[Federal Register Volume 59, Number 57 (Thursday, March 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6884]


[[Page Unknown]]

[Federal Register: March 24, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

 

Provisional Exemption From Registration for Certain List I 
Chemical Handlers

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Interim rule.

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SUMMARY: Under the provisions of the Domestic Chemical Diversion 
Control Act of 1993 (DCDCA), which was enacted on December 17, 1993, 
and becomes effective April 16, 1994, any person who manufactures, 
distributes, imports or exports a list I chemical (formerly known as a 
precursor chemical), or who proposes to do so, must first obtain a 
registration.
    Since regulations implementing the DCDCA may not be finalized by 
April 16, 1994, DEA is establishing a temporary exemption from the 
registration requirement for any person who must register under the 
DCDCA. The exemption will stay in effect for each affected person until 
DEA has either approved the person's application for registration or 
the Administrator has issued a final order regarding the application, 
provided that the person makes proper application for registration 
within 45 days of the effective date of the regulations implementing 
the DCDCA. Failure to submit to a proper application within this time 
period will invalidate the exemption. At this time, affected persons 
are requested to submit to DEA a notice of their intent to seek 
registration.

EFFECTIVE DATE: March 24, 1994.

FOR FURTHER INFORMATION CONTACT: G. THOMAS GITCHEL, CHIEF, LIAISON 
 AND POLICY SECTION, OFFICE OF DIVERSION CONTROL, DRUG ENFORCEMENT 
    ADMINISTRATION, WASHINGTON, DC 20537, TELEPHONE (202) 307-4025.

FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-4025.
SUPPLEMENTARY INFORMATION: On December 17, 1993, the Domestic Chemical 
Diversion Control Act of 1993 was enacted. The DCDCA redesignates 
precursor chemicals and essential chemicals in Title 21, section 802, 
as list I chemicals and list II chemicals respectively, and requires 
that any person who manufactures, distributes, imports or exports a 
list I chemical shall obtain an annual registration from DEA for each 
location where such activities are carried out.
    The DCDCA also removes the exemption from the definition of a 
regulated transaction for drugs marketed or distributed under the Food, 
Drug and Cosmetic Act which either, (1) contain ephedrine or its salts, 
optical isomers, or salts of optical isomers either as the only active 
medicinal ingredient or in combination with therapeutically 
insignificant quantities of another active medicinal ingredient, or (2) 
contain another listed chemical which DEA has determined is being 
diverted to obtain the listed chemical for use in the manufacture of a 
controlled substance. As a result, any person who manufactures, 
imports, exports or distributes, either by wholesale or retail sales, 
any drug described above will be required to register and will also be 
subject to the applicable requirements of the DCDCA and title 21, Code 
of Federal Regulations, parts 1310 and 1313, when the DCDCA becomes 
effective on April 16, 1994. Those persons manufacturing, distributing, 
importing, or exporting drugs distributed or marketed under the Food, 
Drug and Cosmetic Act which contain ephedrine in combination with 
therapeutically significant quantities of another drug will remain 
exempt from the requirements of the DCDCA and the applicable portions 
of title 21 of the regulations.
    The DCDCA also establishes certain other requirements with respect 
to listed chemicals which will be addressed in a separate Federal 
Register notice proposing the establishment of regulations implementing 
the DCDCA.
    In the event that the regulations and administrative mechanisms to 
implement the DCDCA are not finalized prior to the April 16, 1994 
effective date, DEA is establishing a temporary exemption from the 
registration requirement for affected persons who manufacture, 
distribute, import or export list I chemicals. Each affected person 
will be exempted from the registration requirement until they have made 
proper application for registration with DEA, provided such application 
is made within 45 days after the effective date of the regulations 
implementing the DCDCA, and that application has either been approved 
by DEA or the Administrator has issued a final order regarding the 
application following a full administrative proceeding pursuant to 
sections 823 and 824 of the Controlled Substances Act. Failure to make 
proper application within the specified time period will result in loss 
of the exemption. Further, the exemption will apply only to the 
requirement to register which goes into effect in April 16, 1994. All 
other requirements of the DCDCA become effective on April 16, 1994, and 
the requirements of parts 1310 and 1313 of title 21 of the regulations 
will remain in full force and effect. The change in the designation of 
the regulated chemicals from precursor and essential to list I and list 
II chemicals will have no effect on the requirements of parts 1310 and 
1313.
    To assist DEA in ensuring that the necessary information regarding 
registration and application forms reaches the affected persons, these 
persons are requested to notify DEA at this time of their intent to 
register for their activities. The notice should reflect the name under 
which business is conducted, the address at which the list I chemical 
activities are conducted, the type of activity (i.e., manufacture, 
distribute, import or export), and the specific list I chemical(s) 
involved. Notice should be submitted for each separate physical 
location at which such activities are carried out. Notices should be 
sent to:
    Drug Enforcement Administration, Chemical Operations Section, 
Office of Diversion Control, Washington, DC 20537.
    With respect to persons who manufacture list I chemicals, DEA has 
made a preliminary determination that registration will not be required 
for persons who manufacture a list I chemical solely for internal 
consumption with no subsequent distribution or exportation of the List 
I chemical. Those persons who manufacture a list I chemical for 
distribution will be required to register. Specific details regarding 
DEA's determination will be set forth in the Federal Register notice 
proposing the regulations to implement the DCDCA.
    The Acting Administrator of the Drug Enforcement Administration 
hereby certifies that this interim rulemaking will have no significant 
impact upon entities whose interests must be considered under the 
Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This interim 
rulemaking grants a temporary exemption from the registration 
requirements of the DCDCA pending completion of the regulatory 
amendments necessary to implement the DCDCA.
    This rule is not a significant regulatory action and therefore has 
not been reviewed by the Office of Management and Budget pursuant to 
Executive Order 12866.
    This action has been analyzed in accordance with the principles and 
criteria in Executive Order 12612, and it has been determined that the 
interim rule does not have sufficient federalism implications to 
warrant the preparation of a Federalism Assessment.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, Reporting and recordkeeping requirements, 
List I and List II chemicals.
    For reasons set out above, title 21, Code of Federal Regulations, 
part 1310 is amended as follows.

PART 1310--[AMENDED]

    1. The authority citation for part 1310 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 830, 871(b).

    2. Section 1310.09 is added to read as follows:


Sec. 1310.09  Temporary exemption from registration.

    Each person required by section 3(b) of the Domestic Chemical 
Diversion Control Act of 1993 (Pub. L. 103-200, effective April 16, 
1994), to obtain a registration to manufacture, distribute, import, or 
export a list I chemical (other than those list I chemicals exempted 
under Sec. 1310.01(f)(1)(iv)), is temporarily exempted from the 
registration requirement. The exemption will remain in effect for each 
person until the person has made proper application for registration 
and the Administration has approved or denied such application, 
provided that the application has been submitted within 45 days 
following the effective date of the regulations in part 1309 
implementing the Domestic Chemical Diversion Control Act of 1993. This 
exemption applies only to registration; all other chemical control 
requirements set forth in the Domestic Chemical Diversion Control Act 
of 1993 and in parts 1310 and 1313 of this chapter remain in full force 
and effect.

    Dated: March 17, 1994.
Stephen H. Greene,
Acting Administrator, Drug Enforcement Administration.
[FR Doc. 94-6884 Filed 3-23-94; 8:45 am]
BILLING CODE 4410-09-M