[Federal Register Volume 72, Number 85 (Thursday, May 3, 2007)]
[Rules and Regulations]
[Pages 24532-24534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8421]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-301F]


Schedules of Controlled Substances: Placement of Lisdexamfetamine 
Into Schedule II

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final Rule.

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SUMMARY: With the issuance of this final rule, the Deputy Administrator 
of the Drug Enforcement Administration (DEA) places the substance 
lisdexamfetamine, including its salts, isomers and salts of isomers 
into schedule II of the Controlled Substances Act (CSA). As a result of 
this rule, the regulatory controls and criminal sanctions of schedule 
II will be applicable to the manufacture, distribution, dispensing, 
importation and exportation of lisdexamfetamine and products containing 
lisdexamfetamine.

EFFECTIVE DATE: June 4, 2007.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, (202) 307-7183.

SUPPLEMENTARY INFORMATION: Lisdexamfetamine is a central nervous system 
stimulant drug. On February 23, 2007, the Food and Drug Administration 
(FDA) approved lisdexamfetamine for marketing under the trade name 
Vyvanse <SUP>TM</SUP>. Lisdexamfetamine will be marketed as a 
prescription drug product for the treatment of Attention Deficit 
Hyperactivity Disorder (ADHD).
    Lisdexamfetamine is an amide ester conjugate comprised of the amino 
acid L-lysine covalently bound to the amino group of d-amphetamine. The 
chemical name of its dimesylate salt form is (2S)-2,6-diamino-N-[(1S)-
1-methyl-2-phenethyl]hexanamide dimethanesulfonate (CAS number 608137-
32-3). Lisdexamfetamine per se is pharmacologically inactive and its 
effects are due to its in vivo metabolic conversion to d-amphetamine.
    Lisdexamfetamine is a new molecular entity and has not been 
marketed in the United States or other countries. Therefore, there has 
been no evidence of diversion, abuse, or law enforcement encounters 
involving lisdexamfetamine.
    On November 14, 2006, the Assistant Secretary for Health, 
Department of Health and Human Services (DHHS), sent the Deputy 
Administrator of DEA a scientific and medical evaluation and a letter 
recommending that lisdexamfetamine be placed into schedule II of the 
CSA. Enclosed with the November 14, 2006, letter was a document 
prepared by the FDA entitled, ``Basis for the Recommendation for 
Control of Lisdexamfetamine in Schedule II of the Controlled Substances 
Act (CSA).'' The document contained a review of the factors which the 
CSA requires the Secretary to consider (21 U.S.C. 811(b)).
    After a review of the available data, including the scientific and 
medical evaluation and the scheduling recommendation received from 
DHHS, the Deputy Administrator of the DEA, in a February 22, 2007, 
Notice of Proposed Rulemaking (72 FR 7945), proposed placement of 
lisdexamfetamine into schedule II of the CSA. The proposed rule 
provided an opportunity for all interested persons to submit their 
written comments to be postmarked and electronic comments be sent on or 
before March 26, 2007.

Comments Received

    The DEA received two comments in response to the Notice of Proposed 
Rulemaking. One commenter stated that monthly visits to obtain refills 
for Concerta [supreg]--like drugs used in children are very expensive 
and the law needs to be changed. DEA notes that statutory requirements 
for schedule II drugs do not permit prescription refills. DEA does not 
regulate the size of each prescription or the frequency of medical 
visits; these matters are within the purview of prescribing physician. 
DEA has no authority regarding either the cost of medical care or the 
cost of the medications a prescribing practitioner may prescribe. 
Another commenter requested the name of the company that filed the New 
Drug Application for lisdexamfetamine in order to obtain standard 
analytical reference material and/or analytical data from the company. 
This comment is not relevant to the present scheduling action.

Scheduling of Lisdexamfetamine

    Relying on the scientific and medical evaluation and the 
recommendation of the Acting Assistant Secretary for Health, received 
in accordance with section 201(b) of the Act (21 U.S.C. 811(b)), and 
the independent review of the available data by DEA, and after a review 
of the comments received in response to the Notice of Proposed 
Rulemaking, the Deputy Administrator of DEA, pursuant to sections 
201(a) and 201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:

[[Page 24533]]

    (1) Lisdexamfetamine has a high potential for abuse;
    (2) Lisdexamfetamine has a currently accepted medical use in 
treatment in the United States; and
    (3) Abuse of lisdexamfetamine may lead to severe psychological or 
physical dependence.
    Based on these findings, the Deputy Administrator of DEA concludes 
that lisdexamfetamine, including its salts, isomers, and salts of 
isomers, warrants control in schedule II of the CSA. The applicable 
regulations are as follows:
    Registration. Any person who manufactures, distributes, dispenses, 
imports, exports, engages in research or conducts instructional 
activities with lisdexamfetamine, or who desires to manufacture, 
distribute, dispense, import, export, engage in instructional 
activities or conduct research with lisdexamfetamine, must be 
registered to conduct such activities in accordance with Part 1301 of 
Title 21 of the Code of Federal Regulations. Any person who is 
currently engaged in any of the above activities and is not registered 
with DEA must submit an application for registration on or before June 
4, 2007 and may continue their activities until DEA has approved or 
denied that application.
    Security. Lisdexamfetamine is subject to schedule II security 
requirements and must be manufactured, distributed and stored in 
accordance with Sec. Sec.  1301.71, 1301.72(a), (c), and (d), 1301.73, 
1301.74, 1301.75(b) and (c), 1301.76 and 1301.77 of Title 21 of the 
Code of Federal Regulations on or after June 4, 2007.
    Labeling and Packaging. All labels and labeling for commercial 
containers of lisdexamfetamine must comply with requirements of 
Sec. Sec.  1302.03-1302.07 of Title 21 of the Code of Federal 
Regulations on or after June 4, 2007.
    Quotas. Quotas for lisdexamfetamine must be established pursuant to 
part 1303 of Title 21 of the Code of Federal Regulations.
    Inventory. Every registrant required to keep records and who 
possesses any quantity of lisdexamfetamine must keep an inventory of 
all stocks of lisdexamfetamine on hand pursuant to Sec. Sec.  1304.03, 
1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations on 
or after June 4, 2007. Every registrant who desires registration in 
schedule II for lisdexamfetamine must conduct an inventory of all 
stocks of the substance on hand at the time of registration.
    Records. All registrants must keep records pursuant to Sec. Sec.  
1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of Title 21 of the Code 
of Federal Regulations on or after June 4, 2007.
    Reports. All registrants required to submit reports to the 
Automation of Reports and Consolidated Order System (ARCOS) in 
accordance with Sec.  1304.33 of Title 21 of the Code of Federal 
Regulations must do so for lisdexamfetamine.
    Orders for Lisdexamfetamine. All registrants involved in the 
distribution of lisdexamfetamine must comply with the order 
requirements of part 1305 of Title 21 of the Code of Federal 
Regulations on or after June 4, 2007.
    Prescriptions. All prescriptions for lisdexamfetamine or 
prescriptions for products containing lisdexamfetamine must be issued 
pursuant to 21 CFR 1306.03-1306.06 and 1306.11-1306.15.
    Importation and Exportation. All importation and exportation of 
lisdexamfetamine must be in compliance with part 1312 of Title 21 of 
the Code of Federal Regulations on or after June 4, 2007.
    Criminal Liability. Any activity with lisdexamfetamine not 
authorized by, or in violation of, the Controlled Substances Act or the 
Controlled Substances Import and Export Act shall be unlawful on or 
after June 4, 2007.

Regulatory Certifications

Executive Order 12866

    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 5 U.S.C. 556 and 557 and, as such, are exempt from review 
by the Office of Management and Budget pursuant to Executive Order 
12866, section 3(d)(1).

Regulatory Flexibility Act

    The Deputy Administrator, in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), has reviewed this final rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. Lisdexamfetamine 
products will be prescription drugs used for the treatment of Attention 
Deficit Hyperactivity Disorder (ADHD). Handlers of lisdexamfetamine 
also handle other controlled substances used to treat ADHD which are 
already subject to the regulatory requirements of the CSA.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This 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.

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 
$120,000,000 or more 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.

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act). This rule will not result in an annual 
effect on the economy of $100,000,000 or more; a major increase in 
costs or prices; or significant adverse effects on competition, 
employment, investment, productivity, innovation, or on the ability of 
United States-based companies to compete with foreign-based companies 
in domestic and export markets.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Narcotics, Prescription drugs.


0
Under the authority vested in the Attorney General by section 201(a) of 
the CSA (21 U.S.C. 811(a)), and delegated to the Administrator of DEA 
by Department of Justice regulations (28 CFR 0.100), and redelegated to 
the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy 
Administrator hereby amends 21 CFR part 1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

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


0
2. Section 1308.12 is amended by adding a new paragraph (d)(5) to read 
as follows:


Sec.  1308.12  Schedule II.

* * * * *
    (d) * * *

[[Page 24534]]

    (5) Lisdexamfetamine, its salts, isomers, and salts of its 
isomers--1205.
* * * * *

    Dated: April 25, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-8421 Filed 5-2-07; 8:45 am]
BILLING CODE 4410-09-P