(a) Removal
of exemption
The Attorney General shall by regulation remove from exemption under
section 802(39)(A)(iv) of this title a drug or group of drugs that the
Attorney General finds is being diverted to obtain a listed chemical
for use in the illicit production of a controlled substance.
(b) Factors
to be considered
In removing a drug or group of drugs from exemption under subsection
(a) of this section, the Attorney General shall
consider, with respect to a drug or group of drugs that is proposed
to be removed from exemption -
(1) the scope, duration,
and significance of the diversion;
(2) whether the drug or
group of drugs is formulated in such a way that it cannot be easily
used in the illicit production of a controlled substance; and
(3) whether the listed chemical
can be readily recovered from the drug or group of drugs.
(c) Specificity
of designation
The Attorney General shall limit the designation of a drug or a group
of drugs removed from exemption under subsection (a) of this section
to the most particularly identifiable type of drug or group of drugs
for which evidence of diversion exists unless there is evidence, based
on the pattern of diversion and other relevant factors, that the diversion
will not be limited to that particular drug or group of drugs.
(d) Reinstatement
of exemption with respect to particular drug products
(1) Reinstatement
On application by
a manufacturer of a particular drug product that has been removed
from exemption under subsection (a) of this section, the Attorney
General shall by regulation reinstate the exemption with respect to
that particular drug product if the Attorney General determines that
the particular drug product is manufactured and distributed in a manner
that prevents diversion.
(2) Factors to be considered
In deciding whether to reinstate the exemption with respect to a particular
drug product under paragraph (1), the Attorney General shall consider
-
(A) the package sizes
and manner of packaging of the drug product;
(B) the manner of distribution
and advertising of the drug product;
(C) evidence of diversion
of the drug product;
(D) any actions taken
by the manufacturer to prevent diversion of the drug product; and
(E) such other factors
as are relevant to and consistent with the public health and safety,
including the factors described in subsection (b) of this section
as applied to the drug product.
(3) Status pending application
for reinstatement A transaction involving a particular drug product
that is the subject of a bona fide pending application for reinstatement
of exemption filed with the Attorney General not later than 60 days
after a regulation removing the exemption is issued pursuant to subsection
(a) of this section shall not be considered to be a regulated transaction
if the transaction occurs during the pendency of the application and,
if the Attorney General denies the application, during the period
of 60 days following the date on which the Attorney General denies
the application, unless -
(A) the Attorney General
has evidence that, applying the factors described in subsection
(b) of this section to the drug product, the drug product is being
diverted; and (B) the Attorney General so notifies the applicant.
(4) Amendment and modification
A regulation reinstating an exemption under paragraph (1) may be modified
or revoked with respect to a particular drug product upon a finding
that -
(A) applying the factors
described in subsection (b) of this section to the drug product,
the drug product is being diverted; or
(B) there is a significant
change in the data that led to the issuance of the regulation.
(e) Reinstatement
of exemption with respect to ephedrine, pseudoephedrine, and phenylpropanolamine
drug products
Pursuant to subsection (d)(1) of this section, the Attorney General
shall by regulation reinstate the exemption with respect to a particular
ephedrine, pseudoephedrine, or phenylpropanolamine drug product if the
Attorney General determines that the drug product is manufactured and
distributed in a manner that prevents diversion. In making this determination
the Attorney General shall consider the factors listed in subsection
(d)(2) of this section. Any regulation issued pursuant to this subsection
may be amended or revoked based on the factors listed in subsection
(d)(4) of this section.
(Pub. L. 91-513, title II,
Sec. 204, as added Pub. L. 103-200, Sec. 2(b)(1), Dec. 17, 1993, 107
Stat. 2334; amended Pub. L. 104-237, title IV, Sec. 401(c), Oct. 3,
1996, 110 Stat. 3108.)
Amendment by Pub. L. 104-237
not applicable to sale of any pseudoephedrine or phenylpropanolamine
product prior to 12 months after Oct. 3, 1996, except that, on application
of manufacturer of particular drug product, Attorney General may exercise
sole and judicially unreviewable discretion to extend such effective
date up to additional 6 months, see section 401(g) of Pub. L. 104-237,
set out as a note under section 802 of this title.