Drug Enforcement Administration (DEA), Department of Justice.
Notice of proposed rulemaking.
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.
Comments must be received by February 9, 2001.Start Printed Page 77329
Comments should be submitted in triplicate to the Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537; Attention: DEA Federal Register Representative/CCR.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537, (202) 307-7183.End Further Info End Preamble Start Supplemental 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:
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.
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.
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.
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.
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.Start Printed 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 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.
This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
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.Start List of Subjects
List of Subjects in 21 CFR Part 1308End List of Subjects
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:Start Part
1. The authority citation for 21 CFR part 1308 continues to read as follows:
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:
(c) * * *
Dated: November 30, 2000.
Julio F. Mercado,
[FR Doc. 00-31356 Filed 12-8-00; 8:45 am]
BILLING CODE 4410-09-M