Sec. 6. Registration requirements for handlers of schedule A substances
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Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended— in subsection (f), in the undesignated matter following paragraph (5)— by inserting or A after schedule I each place it appears; and by adding at the end the following: A separate registration for engaging in research with a controlled substance in schedule A for practitioners already registered under this part to engage in research with controlled substances in schedule I shall not be required. The Secretary shall determine the merits of the research protocol submitted by the practitioner registering to engage in research with a controlled substance in schedule A, and the Attorney General may deny or revoke the registration only on a ground specified in section 304. ; and by adding at the end the following:
The Attorney General shall register an applicant to manufacture schedule A substances if— the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and the Attorney General determines that such registration is consistent with the public interest and with the United States obligations under international treaties, conventions, or protocols in effect on the date of enactment of this subsection.
In determining the public interest under paragraph (1)(B), the Attorney General shall consider— maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule A compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes; compliance with applicable State and local law; promotion of technical advances in the art of manufacturing substances described in subparagraph
(A)and the development of new substances; prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of substances described in paragraph (A); past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and such other factors as may be relevant to and consistent with the public health and safety. If an applicant is registered to manufacture controlled substances in schedule I or II under subsection (a), the applicant shall not be required to apply for a separate registration under this subsection. The Attorney General shall register an applicant to distribute schedule A substances— if the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and unless the Attorney General determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest under paragraph (1)(B), the Attorney General shall consider— maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels; compliance with applicable State and local law; prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of substances described in subparagraph (A); past experience in the distribution of controlled substances; and such other factors as may be relevant to and consistent with the public health and safety. If an applicant is registered to distribute a controlled substance in schedule I or II under subsection (b), the applicant shall not be required to apply for a separate registration under this subsection. Not later than 90 days after the date on which a substance is placed in schedule A, any practitioner who was engaged in research on the substance before the placement of the substance in schedule A and any manufacturer or distributor who was handling the substance before the placement of the substance in schedule A shall register with the Attorney General. Not later than 60 days after the date on which the Attorney General receives an application for registration to conduct research on a schedule A substance, the Attorney General shall— grant, or initiate proceedings under section 304(c) to deny, the application; or request supplemental information from the applicant. Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) in connection with an application described in subparagraph (A), the Attorney General shall grant or deny the application. . Section 1008 of the Controlled Substances Import and Export Act ( 21 U.S.C. 958 ) is amended by adding at the end the following: The Attorney General shall register an applicant to import or export a schedule A substance if— the applicant demonstrates that the schedule A substances will be used for research, analytical, or industrial purposes approved by the Attorney General; and the Attorney General determines that such registration is consistent with the public interest and with the United States obligations under international treaties, conventions, or protocols in effect on the date of enactment of this subsection. In determining the public interest under paragraph (1)(B), the Attorney General shall consider the factors described in subparagraphs
(A)through
(F)of section 303(k)(2). If an applicant is registered to import or export a controlled substance in schedule I or II under subsection (a), the applicant shall not be required to apply for a separate registration under this subsection. .
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