Page:United States Statutes at Large Volume 107 Part 3.djvu/397

 PUBLIC LAW 103-200—DEC. 17, 1993 107 STAT. 2335 "(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) to the most particularly identifiable t3npe 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 PARTICU- LAR DRUG PRODUCTS.— "(1) REINSTATEMENT. —On application by a manufacturer Regulations. of a particular drug product that has been removedfiromexemption 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 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 manijdacturer 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 m subsection (b) 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) 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 ^.ttomey 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 afindingthat— "(A) applying the factors described in subsection (b) to the drug product, the drug product is being diverted; or

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