[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68513-68523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26227]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-888]


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 2022

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This final order establishes the initial 2022 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: The initial 2022 aggregate production quotas and assessment of 
annual needs are effective December 2, 2021.

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, VA 22152, Telephone: (571) 776-2265.

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 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 2022 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 
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.
    On October 18, 2021, 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 2022'' was published in 
the Federal Register. 86 FR 57690. This notice proposed the 2022 APQ 
for each basic class of controlled substance listed in schedules I and 
II and the 2022 AAN for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine. All interested persons were 
invited to comment on or object to the proposed

[[Page 68514]]

APQ and the proposed AAN on or before November 17, 2021.

III. Comments Received

    Within the public comment period, DEA received 610 comments from 
DEA registrants, chronic pain patients, pain advocacy associations, 
professional associations, doctors, nurses, State Attorneys General, 
and others. The comments included requests for clarification about the 
data DEA used to determine diversion for the purposes of the APQ for 
certain schedule II opioids; concerns about potential drug shortages 
due to further quota reductions; concerns that medical professionals 
might be impeded from exercising their medical expertise regarding 
opioid prescriptions; concerns about the quota process; requests for a 
public hearing; and comments not pertaining to DEA regulated 
activities.

DEA's Regulatory Authority

    Issue: DEA received comments that raised the question of whether 
DEA has the authority to regulate activities related to controlled 
substances, including the manufacture of Food and Drug Administration 
(FDA)-approved pharmaceutical products containing controlled 
substances.
    DEA Response: The CSA, which was initially enacted in 1970 and has 
been amended several times, requires DEA to establish production quotas 
for certain controlled substances. 21 U.S.C. 826(a). In the CSA, 
Congress granted DEA (as delegated by the Attorney General under 21 
U.S.C. 871(a)) the authority to promulgate ``rules and regulations'' 
relating to the ``registration and control of the manufacture, 
distribution, and dispensing of controlled substances and to listed 
chemicals'' (21 U.S.C. 821), and to the ``registration and control of 
importers and exporters of controlled substances'' (21 U.S.C. 958(f)), 
as well as those ``necessary and appropriate for the efficient 
execution'' of the authorities granted by the CSA (21 U.S.C. 871(b)), 
among other provisions. In its findings, Congress acknowledged that 
many controlled substances ``have a useful and legitimate medical 
purpose.'' 21 U.S.C. 801(1).
    Congress explicitly directed DEA to establish production quotas for 
controlled substances in schedule I and II and for ephedrine, 
pseudoephedrine, and phenylpropanolamine. 21 U.S.C. 826(a). In 
recognition of FDA's related but distinct role in regulating 
pharmaceutical products, DEA's regulations require DEA to consider 
relevant information from FDA before DEA establishes the APQs. As DEA 
has acknowledged in previous Federal Register publications relating to 
quotas, the responsibility to provide estimates of legitimate domestic 
medical needs resides with FDA. DEA considers this important 
information in proposing and revising the APQs.

Medication Shortages

    Issue: DEA received many comments expressing general concerns that 
the proposed decreases to the production quotas of certain controlled 
substances may result in shortages of drug products containing those 
controlled substances.
    DEA Response: DEA is committed to ensuring an adequate and 
uninterrupted supply of controlled substances in order to meet the 
estimated legitimate medical, scientific, research, and industrial 
needs of the United States, for lawful export requirements, and for the 
establishment and maintenance of reserve stocks. DEA sets APQs in a 
manner to provide for all legitimate medical purposes.
    Additionally, DEA and FDA are required to, and routinely do, 
coordinate efforts to prevent or alleviate drug shortages pursuant to 
21 U.S.C. 826(h). Such efforts may include adjusting the APQ, adjusting 
individual domestic manufacturers' quotas, FDA approval of additional 
market competitors, and coordination between the agencies to allow 
importation of foreign-manufactured drug products that meet FDA 
approval. For example, in 2020, DEA adjusted its quota to increase the 
aggregate production quota for drug products containing fentanyl, 
hydromorphone, morphine, and codeine, and the assessments of annual 
needs for drug products containing pseudoephedrine and ephedrine. The 
increased production needs for those substances, which are used to 
treat patients in intensive care units and those on ventilators, was a 
result of the COVID-19 public health emergency. These actions were 
taken based on DEA's consultations with federal partners at the 
Department of Health and Human Services (HHS), drug manufacturers, drug 
distributors, and hospital associations. Similarly, in 2018, a domestic 
shortage of injectable hydromorphone was alleviated through FDA and DEA 
collaboration to identify other dosage-form manufacturers with 
injectable hydromorphone products in the market, and to determine 
whether those other dosage-form manufacturers had the capability to 
increase their production levels to meet legitimate patient need in a 
timely manner. When the agencies determined that the domestic 
manufacturers could not increase production adequately to meet 
legitimate patient need, DEA and FDA coordinated and used their 
respective regulatory authorities to allow for the limited importation 
of injectable hydromorphone into the United States.

Prescribing Hesitancy

    Issue: Many commenters, most of whom self-identified as chronic 
pain patients, expressed general concerns that the CDC Guidelines for 
Prescribing Opioids for Chronic Pain, issued in 2016, are preventing 
doctors from prescribing pain medication in dosages that adequately 
control chronic pain, forcing them to taper opioid medication dosages 
inappropriately, and causing them to refuse to prescribe opioid 
prescriptions to chronic pain patients. These comments also raised 
concerns that some health insurers have mandated that opioid medication 
dosages be tapered for continued insurance coverage or have denied 
coverage for prescriptions from out-of-network providers. Commenters 
noted that worker's compensation insurers have denied opioid medication 
coverage for pain patients. One commenter raised concerns that chronic 
pain patients are not allowed to self-pay for opioid medications.
    DEA Response: Provided that the prescription is issued for a 
legitimate medical purpose by a practitioner acting in the usual course 
of his/her professional practice, neither the CSA nor DEA regulations 
impose a specific minimum or maximum limit on the amount of medication 
that may be prescribed on a single prescription, or limit the duration 
of treatment intended with a prescribed controlled substance. DEA has 
consistently emphasized and supported the authority of individual 
practitioners under the CSA to administer, dispense, and prescribe 
controlled substances for the legitimate treatment of pain within 
acceptable medical standards, as outlined in DEA's policy statement 
published in the Federal Register on September 6, 2006, titled 
Dispensing Controlled Substances for the Treatment of Pain. 71 FR 
52716.

Use of Studies/Guidelines To Determine Medical Need

    Issue: Ten State Attorneys General \1\ (referred to collectively as 
State Attorneys General) suggested that DEA consider research studies 
and best practices developed by individual state-level partnerships 
with local medical communities and other individual state regulators to 
determine the extent of

[[Page 68515]]

overprescribing of controlled substances.
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    \1\ The comment received from the Office of the Attorney 
General, State of West Virginia, was also signed by the State 
Attorneys General of Kentucky, Arkansas, Alaska, Idaho, Louisiana, 
Mississippi, Nebraska, Utah and South Dakota.
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    DEA Response: DEA has reviewed the conclusions of these studies and 
believes they are insufficient to support a reduction in the APQs 
because the studies examined a limited set of medical procedures that 
could not be generalized to all prescriptions dispensed in the United 
States. The studies have found, with respect to certain medical 
procedures, that physicians prescribe more controlled substances for 
post-operative pain than patients utilize. While the referenced studies 
are concerning, DEA believes they are insufficient to impact DEA's APQ 
determination.

Percentage of Prescription Opioids Being Diverted

    Issue: Multiple commenters said that the APQs should not be reduced 
from calendar year 2021 APQ levels, given that less than 1 percent of 
prescription controlled substances are diverted. One commenter cited 
DEA's statements in the 2020 Proposed APQ to support this statistic.
    DEA Response: DEA's regulations require it to consider numerous 
relevant factors in its determination of the APQ. One factor is 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. The commenter is correct that 
in the 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 2020 
(84 FR 48170), DEA determined that the quantity of FDA-approved drug 
products containing controlled substances that were diverted in 2018 
represented less than one percent of the total quantity of controlled 
substances distributed to retail purchasers.
    However, DEA also considers other relevant factors, as required by 
regulation, when determining the APQ. 21 U.S.C. 826(a), 21 CFR 
1303.11(b). DEA's consideration of all of these relevant factors 
resulted in the proposed 2022 APQ as published.

Relevant Information From FDA

    Issue: Comments raised questions regarding the data provided by 
FDA, including the methodology it used to determine domestic medical 
need.
    DEA Response: The information DEA received from FDA included the 
observed and projected domestic usage of schedule II controlled 
substances, new drug application and abbreviated new drug application 
approvals, manufacturers discontinuing production, product shortages, 
and clinical trials for schedule I and II controlled substances. FDA 
utilizes a variety of data sources in developing its estimates, and 
also describes certain caveats regarding the forecasts it provides. The 
data provided by FDA contributed to DEA's estimate of declining 
legitimate domestic medical need for opioids.
    FDA provides an important portion of the data that DEA analyzes in 
developing the annual APQs, but DEA also utilizes other data sources to 
meet its statutory and regulatory requirements. For instance, DEA 
utilized information provided by quota applicants and research 
protocols submitted directly to DEA to derive the estimates of 
scientific, research, and industrial needs; lawful export requirements; 
and current reserve stocks. No single data element is adequate to 
address all of the legal factors.
    Issue: The State Attorneys General raised a concern that the 
proposed APQ for the five covered controlled substances defined in 21 
U.S.C. 826(i)(1)(A) as fentanyl, oxycodone, hydrocodone, oxymorphone, 
and hydromorphone are not aligned with the decline in medical need for 
schedule II opioids as projected by FDA.
    DEA Response: DEA notes that the decline of 18.88 percent was an 
average for certain schedule II opioids including but not limited to 
the five covered controlled substances predicted between 2021 and 2022. 
This estimated decline was for the domestic medical need only, which is 
one of several factors that DEA must consider when establishing APQ 
estimates for the entire calendar year.

Estimates of Diversion Mandated by the SUPPORT Act

    Issue: The State Attorneys General inquired about DEA's method of 
assessing diversion of the five covered controlled substances, as 
compared with the other basic classes of controlled substances subject 
to quotas.
    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 each 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. As the State Attorneys General note, the Substance-Use 
Disorder Prevention that Promotes Opioid Recovery Treatment for 
Patients and Communities Act (SUPPORT Act, Pub. L. 115-271) requires 
that DEA provide the diversion estimate only for the five covered 
controlled substances. In compliance with the SUPPORT Act, DEA 
published the estimated diversion for the five covered controlled 
substances in its October 18, 2021 notice, and provides revised 
estimates in Tables 2 and 3 below.
    Issue: DEA received comments that raised questions regarding DEA's 
use of law enforcement data, including seizure data and theft and loss 
reporting, in its estimation of diversion for the five covered 
controlled substances.
    DEA Response: DEA considered the reliability of all reported law 
enforcement data for the purpose of calculating estimates of diversion 
for the APQs of the five covered controlled substances. DEA did not 
include seizure data in its estimate of diversion because DEA could not 
conclusively determine that the collected data did not overlap with 
other data sources used to calculate relevant diversion estimates, nor 
could DEA determine from the reported data whether the seized 
substances contained illicitly manufactured fentanyl.
    Issue: Commenters questioned the inclusion of losses due to 
disasters.
    DEA Response: DEA registrants are required to report thefts and 
significant losses to DEA. These reports are often submitted before the 
registrant has had the opportunity to fully investigate the reason for 
the loss. Loss reports may include incidents of employee pilferage that 
may not be reported initially as theft to DEA. A ``loss in transit'' is 
nominally a loss but may in fact represent diversion by employees or 
other individuals. Generally, loss is considered diversion because it 
involves controlled substances falling outside the closed system of 
distribution. However, DEA agrees that reported losses due to disaster 
(fire, weather, etc.) should be distinguished from diversion for APQ 
purposes. DEA therefore has adjusted its estimate of diversion of 
covered controlled substances in the supply chain by excluding those 
losses due to disaster, fire, weather, etc., as shown in Table 1.

               Table 1--Supply Chain Loss Due to Disaster
                               [Fire, etc]
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                     Controlled substance                         (g)
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Fentanyl.....................................................          1
Hydrocodone..................................................        123
Hydromorphone................................................          5
Oxycodone....................................................        214
Oxymorphone..................................................          4
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[[Page 68516]]

    Issue: DEA received numerous comments expressing concerns that 
DEA's reduction of quotas for pain-relieving controlled substances does 
not correlate to a reduction in overdose deaths. According to the 
commenters, DEA and CDC data show that illicit fentanyl and heroin are 
responsible for the majority of overdose deaths. The commenters state 
that overdose deaths in the U.S. continue to rise because of illegal 
fentanyl, heroin, and illegally manufactured pain pills, not from 
pharmaceutical medications prescribed to chronic pain patients.
    DEA Response: In establishing the APQ, DEA considers the legitimate 
medical need in the United States. DEA strives to ensure that the APQs 
are sufficient to provide for the legitimate controlled substance 
prescription requirements while limiting the potential for diversion of 
controlled substances. DEA also considers changes in currently accepted 
medical use in treatment as part of the determination of legitimate 
medical need, and establishes the APQ for specific controlled 
substances accordingly. 21 CFR 1303.11(b)(7).

Use of PDMP Data in Identifying Potential Diversion

    Issue: DEA received numerous comments that raised questions 
regarding DEA's use of prescriptions filled for the five covered 
controlled substances in dosages exceeding 240 morphine milligram 
equivalents (MME) daily as a potential indicator of diversion. The 
commenters noted that CDC has published guidelines that recommend 
prescribers consider the medical necessity of exceeding a daily dosage 
limit of 90 MME. The State Attorneys General also asked whether, in 
flagging prescriptions that exceed 240 MME daily, DEA considered 
individual prescriptions, or considered combined prescriptions for 
patients at any given time.
    DEA Response: DEA did not consider prescriptions written for the 
five covered controlled substances in quantities lower than 240 MME 
daily because some patients, including oncology patients in particular, 
have legitimate medical needs for covered controlled substance 
prescriptions in excess of 90 MME daily. DEA did not wish to 
inadvertently include legitimate prescriptions for these patients in 
its calculation of diversion. Daily dosages higher than 240 MME place 
individuals at a higher risk of overdose and death, and correlate with 
a heightened risk of diversion. DEA received aggregated data from state 
PDMPs that reflected only individual prescriptions.
    Issue: Commenters asked whether the PDMP data responses from the 
states covered all time periods requested. If they did not, how did 
DEA's calculations account for missing data?
    DEA Response: All responding states provided summarized PDMP data 
for 2018-2020, the entire time period requested by DEA.
    Issue: Some commenters, including the State Attorneys General, 
expressed concerns that the PDMP data obtained from responding states 
that DEA used to identify diversion does not represent the entire U.S. 
population accurately.
    DEA Response: DEA requested data through the National Association 
of State Controlled Substances Authorities (NASCSA), which includes the 
forty-nine member states that utilize PDMPs. As indicated in the 
proposed APQ, DEA did not receive PDMP data from all queried states for 
use in its determination of diversion. The sixteen states and one 
county providing PDMP data represent a geographically diverse cross-
section of 78.5 million people, or 24 percent of the United States 
population. Based on publicly available, established statistical 
methods for sampling very large populations, polling approximately 10 
percent of a given large population provides enough statistical power 
to draw reliable inferences about the population. A sample size of 24 
percent therefore is large enough to accurately generalize that data 
outcome to the whole population of the United States and to be used in 
the calculation of estimated national levels of diversion of the 
covered controlled substances.
    Issue: Commenters raised questions regarding patient privacy issues 
relating to the PDMP data provided to DEA by states.
    DEA Response: DEA requested and received anonymized, aggregated 
PDMP data from the states. No individual patient names, addresses, or 
other discrete, personally identifiable information was shared with 
DEA.
    Issue: The State Attorneys General commented that DEA should have 
used patient address information from the PDMP data to determine a 
metric for potential diversion based on geographic distances between 
patient, prescriber, and pharmacy.
    DEA Response: DEA did not request, nor did it receive, any state 
PDMP data that included individualized identifying data such as patient 
addresses.
    Issue: DEA received comments that raised questions about the 
accuracy of PDMP data regarding patients' current and discontinued use 
of opioid prescriptions containing the covered controlled substances 
within discrete time periods.
    DEA Response: DEA requested aggregated PDMP data for filled 
prescriptions containing the five covered controlled substances. In 
many instances, prescriptions that are filled but not used by patients 
create the potential for diversion because of the opportunity for 
misuse by non-patients. The most common sources of misused 
pharmaceutical opioids are family and friends. The Substance Abuse and 
Mental Health Services Administration's 2019 National Survey on Drug 
Use and Health Annual National Report published data demonstrating that 
more than half (50.8 percent) of people who self-reported misusing 
prescription pain relief medicine obtained their most recent pain 
reliever from a friend or relative, either for free, by purchase, or by 
taking without asking. Such misuses of prescriptions constitute 
diversion.
    Issue: One commenter questioned whether it is appropriate to use 
data showing instances of patients receiving specific controlled 
substance prescriptions issued by three or more doctors within a 90-day 
period as a metric to determine potential diversion.
    DEA Response: DEA developed the metric of patients prescribed 
covered controlled substances from three or more prescribers in a 90-
day period to identify potential doctor shopping, a common technique 
used to obtain large amounts of controlled substances for the purpose 
of abuse or diversion. Federal administrative and criminal case law 
demonstrates that multiple prescriptions from multiple prescribers in a 
short timeframe is a reliable indicator of diversion.\2\
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    \2\ The Medicine Shoppe, 29 FR 59504, 59507, 59512-13 (2014); 
Holiday CVS, LLC, d/b/a CVS Pharmacy Nos. 219 and 5195, 57 FR 62316 
(2012).
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    Issue: DEA received comments from the State Attorneys General and 
the general public questioning whether DEA derived its diversion 
estimates from individual prescriptions paid for with cash, and if 
entire classes of prescribers or pharmacies with large cash 
transactions were excluded.
    DEA Response: DEA received reports from state PDMP administrators 
which were designed by NASCSA to respond to DEA's request for 
aggregated information. The reports contained the number of patients 
and prescriptions that met each of the diversion metrics DEA 
identified. These reports did not include individualized information 
that would be contained on prescriptions. DEA did not consider whether 
this data

[[Page 68517]]

included specific classes of prescribers or pharmacies.
    Issue: The State Attorneys General suggested that DEA consider PDMP 
data about inconsistent or early refills of prescription opioids in 
estimating potential diversion.
    DEA Response: Prescriptions for schedule II controlled substances 
cannot be refilled. 21 U.S.C. 829(a). All of the substances for which 
DEA requested PDMP data were schedule II controlled substances.

Schedule I Controlled Substances

    Issue: Several commenters requested that DEA consider increasing 
production quotas for certain schedule I controlled substances, 
including: Bufotenine, 5-methoxy-N,N-dimethyltryptamine (5-MEO-DMT), 
ibogaine, psilocybin, mescaline, 3,4-methylenedioxymethamphetamine 
(MDMA), and dimethyltryptamine (DMT) for research activities and 
clinical trials in Canada and the United States.
    DEA Response: The APQs established today reflect DEA's estimates of 
the medical, scientific, research, and industrial needs of the United 
States for 2022, as well as lawful export requirements and 
establishment and maintenance of reserve stocks. DEA can adjust the 
established APQs if these needs change. For instance, if DEA receives 
additional research protocols from DEA-registered researchers, or 
additional quota applications from DEA-registered manufacturers, DEA 
will consider revising the APQ.
    DEA did receive additional quota applications from DEA-registered 
manufacturers for 5-MEO-DMT, psilocybin, and MDMA. DEA considered those 
applications accordingly, as discussed below. DEA has not received 
quota applications from DEA-registered manufacturers to support the 
requested changes in the APQ for the other controlled substances 
mentioned.
    Issue: DEA received a comment from a biotech company suggesting 
that DEA discuss involving representatives from indigenous communities 
in determining APQ for controlled substances that are potentially 
derived from plants traditionally used by indigenous groups in the 
Americas and beyond.
    Response: In accordance with 21 CFR 1303.11(c), DEA invites all 
interested persons to participate by commenting on proposed APQs. The 
CSA requires DEA to establish APQ to provide for the estimated medical, 
scientific, research, and industrial needs of the U.S., for lawful 
export requirements, and for the establishment and maintenance of 
reserve stocks. The APQs and the individual manufacturing quotas are 
informed in part by the quota requests submitted by DEA-registered 
manufacturers of these substances.
    Issue: The Native American Church of North America commented on the 
proposal to set the APQ for mescaline at 100 grams. They commented that 
their peyote ceremonies are contingent on the continued availability of 
peyote in the wild for sacramental use, and that the non-Native use of 
mescaline in research and clinical studies will have a direct impact 
upon the church's ability to use, purchase, transport, and possess 
peyote pursuant to the American Indian Religious Freedom Act (AIRFA), 
as it will lead to commercialization and exploitation of peyote across 
its natural range and potential reclassification of its scheduling 
status.
    DEA Response: Mescaline is the schedule I controlled substance 
naturally occurring in peyote. The 2022 APQ for mescaline will only be 
used for the production of synthetic mescaline which is utilized to 
produce analytical reference standards. Thus, the 2022 APQ for 
mescaline does not have any material effect on the use of peyote by 
members of the Native American Church.

Schedule II Controlled Substances

    Issue: One commenter asked why DEA does not consider significantly 
reducing the hydrocodone quota to come in line with the rest of the 
world. The commenter also asked why DEA does not consider global use 
data in establishing APQ.
    DEA Response: DEA is bound by the language of 21 U.S.C. 826 to 
consider the needs of the United States. After considering the factors 
defined in 21 CFR 1303.11(b), this APQ represents DEA's best estimate 
of domestic needs, as well as quantities needed for lawful export and 
for the establishment and maintenance of reserve stocks.
    Issue: DEA received a comment suggesting that DEA evaluate 
adjustments for the APQ of oral solid and injectable dosage forms of 
medicines separately. The commenter specifically highlighted 
differences between dosage forms of certain opioids.
    DEA Response: DEA sets APQ in a manner to include dispensings for 
legitimate medical purposes and, in turn, the APQ takes 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 individual quotas to DEA-
registered manufacturers in terms of dosage forms if the Agency 
determines that doing so will assist in avoiding the overproduction, 
shortage, or diversion of controlled substances. By issuing a single 
APQ covering all dosage forms of the basic class, rather than 
estimating APQ for each dosage form, DEA retains the flexibility to 
alleviate potential shortages and to react to unforeseen emergencies by 
adjusting the individual quotas granted to manufacturers under that 
APQ.

Assessment of Annual Needs for List I Chemicals

    Issue: DEA received comments expressing concerns that the AAN 
limits the amount of pseudoephedrine (for sale), a chemical found in 
the allergy medication SUDAFED.
    DEA Response: The CSA requires DEA to establish the AAN for 
ephedrine, pseudoephedrine, and phenylpropanolamine to provide for the 
estimated legitimate medical, scientific, research, and industrial 
needs of the United States, lawful exports, and reserve stocks. 21 
U.S.C. 826(a). Control of the chemical pseudoephedrine in this manner 
over the past 15 years has not been shown to limit the availability of 
over-the-counter products such as Sudafed for legitimate needs. In 
anticipation of increased need due to the COVID-19 public health 
emergency, the AAN for pseudoephedrine (for sale) was increased in 
2020; however, the expected need did not materialize. Therefore, DEA 
has reduced the AAN for pseudoephedrine (for sale) back to the 2019 
level.

Comments From DEA-Registered Manufacturers

    Issue: DEA received comments from three DEA-registered 
manufacturers regarding 13 different schedule I and II controlled 
substances, requesting that the proposed APQ for 5-MEO-DMT, d-
amphetamine (for conversion), dexmethylphenidate (for sale), DMT, 
lisdexamfetamine, methadone, methadone intermediate, methylphenidate 
(for sale), noroxymorphone (for conversion), phenylacetone, psilocybin, 
psilocin, and remifentanil be established to sufficient levels to allow 
for manufacturers to meet medical and scientific needs.
    DEA Response: DEA considered the comments for specific controlled 
substances and made adjustments as needed, which are described below in 
the section titled Determination of 2022 Aggregate Production Quotas 
and Assessment of Annual Needs.

[[Page 68518]]

U.S. Treaty Obligations

    Issue: DEA received several comments requesting that the United 
States become a signatory to the Nagoya Protocol and Convention on 
Biological Diversity.
    DEA Response: DEA does not have the authority to enter into or sign 
treaty agreements on behalf of the United States. This request is 
outside the scope of this notice.

Request for Public Hearing

    Issue: One commenter requested a public hearing on the data and 
methodology used by DEA for this 2022 proposed APQ determination. The 
commenter also raised issues relating to the 2018 and 2019 APQs.
    DEA Response: The decision whether to grant a hearing on the issues 
raised by the commenter lies solely within the discretion of the 
Administrator. 21 CFR 1303.11(c). This commenter is not a state. This 
request does not present any evidence that would lead to the conclusion 
that a hearing is necessary or warranted. The 2018 and 2019 APQs also 
fall outside of the scope of this order.

Stakeholder Forum

    Issue: One commenter requested DEA schedule a public hearing or 
engage in an organized public process to allow interested parties to 
express their views and concerns about quota issues at least six months 
in advance of the proposed APQ.
    DEA Response: DEA invites all interested persons to participate by 
commenting on proposed APQs. 21 CFR 1303.11(c). The Federal Register 
comment period provides an opportunity for all stakeholders to make 
their issues known to DEA.

Out of Scope Comments

    DEA received comments that are outside the scope of this order. The 
comments were general in nature and raised issues of specific medical 
illnesses, medical treatments, and medication costs. These comments do 
not impact the analysis involved in establishing the 2022 APQ.

IV. Determination of 2022 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the established 2022 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). These factors include, but are not 
limited to, the 2021 manufacturing quotas, current 2021 sales and 
inventories, anticipated 2022 export requirements, industrial use, 
additional applications for 2022 quotas, and information on research 
and product development requirements.
    Based on all of the above, the Administrator establishes the 2022 
APQ for 5-MEO-DMT, DMT, lisdexamfetamine, MDMA, phenylacetone, 
psilocybin, and psilocin at higher levels than was proposed.
    DEA has determined that the proposed APQs for D-amphetamine (for 
conversion), dexmethylphenidate (for sale), methadone, methadone 
intermediate, methylphenidate (for sale), noroxymorphone (for 
conversion), and remifentanil are sufficient to provide for the 2022 
estimated medical, scientific, research, and industrial needs of the 
United States, export requirements, and the establishment and 
maintenance of reserve stocks. This final order establishes these APQ 
at the same amounts as proposed.

Estimates of Diversion Pursuant to the SUPPORT Act

    As specified in the proposal, and as required by 21 U.S.C. 826(i), 
DEA calculated a national diversion estimate for each of the covered 
controlled substances.
    DEA solicited PDMP data through NASCSA from state PDMP 
Administrators. Based on the data received, DEA considered the number 
of individuals who received a prescription for a covered controlled 
substance that met any of the three diversion metrics (``red flags'') 
mentioned in the October 18, 2021, notice for each of calendar years 
2018-20. 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 meeting one of the 
red flag metrics. 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 IQVIA's National Sales 
Perspective.\3\
---------------------------------------------------------------------------

    \3\ 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.
---------------------------------------------------------------------------

    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. This data, which remains unchanged, was 
published in the 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, and contributed to the final diversion estimates for covered 
controlled substances, as set forth in Table 3.

Registrant Reported Legitimate Distribution Chain Diversion

    DEA extracted data from its Drug Theft and Loss database and 
categorized it by basic class. The quantity of active pharmaceutical 
ingredient (API) in each dosage form was determined, 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, which does not contain any loss reported 
due to fire, weather, or other disaster, is displayed in Table 2. This 
data contributed to the final diversion estimates for covered 
controlled substances, as set forth in Table 3.

  Table 2--Diversion Estimates Based on Supply Chain Diversion Data for
                      Covered Controlled Substances
------------------------------------------------------------------------
                     Controlled substance                         (g)
------------------------------------------------------------------------
Fentanyl.....................................................         76
Hydrocodone..................................................     19,325
Hydromorphone................................................        896
Oxycodone....................................................     45,368
Oxymorphone..................................................        524
------------------------------------------------------------------------

    DEA's estimate of diversion for the five covered controlled 
substances was calculated by combining the diversion estimates from the 
state PDMP data and the supply chain diversion data. DEA reduced 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
------------------------------------------------------------------------
                     Controlled substance                         (g)
------------------------------------------------------------------------
Fentanyl.....................................................         92
Hydrocodone..................................................    154,916

[[Page 68519]]

 
Hydromorphone................................................      1,170
Oxycodone....................................................    210,206
Oxymorphone..................................................        524
------------------------------------------------------------------------

    In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Administrator hereby establishes the 2022 APQ for the 
following schedule I and II controlled substances and the 2022 AAN for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, expressed in grams of anhydrous acid or base, as 
follows:

------------------------------------------------------------------------
                                                       Established  2022
                     Basic class                           quotas (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
-[1-(2-Thienyl)cyclohexyl]pyrrolidine................                 20
1-(1-Phenylcyclohexyl)pyrrolidine....................                 30
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine.......                 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....                 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...                 30
1-[1-(2-Thienyl)cyclohexyl]piperidine................                 15
2'-fluoro 2-fluorofentanyl...........................                 30
1-Benzylpiperazine...................................                 25
1-Methyl-4-phenyl-4-propionoxypiperidine.............                 10
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).....                 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....                 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....                 30
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..                 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).............                100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                                 30
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe;
 25B; Cimbi-36)......................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....                 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe;
 25C; Cimbi-82)......................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......                 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  30
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe;
 25I; Cimbi-5).......................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)..............                 25
2,5-Dimethoxy-4-n-propylthiophenethylamine...........                 25
2,5-Dimethoxyamphetamine.............................                 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-                30
 2)..................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine                   30
 (2C-T-4)............................................
3,4,5-Trimethoxyamphetamine..........................                 30
3,4-Methylenedioxyamphetamine (MDA)..................                200
3,4-Methylenedioxymethamphetamine (MDMA).............              8,200
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........                 40
3,4-Methylenedioxy-N-methylcathinone (methylone).....                 40
3,4-Methylenedioxypyrovalerone (MDPV)................                 35
3-FMC; 3-Fluoro-N-methylcathinone....................                 25
3-Methylfentanyl.....................................                 30
3-Methylthiofentanyl.................................                 30
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                 30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                 25
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-                    25
 alpha-PVP)..........................................
4-CN-Cumyl-Butinaca..................................                 25
4-Fluoroisobutyryl fentanyl..........................                 30
4F-MDMB-BINACA.......................................                 30
4-FMC; Flephedrone...................................                 25
4-MEC; 4-Methyl-N-ethylcathinone.....................                 25
4-Methoxyamphetamine.................................                150
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 25
4-Methylaminorex.....................................                 25
4-Methyl-N-methylcathinone (mephedrone)..............                 45
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)......                 25
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP)........                 25
4'-Methyl acetyl fentanyl............................                 30
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..                 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  50
 hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
5F-AB-PINACA ; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-                  25
 (5-fluoropentyl)-1H-indazole-3-carboxamide..........
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-                 25
 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)...
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-                25
 2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide........
5F-CUMYL-PINACA......................................                 25
5F-EDMB-PINACA.......................................                 25
5F-MDMB-PICA.........................................                 25
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   25
 carboxamido)-3-methylbutanoate).....................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        25
 fluoropentyl)-1H-indazole-3-carboxamide)............

[[Page 68520]]

 
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 (5-MEO-DMT).........              2,550
AB-CHMINACA..........................................                 30
AB-FUBINACA..........................................                 50
AB-PINACA............................................                 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-                   30
 yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)...
Acetorphine..........................................                 25
Acetyl Fentanyl......................................                100
Acetyl-alpha-methylfentanyl..........................                 30
Acetyldihydrocodeine.................................                 30
Acetylmethadol.......................................                 25
Acryl Fentanyl.......................................                 25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-                 50
 1-pentyl-1H-indazole-3-carboxamide).................
AH-7921..............................................                 30
All other tetrahydrocannabinol.......................              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
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
delta-9-tetrahydrocannabinol.........................            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 (DMT).............................              3,000
Dioxyaphetyl butyrate................................                 25
Dipipanone...........................................                 25
Drotebanol...........................................                 25
Ethylmethylthiambutene...............................                 25

[[Page 68521]]

 
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)........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-                                30
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
 dimethylbutanoate)..................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-                       30
 indazole-3-carboxamido)-3,3-dimethylbutanoate)......
MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-                                 25
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3-
 methylbutanoate.....................................
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

[[Page 68522]]

 
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...........................................              8,000
Psilocyn.............................................              4,000
Racemoramide.........................................                 25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                              45
 methoxyphenylacetyl)indole).........................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-                             30
 benzoyl]indole).....................................
Tetrahydrofuranyl fentanyl...........................                 15
Thebacon.............................................                 25
Thiafentanil.........................................                 25
Thiofentanyl.........................................                 25
Thiofuranyl fentanyl.................................                 30
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-                          30
 yl](naphthalen-1-yl)methanone)......................
Tilidine.............................................                 25
Trimeperidine........................................                 25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl)methanone....................
U-47700..............................................                 30
Valeryl fentanyl.....................................                 25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                 15
1-Piperidinocyclohexanecarbonitrile..................                 25
4-Anilino-N-phenethyl-4-piperidine (ANPP)............            886,415
Alfentanil...........................................              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).......................         20,000,000
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

[[Page 68523]]

 
Hydromorphone........................................          2,097,255
Isomethadone.........................................                 30
L-amphetamine........................................                 30
Levo-alphacetylmethadol (LAAM).......................                 25
Levomethorphan.......................................                 30
Levorphanol..........................................             23,010
Lisdexamfetamine.....................................         26,500,000
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
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........................................          8,000,000
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 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 
2022 APQ and AAN as needed.

Anne Milgram,
Administrator.
[FR Doc. 2021-26227 Filed 11-29-21; 4:15 pm]
BILLING CODE 4410-09-P