Established 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 2021, 76604-76613 [2020-26289]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76604-76613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26289]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-688E]


Established 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 2021

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This final order establishes the initial 2021 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act and the assessment of annual needs for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Applicable Date: Applicable November 30, 2020.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, VA 22152, Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

I. Legal Authority

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) 
requires the Attorney General to establish aggregate production quotas 
for each basic class of controlled substance listed in schedule I and 
II and assessment of annual needs for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine. The Attorney General has 
delegated this function to the Administrator of the Drug Enforcement 
Administration (DEA) pursuant to 28 CFR 0.100.

II. Background

    The 2021 aggregate production quotas (APQ) and assessment of annual 
needs (AAN) represent those quantities of schedule I and II controlled 
substances and the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine that may be manufactured in the United States in 
2021 to provide for the estimated medical, scientific, research, 
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

[[Page 76605]]

substances for use in industrial processes.
    On September 1, 2020, a notice titled ``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 2021'' (hereinafter 
``Proposed 2021 APQ'') was published in the Federal Register. 85 FR 
54407. This notice proposed the 2021 APQ for each basic class of 
controlled substance listed in schedules I and II and the 2021 AAN for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. All interested persons were invited to comment on 
or object to the proposed APQ and the proposed AAN on or before October 
1, 2020.

III. Comments Received

    Within the public comment period, DEA received 294 comments from 
DEA registrants, hospital associations, professional associations, 
doctors, nurses, health system organizations, State Attorneys General, 
and others. The comments included concerns over drug shortages due to 
further quota reductions from doctors and nurses, patients, and various 
health groups and hospital affiliations; requests for less interference 
in the doctor-patient relationship; concerns about the quota process 
with a request for public hearing; and comments not pertaining to DEA 
regulated activities.
    The majority of the commenters expressed concerns regarding the 
potential adverse impact of the decrease to the APQ of controlled 
substances on the availability of pain-relieving prescription drugs for 
people with chronic pain. DEA received comments from four DEA-
registered manufacturers regarding ten different schedule I and II 
controlled substances. Commenters stated the proposed APQ for ANPP, d-
amphetamine (for conversion), fentanyl, hydrocodone (for sale), 
hydromorphone, lisdexamfetamine, morphine (for conversion), 
noroxymorphone (for conversion), oxycodone (for sale), and sufentanil 
be sufficient for manufacturers to meet medical and scientific needs. 
DEA has considered the comments for specific controlled substances in 
establishing the 2021 APQ.
    DEA received no comments regarding the proposed established 2021 
AAN for ephedrine, pseudoephedrine, and phenylpropanolamine.

A. Shortages

    Issue: Some commenters expressed concerns about the decrease in 
certain APQ. These commenters alleged that decreases to the APQ have 
resulted in a shortage of injectable opioid medications and interfere 
with the treatment of patients. Some of these commenters also suggested 
that DEA separate quotas for solid oral controlled substances and 
injectable controlled substances, and urged DEA to utilize its 
discretionary authority under the Substance Use-Disorder Prevention 
that Promotes Opioid Recovery and Treatment Act (SUPPORT Act),\1\ to 
establish APQ in terms of pharmaceutical dosage form for all schedule 
II controlled substances.
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    \1\ Public Law 115-271.
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    DEA Response: DEA is committed to ensuring an adequate and 
uninterrupted supply of controlled substances in order to meet the 
legitimate medical, scientific, and export needs of the United States. 
DEA sets APQ in a manner to provide for all dispensings authorized for 
legitimate medical purposes, and in turn, the APQ take into 
consideration both injectable opioids and solid oral opioids to meet 
the estimated medical needs of the United States. The SUPPORT Act 
allows, but does not require, DEA to grant quotas in terms of dosage 
forms if the agency determines that doing so will assist in avoiding 
the overproduction, shortages, or diversion of a controlled substance. 
DEA believes that incorporating all dosage forms into the APQ, rather 
than allocating APQ by dosage form, allows the agency flexibility to 
adjust the individual quotas granted to manufacturers to alleviate any 
potential shortages and react to unforeseen emergencies. DEA believes 
the most accurate use of this authority would be in determining 
individual procurement quotas, if warranted under the circumstances. 
For example, if there was a shortage of any dosage form, the APQ would 
not need to be raised for manufacturers to produce that specific dosage 
form. Conversely, if multiple APQ for dosage forms were permitted, it 
is more likely that the APQ for that dosage form would need to be 
raised to respond to such a shortage before production could commence, 
thereby delaying the response time to the shortage.
    Although DEA sets the APQ, it is possible that the business 
practices of manufacturers may lead to a shortage of controlled 
substances at the patient level, despite the adequacy of the APQ set by 
DEA. DEA can grant an individual quota to a manufacturer, and pursuant 
to the SUPPORT Act, also has the authority to grant individual 
manufacturing and/or procurement quotas for specific dosage forms; 
however, DEA cannot demand that the manufacturer utilize the quota 
immediately, nor does it have the authority to demand immediate 
production of dosage forms.
    DEA and the Food and Drug Administration (FDA) are required to 
coordinate efforts to prevent or alleviate drug shortages pursuant to 
21 U.S.C. 826(h) and maintain a collaborative working relationship. In 
addition, DEA and FDA have worked collaboratively. For example, in 2016 
the domestic shortage of injectable controlled substances was 
alleviated by the importation of certain injectable controlled 
substances coordinated by the collaborated effort of FDA and DEA. The 
alleviation of this drug shortage did not require an adjustment to the 
APQ. Again in 2020, when hospitals informed DEA that there was a 
domestic shortage of injectable controlled substances due to the 
Coronavirus Disease of 2019 (COVID-19) health emergency, DEA 
collaborated with FDA to increase the appropriate APQ and individual 
quotas to allow for increased manufacturing of the specific drug 
products.

B. Pain Management Association Letters

    Issue: DEA received comments that expressed concern that DEA's 
proposed reduction of opioids would adversely impact the availability 
of pain-relieving prescription drugs for people with chronic pain. The 
general concern is that lowering the APQ, which in turn decreases the 
amount available for physicians to write prescriptions, increases the 
probability that a physician cannot or will not prescribe such pain-
relieving drugs.
    DEA Response: DEA sets APQ in a manner to ensure that all 
prescriptions authorized for legitimate medical purposes can be filled. 
DEA does not set guidelines regarding patterns of prescribing 
medications, nor does DEA determine what dosage(s) are deemed 
``medically necessary.'' Prescribers authorized to dispense controlled 
substances are responsible for adhering to the laws and regulations set 
forth under the CSA, which requires doctors to only write prescriptions 
for legitimate medical needs. Any practitioner issuing an invalid 
prescription for controlled substances and any pharmacy knowingly 
filling such a prescription would be in violation of the CSA.

C. Relevant Information Obtained From Health and Human Services (HHS) 
Agencies

    Some commenters, including the State Attorneys General for West 
Virginia, Kentucky, Arkansas, and

[[Page 76606]]

South Dakota, were concerned with DEA's use and/or analysis of relevant 
information from HHS, including: (1) Centers for Medicare and Medicaid 
Services (CMS) data on overprescribing; (2) FDA data; and (3) Centers 
for Disease Control and Prevention (CDC) data on overdose deaths.
CMS Data on Over-Prescribing
    Issue: Some commenters expressed concern with DEA's use and 
interpretation of CMS data; particularly, in how such raw data would be 
used in the future to draw conclusions on the issue of overprescribing. 
Pain management associations questioned how DEA would distinguish 
between appropriate and inappropriate prescribing, and urged DEA to use 
``nuanced and evidence-based means to draw distinctions between 
appropriate and inappropriate use.'' These associations also cautioned 
against misapplying dosage thresholds from CDC prescription guidance 
for schedule II substances to determine overprescribing rates.
    DEA Response: As previously stated, DEA sets APQ in a manner to 
ensure that all prescriptions authorized for legitimate medical 
purposes can be filled. DEA does not set guidelines regarding patterns 
of prescribing medications, nor does DEA determine what dosage(s) can 
be deemed ``medically necessary.'' Prescribers authorized to dispense 
controlled substances are responsible for adhering to the laws and 
regulations set forth under the CSA, which require doctors to only 
write prescriptions for legitimate medical needs. Any practitioner 
issuing an invalid prescription for controlled substances and any 
pharmacy knowingly filling such a prescription would be in violation of 
the CSA.
    As DEA discussed in the prior Proposed 2021 APQ, DEA contacted HHS 
and CMS, a component of HHS, to explore the possibility of using the 
agencies' data to estimate over prescribing. CMS informed DEA that the 
agency had reviewed its internal databases, and did not have the 
ability to systematically distinguish between appropriate and 
inappropriate prescriptions without investigating each prescription.
    Issue: West Virginia, and joining state commenters, raised concerns 
that overprescribing, i.e., opioids prescribed beyond actual medical 
needs, was not accounted for as part of diversion. The States noted 
that ``DEA has not accounted for illegitimate--but legal--demand for 
opioids through overprescribing.''
    DEA Response: DEA sets APQ in a manner to ensure that all 
prescriptions authorized for legitimate medical purposes can be filled. 
Again, DEA does not set guidelines regarding patterns of prescribing 
medications, nor does DEA set guidelines as to what dosage(s) can be 
deemed ``medically necessary.'' Upon review of the studies cited in 
West Virginia's comment letter, DEA has determined that they are 
insufficient to support a reduction in the APQ. The studies cited found 
that for a variety of medical procedures, physicians prescribe more 
controlled substances for post-operative pain than patients utilize. 
While the referenced studies are concerning, DEA has concluded they are 
insufficient to support a determination on the level of overprescribing 
that occurs across the range of the medical procedures performed each 
year nationwide.
    Prescribers authorized to dispense controlled substances are 
responsible for adhering to the laws and regulations set forth under 
the CSA, which require doctors to only write prescriptions for 
legitimate medical needs. Any practitioner issuing an invalid 
prescription for controlled substances and any pharmacy knowingly 
filling such a prescription would be in violation of the CSA. As DEA 
explores the possibility of using state Prescription Drug Monitoring 
Program (PDMP) data to estimate diversion, it may be possible to 
reliably discern over-prescribing on a national level and use this 
information to help determine the APQ. However, DEA does not currently 
have access to this data. Additionally, DEA previously attempted to use 
CMS data, but CMS did not have the ability to systematically 
distinguish between appropriate and inappropriate prescriptions without 
investigating each prescription.
FDA Data
    Issue: West Virginia, and joining state commenters, took exception 
to DEA's response to FDA's projected levels of medical need for 
selected controlled substances, claiming that DEA outright rejected FDA 
recommendations.
    DEA Response: DEA did not reject critical FDA ``recommendations.'' 
The term ``recommendation'' as used by the states appears to have been 
incorrectly interpreted; FDA only provided to DEA data that estimated 
legitimate domestic medical need. The data allowed DEA to estimate a 
collective decline in opioids to meet legitimate domestic medical need. 
Scientific, research, industrial needs, lawful export requirements, and 
the establishment and maintenance of reserve stocks are derived from 
information provided from quota applicants and research protocols 
submitted directly to DEA. On April 10, 2020, DEA published adjustments 
to the 2020 APQ for specific controlled substances identified by HHS 
COVID-19 treatment protocols, in order to allow manufacturers to meet 
the new and unforeseen medical need. 85 FR 20302. As explained in that 
notice, FDA's data was based on an analysis performed prior to the 
declaration of a national public health emergency due to COVID-19 by 
the HHS Secretary on January 31, 2020. DEA and HHS subsequently worked 
in concert to determine changes in legitimate medical need based on the 
unforeseen emergency posed by COVID-19, particularly the need of 
certain controlled substances required to treat patients on 
ventilators.
    As stated in the Proposed 2021 APQ, DEA considered both the 
potential for diversion as well as the anticipated increase in demand 
for opioids used to treat patients with COVID-19, as previously 
identified by HHS, in proposing the 2021 APQ for those specific 
controlled substances.
    Issue: Another commenter pointed out that while FDA's 
recommendation may have been made prior to the declaration of the 
COVID-19 emergency, DEA still did not provide any information about how 
it accounted for the impact of COVID-19 when arriving at its 2021 
proposed APQ.
    DEA Response: In the April 10, 2020 notice, DEA stated that DEA and 
HHS worked in concert to determine changes in legitimate medical need 
based on the unforeseen emergency posed by COVID-19, particularly the 
need of certain controlled substances required to treat patients on 
ventilators. DEA extended the projections provided by HHS to insure the 
relevant APQ were established to account for the predicted ``second 
wave'' of COVID-19 patients for the upcoming months.
CDC Data and Overdose Deaths
    Issue: One commenter took issue with DEA's analysis of CDC data and 
DEA not differentiating between types of fentanyl overdoses, i.e., 
overdoses that are the result of lawfully manufactured fentanyl versus 
illicit fentanyl.
    DEA Response: CDC provided DEA with data from their National Vital 
Statistics System-Mortality files. DEA could not determine from CDC's 
data if the patient overdosed on an illicit opioid or a FDA-approved 
opioid product. Nor could DEA determine if the overdose was a result of 
accidental or intentional ingestion. As such, DEA is unable to 
determine the number of

[[Page 76607]]

overdose deaths resulting from fentanyl diverted from legitimate 
sources.
    Whereas DEA is required to consider rates of overdose deaths 
pursuant to changes made by the SUPPORT Act, DEA concluded that the 
provided data on overdose deaths for 2015 through 2017 could not be 
reliably utilized to estimate the amount of diversion for the five 
covered controlled substances for the 2021 APQ.

D. Relevant Information Obtained From the States

    Issue: Some commenters raised concerns that DEA did not adequately 
utilize data from the States. West Virginia, and joining state 
commenters, encouraged DEA to expand its methodology to enable better 
use of state data that does currently exist, despite not having a 
fulsome set of state data.
    DEA Response: DEA solicited relevant information from the States 
and federal partners to be considered when setting the APQ pursuant to 
21 CFR 1303.11. As DEA stated in the Proposed 2021 APQ, only 20 of the 
56 State and Territory Attorneys General acknowledged receipt of DEA's 
letters requesting information on diversion, and of those 20, only nine 
states sent some form of Prescription Drug Monitoring Program (PDMP) 
data to DEA. The limited PDMP data that DEA received varied in form and 
content, and was ultimately determined to be insufficient to develop 
national estimates of diversion for each of the five covered controlled 
substances.
    DEA is currently working with states and other federal agencies to 
obtain reliable data that will allow DEA to effectively estimate 
diversion. For example, DEA is seeking data from state PDMPs which can 
be evaluated to identify common diversion schemes such as ``doctor 
shopping,'' a scheme in which a patient obtains controlled substances 
from multiple treatment providers without the providers knowing of the 
other prescriptions. Information from PDMPs could assist in identifying 
additional ``red flags'' that may be evidence of diversion and misuse 
of covered controlled substances, such as: Over-prescribing; patients 
traveling long distances or across state lines to have prescriptions 
filled; early refills; and dangerous drug combinations.

E. The SUPPORT Act Mandates

Disparate Account of Diversion
    Issue: West Virginia, and joining state commenters, raised concern 
over the disparate treatment of the five SUPPORT Act covered controlled 
substances and other regulated controlled substances in considering 
diversion.
    DEA Response: Pursuant to 21 CFR 1303.11(b)(5), DEA considered the 
extent of diversion of the basic class as a factor in setting the APQ 
for each respective basic class, as well as the extent of diversion for 
all other schedule I and II controlled substances in proposing the 
estimated APQ. The regulation does not, however, mandate that DEA 
publish the diversion estimates for all controlled substances. As the 
state attorneys general comment notes, the SUPPORT Act specifically 
requires that DEA provide the diversion estimate only for the following 
five covered controlled substances: Fentanyl, hydrocodone, 
hydromorphone, oxycodone, and oxymorphone. In compliance with the 
SUPPORT Act, DEA published the estimated diversion for the five covered 
controlled substances.

F. Methodology for Determining the APQ and AAN Values

    Issue: Some commenters wanted a more explicit explanation of DEA's 
methodology in determining the APQ and AAN values. West Virginia, and 
joining state commenters, for instance, called for DEA to adopt a 
``specific, clear, and reproducible methodology developed and explained 
in advance'' to address the ``medically and scientifically necessary 
amount of controlled substances.'' Another commenter noted that DEA 
described one such methodology in the 2010 and 2011 AAN, but claimed 
that a more ``explicit discussion of how that methodology was applied 
would be beneficial.'' The same commenter also asked that DEA 
``publicly provide and explicitly discuss the data it consulted to 
validate the need'' for APQ reductions.
    DEA Response: As stated in the September 1, 2020, notice, DEA 
applies the factors listed in 21 CFR 1303.11 in determining the APQ and 
21 CFR 1315.11 in determining the AAN. FDA is required to provide an 
estimate of the quantity of controlled substances together with 
reserves of such drugs that are necessary to supply the normal and 
emergency medicinal and scientific requirements of the United States to 
DEA. 42 U.S.C. 242(a). Under this statute, HHS has delegated that 
responsibility to FDA, which provided the relevant information to DEA. 
DEA considered this information, including the observed and estimated 
domestic usage of marketed schedule II controlled substances, new drug 
applications and abbreviated drug application approvals, and clinical 
trials for schedule I and II controlled substances. The determination 
of scientifically necessary amounts of controlled substances occurs 
through the submission of business confidential and proprietary 
information from manufacturers. DEA also considered the impact of 
products entering and exiting the market, expected product development, 
expected exports, and inventory data.
    Since 2014, FDA has observed a decline in the number of 
prescriptions written for schedule II opioids. DEA continues to set 
aggregate production quotas to meet the medical needs of the United 
States while combating the opioid crisis. These decreases take into 
account the combined efforts of DEA, FDA, and CDC enforcing regulations 
and issuing guidance documents, as well as many states enacting 
prescription monitoring database programs to stem the opioid epidemic.

G. Further Collaboration of Agencies and Stakeholders; Request for a 
Public Hearing

    Issue: Some commenters suggested that DEA further or better 
collaborate with the states, other federal agencies, and other industry 
stakeholders. One commenter urged DEA to ``collaborate with a broad 
range of stakeholders'' to ``address the opioid crisis while ensuring 
an adequate supply of opioids for clinically appropriate care.'' The 
commenter further suggested that DEA should engage such stakeholders in 
roundtable discussions, listening sessions, or public hearings. West 
Virginia, and joining state commenters, urged DEA to work with states 
and other partners to develop methods to measure overprescribing and 
related forms of diversion. Another commenter asked that DEA work with 
``HHS, Department of Defense, and others tasked with national security 
and emergency preparedness'' to ``address any emergent supply needs or 
preemptive supply preparation'' such as those arising from the 
pandemic.
    DEA Response: DEA has and will continue to collaborate with federal 
agencies, industry, and medical associations to combat the opioid 
crisis, prevent diversion, and set appropriate manufacturing quantities 
of controlled substances and chemicals to meet legitimate need and 
preparedness for unforeseen circumstances within the United States. 
Additionally, the Federal Register comment period provides an 
opportunity for all stakeholders to make their issues known to DEA. 
Unfortunately, many of those issues revolve around prescribing 
practices for

[[Page 76608]]

specific medical conditions. As stated previously, DEA does not set 
guidelines regarding patterns of prescribing medications nor does DEA 
determine what dosages can be deemed ``medically necessary.''
    Issue: One commenter stated that the DEA should have a hearing to 
gather stakeholder feedback on how DEA can help address the opioid 
epidemic while ensuring an adequate supply of opioids for clinically 
appropriate care and enable stakeholders to express their views about 
the proposed reductions.
    DEA Response: Under DEA's regulations, the decision of whether to 
grant this type of a hearing on the issues raised by the commenter lies 
solely within the discretion of the Administrator. 21 CFR 1303.11(c) 
and 21 CFR 1303.13(c). The Administrator has considered the commenter's 
request and determined that a hearing is not necessary.

H. Comments From DEA-Registered Manufacturers

    DEA received comments from four DEA-registered manufacturers 
regarding ten different schedule I and II controlled substances, 
requesting that the proposed APQ for ANPP, d-amphetamine (for 
conversion), fentanyl, hydrocodone (for sale), hydromorphone, 
lisdexamfetamine, morphine (for conversion), noroxymorphone (for 
conversion), oxycodone (for sale), and sufentanil be established to 
sufficient levels to allow for manufacturers to meet medical and 
scientific needs.
    DEA considered the comments for specific controlled substances and 
made adjustments as needed which are described below in the section 
titled Determination of 2021 Aggregate Production Quotas and Assessment 
of Annual Needs.

I. Out of Scope Comments

    DEA received several comments which addressed issues that are 
outside the scope of this final order. The comments were general in 
nature and raised issues of specific medical illnesses, medical 
treatments, and medication costs, as well as issues related to a 
separate Federal Register notice, and, therefore, were outside of the 
scope of this Final Order, and do not impact the original analysis 
involved in establishing the 2021 APQ.

IV. Determination of 2021 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the final 2021 aggregate production quotas and 
assessment of annual needs, DEA has considered the above comments along 
with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in 
accordance with 21 U.S.C. 826(a), and other relevant factors, including 
the 2020 manufacturing quotas, current 2020 sales and inventories, 
anticipated 2021 export requirements, industrial use, additional 
applications for 2021 quotas, as well as information on research and 
product development requirements.
    DEA also considered the HHS Secretary's renewal of the public 
health emergency due to COVID-19 and worked with both FDA and the 
Assistant Secretary for Preparedness and Response (ASPR), including 
their revised estimated medical and Strategic National Stockpile 
requirements for fentanyl, hydromorphone, and morphine in establishing 
the 2021 APQ. Based on all of the above, the Administrator is adjusting 
the 2021 APQ for 4-anilino-N-phenethyl-4-piperadine (ANPP), 5-methoxy-
n-n-dimethyltryptamine, Crotonyl fentanyl, D-methamphetamine (for 
sale), Fentanyl, Ethylone, Etonitazene, Gamma hydroxybutyric acid, 
Lisdexamfetamine, and Norlevorphanol.
    Regarding D-amphetamine (for conversion), hydrocodone (for sale), 
hydromorphone, morphine (for conversion), noroxymorphone (for 
conversion), oxycodone (for sale), and sufentanil, DEA has determined 
the proposed APQ are sufficient to provide for the 2021 estimated 
medical, scientific, research, industrial needs of the United States, 
export requirements, and the establishment and maintenance of reserve 
stocks. This final order establishes these APQ as well as the AAN at 
the same amounts as proposed.

Estimates of Diversion Pursuant to the SUPPORT Act

    The SUPPORT Act (21 U.S.C. 826(i)(1)(a)) requires that ''in 
establishing any quota under this section . . . , for [the covered 
controlled substances], the Attorney General shall estimate the amount 
of diversion of the [covered controlled substances] that occurs in the 
United States.'' To estimate diversion as is required by the SUPPORT 
Act, DEA aggregated the active pharmaceutical ingredient (API) of each 
covered controlled substance by metric weight where the data was 
available in the aforementioned databases. Based on the individual 
entries into the aforementioned databases, 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 kilograms of the controlled substance 
being diverted. The estimate of diversion for each of the covered 
controlled substances is reported below.

                      Diversion Estimates for 2019
                                  [kg]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Fentanyl................................................           0.090
Hydrocodone.............................................          30.294
Hydromorphone...........................................           1.424
Oxycodone...............................................          60.959
Oxymorphone.............................................           1.311
------------------------------------------------------------------------

    In accordance with the SUPPORT Act, after estimating the amount of 
diversion for the foregoing five controlled substances, DEA made 
adjustments to the individual aggregate production quotas for each 
covered controlled substance by the corresponding quantities listed in 
the table. In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Administrator hereby establishes the 2021 APQ for the 
following schedule I and II controlled substances and the 2021 AAN for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, expressed in grams of anhydrous acid or base, as 
follows:

------------------------------------------------------------------------
                                                       Final 2021 quotas
                     Basic class                              (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine...............                 20
1-(1-Phenylcyclohexyl)pyrrolidine....................                 15
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-Benzylpiperazine...................................                 25
1-Methyl-4-phenyl-4-propionoxypiperidine.............                 10

[[Page 76609]]

 
1-[1-(2-Thienyl)cyclohexyl]piperidine................                 15
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 (DMA).......................                 25
2-(4-Ethylthio-2,5-dimethoxyphenyl)ethanamine (2C-T-                  30
 2)..................................................
2-(4-(Isopropylthio)-2,5-dimethoxyphenyl)ethanamine                   30
 (2C-T-4)............................................
3,4,5-Trimethoxyamphetamine..........................                 30
3,4-Methylenedioxyamphetamine (MDA)..................                 55
3,4-Methylenedioxymethamphetamine (MDMA).............                 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........                 40
3,4-Methylenedioxy-N-methylcathinone (methylone).....                 40
3,4-Methylenedioxypyrovalerone (MDPV)................                 35
3-Fluoro-N-methylcathinone (3-FMC)...................                 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-                    25
 alpha-PVP)..........................................
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-                25
 3-carboximide (4CN-Cumyl-Butinaca)..................
4-Fluoroisobutyryl fentanyl..........................                 30
4-Fluoro-N-methylcathinone (4-FMC; Flephedrone)......                 25
4-Methyl-N-ethylcathinone (4-MEC)....................                 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-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-CUMYL-PINACA......................................                 25
5F-EDMB-PINACA.......................................                 25
5F-MDMB-PICA.........................................                 25
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-                 25
 (5-fluoropentyl)-1H-indazole-3-carboxamide..........
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-                            25
 phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-
 carboximide)........................................
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-                 30
 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)...
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   30
 carboxamido)-3-methylbutanoate).....................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        30
 fluoropentyl)-1H-indazole-3-carboxamide)............
5-Fluoro-PB-22; 5F-PB-22.............................                 20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-                 25
 3-yl](2,2,3,3-tetramethylcyclopropyl)methanone......
5-Methoxy-3,4-methylenedioxyamphetamine..............                 25
5-Methoxy-N,N-diisopropyltryptamine..................                 25
5-Methoxy-N,N-dimethyltryptamine.....................                 35
AB-CHMINACA..........................................                 30
AB-FUBINACA..........................................                 50
AB-PINACA............................................                 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-                   30
 yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)...
Acetorphine..........................................                 25
Acetyl Fentanyl......................................                100
Acetyl-alpha-methylfentanyl..........................                 30
Acetyldihydrocodeine.................................                 30
Acetylmethadol.......................................                 25
Acryl Fentanyl.......................................                 25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-                 50
 1-pentyl-1H-indazole-3-carboxamide).................
AH-7921..............................................                 30
All other tetrahydrocannabinols......................              1,000
Allylprodine.........................................                 25
Alphacetylmethadol...................................                 25
Alpha-Ethyltryptamine................................                 25
Alphameprodine.......................................                 25
Alphamethadol........................................                 25
Alphaprodine.........................................                 25

[[Page 76610]]

 
Alpha-Methylfentanyl.................................                 30
Alpha-Methylthiofentanyl.............................                 30
Alpha-Methyltryptamine (AMT).........................                 25
Alpha-Pyrrolidinobutiophenone ([alpha]-PBP)..........                 25
Alpha-Pyrrolidinoheptaphenone (PV8)..................                 25
Alpha-Pyrrolidinohexanophenone ([alpha]-PHP).........                 25
Alpha-Pyrrolidinopentiophenone ([alpha]-PVP).........                 25
Aminorex.............................................                 25
Anileridine..........................................                 20
APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-                 25
 3-carboxamide)......................................
Benzethidine.........................................                 25
Benzylmorphine.......................................                 30
Betacetylmethadol....................................                 25
Beta-Hydroxy-3-methylfentanyl........................                 30
Beta-Hydroxyfentanyl.................................                 30
Beta-Hydroxythiofentanyl.............................                 30
Betameprodine........................................                 25
Betamethadol.........................................                  4
Betaprodine..........................................                 25
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
Delta 9-THC..........................................            384,460
Desomorphine.........................................                 25
Dextromoramide.......................................                 25
Diampromide..........................................                 20
Diethylthiambutene...................................                 20
Diethyltryptamine....................................                 25
Difenoxin............................................              9,200
Dihydromorphine......................................            753,500
Dimenoxadol..........................................                 25
Dimepheptanol........................................                 25
Dimethylthiambutene..................................                 20
Dimethyltryptamine...................................                 50
Dioxaphetyl butyrate.................................                 25
Dipipanone...........................................                 25
Drotebanol...........................................                 25
Ethylmethylthiambutene...............................                 25
Ethylone.............................................                 25
Etonitazene..........................................                 25
Etorphine............................................                 30
Etoxeridine..........................................                 25
Fenethylline.........................................                 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...............................................                 45
Hydromorphinol.......................................                 40
Hydroxypethidine.....................................                 25
Ibogaine.............................................                 30
Isobutyryl Fentanyl..................................                 25
Isotonitazene........................................                 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

[[Page 76611]]

 
Ketobemidone.........................................                 30
Levomoramide.........................................                 25
Levophenacylmorphan..................................                 25
Lysergic acid diethylamide (LSD).....................                 40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-                                30
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
 dimethylbutanoate)..................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-                       30
 indazole-3-carboxamido)-3,3-dimethylbutanoate)......
MMB-CHMICA (AMB-CHMICA); Methyl-2-(1-                                 25
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3-
 methylbutanoate.....................................
Marihuana............................................          1,500,000
Marihuana extract....................................            200,000
Mecloqualone.........................................                 30
Mescaline............................................                 25
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-fluoropentyl)-1H-indole-                 25
 3-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
N-Methyl-3-Piperidyl Benzilate.......................                 30
Nicocodeine..........................................                 25
Nicomorphine.........................................                 25
Noracymethadol.......................................                 25
Norlevorphanol.......................................              2,550
Normethadone.........................................                 25
Normorphine..........................................                 40
Norpipanone..........................................                 25
Ocfentanil...........................................                 25
Ortho-fluorofentanyl, 2-fluorofentanyl...............                 30
Para-chloroisobutyryl fentanyl.......................                 30
Para-fluorofentanyl..................................                 25
Para-fluorobutyryl fentanyl..........................                 25
Para-methoxybutyryl fentanyl.........................                 30
Parahexyl............................................                  5
PB-22; QUPIC.........................................                 20
Pentedrone...........................................                 25
Pentylone............................................                 25
Phenadoxone..........................................                 25
Phenampromide........................................                 25
Phenomorphan.........................................                 25
Phenoperidine........................................                 25
Pholcodine...........................................                  5
Piritramide..........................................                 25
Proheptazine.........................................                 25
Properidine..........................................                 25
Propiram.............................................                 25
Psilocybin...........................................                 30
Psilocyn.............................................                 50
Racemoramide.........................................                 25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                              45
 methoxyphenylacetyl)indole).........................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-                             30
 benzoyl]indole).....................................
Tetrahydrofuranyl fentanyl...........................                 15
Thebacon.............................................                 25
Thiafentanil.........................................                 25
Thiofentanyl.........................................                 25
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....................

[[Page 76612]]

 
U-47700..............................................                 30
Valeryl fentanyl.....................................                 25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                 15
1-Piperidinocyclohexanecarbonitrile..................                 25
4-Anilino-N-phenethyl-4-piperidine (ANPP)............            937,758
Alfentanil...........................................              3,260
Alphaprodine.........................................                 25
Amobarbital..........................................             20,100
Bezitramide..........................................                 25
Carfentanil..........................................                 20
Cocaine..............................................             68,576
Codeine (for conversion).............................          1,612,500
Codeine (for sale)...................................         27,616,684
D-amphetamine (for sale).............................         21,200,000
D-amphetamine (for conversion).......................         14,137,578
D-methamphetamine (for conversion)...................             485,02
D-methamphetamine (for sale).........................             40,000
D,L-amphetamine......................................         21,200,000
D,L-methamphetamine..................................                 50
Dextropropoxyphene...................................                 35
Dihydrocodeine.......................................            156,713
Dihydroetorphine.....................................                 25
Diphenoxylate (for conversion).......................             14,100
Diphenoxylate (for sale).............................            770,800
Ecgonine.............................................             68,576
Ethylmorphine........................................                 30
Etorphine hydrochloride..............................                 32
Fentanyl.............................................            731,452
Glutethimide.........................................                 25
Hydrocodone (for conversion).........................              1,250
Hydrocodone (for sale)...............................         30,821,224
Hydromorphone........................................          2,827,940
Isomethadone.........................................                 30
L-amphetamine........................................                 30
L-methamphetamine....................................            587,229
Levo-alphacetylmethadol (LAAM).......................                 25
Levomethorphan.......................................                 30
Levorphanol..........................................             26,495
Lisdexamfetamine.....................................         21,000,000
Meperidine...........................................            856,695
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
Methylphenidate......................................         57,438,334
Metopon..............................................                 25
Moramide-intermediate................................                 25
Morphine (for conversion)............................          3,376,696
Morphine (for sale)..................................         27,784,062
Nabilone.............................................             62,000
Norfentanyl..........................................                 25
Noroxymorphone (for conversion)......................         22,044,741
Noroxymorphone (for sale)............................            376,000
Opium (powder).......................................            250,000
Opium (tincture).....................................            530,837
Oripavine............................................         33,010,750
Oxycodone (for conversion)...........................            620,887
Oxycodone (for sale).................................         57,110,032
Oxymorphone (for conversion).........................         28,204,371
Oxymorphone (for sale)...............................            563,174
Pentobarbital........................................         25,850,000
Phenazocine..........................................                 25
Phencyclidine........................................                 35
Phenmetrazine........................................                 25
Phenylacetone........................................                 40
Piminodine...........................................                 25
Racemethorphan.......................................                  5
Racemorphan..........................................                  5

[[Page 76613]]

 
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).......................         16,690,000
Pseudoephedrine (for conversion).....................              1,000
Pseudoephedrine (for sale)...........................        174,246,000
------------------------------------------------------------------------

    The Administrator also establishes APQ for all other schedule I and 
II controlled substances included in 21 CFR 1308.11 and 1308.12 at 
zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon 
consideration of the relevant factors, the Administrator may adjust the 
2021 APQ and AAN as needed.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-26289 Filed 11-27-20; 8:45 am]
BILLING CODE 4410-09-P