Sec. 6. Registration requirements for schedule A substances
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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 substance 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 importation, manufacture, distribution, or dispensing of substances described in subparagraph (A); past experience in the importation and 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 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. . Section 302(e) of the Controlled Substances Act ( 21 U.S.C. 822(e) ) is amended by adding at the end the following: If a person is conducting research on a substance at the time the substance is added to schedule A, and such person, subject to an exemption that is in effect for investigational use, for that person, under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) to the extent conduct with respect to such substance is pursuant to such exemption. . Section 302(e) of the Controlled Substances Act ( 21 U.S.C. 822(e) ), as amended by subsection
(b)of this section, is amended by adding at the end the following: If a person is conducting research on a substance at the time the substance is added to schedule A, and such person is already registered to conduct research with a controlled substance in schedule I or II, then— the person shall, within 30 days of the scheduling of the newly-scheduled substance, submit a completed application for registration or modification of existing registration, to conduct research on such substance, in accordance with the regulations issued by the Attorney General; the person may continue to conduct the research on such substance until the application described in clause
(i)is withdrawn by the applicant or until the Attorney General serves on the applicant an order to show cause proposing the denial of the application pursuant to section 304(c); and if the Attorney General serves order to show cause under clause
(ii)and the applicant requests a hearing, such hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time if so requested by the applicant. A person who is registered to conduct research with a controlled substance in schedule A may conduct research with another controlled substance in schedule I, only if— the person has applied for a modification of the person's registration to authorize research with such other controlled substance in accordance with the regulations issued by the Attorney General; the Attorney General has obtained verification from the Secretary that the research protocol submitted with the application is meritorious; and the Attorney General has determined, not later than 30 days after receiving the application described in clause (i), that such activity is consistent with United States obligations under the Single Convention on Narcotic Drugs, 1961. Nothing in this paragraph shall be construed to alter the authority of the Attorney General to initiate proceedings to deny, suspend, or revoke any registration in accordance with sections 303 and 304. .
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