[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
