[Federal Register Volume 66, Number 159 (Thursday, August 16, 2001)]
[Rules and Regulations]
[Pages 42943-42944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20579]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-209F]
RIN 1117-AA59


Schedule of Controlled Substances: Placement of 
Dichloralphenazone Into Schedule IV

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

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Acting Administrator 
of the DEA specifically lists the substance dichloralphenazone, 
including its salts, isomers, and salts of isomers in Schedule IV of 
the Controlled Substances Act (CSA, 21 U.S.C. 801 et seq.). 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 dichloralphenazone and 
products containing dichloralphenazone.

EFFECTIVE DATE: Effective August 16, 2001.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 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-3H-pyrazol-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 Rulemaking?

    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.
    Since dichloralphenazone has not been recognized as a compound 
containing chloral hydrate and confusion has existed with regard to its 
control status, the DEA published a proposed rule in the Federal 
Register on December 11, 2000 (65 FR 77328) to expressly list 
dichloralphenazone as a Schedule IV depressant. This proposed rule 
provided 60 days for comments.

Were There Any Comments Regarding the Proposed Rule?

    The DEA received two comments regarding the proposal. The 
Healthcare Distribution Management Association (formerly the National 
Wholesale Druggists' Association), whose members operate over 200 
distribution centers throughout the U.S., requested an additional 30 
days from the date of publication of this final rule to comply with 
security, inventory, recordkeeping and reporting, and importing and 
exporting requirements for the handling of dichloralphenazone. They 
felt that moving dichloralphenazone from an uncontrolled status to a 
controlled status required system and operational changes that could 
not be implemented immediately upon publication of this final rule. The 
DEA has no objection to the additional 30 days and is incorporating 
this change into this final rule.
    Elan Pharmaceuticals, manufacturer of Midrin (a 
prescription product containing isometheptene, dichloralphenazone and 
acetaminophen marketed in the U.S. for over 30 years) commented that 
federal and state authorities have not regulated dichloralphenazone as 
a Schedule IV substance, physicians and pharmacists have not treated 
Midrin as a controlled drug product and major drug 
compendiums (Physician's Desk Reference, Merck Index, Drug Facts and 
Comparisons) have not identified dichloralphenazone or Midrin 
as a controlled substance. In addition they noted that the DEA 
interpretation that Midrin is a scheduled drug would likely 
affect prescribing practices and raise DEA registration, labeling, 
recordkeeping and reporting issues and create confusion among 
practitioners and patients. Further, Elan poses that there is little 
evidence that Midrin or any other dichloralphenazone product 
has been misused, abused or diverted. The DEA received a formal request 
from Elan Pharmaceuticals for an exemption for Midrin as an 
exempt non-narcotic prescription product. That request will be 
evaluated according to 21 CFR 1308.31.
    The DEA is aware that dichloralphenazone and products containing 
this substance have not been identified or treated as controlled 
substances. The determination that dichloralphenazone is a controlled 
substance is based, in part, on its status as a compound containing 
chloral hydrate. In addition, numerous drug abuse emergency room 
episodes have involved Midrin. The DEA has made every effort 
to reduce any confusion on the part of handlers of dichloralphenazone 
or products containing this substance and chose to expressly list this 
substance in order to eliminate confusion. The DEA invites any other 
company to submit a formal request for an exemption from Schedule IV 
regulation for any dichloralphenazone product. The data submitted under 
21 CFR 1308.31 are evaluated to determine if such an exemption is 
warranted.

What Regulatory Requirements Will Be Applied to Handlers of 
Dichoralphenazone?

    Persons who manufacture, distribute, dispense, import, export, 
store or engage in research with dichloralphenazone must comply with 
the following regulatory requirements:
    1. Registration. Any person who manufactures, distributes, 
dispenses, imports or exports dichloralphenazone or engages in research 
or conducts instructional activities or chemical analysis with respect 
to this preparation must be registered to conduct such activities in 
accordance with 21 CFR part 1301. Any person who is currently engaged 
in any of the above activities must submit an application for 
registration by September 17, 2001 and may 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 
September 17, 2001, 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

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September 17, 2001. 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 September 17, 
2001.
    4. Labeling and packaging. All commercial containers of 
dichloralphenazone that are packaged on or after February 12, 2002 must 
have the appropriate Schedule IV labeling and packaging as required by 
21 CFR 1302.03-1302.07. Commercial containers of dichloralphenazone 
packaged before February 12, 2002 and not meeting the requirements 
specified in 21 CFR 1302.03-1302.07 may be distributed until May 13, 
2002. On and after May 13, 2002 all commercial containers of 
dichloralphenazone must bear the CIV labels as specified in 21 CFR 
1302.03-1032.07.
    5. Inventory. Registrants possessing dichloralphenazone are 
required to take inventories pursuant to 21 CFR 1304.03, 1304.04 and 
1304.11 after September 17, 2001.
    6. Records. All registrants must keep records pursuant to 21 CFR 
1304.03, 1304.04 and 1304.21-1304.23 after September 17, 2001.
    7. Prescriptions. All prescriptions for dichloralphenazone or 
prescriptions for products containing 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 October 15, 2001, if authorized 
for refilling, shall, as of that date, be limited to five refills and 
shall not be refilled after February 12, 2002.
    8. Importation and Exportation. All importation and exportation of 
dichloralphenazone shall be in compliance with 21 CFR part 1312 after 
September 17, 2001.
    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 August 16, 2001, 
except as authorized in this rule.

Regulatory Certifications

Regulatory Flexibility Act

    The Acting 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 Acting 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, DC 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), the Acting Administrator hereby rules 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 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.
* * * * *

    Dated: August 3, 2001.
William B. Simpkins,
Acting Administrator.
[FR Doc. 01-20579 Filed 8-15-01; 8:45 am]
BILLING CODE 4410-09-M