[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