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, 57690-57699 [2021-22624]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 198 (Monday, October 18, 2021)]
[Notices]
[Pages 57690-57699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
https://www.regulations.gov and follow the online instructions at that 
site for submitting comments. Upon completion of your submission, you 
will receive a Comment Tracking Number for your comment. Please be 
aware that submitted comments are not instantaneously available for 
public view on Regulations.gov. If you have received a Comment Tracking 
Number, your comment has been successfully submitted, and there is no 
need to resubmit the same comment. Paper comments that duplicate 
electronic submissions are not necessary and are discouraged. Should 
you wish to mail a paper comment in lieu of an electronic comment, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152, Telephone: (571) 776-2265.

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 https://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    The Freedom of Information Act applies to all comments received. If 
you want to submit personal identifying information (such as your name, 
address, etc.) as part of your comment, but do not want it to be made 
publicly available, you must include the phrase ``PERSONAL IDENTIFYING 
INFORMATION'' in the first paragraph of your comment. You must also 
place all the personal identifying information you do not want made 
publicly available in the first paragraph of your comment and identify 
what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
contains so much confidential business information or personal 
identifying information that it cannot be effectively redacted, all or 
part of that comment may not be made publicly available. Comments 
posted to https://www.regulations.gov may include any personal 
identifying information (such as name, address, and phone number) 
included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document is available at https://www.regulations.gov 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.1 2 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.5 6 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.
------------------------------------------------------------------------

    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:
     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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     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\ www.cdc.gov/drugoverdose/pdf/prescribing/Guidelines_factsheet-a.pdf.
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     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