21 U.S.C. § 814 : US Code - Section 814: Removal of exemption of certain drugs

Search 21 U.S.C. § 814 : US Code - Section 814: Removal of exemption of certain drugs

(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.