[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Rules and Regulations]
[Pages 16935-16937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6703]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-262F]
Schedules of Controlled Substances: Placement of Zopiclone Into
Schedule IV
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,
zopiclone, including its salts, isomers and salts of isomers into
Schedule IV of the Controlled Substances Act (CSA). As a result of this
rule, the regulatory controls and criminal sanctions of Schedule IV
will be applicable to the manufacture, distribution, dispensing,
importation and exportation of zopiclone and products containing
zopiclone.
DATES: Effective Date: April 4, 2005.
FOR FURTHER INFORMATION CONTACT: Christine Sannerud, Ph.D., Chief, Drug
and Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, (202) 307-7183.
SUPPLEMENTARY INFORMATION: Zopiclone is a central nervous system
depressant drug. On December 15, 2004, the Food and Drug Administration
(FDA) approved (S)-zopiclone (or eszopiclone), the active (S) isomer of
zopiclone, for marketing under the trade name Lunesta TM. Eszopiclone
will be marketed as a prescription drug product for the treatment of
insomnia.
On January 18, 2005, the Acting Assistant Secretary for Health,
Department of Health and Human Services (DHHS), sent the Deputy
Administrator of DEA a letter recommending that zopiclone and its
isomers be placed into Schedule IV of the CSA (21 U.S.C. 801 et seq.).
Enclosed with the January 18, 2005, letter was a document prepared by
the FDA entitled, ``Basis for the Recommendation for Control of
Zopiclone and its Optical Isomers in Schedule IV 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)).
The correspondence from the Acting Assistant Secretary for Health
to DEA dated January 18, 2005, confirmed that FDA approved the New Drug
Application (NDA) for eszopiclone and issued an approval letter to the
NDA sponsor on December 15, 2004. After a review of the available data,
including the DHHS recommendation, the Deputy Administrator of the DEA,
in a February 14, 2005, Federal Register notice of proposed rulemaking
(70 FR 7449), proposed placement of zopiclone into Schedule IV of the
CSA. The proposed rule provided an opportunity for all interested
persons to submit their comments, objections, or requests for hearing
to be received by the DEA on or before March 16, 2005.
Comments Received
DEA received one comment in response to this notice of proposed
rulemaking. The commenter stated that the current federal regulations
governing the process of drug control and approval are excessive and
are interfering with the practice of medicine.
DEA disagrees. The Controlled Substances Act contains specific
mandates pertaining to the scheduling of controlled substances. DEA has
followed all of those mandates regarding the scheduling of zopiclone,
including receiving from the Secretary of DHHS a scientific and medical
evaluation, and recommendation, regarding control (21 U.S.C. 811(b));
considering the factors enumerated in 21 U.S.C. 811(c); determining,
based on the above, appropriate scheduling for zopiclone (21 U.S.C.
812(b)); and conducting a formal rulemaking to schedule zopiclone (21
U.S.C. 811(a)). In no way does this scheduling action interfere with
the practice of medicine.
Scheduling of Zopiclone
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
[[Page 16936]]
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:
(1) Zopiclone has a low potential for abuse relative to the drugs
or other substances in Schedule III;
(2) Zopiclone has a currently accepted medical use in treatment in
the United States; and
(3) Abuse of zopiclone may lead to limited physical dependence or
psychological dependence relative to the drugs or other substances in
Schedule III. (21 U.S.C. 812(b)(4)).
Based on these findings, the Deputy Administrator of DEA concludes
that zopiclone, including its salts, isomers, and salts of isomers,
warrants control in Schedule IV of the CSA.
In order to make zopiclone pharmaceutical products available for
medical use as soon as possible, the Schedule IV controls of zopiclone
will be effective April 4, 2005. In the event that the regulations
impose special hardships on the registrants, the DEA will entertain any
justified request for an extension of time to comply with the Schedule
IV regulations regarding zopiclone. The applicable regulations are as
follows:
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with zopiclone, or who desires to manufacture, distribute,
dispense, import, export, engage in instructional activities or conduct
research with zopiclone, 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 April 4, 2005, and may continue their
activities until DEA has approved or denied that application.
Security. Zopiclone is subject to Schedule III-V security
requirements and must be manufactured, distributed and stored in
accordance with Sec. Sec. 1301.71, 1301.72(b), (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 after April 4, 2005.
Labeling and Packaging. All labels and labeling for commercial
containers of zopiclone shall comply with requirements of Sec. Sec.
1302.03-1302.07 of Title 21 of the Code of Federal Regulations.
Inventory. Every registrant required to keep records and who
possesses any quantity of zopiclone must keep an inventory of all
stocks of zopiclone on hand pursuant to Sec. Sec. 1304.03, 1304.04 and
1304.11 of Title 21 of the Code of Federal Regulations after April 4,
2005. Every registrant who desires registration in Schedule IV for
zopiclone is required to 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 after April 4, 2005.
Prescriptions. All prescriptions for zopiclone or prescriptions for
products containing zopiclone are to be issued pursuant to 21 CFR
1306.03-1306.06 and 1306.21-1306.27. All prescriptions for zopiclone or
products containing zopiclone issued after April 4, 2005, if authorized
for refilling, shall, as of that date, be limited to five refills and
shall not be refilled after October 3, 2005.
Importation and Exportation. All importation and exportation of
zopiclone must be in compliance with part 1312 of Title 21 of the Code
of Federal Regulations after April 4, 2005.
Criminal Liability. Any activity with zopiclone 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 April 4,
2005.
Regulatory Certifications
Administrative Procedure Act
The Administrative Procedure Act permits an agency to make a rule
effective upon the date of publication where the agency finds good
cause exists and publishes its findings with the rule (5 U.S.C.
553(d)(3)). As noted previously, on December 15, 2004, the Food and
Drug Administration (FDA) approved (S)-zopiclone (or eszopiclone), the
active (S) isomer of zopiclone, for marketing under the trade name
Lunesta\TM\. Further, on January 18, 2005, the Acting Assistant
Secretary for Health, Department of Health and Human Services, sent the
Deputy Administrator of DEA a letter recommending that zopiclone and
its isomers be placed into Schedule IV of the Controlled Substances
Act. Since this is a new drug not previously available in the United
States, in order to prevent harm to the public health and safety by
delaying the availability of this new drug, the Drug Enforcement
Administration finds good cause exists to make this Final Rule
effective immediately upon publication.
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. Eszopiclone products
will be prescription drugs used for the treatment of insomnia. Handlers
of eszopiclone also handle other controlled substances used to treat
insomnia which are already subject to the regulatory requirements of
the CSA.
Eszopiclone is a new drug in the United States; recent approval of
the product and its labeling by the FDA will allow it to be marketed
once it is placed into Schedule IV of the CSA. This final rule will
allow these entities to have access to a new pharmaceutical product.
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
$115,000,000 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.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement
[[Page 16937]]
Fairness Act of 1996. 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 [AMENDED]
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 1308.14 is amended by adding a new paragraph (c)(51) to read
as follows:
Sec. 1308.14 Schedule IV.
* * * * *
(c) * * *
(51) Zopiclone--2784
* * * * *
Dated: March 30, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-6703 Filed 3-31-05; 12:24 pm]
BILLING CODE 4410-09-P