90 FR 106 pgs. 23711-23713 - Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals
Type: NOTICEVolume: 90Number: 106Pages: 23711 - 23713
Pages: 23711, 23712, 23713Docket number: [Docket No. DEA-1086]
FR document: [FR Doc. 2025-10087 Filed 6-3-25; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1086]
Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals
AGENCY:
Drug Enforcement Administration, Department of Justice.
ACTION:
Notice.
SUMMARY:
The Controlled Substances Act provides for civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. The term laboratory supply is defined as a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. The Drug Enforcement Administration is hereby publishing a notice to update the Special Surveillance List.
DATES:
This notice is applicable June 4, 2025.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.
As required by 5 U.S.C. 553(b)(4), a summary of this notice may be found in the docket for this notice at www.regulations.gov.
SUPPLEMENTARY INFORMATION:
The Controlled Substances Act (CSA), as amended by the Comprehensive Methamphetamine Control Act of 1996 (MCA), provides for the publication of a Special Surveillance List by the Attorney General. 1 The Special Surveillance List identifies laboratory supplies which are used in the manufacture of controlled substances and listed chemicals. The CSA defines "laboratory supply" as "a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals."? 2 The CSA provides for a civil penalty of not more than $250,000 for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with "reckless disregard" for the illegal uses to which such a laboratory supply will be put. 3 The CSA further states that, for purposes of 21 U.S.C. 842(a)(11), "there is a rebuttable presumption of reckless disregard at trial if the Attorney General notifies a firm in writing that a laboratory supply sold by the firm, or any other person or firm, has been used by a customer of the notified firm, or distributed further by that customer, for the unlawful production of controlled substances or listed chemicals a firm distributes and 2 weeks or more after the notification the notified firm distributes a laboratory supply to the customer."? 4
Footnotes:
1 ?21 U.S.C. 842(a).
2 ? Id.
3 ?21 U.S.C. 842(c)(2)(C). This civil monetary penalty has been adjusted for inflation. For penalties assessed after January 30, 2023, with respect to violations occurring after November 2, 2015, the maximum penalty is $470,640. 88 FR 5776, 5780 (Jan. 30, 2023).
4 ?21 U.S.C. 842(a).
[top] The publication of the Special Surveillance List serves two purposes. First, it informs individuals and firms of the potential use of the items on the list in the manufacture of controlled substances and listed chemicals. Second, it reminds individuals and firms that civil penalties may be imposed on them if they distribute a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, in violation of the CSA, with reckless disregard for the illegal uses to which such a laboratory supply will be put. 5 The publication of the updated Special Surveillance List provides an increased level of public awareness and law enforcement control to prevent the diversion of laboratory supplies used for
Footnotes:
5 ?21 U.S.C. 842(a)(11).
In developing the updated Special Surveillance List, the Drug Enforcement Administration (DEA) consulted with Federal, State, local, and foreign law enforcement officials, forensic laboratory authorities, intelligence groups, drug signature and profiling programs, and international organizations. DEA examined clandestine laboratory seizure reports, drug signature and profiling reports, intelligence reports, and scientific literature for information regarding: (1) illicit drug production methods; (2) chemicals, materials, and equipment actually used in the clandestine production of controlled substances and listed chemicals; and (3) the role and importance of chemicals, materials, and equipment used in the synthesis of controlled substances and listed chemicals. The updated Special Surveillance List includes chemicals, materials, and equipment used in the manufacture, production, and distribution of synthetic drugs such as fentanyl, amphetamine, methamphetamine, PCP, LSD, ketamine, and other controlled substances and listed chemicals.
DEA is updating the Special Surveillance List by adding the following laboratory supplies to the existing Special Surveillance List:
Chemicals, Including Their Salts Whenever the Existence of Such Salts Is Possible
New Chemicals
(1-bromocyclopentyl)(2-chlorophenyl)methanone
(2-chlorophenyl)(cyclopenyl)methanone (2-chlorophenyl cyclopentyl ketone)
1-((2-chlorophenyl)(methylimino)methyl)cyclopentane-1-ol
1-chloro-2,4-dinitrobenzene
2-(1,3-benzodioxol-5-yl)-3-oxobutanoic acid and its esters ( e.g. methyl 2-(1,3-benzodioxol-5-yl)-3-oxobutanoate)
4-anilino-1-benzylpiperidine; N -benzyl-4-anilinopiperidine
4-carbomethoxy 4-ANPP
4-nitro-1,2-phenylenediamine
diethyl 2-(2-phenylacetyl)malonate (DEPAPD)
N,N -diethylethylenediamine
isopropylidene (2-(3,4-methylenedioxyphenyl)acetyl)malonate (IMDPAM)
norcarfentanil
1-boc-norcarfentanil
para -methyl boc-4-AP
4-piperidinol (4-hydroxypiperidine)
1-boc-4-piperidinol ( N -boc-piperidinol)
In addition to the chemicals listed above, DEA is updating the listing of ethyl-3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (3,4-MDP-2-P ethyl glycidate) to include other esters of 3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylic acid. DEA updates the listing of this chemical to read as follows:
3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylic acid (3,4-MDP-2-P glycidic acid; PMK glycidic acid) and its esters ( e.g. ethyl-3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate)
Materials
Furthermore, DEA is updating the Special Surveillance List to include the addition of materials to the existing Special Surveillance List. This addition includes, but is not limited to, materials such as binding, disintegrating, filling, flowing, and lubricating agents, also referred to as excipients, used for the illicit manufacture, production, or distribution of tablets, capsules, or pills. These materials have been linked to law enforcement encounters, intelligence reports, and investigations that involve illicit manufacture, production, or distribution of controlled substances in forms such as pills, tablets, and capsules, and counterfeit, fake, or imitation products of legitimate substances. The select excipients are being added to the Special Surveillance List for a deterrence purpose in the prevention of illicit manufacture, production or distribution of controlled substances and the potential reduction of counterfeit, fake, or imitation products.
New Materials
Products containing at least one of these listed materials, including premixed products, used in the illicit manufacture, production, or distribution of tablets, capsules, or pills.
dicalcium phosphate
magnesium stearate
microcrystalline cellulose
silicon dioxide
stearic acid
The Special Surveillance List continues to include all listed chemicals as specified in 21 CFR 1310.02(a) or (b). DEA is removing an individually listed chemical from the Special Surveillance List ( tert -butyl 4-((4-fluorophenyl)amino)piperidine-1-carboxylate ( para -fluoro 1-boc-4-AP)), given that this chemical has since been added to List I and is, therefore, automatically included as a laboratory supply. The phrase "all listed chemicals" includes all chemical mixtures and all over-the-counter (OTC) pharmaceutical products and dietary supplements which contain a listed chemical, regardless of their dosage form or packaging and regardless of whether the chemical mixture, drug product or dietary supplement is exempt from regulatory controls. The following is the updated Special Surveillance List for laboratory supplies used in the manufacture of controlled substances and listed chemicals, including the additions and modifications listed above:
Special Surveillance List Published Pursuant to 21 U.S.C. 842(a)
Chemicals, Including Their Salts Whenever the Existence of Such Salts Is Possible
The Special Surveillance List of laboratory supplies which are used in the manufacture of controlled substances and listed chemicals includes all listed chemicals as specified in 21 CFR 1310.02(a) or (b). This includes all chemical mixtures and all over-the-counter (OTC) products and dietary supplements which contain a listed chemical, regardless of their dosage form or packaging and regardless of whether the chemical mixture, drug product or dietary supplement is exempt from regulatory controls. In addition, the Special Surveillance List includes the following:
(1-bromocyclopentyl)(2-chlorophenyl)methanone
(2-chlorophenyl)(cyclopentyl)methanone (2-chlorophenyl cyclopentyl ketone)
(2-nitroprop-1-en-1-yl)benzene (1-phenyl-2-nitropropene; P2NP)
1-((2-chlorophenyl)(methylimino)methyl)cyclopentane-1-ol
1-(4-bromophenyl)propan-1-one
1-(4-chlorophenyl)propan-1-one
1-(4-methylphenyl)propan-1-one
1,1'-carbonyldiimidazole
1,1-dichloro-1-fluoroethane ( e.g., Freon 141B)
1-benzylpiperidin-4-one ( N -benzyl-4-piperidone)
1-boc-4-piperidinol ( N -boc-piperidinol)
1-boc-norcarfentanil
1-chloro-2,4-dinitrobenzene
1-chloro- N -methyl-1-phenylpropan-2-amine (chloroephedrine; chloropseudoephedrine)
1-phenylbutan-1-one
1-phenylpentan-1-one
1-phenylpropan-1-one
2-(1,3-benzodioxol-5-yl)-3-oxobutanoic acid and its esters ( e.g. methyl 2-(1,3-benzodioxol-5-yl)-3-oxobutanoate)
2,5-dimethoxyphenethylamine
2-bromo-1-(4-chlorophenyl)propan-1-one
2-bromo-1-(4-methoxyphenyl)propan-1-one
2-bromo-1-(4-methylphenyl)propan-1-one
2-bromo-1-phenylpentan-1-one
2-bromo-1-phenylpropan-1-one
3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylic acid (3,4-MDP-2-P glycidic acid; PMK glycidic acid) and its esters ( e.g. ethyl-3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate)
[top] 3-methyl-3-phenyloxirane-2-carboxylic acid (BMK glycidic acid; P2P glycidic acid) and its esters ( e.g., methyl 3-methyl-3-phenyloxirane-2-carboxylate (BMK methyl
3-oxo-2-phenylbutanoic acid and its esters ( e.g., alpha-phenylacetoacetic acid; ethyl 3-oxo-2-phenylbutanoate (EAPA))
4-anilino-1-benzylpiperidine; N -benzyl-4-anilinopiperidine
4-carbomethoxy 4-ANPP
4-nitro-1,2-phenylenediamine
4-piperidinol (4-hydroxypiperidine)
5-(2-nitroprop-1-en-1-yl)benzodioxole (3,4-methylenedioxyphenyl-2-nitropropene; 3,4-MDP2NP)
ammonia gas
ammonium formate
azobisisobutyronitrile
bromobenzene
butane-1,4-diol (1,4-butanediol)
cyclohexanone
diethyl 2-(2-phenylacetyl)malonate (DEPAPD)
diethylamine and its salts
N,N -diethylethylenediamine
ethyl 3-oxo-4-phenylbutanoate
formamide
formic acid
isopropylidene (2-(3,4-methylenedioxyphenyl)acetyl)malonate (IMDPAM)
lithium aluminum hydride
lithium metal
magnesium metal (turnings)
mercuric chloride
methyl 2-(1,3-benzodioxol-5-yl)-3-oxobutanoate (MAMDPA; MDMAPA)
N -methylformamide
norcarfentanil
organomagnesium halides (Grignard reagents) ( e.g., ethylmagnesium bromide and phenylmagnesium bromide)
ortho -toluidine
para -methyl boc-4-AP
phenethyl bromide ((2-bromoethyl)benzene)
phenylethanolamine and its salts
phosphorus pentachloride
potassium dichromate
propionyl chloride
pyridine and its salts
sodium borohydride
sodium dichromate
sodium metal
sodium triacetoxyborohydride
thioglycolic acid and its esters ( e.g., methyl thioglycolate)
thionyl chloride
trichloromonofluoromethane ( e.g., Freon-11, Carrene-2)
trichlorotrifluoroethane ( e.g., Freon 113)
Materials
Products containing at least one of these listed materials, including premixed products, used in the illicit manufacture, production, or distribution of tablets, capsules, or pills.
dicalcium phosphate
magnesium stearate
microcrystalline cellulose
silicon dioxide
stearic acid
Equipment
hydrogenators
tableting machines, including punches and dies
encapsulating machines
22 liter heating mantels
The Attorney General has delegated authority under the CSA and all subsequent amendments to the CSA to the Administrator of DEA pursuant to 28 CFR 0.100. The Special Surveillance List may be updated as needed to reflect changes in the chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals by publication of a notice in the Federal Register . DEA will disseminate the updated Special Surveillance List as widely as possible. In addition, the Special Surveillance List will be available on the DEA Diversion Control homepage at https://www.deadiversion.usdoj.gov/.
Regulatory Analyses
The updated Special Surveillance List applies to all individuals and firms which distribute the listed chemicals and laboratory supplies (chemicals, products, materials, or equipment) on the list. As noted above, the Special Surveillance List serves two purposes. First, it informs individuals and firms of the potential use of the items on the list in the manufacture of controlled substances and listed chemicals. Second, it reminds individuals and firms that civil penalties may be imposed on them if they distribute a laboratory supply to a person with reckless disregard for the illegal use to which such a laboratory supply will be put.
This update provides an increased level of law enforcement control to prevent the diversion of laboratory supplies used for the manufacture of listed chemicals and controlled substances. It does not impose any new regulatory burden on the public as there are no corresponding recordkeeping or reporting requirements of the laboratory supplies. However, it does impose potential civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. This update fulfills the requirement imposed by Section 205 of the MCA that the Attorney General shall publish a Special Surveillance List which contains chemicals, products, materials, or equipment used in the manufacture of listed chemicals and controlled substances.
Signing Authority
This document of the Drug Enforcement Administration was signed on May 27, 2025, by Acting Administrator Robert J. Murphy. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-10087 Filed 6-3-25; 8:45 am]
BILLING CODE 4410-09-P