75312 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

demonstrate that he has undertaken 

corrective measures. Holiday CVS, 

L.L.C., dba CVS Pharmacy Nos 219 and 

5195, 77 FR 62316, 62339 (2012) 

(internal quotations omitted). Trust is 

necessarily a fact-dependent 

determination based on individual 

circumstances; therefore, the Agency 

looks at factors such as the acceptance 

of responsibility, the credibility of that 

acceptance as it relates to the 

probability of repeat violations or 

behavior, the nature of the misconduct 

that forms the basis for sanction, and the 

Agency’s interest in deterring similar 

acts. See, e.g., Robert Wayne Locklear, 

M.D., 86 FR 33738, 33746 (2021). 

When a respondent declines to testify 

and ‘‘neither [takes] responsibility for 

his misconduct nor provid[es] any 

assurances that he has implemented 

remedial measures to ensure such 

conduct is not repeated,’’ the 

respondent’s silence weighs against 

registration. Zvi H. Perper, M.D., 77 FR 

64131, 64142 (2012) (citing Medicine 

Shoppe-Jonesborough, 73 FR 364, 387 

(2008)); see also Jeanne E. Germeil, 

M.D., 85 FR 73786, 73803 (2020). Such 

silence also warrants an adverse 

inference against the respondent. 

MacKay v. Drug Enf’t Admin, 664 F.3d 

808, 820 (10th Cir. 2011) (upholding the 

Agency’s finding that a respondent’s 

failure to testify warranted an adverse 

inference because there was ‘‘no 

evidence that [respondent] recognized 

the extent of his misconduct and was 

prepared to remedy his prescribing 

practices’’); T.J. McNichol, M.D., 77 FR 

57133, 57153–54 (2012) (stating that ‘‘it 

is appropriate to draw an adverse 

inference from Respondent’s failure to 

testify’’). 

Here, Respondent has failed to accept 

responsibility or offer any basis for the 

Agency to trust him, despite his past 

misconduct, with the responsibility of a 

registration. RD, at 21. In light of 

Respondent’s silence, he has not 

sufficiently demonstrated that he can be 

entrusted with a DEA registration. See 

id.; MacKay, 664 F.3d at 820; Jeanne E. 

Germeil, M.D., 85 FR at 73803; Zvi H. 

Perper, M.D., 77 FR at 64142. 

In addition to acceptance of 

responsibility, the Agency looks to the 

egregiousness and extent of the 

misconduct, Garrett Howard Smith, 

M.D., 83 FR at 18910 (collecting cases), 

and considers both specific and general 

deterrence when determining an 

appropriate sanction. Daniel A. Glick, 

D.D.S., 80 FR 74800, 74810 (2015). Here, 

Respondent’s blatant and repeated 

disregard for the laws relating to 

controlled substances warrants a 

sanction. Respondent’s inappropriate 

and unlawful prescribing of controlled 

substances placed multiple patients, 

and the public, at risk of harm. In this 

case, the Agency believes that denial of 

Respondent’s application would deter 

Respondent and the general registrant 

community from disregarding 

controlled substance laws and engaging 

in the pattern of misconduct that 

permeated Respondent’s actions as a 

registrant. See RD, at 22. As the Chief 

ALJ noted, ‘‘[t]he misconduct 

established was sufficiently egregious 

that a denial is strongly supported.’’ RD, 

at 22. Further, there is no evidence that 

Respondent’s behavior is unlikely to 

recur in the future such that the Agency 

can entrust him with a registration. 

In sum, the public interest factors 

weigh in favor of denial as a sanction; 

accordingly, the Agency shall order the 

sanctions the Government requested, as 

contained in the Order below. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

823(g)(1), I hereby deny the DEA 

registration application of Osmin A. 

Morales, M.D. (Control No. 

W20125906C) and any other pending 

application of Osmin A. Morales, M.D., 

for a DEA registration in Florida. This 

Order is effective December 4, 2023. 

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. 

Heather Achbach, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2023–24151 Filed 11–1–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1228P] 

Proposed Aggregate Production 

Quotas for Schedule I and II Controlled 

Substances and Assessment of 

Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2024 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice with request for 

comments. 

SUMMARY: The Drug Enforcement 

Administration (DEA) proposes to 

establish the 2024 aggregate production 

quotas (APQ) for controlled substances 

in schedules I and II of the Controlled 

Substances Act (CSA) and the 

assessment of annual needs (AAN) for 

the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. For the 2024 

quota year, DEA intends to allocate 

procurement quotas to DEA-registered 

manufacturers of schedule II controlled 

substances on a quarterly basis. In order 

to address domestic drug shortages of 

controlled substances, procurement 

quota allocations will be divided 

between quantities authorized for 

domestic sales and quantities 

authorized for export sales. 

DATES: Electronic comments must be 

submitted, and written comments must 

be postmarked, on or before December 

4, 2023. Interested persons may file 

written comments on this notice in 

accordance with 21 CFR 1303.11(c) and 

1315.11(d). Commenters should be 

aware that the electronic Federal Docket 

Management System will not accept 

comments after 11:59 p.m. Eastern Time 

on the last day of the comment period. 

Based on comments received in 

response to this notice, the 

Administrator may hold a public 

hearing on one or more issues raised. In 

the event the Administrator decides in 

her sole discretion to hold such a 

hearing, the Administrator will publish 

a notice of any such hearing in the 

Federal Register. After consideration of 

any comments or objections, or after a 

hearing, if one is held, the 

Administrator will publish in the 

Federal Register a final order 

establishing the 2024 aggregate 

production quotas for schedule I and II 

controlled substances, and an 

assessment of annual needs for the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75313 

1Proposed Adjustments to the Aggregate 

Production Quotas for Schedule I and II Controlled 

Substances and Assessment of Annual Needs for 

List I Chemicals Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2021, 85 FR 54414 (Sept. 

1, 2020) and Proposed Aggregate Production Quotas 

for Schedule I and II Controlled Substances and 

Assessment of Annual Needs for List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2021, 85 FR 54407 (Sept. 

1, 2020). 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–1228P’’ on all correspondence, 

including any attachments. DEA 

encourages that all comments be 

submitted electronically through the 

Federal eRulemaking Portal, which 

provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to http:// 

www.regulations.gov and follow the 

online instructions at that site for 

submitting comments. Upon completion 

of your submission, you will receive a 

Comment Tracking Number for your 

comment. Please be aware that 

submitted comments are not 

instantaneously available for public 

view on Regulations.gov. If you have 

received a Comment Tracking Number, 

your comment has been successfully 

submitted, and there is no need to 

resubmit the same comment. Paper 

comments that duplicate electronic 

submissions are not necessary and are 

discouraged. Should you wish to mail a 

paper comment in lieu of an electronic 

comment, it should be sent via regular 

or express mail to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Brinks, Regulatory Drafting and 

Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (571) 776–3882. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received in response to this docket are 

considered part of the public record. 

They will, unless reasonable cause is 

given, be made available by the Drug 

Enforcement Administration (DEA) for 

public inspection online at http://

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. 

The Freedom of Information Act 

applies to all comments received. If you 

want to submit personal identifying 

information (such as your name, 

address, etc.) as part of your comment, 

but do not want it to be made publicly 

available, you must include the phrase 

‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want made publicly 

available in the first paragraph of your 

comment and identify what information 

you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. 

Comments containing personal 

identifying information or confidential 

business information identified and 

located as directed above will generally 

be made available in redacted form. If a 

comment contains so much confidential 

business information or personal 

identifying information that it cannot be 

effectively redacted, all or part of that 

comment may not be made publicly 

available. Comments posted to http://

www.regulations.gov may include any 

personal identifying information (such 

as name, address, and phone number) 

included in the text of your electronic 

submission that is not identified as 

directed above as confidential. 

An electronic copy of this document 

is available at http://

www.regulations.gov for easy reference. 

Legal Authority 

Section 306 of the Controlled 

Substances Act (21 U.S.C. 826) requires 

the Attorney General to establish 

production quotas for each basic class of 

controlled substances listed in 

schedules I and II, and for the list I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine. The 

Attorney General has delegated this 

function to the Administrator of DEA 

pursuant to 28 CFR 0.100. 

Analysis for Proposed 2024 Aggregate 

Production Quotas and Assessment of 

Annual Needs 

The proposed 2024 aggregate 

production quotas (APQ) and 

assessment of annual needs (AAN) 

represent those quantities of schedule I 

and II controlled substances, and the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, to be 

manufactured in the United States (U.S.) 

in 2024 to provide for the estimated 

medical, scientific, research, and 

industrial needs of the United States, 

lawful export requirements, and the 

establishment and maintenance of 

reserve stocks. These quotas include 

imports of ephedrine, pseudoephedrine, 

and phenylpropanolamine, but do not 

include imports of controlled 

substances for use in industrial 

processes. 

Aggregate Production Quotas 

In determining the proposed 2024 

APQ, the Administrator has taken into 

account the criteria of 21 U.S.C. 826(a) 

and 21 CFR 1303.11, including the 

following seven factors: 

(1) Total net disposal of the class by 

all manufacturers during the current 

and two preceding years; 

(2) Trends in the national rate of net 

disposal of the class; 

(3) Total actual (or estimated) 

inventories of the class and of all 

substances manufactured from the class, 

and trends in inventory accumulation; 

(4) Projected demand for such class as 

indicated by procurement quotas 

requested pursuant to [21 CFR] 1303.12; 

(5) The extent of any diversion of the 

controlled substance in the class; 

(6) Relevant information obtained 

from the Department of Health and 

Human Services (HHS), including from 

the Food and Drug Administration 

(FDA), the Centers for Disease Control 

and Prevention (CDC), and the Centers 

for Medicare and Medicaid Services 

(CMS), and relevant information 

obtained from the states; and 

(7) Other factors affecting medical, 

scientific, research, and industrial needs 

in the United States and lawful export 

requirements, as the Administrator finds 

relevant, including changes in the 

currently accepted medical use in 

treatment with the class or the 

substances manufactured from it, the 

economic and physical availability of 

raw materials for use in manufacturing 

and for inventory purposes, yield and 

stability problems, potential disruptions 

to production (including possible labor 

strikes), and recent unforeseen 

emergencies such as floods and fires. 

21 CFR 1303.11(b) 

DEA formally solicited input from 

FDA and CDC in February of 2023 and 

from the states in April 2023, as 

required by 21 U.S.C. 826 and 21 CFR 

part 1303. DEA did not solicit input 

from CMS for reasons discussed in 

previous notices.1 DEA requested 

information on trends in the legitimate 

use of select schedule I and II controlled 

substances from FDA and rates of 


khammond on DSKJM1Z7X2PROD with NOTICES
75314 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

2New Long-Haul COVID Clinics Treat Mysterious 

and Ongoing Symptoms, Scientific American, June 

30, 2021; Successful Treatment of Post-COVID–19 

ADHD-like Syndrome-A case Report, J Atten 

Disord., 2023 Aug; 27(10): 1092–1098. 

3The estimates of diversion for five ‘‘covered 

controlled substances’’ as required by 21 U.S.C. 

826(i) are discussed later in the document. 

overdose deaths for covered controlled 

substances from CDC. DEA’s request for 

information from the states was made 

directly to the Prescription Drug 

Monitoring Program (PDMP) 

Administrators in each state as well as 

through the National Association of 

State Controlled Substances Authorities 

(NASCSA). 

Assessment of Annual Needs 

In similar fashion, in determining the 

proposed 2024 AAN for the list I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine, the 

Administrator has taken into account 

the criteria of 21 U.S.C. 826(a) and 21 

CFR 1315.11, including the five 

following factors: 

(1) Total net disposal of the chemical 

by all manufacturers and importers 

during the current and two preceding 

years; 

(2) Trends in the national rate of net 

disposal of each chemical; 

(3) Total actual (or estimated) 

inventories of the chemical and of all 

substances manufactured from the 

chemical, and trends in inventory 

accumulation; 

(4) Projected demand for each 

chemical as indicated by procurement 

and import quotas requested pursuant to 

[21 CFR] 1315.32; and 

(5) Other factors affecting medical, 

scientific, research, and industrial needs 

in the United States, lawful export 

requirements, and the establishment 

and maintenance of reserve stocks, as 

the Administrator finds relevant, 

including changes in the currently 

accepted medical use in treatment with 

the chemicals or the substances 

manufactured from them, the economic 

and physical availability of raw 

materials for use in manufacturing and 

for inventory purposes, yield and 

stability problems, potential disruptions 

to production (including possible labor 

strikes), and recent unforeseen 

emergencies such as floods and fires. 

21 CFR 1315.11(b) 

In determining the proposed 2024 

AAN, DEA used the calculation 

methodology previously described in 

the 2010 and 2011 assessments of 

annual needs (74 FR 60294, Nov. 20, 

2009, and 75 FR 79407, Dec. 20, 2010, 

respectively). 

Estimates of Medical Need for Schedule 

II Opioids and Stimulants 

In accordance with 21 CFR part 1303, 

21 U.S.C. 826, and 42 U.S.C. 242, HHS 

continues to provide DEA with 

estimates of the quantities of select 

schedule I and II controlled substances 

and three list I chemicals that will be 

required to meet the legitimate medical 

needs of the United States for a given 

calendar year. The responsibility to 

provide these estimates of legitimate 

domestic medical needs resides with 

FDA. FDA provides DEA with predicted 

estimates of domestic medical usage for 

selected controlled substances based on 

information available to them at a 

specific point in time in order to meet 

statutory requirements. 

FDA predicts that levels of medical 

need for schedule II opioids in the 

United States in calendar year 2024 will 

decline on average 7.9 percent from 

calendar year 2023 levels. These 

declines are expected to occur across a 

variety of schedule II opioids including 

fentanyl, hydrocodone, hydromorphone, 

oxycodone, and oxymorphone. DEA 

considered the potential for diversion of 

schedule II opioids, as required by 21 

CFR 1303.11(b)(5), as well as a potential 

increase in demand for certain opioids 

identified as being necessary to support 

the previously postponed elective 

surgeries now that the COVID–19 public 

health emergency has ended, pursuant 

to 21 CFR 1303.11(b)(7), in developing 

the proposed 2024 APQ. 

FDA predicted an average of a 3.1 

percent increase in domestic medical 

use of the schedule II stimulants 

amphetamine, methylphenidate 

(including dexmethylphenidate), and 

lisdexamfetamine, which are prescribed 

to treat patients with attention deficit 

hyperactivity disorder (ADHD) and 

more recently prescribed off-label to 

treat patients diagnosed with longCOVID symptoms commonly known as 

brain fog where fatigue and cognitive 

impairment persist 4 to 12 weeks after 

a COVID infection.2 FDA also raised 

concerns over drug shortage 

notifications it received from patients 

for specific ADHD medications 

containing methylphenidate and 

amphetamine. FDA’s stated reasons for 

these specific shortages include 

increased prescribing potentially related 

to the growth in telemedicine, supply 

chain issues, manufacturing and quality 

issues, and business decisions of 

manufacturers. DEA considered FDA’s 

concerns when determining the APQ for 

these substances. DEA believes that 

manufacturers will be able to meet the 

increase in domestic medical need with 

the APQs proposed in this notice. 

DEA Projected Trends for Certain 

Schedule I Controlled Substances 

There has been a significant increase 

in the use of schedule I hallucinogenic 

controlled substances for research and 

clinical trial purposes. DEA has 

received and subsequently approved 

new registration applications for 

schedule I researchers and new 

applications for registration from 

manufacturers to grow, synthesize, 

extract, and prepare dosage forms 

containing specific schedule I 

hallucinogenic substances for research 

and clinical trial purposes. DEA 

supports regulated research with 

schedule I controlled substances, as 

evidenced by the higher APQ proposed 

for 2024 as compared with APQ for 

these substances in 2023. Further, DEA 

published the final rule, ‘‘Controls to 

Enhance the Cultivation of Marihuana 

for Research in the United States’’ in 

December 2020, and the Medical 

Marijuana and Cannabidiol Research 

Expansion Act (Pub. L. 117–215) was 

enacted in December 2022. The agency 

continues to review and approve 

applications for schedule I 

manufacturers of marihuana that 

conform to the federal requirements 

contained in the CSA. See 21 CFR part 

1318. 

Thus, DEA is proposing APQ for 

ibogaine, psilocyn, psilocybin, delta-9- 

tetrahydrocannabinol (d-9-THC), and all 

other tetrahydrocannabinols to support 

manufacturing activities related to the 

increased level of research and clinical 

trials with these schedule I controlled 

substances. Additionally, DEA proposes 

APQs for d-9-THC and all other 

tetrahydrocannabinols for 2024 to 

reflect the relocation of manufacturing 

of these controlled substances from 

abroad to the United States. 

Information Received for Consideration 

of the Remaining Factors 

For the factors listed in 21 CFR 

1303.11(b)(3) and (4), DEA registered 

manufacturers of controlled substances 

in schedules I and II provide 

information such as inventory, 

distribution, manufacturing, sales 

forecasts and quota requests to the DEA 

database systems. See 21 CFR 1303.12, 

1303.22, and part 1304. 

The regulation at 21 CFR 

1303.11(b)(5) requires DEA to consider 

the extent of diversion of controlled 

substances.3 Diversion is defined as all 

distribution, dispensing, or other use of 

controlled substances for other than 

legitimate medical purposes. In order to 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75315 

4 21 U.S.C. 826(i)(1)(C). 

5National Association of Boards of Pharmacy 

(NABP) coalition consensus document 

‘‘Stakeholders’ Challenges and Red Flag Warning 

Signs Related to Prescribing and Dispensing 

Controlled Substances’’ (2015). 

www.nabp.pharmacy/resources/reports. 

6The Medicine Shoppe, 79 FR 59504, 59507, 

59512–13 (2014); Holiday CVS, L.L.C., d/b/a CVS 

Pharmacy Nos. 219 and 5195, 77 FR 62316 (Oct. 12, 

2012). 

7The mere indicia of red flags alone is not proof 

of violation of 21 U.S.C. 824 or any other provision 

of the CSA. This rule discusses only their use by 

DEA as an analytical tool to estimate diversion. 

8NASCSA formatted DEA’s request into an 

analytics model developed by one of its associates, 

Appriss Inc. 

consider the extent of diversion, DEA 

analyzed reports of diversion of 

controlled substances from 2022 

submitted to its Theft Loss Report 

database. This database is comprised of 

DEA registrant reports documenting 

diversion from the legitimate 

distribution chain, including employee 

thefts, break-ins, armed robberies, and 

material lost in transit. The data was 

categorized by basic drug class, and the 

amount of active pharmaceutical 

ingredient (API) in the dosage form was 

delineated with an appropriate metric 

for use in proposing aggregate 

production quota values (i.e., weight). 

In this proposed 2024 APQ, DEA also 

considered the lingering effects of the 

COVID–19 pandemic on the global 

supply chain, pursuant to 21 CFR 

1303.11(b)(7), and specifically the 

continued impacts on the availability of 

raw materials for use in the domestic 

manufacturing process. Additionally, 

DEA considered the impact of the 

demand for surgical care for elective 

surgeries that were deferred during the 

COVID–19 public health emergency. 

Estimates of Diversion of Covered 

Controlled Substances 

In establishing any quota . . . , or 

any procurement quota established by 

[DEA] by regulation, for fentanyl, 

oxycodone, hydrocodone, 

oxymorphone, or hydromorphone (in 

this subsection referred to as a ‘‘covered 

controlled substance’’), [DEA] shall 

estimate the amount of diversion of the 

covered controlled substance that 

occurs in the United States. 

21 U.S.C. 826(i)(1)(A) 

In estimating diversion under that 

provision, DEA: 

(i) shall consider information . . . , 

in consultation with the Secretary of 

Health and Human Services, [it] 

determines reliable on rates of overdose 

deaths and abuse and overall public 

health impact related to the covered 

controlled substance in the United 

States; and 

(ii) may take into consideration 

whatever other sources of information 

[it] determines reliable. 

21 U.S.C. 826(i)(1)(B) 

The statute further mandates that DEA 

‘‘make appropriate quota reductions, as 

determined by [DEA], from the quota [it] 

would have otherwise established had 

such diversion not been considered.’’ 4

In estimating the amount of diversion 

of each covered controlled substance 

that occurs in the United States, DEA 

considered information from state 

PDMP Administrators and from 

legitimate distribution chain 

participants. 

Consideration of Information From 

Certain State PDMPs and From National 

Sales Data 

Pursuant to 21 CFR 1303.11(b)(6), 

DEA requested state PDMP data for the 

purpose of establishing its APQ. DEA 

believes state PDMPs to be an essential, 

reliable source of information for use in 

effectively estimating diversion of the 

five covered controlled substances. In 

April 2023, DEA sent a letter to 

NASCSA requesting its assistance in 

obtaining aggregated PDMP data for the 

five covered controlled substances from 

each state covering the years 2020–2022. 

The letter indicated that DEA was 

specifically interested in an analysis of 

prescription data from each state’s 

PDMP that would assist DEA in 

estimating diversion and setting 

appropriate quotas in compliance with 

21 U.S.C. 826(i). In its request, DEA 

provided specific questions, discussed 

in detail below, based on common 

indicia of potential diversion known as 

‘‘red flags’’ by physicians, pharmacists, 

manufacturers, distributors, and federal 

and state regulatory and law 

enforcement agencies.5 DEA 

investigators and administrative 

prosecutors also rely on Agency case 

law in which these red flags of diversion 

have been upheld as indicia of potential 

diversion.6 Certain state regulations 

now include red flag circumstances as 

potential indicators of illegitimate 

prescriptions, and thus of potential 

abuse and diversion of controlled 

substances.7 See The Pharmacy Place 

Order, 86 FR 21008, 21012 (Apr. 21, 

2021) (citing 22 Tex. Admin. Code 

291.29(c)(4), specifying the geographical 

distance between the practitioner and 

the patient or between the pharmacy 

and the patient as a red flag). 

DEA requested responses from state 

PDMP Administrators by June 15, 2023. 

NASCSA disseminated DEA’s request to 

its PDMP Administrators and provided 

them with a report tool to ensure that 

responses to DEA’s questions were 

extracted consistently across all 

responsive states. Thirty states and two 

territories provided DEA with 

summarized PDMP data between May 3, 

and June 15, 2023, utilizing the 

standardized report developed by 

NASCSA.8 See Table 1a below. 

TABLE 1a—STATES/TERRITORIES THAT

RESPONDED TO DEA’S DATA REQUEST

State/territory 

1. Alabama 

2. Alaska 

3. Arizona 

4. Arkansas 

5. Connecticut 

6. Delaware 

7. District of Columbia 

8. Hawaii 

9. Idaho 

10. Indiana 

11. Iowa 

12. Kansas 

13. Kentucky 

14. Louisiana 

15. Maine 

16. Maryland 

17. Michigan 

18. Minnesota 

19. Mississippi 

20. Montana 

21. Nevada 

22. New Jersey 

23. North Carolina 

24. North Dakota 

25. Ohio 

26. Oklahoma 

27. Puerto Rico 

28. Rhode Island 

29. South Carolina 

30. South Dakota 

31. Texas 

32. Utah 

Pharmacies are required by state law 

to enter controlled substance dispensing 

data into the state’s PDMP database, 

including the prescriber’s name, 

registered address and DEA number; 

prescription information (such as drug 

name); dispensing date; dosage 

dispensed; pharmacy registered address; 

and patient name and address. DEA 

considers PDMP data to be an accurate 

representation of dispensing activities 

in states. DEA received data for the 

following red-flag metrics: 

• The total number of patients who 

saw three or more prescribers in a 90- 

day period and were dispensed an 

opioid following each visit. For this 

metric, DEA requested and was 

provided the number of prescriptions 

for the five covered controlled 

substances dispensed to these patients, 

as a percentage of the total prescriptions 

dispensed for that particular covered 

controlled substance, as well as the 

corresponding quantity of the covered 


khammond on DSKJM1Z7X2PROD with NOTICES
75316 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

9Frank’s Corner Pharmacy, 60 FR 17574 (1995); 

Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 

and 5195, 77 FR 62316 (Oct. 12, 2012). 

10This total does not include insurance copayments made with cash. 

11Suntree Pharmacy and Suntree Medical 

Equipment, LLC, 85 FR 73753 (2018) (finding that 

the pharmacy filled prescriptions despite the 

presence of multiple unresolved red flags, including 

cash payments); Pharmacy Doctors Enterprises d/b/ 

a Zion Clinic Pharmacy, 83 FR 10876 (Mar. 13, 

2018) (revoking pharmacy’s registration for filling 

prescriptions that raised the red flag of customers 

paying cash for their prescriptions, among other red 

flags). 

12 DEA has purchased this data from IQVIA for 

decades and routinely uses this information to 

administer several regulatory functions, including 

the administration of DEA’s quota program. 

controlled substance dispensed. This 

metric (patients being prescribed 

covered controlled substances from 

three or more prescribers in a 90-day 

period) is used to identify potential 

doctor shopping, a common technique 

to obtain a high number of controlled 

substances, which may lead to abuse or 

diversion of controlled substances. DEA 

has long considered doctor shopping to 

be an indicator of potential diversion.9

• The number of patients that were 

dispensed prescriptions for each of the 

five covered controlled substances that 

exceeded 240 morphine milligram 

equivalents (MME) daily. States 

provided the raw number of such 

prescriptions dispensed, the number of 

prescriptions as a percentage of the total 

covered controlled substance 

prescriptions dispensed, and the 

corresponding quantity of the covered 

controlled substance dispensed. DEA 

believes that accounting for quantities 

in excess of 240 MME daily allows for 

consideration of oncology patients with 

legitimate medical needs for covered 

controlled substance prescriptions with 

high MME. Higher dosages place 

individuals at higher risk of overdose 

and death. Prescriptions involving 

dosages exceeding 240 MME daily may 

indicate diversion, such as illegal 

distribution of controlled substances or 

prescribing outside the usual course of 

professional practice. 

• The number of patients that paid 

cash for covered controlled substance 

prescriptions, without submitting for 

insurance reimbursement.10 States also 

provided the number of prescriptions 

paid entirely with cash as a percentage 

of the total prescriptions for the five 

covered controlled substances 

dispensed, as well as the corresponding 

quantity of the covered controlled 

substances dispensed. When 

investigating potential diversion, cash 

payments are one element considered in 

identifying prescriptions filled for 

nonmedical purposes. Unusually high 

percentages of cash payments made to a 

prescriber or pharmacy for controlled 

substances may indicate diversion.11

DEA received PDMP data from the 

states in a standardized format that 

allowed DEA to aggregate the data. The 

PDMP data sample represents a 

population of approximately 150.7 

million people, which is approximately 

45 percent of the U.S. population. DEA 

believes this sample is sufficient to 

derive a reasonable nationwide 

estimate. 

While PDMP data is useful in 

estimating diversion, it is not 

conclusive. Further investigation would 

be required before concluding that any 

of the subject prescriptions were 

actually diverted. DEA continues to 

evaluate its methodologies in estimating 

diversion in an effort to adjust quotas 

more efficiently. State participation is 

crucial to accurate data analysis, and 

DEA anticipates working closely with 

states, as well as other federal and state 

entities, in future quota determinations. 

To calculate a national diversion 

estimate for each of the covered 

controlled substances from the 

responses received from state PDMP 

Administrators, DEA relied upon the 

number of individuals who received a 

prescription for a covered controlled 

substance that met any of the three redflag metrics for each of calendar years 

2020–2022. Using the population of the 

states responding to DEA’s request, DEA 

then calculated the percentage of the 

population issued a prescription with a 

red flag. Using this estimated percentage 

for 2020–2022, DEA analyzed trends in 

the data to predict the estimated 

percentage of patients who would be 

expected to be included in these red-flag 

metrics for 2024. 

DEA also reviewed aggregate sales 

data for each of the covered controlled 

substances, which it extracted from 

IQVIA’s National Sales Perspective.12

IQVIA sales data was selected to help 

quantify diversion at the national level 

because it reflects the best national 

estimate for all prescriptions written 

and filled, including the total quantity 

available for diversion or misuse. DEA 

analyzed trends in IQVIA sales data 

from January 2020—April 2023, in order 

to predict the estimated national sales 

for 2024. 

To estimate diversion for each of the 

covered controlled substances, DEA 

multiplied the forecasted percentage of 

patients likely to receive a prescription 

for a covered controlled substance that 

meet any of the three red-flag metrics in 

2024 by the forecasted sales data from 

IQVIA for 2024. The resulting estimate 

of diversion from data submitted by 

state PDMP Administrators is 

summarized below in Table 1b. This 

data contributed to the final diversion 

estimate set forth in Table 3. 

TABLE 1B—DIVERSION ESTIMATES FOR

2024 BASED ON STATE PDMP 

DATA FOR COVERED CONTROLLED

SUBSTANCES FROM 2020–2022 

Controlled substance (g) 

Fentanyl ................................ 18 

Hydrocodone ........................ 83,823 

Hydromorphone .................... 356 

Oxycodone ............................ 150,684 

Oxymorphone ....................... 0 

Consideration of Registrant Reported 

Diversion in the Legitimate Distribution 

Chain 

DEA extracted data from its Theft 

Loss Report database and categorized it 

by each basic drug class. DEA calculated 

the estimated amount of diversion by 

multiplying the quantity of API in each 

finished dosage form by the total 

amount of units reported stolen or lost 

to estimate the metric weight in grams 

of the controlled substance being 

diverted. This estimate of diversion 

from the legitimate supply chain for 

each of the covered controlled 

substances is displayed in Table 2. This 

data contributed to the final diversion 

estimates set forth in Table 3. 

TABLE 2—DIVERSION ESTIMATES

BASED ON SUPPLY CHAIN DIVERSION DATA FOR COVERED CONTROLLED SUBSTANCES

Controlled Substance (g) 

Fentanyl ................................ 74 

Hydrocodone ........................ 12,454 

Hydromorphone .................... 481 

Oxycodone ............................ 31,698 

Oxymorphone ....................... 252 

In accordance with 21 U.S.C. 826(i), 

DEA’s estimate of diversion for the five 

controlled substances was calculated by 

combining the values in Tables 1b and 

2. DEA reduced the APQ for each 

covered controlled substance by the 

quantities listed in Table 3. 

TABLE 3—TOTAL ESTIMATES OF DIVERSION FOR COVERED CONTROLLED SUBSTANCES TO BE APPLIED TO THE 2024 APQS

Controlled substance (g) 

Fentanyl ................................ 92 

Hydrocodone ........................ 96,277 

Hydromorphone .................... 838 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75317 

13Both DEA and FDA released this letter on Aug. 

1, 2023. It is available at: https://www.dea.gov/sites/ 

default/files/2023-08/DEA%20and

%20FDA%20Issue%20Joint%20Letter

%20to%20the%20Public.pdf. 14Both reports are available at: https://

www.deadiversion.usdoj.gov/drug_chem_info/

stimulants/. 

15 In July 2023, several manufacturers who— 

according to their reporting to DEA—had failed to 

use their full amphetamine procurement quotas in 

2022 received correspondence from DEA and FDA 

asking them to confirm that they would use their 

full 2023 procurement quotas. Upon receiving that 

correspondence—approximately seven months after 

the close of calendar year 2022—one such 

manufacturer then revised its 2022 reporting to 

DEA to reflect that it had, in fact, used nearly all 

of its 2022 amphetamine procurement quota. 

16While amphetamine and methylphenidate are 

currently recognized as schedule II controlled 

substances under the Convention on Psychotropic 

Substances of 1971, lisdexamfetamine is not. 

Additional details may be found at: https://

www.incb.org/incb/en/psychotropics/1971_

convention.html. 

17Management of Quotas for Controlled 

Substances and List I Chemicals, 88 FR 60117 (Aug. 

31, 2023) (effective Nov. 29, 2023). 

TABLE 3—TOTAL ESTIMATES OF DIVERSION FOR COVERED CONTROLLED SUBSTANCES TO BE APPLIED TO THE 2024 APQS—Continued 

Controlled substance (g) 

Oxycodone ............................ 182,382 

Oxymorphone ....................... 252 

Forthcoming Regulatory Changes and 

Administration of Individual Quotas 

for 2024 

DEA is committed to ensuring that all 

Americans can access appropriately 

prescribed medications. As part of this 

commitment, DEA undertook work to 

understand the supply chain dynamics 

for controlled substances subject to 

quotas over the last year and a half, 

especially in highly genericized 

markets. Based on that review, DEA 

observed various challenges in the quota 

allocation process stemming from the 

lack of real-time inventory and sales 

data accessible to DEA, the lack of 

information on manufacturers’ 

production lead times, and issues of 

timeliness in ARCOS reporting. 

Relatedly, beginning in the latter half 

of 2022, the DEA and FDA observed an 

increase in the number of drug shortages 

reported by manufacturers of schedule II 

stimulants including mixed-salt 

amphetamine products starting in April 

2022 and lisdexamfetamine and 

methylphenidate starting in July 2023. 

As DEA and FDA stated in their open 

letter,13 we remain committed to doing 

all we can to prevent stimulant drug 

shortages, limit their impact, and 

resolve them as quickly as possible. 

DEA commissioned two reports by 

IQVIA 14 in order to understand the 

demographic shifts impacting the 

prescribing of schedule II stimulants. 

The reports provided valuable insights. 

Chief among those insights was the 

observed increase in prescriptions 

dispensed for mixed-salt amphetamine 

products to adults between the ages of 

31–40 years, particularly women, and 

older patients (71–80 years old), 

particularly during the COVID–19 

pandemic (i.e. 2020 and 2021). In 

contrast, during 2022, dispensed 

prescriptions for products containing 

methylphenidate HCl and 

dexmethylphenidate HCl had a higher 

annual increase in 2022 (than in 2021) 

as compared to mixed-salt amphetamine 

products which may be indicative of 

product switching from amphetamine to 

methylphenidate and 

dexmethylphendiate. Neither DEA nor 

FDA anticipated these changes. 

In addition to these demographic 

shifts in prescribing, DEA also evaluated 

inventory, manufacturing, and sales 

data submitted by manufacturers 

through ARCOS and through reports 

submitted to DEA’s Quota Management 

System. That analysis revealed that 

dosage manufacturers of amphetamine 

did not utilize the full extent of their 

authorized quotas. DEA authorized 

amphetamine medication dosage form 

manufacturers across the entire market 

to purchase and use 38,418 kilograms of 

amphetamine but those manufacturers 

initially 15 reported the purchase of only 

31,539 kg. Of that quantity, dosage 

manufacturers only shipped 26,953 kg 

of amphetamine medications. 

This ongoing work has led DEA to 

conclude that changes to its regulations 

likely will be useful in developing more 

precise quotas that will provide for the 

estimated medical, scientific, research, 

and industrial needs of the United 

States, for lawful export requirements, 

and for the establishment and 

maintenance of reserve stocks, while 

also reducing opportunities for 

diversion. For instance, DEA believes 

that changes to reporting requirements 

are necessary to improve both the type 

of data collected and the timeliness of 

that data, allowing DEA to be more 

nimble in its administration of the quota 

program. Future regulatory changes may 

seek to address the lack of real-time 

inventory and sales data accessible to 

DEA, the lack of information on 

production lead times, and issues of 

timeliness in ARCOS reporting, by 

considering, for example, requiring 

manufacturers to provide anticipated 

production timelines and monthly 

ARCOS reporting. DEA is not seeking 

comments on these concepts through 

this notice, but will publish detailed 

proposals for comment in the future. 

DEA also will seek additional 

information that will assist the agency 

to more accurately forecast export 

requirements, especially for those 

substances that are not controlled 

internationally.16 DEA understands that 

manufacturers have contractual 

obligations that dictate business 

decisions regarding the quantities of 

finished dosage forms they will produce 

under a single DEA-issued quota, which 

applies to products manufactured with 

an active ingredient, whether for 

domestic or foreign markets. DEA also is 

exploring the purchase of third-party 

data to improve its understanding of the 

dynamic changes in foreign markets. 

Building off the recently issued quota 

management rule,17 DEA also intends to 

add new subcategories to individual 

manufacturing quotas and procurement 

quotas, to distinguish between domestic 

requirements and export requirements. 

DEA also is considering methods by 

which it might increase transparency in 

its quota setting process. Future 

regulatory proposals may define 

additional steps, including such 

concepts as public notification and an 

opportunity for public input when 

prescribing rates for controlled 

substances deviate substantially from 

FDA’s estimate of future use. 

Furthermore, DEA is considering 

regulatory changes which will authorize 

it to reduce a manufacturer’s individual 

manufacturing or procurement quota in 

order to apportion it to another 

manufacturer. As with the regulatory 

changes mentioned above, DEA will 

welcome comment on detailed 

proposals in the future, and is not 

requesting comment on these general 

concepts in this notice. 

The abovementioned regulatory 

changes will take time. In the meantime, 

for the 2024 quota year, DEA intends to 

allocate procurement quotas to DEAregistered manufacturers of schedule II 

controlled substances on a quarterly 

basis. In order to address domestic drug 

shortages of controlled substances, 

procurement quota allocations for 

schedule II controlled substances will 

be divided between quantities 

authorized for domestic sales and 

quantities authorized for export sales. 

DEA will be sending a letter to each 

manufacturer with instructions on the 

data that will be necessary to allow DEA 

to process subsequent quarterly 

procurement quota allocations. DEA 

may publish or post how many 

companies have been allocated quota in 


khammond on DSKJM1Z7X2PROD with NOTICES
75318 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

a given calendar year, and how many of 

those companies have utilized their 

allocated quota. Further, DEA may 

publish or post the names of the 

companies that have been allocated 

quota. 

The Administrator, therefore, 

proposes to establish the 2024 APQ for 

certain schedule I and II controlled 

substances and AAN for the list I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine, expressed in 

grams of anhydrous acid or base, as 

follows: 

Basic class 

Proposed 

2024 quotas 

(g) 

Schedule I 

-[1-(2-Thienyl)cyclohexyl]pyrrolidine .................................................................................................................................................... 20 

1-(1-Phenylcyclohexyl)pyrrolidine ........................................................................................................................................................ 30 

1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine .................................................................................................................................. 10 

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ............................................................................................................................ 30 

1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ........................................................................................................................... 30 

1-[1-(2-Thienyl)cyclohexyl]piperidine ................................................................................................................................................... 15 

2′-fluoro 2-fluorofentanyl ...................................................................................................................................................................... 30 

1-Benzylpiperazine .............................................................................................................................................................................. 25 

1-Methyl-4-phenyl-4-propionoxypiperidine ........................................................................................................................................... 10 

2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) .......................................................................................................................... 30 

2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) ....................................................................................................................... 30 

2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) ......................................................................................................................... 30 

2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C–P) ..................................................................................................................... 30 

2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) ...................................................................................................................................... 100 

2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B–NBOMe; 2C–B–NBOMe; 25B; Cimbi-36) ...................... 30 

2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ........................................................................................................................ 30 

2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C–NBOMe; 2C–C–NBOMe; 25C; Cimbi-82) ..................... 25 

2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) ............................................................................................................................. 30 

2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I–NBOMe; 2C–I–NBOMe; 25I; Cimbi-5) ................................ 30 

2,5-Dimethoxy-4-ethylamphetamine (DOET) ...................................................................................................................................... 25 

2,5-Dimethoxy-4-n-propylthiophenethylamine ..................................................................................................................................... 25 

2,5-Dimethoxyamphetamine ................................................................................................................................................................ 25 

2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) ............................................................................................................... 30 

2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) ........................................................................................................ 30 

3,4,5-Trimethoxyamphetamine ............................................................................................................................................................ 30 

3,4-Methylenedioxyamphetamine (MDA) ............................................................................................................................................ 12,000 

3,4-Methylenedioxymethamphetamine (MDMA) ................................................................................................................................. 12,000 

3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ............................................................................................................................. 40 

3,4-Methylenedioxy-N-methylcathinone (methylone) .......................................................................................................................... 5,200 

3,4-Methylenedioxypyrovalerone (MDPV) ........................................................................................................................................... 35 

3–FMC; 3-Fluoro-N-methylcathinone .................................................................................................................................................. 25 

3-Methylfentanyl ................................................................................................................................................................................... 30 

3-Methylthiofentanyl ............................................................................................................................................................................. 30 

4,4′-Dimethylaminorex ......................................................................................................................................................................... 30 

4-Bromo-2,5-dimethoxyamphetamine (DOB) ...................................................................................................................................... 30 

4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ................................................................................................................................. 5,100 

4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP) ......................................................................................................... 25 

4–CN-Cumyl-Butinaca ......................................................................................................................................................................... 25 

4-Fluoroisobutyryl fentanyl ................................................................................................................................................................... 30 

4F–MDMB–BINACA ............................................................................................................................................................................ 30 

4–FMC; Flephedrone ........................................................................................................................................................................... 25 

4–MEC; 4-Methyl-N-ethylcathinone ..................................................................................................................................................... 25 

4-Methoxyamphetamine ...................................................................................................................................................................... 150 

4-Methyl-2,5-dimethoxyamphetamine (DOM) ...................................................................................................................................... 25 

4-Methylaminorex ................................................................................................................................................................................ 25 

4-Methyl-N-methylcathinone (mephedrone) ........................................................................................................................................ 45 

4-Methyl-alpha-ethylaminopentiophenone (4–MEAP) ......................................................................................................................... 25 

4-Methyl-alpha-pyrrolidinohexiophenone (MPHP) ............................................................................................................................... 25 

4′-Methyl acetyl fentanyl ...................................................................................................................................................................... 30 

4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ............................................................................................................................... 25 

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ......................................................................................................... 50 

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog) .......................... 40 

5F–AB–PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide ............................................. 25 

5F–ADB; 5F–MDMB–PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) .......................... 25 

5F–CUMYL–P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide ...................................... 25 

5F–CUMYL–PINACA ........................................................................................................................................................................... 25 

5F–EDMB–PINACA ............................................................................................................................................................................. 25 

5F–MDMB–PICA ................................................................................................................................................................................. 25 

5F–AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) .................................................................. 25 

5F–APINACA; 5F–AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ....................................................... 25 

5-Fluoro-PB–22; 5F–PB–22 ................................................................................................................................................................ 25 

5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ............................................ 25 

5-Methoxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... 25 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75319 

Basic class 

Proposed 

2024 quotas 

(g) 

5-Methoxy-N,N-diisopropyltryptamine .................................................................................................................................................. 25 

5-Methoxy-N,N-dimethyltryptamine ..................................................................................................................................................... 11,000 

AB–CHMINACA ................................................................................................................................................................................... 30 

AB–FUBINACA .................................................................................................................................................................................... 50 

AB–PINACA ......................................................................................................................................................................................... 30 

ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ................................. 30 

Acetorphine .......................................................................................................................................................................................... 25 

Acetyl Fentanyl .................................................................................................................................................................................... 100 

Acetyl-alpha-methylfentanyl ................................................................................................................................................................. 30 

Acetyldihydrocodeine ........................................................................................................................................................................... 30 

Acetylmethadol .................................................................................................................................................................................... 25 

Acryl Fentanyl ...................................................................................................................................................................................... 25 

ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ..................................................... 50 

AH–7921 .............................................................................................................................................................................................. 30 

All other tetrahydrocannabinol ............................................................................................................................................................. 790,010 

Allylprodine .......................................................................................................................................................................................... 25 

Alphacetylmethadol .............................................................................................................................................................................. 25 

alpha-Ethyltryptamine .......................................................................................................................................................................... 25 

Alphameprodine ................................................................................................................................................................................... 25 

Alphamethadol ..................................................................................................................................................................................... 25 

alpha-Methylfentanyl ............................................................................................................................................................................ 30 

alpha-Methylthiofentanyl ...................................................................................................................................................................... 30 

alpha-Methyltryptamine (AMT) ............................................................................................................................................................ 25 

alpha-Pyrrolidinobutiophenone (a-PBP) .............................................................................................................................................. 25 

alpha-pyrrolidinoheptaphenone (PV8) ................................................................................................................................................. 25 

alpha-pyrrolidinohexabophenone (alpha-PHP) .................................................................................................................................... 25 

alpha-Pyrrolidinopentiophenone (a-PVP) ............................................................................................................................................ 25 

Amineptine ........................................................................................................................................................................................... 30 

Aminorex .............................................................................................................................................................................................. 25 

Anileridine ............................................................................................................................................................................................ 20 

APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ......................................................................................... 25 

Benzethidine ........................................................................................................................................................................................ 25 

Benzylmorphine ................................................................................................................................................................................... 30 

Betacetylmethadol ............................................................................................................................................................................... 25 

beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................ 30 

beta-Hydroxyfentanyl ........................................................................................................................................................................... 30 

beta-Hydroxythiofentanyl ..................................................................................................................................................................... 30 

beta-Methyl fentanyl ............................................................................................................................................................................ 30 

beta′-Phenyl fentanyl ........................................................................................................................................................................... 30 

Betameprodine ..................................................................................................................................................................................... 25 

Betamethadol ....................................................................................................................................................................................... 4 

Betaprodine .......................................................................................................................................................................................... 25 

Brorphine ............................................................................................................................................................................................. 30 

Bufotenine ............................................................................................................................................................................................ 15 

Butonitazene ........................................................................................................................................................................................ 30 

Butylone ............................................................................................................................................................................................... 25 

Butyryl fentanyl .................................................................................................................................................................................... 30 

Cathinone ............................................................................................................................................................................................. 40 

Clonitazene .......................................................................................................................................................................................... 25 

Codeine methylbromide ....................................................................................................................................................................... 30 

Codeine-N-oxide .................................................................................................................................................................................. 192 

Crotonyl Fentanyl ................................................................................................................................................................................. 25 

Cyclopentyl Fentanyl ........................................................................................................................................................................... 30 

Cyclopropyl Fentanyl ........................................................................................................................................................................... 20 

Cyprenorphine ..................................................................................................................................................................................... 25 

d-9–THC .............................................................................................................................................................................................. 900,610 

Desomorphine ...................................................................................................................................................................................... 25 

Dextromoramide .................................................................................................................................................................................. 25 

Diapromide ........................................................................................................................................................................................... 20 

Diethylthiambutene .............................................................................................................................................................................. 20 

Diethyltryptamine ................................................................................................................................................................................. 25 

Difenoxin .............................................................................................................................................................................................. 9,300 

Dihydromorphine .................................................................................................................................................................................. 639,954 

Dimenoxadol ........................................................................................................................................................................................ 25 

Dimepheptanol ..................................................................................................................................................................................... 25 

Dimethylthiambutene ........................................................................................................................................................................... 20 

Dimethyltryptamine .............................................................................................................................................................................. 3,000 

Dioxyaphetyl butyrate .......................................................................................................................................................................... 25 

Dipipanone ........................................................................................................................................................................................... 25 

Drotebanol ........................................................................................................................................................................................... 25 

Ethylmethylthiambutene ....................................................................................................................................................................... 25 


khammond on DSKJM1Z7X2PROD with NOTICES
75320 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

Basic class 

Proposed 

2024 quotas 

(g) 

Ethylone ............................................................................................................................................................................................... 25 

Etodesnitazene .................................................................................................................................................................................... 30 

Etonitazene .......................................................................................................................................................................................... 25 

Etorphine .............................................................................................................................................................................................. 30 

Etoxeridine ........................................................................................................................................................................................... 25 

Eutylone ............................................................................................................................................................................................... 30 

Fenethylline .......................................................................................................................................................................................... 30 

Fentanyl carbamate ............................................................................................................................................................................. 30 

Fentanyl related substances ................................................................................................................................................................ 600 

Flunitazene .......................................................................................................................................................................................... 30 

FUB–144 .............................................................................................................................................................................................. 25 

FUB–AKB48 ......................................................................................................................................................................................... 25 

Fub-AMB, MMB-Fubinaca, AMB-Fubinaca ......................................................................................................................................... 25 

Furanyl fentanyl ................................................................................................................................................................................... 30 

Furethidine ........................................................................................................................................................................................... 25 

gamma-Hydroxybutyric acid ................................................................................................................................................................ 29,417,000 

Heroin .................................................................................................................................................................................................. 150 

Hydromorphinol .................................................................................................................................................................................... 40 

Hydroxypethidine ................................................................................................................................................................................. 25 

Ibogaine ............................................................................................................................................................................................... 150 

Isobutyryl Fentanyl ............................................................................................................................................................................... 25 

Isotonitazine ......................................................................................................................................................................................... 25 

JWH–018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) ..................................................................................................................... 35 

JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) .......................................................................................................................................... 45 

JWH–073 (1-Butyl-3-(1-naphthoyl)indole) ........................................................................................................................................... 45 

JWH–081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) ...................................................................................................................... 30 

JWH–122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) .......................................................................................................................... 30 

JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) .............................................................................................................. 35 

JWH–203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ........................................................................................................................... 30 

JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) ....................................................................................................................... 30 

JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ........................................................................................................................... 30 

Ketobemidone ...................................................................................................................................................................................... 30 

Levomoramide ..................................................................................................................................................................................... 25 

Levophenyacylmorphan ....................................................................................................................................................................... 25 

Lysergic acid diethylamide (LSD) ........................................................................................................................................................ 1,200 

MAB–CHMINACA; ADB–CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3- 

carboxamide) .................................................................................................................................................................................... 30 

MDMB–CHMICA; MMB–CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ............... 30 

MDMB–FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) .......................................... 30 

MMB–CHMICA-(AMB–CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ............................ 25 

Mesocarb ............................................................................................................................................................................................. 30 

Metodesnitazene .................................................................................................................................................................................. 30 

Metonitazene ....................................................................................................................................................................................... 30 

Marijuana ............................................................................................................................................................................................. 6,675,000 

Marijuana extract ................................................................................................................................................................................. 1,000,000 

Mecloqualone ....................................................................................................................................................................................... 30 

Mescaline ............................................................................................................................................................................................. 1,200 

Methaqualone ...................................................................................................................................................................................... 60 

Methcathinone ..................................................................................................................................................................................... 25 

Methiopropamine ................................................................................................................................................................................. 30 

Methoxetamine .................................................................................................................................................................................... 30 

Methoxyacetyl fentanyl ........................................................................................................................................................................ 30 

Methyldesorphine ................................................................................................................................................................................. 5 

Methyldihydromorphine ........................................................................................................................................................................ 25 

Morpheridine ........................................................................................................................................................................................ 25 

Morphine methylbromide ..................................................................................................................................................................... 5 

Morphine methylsulfonate .................................................................................................................................................................... 5 

Morphine-N-oxide ................................................................................................................................................................................ 150 

MT–45 .................................................................................................................................................................................................. 30 

Myrophine ............................................................................................................................................................................................ 25 

NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate .................................................................................................. 25 

N,N-Dimethylamphetamine .................................................................................................................................................................. 25 

Naphyrone ........................................................................................................................................................................................... 25 

N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................ 25 

N-Ethyl-3-piperidyl benzilate ................................................................................................................................................................ 10 

N-Ethylamphetamine ........................................................................................................................................................................... 24 

N-Ethylhexedrone ................................................................................................................................................................................ 25 

N-Ethylpentylone, ephylone ................................................................................................................................................................. 30 

N-Hydroxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... 24 

Nicocodeine ......................................................................................................................................................................................... 25 

Nicomorphine ....................................................................................................................................................................................... 25 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75321 

Basic class 

Proposed 

2024 quotas 

(g) 

N-methyl-3-piperidyl benzilate ............................................................................................................................................................. 30 

N-Pyrrolidino Etonitazene .................................................................................................................................................................... 30 

Noracymethadol ................................................................................................................................................................................... 25 

Norlevorphanol ..................................................................................................................................................................................... 2,550 

Normethadone ..................................................................................................................................................................................... 25 

Normorphine ........................................................................................................................................................................................ 40 

Norpipanone ........................................................................................................................................................................................ 25 

Ocfentanil ............................................................................................................................................................................................. 25 

ortho-Fluoroacryl fentanyl .................................................................................................................................................................... 30 

ortho-Fluorobutyryl fentanyl ................................................................................................................................................................. 30 

Ortho-Fluorofentanyl,2-Fluorofentanyl ................................................................................................................................................. 30 

ortho-Fluoroisobutyryl fentanyl ............................................................................................................................................................ 30 

ortho-Methyl acetylfentanyl .................................................................................................................................................................. 30 

ortho-Methyl methoxyacetyl fentanyl ................................................................................................................................................... 30 

Para-Chlorisobutyrl fentanyl ................................................................................................................................................................ 30 

Para-flourobutyryl fentanyl ................................................................................................................................................................... 25 

Para-fluorofentanyl ............................................................................................................................................................................... 25 

para-Fluoro furanyl fentanyl ................................................................................................................................................................. 30 

Para-Methoxybutyrl fentanyl ................................................................................................................................................................ 30 

Para-methoxymethamphetamine ......................................................................................................................................................... 30 

para-Methylfentanyl ............................................................................................................................................................................. 30 

Parahexyl ............................................................................................................................................................................................. 5 

PB–22; QUPIC ..................................................................................................................................................................................... 20 

Pentedrone .......................................................................................................................................................................................... 25 

Pentylone ............................................................................................................................................................................................. 25 

Phenadoxone ....................................................................................................................................................................................... 25 

Phenampromide ................................................................................................................................................................................... 25 

Phenomorphan .................................................................................................................................................................................... 25 

Phenoperidine ...................................................................................................................................................................................... 25 

Phenyl fentanyl .................................................................................................................................................................................... 30 

Pholcodine ........................................................................................................................................................................................... 5 

Piritramide ............................................................................................................................................................................................ 25 

Proheptazine ........................................................................................................................................................................................ 25 

Properidine ........................................................................................................................................................................................... 25 

Propiram .............................................................................................................................................................................................. 25 

Protonitazene ....................................................................................................................................................................................... 30 

Psilocybin ............................................................................................................................................................................................. 15,000 

Psilocyn ................................................................................................................................................................................................ 24,000 

Racemoramide ..................................................................................................................................................................................... 25 

SR–18 and RCS–8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ......................................................................................... 45 

SR–19 and RCS–4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) ............................................................................................................ 30 

Tetrahydrofuranyl fentanyl ................................................................................................................................................................... 15 

Thebacon ............................................................................................................................................................................................. 25 

Thiafentanil .......................................................................................................................................................................................... 25 

Thiofentanyl ......................................................................................................................................................................................... 25 

Thiofuranyl fentanyl ............................................................................................................................................................................. 30 

THJ–2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) .................................................................................... 30 

Tilidine .................................................................................................................................................................................................. 25 

Trimeperidine ....................................................................................................................................................................................... 25 

UR–144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone ..................................................................................... 25 

U–47700 .............................................................................................................................................................................................. 30 

Valeryl fentanyl .................................................................................................................................................................................... 25 

Zipeprol ................................................................................................................................................................................................ 30 

Schedule II 

1-Phenylcyclohexylamine .................................................................................................................................................................... 15 

1-Piperidinocyclohexanecarbonitrile .................................................................................................................................................... 25 

4-Anilino-N-phenethyl-4-piperidine (ANPP) ......................................................................................................................................... 866,746 

Alfentanil .............................................................................................................................................................................................. 5,000 

Alphaprodine ........................................................................................................................................................................................ 25 

Amobarbital .......................................................................................................................................................................................... 20,100 

Bezitramide .......................................................................................................................................................................................... 25 

Carfentanil ............................................................................................................................................................................................ 20 

Cocaine ................................................................................................................................................................................................ 60,492 

Codeine (for conversion) ..................................................................................................................................................................... 942,452 

Codeine (for sale) ................................................................................................................................................................................ 19,262,957 

d-amphetamine (for sale) .................................................................................................................................................................... 21,200,000 

d,l-amphetamine .................................................................................................................................................................................. 21,200,000 

d-amphetamine (for conversion) .......................................................................................................................................................... 20,000,000 

Dexmethylphenidate (for sale) ............................................................................................................................................................. 6,200,000 


khammond on DSKJM1Z7X2PROD with NOTICES
75322 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 

Basic class 

Proposed 

2024 quotas 

(g) 

Dexmethylphenidate (for conversion) .................................................................................................................................................. 4,200,000 

Dextropropoxyphene ............................................................................................................................................................................ 35 

Dihydrocodeine .................................................................................................................................................................................... 115,227 

Dihydroetorphine .................................................................................................................................................................................. 25 

Diphenoxylate (for conversion) ............................................................................................................................................................ 14,100 

Diphenoxylate (for sale) ....................................................................................................................................................................... 770,800 

Ecgonine .............................................................................................................................................................................................. 60,492 

Ethylmorphine ...................................................................................................................................................................................... 30 

Etorphine hydrochloride ....................................................................................................................................................................... 32 

Fentanyl ............................................................................................................................................................................................... 676,062 

Glutethimide ......................................................................................................................................................................................... 25 

Hydrocodone (for conversion) ............................................................................................................................................................. 1,250 

Hydrocodone (for sale) ........................................................................................................................................................................ 27,143,545 

Hydromorphone ................................................................................................................................................................................... 1,951,801 

Isomethadone ...................................................................................................................................................................................... 30 

L-amphetamine .................................................................................................................................................................................... 30 

Levo-alphacetylmethadol (LAAM) ........................................................................................................................................................ 25 

Levomethorphan .................................................................................................................................................................................. 30 

Levorphanol ......................................................................................................................................................................................... 20,000 

Lisdexamfetamine ................................................................................................................................................................................ 26,500,000 

Meperidine ........................................................................................................................................................................................... 681,184 

Meperidine Intermediate-A .................................................................................................................................................................. 30 

Meperidine Intermediate-B .................................................................................................................................................................. 30 

Meperidine Intermediate-C .................................................................................................................................................................. 30 

Metazocine ........................................................................................................................................................................................... 15 

Methadone (for sale) ........................................................................................................................................................................... 25,619,700 

Methadone Intermediate ...................................................................................................................................................................... 27,673,600 

d,l-Methamphetamine .......................................................................................................................................................................... 150 

d-methamphetamine (for conversion) .................................................................................................................................................. 485,020 

d-methamphetamine (for sale) ............................................................................................................................................................ 47,000 

l-methamphetamine ............................................................................................................................................................................. 587,229 

Methylphenidate (for sale) ................................................................................................................................................................... 53,283,000 

Methylphenidate (for conversion) ........................................................................................................................................................ 19,975,468 

Metopon ............................................................................................................................................................................................... 25 

Moramide-intermediate ........................................................................................................................................................................ 25 

Morphine (for conversion) .................................................................................................................................................................... 2,393,200 

Morphine (for sale) .............................................................................................................................................................................. 20,805,957 

Nabilone ............................................................................................................................................................................................... 62,000 

Norfentanyl ........................................................................................................................................................................................... 25 

Noroxymorphone (for conversion) ....................................................................................................................................................... 22,044,741 

Noroxymorphone (for sale) .................................................................................................................................................................. 1,000 

Oliceridine ............................................................................................................................................................................................ 25,100 

Opium (powder) ................................................................................................................................................................................... 250,000 

Opium (tincture) ................................................................................................................................................................................... 530,837 

Oripavine .............................................................................................................................................................................................. 33,010,750 

Oxycodone (for conversion) ................................................................................................................................................................ 437,827 

Oxycodone (for sale) ........................................................................................................................................................................... 53,658,226 

Oxymorphone (for conversion) ............................................................................................................................................................ 28,204,371 

Oxymorphone (for sale) ....................................................................................................................................................................... 464,464 

Pentobarbital ........................................................................................................................................................................................ 33,843,337 

Phenazocine ........................................................................................................................................................................................ 25 

Phencyclidine ....................................................................................................................................................................................... 35 

Phenmetrazine ..................................................................................................................................................................................... 25 

Phenylacetone ..................................................................................................................................................................................... 100 

Piminodine ........................................................................................................................................................................................... 25 

Racemethorphan ................................................................................................................................................................................. 5 

Racemorphan ...................................................................................................................................................................................... 5 

Remifentanil ......................................................................................................................................................................................... 3,000 

Secobarbital ......................................................................................................................................................................................... 172,100 

Sufentanil ............................................................................................................................................................................................. 4,000 

Tapentadol ........................................................................................................................................................................................... 10,390,226 

Thebaine .............................................................................................................................................................................................. 57,137,944 

List I Chemicals 

Ephedrine (for conversion) .................................................................................................................................................................. 41,100 

Ephedrine (for sale) ............................................................................................................................................................................. 3,933,336 

Phenylpropanolamine (for conversion) ................................................................................................................................................ 14,878,320 

Phenylpropanolamine (for sale) ........................................................................................................................................................... 7,990,000 

Pseudoephedrine (for conversion) ...................................................................................................................................................... 1,000 

Pseudoephedrine (for sale) ................................................................................................................................................................. 170,360,314 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75323 

1Effective December 2, 2022, the Medical 

Marijuana and Cannabidiol Research Expansion 

Act, Public Law 117–215, 136 Stat. 2257 (2022) 

(Marijuana Research Amendments or MRA), 

amended the Controlled Substances Act (CSA) and 

other statutes. Relevant to this matter, the MRA 

redesignated 21 U.S.C. 823(f), cited in the OSC/ISO, 

as 21 U.S.C. 823(g)(1). Accordingly, this Decision 

cites to the current designation, 21 U.S.C. 823(g)(1), 

and to the MRA-amended CSA throughout. 

2The Agency adopts the ALJ’s summary of each 

of the witnesses’ testimonies as well as the ALJ’s 

assessment of each of the witnesses’ credibility. See 

RD, at 3–17. The Agency agrees with the ALJ that 

the Diversion Investigator’s testimony, which was 

focused on the uncontroversial introduction of 

documentary evidence and her contact with the 

case, was credible in that it was sufficiently 

detailed, plausible, and internally consistent. Id. at 

4. Further, the Agency agrees with the ALJ that the 

testimony from the Government’s expert witness, 

Dr. Steven Lobel, M.D., which was focused on the 

Georgia standard of care and Respondent’s 

prescribing to the patients listed in the OSC/ISO, 

was credible in that it was consistent with Georgia 

statutes governing the prescribing of controlled 

substances, especially in the pain management 

context, and was clear, direct, substantial, and 

consistent with regards to the individual patients. 

Id. at 4–5. Finally, the Agency agrees with the ALJ 

that although Respondent’s testimony was credible 

as to general facts, including Respondent 

volunteering information regarding prior 

disciplinary actions, on the issue of whether his 

prescriptions were within the usual course of 

professional practice and for a legitimate medical 

purpose, Respondent’s testimony was not fully 

credible in that his interpretations of the Georgia 

standard of care were inconsistent with the Georgia 

state statutes. Id. at 9–10. 

3 During the hearing, both Government counsel 

and Dr. Lobel initially referenced a national 

standard of care established by the CDC Guidelines, 

see RD, at 10, but Dr. Lobel ultimately testified that 

the Georgia standard of care, upon which this 

decision is based, is grounded in the state medical 

board’s publications and Georgia state statutes, with 

the CDC Guidelines incorporated to the extent that 

they deal with the prescriptions of opioids. RD, at 

10; Tr. 114–115, 119, 125. 

The Administrator further proposes 

that aggregate production quotas for all 

other schedule I and II controlled 

substances included in 21 CFR 1308.11 

and 1308.12 remain at zero. 

These proposed 2024 quotas reflect 

the quantities that DEA believes are 

necessary to meet the estimated 

medical, scientific, research, and 

industrial needs of the United States, 

lawful export requirements; and the 

establishment and maintenance of 

reserve stocks. DEA remains committed 

to conducting continuous surveillance 

on the supply of schedule II controlled 

substances and list I chemicals 

necessary to treat patients with COVID– 

19, and, pursuant to her authority, the 

Administrator will move swiftly and 

decisively to increase any 2024 APQ 

that she determines is necessary to 

address an unforeseen increase in 

demand, should that occur. 

In accordance with 21 CFR 1303.13 

and 1315.13, upon consideration of the 

relevant factors, the Administrator may 

adjust the 2024 APQ and AAN as 

needed. 

Conclusion 

After consideration of any comments 

or objections, or after a hearing, if one 

is held, the Administrator will issue and 

publish in the Federal Register a final 

order establishing the 2024 APQ for 

controlled substances in schedules I and 

II and establishing an AAN for the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, as directed by 21 

CFR 1303.11(c) and 1315.11(f). 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 30, 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. 

[FR Doc. 2023–24282 Filed 11–1–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 23–17] 

Isaac Sved, M.D.; Decision and Order 

On December 8, 2022, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause and Immediate Suspension of 

Registration (OSC/ISO) to Isaac Sved, 

M.D. (Respondent) of Buford, Georgia. 

OSC/ISO, at 1. The OSC/ISO informed 

Respondent of the immediate 

suspension of his DEA Certificate of 

Registration, Control No. BS4103610, 

pursuant to 21 U.S.C. 824(d), alleging 

that Respondent’s continued registration 

constitutes ‘‘ ‘an imminent danger to the 

public health or safety.’ ’’ Id. (quoting 21 

U.S.C. 824(d)). The OSC/ISO also 

proposed the revocation of 

Respondent’s registration, alleging that 

Respondent has ‘‘committed such acts 

as would render [his] registration 

inconsistent with the public interest.’’ 

Id. at 1, 4 (citing 21 U.S.C. 823(g)(1),1

824(a)(4)). 

A hearing was held before DEA 

Administrative Law Judge Teresa A. 

Wallbaum (the ALJ) who, on June 20, 

2023, issued her Recommended Rulings, 

Findings of Fact, Conclusions of Law, 

and Decision (Recommended Decision 

or RD), which recommended revocation 

of Respondent’s registration. RD, at 27. 

Respondent did not file exceptions to 

the RD. Having reviewed the entire 

record, the Agency adopts and hereby 

incorporates by reference the entirety of 

the ALJ’s rulings, credibility findings,2

findings of fact, conclusions of law, 

sanctions analysis, and recommended 

sanction as found in the RD. 

I. Findings of Fact 

Georgia Standard of Care 

DEA hired Dr. Lobel to testify as an 

expert in the standard of care for the 

practice of medicine and the prescribing 

of controlled substances in the state of 

Georgia, with a focus on pain 

management. RD, at 4; Tr. 105.3 Dr. 

Lobel defined ‘‘standard of care’’ as a 

‘‘minimum level of competence or care 

so as not to harm the patient,’’ and 

described how the Georgia standard of 

care requires a practitioner to, prior to 

prescribing controlled substances, 

obtain a patient’s prior medical records; 

obtain a medical history, including 

family medical history and mental 

health history; conduct an appropriate 

physical examination; obtain a urine 

drug screen; check the PDMP; obtain 

informed consent from the patient; and 

document all information. RD, at 11; Tr. 

120, 128–129, 134, 136. Further, the 

physical examination must be 

appropriate to the complaint, and for 

patients who have spinal pain, the 

practitioner should also conduct a 

complete neurologic exam. RD, at 11; 

Tr. 129–130. In addition, the Georgia 

standard of care requires that a 

practitioner determine and document 

the severity of pain. RD, at 11; Tr. 135– 

136. 

Dr. Lobel testified that under the 

Georgia standard of care, opioids ‘‘are 

not first-line treatment for chronic 

pain,’’ so a practitioner must ‘‘weigh the 

risks and benefits at every visit,’’ as well 

as look out for adverse effects, side 

effects, and aberrant behavior. RD, at 11; 

Tr. 132–133, 136–137. According to Dr. 

Lobel, under the Georgia standard of 

care, a practitioner should consider 

taking a patient off of opioids when 

there is a ‘‘lack of functional benefit, 

toxic effects of the medicine where 

they’re having end organ damage, . . . 

[or] someone [] showing any signs or 

symptoms of addiction,’’ and patients 


khammond on DSKJM1Z7X2PROD with NOTICES