[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Rules and Regulations]
[Pages 6862-6864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3439]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA No. 173F]
Schedules of Controlled Substances: Placement of Sibutramine 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 Acting Deputy
Administrator of the Drug Enforcement Administration (DEA) places the
substance,
[[Page 6863]]
sibutramine, including its salts and optical 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, importation and
exportation of sibutramine and products containing sibutramine.
EFFECTIVE DATE: February 11, 1998.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Sibutramine is an amphetamine analogue
pharmacologically similar to other anorectic agents that produce
central nervous system stimulation and amphetamine-like effects in
humans and animals. Sibutramine hydrochloride will be marketed under
the trade name of Meridia as an oral anorectic for the long-term
management of obesity.
The Acting Deputy Administrator of the DEA received a letter dated
November 12, 1997, from the Acting Assistant Secretary of Health, on
behalf of the Secretary of the Department of Health and Human Services
(DHHS), recommending that the substance, sibutramine, and its salts and
isomers, be placed into Schedule IV of the CSA (21 U.S.C. 801 et seq.).
Encloded with the letter from the Assistant Secretary was a document
prepared by the Food and Drug Administration (FDA) entitled ``Basis for
the Recommendation for Control of Sibutramine and its Salts 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)] and the summarized recommendations regarding the
placement of sibutramine into Schedule IV of the CSA. The Acting Deputy
Administrator of the DEA, in a December 8, 1997, Federal Register
notice (62 FR 64526), proposed placement of sibutramine into Schedule
IV of the CSA. The notice provided an opportunity for all interested
persons to submit their comments, objections, or requests for hearing
in writing to be received by the DEA on or before January 7, 1998. The
DEA received no comments, objections or requests for hearing.
Based on the scientific and medical evaluation and the
recommendation of the Assistant Secretary for Health, the FDA New Drug
Application (NDA) approval on November 22, 1997, and a DEA review, the
Acting Deputy Administrator of the DEA, pursuant to sections 201(a) and
201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:
(1) Sibutramine has a low potential for abuse relative to the drugs
or other substances in Schedule III.
(2) Sibutramine has a currently accepted medical use in treatment
in the United States.
(3) Abuse of sibutramine may lead to limited physical and
psychological dependence relative to drugs or other substances in
Schedule III.
Based on these findings, the Acting Deputy Administrator of the DEA
concludes that sibutramine, including its salts and isomers, warrants
control in Schedule IV of the CSA. In order to make sibutramine
pharmaceutical products available for medical use as soon as possible,
the Schedule IV controls of sibutramine will be effective February 11,
1998. 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
sibutramine. The applicable regulations are as follows:
1. Registration. Any person who manufactures, distributes,
dispenses, imports or exports sibutramine or who engages in research or
conducts instructional activities with sibutramine, or who proposes to
engage in such activities, must be registered to conduct such
activities in accordance with Part 1301 of Title 21 of the Code of
Federal Regulations.
2. Security. Sibutramine must be manufactured, distributed and
stored in accordance with Secs. 1301.71, 1301.72 (b), (c), and (d),
1301.73, 1301.74, 1301.75 (b) and (c) and 1301.76 of Title 21 of the
Code of Federal Regulations.
3. Labeling and Packaging. All labels on commercial containers of,
and all labeling of, sibutramine which is distributed shall comply with
the requirements of Secs. 1302.03-1302.07 of Title 21 of the Code of
Federal Regulations.
4. Inventory. Registrants possessing sibutramine are required to
take inventories pursuant to Secs. 1304.03, 1304.04 and 1304.11 of
Title 21 of the Code of Federal Regulations.
5. Records. All registrants must keep records pursuant to
Secs. 1304.03, 1304.04 and 1304.21-1304.23 of Title 21 of the Code of
Federal Regulations.
6. Prescriptions. All prescriptions for sibutramine are to be
issued pursuant to Secs. 1306.03-1306.06 and 1306.21-1306.26 of Title
21 of the Code of Federal Regulation.
7. Importation and Exportation. All importation and exportation of
sibutramine shall be in compliance with Part 1312 of Title 21 of the
Code of Federal Regulations.
8. Criminal Liability. Any activity with sibutramine not authorized
by, or in violation of, the CSA or the Controlled Substances Import and
Export Act shall be unlawful.
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 (E.O.) 12866,
Section 3(d)(1).
The Acting 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-business entities. Sibutramine
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.
This rule will not result in the expenditure by State, local and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more in any one year, and it will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement 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 the United States-based companies to
compete with foreign-based companies in domestic and export markets.
This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with E.O. 12612, it is
determined that this rule does not have sufficient federalism
implications to warrant the preparation of a Federalism Assessment.
[[Page 6864]]
List of Subjects in 21 CFR Part 1308
Administraitve practice and procedure, Drug traffic control,
Narcotics, Prescription drugs.
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 the DEA by the Department of Justice regulations (28
CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28
CFR 0.104, the Acting Deputy Administrator hereby amends 21 CFR part
1308 as follows:
PART 1308--[AMENDED]
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.
2. Section 1308.14 is amended by redesignating the existing
paragraph (e)(10) as (e)(11) and adding a new paragraph (e)(10) to read
as follows:
Sec. 1308.14 Schedule IV.
* * * * *
(e) * * *
(10) Sibutramine...................................................1675
* * * * *
Dated: February 5, 1998.
Peter F. Gruden,
Acting Deputy Administrator.
[FR Doc. 98-3439 Filed 2-10-98; 8:45 am]
BILLING CODE 4410-09-M