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Regulations &
Codified CSA > CFR > Section 1310 > Section 1310.09
Section 1310.09 Temporary exemption from registration.
(a) Each person required by section 302 of the act (21
U.S.C. 822) to obtain a registration to
distribute, import, or export a combination ephedrine product is temporarily exempted from the
registration requirement, provided that the person submits a proper application for registration on
or before July 12, 1997. The exemption will remain in effect for each person who has made such
application until the Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements set forth in parts
1309, 1310,
and 1313 of this chapter remain in full force and effect.
(b) Each person required by section 302 of the act (21
U.S.C. 822) to obtain a registration to
distribute, import, or export a drug product that contains pseudoephedrine or
phenylpropanolamine that is regulated pursuant to Sec. 1300.02(b)(28)(1)(D) of this chapter is
temporarily exempted from the registration requirement, provided that the person submits a
proper application for registration on or before December 3, 1997. The exemption will remain in
effect for each person who has made such application until the Administration has approved or
denied that application. This exemption applies only to registration; all other chemical control
requirements set forth in parts 1309,
1310, and 1313 of this chapter remain in full force and
effect.
(c) Each person required by section 302 of the act (21
U.S.C. 822) to obtain a registration to distribute, import, or export GBL is
temporarily exempted from the registration requirement, provided that the DEA receives a proper application for registration on or before
July 24, 2000. The exemption will remain in effect for each person who has made such application until the Administration has approved or
denied that application. This exemption applies only to registration; all other chemical control requirements set forth in
parts 1309, 1310,
and 1313 of this chapter remain in full force and effect.
(d) Each person required by section 302 of the Act
(21 U.S.C. 822) to obtain
a registration to distribute, import, or export the List I chemicals
red phosphorus, white phosphorus, and hypophosphorous acid (and its
salts), is temporarily exempted from the registration requirement,
provided that the person submits a proper application for
registration on or before December 17, 2001. The exemption will
remain in effect for each person who has made such application until
the Administration has approved or denied that application. This
exemption applies only to registration; all other chemical control
requirements set forth in parts 1309,
1310, and 1313
of this chapter remain in full force and effect.
(e) Each person required by section 302 of the Act
(21 U.S.C. 822) to obtain a registration to distribute, import, or
export regulated chemical mixtures which contain ephedrine, N-methylephedrine,
N-methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or
pseudoephedrine, pursuant to § § 1310.12 and 1310.13, is
temporarily exempted from the registration requirement, provided that
DEA receives a proper application for registration or application for
exemption on or before June 30, 2003. The exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in parts 1309,
1310, and 1313 of this chapter remain in full
force and effect. Any person who distributes, imports or exports a
chemical mixture whose application for exemption is subsequently denied
by DEA must obtain a registration with DEA. A temporary exemption from
the registration requirement will also be provided for these persons,
provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has not been approved. The temporary
exemption for such persons will remain in effect until DEA takes final
action on their registration application.
(f) Except for chemical mixtures containing the listed chemicals in
paragraph (e) of this section, each person required by section 302 of
the Act (21 U.S.C. 822) to obtain a registration to distribute, import,
or export regulated chemical mixtures, pursuant to Sec. Sec. 1310.12 and
1310.13, is temporarily exempted from the registration requirement,
provided that DEA receives a proper application for registration or
application for exemption on or before February 14, 2005. The exemption
will remain in effect for each person who has made such application
until the Administration has approved or denied that application. This
exemption applies only to registration; all other chemical control
requirements set forth in parts 1309, 1310, and 1313 of this chapter
remain in full force and effect.
(g) Any person who distributes, imports, or exports a chemical
mixture whose application for exemption is subsequently denied by DEA
must obtain a registration with DEA. A temporary [[Page 133]] exemption
from the registration requirement will also be provided for these
persons, provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has not been approved.
The temporary exemption for such persons will remain in effect until DEA
takes final action on their registration application.
(h) Each person required under 21
U.S.C. 822 and 21
U.S.C. 957 to obtain
a registration to manufacture, distribute, import, or export regulated
N-phenethyl-4-piperidone (NPP), including regulated chemical mixtures
pursuant to Sec. 1310.12, is temporarily exempted from the registration
requirement, provided that DEA receives a proper application for
registration or application for exemption for a chemical mixture containing
NPP pursuant to Sec. 1310.13 on or before June 22, 2007. The exemption will
remain in effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements set
forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain
in full force and effect. Any person who manufactures, distributes, imports
or exports a chemical mixture containing N-phenethyl-4-piperidone (NPP)
whose application for exemption is subsequently denied by DEA must obtain a
registration with DEA. A
temporary exemption from the registration requirement will also be
provided for those persons whose application for exemption are denied,
provided that DEA receives a properly completed application for registration
on or before 30 days following the date of official DEA notification that
the application for exemption has been denied. The temporary exemption for
such persons will remain in effect until DEA takes final action on their
registration application.
(i) Each person required by section 302 of the Act (21
U.S.C. 822) to obtain a registration to manufacture,
distribute, import, or export regulated iodine, including
regulated iodine chemical mixtures pursuant to Sec.
Sec. 1310.12 and 1310.13,
is temporarily exempted from the registration requirement,
provided that the Administration receives a proper application
for registration or application for exemption for a chemical
mixture containing iodine on or before August 31, 2007. The
exemption will remain in effect for each person who has made
such application until the Administration has approved or denied
that application. This exemption applies only to registration;
all other chemical control requirements set forth in the Act and
parts 1309, 1310, and
1313 of this chapter remain in full force and effect. Any
person who distributes, imports, or exports a chemical mixture
containing iodine whose application for exemption is
subsequently denied by the Administration must obtain a
registration with the Administration. A temporary exemption from
the registration requirement will also be provided for these
persons, provided that the Administration receives a properly
completed application for registration on or before 30 days
following the date of official Administration notification that
the application for exemption has not been approved. The
temporary exemption for such persons will remain in effect until
the Administration takes final action on their registration
application.
(j) Each person required by section 302 of the Act (21
U.S.C. 822) to
obtain a registration to manufacture, distribute, import, or export regulated
chemical mixtures which contain ephedrine, and/or pseudoephedrine, pursuant to
Sections 1310.12 and 1310.13, is temporarily exempted from the registration
requirement, provided that DEA receives a properly completed application for
registration or application for exemption on or before August 24, 2007. The
exemption will remain in effect for each person who has made such application
until the Administration has approved or denied that application. This
exemption applies only to registration; all other chemical control
requirements set forth in parts 1309,
1310, 1313, and
1315 of this chapter
remain in full force and effect. Any person who manufactures, distributes,
imports, or exports a chemical mixture whose application for exemption is
subsequently denied by DEA must obtain a registration with DEA. A temporary
exemption from the registration requirement will also be provided for these
persons, provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has not been approved. The
temporary exemption for such persons will remain in effect until DEA takes
final action on their registration application.
[62 FR 27693, May 21, 1997, as amended at 62 FR 53960, Oct. 17, 1997; 65 FR
21647, Apr. 24, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, May 1, 2003; 69
FR 74971, Dec. 15, 2004; Apr. 23, 2007; 72 FR 35931, July 2, 2007; 72 FR 40239,
July 24, 2007; 72 FR 40744, July 25, 2007]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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