[Federal Register Volume 65, Number 238 (Monday, December 11, 2000)]
[Proposed Rules]
[Pages 77328-77330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31356]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-209P]
RIN 1117-AA59


Schedule of Controlled Substances: Placement of 
Dichloralphenazone Into Schedule IV

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This proposed rule is issued by the Deputy Administrator of 
the Drug Enforcement Administration (DEA) to expressly list 
dichloralphenazone as a Schedule IV controlled substance under the 
Controlled Substances Act (CSA). This proposed action is based on the 
DEA's interpretation that dichloralphenazone is a compound containing 
chloral hydrate, a Schedule IV controlled substance under 21 CFR part 
1308; by definition, dichloralphenazone is also a Schedule IV 
substance. If finalized, this action will impose the regulatory 
controls and criminal sanctions of Schedule IV on those persons who 
handle dichloralphenazone or products containing dichloralphenazone.

DATES: Comments must be received by February 9, 2001.

[[Page 77329]]


ADDRESSES: Comments should be submitted in triplicate to the Deputy 
Administrator, Drug Enforcement Administration, Washington, D.C. 20537; 
Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, D.C. 20537, (202) 307-7183.

SUPPLEMENTARY INFORMATION:

What Is Dichloralphenazone?

    Dichloralphenazone (also known as dichloralantipyrine) is a 
compound containing two molecules of chloral hydrate (2,2,2-trichloro-
1,1-ethanediol) and one molecule of phenazone (1,2-dihydro-1,5-
dimethyl-2-phenyl-3Hpyrazol-3-one); CAS No. 480-30-8. 
Dichloralphenazone is a sedative typically used in combination with 
isometheptene mucate and acetaminophen in formulating prescription 
pharmaceuticals for the relief of tension and vascular headaches. When 
dichloralphenazone is administered or placed in an aqueous solution (a 
liquid preparation of any substance dissolved in water) it dissociates 
to form chloral hydrate and phenazone.

Why Is DEA Issuing This Notice?

    Schedule IV controlled substances are listed in 21 CFR 1308.14. 
Section 1308.14(c) lists 49 depressants, including chloral hydrate, 
that are Schedule IV controlled substances. The first sentence of 21 
CFR 1308.14(c) states that the category of Schedule IV depressants 
includes ``any material, compound, mixture, or preparation which 
contains any quantity of'' the substances listed in the section. Since 
dichloralphenazone is a compound containing chloral hydrate, it is 
likewise a Schedule IV depressant.
    It has come to the attention of the DEA that a large portion of the 
pharmaceutical industry that handles dichloralphenazone or products 
containing dichloralphenazone has failed to recognize that this is a 
compound containing chloral hydrate. To clarify this situation, the 
Deputy Administrator is publishing this notice proposing that 
dichloralphenazone be expressly listed as a Schedule IV depressant and 
assigned a specific DEA control number.

What Is the Effect of This Notice?

    This notice clarifies the DEA's position regarding the control 
status for dichloralphenazone. This proposed rule, if finalized, would 
specifically list dichloralphenazone as a Schedule IV depressant. In 
addition, this notice provides an opportunity for interested persons to 
comment, in writing, with regard to any information they feel may have 
a bearing on this matter.

What Regulatory Requirements Will Be Applied to Handlers of 
Dichloralphenazone?

    Persons currently involved with the manufacture or handling of this 
substance are not expected to comply with DEA regulations applicable to 
a Schedule IV substance until such time as a final rule is published in 
the Federal Register. If/When a final rule is published in the Federal 
Register, persons who manufacture, distribute, dispense, import, 
export, store or engage in research with dichloralphenazone will be 
provided with delayed dates for compliance with Federal regulations in 
order to avoid imposing any special hardship. Upon publication of a 
final rule, the applicable regulations and amount of time for 
compliance will be as follows:

1. Registration

    Any person who manufactures, distributes, dispenses, imports or 
exports dichloralphenazone or who engages in research or conducts 
instructional activities or chemical analysis with respect to this 
preparation, or who proposes to engage in such activities, must be 
registered to conduct such activities in accordance with 21 CFR part 
1301 on and after 30 days from date of the publication of the final 
rule in the Federal Register. Any person who is currently engaged in 
any of the above activities must submit an application for registration 
by 30 days from date of publication of the final rule in the Federal 
Register. Any such person may then continue their activities until the 
DEA has approved or denied that application.

2. Disposal of Stocks

    Any person who elects not to obtain a Schedule IV registration or 
is not entitled to such registration must surrender all quantities of 
currently held dichloralphenazone in accordance with procedures 
outlined in 21 CFR 1307.21 on or before 30 days from date of 
publication of the final rule in the Federal Register, or may transfer 
all quantities of currently held dichloralphenazone to a person 
registered under the CSA and authorized to possess Schedule IV control 
substances on or before 30 days from date of publication of the final 
rule in the Federal Register. Dichloralphenazone to be surrendered to 
DEA must be listed on a DEA Form 41, ``Inventory of Controlled 
Substances Surrendered for Destruction.'' DEA Form 41 and instructions 
can be obtained from the nearest DEA office.

3. Security

    Dichloralphenazone must be manufactured, distributed and stored in 
accordance with 21 CFR 1301.71, 1301.72(b), (c), and (d), 1301.73, 
1301.74, 1301.75(b) and (c) and 1301.76 after date of publication of 
the final rule in the Federal Register.

4. Labeling and Packaging

    All commercial containers of dichloralphenazone that are packaged 
on or after 180 days from date of publication of the final rule in the 
Federal Register must have the appropriate Schedule IV labeling and 
packaging as required by 21 CFR 1302.03-1302.07. Commercial containers 
of dichloralphenazone packaged before 180 days from date of publication 
of the final rule in the Federal Register and not meeting the 
requirements specified in 21 CFR 1302.03-1302.07 may be distributed 
until 270 days from date of publication of the final rule in the 
Federal Register. On and after 270 days from date of publication of the 
final rule in the Federal Register all commercial containers of 
dichloralphenazone must bear the CIV labels as specified in 21 CFR 
1302.03-1302.07.

5. Inventory

    Registrants possessing dichloralphenazone are required to take 
inventories pursuant to 21 CFR 1304.03, 1304.04 and 1304.11 after 
publication of the final rule in the Federal Register.

6. Records

    All registrants must keep records pursuant to 21 CFR 1304.03, 
1304.04 and 1304.21-1304.23 after publication of the final rule in the 
Federal Register.

7. Prescriptions

    All prescriptions for dichloralphenazone or prescriptions for 
products containing dichloralphenazone are to be issued pursuant to 21 
CFR 1306.03-1306.06 and 1306.21-1306.26. All prescriptions for 
dichloralphenazone or products containing dichloralphenazone issued on 
or before 60 days from date of publication of the final rule in the 
Federal Register, if authorized for refilling, shall, as of that date, 
be limited to five refills and shall not be refilled after 180 days 
from date of publication of the final rule in the Federal Register.

[[Page 77330]]

8. Importation and Exportation

    All importation and exportation of dichloralphenazone shall be in 
compliance with 21 CFR part 1312 after publication of the final rule in 
the Federal Register.

9. Criminal Liability

    Any activity with dichloralphenazone not authorized by, or in 
violation of, the CSA or the Controlled Substances Import and Export 
Act shall be unlawful on or after 30 days from date of publication of 
the final rule in the Federal Register, except as authorized in that 
rule.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Administrator hereby certifies that this rulemaking has 
been drafted in a manner consistent with the principles of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). It will not have a 
significant economic impact on a substantial number of small business 
entities. Most handlers of dichloralphenazone or prescription products 
containing this substance are already registered to handle controlled 
substances and are subject to the regulatory requirements of the CSA.

Executive Order 12866

    The Deputy Administrator further certifies that this rulemaking has 
been drafted in accordance with the principles in Executive Order 12866 
Section 1(b). DEA has determined that this is not a significant 
rulemaking action. Therefore, this action has not been reviewed by the 
Office of Management and Budget.

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 
$100,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the 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.

Plain Language Instructions

    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
this regulation, call or write Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537, telephone (202) 307-7297.

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 CSA [21 U.S.C. 811(a)], and delegated to the 
Administrator of the DEA by the Department of Justice regulations (21 
CFR 0.100), and redelegated to the Deputy Administrator of the DEA 
pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes that 
21 CFR part 1308 be amended 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 proposed to be amended by redesignating the 
existing paragraphs (c)(15) through (c)(49) as (c)(16) through (c)(50) 
and by adding a new paragraph (c)(15) to read as follows:


Sec. 1308.14  Schedule IV.

* * * * *
    (c) * * *

(15) Dichloralphenazone..........................................   2467
 

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    Dated: November 30, 2000.
Julio F. Mercado,
Deputy Administrator.
[FR Doc. 00-31356 Filed 12-8-00; 8:45 am]
BILLING CODE 4410-09-M