Date="02/05/93" Citation="58 FR 7186" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances; Placement of Zolpidem into Schedul e IV"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Placement of Zolpidem into Schedule IV AGENCY: Drug Enforcement Administration, Justice. ACTION: Final rule.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Placement of Zolpidem into Schedule IV AGENCY: Drug Enforcement Administration, Justice. ACTION: Final rule. + ------------------------------------------------------------ SUMMARY: With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places zolpidem into 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, importation and exportation of zolpidem. EFFECTIVE DATE: February 5, 1993. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: Zolpidem is a hypnotic drug pharmacologically similar to the benzodiazepines. It will be marketed under the trade name of Ambien for the treatment of transient, short-term and chronic insomnia. The Assistant Secretary for Health, acting on behalf of the Secretary of the Department of Health and Human Services, by letter dated September 4, 1992, recommended to the Administrator of the DEA that zolpidem be placed into Schedule IV of the CSA pending approval of a New Drug Application (NDA) for the drug. The Administrator of the DEA, in a November 24, 1992 Federal Register notice (57 FR 55201), proposed to place zolpidem into Schedule IV of the CSA if and when the Food and Drug Administration (FDA) approved an NDA for zolpidem. This notice provided an opportunity for all interested persons to submit their comments, objections or requests for a hearing in writing on the proposed scheduling of zolpidem until December 24, 1992. DEA received no comments regarding this proposal. The FDA notified the DEA that it has determined that zolpidem is safe and effective for use as recommended in the final labelling and accordingly approved the NDA for zolpidem on December 16, 1992. Based on the information gathered and reviewed by the DEA, the scientific and medical evaluation and scheduling recommendation of the Assistant Secretary for Health, and the FDA's approval of the NDA for zolpidem, the Administrator of the DEA, pursuant to the provisions of 21 U.S.C. 811 (a) and (b), finds that: (1) Zolpidem has a low potential for abuse relative to the drugs or other substances currently listed in Schedule III; (2) Zolpidem has a currently accepted medical use in treatment in the United States; and (3) Abuse of zolpidem may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Schedule III. The above findings are consistent with the placement of zolpidem into Schedule IV of the CSA. In order to avoid delays in the marketing of zolpidem, the Schedule IV control of zolpidem will be effective upon publication of this final notice in the Federal Register. In the event that the regulations impose special hardships on any registrant, the DEA will entertain any justified request for an extension of time to comply with the Schedule IV regulations regarding zolpidem. The applicable regulations are as follows: 1. Registration. Any person who manufactures, distributes, delivers, imports or exports zolpidem, or who engages in research or conducts instructional activities with zolpidem, or who proposes to engage in such activities, must be registered to conduct such activities in accordance with Parts 1301 and 1311 of Title 21 of the Code of Federal Regulations. 2. Security. Zolpidem must be manfactured, distributed and stored in accordance with secsec1301.71-1301.76 of Title 21 of the Code of Federal Regulations. 3. Labeling and Packaging. All labels and labeling for commercial containers of zolpidem shall comply with the requirements of secsec1302.03-1302.05 and 1302.08 of Title 21 of the Code of Federal Regulations. 4. Inventory. Every registrant required to keep records and who possesses any quantity of zolpidem shall maintain an inventory pursuant to secsec1304.11-1304.19 of Title 21 of the Code of Federal Regulations. 5. Records. All registrants required to keep records pursuant to secsec1304.21-1304.27 of Title 21 of the Code of Federal Regulations shall do so regarding zolpidem. 6. Prescriptions. All prescriptions for products containing zolpidem shall comply with secsec1306.01-1306.06 and secsec1306.21-1306.26 of Title 21 of the Code of Federal Regulations. 7. Importation and Exportation. All importation and exportation of zolpidem shall be in compliance with Part 1312 of Title 21 of the Code of Federal Regulations. 8. Criminal Liability. Any activity with respect to zolpidem not authorized by, or in violation of the CSA or the Controlled Substances Import and Export Act shall be unlawful. Pursuant to 5 U.S.C. 605(b), the Administrator certifies that the placement of zolpidem into Schedule IV of the CSA will have no impact upon small businesses or other entities whose interests must be considered under the Regulatory Flexibility Act (Pub. L. 96-354). This action will allow the initial marketing of a drug product which has been approved by the FDA. This action has been analyzed in accordance with the principles and criteria contained in E.O. 12612, and it has been determined that this matter does not have sufficient federalism implications to require the preparation of a Federalism Assessment. In accordance with the provisions of 21 U.S.C. 811(a), this order to place zolpidem into Schedule IV of the CSA is a formal rulemaking "on the record after opportunity for a hearing." Such formal proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and as such have been exempted from the consultation requirements of Executive Order 12291 (46 FR 13193). Accordingly, this action is not subject to those provisions of E.O. 12778 which are contingent upon review by OMB. Nevertheless, the Administrator has determined that this is not a "major rule," as that term is used in E.O. 12291, and that it would otherwise meet the applicable standards of Sections 2(a) and 2(b)(2) of E.O. 12778. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. Pursuant to the authority vested in the Attorney General by 21 U.S.C. 811(a) and delegated to the Administrator of DEA by the regulations of the Department of Justice (28 CFR part 0.100), and based on the information gathered and reviewed by the DEA, the scientific and medical evaluation and scheduling recommendation of the Assistant Secretary for Health, and the FDA's approval of the NDA for zolpidem, the Administrator of the DEA hereby amends 21 CFR part 1308 as follows: PART 1308-SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation of 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 adding paragraph (c)(48) to read as follows: sec1308.14 Schedule IV. * * * * * (c) * * * (48) Zolpidem ..........................................2783 * * * * * Dated: January 27, 1993. Robert C. Bonner, Administrator of Drug Enforcement. [FR Doc. 93-2753 Filed 2-4-93; 8:45 am] BILLING CODE 4410-09-M