74352 Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Rules and Regulations 

1 88 FR 22955 (Apr. 14, 2023). 

2 21 U.S.C. 802(34). 

3 Id. 

4 85 FR 20822 (Apr. 15, 2020). 

5 Id. 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

1 year * * *.’’ Therefore, neither a 

Small Government Agency Plan nor any 

other action is required under UMRA of 

1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by the Congressional Review 

Act (CRA), 5 U.S.C. 804. However, 

pursuant to the CRA, DEA is submitting 

a copy of this IFR to both Houses of 

Congress and to the Comptroller 

General. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 25, 2023, by Administrator 

Anne Milgram. 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. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, DEA 

amends 21 CFR part 1308 as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

956(b) unless otherwise noted. 

■ 2. In § 1308.14: 

a. Add a new paragraph (c)(60) to read 

as follows: 

§ 1308.14 Schedule IV. 

* * * * * 

(c) * * * 

* * * * * 

(60) Zuranolone ............................ 2420 

* * * * * 

[FR Doc. 2023–23982 Filed 10–30–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1310 

[Docket No. DEA–1098] 

Designation of Halides of 4- 

Anilinopiperidine as List I Chemicals 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is finalizing the 

modification of the listing of the list I 

chemical, N-phenylpiperidin-4-amine 

(also known as 4-anilinopiperidine; Nphenyl-4-piperidinamine; 4–AP) 

(hereinafter referred to as 4- 

anilinopiperidine), to include halides of 

4-anilinopiperidine. This rule finalizes 

the modification of the listing of 4- 

anilinopiperidine as a list I chemical. 

DATES: This rule is effective November 

30, 2023. Persons currently 

manufacturing, distributing, importing, 

or exporting halides of 4- 

anilinopiperidine or a chemical mixture 

containing halides of 4- 

anilinopiperidine, if they are not 

already registered to handle list I 

chemicals, must apply on or before 

November 30, 2023, to continue their 

business pending final action by DEA 

on their application. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: The Drug 

Enforcement Administration (DEA) is 

extremely concerned with the recent 

increase in the illicit manufacture and 

distribution of fentanyl and fentanyl 

analogues. Therefore, on April 14, 2023, 

DEA published a Notice of Proposed 

Rulemaking (NPRM) to include halides 

of 4-anilinopiperidine as list I 

chemicals.1 This rulemaking finalizes 

that NPRM. 

This action subjects handlers of 

halides of 4-anilinopiperidine to the 

regulatory provisions of the Controlled 

Substances Act (CSA) and its 

implementing regulations regarding list 

I chemicals. This rulemaking does not 

establish a threshold for domestic and 

international transactions of halides of 

4-anilinopiperidine. As such, all 

transactions involving halides of 4- 

anilinopiperidine, regardless of size, 

shall be regulated and are subject to 

control under the CSA. In addition, 

chemical mixtures containing halides of 

4-anilinopiperidine are not exempt from 

regulatory requirements at any 

concentration. Therefore, all 

transactions of chemical mixtures 

containing any quantity of halides of 4- 

anilinopiperidine shall be regulated 

pursuant to the CSA as list I chemicals. 

Legal Authority 

The CSA gives the Attorney General 

the authority to specify, by regulation, 

chemicals as list I chemicals.2 A ‘‘list I 

chemical’’ is a chemical that is used in 

manufacturing a controlled substance in 

violation of the CSA and is important to 

the manufacture of the controlled 

substances.3 The current list of all listed 

chemicals is published at 21 CFR 

1310.02(a). Pursuant to 28 CFR 0.100(b), 

the Attorney General has delegated his 

authority to designate list I chemicals to 

the Administrator of DEA 

(Administrator). The DEA regulations 

set forth the process by which DEA may 

add a chemical as a listed chemical. As 

set forth in 21 CFR 1310.02(c), the 

agency may do so by publishing a final 

rule in the Federal Register following a 

published notice of proposed 

rulemaking with at least 30 days for 

public comments. 

Background 

DEA previously found that 4- 

anilinopiperidine is used in the illicit 

manufacture of the controlled substance 

fentanyl (a schedule II substance under 

the CSA) and fentanyl analogues 

controlled in schedule I of the CSA, and 

is important to the manufacture of the 

controlled substance fentanyl and 

fentanyl analogues, because it cannot be 

replaced by other chemicals in its 

respective synthetic pathways that are 

used in the illicit manufacture of 

fentanyl and fentanyl analogues.4 On 

this basis, DEA previously specified that 

4-anilinopiperidine is a list I chemical.5

DEA has now found that halides of 4- 

anilinopiperidine are also used in the 

illicit manufacture of schedule I 

controlled substances, such as parafluorofentanyl, ortho-fluorofentanyl, 

and para-chlorofentanyl. Accordingly, 

this action adds halides of 4- 

anilinopiperidine to the prior listing of 

4-anilinopiperidine and thereby subjects 

handlers of halides of 4- 

anilinopiperidine to the regulatory 

provisions of the CSA and its 

implementing regulations. 


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Federal Register / Vol. 88, No. 209 / Tuesday, October 31, 2023 / Rules and Regulations 74353 

6 21 U.S.C. 812(c), Schedule II(b)(6); 21 CFR 

1308.12(c). 

7United Nations Office on Drugs and Crime, 

Global SMART Update Volume 17, March 2017. 

https://www.unodc.org/documents/scientific/ 

Global_SMART_Update_17_web.pdf. 

8Centers for Disease Control and Prevention, 

National Center for Health Statistics. National Vital 

Statistics System, Provisional Mortality on CDC 

WONDER Online Database. Data are from the final 

Multiple Cause of Death Files, 2018–2020, and from 

provisional data for years 2021–2022, as compiled 

from data provided by the 57 vital statistics 

jurisdictions through the Vital Statistics 

Cooperative Program. Accessed at https://

wonder.cdc.gov/mcd-icd10-provisional.html on 

August 15, 2022. 

9Ahmad FB, Rossen LM, Sutton P. Provisional 

drug overdose death counts. National Center for 

Health Statistics. 2021. Accessed at https://

www.cdc.gov/nchs/nvss/vsrr/drug-overdosedata.htm on May 5, 2022. 

10The National Forensic Laboratory Information 

System (NFLIS-Drug) is a national forensic 

laboratory reporting system that systematically 

collects results from drug chemistry analyses 

conducted by Federal, State and local forensic 

laboratories in the United States. While NFLIS-Drug 

data is not direct evidence of abuse, it can lead to 

an inference that a drug has been diverted and 

abused. See 76 FR 77330, 77332 (Dec. 12, 2011). 

NFLIS-Drug data was queried on August 15, 2022. 

11Halogenated fentanyl analogues reported to 

NFLIS-Drug include: meta-fluorofentanyl, metafluoroisobutyryl fentanyl, para-fluoroisobutyryl 

fentanyl, chlorofentanyl, fluoro furanyl fentanyl, 

fluorobutyryl fentanyl, fluorobutyryl/ 

fluoroisobutyryl fentanyl, fluorofentanyl, 

fluoroisobutyryl fentanyl, meta-fluoro furanyl 

fentanyl, ortho-fluorobutyryl fentanyl, orthofluoroisobutyryl fentanyl, ortho-fluoro 

acrylfentanyl, ortho-fluoro furanyl fentanyl, orthofluorofentanyl, ortho-chlorofentanyl, parachlorofentanyl, para-fluoro furanyl fentanyl, parafluoro valeryl fentanyl, para-fluorobutyryl fentanyl, 

and para-fluorofentanyl. 

12 72 FR 20039 (Apr. 23, 2007). 

13 85 FR 20822 (Apr. 15, 2020). 

14 88 FR 21902 (Apr. 12, 2023). 

15 75 FR 37295 (Aug. 30, 2010). 

16 85 FR 21320 (Apr. 17, 2020). 

This rule does not affect current 

handlers of 4-anilinopiperidine, 

including its amides, its carbamates, 

and its salts, as they are already 

required to be registered to handle 4- 

anilinopiperidine. This rule does not 

establish a threshold for domestic and 

international transactions of halides of 

4-anilinopiperidine. As such, all 

transactions involving halides of 4- 

anilinopiperidine, regardless of size, 

shall be regulated as list I chemicals and 

are subject to control under the CSA. In 

addition, chemical mixtures containing 

halides of 4-anilinopiperidine are not 

exempt from regulatory requirements at 

any concentration. Therefore, all 

transactions of chemical mixtures 

containing any quantity of halides of 4- 

anilinopiperidine shall be regulated as 

list I chemicals pursuant to the CSA. 

Fentanyl is a synthetic opioid and 

was first synthesized in Belgium in the 

late 1950s. Fentanyl was introduced 

into medical practice and is approved 

for medical practitioners in the United 

States to prescribe lawfully for 

anesthesia and analgesia. Yet, due to its 

pharmacological effects, fentanyl can be 

used as a substitute for heroin, 

oxycodone, and other opioids. 

Therefore, despite its accepted medical 

use in treatment in the United States, 

the DEA controls fentanyl as a schedule 

II controlled substance due to its high 

potential for abuse and dependence.6

The unlawful trafficking and 

distribution of fentanyl and fentanyl 

analogues in the United States 

continues to pose an imminent hazard 

to public safety. Since 2012, fentanyl 

has shown a dramatic increase in the 

illicit drug supply as a single substance, 

in mixtures with other illicit drugs (i.e., 

heroin, cocaine, and 

methamphetamine), or in forms that 

mimic pharmaceutical preparations, 

including prescription opiates and 

benzodiazepines.7

In recent years, the United States has 

experienced a significant increase in 

overdoses and overdose fatalities from 

fentanyl and fentanyl analogues. 

According to the Centers for Disease 

Control and Prevention (CDC), druginduced overdose deaths involving 

synthetic opioids (excluding 

methadone) in the United States 

increased from 36,359 in 2019, to 56,516 

in 2020, and to 70,589 in 2021 

(provisional).8 Further, CDC reports that 

opioids, mainly synthetic opioids 

(which includes fentanyl), are 

predominately responsible for drug 

overdose fatalities, as the drug overdose 

death data (109,247) predicted for the 12 

month-ending March 2022, synthetic 

opioids were involved in about 67.3 

percent of all drug-induced overdose 

deaths.9

The increase in overdose fatalities 

involving synthetic opioids coincides 

with a dramatic increase in law 

enforcement encounters of fentanyl and 

fentanyl analogues. According to the 

National Forensic Laboratory 

Information System (NFLIS-Drug),10

reports from forensic laboratories of 

drug items containing fentanyl and 

several schedule I fentanyl analogues 

increased dramatically since 2014, as 

shown in Table 1. 

TABLE 1—ANNUAL REPORTS OF FENTANYL AND HALOGENATED FENTANYL ANALOGUES IDENTIFIED IN DRUG ENCOUNTERS

Year 2014 2015 2016 2017 2018 2019 2020 2021 

Fentanyl ........................... 5,553 15,461 37,144 61,628 89,890 107,928 124,773 156,629 

Halogenated Fentanyl 

Analogues 11 ................. 1 10 435 2,628 2,960 1,013 743 19,831 

Role of 4-Anilinopiperidine in the 

Synthesis of Fentanyl and Fentanyl 

Analogues 

Fentanyl and its analogues are not 

naturally occurring substances. As such, 

the manufacture of these substances 

requires them to be produced through 

synthetic organic chemistry. Synthetic 

organic chemistry is the process in 

which a new organic molecule is 

created through a series of chemical 

reactions, which involve precursor 

chemicals. Through chemical reactions, 

the chemical structures of precursor 

chemicals are modified in a desired 

fashion. These chemical reaction 

sequences, also known as synthetic 

pathways, are designed to create a 

desired substance. Several synthetic 

pathways to fentanyl and fentanyl 

analogues have been identified in 

clandestine laboratory settings, 

including the original ‘‘Janssen 

method,’’ the ‘‘Siegfried method,’’ and 

the ‘‘Gupta method,’’ which are further 

explained below. 

In response to the illicit manufacture 

of fentanyl using these methods, DEA 

controlled N-phenethyl-4-piperidone 

(NPP); 12 N-(1-benzylpiperidin-4-yl)-Nphenylpropionamide (benzylfentanyl), 

N-phenylpiperidin-4-amine (4- 

anilinopiperidine); 13 and 4- 

piperidone 14 as list I chemicals. DEA 

also controlled 4-anilino-Nphenethylpiperidine (ANPP) 15 and Nphenyl-N-(piperidin-4-yl)propionamide 

(norfentanyl) 16 as schedule II 

immediate precursors to fentanyl under 

the CSA. 

In 2017, the United Nations 

Commission on Narcotic Drugs (CND) 

placed NPP and ANPP in Table I of the 

Convention Against Illicit Traffic in 

Narcotic Drugs and Psychotropic 

Substances of 1988 (1988 Convention) 

in response to the international 


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17 60th Session of the CND Dec/60/12 (ANPP) and 

Dec/60/13 (NPP). 

18https://www.dea.gov/press-release/2018/01/05/ 

china-announces-scheduling-controls-two-fentanylprecursor-chemicals. Accessed March 9, 2022. 

19 In a letter dated May 27, 2022, the United 

Nations Office on Drugs and Crime, in accordance 

with Article 12, paragraph 6 of the 1988 

Convention, informed the Permanent Mission of the 

United States of America to the United Nations 

(Vienna) that the CND decided to place the 

chemical 4–AP in Table I of the 1988 Convention 

(CND Dec/65/4) and the chemical 1-boc-4–AP in 

Table I of the 1988 Convention (CND Dec/65/5) at 

its 65th Session on March 16, 2022. 

20 85 FR 20822 (April 15, 2020). 

21 88 FR 21902 (Apr. 12, 2023). 

22 85 FR 20822 (Apr. 15, 2020). 

23 85 FR 21320 (Apr. 17, 2020). 

24 72 FR 20039 (Apr. 23, 2007). 

25 75 FR 37295 (Aug. 30, 2010). 

26 85 FR 20822 (Apr. 15, 2020). 

27Chemicals included the folowing: ortho-fluoro 

4–AP, ortho-chloro 4–AP, ortho-bromo 4–AP, metafluoro 4–AP, meta-chloro 4–AP, meta-bromo 4–AP, 

para-fluoro 4–AP, para-chloro 4–AP, para-bromo 

4–AP, ortho-fluoro 1-boc-4–AP, ortho-chloro 1-boc4–AP, ortho-bromo 1-boc-4–AP, meta-fluoro 1-boc4–AP, meta-chloro 1-boc-4–AP, meta-bromo 1-boc4–AP, para-fluoro 1-boc-4–AP, para-chloro 1-boc4–AP, and para-bromo 1-boc-4–AP. 

28On October 1, 2014, DEA implemented 

STARLiMS (a web-based, commercial laboratory 

information management system) to replace the 

System to Retrieve Information from Drug Evidence 

(STRIDE) as its laboratory drug evidence data 

system of record. STARLiMS data was queried on 

September 12, 2022. 

reintroduction of fentanyl on the illicit 

drug market.17 As such, member states 

of the United Nations were required to 

regulate these precursor chemicals at 

the national level. In addition, the 

People’s Republic of China regulated 

NPP and ANPP on February 1, 2018.18

Following the international control of 

NPP and ANPP under the 1988 

Convention, illicit fentanyl 

manufacturers moved to unregulated 

precursor chemicals. These included 4- 

anilinopiperidine, 1-boc-4–AP, and 

norfentanyl. In response, the CND 

placed 4-anilinopiperidine, 1-boc-4–AP, 

and norfentanyl in Table I of the 1988 

Convention.19

On May 15, 2020, 4-anilinopiperidine 

became a list I chemical in the United 

States due to its role in the illicit 

manufacture of fentanyl.20 Since that 

control action, DEA has observed an 

increase in identifications of certain 

fentanyl analogues by law enforcement 

and public health officials. Many of 

these fentanyl analogues contain a 

halogen atom on the aniline ring of its 

respective chemical structure. The 

presence of the halogen atom suggests 

that the fentanyl analogue was 

synthesized from a halogenated 

precursor chemical. Indeed, halogenated 

fentanyl precursors have been identified 

by law enforcement, such as tert-butyl 

4-((4-fluorophenyl)amino)piperidine-1- 

carboxylate (para-fluoro 1-boc 4–AP). 

The chemical structure of this precursor 

defines it as a halide and carbamate of 

4-anilinopiperidine. As such, it falls 

outside of the current definitions of a 

list I chemical, simply due to the 

presence of the fluorine (a halogen) 

atom. Although not previously regulated 

as a list I chemical, it can be used in the 

synthesis of fentanyl analogues, such as 

the schedule I substances parafluorofentanyl, para-fluoroisobutyryl 

fentanyl, para-fluorobutyryl fentanyl, 

and para-fluoro furanyl fentanyl. 

In addition, fentanyl analogues with 

both meta- and ortho-fluoro 

substitutions have been identified, such 

as ortho-fluorofuranyl fentanyl and 

meta-fluorofuranyl fentanyl. The 

identification of these substances 

suggests illicit fentanyl analogue 

manufacturers attempt to utilize 

unregulated precursor chemicals to 

evade law enforcement detection and 

precursor chemical controls. This 

strategy allows for the synthesis of a 

variety of fentanyl analogues by simply 

moving the fluorine atom around the 

aniline ring while maintaining the same 

synthetic methodology used to 

synthesize fentanyl and fentanyl 

analogues. 

Likewise, other halogenated fentanyl 

analogues, such as those containing a 

chlorine atom, have been reported by 

forensic laboratories. According to 

NFLIS-Drug, para-chlorofentanyl and 

ortho-chlorofentanyl were reported for 

the first time in 2020. The identification 

of these substances suggests that illicit 

fentanyl analogue manufacturers utilize 

precursor chemicals containing a 

chlorine atom as an alternative to a 

fluorine atom in effort to evade law 

enforcement detection. 

4-Anilinopiperidine 

The original published synthetic 

pathway to fentanyl, known as the 

Janssen method, involves the two 

important precursors, benzylfentanyl 

and norfentanyl. 4-Piperidone,21 a list I 

chemical under the CSA, serves as a 

precursor chemical to benzylfentanyl, a 

list I chemical under the CSA,22 which 

is converted to norfentanyl, the 

schedule II immediate precursor in this 

synthetic pathway. Norfentanyl is then 

subjected to one simple chemical 

reaction to complete the synthesis of 

fentanyl. Norfentanyl is controlled in 

schedule II of the CSA.23

Like the Janssen method, 4- 

piperidone serves as an early-stage 

precursor chemical in the Siegfried 

method. 4-Piperidone is a precursor to 

NPP, a known fentanyl precursor and 

list I chemical under the CSA,24 in the 

Siegfried method. NPP is then converted 

to ANPP, the schedule II immediate 

precursor in this synthetic pathway. 

ANPP is then subjected to a simple onestep chemical reaction to complete the 

synthesis of fentanyl. ANPP is 

controlled as a schedule II immediate 

precursor under the CSA.25

In addition to the Janssen and 

Siegfried methods, clandestine 

manufacturers are using other methods 

to synthesize fentanyl, one of which is 

known as the Gupta method. 4- 

Anilinopiperidine, a list I chemical 

under the CSA,26 is the key precursor in 

the Gupta method. 4-Anilinopiperidine 

serves as an alternative precursor 

chemical to NPP in the synthesis of 

ANPP, albeit through a different 

synthetic process. The resulting ANPP 

is then used as the immediate precursor 

chemical in the illicit manufacture of 

fentanyl. 

Recent encounters of precursor 

chemicals related to 4-anilinopiperidine 

in chemical structure have occurred. 

These precursor chemicals contain a 

halogen atom on the aniline ring of 4- 

anilinopiperidine. Modifications have 

included the addition of a fluorine 

atom, a chlorine atom, or a bromine 

atom at different positions on the 

aniline ring of the 4-anilinopiperidine 

structure. The use of these halogenated 

4-anilinopiperidine precursor chemicals 

in place of 4-anilinopiperidine has 

resulted in the illicit manufacturing of 

schedule I fentanyl analogues. 

Halogenated 4-anilinopiperidines 27

are commercially available from both 

domestic and foreign suppliers. DEA is 

aware of at least 25 domestic suppliers 

and 14 foreign suppliers. Modified 

versions of 4-anilinopiperidine, such as 

para-fluoro 1-boc-4–AP, are attractive to 

illicit manufacturers because they are 

readily available from chemical 

suppliers and the lack of regulatory 

control on these substituted precursor 

chemicals. 

para-Fluoro 1-boc-4–AP has been 

identified in law enforcement 

encounters in the United States. 

According to NFLIS-Drug, beginning in 

2020, there have been at least nine 

reports of para-fluoro 1-boc-4–AP from 

forensic laboratories in the United 

States. A query of DEA’s STARLiMS 28

database provided 16 reports of parafluoro 1-boc-4–AP from analyses 

conducted on submitted drug evidence 

by DEA forensic laboratories. Of these 

16 reports, para-fluoro 1-boc-4–AP was 

the only substance reported in nine 

exhibits (totaling more than 29 kg), 

suggesting that these seizures were 

intended to be used as precursor 

chemicals in the synthesis of fentanyl 


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29PICS is a platform that allows governments to 

exchange operational and investigative intelligence 

and to generate strategic intelligence on precursors 

trafficking. PICS reports were collected up to 

August 23, 2022. 

30 21 CFR 1310.13. 

31 21 U.S.C. 802(39)(A)(vi). 

analogues. Additionally, para-fluoro 1- 

boc-4–AP was reported in combination 

with para-fluorofentanyl in four of the 

seven exhibits containing a mixture of 

substances, suggesting that para-fluoro 

1-boc-4–AP was a precursor chemical 

involved in the synthesis of parafluorofentanyl, a schedule I substance 

under the CSA. 

As of August 2022, in addition to 

domestic encounters, the International 

Narcotics Control Board of the United 

Nations reported two international 

transactions of para-fluoro 1-boc-4–AP 

through the Precursors Incident 

Communication System (PICS) 29

reporting system. These incidents 

reported to PICS totaled approximately 

51 kg and had destinations located in 

North America. 

These recent law enforcement 

encounters of para-fluoro 1-boc-4–AP 

coincide with the placement of NPP, 

ANPP, 4-anilinopiperidine, 1-boc-4–AP 

(tert-butyl 4-(phenylamino)piperidine-1- 

carboxylate), and norfentanyl in Table I 

of the 1988 Convention, the People’s 

Republic of China regulating NPP and 

ANPP as of February 1, 2018, and the 

regulation of benzylfentanyl and 

proposed control of 4-piperidone as list 

I chemicals in the United States. The 

domestic encounters of para-fluoro 1- 

boc-4–AP at ports of entry indicate a 

change in precursors used in the illicit 

manufacture of fentanyl to substituted 

precursor chemicals used in the illicit 

manufacture of fentanyl analogues in 

efforts to evade international controls on 

NPP, ANPP, 4-anilinopiperidine, 1-boc4–AP, and norfentanyl and additional 

controls on benzylfentanyl in the United 

States. 

Regulation of 4-Anilinopiperidine, 

Including Its Amides, Its Carbamates, 

Its Halides, Its Salts, and Any 

Combination Thereof, Whenever the 

Existence of Such Is Possible, as a List 

I Chemical 

The CSA, specifically 21 U.S.C. 

802(34), and its implementing 

regulations at 21 CFR 1310.02(c), 

provide the Attorney General with the 

authority to specify, by regulation, 

additional precursor or essential 

chemicals as listed chemicals if they are 

used in the manufacture of controlled 

substances in violation of the CSA. 

Recent law enforcement encounters 

indicate halides of 4-anilinopiperidine 

are being used in the illicit manufacture 

of schedule I fentanyl analogues. This 

rule modifies the current listing of 4- 

anilinopiperidine, including its amides, 

its carbamates, and its salts to include 

halides of 4-anilinopiperidine. DEA 

finds that 4-anilinopiperidine, including 

its amides, its carbamates, its halides, its 

salts, and any combination thereof, 

whenever the existence of such is 

possible, is used in the illicit 

manufacture of controlled substances, 

such as fentanyl and fentanyl analogues, 

and is important to the manufacture of 

these substances because it cannot be 

replaced by other chemicals in their 

respective synthetic pathways that are 

used in the illicit manufacture of 

fentanyl and fentanyl analogues. 

Comments Received 

As part of this rulemaking, DEA 

solicited information on any possible 

legitimate uses of halides of 4- 

anilinopiperidine unrelated to fentanyl 

production (including industrial uses) 

in order to assess the potential 

economic impact of controlling halides 

of 4-anilinopiperidine as defined in this 

rule. DEA has searched information in 

the public domain for legitimate uses of 

this chemical, and has not documented 

a legitimate commercial or industrial 

use for halides of 4-anilinopiperidine. 

DEA sought, however, to document any 

unpublicized use(s) and other 

proprietary use(s) of halides of 4- 

anilinopiperidine that are not in the 

public domain. Therefore, DEA solicited 

comment on the uses of halides of 4- 

anilinopiperidine in the legitimate 

marketplace. 

DEA solicited input from all 

potentially affected parties regarding: (1) 

The types of legitimate industries using 

halides of 4-anilinopiperidine; (2) the 

legitimate uses of halides of 4- 

anilinopiperidine, if any; (3) the size of 

the domestic market for halides of 4- 

anilinopiperidine; (4) the number of 

manufacturers of halides of 4- 

anilinopiperidine; (5) the number of 

distributors of halides of 4- 

anilinopiperidine; (6) the level of import 

and export of halides of 4- 

anilinopiperidine; (7) the potential 

burden these regulatory controls of 

halides of 4-anilinopiperidine may have 

on any legitimate trade; (8) the potential 

number of individuals/firms that may be 

adversely affected by these regulatory 

controls (particularly with respect to the 

impact on small businesses); and (9) any 

other information on the manner of 

manufacturing, distribution, 

consumption, storage, disposal, and 

uses of halides of 4-anilinopiperidine by 

industry and others. DEA invited all 

interested parties to provide any 

information on any legitimate uses of 

halides of 4-anilinopiperidine in 

industry, commerce, academia, research 

and development, or other applications. 

DEA sought both quantitative and 

qualitative data. DEA did not receive 

any responses to these specific 

solicitations, nor did DEA receive any 

other comments in response to the 

NPRM. 

Chemical Mixtures of 4- 

Anilinopiperidine 

This rulemaking modifies the current 

regulations for 4-anilinopiperidine, 

including its amides, its carbamates, 

and its salts to include halides of 4- 

anilinopiperidine. The regulations 

specify that chemical mixtures 

containing halides of 4- 

anilinopiperidine are not exempt from 

regulatory requirements at any 

concentration, unless an application for 

exemption of a chemical mixture is 

submitted by a manufacturer of halides 

of 4-anilinopiperidine and the 

application is reviewed and accepted by 

DEA under 21 CFR 1310.13 (Exemption 

by Application Process). The control of 

chemical mixtures containing any 

amount of halides of 4- 

anilinopiperidine is necessary to 

prevent the extraction, isolation, and 

use of halides of 4-anilinopiperidine in 

the illicit manufacture of schedule I 

fentanyl analogues. This rule modifies 

the Table of Concentration Limits in 21 

CFR 1310.12(c) to reflect the fact that 

chemical mixtures containing any 

amount of 4-anilinopiperidine, 

including its amides, its carbamates, its 

halides, its salts, and any combination 

thereof, whenever the existence of such 

is possible, are subject to the CSA 

chemical control provisions as list I 

chemicals. 

Exemption by Application Process 

DEA has implemented an application 

process to exempt mixtures from the 

requirements of the CSA and its 

implementing regulations.30 Under the 

application process, manufacturers may 

submit an application for exemption for 

those mixtures that do not qualify for 

automatic exemption. Exemption status 

can be granted if DEA determines that 

the mixture is formulated in such a way 

that it cannot be easily used in the illicit 

production of a controlled substance 

and that the listed chemical cannot be 

readily recovered.31

Requirements for Handling List I 

Chemicals 

On May 15, 2020, DEA promulgated 

regulations which listed 4- 

anilinopiperidine, including its amides, 

its carbamates, and its salts, as a list I 


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32 85 FR 20822. 

33 21 CFR 1309.21. 

34 21 U.S.C. 822(e)(1); 21 CFR 1309.23(a). 

35 21 U.S.C. 822(c)(2). 36 21 U.S.C. 822(a)(1). 

37 21 CFR 1310.05(d). 

38 21 U.S.C. 830(b); 21 CFR 1310.05(a) and (b). 

chemical under the CSA. Chemicals that 

meet the current definition of 4- 

anilinopiperidine 32 have been, and 

continue to be, subject to the regulatory 

provisions of the CSA since May 15, 

2020. This rule expands the definitions 

of 4-anilinopiperidine to include its 

halides. Halides of 4-anilinopiperidine 

become subject to the regulatory 

provisions of the CSA upon the effective 

date of this rule. 

Upon the effective date of this final 

rule, halides of 4-anilinopiperidine will 

be subject to all of the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to the 

manufacture, distribution, importing, 

and exporting of list I chemicals, just as 

4-anilinopiperidine, including its 

amides, its carbamates, and its salts are 

currently regulated. Upon the effective 

date of this final rule, persons 

potentially handling halides of 4- 

anilinopiperidine, including regulated 

chemical mixtures containing halides of 

4-anilinopiperidine, will be required to 

comply with list I chemical regulations, 

including the following: 

1. Registration. Any person who 

manufactures, distributes, imports, or 

exports halides of 4-anilinopiperidine, 

including chemical mixtures containing 

halides of 4-anilinopiperidine, or 

proposes to engage in the manufacture, 

distribution, importation, or exportation 

of halides of 4-anilinopiperidine, 

including chemical mixtures containing 

halides of 4-anilinopiperidine, must 

obtain a registration pursuant to 21 

U.S.C. 822, 823, 957, and 958, if they are 

not already registered to handle list I 

chemicals. Regulations describing 

registration for list I chemical handlers 

are set forth in 21 CFR part 1309. DEA 

regulations require separate registrations 

for manufacturing, distributing, 

importing, and exporting of list I 

chemicals.33 Further, a separate 

registration is required for each 

principal place of business at one 

general physical location where list I 

chemicals are manufactured, 

distributed, imported, or exported by a 

person.34

DEA notes that under the CSA, 

‘‘warehousemen’’ are not required to 

register and may lawfully possess list I 

chemicals, if the possession of those 

chemicals is in the usual course of 

business or employment.35 Under DEA 

implementing regulations, the 

warehouse in question must receive the 

list I chemical from a DEA registrant 

and shall only distribute the list I 

chemical back to the DEA registrant and 

registered location from which it was 

received. A warehouse that distributes 

list I chemicals to persons other than the 

registrant and registered location from 

which they were obtained is conducting 

distribution activities and is required to 

register as such.36

Upon the effective date of this final 

rule, any person manufacturing, 

distributing, importing, or exporting 

halides of 4-anilinopiperidine or a 

chemical mixture containing halides of 

4-anilinopiperidine will become subject 

to the registration requirement under 

the CSA for list I chemicals. DEA 

recognizes, however, that it is not 

possible for persons who become 

subject to the registration requirements 

under this rule to immediately complete 

and submit an application for 

registration, and for DEA to immediately 

issue registrations for those activities. 

Therefore, to allow any continued 

legitimate commerce in halides of 4- 

anilinopiperidine or a chemical mixture 

containing halides of 4- 

anilinopiperidine, DEA is updating the 

listing in 21 CFR 1310.09(p), to include 

a temporary exemption from the 

registration requirement for persons 

desiring to engage in activities with the 

updated definitions of halides of 4- 

anilinopiperidine or a chemical mixture 

containing halides of 4- 

anilinopiperidine, provided that DEA 

receives a properly completed 

application for registration or 

application for exemption of a chemical 

mixture under 21 CFR 1310.13 on or 

before November 30, 2023. The 

temporary exemption for such persons 

will remain in effect until DEA takes 

final action on their application for 

registration or application for exemption 

of a chemical mixture. 

The temporary exemption applies 

solely to the registration requirement; 

all other chemical control requirements, 

including recordkeeping and reporting, 

will become effective on the effective 

date of this final rule. This is necessary 

because a delay in regulating these 

transactions could result in increased 

diversion of chemicals desirable to drug 

traffickers. 

Additionally, the temporary 

exemption for registration does not 

suspend applicable Federal criminal 

laws relating to halides of 4- 

anilinopiperidine, nor does it supersede 

State or local laws or regulations. All 

handlers of halides of 4- 

anilinopiperidine must comply with 

applicable State and local requirements 

in addition to the CSA regulatory 

controls. 

2. Records and Reports. Every DEA 

registrant must maintain records and 

submit reports with respect to halides of 

4-anilinopiperidine pursuant to 21 

U.S.C. 830 and in accordance with 21 

CFR part 1310.04 and 1310.05. Pursuant 

to 21 CFR 1310.04, a record must be 

kept for two years after the date of a 

transaction involving a listed chemical, 

provided the transaction is a regulated 

transaction. 

Each regulated bulk manufacturer of a 

listed chemical must submit 

manufacturing, inventory, and use data 

on an annual basis. Existing standard 

industry reports containing the required 

information are acceptable, provided the 

information is separate or readily 

retrievable from the report.37

The CSA and its implementing 

regulations require that each regulated 

person must report to DEA any 

regulated transaction involving an 

extraordinary quantity of a listed 

chemical, an uncommon method of 

payment or delivery, or any other 

circumstance that the regulated person 

believes may indicate that the listed 

chemical will be used in violation of 

subchapter I of the CSA. In addition, 

regulated persons must report any 

proposed regulated transaction with a 

person whose description or other 

identifying characteristics DEA has 

previously furnished to the regulated 

person, any unusual or excessive loss or 

disappearance of a listed chemical 

under the control of the regulated 

person, and any in-transit loss in which 

the regulated person is the supplier.38

3. Importation and Exportation. All 

importation and exportation of halides 

of 4-anilinopiperidine or a chemical 

mixture containing halides of 4- 

anilinopiperidine must be done in 

compliance with 21 U.S.C. 957, 958, 

and 971, and in accordance with 21 CFR 

part 1313. 

4. Security. All applicants and 

registrants must provide effective 

controls against theft and diversion of 

list I chemicals in accordance with 21 

CFR 1309.71–1309.73. 

5. Administrative Inspection. Places, 

including factories, warehouses, or 

other establishments and conveyances, 

where registrants or other regulated 

persons may lawfully hold, 

manufacture, distribute, or otherwise 

dispose of a list I chemical or where 

records relating to those activities are 

maintained, are controlled premises as 

defined in 21 U.S.C. 880(a) and 21 CFR 

1316.02(c). The CSA allows for 

administrative inspections of these 


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39 21 U.S.C. 880. 

40Office of Information and Regulatory Affairs. 

controlled premises as provided in 21 

CFR part 1316, subpart A.39

6. Liability. Any activity involving 

halides of 4-anilinopiperidine not 

authorized by, or in violation of, the 

CSA, would be unlawful, and would 

subject the person to administrative, 

civil, and/or criminal action. 

Regulatory Analyses 

Executive Orders 12866 and 13563, 

Regulatory Planning and Review, 

Improving and Regulation and 

Regulatory Review 

This final rule, which adds halides of 

4-anilinopiperidine to the prior listing 

of the list I chemical 4- 

anilinopiperidine, was developed in 

accordance with the principles of 

Executive orders (E.O.) 12866, 13563, 

and 14094. E.O. 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, if 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health, 

and safety effects; distributive impacts; 

and equity). E.O. 13563 is supplemental 

to and reaffirms the principles, 

structures, and definitions governing 

regulatory review as established in E.O. 

12866. 

E.O. 12866 classifies a ‘‘significant 

regulatory action,’’ requiring review by 

the Office of Management and Budget 

(OMB), as any regulatory action that is 

likely to result in a rule that may: (1) 

have an annual effect on the economy 

of $200 million or more (adjusted every 

three years by the Administrator of 

OIRA 40 for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise legal or 

policy issues for which centralized 

review would meaningfully further the 

President’s priorities or the principles 

set forth in the E.O., as specifically 

authorized in a timely manner by the 

Administrator of OIRA in each case. 

A review of the 25 domestic suppliers 

of halides of 4-anilinopiperidine 

indicates that these entities are not 

currently registered with DEA to handle 

list I chemicals. These 25 suppliers are 

entities that do not also supply 4- 

anilinopiperidine, as these entities 

would already be required to register to 

handle list I chemicals since 4- 

anilinopiperidine is currently a list I 

chemical under the CSA. Therefore, the 

modified definitions of 4- 

anilinopiperidine in this final rule 

would potentially affect 25 entities. 

DEA anticipates that this rule will 

impose minimal or no economic impact 

on affected entities; and thus, will not 

have a significant economic impact on 

any of the 25 affected small entities. 

Therefore, DEA concludes this rule is 

not a significant regulatory action under 

E.O. 12866. Upon the effective date of 

this final rule, halides of 4- 

anilinopiperidine will be subject to all 

of the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, importing, and exporting of 

list I chemicals, just as 4- 

anilinopiperidine, including its amides, 

its carbamates, and its salts, is currently 

regulated. 4-Anilinopiperidine is a 

precursor chemical used in, and is 

important to, the illicit manufacture of 

the schedule II controlled substance 

fentanyl and schedule I fentanyl 

analogues. The distribution of illicitly 

manufactured fentanyl and fentanyl 

analogues has caused an unprecedented 

outbreak of thousands of fentanylrelated overdoses in the United States in 

recent years. 

DEA has searched information in the 

public domain for any legitimate uses of 

halides of 4-anilinopiperidine, and has 

not documented a use for halides of 4- 

anilinopiperidine. DEA requested 

public comment regarding this estimate; 

however, no public comment was 

received during the notice and comment 

period. 

DEA evaluated the costs and benefits 

of this action. 

Costs 

DEA believes the market for halides of 

4-anilinopiperidine for the legitimate 

manufacturing of pharmaceutical 

fentanyl is minimal, because halides of 

4-anilinopiperidine are not used to 

synthesize fentanyl or any schedule II 

fentanyl analogue currently used in 

medical practice. As stated above, DEA 

is not aware of any legitimate uses of 

halides of 4-anilinopiperidine. Any 

manufacturer, distributor, importer, or 

exporter of halides of 4- 

anilinopiperidine will incur costs. The 

primary costs associated with this rule 

would be the annual registration fees for 

list I chemicals ($3,699 for 

manufacturers and $1,850 for 

distributors, importers, and exporters). 

However, DEA believes that the cost 

will be minimal. 

DEA has identified 25 domestic 

suppliers of halides of 4- 

anilinopiperidine. None of these 25 

suppliers are registered to handle list I 

chemicals. It is difficult to estimate the 

quantity of distribution of halides of 4- 

anilinopiperidine by these suppliers. It 

is common for chemical distributors to 

have items in their catalog while not 

actually having any material level of 

sales. Suppliers for the legitimate use of 

halides of 4-anilinopiperidine are 

expected to choose the least-cost option, 

and depending on the circumstances, 

some suppliers might choose to stop 

selling the minimal quantities, if any, of 

halides of 4-anilinopiperidine, rather 

than incur the registration cost. Because 

DEA believes the quantities of halides of 

4-anilinopiperidine supplied for the 

legitimate manufacturing of 

pharmaceutical fentanyl are minimal, 

DEA estimates that the cost of foregone 

sales is minimal; thus, the cost of this 

rule is minimal. DEA requested public 

comment regarding this estimate; 

however, no public comment was 

received during the notice and comment 

period. 

This analysis excludes consideration 

of any economic impact to those 

businesses that facilitate the 

manufacturing and distribution of 

halides of 4-anilinopiperidine for the 

manufacturing of illicit fentanyl and 

fentanyl analogues. As a law 

enforcement organization and as a 

matter of principle, DEA believes 

considering the economic utility of 

facilitating the manufacture of illicit 

fentanyl would be improper. 

Benefits 

Controlling halides of 4- 

anilinopiperidine is expected to 

prevent, curtail, and limit the unlawful 

manufacture and distribution of 

fentanyl and fentanyl analogues. As a 

list I chemical, handling of halides of 4- 

anilinopiperidine requires registration 

with DEA and various controls and 

monitoring as required by the CSA. This 

rule is also expected to assist preventing 

the possible theft or diversion of halides 

of 4-anilinopiperidine from any 

legitimate firms. DEA also believes 

control is necessary to prevent 

unscrupulous chemists from 

synthesizing halides of 4- 

anilinopiperidine and selling them (as 

unregulated materials) through the 

internet and other channels, to 

individuals who may wish to acquire 

unregulated intermediary chemicals for 

the purpose of illicitly manufacturing 

fentanyl and fentanyl analogues. 


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41https://www.sba.gov/sites/default/files/2018- 

07/NAICS%202017%20Table%20of%20Size%20

Standards.pdf. 

In summary, DEA conducted a 

qualitative analysis of costs and 

benefits. DEA believes this action will 

minimize the diversion of halides of 4- 

anilinopiperidine. DEA believes the 

market for halides of 4- 

anilinopiperidine for the legitimate 

manufacturing of fentanyl or schedule II 

fentanyl analogues currently used in 

medical practice is minimal, since 

halides of 4-anilinopiperidine are not 

used to synthesize fentanyl or any 

schedule II fentanyl analogue currently 

used in medical practice. Therefore, any 

potential cost as a result of this 

regulation is minimal. 

Executive Order 12988, Civil Justice 

Reform 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of E.O. 12988 Civil Justice 

Reform to eliminate drafting errors and 

ambiguity, minimize litigation, provide 

a clear legal standard for affected 

conduct, and promote simplification 

and burden reduction. 

Executive Order 13132, Federalism 

This rule does not have federalism 

implications warranting the application 

of E.O. 13132. The rule does not have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

the distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This rule does not have tribal 

implications warranting the application 

of E.O. 13175. This rule does not have 

substantial direct effects on one or more 

Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act (5 

U.S.C. 601–612), has reviewed this rule 

and by approving it certifies that it will 

not have a significant economic impact 

on a substantial number of small 

entities. As discussed above, halides of 

4-anilinopiperidine or a chemical 

mixture containing halides of 4- 

anilinopiperidine shall be subject to all 

of the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, importing, and exporting of 

list I chemicals. Halides of 4- 

anilinopiperidine are precursor 

chemicals used in, and important to, the 

illicit manufacture of the schedule I 

fentanyl analogues. The distribution of 

illicitly manufactured fentanyl and 

fentanyl analogues has caused an 

unprecedented outbreak of thousands of 

fentanyl-related overdoses in the United 

States in recent years. DEA has not 

identified any legitimate industrial use 

for halides of 4-anilinopiperidine. 

Therefore, DEA believes the vast 

majority, if not all, of halides of 4- 

anilinopiperidine is used for the illicit 

manufacturing of schedule I fentanyl 

analogues. The primary costs associated 

with this rule are the annual registration 

fees ($3,699 for manufacturers and 

$1,850 for distributors, importers, and 

exporters). DEA has identified 25 

domestic suppliers of halides of 4- 

anilinopiperidine, all of which are not 

currently registered with DEA to handle 

list I chemicals. All non-registered 

domestic suppliers are affected and are 

estimated to be small entities (based on 

Small Business Administration size 

standard for chemical distributors and 

Statistics of U.S. Business data).41 It is 

impossible to know how much halides 

of 4-anilinopiperidine is distributed by 

these suppliers. It is common for 

chemical distributors to have items in 

their catalog while not actually having 

any material level of sales. Therefore, 

DEA estimates the cost of this rule on 

any affected small entity is minimal. 

DEA did not receive public comment 

regarding this estimate. Based on these 

factors, DEA projects that this rule will 

not result in a significant economic 

impact on a substantial number of small 

entities. 

Unfunded Mandates Reform Act of 1995 

On the basis of information contained 

in the Regulatory Flexibility Act section 

above, DEA has determined and certifies 

pursuant to the Unfunded Mandates 

Reform Act of 1995 (UMRA), 2 U.S.C. 

1501 et seq., that this action would not 

result in any Federal mandate that may 

result ‘‘in the expenditure by State, 

local, and tribal governments, in the 

aggregate, or by the private sector, of 

$100,000,000 or more (adjusted for 

inflation) in any one year . . . .’’ 

Therefore, neither a Small Government 

Agency Plan nor any other action is 

required under provisions of UMRA. 

Congressional Review Act 

This rule is not a major rule as 

defined by the Congressional Review 

Act (CRA), 5 U.S.C. 804. However, 

pursuant to the CRA, DEA is submitting 

a copy of this final rule to both Houses 

of Congress and to the Comptroller 

General. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 25, 2023, by Administrator 

Anne Milgram. 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. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

List of Subjects in 21 CFR Part 1310 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, DEA 

amends 21 CFR part 1310 to read as 

follows: 

PART 1310—RECORDS AND 

REPORTS OF LISTED CHEMICALS 

AND CERTAIN MACHINES; 

IMPORTATION AND EXPORTATION OF 

CERTAIN MACHINES 

■ 1. The authority citation for 21 CFR 

part 1310 continues to read as follows: 

Authority: 21 U.S.C. 802, 827(h), 830, 

871(b), 890. 

■ 2. In § 1310.02, revise paragraph 

(a)(33) to read as follows: 

§ 1310.02 Substances covered. 

* * * * * 

(a) * * * 


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*******

(33) N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4–AP), its amides, its carbamates, its halides, its 

salts, and any combination thereof, whenever the existence of such is possible .......................................................................... 8335 

*******

* * * * * 

■ 3. In § 1310.04, revise paragraph 

(g)(1)(xiv) to read as follows: 

§ 1310.04 Maintenance of records. 

* * * * * 

(g) * * * 

(1) * * * 

(xiv) N-phenylpiperidin-4-amine (4- 

anilinopiperidine; N-phenyl-4- 

piperidinamine; 4–AP), its amides, its 

carbamates, its halides, its salts, and any 

combination thereof, whenever the 

existence of such is possible. 

* * * * * 

■ 4. In § 1310.09, revise paragraph (p) to 

read as follows: 

§ 1310.09 Temporary exemption from 

registration. 

* * * * * 

(p)(1) Each person required under 21 

U.S.C. 822 and 21 U.S.C. 957 to obtain 

a registration to manufacture, distribute, 

import, or export regulated Nphenylpiperidin-4-amine (4- 

anilinopiperidine; N-phenyl-4- 

piperidinamine; 4–AP), its amides, its 

carbamates, its halides, its salts, and any 

combination thereof, whenever the 

existence of such is possible, including 

regulated chemical mixtures pursuant to 

§ 1310.12, is temporarily exempted from 

the registration requirement, provided 

that DEA receives a properly completed 

application for registration or 

application for exemption for a 

chemical mixture containing halides of 

4-anilinopiperidine pursuant to 

§ 1310.13 on or before November 30, 

2023. The exemption would remain in 

effect for each person who has made 

such application until the 

Administration has approved or denied 

that application. This exemption applies 

only to registration; all other chemical 

control requirements set forth in the Act 

and parts 1309, 1310, 1313, and 1316 of 

this chapter remain in full force and 

effect. 

(2) Any person who manufactures, 

distributes, imports, or exports a 

chemical mixture containing Nphenylpiperidin-4-amine (4- 

anilinopiperidine; N-phenyl-4- 

piperidinamine; 4–AP), its amides, its 

carbamates, its halides, its salts, and any 

combination thereof, whenever the 

existence of such is possible, whose 

application for exemption is 

subsequently denied by DEA must 

obtain a registration with DEA. A 

temporary exemption from the 

registration requirement will also be 

provided for those persons whose 

application for exemption is denied, 

provided that DEA receives a properly 

completed application for registration 

on or before 30 days following the date 

of official DEA notification that the 

application for exemption has been 

denied. The temporary exemption for 

such persons will remain in effect until 

DEA takes final action on their 

registration application. 

* * * * * 

■ 5. In § 1310.12, in the table in 

paragraph (c), revise the entry for Nphenylpiperidin-4-amine to read as 

follows: 

§ 1310.12 Exempt chemical mixtures. 

* * * * * 

(c) * * * 

TABLE OF CONCENTRATION LIMITS

DEA chemical 

code number Concentration Special conditions 

List I Chemicals 

*******

N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4- 

piperidinamine; 4–AP), its amides, its carbamates, its 

halides, its salts, and any combination thereof, whenever 

the existence of such is possible.

8335 Not exempt at any 

concentration.

Chemical mixtures containing any 

amount of 4-anilinopiperidine are not 

exempt. 

* * * * * * * 

* * * * * 

[FR Doc. 2023–23927 Filed 10–30–23; 8:45 am] 

BILLING CODE 4410–09–P 


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