21 U.S.C. § 814: Removal of exemption of certain drugs

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. the scope, duration, and significance of the diversion; 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 whether the listed chemical can be readily recovered from the drug or group of drugs. 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. the package sizes and manner of packaging of the drug product; the manner of distribution and advertising of the drug product; evidence of diversion of the drug product; any actions taken by the manufacturer to prevent diversion of the drug product; and 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. the Attorney General has evidence that, applying the factors described in subsection (b) to the drug product, the drug product is being diverted; and the Attorney General so notifies the applicant. applying the factors described in subsection (b) to the drug product, the drug product is being diverted; or there is a significant change in the data that led to the issuance of the regulation.