ACTION: Final rule.


SUMMARY: This final rule is issued by the Administrator of the Drug Enforcement Administration (DEA) in order to temporarily place cathine ((+)-norpseudoephedrine), fencamfamin, fenproporex and mefenorex into Schedule IV of the Controlled Substances Act (21 U.S.C. et seq.). This temporary scheduling action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. As a result of this rule, the regulatory controls and criminal sanctions of a Schedule IV substance under the Controlled Substances Act (CSA) will be applicable to the manufacture, distribution and possession of cathine ((+)-norpseudoephedrine), fencamfamin, fenproporex or mefenorex. The temporary scheduling order for each substance shall remain in effect until the process of permanent scheduling, pursuant to section 201 (a) and (b) (21 U.S.C. 811 (a) and (b)) of the CSA, is completed.


EFFECTIVE DATE: June 16, 1988.


FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug Control Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 633-1366.

TEXT:
SUPPLEMENTARY INFORMATION: A notice of proposed rulemaking to place cathine ((+)-norpseudoephedrine), fencamfamin, fenproporex and mefenorex into Schedule IV of the CSA was published in the Federal Register On October 30, 1987 (52 FR 41736). As stated in that proposal (52 FR 41736), the Administrator, in order to satisfy treaty obligations under the 1971 Convention on Psychotropic Substances, has found that the placement of cathine ((+)-norpseudoephedrine), fencamfamin, fenproporex and mefenorex in Schedule IV of the CSA is necessary. In order to satisfy said treaty obligations in a timely manner, cathine ((+)-norpseudoephedrine), fencamfamin, fenproporex and mefenorex will be controlled on a temporary basis in Schedule IV of the CSA, pursuant to 21 U.S.C. 811(d)(4)(A).

In the October 30, 1987 notice of proposed rulemaking, comments were solicited from persons interested in the proposed control action. DEA received comments regarding the proposed control of cathine ((+)-norpseudoephedrine) and its impact on the use of the plant known as khat. Following a review of the information available on the chemical constituents found in khat, it has been determined that khat will be subject to the same Schedule IV controls as cathine ((+)-norpseudoephedrine), one of the psychoactive substances found in khat. Such a position is consistent with the controls imposed on many other plants containing controlled psychoactive substances.

It is the position of the Administrator that the temporary placement of the above substances into Schedule IV is consistent with the obligations of the United States under the Convention on Psychotropic Substances of 1971, namely that control of psychotropic substances in the United States should be accomplished within the framework of the procedures and criteria for classification of substances provided in the CSA (21 U.S.C. 811(d)(4)(B)).

Regulations that are effective on or after June 16, 1988, and imposed on all of the above listed substances are as follows:


1. Registration

Any person who manufactures, distributes, engages in research, imports or exports any of the above listed substances or who proposes to engage in the manufacture, distribution, importation, exportation or research on such substances shall obtain a registration to conduct that activity by June 16, 1988, pursuant to Parts 1301 and 1311 of Title 21 of the Code of Federal Regulations.


2. Security

The above listed substances must be manufactured, distributed and stored in accordance with §§ 1301.71-1301.76 of Title 21 of the Code of Federal Regulations.


3. Labeling Packaging

All labels on commercial containers of, and all labeling of, the above listed substances which are packaged on or after June 16, 1988, shall comply with the requirements of §§ 1302.03-1302.05, 1302.07 and 1302.08 of Title 21 of the Code of Federal Regulations.


4. Inventory

Registrants possessing the above listed substances are required to take inventories pursuant to §§ 1304.11-1304.19 of Title 21 of the Code of Federal Regulations.


5. Records

All registrants must keep records pursuant to §§ 1304.21-1304.27 of Title 21 of the Code of Federal Regulations.


6. Importation and Exportation

All importation and exportation of the above listed substances shall be in compliance with Part 1312 of Title 21 of the Code of Federal Regulations.


7. Criminal Liability

Any activity with the above listed substances not authorized by or in violation of the CSA or the Controlled Substances Import and Export Act occurring on or after June 16, 1988, shall be unlawful.

Pursuant to Title 5, United States Code, Section 605(b), the Administrator certifies that the placement of cathine ((+)-norpseudoephedrine), fencamfamin, fenproporex and mefenorex into Schedule IV of the CSA, as ordered herein, will not have a significant impact upon small businesses or other entities whose interests must be considered under the Regulatory Flexibility Act (Pub. L. 96-354). None of the substances listed above are marketed in the United States. This action is required in order to fulfill United States international treaty obligations.

In accordance with the provisions of 21 U.S.C. 811(d), this scheduling action is a formal rulemaking that is required by United States obligations under an international convention, namely the Convention on Psychotropic Substances, 1971. 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).


List of Subjects in 21 CFR Part 1308

Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs.

Therefore, based upon the notification of the Secretary-General of the United Nations, and in accordance with the recommendations of the Assistant Secretary for Health, Department of Health and Human Services, under the authority vested in the Attorney General by 21 U.S.C. 811(d)(4) (A) and (C) and delegated to the Administrator of DEA by Department of Justice regulations (28 CFR 0.100), the Administrator hereby amends 21 CFR Part 1308 as follows:

PART 1308 -- SCHEDULES OF CONTROLLED SUBSTANCES

1. The authority citation for 21 CFR Part 1308 continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871(b).

2. Section 1308.14 is amended by redesignating paragraph (e)(2) as (5), paragraph (e)(1) as (2), paragraphs (e) (3) through (6) as (e) (7) through (10) and by adding new paragraphs (e) (1), (3), (4) and (6) to read as follows:

§ 1308.14 Schedule IV.


* * * * *

(e) * * *


(1) Cathine ((+)-norpseudoephedrine) . . . 1230


* * * * *


(3) Fencamfamin . . . 1760


(4) Fenproporex . . . 1575


* * * * *


(6) Mefenorex . . . 1580


* * * * *


John C. Lawn,

Administrator, Drug Enforcement Administration.

Dated: May 12, 1988.
[FR Doc. 88-11014 Filed 5-16-88; 8:45 am]

BILLING CODE 4410-09-M