Notice2022-22638
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 2023
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Published
October 18, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) proposes to establish the 2023 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Full Text
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<title>Federal Register, Volume 87 Issue 200 (Tuesday, October 18, 2022)</title>
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[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Pages 63091-63100]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22638]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1051P]
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 2023
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice with request for comments.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes to
establish the 2023 aggregate production quotas for controlled
substances in schedules I and II of the Controlled Substances Act (CSA)
and the assessment of annual needs for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before November 17, 2022. 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 2023
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.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-1051P'' 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
<a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://Regulations.gov">Regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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
[[Page 63092]]
identifying information that it cannot be effectively redacted, all or
part of that comment may not be made publicly available. Comments
posted to <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 2023 Aggregate Production Quotas and Assessment
of Annual Needs
The proposed 2023 aggregate production quotas (APQ) and assessment
of annual needs 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 2023 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 2023 aggregate production quotas, 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 of 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.
DEA formally solicited input from FDA and CDC in February of 2022
and from the states in April 2022, 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 (see 85 FR 54414; 85 FR 54407). DEA requested
information on trends in the legitimate use of select schedule I and II
controlled substances from FDA and rates of 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 2023 assessment of
annual needs 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 2023 assessment of annual needs, 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 2023 will decline on average 5.3
percent from calendar year 2022 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 treat ventilated
patients with COVID-19, pursuant to 21 CFR 1303.11(b)(7), in the
proposed 2023 aggregate production quotas.
FDA predicted less than a 0.1 percent decline in domestic medical
use of the schedule II stimulants amphetamine, methylphenidate
(including
[[Page 63093]]
dexmethylphenidate), and lisdexamfetamine, which are widely used to
treat patients with attention deficit hyperactivity disorder (ADHD).
FDA also raised concerns over drug shortage notifications it received
from patients for specific ADHD medications containing methylphenidate
and amphetamine. DEA considered FDA's concerns when calculating the
aggregate production quota for these substances.
DEA has grown increasingly concerned over the forces that may be
impacting the misuse of prescription stimulants among young adults,
which coincides with an increase in demand for illicit methamphetamine
and cocaine. These medications are all placed in schedule II because of
their high abuse liability and associated risk of addiction. Due to the
expansion of diagnostic criteria and treatment of ADHD, the domestic
demand for these products (in terms of prescriptions written) has
increased over the past two decades and so have the number of FDA
approved drug products used to treat the condition. For example,
Concerta (long-acting methylphenidate) was introduced in 2000, Ritalin
LA (methylphenidate) in 2002, Adderall (dextroamphetamine saccharate,
amphetamine aspartate, dextroamphetamine sulfate, and amphetamine
sulfate) in 2002, and Vyvanse (lisdexamfetamine) in 2007. Patients
respond in different ways to different medications; therefore, a
variety of products to treat ADHD are available now, but domestic
demand is no longer increasing as it was in the past.
Stimulants prescribed to treat ADHD are some of the most diverted
drugs among those adolescents that are at risk of substance abuse and
dependence.\1\ The diversion of ADHD medications for the purposes of
recreational use or performance enhancement is common,\2\ with
approximately 5-10 percent of high school students and 5-35 percent of
college students, depending on the study, misusing and diverting
stimulants prescribed for ADHD.\3\ As a consequence, DEA continues to
consult with federal partners at HHS and is closely monitoring trends
in licit and illicit stimulant use and corresponding diversion and
misuse.
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\1\ Epstein-Ngo QM, et al., Diversion of ADHD Stimulants and
Victimization Among Adolescents, 41 J Ped Psychol 788-798 (2015).
\2\ Wilens TE, et al., Misuse and Diversion of Stimulants
Prescribed for ADHD: A Systematic Review of the Literature, 47 J
Amer Acad Child Adolesc Psychiatry 21-31 (2008).
\3\ Epstein-Ngo QM, et al., Diversion of ADHD Stimulants and
Victimization Among Adolescents, 41 J Ped Psychol 788-798 (2015).
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DEA Estimated 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 clinical trial purposes. DEA supports regulated research
with schedule I controlled substances, as evidenced by increases
proposed for 2023 as compared with aggregate production quotas for
these substances in 2022. Further, DEA published the final rule,
``Controls to Enhance the Cultivation of Marihuana for Research in the
United States'' in December 2020, and 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. DEA has proposed increases in 5-Methoxy-N,N-
dimethyltryptamine, Lysergic acid diethylamide (LSD), Marijuana,
Mescaline, Psilocyn, and All Other Tetrahydrocannabinols to support
manufacturing activities related to the increased level of research and
clinical trials with these schedule I controlled substances.
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
provided information by submitting their individual data to DEA
database systems used for reporting inventory, and for distribution,
manufacturing, and estimated quota requirements to meet sales
forecasts, for each class of controlled substance. 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.\4\ Diversion is defined
as all distribution, dispensing, or other use of controlled substances
for other than legitimate medical purposes. In order to consider the
extent of diversion, DEA analyzed reports of diversion of controlled
substances from 2021 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).
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\4\ The estimates of diversion for five ``covered controlled
substances'' as required by 21 U.S.C. 826(i) are discussed later in
the document.
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In this proposed 2023 aggregate production quota, DEA also
considered the effects of the COVID-19 pandemic, pursuant to 21 CFR
1303.11(b)(7), relative to the continued increase in demand for opioids
necessary to treat ventilated patients.
Estimates of Diversion of Covered Controlled Substances
DEA is required:
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''), [to] 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.'' \5\
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\5\ 21 U.S.C. 826(i)(1)(C).
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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.
[[Page 63094]]
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 aggregate production quotas. 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 2022, 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
2019-2021. 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.\6\
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\6\ National Association of Boards of Pharmacy (NABP) coalition
consensus document ``Stakeholders Challenges and Red Flags and
Warning Signs Related to Prescribing and Dispensing Controlled
Substances'' (2015). www.nabp.pharmacy/resources/reports. For
example, DEA investigators and administrative prosecutors rely on
Agency case law in which these red flags of diversion have been
upheld as indicia of potential diversion. See, e.g., The 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 (2012). Certain
state regulations also now include red flag circumstances as
potential indicators of illegitimate prescriptions, and thus of
potential abuse and diversion of controlled substances. See The
Pharmacy Place Order, 86 FR 21008, at 21012 (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). This rule discusses only the use of red flags by DEA
as an analytical tool to estimate diversion, not for any other
purpose.
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DEA requested responses from state PDMP Administrators by June 1,
2022. 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.
Twenty-seven states and three territories provided DEA with summarized
PDMP data between April 12 and June 27, 2022, utilizing the
standardized report developed by NASCSA.\7\ See Table 1a below.
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\7\ NASCSA formatted DEA's request into an analytics model
developed by one of its associates, Appriss Inc.
Table 1a--States/Territories That Responded to DEA's Data Request
------------------------------------------------------------------------
State/territory
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1. Alabama.
2. Alaska.
3. Arizona.
4. Arkansas.
5. Delaware.
6. District of Columbia.
7. Guam.
8. Hawaii.
9. Indiana.
10. Iowa.
11. Kansas.
12. Kentucky.
13. Louisiana.
14. Maryland.
15. Michigan.
16. Mississippi.
17. Montana.
18. Nevada.
19. New Jersey.
20. New Mexico.
21. North Carolina.
22. North Dakota.
23. Oregon.
24. Puerto Rico.
25. Rhode Island.
26. South Carolina.
27. South Dakota.
28. Texas.
29. Utah.
30. Virginia.
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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:
<bullet> 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 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.\8\
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\8\ Frank's Corner Pharmacy, 60 FR 17574 (1995); Holiday CVS,
L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77 FR 62316 (2012).
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<bullet> 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. The CDC has advised prescribers to avoid
increasing dosages of opioids beyond 90 MME for patients with chronic
pain.\9\ 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 in excess
of 90 MME daily. 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.
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\9\ <a href="http://www.cdc.gov/drugoverdose/pdf/prescribing/Guidelines_factsheet-a.pdf">www.cdc.gov/drugoverdose/pdf/prescribing/Guidelines_factsheet-a.pdf</a>.
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<bullet> 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\
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\10\ This total does not include insurance co-payments made with
cash.
\11\ Suntree 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 (2018) (revoking pharmacy's registration for filling
prescriptions that raised the red flag of customers paying cash for
their prescriptions, among other red flags).
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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 125.9
[[Page 63095]]
million people, which is approximately 38 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 diversion metrics for each of calendar years 2019-2021. 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 2019-2021, DEA analyzed
trends in the data to predict the estimated percentage of patients who
would be expected to meet these diversion metrics for 2023.
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 2019-May 2022, in order to predict the
estimated national sales for 2023.
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\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.
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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 diversion-related metrics in 2023 by the forecasted
sales data from IQVIA for 2023. 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 Based on State PDMP Data for Covered
Controlled Substances
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl...................................................... 58
Hydrocodone................................................... 112,346
Hydromorphone................................................. 355
Oxycodone..................................................... 146,201
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...................................................... 6
Hydrocodone................................................... 4,048
Hydromorphone................................................. 227
Oxycodone..................................................... 16,750
Oxymorphone................................................... 109
------------------------------------------------------------------------
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 aggregate production quotas
for each covered controlled substance by the quantities listed in Table
3.
Table 3--Total Estimates of Diversion for Covered Controlled Substances
------------------------------------------------------------------------
------------------------------------------------------------------------
Total diversion estimates applied to the 2023 APQ (g)
------------------------------------------------------------------------
Fentanyl...................................................... 64
Hydrocodone................................................... 116,394
Hydromorphone................................................. 582
Oxycodone..................................................... 162,951
Oxymorphone................................................... 109
------------------------------------------------------------------------
The Administrator, therefore, proposes to establish the 2023
aggregate production quotas for certain schedule I and II controlled
substances and assessment of annual needs for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams
of anhydrous acid or base, as follows:
------------------------------------------------------------------------
Proposed 2023
Basic class 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
[[Page 63096]]
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)............. 100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe;
25B; Cimbi-36)......................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).... 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 25
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe;
25C; Cimbi-82)......................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)...... 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe;
25I; Cimbi-5).......................................
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- 30
2)..................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 30
(2C-T-4)............................................
3,4,5-Trimethoxyamphetamine.......................... 30
3,4-Methylenedioxyamphetamine (MDA).................. 200
3,4-Methylenedioxymethamphetamine (MDMA)............. 8,200
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......... 40
3,4-Methylenedioxy-N-methylcathinone (methylone)..... 40
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)........... 25
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro- 25
alpha-PVP)..........................................
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-[alpha]-pyrrolidinopropiophenone (4-MePPP).. 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 50
hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 40
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
5F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5- 25
fluoropentyl)-1H-indazole-3-carboxamide.............
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)- 25
1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)...
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan- 25
2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide........
5F-CUMYL-PINACA...................................... 25
5F-EDMB-PINACA....................................... 25
5F-MDMB-PICA......................................... 25
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 25
carboxamido)-3-methylbutanoate).....................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5- 25
fluoropentyl)-1H-indazole-3-carboxamide)............
5-Fluoro-PB-22; 5F-PB-22............................. 25
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3- 25
yl](2,2,3,3-tetramethylcyclopropyl)methanone........
5-Methoxy-3,4-methylenedioxyamphetamine.............. 25
5-Methoxy-N,N-diisopropyltryptamine.................. 25
5-Methoxy-N,N-dimethyltryptamine..................... 6,000
AB-CHMINACA.......................................... 30
AB-FUBINACA.......................................... 50
AB-PINACA............................................ 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2- 30
yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)...
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)- 50
1-pentyl-1H-indazole-3-carboxamide).................
AH-7921.............................................. 30
All other tetrahydrocannabinol....................... 15,000
Allylprodine......................................... 25
Alphacetylmethadol................................... 25
alpha-Ethyltryptamine................................ 25
Alphameprodine....................................... 25
Alphamethadol........................................ 25
alpha-Methylfentanyl................................. 30
alpha-Methylthiofentanyl............................. 30
[[Page 63097]]
alpha-Methyltryptamine (AMT)......................... 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP).......... 25
alpha-pyrrolidinoheptaphenone (PV8).................. 25
alpha-pyrrolidinohexabophenone (alpha-PHP)........... 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)......... 25
Aminorex............................................. 25
Anileridine.......................................... 20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3- 25
carboxamide)........................................
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.............................................. 384,460
Desomorphine......................................... 25
Dextromoramide....................................... 25
Diapromide........................................... 20
Diethylthiambutene................................... 20
Diethyltryptamine.................................... 25
Difenoxin............................................ 9,300
Dihydromorphine...................................... 653,548
Dimenoxadol.......................................... 25
Dimepheptanol........................................ 25
Dimethylthiambutene.................................. 20
Dimethyltryptamine................................... 3,000
Dioxyaphetyl butyrate................................ 25
Dipipanone........................................... 25
Drotebanol........................................... 25
Ethylmethylthiambutene............................... 25
Ethylone............................................. 25
Etodesnitazene....................................... 30
Etonitazene.......................................... 25
Etorphine............................................ 30
Etoxeridine.......................................... 25
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............................................. 30
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
[[Page 63098]]
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- 35
naphthoyl)indole)...................................
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- 30
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide)........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1- 30
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
dimethylbutanoate)..................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H- 30
indazole-3-carboxamido)-3,3-dimethylbutanoate)......
MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1- 25
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-
methylbutanoate.....................................
Metodesnitazene...................................... 30
Metonitazene......................................... 30
Marijuana............................................ 6,675,000
Marijuana extract.................................... 1,000,000
Mecloqualone......................................... 30
Mescaline............................................ 1,200
Methaqualone......................................... 60
Methcathinone........................................ 25
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- 25
carboxylate.........................................
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
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
[[Page 63099]]
Phenoperidine........................................ 25
Phenyl fentanyl...................................... 30
Pholcodine........................................... 5
Piritramide.......................................... 25
Proheptazine......................................... 25
Properidine.......................................... 25
Propiram............................................. 25
Protonitazene........................................ 30
Psilocybin........................................... 8,000
Psilocyn............................................. 8,000
Racemoramide......................................... 25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2- 45
methoxyphenylacetyl)indole).........................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)- 30
benzoyl]indole).....................................
Tetrahydrofuranyl fentanyl........................... 15
Thebacon............................................. 25
Thiafentanil......................................... 25
Thiofentanyl......................................... 25
Thiofuranyl fentanyl................................. 30
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3- 30
yl](naphthalen-1-yl)methanone)......................
Tilidine............................................. 25
Trimeperidine........................................ 25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3- 25
tetramethylcyclopropyl)methanone....................
U-47700.............................................. 30
Valeryl fentanyl..................................... 25
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.............................. 15
1-Piperidinocyclohexanecarbonitrile.................. 25
4-Anilino-N-phenethyl-4-piperidine (ANPP)............ 886,415
Alfentanil........................................... 5,000
Alphaprodine......................................... 25
Amobarbital.......................................... 20,100
Bezitramide.......................................... 25
Carfentanil.......................................... 20
Cocaine.............................................. 60,492
Codeine (for conversion)............................. 1,085,024
Codeine (for sale)................................... 21,003,397
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
Dexmethylphenidate (for conversion).................. 4,200,000
Dextropropoxyphene................................... 35
Dihydrocodeine....................................... 132,658
Dihydroetorphine..................................... 25
Diphenoxylate (for conversion)....................... 14,100
Diphenoxylate (for sale)............................. 770,800
Ecgonine............................................. 60,492
Ethylmorphine........................................ 30
Etorphine hydrochloride.............................. 32
Fentanyl............................................. 691,447
Glutethimide......................................... 25
Hydrocodone (for conversion)......................... 1,250
Hydrocodone (for sale)............................... 27,239,822
Hydromorphone........................................ 1,994,117
Isomethadone......................................... 30
L-amphetamine........................................ 30
Levo-alphacetylmethadol (LAAM)....................... 25
Levomethorphan....................................... 30
Levorphanol.......................................... 23,010
Lisdexamfetamine..................................... 26,500,000
Meperidine........................................... 681,289
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
Methamphetamine...................................... 150
d-methamphetamine (for conversion)................... 485,020
d-methamphetamine (for sale)......................... 40,000
[[Page 63100]]
l-methamphetamine.................................... 587,229
Methylphenidate (for sale)........................... 41,800,000
Methylphenidate (for conversion)..................... 15,300,000
Metopon.............................................. 25
Moramide-intermediate................................ 25
Morphine (for conversion)............................ 2,458,460
Morphine (for sale).................................. 21,747,625
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)................................. 53,840,608
Oxymorphone (for conversion)......................... 28,204,371
Oxymorphone (for sale)............................... 516,351
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........................................... 11,941,416
Thebaine............................................. 57,137,944
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)........................... 100
Ephedrine (for sale)................................. 4,136,000
Phenylpropanolamine (for conversion)................. 14,878,320
Phenylpropanolamine (for sale)....................... 7,990,000
Pseudoephedrine (for conversion)..................... 1,000
Pseudoephedrine (for sale)........................... 174,246,000
------------------------------------------------------------------------
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 2023 quotas reflect the quantities that DEA believes
are necessary to meet the estimated medical, scientific, research, and
industrial needs of the United States, including any increase in demand
for certain controlled substances used to treat patients with COVID-19;
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 2023 aggregate production quota 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 2023
aggregate production quotas and assessment of annual needs as needed.
These assessments are subject to reevaluation pursuant to 21 U.S.C. 826
and 21 CFR 1303.13(a)-(b).
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 2023 aggregate
production quotas for controlled substances in schedule I and II and
establishing an assessment of annual needs 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 13, 2022, 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. 2022-22638 Filed 10-14-22; 8:45 am]
BILLING CODE P
</pre></body>
</html>Indexed from Federal Register on October 18, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.