Schedules of Controlled Substances: Placement of Lorcaserin Into Schedule IV, 75075-75079 [2012-30531]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Proposed Rules]
[Pages 75075-75079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30531]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-369]


Schedules of Controlled Substances: Placement of Lorcaserin Into 
Schedule IV

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) proposes placing the 
substance lorcaserin, including its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible, into Schedule IV of the Controlled Substances Act 
(CSA). This proposed action is based on a recommendation from the 
Assistant Secretary for Health of the Department of Health and Human 
Services (HHS) and on an evaluation of all other relevant data by DEA. 
If finalized, this action would impose the regulatory controls and 
criminal sanctions of Schedule IV on the manufacture, distribution, 
dispensing, importation, exportation, and possession of lorcaserin and 
products containing lorcaserin.

DATES: DEA will permit interested persons to file written comments on 
this proposal pursuant to 21 CFR 1308.43(g). Electronic comments must 
be submitted and written comments must be postmarked on or before 
January 18, 2013. Commenters should be aware that the electronic 
Federal Docket Management System will not accept comments after 
midnight Eastern Time on the last day of the comment period.

[[Page 75076]]

    Interested persons, defined as those ``adversely affected or 
aggrieved by any rule or proposed rule issuable pursuant to section 201 
of the Act (21 U.S.C. 811),'' \1\ may file a request for hearing or 
waiver of participation pursuant to 21 CFR 1308.44 and in accordance 
with 21 CFR 1316.45. Requests for hearing and waivers of participation 
must be received on or before January 18, 2013.
---------------------------------------------------------------------------

    \1\ 21 CFR 1300.01.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-369'' on all electronic and written correspondence. 
DEA encourages all comments be submitted electronically through https://www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document and supplemental information 
to this proposed rule are also available at the https://www.regulations.gov Web site for easy reference. Paper comments that 
duplicate the electronic submission are not necessary as all comments 
submitted to www.regulations.gov will be posted for public review and 
are part of the official docket record. Should you, however, wish to 
submit written comments via regular or express mail, they should be 
sent to the Drug Enforcement Administration, Attention: DEA Federal 
Register Representative/OD, 8701 Morrissette Drive, Springfield, VA 
22152. All requests for hearing and waivers of participation must be 
sent to Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 
---------------------------------------------------------------------------
8701 Morrissette Drive, Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152. Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record and made available for public inspection online at https://www.regulations.gov and in the DEA's public docket. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the ``For Further Information Contact'' paragraph, above.

Requests for Hearing or Waiver of Participation in Hearing

    In accordance with the provisions of the CSA (21 U.S.C. 811(a)), 
this action is a formal rulemaking ``on the record after opportunity 
for a hearing.'' Such proceedings are conducted pursuant to the 
provisions of the Administrative Procedure Act (5 U.S.C. 556 and 557) 
and 21 CFR 1308.41. Pursuant to 21 CFR 1308.44(a) and (c), requests for 
a hearing and waivers of participation may be submitted only by 
interested persons, defined as those ``adversely affected or aggrieved 
by any rule or proposed rule issuable pursuant to section 201 of the 
Act (21 U.S.C. 811).'' \2\ Requests for a hearing must conform to the 
requirements of 21 CFR 1308.44(a) and 1316.47. A request should state, 
with particularity, the interest of the person in the proceeding and 
the objections or issues, if any, concerning which the person desires 
to be heard. Any waiver must conform to the requirements of 21 CFR 
1308.44(c), including a written statement regarding the interested 
person's position on the matters of fact and law involved in any 
hearing.
---------------------------------------------------------------------------

    \2\ 21 CFR 1300.01.
---------------------------------------------------------------------------

    Please note that pursuant to 21 U.S.C. 811(a), the purpose and 
subject matter of the hearing is restricted to ``(A) find[ing] that 
such drug or other substance has a potential for abuse, and (B) 
mak[ing] with respect to such drug or other substance the findings 
prescribed by subsection (b) of section 812 of this title for the 
schedule in which such drug is to be placed * * *'' Requests for 
hearing and waivers of participation in the hearing should be submitted 
to DEA using the address information provided above. DEA may grant a 
hearing only ``for the purpose of receiving factual evidence and expert 
opinion regarding the issues involved in the issuance, amendment or 
repeal of a rule issuable'' pursuant to 21 U.S.C. 811(a).

Legal Authority

    DEA implements and enforces Titles II and III of the Comprehensive 
Drug Abuse Prevention and Control Act of 1970, often referred to as the 
Controlled Substances Act (CSA) and the Controlled Substances Import 
Export Act (CSIEA) (21 U.S.C. 801-971), as amended (hereinafter, 
``CSA'').
    Under the CSA, controlled substances are classified in one of five 
schedules based upon their potential for abuse, their currently 
accepted medical use, safety and the degree of dependence the substance 
may cause. 21 U.S.C. 812. The initial schedules of controlled 
substances are found at 21 U.S.C. 812(c). Pursuant to 21 U.S.C. 
811(a)(1), the Attorney General may, by rule, ``add to such a schedule 
or transfer between such schedules any drug or other substance if he 
(A) finds that such drug or other substance has a potential for abuse, 
and (B) makes with respect to such drug or other substance the findings 
prescribed by subsection (b) of section 812 of this title for the 
schedule in which such drug is to be placed* * *'' Pursuant to 28 CFR 
0.100(b), the Attorney General has delegated this scheduling authority 
to the Administrator of DEA.

Background

    Lorcaserin ((R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzepine 
hydrochloride hemihydrate) is a new chemical entity which has central 
nervous system hallucinogenic properties. Lorcaserin is a serotonin 
receptor agonist, at the 5HT2C and 5HT2A receptor 
subtypes. Lorcaserin was approved by the Food and Drug Administration 
(FDA) on June 27, 2012, as an addition to a reduced-calorie diet and 
exercise, for chronic weight

[[Page 75077]]

management and it will be marketed under the trade name BELVIQ[supreg].

Proposed Determination To Schedule Lorcaserin

    Pursuant to the CSA, 21 U.S.C. 811(a), proceedings to add a drug or 
substance to those controlled under the CSA may be initiated by request 
of the Secretary of HHS. On June 25, 2012, HHS provided DEA with a 
scientific and medical evaluation document prepared by FDA entitled 
``Basis for the Recommendation for Control of Lorcaserin in Schedule IV 
of the Controlled Substances Act.'' Pursuant to 21 U.S.C. 811(b), (c), 
and (f), this document contained an eight-factor analysis of the abuse 
potential of lorcaserin as a new drug, along with HHS' recommendation 
to control lorcaserin under Schedule IV of the CSA.
    In response, DEA conducted an eight-factor analysis of abuse 
potential of lorcaserin pursuant to 21 U.S.C. 811(c). Included below is 
a brief summary of each factor as considered by HHS and DEA. Please 
note that both the DEA and HHS analyses are available in whole in the 
``Supporting and Related Material'' of the public docket for this rule 
at www.regulations.gov under docket number DEA-369. Full analysis of 
and citations to the information referenced in the summary may be found 
in the supporting material.
    1. The Drug's Actual or Relative Potential for Abuse: Lorcaserin is 
a new chemical substance that has not been marketed in the U.S. or in 
any other country. As such, there is no information available which 
details actual abuse of lorcaserin. However, the legislative history of 
the CSA offers another methodology for assessing a drug or substance's 
potential for abuse:

    The drug or drugs containing such a substance are new drugs so 
related in their action to a drug or drugs already listed as having 
a potential for abuse to make it likely that the drug will have the 
same potentiality for abuse as such drugs, thus making it reasonable 
to assume that there may be significant diversions from legitimate 
channels, significant use contrary to or without medical advice, or 
that it has a substantial capability of creating hazards to the 
health of the user or to the safety of the community.\3\
---------------------------------------------------------------------------

    \3\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N. 
4566, 4601.

    According to HHS, lorcaserin is an agonist at the serotonin 
receptor subtypes 5-HT2C and 5-HT2A. Lorcaserin 
is indicated as an addition to a reduced-calorie diet and exercise, for 
chronic weight management. There is evidence, described below, that 
lorcaserin produces subjective effects in humans and in animals that 
are similar to those produced by zolpidem (Schedule IV) and ketamine 
(Schedule III)
    HHS described a human abuse potential study in recreational drug 
abusers of psychedelic drugs and CNS depressants, in which lorcaserin 
and the comparator drugs zolpidem (Schedule IV) and ketamine (Schedule 
III) produced significant increases on positive subjective measures 
(visual analog scales (VAS)) for ``high'' and ``good drug effects as 
well as an increase on the VAS for ``hallucinations.'' Lorcaserin, as 
well as zolpidem and ketamine, significantly increased reports of 
``sedation'' on the subjective scale of the Addiction Research Center 
Inventory (ARCI), compared to placebo. HHS summarized that these 
subjective response data suggest that lorcaserin produces subjective 
effects similar to those produced by zolpidem and ketamine. According 
to HHS, 20-60 mg of lorcaserin produced a high rate of euphoria in 6-
19% of the subjects in a human abuse potential study. The incidence of 
euphoria following lorcaserin administration in the human abuse 
potential study is similar to that reported following zolpidem 
(Schedule IV) administration (13-16%) and lower than that following 
ketamine (Schedule III) administration (50%).
    According to HHS, lorcaserin is not available or marketed in any 
country. Thus there is no evidence of lorcaserin diversion, illicit 
manufacturing, or deliberate ingestion. Because lorcaserin has been 
shown to produce euphoria in humans, it is anticipated that there will 
be significant use contrary to or without medical advice. Lorcaserin is 
not readily synthesized from available substances, and thus its 
diversion will be likely from the legitimate channels.
    2. Scientific Evidence of the Drug's Pharmacological Effects, If 
Known: HHS stated that lorcaserin is a 5-HT2C and 5-
HT2A serotonin receptor agonist. DEA further notes that it 
has been shown that lorcaserin through activation of 5-HT2C 
receptors causes inositol phosphate accumulation with an 
EC50 of 9 nM. Lorcaserin also activated the 5-
HT2A and 5-HT2B receptors, with EC50s 
of 168 nM and 943 nM, respectively.
    HHS stated that acutely, lorcaserin decreases locomotor activity in 
rats. Tolerance does develop to this effect, because after 21 days, 
lorcaserin does not affect the locomotor activity of the rats. DEA 
further notes that a study showed that food intake in rats was reduced 
after a single administration of lorcaserin. The doses administered 
were 3, 6, 12, and 24 mg/kg. Lorcaserin decreased the cumulative food 
intake at 2, 4, 6, and 22 hours. The ED50 for food intake 
inhibition was 18 mg/kg.
    According to HHS' review, a drug discrimination study conducted in 
2,5-dimethoxy-4-methylamphetamine (DOM)-trained rats showed that 
lorcaserin (0.1-10 mg/kg) produced full generalization (= 
80%) to the DOM cue in 7 of 9 rats. DOM is a Schedule I hallucinogen 
and a 5-HT2A and 5-HT2C receptor agonist. These 
data suggest that lorcaserin in doses 0.1 to 10 mg/kg produces 
discriminative stimulus responses similar to DOM, a hallucinogen.
    As described by HHS in a human abuse potential study with 
individuals with a history of abusing drugs, lorcaserin was evaluated 
for its abuse potential; it was compared to ketamine (Schedule III NMDA 
antagonist), zolpidem (Schedule IV GABA agonist), and a placebo. In 
clinical trials, lorcaserin, similar to ketamine and zolpidem, produced 
euphoric and hallucinogenic adverse events (AEs).
    3. The State of the Current Scientific Knowledge Regarding the Drug 
or Other Substance: HHS states that lorcaserin ((R)-8-chloro-1-methyl-
2,3,4,5-tetrahydro-1H-3-benzepine hydrochloride hemihydrate) is water-
soluble. The molecular formula is C11H14ClN and 
its molecular weight is 241.6 g/mol, the CAS number is 616202-92-7.
    According to HHS, in humans, lorcaserin is rapidly absorbed from 
the gastrointestinal tract after oral administration, the 
tmax (time to reach maximum plasma concentration) is <= 2 
hours and its half-life in plasma is about 11 hours. DEA further notes 
that after a single oral administration of 10 mg/kg lorcaserin to rats, 
the absorption from the gastrointestinal tract was rapid, resulting in 
a mean maximum plasma concentration (Cmax) of 0.76 [micro]g/
ml at 0.25 hour. The time from oral administration to brain maximal 
exposure was 1 hour.
    According to HHS, the major circulating metabolite of lorcaserin is 
lorcaserin sulfamate (M1). Lorcaserin is metabolized by the liver and 
excreted by the kidney. M1 is considered inactive and it does not bind 
significantly to monoamine transporters. DEA further notes that the 
major metabolite in the urine is N-carbamoyl glucuronide (M5).
    4. Its History and Current Pattern of Abuse: History and current 
pattern of abuse of lorcaserin is not available since it has not been 
marketed in any country. As stated in HHS' review, lorcaserin produced 
positive subjective effects in a human abuse potential study that are

[[Page 75078]]

similar to those produced by zolpidem (Schedule IV) and ketamine 
(Schedule III). HHS states that the positive subjective effects 
reported from supratherapeutic doses of lorcaserin administration, are 
predictive of its potential for abuse.
    5. The Scope, Duration, and Significance of Abuse: According to the 
HHS review, the information on lorcaserin's scope, duration and 
significance of abuse is not available since it has not been marketed 
in any country. Thus, the evaluation of the significance of abuse of 
lorcaserin derives from positive indicators in pre-market clinical 
trials which are believed to be predictive of drug abuse. Based on the 
AEs reported in the clinical efficacy studies and the data from a human 
abuse potential lorcaserin study, HHS concluded that the scope and 
significance of the abuse potential of lorcaserin is similar to 
Schedule IV substances. HHS states that marketing lorcaserin as a 
Schedule IV substance will decrease its abuse, as opposed to marketing 
it as an uncontrolled or Schedule V substance.
    6. What, if any, Risk There is to the Public Health: According to 
HHS, the abuse potential of lorcaserin presents a risk to the public 
health. HHS states that lorcaserin produces a number of AEs that are 
commonly seen with other Schedule IV substances that are abused. Some 
of these AEs include feeling jittery, psychomotor hyperactivity, 
paresthesia, abnormal dreams, and state of confusion. Headache, nausea, 
and dizziness were the most commonly reported AEs in lorcaserin 
clinical studies. In a human abuse potential study, 20-60 mg lorcaserin 
produced a high incidence of the AE euphoria in 6-19% of the subjects. 
According to HHS, because lorcaserin binds to 5-HT2 
receptors and generalizes to 5-HT2 agonists in drug 
discrimination studies in rats, it is expected to have a hallucinogenic 
profile. DEA further notes that in the human abuse potential study 
conducted by Shram and colleagues (2011), supratherapeutic doses of 
lorcaserin were associated with significantly higher peak scores on the 
``Detached'' (40 and 60 mg), ``Hallucinations'' (40 mg), and ``Spaced 
Out'' (40 and 60 mg) visual analog scales.
    7. Its Psychic or Physiological Dependence Liability: According to 
HHS' review, there were two clinical studies conducted to determine the 
ability of lorcaserin to induce physical dependence. The patients in 
these studies were obese and lorcaserin was administered for 4 and 12 
weeks prior to drug discontinuation. Upon lorcaserin discontinuation, 
there were no signs of changes in mood, food interest, or body weight. 
Discontinuation of lorcaserin administration to animals also did not 
produce typical withdrawal symptoms. However, according to HHS, the 
ability of lorcaserin to produce hallucinations, euphoria, and positive 
subjective responses at supratherapeutic doses is suggestive of its 
potential to produce psychic dependence.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: Lorcaserin is not an immediate 
precursor of a substance already controlled under the CSA.
    Conclusion: Based on consideration of the scientific and medical 
evaluation conducted by HHS and its recommendation, and after 
considering its own eight-factor analysis, DEA has determined that 
these facts and all relevant data constitute substantial evidence of 
potential for abuse of lorcaserin. As such, DEA hereby proposes to 
schedule lorcaserin as a controlled substance under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as Schedules I, II, III, IV, and V. The statute outlines the findings 
required in placing a drug or other substance in any schedule. 21 
U.S.C. 812(b). After consideration of the analysis and recommendation 
of the Assistant Secretary for Health of HHS and review of all 
available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b), 
finds that:
    (1) Lorcaserin has a low potential for abuse relative to the drugs 
or other substances in Schedule III. The overall abuse potential of 
lorcaserin is comparable to the Schedule IV substances;
    (2) Lorcaserin has a currently accepted medical use in treatment in 
the United States. Lorcaserin was approved for marketing by FDA as an 
addition to a reduced-calorie diet and exercise, for chronic weight 
management; and
    (3) Abuse of lorcaserin may lead to limited psychological 
dependence relative to the drugs or other substances in Schedule III. 
This finding is based on the ability of lorcaserin to produce positive 
subjective effects at supratherapeutic doses.
    Based on these findings, the Administrator of DEA concludes that 
lorcaserin, including its salts, isomers, and salts of isomers whenever 
the existence of such salts, isomers, and salts of isomers is possible, 
warrants control in Schedule IV of the CSA (21 U.S.C. 812(b)(4)).

Requirements for Handling Lorcaserin

    If this rule is finalized as proposed, lorcaserin would be subject 
to CSA regulatory controls and administrative, civil and criminal 
sanctions applicable to the manufacture, distribution, dispensing, 
importing and exporting of a Schedule IV controlled substance, 
including the following:
    Registration. Any person who manufactures, distributes, dispenses, 
imports, exports, engages in research or conducts instructional 
activities with lorcaserin, or who desires to manufacture, distribute, 
dispense, import, export, engage in instructional activities or conduct 
research with lorcaserin, would need to be registered to conduct such 
activities pursuant to 21 U.S.C. 822 and in accordance with 21 CFR Part 
1301.
    Security. Lorcaserin would be subject to Schedules III-V security 
requirements and would need to be manufactured, distributed, and stored 
pursuant to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71, 
1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 
1301.76, and 1301.77.
    Labeling and Packaging. All labels and labeling for commercial 
containers of lorcaserin which are distributed on or after finalization 
of this rule would need to be in accordance with 21 CFR 1302.03-
1302.07, pursuant to 21 U.S.C. 825.
    Inventory. Every registrant required to keep records and who 
possesses any quantity of lorcaserin would be required to keep an 
inventory of all stocks of lorcaserin on hand pursuant to 21 U.S.C. 827 
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Every 
registrant who desires registration in Schedule IV for lorcaserin would 
be required to conduct an inventory of all stocks of the substance on 
hand at the time of registration.
    Records. All registrants would be required to keep records pursuant 
to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, 
1304.21, 1304.22, and 1304.23.
    Prescriptions. All prescriptions for lorcaserin or prescriptions 
for products containing lorcaserin would be required to be issued as a 
controlled substance pursuant to 21 U.S.C. 829 and in accordance with 
21 CFR 1306, including but not limited to 21 CFR 1306.03-1306.06, 
1306.08, 1306.09, and 1306.21-1306.27.
    Importation and Exportation. All importation and exportation of 
lorcaserin would need to be done in

[[Page 75079]]

accordance with 21 CFR Part 1312, pursuant to 21 U.S.C. 952, 953, 957, 
and 958.
    Criminal Liability. Any activity with lorcaserin not authorized by, 
or in violation of, Subchapter I Part D and Subchapter II of the CSA 
occurring on or after finalization of this proposed rule would be 
unlawful.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this proposed scheduling 
action is subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. Such actions are exempt from review 
by the Office of Management and Budget pursuant to Section 3(d)(1) of 
Executive Order 12866 and the principles reaffirmed in Executive Order 
13563.

Executive Order 12988

    This proposed regulation meets the applicable standards set forth 
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards and reduce burden.

Executive Order 13132

    This proposed rulemaking does not preempt or modify any provision 
of State law; nor does it impose enforcement responsibilities on any 
State; nor does it diminish the power of any State to enforce its own 
laws. Accordingly, this rulemaking does not have federalism 
implications warranting the application of Executive Order 13132.

Executive Order 13175

    This proposed rule will not have tribal implications and will not 
impose substantial direct compliance costs on Indian tribal 
governments.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612), has reviewed this proposed rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. Lorcaserin products, 
as recently approved by the FDA, will be used as an adjunct treatment 
of partial onset seizure. Handlers of lorcaserin will also handle other 
controlled substances used as anti-seizure agents, which are already 
subject to the regulatory requirements of the CSA.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector, of 
$136,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under provisions of the Unfunded Mandates 
Reform Act of 1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-
3521.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1308 is proposed to be 
amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

    1. The authority citation for part 1308 continues to read as 
follows:

    Authority:  21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    2. Section 1308.14 is amended by redesignating paragraphs (e) and 
(f) as paragraphs (f) and (g) and adding a new paragraph (e) to read as 
follows:


Sec.  1308.14  Schedule IV.

* * * * *
    (e) Lorcaserin. Any material, compound, mixture, or preparation 
which contains any quantity of the following substances, including its 
salts, isomers, and salts of such isomers, whenever the existence of 
such salts, isomers, and salts of isomers is possible:

(1) Lorcaserin...............................................       1625
 

* * * * *

    Dated: December 13, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-30531 Filed 12-18-12; 8:45 am]
BILLING CODE 4410-09-P