Federal Register / Vol. 66, No. 159 / Thursday, August 16, 2001 / Rules and Regulations 42943
DEPARTMENT OF JUSTICE Schedule IV controlled substances. The any other dichloralphenazone product first sentence of 21 CFR 1308.14(c) has been misused, abused or diverted. Drug Enforcement Administration states that the category of Schedule IV The DEA received a formal request from depressants includes ‘‘any material, Elan Pharmaceuticals for an exemption 21 CFR Part 1308 compound, mixture, or preparation for Midrin as an exempt non-narcotic which contains any quantity of’’ the prescription product. That request will [DEA–209F] substances listed in the section. Since be evaluated according to 21 CFR RIN 1117–AA59 dichloralphenazone is a compound 1308.31. containing chloral hydrate, it is likewise The DEA is aware that Schedule of Controlled Substances: a Schedule IV depressant. dichloralphenazone and products Placement of Dichloralphenazone Into Since dichloralphenazone has not containing this substance have not been Schedule IV been recognized as a compound identified or treated as controlled containing chloral hydrate and substances. The determination that AGENCY: Drug Enforcement confusion has existed with regard to its dichloralphenazone is a controlled Administration (DEA), Department of control status, the DEA published a substance is based, in part, on its status Justice. proposed rule in the Federal Register on as a compound containing chloral ACTION: Final rule. December 11, 2000 (65 FR 77328) to hydrate. In addition, numerous drug expressly list dichloralphenazone as a abuse emergency room episodes have SUMMARY: With the issuance of this final Schedule IV depressant. This proposed involved Midrin. The DEA has made rule, the Acting Administrator of the rule provided 60 days for comments. every effort to reduce any confusion on DEA specifically lists the substance the part of handlers of Were There Any Comments Regarding dichloralphenazone, including its salts, dichloralphenazone or products the Proposed Rule? isomers, and salts of isomers in containing this substance and chose to Schedule IV of the Controlled The DEA received two comments expressly list this substance in order to Substances Act (CSA, 21 U.S.C. 801 et regarding the proposal. The Healthcare eliminate confusion. The DEA invites seq.). As a result of this rule, the Distribution Management Association any other company to submit a formal regulatory controls and criminal (formerly the National Wholesale request for an exemption from Schedule sanctions of Schedule IV will be Druggists’ Association), whose members IV regulation for any applicable to the manufacture, operate over 200 distribution centers dichloralphenazone product. The data distribution, dispensing, importation throughout the U.S., requested an submitted under 21 CFR 1308.31 are and exportation of dichloralphenazone additional 30 days from the date of evaluated to determine if such an and products containing publication of this final rule to comply exemption is warranted. dichloralphenazone. with security, inventory, recordkeeping and reporting, and importing and What Regulatory Requirements Will Be EFFECTIVE DATE: Effective August 16, Applied to Handlers of 2001. exporting requirements for the handling of dichloralphenazone. They felt that Dichoralphenazone? FOR FURTHER INFORMATION CONTACT: moving dichloralphenazone from an Persons who manufacture, distribute, Frank Sapienza, Chief, Drug and uncontrolled status to a controlled dispense, import, export, store or engage Chemical Evaluation Section, Drug status required system and operational in research with dichloralphenazone Enforcement Administration, changes that could not be implemented must comply with the following Washington, DC 20537, (202) 307–7183. immediately upon publication of this regulatory requirements: SUPPLEMENTARY INFORMATION: final rule. The DEA has no objection to 1. Registration. Any person who the additional 30 days and is manufactures, distributes, dispenses, What Is Dichloralphenazone? incorporating this change into this final imports or exports dichloralphenazone Dichloralphenazone (also known as rule. or engages in research or conducts dichloralantipyrine) is a compound Elan Pharmaceuticals, manufacturer instructional activities or chemical containing two molecules of chloral of Midrin (a prescription product analysis with respect to this preparation hydrate (2,2,2-trichloro-1,1-ethanediol) containing isometheptene, must be registered to conduct such and one molecule of phenazone (1,2- dichloralphenazone and acetaminophen activities in accordance with 21 CFR dihydro-1,5-dimethyl-2-phenyl-3H- marketed in the U.S. for over 30 years) part 1301. Any person who is currently pyrazol-3-one); CAS No. 480–30–8. commented that federal and state engaged in any of the above activities Dichloralphenazone is a sedative authorities have not regulated must submit an application for typically used in combination with dichloralphenazone as a Schedule IV registration by September 17, 2001 and isometheptene mucate and substance, physicians and pharmacists may continue their activities until the acetaminophen in formulating have not treated Midrin as a controlled DEA has approved or denied that prescription pharmaceuticals for the drug product and major drug application. relief of tension and vascular headaches. compendiums (Physician’s Desk 2. Disposal of stocks. Any person who When dichloralphenazone is Reference, Merck Index, Drug Facts and elects not to obtain a Schedule IV administered or placed in an aqueous Comparisons) have not identified registration or is not entitled to such solution (a liquid preparation of any dichloralphenazone or Midrin as a registration must surrender all substance dissolved in water) it controlled substance. In addition they quantities of currently held dissociates to form chloral hydrate and noted that the DEA interpretation that dichloralphenazone in accordance with phenazone. Midrin is a scheduled drug would procedures outlined in 21 CFR 1307.21 likely affect prescribing practices and on or before September 17, 2001, or may Why Is DEA Issuing This Rulemaking? raise DEA registration, labeling, transfer all quantities of currently held Schedule IV controlled substances are recordkeeping and reporting issues and dichloralphenazone to a person listed in 21 CFR 1308.14. Section create confusion among practitioners registered under the CSA and 1308.14(c) lists 49 depressants, and patients. Further, Elan poses that authorized to possess Schedule IV including chloral hydrate, that are there is little evidence that Midrin or control substances on or before
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September 17, 2001. drafted in a manner consistent with the Plain Language Instructions Dichloralphenazone to be surrendered principles of the Regulatory Flexibility The Drug Enforcement to DEA must be listed on a DEA Form Act (5 U.S.C. 601 et seq.). It will not Administration makes every effort to 41, ‘‘Inventory of Controlled Substances have a significant economic impact on write clearly. If you have suggestions as Surrendered for Destruction.’’ DEA a substantial number of small business to how to improve the clarity of this Form 41 and instructions can be entities. Most handlers of regulation, call or write Patricia M. obtained from the nearest DEA office. dichloralphenazone or prescription Good, Chief, Liaison and Policy Section, 3. Security. Dichloralphenazone must products containing this substance are Office of Diversion Control, Drug be manufactured, distributed and stored already registered to handle controlled Enforcement Administration, in accordance with 21 CFR 1301.71, substances and are subject to the Washington, DC 20537, telephone (202) 1301.72(b), (c), and (d), 1301.73, regulatory requirements of the CSA. 307–7297. 1301.74, 1301.75(b) and (c) and 1301.76 Executive Order 12866 after September 17, 2001. List of Subjects in 21 CFR Part 1308 4. Labeling and packaging. All The Acting Administrator further Administrative practice and commercial containers of certifies that this rulemaking has been procedure, Drug traffic control, dichloralphenazone that are packaged drafted in accordance with the Narcotics, Prescription drugs. on or after February 12, 2002 must have principles in Executive Order 12866 Under the authority vested in the the appropriate Schedule IV labeling section 1(b). DEA has determined that Attorney General by section 201(a) of and packaging as required by 21 CFR this is not a significant rulemaking the CSA [21 U.S.C. 811(a)], and 1302.03–1302.07. Commercial action. Therefore, this action has not delegated to the Administrator of the containers of dichloralphenazone been reviewed by the Office of DEA by the Department of Justice packaged before February 12, 2002 and Management and Budget. regulations (21 CFR 0.100), the Acting not meeting the requirements specified Administrator hereby rules that 21 CFR in 21 CFR 1302.03–1302.07 may be Executive Order 12988 part 1308 be amended as follows: distributed until May 13, 2002. On and This regulation meets the applicable after May 13, 2002 all commercial standards set forth in Sections 3(a) and PART 1308—[AMENDED] containers of dichloralphenazone must 3(b)(2) of Executive Order 12988 Civil bear the CIV labels as specified in 21 Justice Reform. 1. The authority citation for 21 CFR CFR 1302.03–1032.07. part 1308 continues to read as follows: 5. Inventory. Registrants possessing Executive Order 13132 Authority: 21 U.S.C. 811, 812, 871(b) dichloralphenazone are required to take This rulemaking does not preempt or unless otherwise noted. inventories pursuant to 21 CFR 1304.03, modify any provision of state law; nor 2. Section 1308.14 is amended by 1304.04 and 1304.11 after September 17, does it impose enforcement 2001. redesignating the existing paragraphs responsibilities on any state; nor does it (c)(15) through (c)(49) as (c)(16) through 6. Records. All registrants must keep diminish the power of any state to records pursuant to 21 CFR 1304.03, (c)(50) and by adding a new paragraph enforce its own laws. Accordingly, this (c)(15) to read as follows: 1304.04 and 1304.21–1304.23 after rulemaking does not have federalism September 17, 2001. implications warranting the application § 1308.14 Schedule IV. 7. Prescriptions. All prescriptions for of Executive Order 13132. * * * * * dichloralphenazone or prescriptions for (c) * * * products containing dichloralphenazone Unfunded Mandates Reform Act of 1995 (15) Dichloralphenazone—2467. or prescriptions for products containing This rule will not result in the * * * * * dichloralphenazone are to be issued expenditure by State, local, and tribal pursuant to 21 CFR 1306.03–1306.06 governments, in the aggregate, or by the Dated: August 3, 2001. and 1306.21–1306.26. All prescriptions private sector, of $100,000,000 or more William B. Simpkins, for dichloralphenazone or products in any one year, and will not Acting Administrator. containing dichloralphenazone issued significantly or uniquely affect small [FR Doc. 01–20579 Filed 8–15–01; 8:45 am] on or before October 15, 2001, if governments. Therefore, no actions were BILLING CODE 4410–09–M authorized for refilling, shall, as of that deemed necessary under the provisions date, be limited to five refills and shall of the Unfunded Mandates Reform Act not be refilled after February 12, 2002. of 1995. DEPARTMENT OF JUSTICE 8. Importation and Exportation. All importation and exportation of Small Business Regulatory Enforcement Drug Enforcement Administration dichloralphenazone shall be in Fairness Act of 1996 compliance with 21 CFR part 1312 after This rule is not a major rule as 21 CFR Part 1310 September 17, 2001. defined by Section 804 of the Small [DEA–156FF] 9. Criminal Liability. Any activity Business Regulatory Enforcement with dichloralphenazone not authorized Fairness Act of 1996. This rule will not RIN #1117–AA43 by, or in violation of, the CSA or the result in an annual effect on the Listed Chemicals; Establishment of Controlled Substances Import and economy of $100,000,000 or more; a Export Act shall be unlawful on or after Non-Regulated Transactions in major increase in costs or prices; or Anhydrous Hydrogen Chloride August 16, 2001, except as authorized in significant adverse effects on this rule. competition, employment, investment, AGENCY: Drug Enforcement Regulatory Certifications productivity, innovation, or on the Administration (DEA), Justice. ability of United States-based ACTION: Final rule confirmation. Regulatory Flexibility Act companies to compete with foreign- The Acting Administrator hereby based companies in domestic and SUMMARY: Effective October 3, 1996, the certifies that this rulemaking has been export markets. Comprehensive Methamphetamine
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