March 2025 Controlled Drug legislation news

flags

Since the start of 2025 several regulators globally have updated their controlled drug lists and legislation. Most notably, Dutch authorities in the Netherlands are undertaking a significant extension to their regulations – controlling areas of chemical space for the first time.

For those who want more regular updates, all this information and much, much more is available from Controlled Substances Squared weekly legislation updates. The power of the system is being able to check the regulated status of all your chemicals whenever you want, simply by entering the chemical (name or structure) you want to check.

Below is a brief summary and highlights of some of the countries we monitor and encode in Controlled Substances Squared. The solution that allows you to easily and automatically check if your chemicals are regulated or controlled - even novel and propriatory chemicals

 

 

 

Japan have added 1S-LSD, protonitazepyne, N-methyl-N-propyltryptamine as controlled in March and cP-AL-LAD, 2F-NENDCK, 1cP-MiPLA, Metonitazepyne in January

 

Netherlands generic statements to cover phenethylamines, cannabinoids and fentanyls.

Dutch authorities in the Netherlands are undertaking a significant extension to their regulations – controlling areas of chemical space for the first time. They have proposed generic statements for Phenethylamine, Synthetic cannabinoids and Fentanyl.

While the Synthetic cannabinoids and Fentanyl generic statements seem reasonable and cover chemical space likely to have a psychoactive effect, the Phenethylamine definition raises serious concerns.

We immediately recognised this as being from the German NpSG Act. The NpSG has a strong exemption for legitimate research and commercial usage, however this was missing in the Opium Act update.

This poses a problem for chemical companies and research organisations as it will likely control chemicals used in research and drug discovery programs unrelated to phenethylamines. For example, the follow 4 substances Venlafaxine, Bezafibrate, Mecamylamine and Olodaterol fall within the wording of the generic statement.

NetherlandsMarch2025

As licenced medicines they are “exempted”.

However, had this wording been in place before these chemicals were marketed, it would have been very hard to perform the R&D and discover these 4, plus 1000s of other very similar chemicals created during the R&D process. They would have been considered controlled and probably never made in the Netherlands.  

Even now, even if these 4 are exempted, 10,000s of other similar chemicals, which may have future medicinal value, due to their similarity, would now be considered controlled, severely limiting research with them.

This is just 4 examples, however on one knows what useful potential chemical series will be impacted. But our internal analysis has suggested that in a collection of 10 million drug like molecules, 100,000s became controlled, the majority unrelated to Phenethylamines.

We have contacted the Dutch authorities who have confirmed there is no general research exemption and we are currently enquiring regarding apply for specific organisational exemptions.

Although the wording and chemical space is different, this is reminicent of the 2016 UK "3rd Generation Synthetic Cannabinoids" ammendment, which accidentially controlled large areas of chemical space used by R&D in drug discovery. In that case it wasn't until 2019 that the wording was ammended to reduce the chemical space caught by ~90%.

For further information on this please contact us

 

 

Canada

Health Canada has issued a Notice of intent to control fentanyl precursor chemicals and carisoprodol. It is proposed that phenethyl bromide, propionic anhydride (also known as propanoyl propanoate), and benzyl chloride will be controlled as precursors, while carisoprodol will be controlled as a full controlled substances. Anyone wishing to provide written comments can do so csd.regulatory.policy-politique.reglementaire.dsc@hcsc.gc.ca.

Other proposed new legislation increases requirements around tracking and reporting the sales of precursors chemicals.

 

Taiwan

Butonitazene, 5-Nitro-2-(chloroacetamido)benzophenone and Ethyl 1H-imidazole-5-carboxylate have been added to the Controlled Drugs Act

 

Sweden

Mitragyna speciosa is proposed to be added to the list of Narcotic drugs.

 

USA

The United States International Traffic in Arms Regulations (ITAR) has been updated to reflect changes in the control of toxicological agents, specifically the inclusion of additional nerve agents that align with the Chemical Weapons Convention (CWC) Schedule I.

The commerce control list has been updated with Dipropylamine added

In the Controlled Substances Act,  4-chloromethcathinone (4– CMC, 1-(4-chlorophenyl)-2- (methylamino)propan-1-one), including its salts, isomers, and salts of isomers has been added to schedule I of the Controlled Substances Act.

UN


The following substances have been added to the Yellow Narcotics List and Psychotropics Green List: UN Yellow list Narcotics Schedule I: - Protonitazepyne – Metonitazepyne – Etonitazepipne – N-Desethyl Isotonitazene UN Psychotropic Green List Schedule II: - HHC UN Psychotropic Green List Schedule IV: - Carisoprodol

 

UK

The UK has introduced a new Nitazine generic statement based on the following core 

 

UKNitazinesMarch2025

any compound (not being a compound for the time being specified in subparagraph (a) above) with a maximum molecular mass of 500 atomic mass units and structurally derived from 2-(2-benzylbenzimidazol-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

It also named an additional 22 named substances related to Nitazine

 

India Has added 18 new drug precursors to the Narcotic Drugs and Psychotropic Substances Act, inline with UN precursors lists

 

Updates have also occurred for other countries, including Austria and Brazil.

 

Do you want to be able to easily and automatically check if your chemicals are controlled and regulated - even for novel and propriatory chemicals - then you need Controlled Substances Squared.