Sec. 204. removal of exemption of certain drugs
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## Sec. 204 removal of exemption of certain drugs **[**[21 U.S.C. 814](/us/usc/t21/s814)**]** ###
(a)Removal of Exemption The Attorney General shall by regulation remove from exemption under section 102(39)(A)(iv) 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), 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)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), 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)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 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)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. ### Part C Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances; Piperidine Reporting27 27Prior to the enactment of Public Law 100–690, section 310 of this title concerned reporting requirements regarding the distribution, sale, or import of piperidine. Section 6052 of such Public Law (102 Stat. 4312) amended section 310 in its entirety, with the result that the section now concerns reporting requirements related to listed chemicals, tableting machines, and encapsulating machines. Section 6054 of such Public Law (102 Stat. 4316) made amendments to the definitions in section 102 of this title, including establishing definitions for the terms “**listed chemical**” and “listed precursor chemical”. Piperidine and its salts were included as listed precursor chemicals. Section 2(a) of Public Law 103–200 (107 Stat. 2333) made amendments to the definitions in section 102 of this title, including replacing the term “**listed precursor chemical**” with the term “**list I chemical**”. Piperidine and its salts are currently included as list I chemicals. See section 102(34)(J). Section 2(a) of such Public Law also replaced the term “**listed essential chemical**” with the term “**list II chemical**”.
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- Pub. L. 100-690
- 102 Stat. 4312
- 102 Stat. 4316
- Pub. L. 103-200
- 107 Stat. 2333
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Sec. 204
removal of exemption of certain drugs
Pub. L.Pub. L. 100-690
Stat.102 Stat. 4312
Stat.102 Stat. 4316
Pub. L.Pub. L. 103-200
Stat.107 Stat. 2333
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