(b) Factors to be consideredIn 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—
(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.
(d) Reinstatement of exemption with respect to particular drug products(1) ReinstatementOn 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.
(2) Factors to be consideredIn 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) as applied to the drug product.
(3) Status pending application for reinstatementA 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) the Attorney General has evidence that, applying the factors described in subsection (b) to the drug product, the drug product is being diverted; and
(B) the Attorney General so notifies the applicant.
(4) Amendment and modificationA 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) 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.
(Pub. L. 91–513, title II, § 204, as added Pub. L. 103–200, § 2(b)(1), Dec. 17, 1993, 107 Stat. 2334; amended Pub. L. 104–237, title IV, § 401(c), Oct. 3, 1996, 110 Stat. 3108; Pub. L. 109–177, title VII, § 712(a)(2), Mar. 9, 2006, 120 Stat. 263.)