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

Statutory Instruments

2024 No. 1369

Dangerous Drugs

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

Made

at 9.30 a.m. on 19th December 2024

Laid before Parliament

at 2.00 p.m. on 19th December 2024

Coming into force

15th January 2025

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 7(1)(a) and (b), (4) and (5), 10(1) and 31(1)(a) of the Misuse of Drugs Act 1971(1).

In accordance with sections 7(7) and 31(3) of that Act the Secretary of State has consulted the Advisory Council on the Misuse of Drugs.

Citation, commencement and extent

1.—(1) These Regulations may be cited as the Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) (No. 2) Regulations 2024 and come into force on 15th January 2025.

(2) These Regulations extend to England and Wales and Scotland.

Amendment of the Misuse of Drugs Regulations 2001

2.—(1) The Misuse of Drugs Regulations 2001(2) are amended as follows.

(2) In Schedule 1 (which specifies controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 23, 26 and 27), in paragraph 1—

(a) in sub-paragraph (a)—

(i) in the appropriate places insert—

“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-2H-[1]benzothieno[2,3-e][1,4]diazepin-2-one)”;

“Bretazenil (tert-butyl-8-bromo-11,12,13,13a-tetrahydro-9-oxo-9H-imidazo[1,5-a]-pyrrolo[2,1-c][1,4]benzodiazepine-1-carboxylate)”;

“Clobromazolam (8-bromo-6-(2-chlorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)”;

“Cloniprazepam (5-(2-chlorophenyl)-1-(cyclopropylmethyl)-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-one)”;

“Desalkylgidazepam (7-bromo-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one)”;

“Deschloroclotizolam (2-chloro-9-methyl-4-phenyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine)”;

“Difludiazepam (7-chloro-5-(2,6-difluorophenyl)-1-methyl-3H-1,4-benzodiazepin-2-one)”;

“Flubrotizolam (2-bromo-4-(2-fluorophenyl)-9-methyl-6H-thieno[3,2f][1,2,4]triazolo[4,3a][1,4]diazepine)”;

“Fluclotizolam (2-chloro-4-(2-fluorophenyl)-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine)”;

“Fluetizolam (2-ethyl-4-(2-fluorophenyl)-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine)”;

“Gidazepam (7-bromo-2,3-dihydro-2-oxo-5-phenyl-1H-1,4-benzodiazepine-1-acetic acid hydrazide)”;

“Methylclonazepam (5-(2-chlorophenyl)-1-methyl-7-nitro-3H-1,4-benzodiazepin-2-one)”;

“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)”;

“Rilmazafone (5-([(2-aminoacetyl)amino]methyl)-1-[4-chloro-2-(2-chlorobenzoyl)phenyl]-N,N-dimethyl-1H-1,2,4-triazole-3-carboxamide)”;

“Thionordazepam (7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-thione)”;

“4’-Chloro-deschloroalprazolam (6-(4-chlorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)”;

“2-Methyl-AP-237 (1-[2-methyl-4-[2E]-3-phenyl-2-propen-1-yl]-1-piperazinyl-1-butanone)”;

(ii) in the entry for Methoxyphenidine, at the end insert “(1-[1-(2-methoxyphenyl)-2-phenylethyl]piperidine) (methoxphenidine)”;

(b) after sub-paragraph (r) insert—

“(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 say—

(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.”.

(3) In Schedule 4, in Part 1 (which specifies controlled drugs subject to the requirements of regulations 22, 23, 26 and 27), in paragraph 1 after “Triazolam” insert—

“Xylazine”.

Amendment of the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015

3.  In the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015(3), in Schedule 1, in Part 1 (which specifies controlled drugs to which section 7(4) of the Misuse of Drugs Act 1971 applies), in paragraph 1—

(a) in sub-paragraph (a)—

(i) in the appropriate places insert—

“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-2H-[1]benzothieno[2,3-e][1,4]diazepin-2-one)”;

“Bretazenil (tert-butyl-8-bromo-11,12,13,13a-tetrahydro-9-oxo-9H-imidazo[1,5-a]-pyrrolo[2,1-c][1,4]benzodiazepine-1-carboxylate)”;

“Clobromazolam (8-bromo-6-(2-chlorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)”;

“Cloniprazepam (5-(2-chlorophenyl)-1-(cyclopropylmethyl)-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-one)”;

“Desalkylgidazepam (7-bromo-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one)”;

“Deschloroclotizolam (2-chloro-9-methyl-4-phenyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine)”;

“Difludiazepam (7-chloro-5-(2,6-difluorophenyl)-1-methyl-3H-1,4-benzodiazepin-2-one)”;

“Flubrotizolam (2-bromo-4-(2-fluorophenyl)-9-methyl-6H-thieno[3,2f][1,2,4]triazolo[4,3a][1,4]diazepine)”;

“Fluclotizolam (2-chloro-4-(2-fluorophenyl)-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine)”;

“Fluetizolam (2-ethyl-4-(2-fluorophenyl)-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine)”;

“Gidazepam (7-bromo-2,3-dihydro-2-oxo-5-phenyl-1H-1,4-benzodiazepine-1-acetic acid hydrazide)”;

“Methylclonazepam (5-(2-chlorophenyl)-1-methyl-7-nitro-3H-1,4-benzodiazepin-2-one)”;

“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)”;

“Rilmazafone (5-([(2-aminoacetyl)amino]methyl)-1-[4-chloro-2-(2-chlorobenzoyl)phenyl]-N,N-dimethyl-1H-1,2,4-triazole-3-carboxamide)”;

“Thionordazepam (7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-thione)”;

“4’-Chloro-deschloroalprazolam (6-(4-chlorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)”;

“2-Methyl-AP-237 (1-[2-methyl-4-[2E]-3-phenyl-2-propen-1-yl]-1-piperazinyl-1-butanone)”;

(ii) in the entry for Methoxyphenidine, at the end insert “(1-[1-(2-methoxyphenyl)-2-phenylethyl]piperidine) (methoxphenidine)”;

(b) after sub-paragraph (y), insert—

“(z) 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 say—

(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.”.

Diana Johnson

Minister of State

Home Office

At 9.30 a.m. on 19th December 2024

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Misuse of Drugs Regulations 2001 (S.I. 2001/3998) (“the 2001 Regulations”) and the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 (S.I. 2015/704) (“the 2015 Order”).

The Schedule of the 2001 Regulations in which a controlled drug is placed affects the extent to which the drug can be lawfully imported, exported, produced, supplied or possessed and dictates the controls that the drug is subject to, such as the record-keeping, labelling and destruction requirements in relation to that drug.

Section 7(3) of the Misuse of Drugs Act 1971 (c. 38) requires the Secretary of State to make regulations to allow drugs controlled under that Act to be used for medicinal purposes. Section 7(3), however, does not apply to any drug which is designated by order under section 7(4) of that Act. Controlled drugs are designated where the Secretary of State is of the opinion that it is in the public interest for production, supply and possession of that drug to be either wholly unlawful or unlawful except for research or other special purposes, or for medicinal use of the drug to be unlawful except under licence. Part 1 of Schedule 1 to the 2015 Order specifies the list of controlled drugs to which section 7(4) applies.

Regulation 2(2)(a)(i) adds twenty-one substances (four acyl piperazine opioids, two chemically bridged acyl piperazine derivatives, and fifteen novel benzodiazepines and related compounds) to Schedule 1 to the 2001 Regulations.

Regulation 2(2)(a)(ii) adds an additional common name and the full International Union of Pure and Applied Chemistry (“IUPAC”) name to the entry for methoxyphenidine, which is already included in Schedule 1 to the 2001 Regulations.

Regulation 2(2)(b) adds a range of 2-benzyl benzimidazole variants to Schedule 1 to the 2001 Regulations.

Regulation 2(3) adds xylazine to Part 1 of Schedule 4 to the 2001 Regulations.

Regulation 3(a)(i) adds the twenty-one substances added to Part 1 of Schedule 1 to the 2001 Regulations to Schedule 1 to the 2015 Order.

Regulation 3(a)(ii) adds an additional common name and the full IUPAC name to the entry for methoxyphenidine, which is already included in Part 1 of Schedule 1 to the 2015 Order.

Regulation 3(b) adds a range of 2-benzyl benzimidazole variants to Part 1 of Schedule 1 to the 2015 Order.

A full impact assessment has not been produced for this instrument as no, or no significant impact on the private sector, voluntary sector or community bodies is foreseen. An Explanatory Memorandum and an economic note are available alongside this instrument on www.legislation.gov.uk. Copies may be obtained from the Drug Misuse Unit of the Home Office at 2 Marsham Street, London, SW1P 4DF.

(1)

1971 c. 38.

(2)

S.I. 2001/3998, amended by S.I. 2014/1275, 2017/631 and 2024/248. There are other amending instruments, but none are relevant.

(3)

S.I. 2015/704, amended by S.I. 2017/632 and 2024/248. There are other amending instruments, but none are relevant.