[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Pages 66014-66023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26119]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-508E]
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 2020
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
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SUMMARY: This final order establishes the initial 2020 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: Effective Date: This order is effective December 2, 2019.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control
Division, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION:
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.
Background
The 2020 aggregate production quotas and assessment of annual needs
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
2020 to provide for the estimated medical, scientific, research, and
industrial needs of the United States, for lawful export requirements,
and for the establishment and maintenance of reserve stocks. These
quotas include imports of ephedrine, pseudoephedrine, and
phenylpropanolamine, but do not include imports of controlled
substances for use in industrial processes.
[[Page 66015]]
On September 12, 2019, 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 2020'' was published in
the Federal Register. 84 FR 48170. This notice proposed the 2020
aggregate production quotas for each basic class of controlled
substance listed in schedules I and II, and the 2020 assessment of
annual needs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. All interested persons were invited to comment on
or object to the proposed aggregate production quotas and the proposed
assessment of annual needs on or before October 15, 2019.
Comments Received
Within the public comment period, DEA received 731 comments from
DEA registrants, hospital associations, professional associations,
doctors, nurses, health system organizations, State Attorneys General,
and others. The comments included concerns about the quota process,
concerns that further quota reductions will lead to drug shortages,
requests for less interference in the doctor-patient relationship,
availability of prescription drugs for chronic pain patients, requests
for hearings, requests for increase in specific production quotas, and
other comments outside the scope of this notice. DEA received a joint
comment from two Senators urging DEA to apply DEA's new authorities to
prevent and limit opioid diversion due to excessively high production
levels. Although this comment was received after the close of the
comment period, DEA shares the Senators' concerns and is working to
improve its ability to use available databases to better quantify
diversion as part of the quota process.
Shortages
There were non-DEA registered commenters that expressed concerns
about the decrease in aggregate production quotas. These commenters
alleged that decreases to the aggregate production quotas have resulted
in a shortage of injectable opioid medications and interfere with the
treatment of patients. Some of these commenters also suggested that DEA
separate quotas for solid oral controlled substances and injectable
controlled substances, and that DEA allow consideration by individual
pharmaceutical dosage forms.
DEA also received letters from many doctors, nurses, hospital
administrators, and others in the medical field regarding the proposed
quota reduction for fentanyl and other schedule II narcotics. These
letters characterized the reductions as ``extremely problematic for
American healthcare providers,'' stating that the reduction for
fentanyl and other schedule II narcotics will lead to drug shortages,
raise drug prices, lead to hardships on hospitals and surgical
facilities, and negatively impact patients. These letters discussed
fentanyl's appearance on the Food and Drug Administration's (FDA) drug
shortage list and that fentanyl is the least diverted among the covered
controlled substances.
DEA is committed to ensuring an adequate and uninterrupted supply
of controlled substances in order to meet legitimate medical,
scientific, and export needs of the United States. Although DEA sets
the aggregate production quota, it is possible that manufacturers'
business practices may lead to a shortage of controlled substances at
the consumer level, despite the adequacy of the aggregate production
quota set by DEA. The aggregate production quotas are set by DEA in a
manner to include both injectable opioids and solid oral opioids in
order to ensure that the estimated medical needs of the United States
are met.
Pursuant to 21 U.S.C. 826(a)(1), ``production quotas shall be
established in terms of quantities of each basic class of controlled
substance and not in terms of individual pharmaceutical dosage forms
prepared from or containing such a controlled substance.'' However, the
Substance Use-Disorder Prevention that Promotes Opioid Recovery
Treatment for Patients and Communities Act of 2018 (SUPPORT Act), (Pub.
L. 115-271), provides an exception to that general rule by now giving
DEA the authority to establish quotas in terms of pharmaceutical dosage
forms if the agency determines that doing so will assist in avoiding
the overproduction, shortages, or diversion of a controlled substance.
While DEA is now allowed to issue quotas in terms of pharmaceutical
dosage form, it is not required to do so. DEA will not be utilizing
this authority at the aggregate production quota level, but will be
doing so at the individual dosage-form manufacturing level where it
will have a greater impact on averting potential shortages. Because
quotas set at the individual dosage-form manufacturing level are more
directly connected to distributions of current and new FDA-approved
drug products, they allow DEA to manage manufacturing quotas to
alleviate any potential shortage in a more timely manner than with
quotas set at the aggregate production quota level. This is also true
because the aggregate production quota is initially established prior
to the start of the quota calendar year.
Additionally, DEA and FDA can coordinate efforts to prevent or
alleviate drug shortages pursuant to 21 U.S.C. 826(h). Such efforts may
include adjusting domestic competitors' quota, completion of FDA
approval to increase the number of competitors, and determining a
foreign manufacturer that can meet FDA approval. For example, the
domestic shortage of injectable hydromorphone that occurred in 2018 was
alleviated through the collaboration of FDA and DEA to determine who
were the other dosage-form manufacturers with injectable hydromorphone
products in the market, whether other dosage-form manufacturers had the
capability to increase their production levels to meet legitimate
patient need in a timely manner, and when it was determined that the
domestic manufacturers could not increase production significantly to
meet legitimate patient need, DEA and FDA coordinated their regulatory
authority to allow for the limited importation of injectable
hydromorphone into the United States.
Relevant Information Obtained From the States
Pursuant to 21 CFR 1303.11, DEA must consider relevant information
from the States when setting the aggregate production quota. Seven
State Attorneys General submitted a joint comment expressing concerns
about the estimation of diversion for all controlled substances, not
accounting for over-prescribing, and the consideration of additional
information to set quotas. Their concerns are addressed in more detail
below.
I. Diversion Analysis for All Controlled Substances
The seven State Attorneys General commented that DEA should not
take different approaches when accounting for diversion for the five
covered controlled substances and the remaining controlled substances.
In the letter, they discussed the mandates from the SUPPORT Act, as
well as the requirements implemented through 21 CFR 1303.11 by the
Controlled Substances Quota rule. 83 FR 32784. They expressed that they
have similar language and purposes, even though the SUPPORT Act goes a
bit further in its mandate by requiring the estimation of diversion for
the five covered controlled substances. They pointed out that DEA
[[Page 66016]]
estimated diversion and made straightforward quota reductions by the
corresponding quantities, whereas DEA only noted that the databases
contained usable information in regards to the remaining controlled
substances. DEA did not indicate that diversion estimates were
conducted for any other controlled substance, nor did DEA indicate that
any corresponding decreases were made for other controlled substances.
They commented that if DEA believes they have a sound method for
estimating diversion, then it is unreasonable not to apply that method
for estimating diversion to all controlled substances.
The States also commented that there is a lack of transparency in
the setting of quotas. The States believe that DEA needs to explain the
logic behind using different approaches in setting quotas. They
commented that DEA must include the findings of fact when setting the
quota and that transparency is essential in allowing parties to
evaluate DEA's 2020 Proposed Aggregate Production Quota notice.
DEA considered various data sources in order to determine the
extent of diversion of all controlled substances as is required by the
recent amendments to the CSA and changes to DEA's own regulations. In
accordance with factor six in 21 CFR 1303.11(b), DEA formally solicited
the Department of Health and Human Services (HHS), U.S. Centers for
Disease Control and Prevention (CDC), the Centers for Medicare and
Medicaid Services (CMS), and the states in August 2018, requesting
information including rates of overdose deaths and abuse and overall
public health impact related to controlled substances. This information
was also considered pursuant to the SUPPORT Act. DEA determined that
due to the grouping of drug classes in all of the sources provided, the
data could not be used to estimate diversion for the purpose of setting
the aggregate production quotas. However, DEA estimated diversion of
the covered controlled substances defined in the SUPPORT Act utilizing
DEA's internal data sources. DEA will continue to further define
sources that will be useful in analyzing diversion of the remaining
controlled substances.
II. Methods and Data That Capture Over-Prescribing as Part of its
Diversion Analysis
The States acknowledged that DEA's current approach for accounting
for diversion is a significant improvement but commented that DEA does
not adequately account for over-prescribing. They commented that over-
prescribing results when there is overproduction, which allows
legitimate prescriptions to be diverted. Assuming a controlled
substance is validly dispensed for a legitimate medical purpose, both
the physician and patient will use their judgement to determine how
much medication will be prescribed and how much they will consume. The
physician's decisions may be influenced by recommendations from CDC,
FDA, and professional medical organizations that have conducted and/or
reviewed clinical studies used to determine prescription guidelines.
Patients are ultimately going to decide for themselves how much of the
legitimately prescribed medication they will consume. DEA does not
control the quantity of a substance prescribed to a patient, and DEA
cannot control how much of the prescription a patient decides to
consume. DEA also receives assistance in curbing overprescribing from
programs in place, such as the President's Safer Prescribing Plan,
which seeks to reduce nationwide opioid prescription fills by one-
third. DEA has observed a decline in the number of prescriptions
written for schedule II opioids since 2014 and will continue to set
aggregate production quotas to meet the medical needs of the United
States while combating the opioid crisis. These decreases take into
account the combined efforts of DEA, FDA, and CDC enforcing regulations
and issuing guidance documents, as well as many states enacting
prescription monitoring database programs to stem the opiate/opioid
epidemic.
There are ample reasons not to pursue the methods suggested by the
State Attorneys General, including that the studies on which they
relied are limited in scope of procedures and number of hospitals, such
that the methodology is insufficient to expand to a national level.
As pointed out by the States, ``there is no perfect system of
measuring other sources of diversion like over-prescription.'' The
States pointed to data from drug takeback programs, but currently that
data is not usable for consideration in determining the aggregate
production quota. There is no method in place to determine how much of
the prescription medications are schedule I or II substances and which
controlled substances are being returned. DEA and HHS are working
together to consider options for quantifying Take-Back Program data.
III. Consideration of Additional Information To Determine Production
Quotas
The State Attorneys General commented that DEA should expand its
sources of data used to set aggregate production quotas. They suggested
three steps that DEA should take to gather information to set quotas
which are listed below.
1: Improve Usability of the Automated Reports and Consolidated Ordering
System (ARCOS) and the Suspicious Order Reporting System (SORS)
The State Attorneys General commented that DEA should improve
usability of the ARCOS and SORS databases to gather better information
on prescribing practices. They also note that DEA did not indicate
whether SORS was used and minimally referred to ARCOS not being used
because it contained identical information to the Theft Loss Report
Database. The States commented that DEA needs to reform its process to
upload SORS reports into the SORS database. Further, they commented
that overdose data received from States and the CDC should be cross-
referenced with ARCOS to provide context that should inform the quota-
setting process.
SORS was not centralized until its recent launch on October 23,
2019. DEA will need time to sort through the system to determine its
utility for aggregate production quota purposes. The submission of a
suspicious order alone is not an automatic determination that the order
is illicit in nature. Further investigations need to be completed to
determine if a transgression has occurred.
The differences in reporting frequencies to ARCOS are specified in
21 CFR 1304.33(b). Acquisition and distribution transaction reports
must be completed every quarter no later than the 15th day of the month
succeeding the quarter for which it is being submitted. In the same
section of the CFR, it does mention that a registrant may be given
permission to file a report more frequently, but no more than on a
monthly basis. The State Attorneys General request to change this
regulation is outside of the scope of this final order.
2: Improve Data Collection in Prescription Drug Takeback Programs To
Capture the Quantities of Drugs Overprescribed in Particular Areas
The State Attorneys General expressed that DEA should expand the
National Take Back Program to assist with gathering more precise data
on over-prescribing. They noted that the takeback programs do not track
the types and quantities of what the public turns in, limiting their
value. Currently, DEA and HHS are working together to consider methods
that improve data
[[Page 66017]]
collection and subsequently the usability of data obtained from the
Take-Back Program.
3: Consider Medical Best Practices as Part of the Holistic Diversion
Analysis
The letter submitted by the State Attorneys General also suggested
that DEA study the best practices developed by the medical community
and state regulators to determine what opioid quantities are
``medically necessary.'' They expressed that relying exclusively on
evidence of illegal activity assumes that any legally-sold controlled
substance is a part of the medical and scientific needs of the United
States.
DEA is responsible for enforcing the provisions of the CSA and DEA
regulations that require prescriptions for controlled substances to be
issued by a practitioner for a legitimate medical purpose in the usual
course of his/her professional practice. However, beyond that context,
DEA does not regulate the practice of medicine generally and thus does
not have a role in establishing the type of ``best practices'' to which
the commenter refers.
Pain Management and Medical Associations Letters
DEA also received 106 comments that expressed concern that DEA's
proposed reduction of opioids would adversely impact the availability
of pain relieving prescription drugs for people with chronic pain.
These comments were general in nature, and raised issues of specific
medical illnesses and medical treatment, and therefore are outside of
the scope of this Final Order. As a result, these comments did not
provide new discrete data for consideration, and they do not impact the
original analysis involved in establishing the 2020 aggregate
production quotas.
DEA sets aggregate production quotas in a manner to ensure that all
prescriptions that are authorized for legitimate medical purposes can
be filled. Prescribers who are authorized to dispense controlled
substances are responsible for adhering to the laws and regulations set
forth under the CSA, which require doctors to only write prescriptions
for legitimate medical needs. Any practitioner issuing an invalid
prescription for controlled substances, and any pharmacy knowingly
filling such a prescription, would be in violation of the CSA.
Hearings
Two commenters urged DEA to hold a public hearing to receive
feedback from stakeholders. They asked that DEA bring together all
stakeholders, allowing stakeholders to publicly discuss their concerns.
Under the DEA regulations, the decision of whether to grant this
type of a hearing on the issues raised by the commenters lies solely
within the discretion of the Administrator. (21 CFR 1303.11(c) and 21
CFR 1303.13(c)). I find that neither of the foregoing two requests
presented any evidence that would lead me to conclude that a hearing is
necessary or warranted. Therefore, I decline to order a hearing on the
issues presented by the commenters.
Specific Quota for DEA-Registered Manufacturers
The DEA received comments from five DEA-registered manufacturers
regarding twenty-four different schedule I and II controlled
substances. Commenters stated the proposed aggregate production quotas
for amphetamine (for sale), fentanyl, hydromorphone, methylphenidate,
morphine, noroxymorphone (for conversion), and oxycodone (for sale)
were potentially insufficient to provide for the estimated medical,
scientific, research, and industrial needs of the United States, export
requirements, and the establishment and maintenance of reserve stocks.
Commenters requested the proposed aggregate production quotas for FUB-
144, 5F-AB-PINACA, 5F-EDMB-PINACA, 5F-MDMB-PICA, MMB-CHMICA, FUB-AKB48
(FUB-APINACA), 5F-CUMYL-PINACA, 5F-CUMYL-P7AICA, 4-CN-CUMYL-BUTINACA,
NM2201, 4-Methyl-alpha-ethylaminopentiophenone (4-MEAP), N-
Ethylhexedrone, 4-Chloro-alpha-pyrrolidinovalerophenone (4-Chloro-
alpha-PVP), 4'-Methyl-alpha-pyrrolidinohexiophenone (MPHP), N-
Ethylpentylone, alpha-Pyrrolidinohexanophenone (alpha-PHP), and alpha-
Pyrrolidinoheptaphenone (PV8), be sufficient for additional quota
requests.
DEA has considered the comments for specific controlled substances
and made adjustments as needed which are described below in the section
titled Determination of 2020 Aggregate Production Quotas and Assessment
of Annual Needs. DEA received one comment to the proposed established
2020 assessment of annual needs for ephedrine, pseudoephedrine, and
phenylpropanolamine regarding the difficulty in procuring finished
dosage-forms of ephedrine. DEA has considered this comment in the
section regarding drug shortages of controlled substances. This letter
characterized the reductions of controlled substances and ephedrine as
``extremely problematic for American healthcare providers,'' stating
that these reductions will lead to drug shortages, raise drug prices,
lead to hardships on hospitals and surgical facilities, and negatively
impact patients.
DEA is required under the CSA to establish quotas for ephedrine,
pseudoephedrine, and phenylpropanolamine to provide for the estimated
medical, scientific, research, and industrial needs of the United
States, for lawful export requirements, and for the establishment and
maintenance of reserve stocks. Although DEA sets the assessment of
annual needs, it is possible that manufacturers' business practices may
lead to a shortage of ephedrine drug products at the consumer level,
despite the adequacy of the assessment of annual needs set by DEA. For
instance, DEA does not have the authority to dictate when during the
calendar year the manufacturer actually utilizes the quota granted to
them. Also, DEA cannot dictate how much of the granted quota the
manufacturer allocates for use in a single production run. The
assessment of annual needs is set by DEA in a manner to include all
dosage forms of ephedrine in order to ensure that the estimated medical
needs of the United States are met.
Additionally, DEA and FDA can coordinate efforts to prevent or
alleviate drug shortages. Such efforts may include adjusting
competitors' domestic or import quotas and completion of FDA approval
to increase the number of competitors.
Out of Scope
DEA received comments which addressed issues that are outside the
scope of this final order. The comments were general in nature and
raised issues of specific medical illnesses, medical treatments, and
medication costs and, therefore, are outside of the scope of this Final
Order. DEA also received comments asserting that illicit drug use, and
not prescription drug use, is the main factor in the opioid crisis.
Although DEA is genuinely concerned with illicit drug use and its
involvement in the opioid crisis, the manufacturing of illicit
substances is not considered when determining the aggregate production
quotas because such illicit manufacturing cannot be tempered by
adjusting the aggregate production quotas, therefore it is outside the
scope of this final order.
All of these out of scope issues do not impact the original
analysis involved in establishing the 2020 aggregate production quotas.
[[Page 66018]]
Determination of 2020 Aggregate Production Quotas and Assessment of
Annual Needs
In determining the 2020 aggregate production quotas and assessment
of annual needs, DEA has taken into consideration the above comments
along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11,
in accordance with 21 U.S.C. 826(a), and other relevant factors,
including the 2019 manufacturing quotas, current 2019 sales and
inventories, anticipated 2020 export requirements, industrial use,
additional applications for 2020 quotas, as well as information on
research and product development requirements. Based on all of the
above, the Administrator is adjusting the 2020 aggregate production
quotas for 4-Methyl-alpha-ethylaminopentiophenone (4-MEAP), N-
Ethylhexedrone, 4-Chloro-alpha-pyrrolidinovalerophenone (4-Chloro-
alpha-PVP), 4'-Methyl-alpha-pyrrolidinohexiophenone (MPHP), alpha-
Pyrrolidinohexanophenone (alpha-PHP), alpha-Pyrrolidinoheptaphenone
(PV8), amphetamine (for sale), oxycodone (for sale), and oxymorphone
(for sale).
Regarding FUB-144, 5F-AB-PINACA, 5F-EDMB-PINACA, 5F-MDMB-PICA, MMB-
CHMICA, FUB-AKB48 (FUB-APINACA), 5F-CUMYL-PINACA, 5F-CUMYL-P7AICA, 4-
CN-CUMYL-BUTINACA, NM2201, N-Ethylpentylone, fentanyl, hydromorphone,
methylphenidate, morphine, noroxymorphone (for conversion), and
oxycodone (for sale), DEA has determined the proposed aggregate
production quotas and assessment of annual needs are sufficient to
provide for the 2020 estimated medical, scientific, research,
industrial needs of the United States, export requirements, and the
establishment and maintenance of reserve stocks. This final order
establishes these aggregate production quotas and assessment of annual
needs at the same amounts as proposed.
Estimates of Diversion Pursuant to the SUPPORT Act
The SUPPORT Act (21 U.S.C. 826(i)(1)(a)) requires that ``in
establishing any quota under this section . . ., for [the covered
controlled substances], the Attorney General shall estimate the amount
of diversion of the [covered controlled substances] that occurs in the
United States.'' To estimate diversion as is required by the SUPPORT
Act, DEA aggregated the active pharmaceutical ingredient (API) of each
covered controlled substance by metric weight where the data was
available in the aforementioned databases. Based on the individual
entries into the aforementioned databases, DEA calculated the estimated
amount of diversion by multiplying the strength of the API listed for
each finished dosage form by the total amount of units reported to
estimate the metric weight in kilograms of the controlled substance
being diverted. The estimate of diversion for each of the covered
controlled substances is reported below.
Diversion Estimates for 2018 (kg)
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Fentanyl..................................................... 0.109
Hydrocodone.................................................. 24.259
Hydromorphone................................................ 1.219
Oxycodone.................................................... 57.051
Oxymorphone.................................................. 1.157
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In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR
1315.11, the Administrator hereby establishes the 2020 aggregate
production quotas for the following schedule I and II controlled
substances and the 2020 assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, as follows:
------------------------------------------------------------------------
Established
Basic class 2020 quotas
(g)
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Schedule I
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1-[1-(2-Thienyl)cyclohexyl]pyrrolidine.................. 20
1-(1-Phenylcyclohexyl)pyrrolidine....................... 15
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine.......... 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....... 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...... 30
1-Benzylpiperazine...................................... 25
1-Methyl-4-phenyl-4-propionoxypiperidine................ 10
1-[1-(2-Thienyl)cyclohexyl]piperidine................... 15
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........ 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....... 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....... 30
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................ 100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....... 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 25
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......... 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5)...............................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 25
2,5-Dimethoxy-4-n-propylthiophenethylamine.............. 25
2,5-Dimethoxyamphetamine (DMA).......................... 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) 30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C- 30
T-4)...................................................
3,4,5-Trimethoxyamphetamine............................. 30
3,4-Methylenedioxyamphetamine (MDA)..................... 55
3,4-Methylenedioxymethamphetamine (MDMA)................ 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 40
3,4-Methylenedioxy-N-methylcathinone (methylone)........ 40
3,4-Methylenedioxypyrovalerone (MDPV)................... 35
3-FMC; 3-Fluoro-N-methylcathinone....................... 25
3-Methylfentanyl........................................ 30
3-Methylthiofentanyl.................................... 30
[[Page 66019]]
4-Bromo-2,5-dimethoxyamphetamine (DOB).................. 30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............. 25
4-Chloro-[alpha]-pyrrolidinovalerophenone (4-chloro- 25
alpha-PVP).............................................
4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2- 25
yl)-1H-indazole-3-carboximide..........................
4-Fluoroisobutyryl fentanyl............................. 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-[alpha]-pyrrolidinopropiophenone (4-MePPP)..... 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 50
phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 40
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5F-CUMYL-PINACA......................................... 25
5F-EDMB-PINACA.......................................... 25
5F-MDMB-PICA............................................ 25
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5- 25
fluoropentyl)-1H-indazole-3-carboxamide................
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2- 25
yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide)...........
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H- 30
indazole-3-carboxamido)-3,3-dimethylbutanoate).........
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 30
carboxamido)-3-methylbutanoate)........................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5- 30
fluoropentyl)-1H-indazole-3-carboxamide)...............
5-Fluoro-PB-22; 5F-PB-22................................ 20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-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........................ 25
AB-CHMINACA............................................. 30
AB-FUBINACA............................................. 50
AB-PINACA............................................... 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 30
(4-fluorobenzyl)-1H-indazole-3-carboxamide)............
Acetorphine............................................. 25
Acetyl Fentanyl......................................... 100
Acetyl-alpha-methylfentanyl............................. 30
Acetyldihydrocodeine.................................... 30
Acetylmethadol.......................................... 25
Acryl Fentanyl.......................................... 25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 50
pentyl-1H-indazole-3-carboxamide)......................
AH-7921................................................. 30
Allylprodine............................................ 25
Alphacetylmethadol...................................... 2
alpha-Ethyltryptamine................................... 25
Alphameprodine.......................................... 2
Alphamethadol........................................... 2
Alphaprodine............................................ 25
alpha-Methylfentanyl.................................... 30
alpha-Methylthiofentanyl................................ 30
alpha-Methyltryptamine (AMT)............................ 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)............. 25
alpha-Pyrrolidinoheptaphenone (PV8)..................... 25
alpha-Pyrrolidinohexanophenone ([alpha]-PHP)............ 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............ 25
Aminorex................................................ 25
Anileridine............................................. 20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3- 25
carboxamide)...........................................
Benzethidine............................................ 25
Benzylmorphine.......................................... 30
Betacetylmethadol....................................... 2
beta-Hydroxy-3-methylfentanyl........................... 30
beta-Hydroxyfentanyl.................................... 30
beta-Hydroxythiofentanyl................................ 30
Betameprodine........................................... 25
Betamethadol............................................ 4
Betaprodine............................................. 25
Bufotenine.............................................. 15
Butylone................................................ 25
Butyryl fentanyl........................................ 30
Cathinone............................................... 40
Clonitazene............................................. 25
[[Page 66020]]
Codeine methylbromide................................... 30
Codeine-N-oxide......................................... 192
Cyclopentyl Fentanyl.................................... 30
Cyclopropyl Fentanyl.................................... 20
Cyprenorphine........................................... 25
Desomorphine............................................ 25
Dextromoramide.......................................... 25
Diapromide.............................................. 20
Diethylthiambutene...................................... 20
Diethyltryptamine....................................... 25
Difenoxin............................................... 9,200
Dihydromorphine......................................... 753,500
Dimenoxadol............................................. 25
Dimepheptanol........................................... 25
Dimethylthiambutene..................................... 20
Dimethyltryptamine...................................... 50
Dioxyaphetyl butyrate................................... 25
Dipipanone.............................................. 5
Drotebanol.............................................. 25
Ethylmethylthiambutene.................................. 25
Etorphine............................................... 30
Fenethylline............................................ 30
Fentanyl related substances............................. 40
FUB-144................................................. 25
FUB-AKB48............................................... 25
Furanyl fentanyl........................................ 30
Furethidine............................................. 25
gamma-Hydroxybutyric acid............................... 25,417,000
Heroin.................................................. 45
Hydromorphinol.......................................... 40
Hydroxypethidine........................................ 25
Ibogaine................................................ 30
Isobutyryl Fentanyl..................................... 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
Levophenacylmorphan..................................... 25
Lysergic acid diethylamide (LSD)........................ 40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1- 30
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide)...........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)- 30
1H-indole-3-carboxamido)-3,3-dimethylbutanoate)........
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole- 30
3-carboxamido)-3,3-dimethylbutanoate)..................
MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)- 25
1H-indole-3-carboxamido)-3-methylbutanoate.............
Marihuana............................................... 3,200,000
Mecloqualone............................................ 30
Mescaline............................................... 25
Methaqualone............................................ 60
Methcathinone........................................... 25
Methyoxyacetyl fentanyl................................. 30
Methyldesorphine........................................ 5
Methyldihydromorphine................................... 25
Morpheridine............................................ 25
Morphine methylbromide.................................. 5
Morphine methylsulfonate................................ 5
Morphine-N-oxide........................................ 150
MT-45................................................... 30
Myrophine............................................... 25
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3- 25
carboxylate............................................
N,N-Dimethylamphetamine................................. 25
Naphyrone............................................... 25
N-Ethyl-1-phenylcyclohexylamine......................... 5
N-Ethyl-3-piperidyl benzilate........................... 10
N-Ethylamphetamine...................................... 24
N-Ethylhexedrone........................................ 25
[[Page 66021]]
N-Ethylpentylone, ephylone.............................. 30
N-Hydroxy-3,4-methylenedioxyamphetamine................. 24
N-Methyl-3-Piperidyl Benzilate.......................... 30
Nicocodeine............................................. 25
Nicomorphine............................................ 25
Noracymethadol.......................................... 25
Norlevorphanol.......................................... 55
Normethadone............................................ 25
Normorphine............................................. 40
Norpipanone............................................. 25
Ocfentanil.............................................. 25
Ortho-fluorofentanyl, 2-fluorofentanyl.................. 30
Para-chloroisobutyryl fentanyl.......................... 30
Para-fluorofentanyl..................................... 25
Para-fluorobutyryl fentanyl............................. 25
Para-methoxybutyryl fentanyl............................ 30
Parahexyl............................................... 5
PB-22; QUPIC............................................ 20
Pentedrone.............................................. 25
Pentylone............................................... 25
Phenadoxone............................................. 25
Phenampromide........................................... 25
Phenomorphan............................................ 25
Phenoperidine........................................... 25
Pholcodine.............................................. 5
Piritramide............................................. 25
Proheptazine............................................ 25
Properidine............................................. 25
Propiram................................................ 25
Psilocybin.............................................. 30
Psilocyn................................................ 50
Racemoramide............................................ 25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2- 45
methoxyphenylacetyl)indole)............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) 30
Tetrahydrocannabinols................................... 384,460
Tetrahydrofuranyl fentanyl.............................. 15
Thebacon................................................ 25
Thiafentanil............................................ 25
Thiofentanyl............................................ 25
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3- 30
yl](naphthalen-1-yl)methanone).........................
Tilidine................................................ 25
Trimeperidine........................................... 25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3- 25
tetramethylcyclopropyl)methanone.......................
U-47700................................................. 30
Valeryl fentanyl........................................ 25
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................. 15
1-Piperidinocyclohexanecarbonitrile..................... 25
4-Anilino-N-phenethyl-4-piperidine (ANPP)............... 813,005
Alfentanil.............................................. 3,260
Alphaprodine............................................ 2
Amobarbital............................................. 20,100
Amphetamine (for conversion)............................ 14,137,578
Amphetamine (for sale).................................. 47,000,000
Bezitramide............................................. 25
Carfentanil............................................. 20
Cocaine................................................. 82,127
Codeine (for conversion)................................ 3,225,000
Codeine (for sale)...................................... 30,731,558
Dextropropoxyphene...................................... 35
Dihydrocodeine.......................................... 156,713
Dihydroetorphine........................................ 2
Diphenoxylate (for conversion).......................... 14,100
Diphenoxylate (for sale)................................ 770,800
Ecgonine................................................ 88,134
Ethylmorphine........................................... 30
Etorphine hydrochloride................................. 32
Fentanyl................................................ 813,005
Glutethimide............................................ 25
Hydrocodone (for conversion)............................ 1,250
[[Page 66022]]
Hydrocodone (for sale).................................. 34,836,854
Hydromorphone........................................... 3,054,479
Isomethadone............................................ 30
Levo-alphacetylmethadol (LAAM).......................... 5
Levomethorphan.......................................... 30
Levorphanol............................................. 38,000
Lisdexamfetamine........................................ 21,000,000
Meperidine.............................................. 1,463,873
Meperidine Intermediate-A............................... 30
Meperidine Intermediate-B............................... 30
Meperidine Intermediate-C............................... 30
Metazocine.............................................. 15
Methadone (for sale).................................... 22,278,000
Methadone Intermediate.................................. 24,064,000
Methamphetamine......................................... 1,213,603
------------------------------------------------------------------------
[678,878 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 505,231 grams for methamphetamine mostly for
conversion to a schedule III product; and 29,494 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................... 57,438,334
Metopon................................................. 25
Moramide-intermediate................................... 25
Morphine (for conversion)............................... 4,089,000
Morphine (for sale)..................................... 29,353,655
Nabilone................................................ 62,000
Noroxymorphone (for conversion)......................... 19,169,340
Noroxymorphone (for sale)............................... 376,000
Opium (powder).......................................... 250,000
Opium (tincture)........................................ 530,837
Oripavine............................................... 28,705,000
Oxycodone (for conversion).............................. 914,010
Oxycodone (for sale).................................... 67,593,983
Oxymorphone (for conversion)............................ 24,525,540
Oxymorphone (for sale).................................. 829,051
Pentobarbital........................................... 25,850,000
Phenazocine............................................. 25
Phencyclidine........................................... 35
Phenmetrazine........................................... 25
Phenylacetone........................................... 40
Piminodine.............................................. 25
Racemethorphan.......................................... 5
Racemorphan............................................. 5
Remifentanil............................................ 3,000
Secobarbital............................................ 172,100
Sufentanil.............................................. 4,000
Tapentadol.............................................. 13,447,541
Thebaine................................................ 70,829,235
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................. 25
Ephedrine (for sale).................................... 4,136,000
Phenylpropanolamine (for conversion).................... 14,100,000
Phenylpropanolamine (for sale).......................... 7,990,000
Pseudoephedrine (for conversion)........................ 1,000
Pseudoephedrine (for sale).............................. 174,246,000
------------------------------------------------------------------------
The Administrator also establishes aggregate production quotas 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 2020 aggregate production quotas and
assessment of annual needs as needed.
Dated: November 27, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-26119 Filed 11-29-19; 8:45 am]
BILLING CODE 4410-09-P