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.
In removing a drug or group of drugs from exemption under subsection (a), the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption-
The Attorney General shall limit the designation of a drug or a group of drugs removed from exemption under subsection (a) 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.
On application by a manufacturer of a particular drug product that has been removed from exemption under subsection (a), 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.
In deciding whether to reinstate the exemption with respect to a particular drug product under paragraph (1), the Attorney General shall consider-
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) 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 regulation reinstating an exemption under paragraph (1) may be modified or revoked with respect to a particular drug product upon a finding that-
21 U.S.C. § 814
EDITORIAL NOTES
AMENDMENTS2006-Subsec. (e). Pub. L. 109-177 struck out subsec. (e). Text read as follows: "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."1996-Subsec. (e). Pub. L. 104-237 added subsec. (e).
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 1996 AMENDMENT 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.
EFFECTIVE DATESection effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103-200 set out as an Effective Date of 1993 Amendment note under section 802 of this title.