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
| Published date | 02 December 2021 |
| Citation | 86 FR 68513 |
| Record Number | 2021-26227 |
| Section | Notices |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 86 Issue 229 (Thursday, December 2, 2021)
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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]
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl..................................................... 1
Hydrocodone.................................................. 123
Hydromorphone................................................ 5
Oxycodone.................................................... 214
Oxymorphone.................................................. 4
------------------------------------------------------------------------
[[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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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
