[Federal Register: May 3, 2007 (Volume 72, Number 85)]
[Rules and Regulations]
[Page 24532-24534]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my07-3]
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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 TM. 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