Notice2021-22624
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 2022
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Published
October 18, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) proposes to establish the 2022 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 86 Issue 198 (Monday, October 18, 2021)</title>
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[Federal Register Volume 86, Number 198 (Monday, October 18, 2021)]
[Notices]
[Pages 57690-57699]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22624]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-888P]
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 2022
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 2022 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, 2021. 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 2022
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-888P'' 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) 776-2265.
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
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 CSA (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
the DEA pursuant to 28 CFR 0.100.
Analysis for Proposed 2022 Aggregate Production Quotas and Assessment
of Annual Needs
The proposed 2022 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 2022 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.
[[Page 57691]]
Aggregate Production Quotas
In determining the proposed 2022 aggregate production quotas, the
Administrator has taken into account the criteria of 21 U.S.C. 826(a)
and 21 CFR 1303.11. DEA proposes the aggregate production quotas for
2022 by considering 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 Sec. 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.
Assessment of Annual Needs
In similar fashion, in determining the proposed 2022 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 and considered 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 Sec. 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 2022 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).
DEA formally solicited input from FDA, CDC, CMS, and the states in
February and March of 2021, as required by 21 U.S.C. 826 and 21 CFR
part 1303. Specifically, DEA requested information on trends in the
legitimate use of select schedule I and II controlled substances from
FDA, rates of overdose deaths for covered controlled substances from
CDC, and diversion of covered controlled substances from CMS. DEA's
request for information from the states was made to Prescription Drug
Monitoring Program (PDMP) Administrators through the National
Association of State Controlled Substances Authorities (NASCSA).
Information From the Food and Drug Administration--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 medical needs resides with FDA.
FDA provides DEA with its predicted estimates of medical usage for
selected controlled substances based on information available to them
at a specific point in time in order to meet statutory requirements.
With regard to medical usage of schedule II opioids, FDA predicts
levels of medical need for the United States will decline on average
18.88 percent between calendar years 2021 and 2022. 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 well
as a potential increase in demand for certain opioids identified as
necessary to treat ventilated patients with COVID-19 in the table of
proposed 2022 aggregate production quotas listed below, as is required
pursuant to 21 CFR 1303.11(b)(7).
With regard to the schedule II stimulants amphetamine,
methylphenidate, and lisdexamfetamine, which are widely used to treat
patients with attention deficit hyperactivity disorder (ADHD), FDA
predicted a 1.66 percent decline in domestic medical use. FDA also
raised concerns over drug shortage notifications it received from
patients for certain medications as well as recalls for specific ADHD
medications. DEA considered FDA's concerns when calculating the
aggregate production quota for these substances. In addition, DEA has
observed a significant increase in the number of quota applications for
product development efforts as well as exports for medical use for
these controlled substances. For example, exports of schedule II
stimulant products in calendar year 2020 totaled 75 percent more than
FDA's estimated domestic medical need for stimulant products
manufactured from these three controlled substances, which demonstrated
that significant quantities of schedule II stimulants produced
domestically are intended for export.
While DEA has observed a significant increase in demand among
domestic manufacturers to bring generic ADHD-products to a relatively
stable domestic market, it has also grown increasingly concerned over
how these market forces may impact the misuse of prescription
stimulants among young adults, which in turn coincides with an increase
in demand for illicit stimulants (i.e., methamphetamine and cocaine).
It is notable that major increases in diagnosis and treatment of ADHD
coincide with FDA approval of various stimulants: Concerta (long-acting
methylphenidate) in 2000, Ritalin LA (methylphenidate) in 2002,
Adderall (dextroamphetamine saccharate, amphetamine aspartate,
dextroamphetamine sulfate, and amphetamine sulfate) in 2002, and
Vyvanse (lisdexamfetamine) in 2007. These medications are all placed in
schedule II because of their high abuse liability and associated risk
of addiction.
Stimulants prescribed to treat ADHD are some of the most diverted
drugs among adolescents with risk for the development of abuse and
dependence.<SUP>1 2</SUP> Increasing diagnoses of
[[Page 57692]]
this disorder have led to increases in filled prescriptions and changes
to the APQ to meet patients' medical needs. The diversion of ADHD
medications for the purposes of recreational abuse or performance
enhancement is common, 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 is consulting with federal partners at HHS and 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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Information Received by DEA Regarding 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 applications
for schedule I research registrations and new applications for
registration from manufacturers and corresponding quota applications to
grow, synthesize, extract, and manufacture 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 2022 as compared
with aggregate production quotas for these substances in 2021. 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 is working diligently to review and approve applications for
schedule I manufacturers of marihuana that conform to the federal
requirements contained in the CSA. See 85 FR 82333. Based on the
increase in research and clinical trial applications, DEA has proposed
increases in 3,4-Methylenedioxyamphetamine (MDA), 3,4-
Methylenedioxymethamphetamine (MDMA), 5-Methoxy-N,N-dimethyltryptamine,
Dimethyltryptamine, Lysergic acid diethylamide (LSD), Marihuana,
Marihuana Extract, Mescaline, Psilocybin, 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 by DEA 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.
Factor 1303.11(b)(5) requires DEA to consider the extent of
diversion of controlled substances. 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 extracted individual registrant reports of diversion
of controlled substances from 2020 from its Theft Loss Report database.
This database is comprised of DEA registrant reported entries
documenting diversion in the legitimate distribution chain consisting
of employee theft, 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). The estimates of diversion as
required by the Substance Use-Disorder Prevention that Promotes Opioid
Recovery Treatment for Patients and Communities Act of 2018 (SUPPORT
Act) (Pub. L. 115-271) are discussed later in the document.
In this proposed 2022 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 Pursuant to the SUPPORT Act
The SUPPORT Act mandates that in establishing any quota under 21
U.S.C. 826, or any procurement quota established by regulation, for
fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone
(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.'' In estimating diversion under 21
U.S.C. 826(i)(1), DEA:
(1) ``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
(2) ``may take into consideration'' whatever other sources of
information it determines reliable.
The SUPPORT Act 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.'' 21
U.S.C. 826(i)(1)(C).
In determining an estimate of the amount of diversion of the
covered controlled substance that occurs in the United States, DEA
considered information from state PDMP Administrators and legitimate
distribution chain participants as described in detail below.
Information From PDMPs Provided by Certain States for Consideration in
the Estimate of Diversion
Pursuant to 21 CFR 1303.11(b)(6), DEA requested state PDMP data for
the purpose of establishing its aggregate production quota. DEA
believes state PDMPs to be an essential, reliable source of information
from which it can effectively estimate diversion of the five covered
controlled substances. This year, in March 2021, DEA sent a letter to
NASCSA requesting its assistance in obtaining aggregated PDMP data for
the five covered controlled substances from each state. DEA indicated
that it was specifically interested in obtaining an analysis of
prescription data from each state's PDMP that would assist DEA in
estimating diversion and setting appropriate quotas in compliance with
the SUPPORT Act. In its request, DEA provided specific questions,
discussed in detail below, based on common indicia of potential
diversion well-known as ``red flags'' by physicians, pharmacists,
manufacturers, distributors, and federal and state regulatory and law
enforcement agencies.\4\ 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.<SUP>5 6</SUP> Certain
[[Page 57693]]
state regulations 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 Sec.
291.29(c)(4), specifying the geographical distance between the
practitioner and the patient or between the pharmacy and the patient).
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\4\ 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.
\5\ The Medicine Shoppe, 29 FR 59504, 59507, 59512-13 (2014);
Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 57 FR
62316 (2012).
\6\ The mere indicia of red flags alone is not proof of
violation of 21 U.S.C. 824 or any other violation of the CSA. This
rule discusses only their use by DEA as an analytical tool used to
estimate diversion.
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DEA requested responses from state PDMP Administrators by June 1,
2021. 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 states that responded.
Sixteen states and one county provided DEA with summarized PDMP data
between June 2 and July 13, 2021, 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/Counties That Responded to DEA's Data Request
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State/territory
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1. Alabama.
2. Alaska.
3. Arizona.
4. Delaware.
5. Hawaii.
6. Iowa.
7. Indiana.
8. Michigan.
9. Mississippi.
10. Montana.
11. New Jersey.
12. New Mexico.
13. Nevada.
14. Rhode Island.
15. St. Louis County, Missouri.
16. South Carolina.
17. Virginia.
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Pharmacies are required by state law to enter controlled substance
dispensing data into the state's PDMP database, which includes, among
other things, the prescriber's name, registered address and DEA number,
prescription information (such as drug name), dispensing date, dosage
dispensed, pharmacy registered address information, and patient
address. DEA considers PDMP data to be an accurate representation of
dispensing activities in states. DEA, through NASCSA, requested
information from state PDMP Administrators covering 2018-2020 regarding
the five covered controlled substances. 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 received an opioid at each visit.
For this metric, DEA was specifically interested in the number of
prescriptions dispensed for the five covered controlled substances to
these patients, expressed 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 used 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, 57 FR 62316 (2012).
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<bullet> The number of prescriptions for each of the five covered
controlled substances dispensed that exceeded 240 morphine milligram
equivalents (MME) daily, expressed as a percentage of the total covered
controlled substance prescriptions dispensed as well as 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.
Numerous dispensings of prescriptions with 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 covered controlled substance prescriptions
paid for entirely by cash and not submitted for insurance
reimbursement.\10\ This response was expressed 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 when identifying
prescriptions filled for nonmedical purposes. Prescribers or pharmacies
with unusually high percentages of cash payments 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 of each state. The PDMP data
sample comes from a population of approximately 78.5 million people,
which represents approximately 24 percent of the U.S. population. DEA
believes this sample is sufficient to derive a reasonable nationwide
estimate.
DEA recognizes that the PDMP data received does not show that
meeting any single one of the criteria listed above is enough to
establish conclusively that the subject prescriptions were 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.
DEA's Analysis of Reports Received From State PDMP Administrators
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 2018-2020. That
number was then compared to the corresponding population for the states
responding to DEA's request in order to estimate a percentage of the
population issued a prescription with a red flag. Using this estimated
percentage for 2018-20, DEA analyzed trends in the data to predict the
estimated percentage of patients who would be expected to meet these
diversion metrics for 2022.
DEA also reviewed aggregate sales data for each of the covered
controlled substances, which it extracted from
[[Page 57694]]
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 2018-May 2021, in
order to predict the estimated national sales for 2022.
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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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DEA multiplied the forecasted percentage of patients who received a
prescription for a covered controlled substance that met any of the
three diversion-related metrics for 2022 by the forecasted sales data
from IQVIA for 2022 to estimate diversion for each of the covered
controlled substances. 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 applied in Table
3.
Table 1b--Diversion Estimates Based on State PDMP Data for Covered
Controlled Substances
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl...................................................... 16
Hydrocodone................................................... 135,591
Hydromorphone................................................. 274
Oxycodone..................................................... 164,838
Oxymorphone................................................... 0
------------------------------------------------------------------------
Registrant Reported Legitimate Distribution Chain Diversion
DEA extracted data from its Drug Theft and Loss database, and
categorized it by each basic drug class. The quantity of API in each
dosage form was delineated with the appropriate metric, and then the
quantity of API of each covered controlled substance was aggregated by
metric weight where the data was available. DEA calculated the
estimated amount of diversion by multiplying the strength of the API
listed for each finished dosage form by the total amount of units
reported to estimate the metric weight in grams of the controlled
substance being diverted. The estimate of diversion 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...................................................... 77
Hydrocodone................................................... 19,448
Hydromorphone................................................. 901
Oxycodone..................................................... 45,582
Oxymorphone................................................... 528
------------------------------------------------------------------------
In accordance with the SUPPORT Act, DEA's estimate of diversion for
the five controlled substances was calculated by combining the values
in Tables 1b and 2. DEA made reductions to the aggregate production
quotas for each covered controlled substance by the resulting
quantities listed in Table 3.
Table 3--Total Estimates of Diversion for Covered Controlled Substances
------------------------------------------------------------------------
------------------------------------------------------------------------
Total diversion estimates applied to the 2022 APQ (g)
------------------------------------------------------------------------
Fentanyl...................................................... 93
Hydrocodone................................................... 155,039
Hydromorphone................................................. 1,175
Oxycodone..................................................... 210,420
Oxymorphone................................................... 528
------------------------------------------------------------------------
The Administrator, therefore, proposes to establish the 2022
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 2022
quotas
Basic class ----------------
(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- 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)....................................................
[[Page 57695]]
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C- 30
T-4)..................................................
3,4,5-Trimethoxyamphetamine............................ 30
3,4-Methylenedioxyamphetamine (MDA).................... 200
3,4-Methylenedioxymethamphetamine (MDMA)............... 3,200
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-Bromo-2,5-dimethoxyamphetamine (DOB)................. 30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)............. 25
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha- 25
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-hydroxycyclohexyl]- 50
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)-1H- 25
indazole-3-carboxamido)-3,3-dimethylbutanoate)........
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2- 25
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....................... 550
AB-CHMINACA............................................ 30
AB-FUBINACA............................................ 50
AB-PINACA.............................................. 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 30
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)-1- 50
pentyl-1H-indazole-3-carboxamide).....................
AH-7921................................................ 30
All other tetrahydrocannabinol......................... 2,000
Allylprodine........................................... 25
Alphacetylmethadol..................................... 25
alpha-Ethyltryptamine.................................. 25
Alphameprodine......................................... 25
Alphamethadol.......................................... 25
alpha-Methylfentanyl................................... 30
alpha-Methylthiofentanyl............................... 30
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
[[Page 57696]]
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
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.............................................. 9,200
Dihydromorphine........................................ 653,548
Dimenoxadol............................................ 25
Dimepheptanol.......................................... 25
Dimethylthiambutene.................................... 20
Dimethyltryptamine..................................... 250
Dioxyaphetyl butyrate.................................. 25
Dipipanone............................................. 25
Drotebanol............................................. 25
Ethylmethylthiambutene................................. 25
Ethylone............................................... 25
Etonitazene............................................ 25
Etorphine.............................................. 30
Etoxeridine............................................ 25
Fenethylline........................................... 30
Fentanyl carbamate..................................... 30
Fentanyl related substances............................ 600
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
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)....................... 500
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1- 30
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide)..........................................
[[Page 57697]]
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1- 30
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
dimethylbutanoate)....................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole- 30
3-carboxamido)-3,3-dimethylbutanoate).................
MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)- 25
1H-indole-3-carboxamido)-3-methylbutanoate............
Marijuana.............................................. 3,200,000
Marijuana extract...................................... 1,000,000
Mecloqualone........................................... 30
Mescaline.............................................. 100
Methaqualone........................................... 60
Methcathinone.......................................... 25
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
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
Psilocybin............................................. 3,000
Psilocyn............................................... 2,000
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
[[Page 57698]]
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............................................. 3,260
Alphaprodine........................................... 25
Amobarbital............................................ 20,100
Bezitramide............................................ 25
Carfentanil............................................ 20
Cocaine................................................ 60,492
Codeine (for conversion)............................... 1,364,981
Codeine (for sale)..................................... 22,260,178
D-amphetamine (for sale)............................... 21,200,000
D,l-amphetamine........................................ 21,200,000
d-amphetamine (for conversion)......................... 18,000,000
Dexmethylphenidate (for sale).......................... 6,200,000
Dexmethylphenidate (for conversion).................... 6,500,000
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............................................... 691,511
Glutethimide........................................... 25
Hydrocodone (for conversion)........................... 1,250
Hydrocodone (for sale)................................. 29,599,888
Hydromorphone.......................................... 2,097,255
Isomethadone........................................... 30
L-amphetamine.......................................... 30
Levo-alphacetylmethadol (LAAM)......................... 25
Levomethorphan......................................... 30
Levorphanol............................................ 23,010
Lisdexamfetamine....................................... 24,000,000
Meperidine............................................. 770,588
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
l-methamphetamine...................................... 587,229
Methylphenidate (for sale)............................. 41,800,000
Methylphenidate (for conversion)....................... 15,300,000
Metopon................................................ 25
Moramide-intermediate.................................. 25
Morphine (for conversion).............................. 2,584,860
Morphine (for sale).................................... 22,525,461
Nabilone............................................... 62,000
Norfentanyl............................................ 25
Noroxymorphone (for conversion)........................ 22,044,741
Noroxymorphone (for sale).............................. 1,000
Oliceridine............................................ 22,500
Opium (powder)......................................... 250,000
Opium (tincture)....................................... 530,837
Oripavine.............................................. 33,010,750
[[Page 57699]]
Oxycodone (for conversion)............................. 519,061
Oxycodone (for sale)................................... 54,003,559
Oxymorphone (for conversion)........................... 28,204,371
Oxymorphone (for sale)................................. 516,469
Pentobarbital.......................................... 30,766,670
Phenazocine............................................ 25
Phencyclidine.......................................... 35
Phenmetrazine.......................................... 25
Phenylacetone.......................................... 40
Piminodine............................................. 25
Racemethorphan......................................... 5
Racemorphan............................................ 5
Remifentanil........................................... 3,000
Secobarbital........................................... 172,100
Sufentanil............................................. 4,000
Tapentadol............................................. 13,447,541
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 2022 quotas reflect the quantity that DEA believes
is necessary to meet the estimated medical, scientific, research, and
industrial needs of the United States, to include any increase in
demand for certain controlled substances used to treat patients with
COVID-19. 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 2022 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 2022
aggregate production quotas and assessment of annual needs 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 2022 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, 21 CFR 1303.11(c)
and 1315.11(f).
Anne Milgram,
Administrator.
[FR Doc. 2021-22624 Filed 10-15-21; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on October 18, 2021.
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.