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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.
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
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.
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.
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.
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.
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES [AMENDED]
0 1. The authority citation for 21 CFR part 1308 continues to read as follows: