Federal
Register Notices > Rules
- 2006 >
Schedules of Controlled Substances: Placement of Embutramide
Into Schedule III
FR Doc E6-14287 [Federal Register: August 29, 2006 (Volume 71, Number 167)]
[Rules and Regulations] [Page 51115-51117] From the Federal Register Online
via GPO Access [wais.access.gpo.gov] [DOCID:fr29au06-6]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-269F]
21 CFR Part 1308
Schedules of Controlled Substances: Placement of Embutramide Into
Schedule III
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
SUMMARY: With the issuance of this final rule, the Deputy
Administrator of the Drug Enforcement Administration (DEA) places the
substance embutramide, including its salts, into Schedule III of the
Controlled Substances Act (CSA). As a result of this rule, the regulatory
controls and criminal sanctions of Schedule III will be applicable to the
manufacture, distribution, dispensing, importation and exportation of
embutramide and products containing embutramide.
DATES: Effective Date: September 28, 2006.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D.,
Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, (202) 307-7183.
SUPPLEMENTARY INFORMATION: Embutramide has the chemical name of
N-[2- (m-methoxyphenyl)-2-ethyl-butyl]-gamma-hydroxybutyramide (CAS number
15687-14-6). On May 20, 2005, the Food and Drug Administration (FDA) approved
a New Animal Drug Application (NADA) for embutramide for marketing under the
trade name TributameTM Euthanasia Solution (70 FR 36336). This product is a
combination of embutramide, chloroquine phosphate, and lidocaine for
prescription use by intravenous injection for euthanasia of dogs.
On January 26, 2005, the Acting 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 embutramide
be placed into Schedule III of the CSA. Enclosed with the January 26, 2005,
letter was a document prepared by the FDA entitled, ``Basis for the
Recommendation to Control Embutramide in Schedule III 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))
Similar to barbiturates, embutramide has a central nervous system (CNS)
depressant effect. It produces a reversible stupor-like state (narcosis) in
experimental animals. The effects of embutramide on locomotor activity,
rearing, forelimb grip strength, hind-limb splay, and the performance of
inverted screen tests on rodents were similar to those of pentobarbital, a
classical barbiturate. Embutramide mimics discriminative stimulus effects of
pentrobarbital in mice. Methohexital-trained rhesus monkeys self-administer
embutramide, suggesting that embutramide produces positive reinforcing
effects.
The pharmacological data suggest that the abuse potential of embutramide
may be similar to that of CNS depressants such as barbiturates and their
products (Schedule III through IV) that are controlled under the CSA.
Embutramide as one of the ingredients in the veterinary euthanasia drug
product T-61, was previously marketed in the United States. T-16 was withdrawn
from the market in 1991. Embutramide is not currently marketed in the United
States. During the period of marketing of T-61, a limited number of case
reports of suicides, attempted suicides, and accidental exposures involving
this and similar embutramide containing products were published in the
scientific literature. DEA searched, but has not found, any evidence of abuse
or trafficking of either T-61 or embutramide.
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 July 29, 2005, Federal Register Notice of
Proposed Rulemaking (70 FR 43809), proposed placement of embutramide into
Schedule III 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 August 29, 2005.
On August 2, 2005, DEA received a request for an extension of the period in
which to comment and request a hearing. The requestor indicated that the
additional time was necessary to review the scientific articles and other
information cited by DEA in support of its scheduling proposal. DEA granted a
30 day extension of the time to comment and request a hearing, until September
28, 2005 (70 FR 50996).
Comments Received
DEA received two comments in response to the notice of proposed rulemaking.
One commenter supported the current proposal to control embutramide as a
Schedule III drug. Another commenter supported the proposal to schedule
embutramide, the substance, but not its finished pharmaceutical product,
TributameTM. This commenter stated that the abuse potential of TributameTM is
non-existent because the negative characteristics such as the presence of a
cardiotoxin and the high cost of this formulation outweigh its desirable
effects.
DEA does not agree. Careful consideration of all the available data
suggests that the amounts of cardiotoxin present in the TributameTM
formulation are insufficient to eliminate the abuse potential of this product.
DEA field experience suggests that the cost of a given product is not a
consistent predictor of its actual abuse.
DEA also received a request for a hearing on the scheduling of embutramide
and a request for an exemption of the product, TributameTM, from scheduling;
however, the requestor subsequently withdrew these requests and asked that the
scheduling of embutramide be expedited.
Scheduling of Embutramide
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) Based on information now available, embutramide has a potential for
abuse less than the drugs or other substances in Schedules I and II;
(2) Embutramide has a currently accepted medical use in treatment in the
United States; and
[[Page 51116]]
(3) Abuse of embutramide may lead to moderate or low physical dependence or
high psychological dependence.
Based on these findings, the Deputy Administrator of DEA concludes that
embutramide, including its salts, warrants control in Schedule III 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 embutramide, or who desires to manufacture, distribute, dispense, import,
export, engage in instructional activities or conduct research with
embutramide, 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 September 28,
2006 and may continue their activities until DEA has approved or denied that
application.
Security. Embutramide is subject to Schedule III-V security
requirements and must be manufactured, distributed and stored in accordance
with Sections
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 on and
after September 28, 2006.
Labeling and Packaging. All labels and labeling for commercial
containers of embutramide shall comply with requirements of Sections
1302.03-1302.07 of Title 21 of the Code of Federal Regulations and on and
after September 28, 2006.
Inventory. Every registrant required to keep records and who
possesses any quantity of embutramide must keep an inventory of all stocks of
embutramide on hand pursuant to Sections
1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal
Regulations on and after September 28, 2006. Every registrant who desires
registration in Schedule III for embutramide 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 Sections 1304.03,
1304.04, 1304.21, 1304.22, and 1304.23 of Title 21 of the Code of Federal
Regulations on and after September 28, 2006.
Prescriptions. All prescriptions for embutramide or prescriptions
for products containing embutramide are to be issued pursuant to 21
CFR 1306.03-1306.06 and 1306.21-1306.27. All prescriptions for embutramide
or products containing embutramide issued on and after September 28, 2006, if
authorized for refiling, shall, as of that date, be limited to five refills
and shall not be refilled after six months of the date is issuance.
Importation and Exportation. All importation and exportation of
embutramide must be in compliance with part
1312 of Title 21 of the Code of Federal Regulations on and after September
28, 2006.
Criminal Liability. Any activity with embutramide not authorized by,
or in violation of, the Controlled Substances Act or the Controlled Substances
Import and Export Act shall be unlawful on and after September 28, 2006.
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. 56 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. Embutramide products will be prescription drugs used for the
euthanasia of animals. Handlers of embutramide also handle other controlled
substances used to euthanize animals which are already subject to the
regulatory requirements of the CSA.
Embutramide 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 III of the CSA. This finalrule 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 $118,000,000 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 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.
- Under the authority vested in the Attorney General by section 201(a) of
the Controlled Substances Act (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
- 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
1308.13 is amended by redesignating paragraphs (c)(5) through (c)(13)
as paragraphs (c)(6) through (c)(14), and adding a new paragraph (c)(5) to
read as follows:
Sec. 1308.13 Schedule III.
* * * * *
(c) * * *
(5) Embutramide . . . . 2020
* * * * *
[[Page 51117]]
Dated: August 22, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-14287 Filed 8-28-06; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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