[Federal Register Volume 90, Number 106 (Wednesday, June 4, 2025)]
[Notices]
[Pages 23711-23713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10087]
=======================================================================
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
[[Page 23712]]
the manufacture of listed chemicals and controlled substances.
---------------------------------------------------------------------------
\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)
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
[[Page 23713]]
glycidate); ethyl 3-methyl-3-phenyloxirane-2-carboxylate (BMK ethyl
glycidate))
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