these newly detected substances on 28 March 2024. Benzodiazepines are sedative and anxiolytic (anxiety-reducing) compounds associated with a number of health harms including drowsiness, psychomotor impairment, unsteadiness and incoordination, memory loss and confusion. Higher doses may cause loss of consciousness and respiratory depression, especially if used in combination with alcohol or other sedatives.

Many benzodiazepines are licensed for medicinal use in the UK. However, none of those considered in the ACMD report are licensed as medicines by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This, combined with the health harms covered above, led the ACMD to recommend the control of 15 novel benzodiazepines and related compounds as Class C drugs under the MDA 1971 and their addition to Schedule 1 to the MDR 2001 and the 2015 Order. The previous Government accepted these recommendations. The ACMD’s updated advice on novel benzodiazepines is available at the following link: Uncontrolled novel benzodiazepines: 2024 update - GOV.UK (www.gov.uk).

The 2024 Order (No. 2) therefore controls the following 15 substances as Class C drugs under the MDA 1971:

  • Bentazepam;
  • Bretazenil;
  • 4’-Chloro-deschloroalprazolam;
  • Clobromazolam;
  • Cloniprazepam;
  • Desalkylgidazepam;
  • Deschloroclotizolam;
  • Difludiazepam;
  • Flubrotizolam;
  • Fluclotizolam;
  • Fluetizolam;
  • Gidazepam;
  • Methylclonazepam;
  • Rilmazafone;
  • Thionordazepam.

Possession of a Class C drug carries a maximum penalty of up to 2 years in prison, an unlimited fine or both, whilst production and supply carries a maximum penalty of up to 14 years in prison, an unlimited fine or both.

The 2024 Regulations (No. 2) complement the 2024 Order (No. 2) by placing substances that fall under the new generic definition for nitazenes in Schedule 1 to the MDR 2001. They also designate them under the 2015 Order as they have no known medicinal value in the UK. This means that they can only be accessed for research, or other special purposes, under a Home Office controlled drug licence issued by the DFLU. It is therefore only possible for an authority to lawfully import, export, produce, possess, supply and administer these substances under the aforementioned licence.

Xylazine

Xylazine is a non-opioid tranquiliser that has sedative, analgesic and muscle relaxant properties and is authorised for use in the UK as a veterinary medicine but has not been approved for use in humans by the Medicines and Healthcare products Regulatory Agency (MHRA). In the US, it is increasingly being added to opioids such as heroin or fentanyl by organised criminal groups, to produce a mixture which is known as ‘tranq’ or ‘tranq dope’.

Xylazine is often combined with opioids and when used in this combination, it is known to increase the severity and duration of their sedative effect. This combination can also dangerously lower an individual’s level of consciousness and heart rate. Following the first report of a death in the UK involving xylazine in 2022, the previous Government requested advice from the ACMD on its harms. The ACMD published its report on xylazine on 16 February 2024, in which it recommended control of the substance as a Class C drug under the MDA 1971 and inclusion in Part 1 of Schedule 4 to the 2001 Regulations. The Government accepted these recommendations. The ACMD’s report on xylazine is available at the following link: Use and harms of xylazine, medetomidine and detomidine - GOV.UK (www.gov.uk).

The 2024 Order (No. 2) therefore controls xylazine as a Class C drug under the MDA 1971.

Possession of a Class C drug carries a maximum penalty of up to 2 years in prison, an unlimited fine or both, whilst production and supply carries a maximum penalty of up to 14 years in prison, an unlimited fine or both.

Xylazine is authorised for use in the UK as a veterinary medicine but has not been approved for use in humans by the Medicines and Healthcare products Regulatory Agency (MHRA). In line with ACMD recommendations, the 2024 Regulations (No. 2) place xylazine in Part 1 of Schedule 4 to the MDR 2001, in order to enable its use in veterinary care settings, subject to requirements in the MDR 2001 related to record-keeping, preservation of documents, furnishing of information and destruction.

Methoxyphenidine

In a report on 25 May 2023, the ACMD recommended the control of methoxyphenidine, which has acute toxicity reported to be similar to ketamine and other effects of tachycardia, hallucinations, confusion and paranoia, as a Class B drug under the MDA 1971. The ACMD also recommended that it be placed in Schedule 1 to the MDR 2001 and the 2015 Order, due to it having no recognised medicinal value in the UK. The Government accepted these recommendations and methoxyphenidine was controlled as a Class B drug and placed in Schedule 1 to the MDR 2001 and the 2015 Order on 20 March 2024.

The 2024 Order (No. 2) and 2024 Regulations (No. 2) add an additional common name (methoxphenidine) and the full IUPAC name to the entries for methoxyphenidine in the MDA 1971, MDR 2021 and 2015 Order. This does not affect the existing control, scheduling or designation of the substance but adds clarity on exactly which drug is controlled given that there are multiple common names.

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