Sec. 103. Applications to manufacture marihuana for research

734 words·~3 min read·/bill/116/s/2032/is/section-103

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended— by redesignating subsections

(c)through

(k)as subsections

(d)through (l), respectively; by inserting after subsection

(b)the following: As it relates to applications to manufacture marihuana for research purposes, if the Attorney General places a notice in the Federal Register to increase the number of entities registered under this Act to manufacture marihuana to supply appropriately registered researchers in the United States, the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application— approve the application; or request supplemental information. For purposes of subparagraph (A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following: The requirements designated in the notice in the Federal Register are satisfied. The requirements under this Act are satisfied. The applicant will limit the transfer and sale of any marihuana manufactured under this subsection— to researchers who are registered under this Act to conduct research with controlled substances in schedule I; and for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ). The applicant will transfer or sell any marihuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General. The applicant has completed the application and review process under subsection

(a)for the bulk manufacture of controlled substances in schedule I. The applicant has established and begun operation of a process for storage and handling of controlled substances in schedule I, including for inventory control and monitoring security in accordance with section 105 of the Cannabidiol and Marihuana Research Expansion Act . The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture marihuana, if that State requires such a license. Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) with respect to an application, the Attorney General shall approve or deny the application. If an application described in this subsection is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant. ; in subsection (h)(2), as so redesignated, by striking subsection

(f)each place it appears and inserting subsection

(g); in subsection (j)(1), as so redesignated, by striking subsection

(d)and inserting subsection

(e); and in subsection (k), as so redesignated, by striking subsection

(f)each place it appears and inserting subsection

(g). The Controlled Substances Act ( 21 U.S.C. 801 et seq.) is amended— in section 102 ( 21 U.S.C. 802 )— in paragraph (16)(B)— in clause (i), by striking or at the end; by redesignating clause

(ii)as (iii); and by inserting after clause

(i)the following: the synthetic equivalent of hemp-derived cannabidiol that contains less than 0.3 percent tetrahydrocannabinol; or ; in paragraph (52)(B)— by striking 303(f) each place it appears and inserting 303(g) ; and in clause (i), by striking (d), or

(e)and inserting (e), or

(f); and in paragraph (54), by striking 303(f) each place it appears and inserting 303(g) ; in section 304 ( 21 U.S.C. 824 ), by striking 303(g)(1) each place it appears and inserting 303(h)(1) ; in section 307(d)(2) ( 21 U.S.C. 827(d)(2) ), by striking 303(f) and inserting 303(g) ; in section 311(h) ( 21 U.S.C. 831(h) ), by striking 303(f) each place it appears and inserting 303(g) ; in section 401(h)(2) ( 21 U.S.C. 841(h)(2) ), by striking 303(f) each place it appears and inserting 303(g) ; in section 403(c)(2)(B) ( 21 U.S.C. 843(c)(2)(B) ), by striking 303(f) and inserting 303(g) ; and in section 512(c)(1) ( 21 U.S.C. 882(c)(1) ) by striking 303(f) and inserting 303(g) . Section 1008(c) of the Controlled Substances Import and Export Act ( 21 U.S.C. 958(c) ) is amended— in paragraph (1), by striking 303(d) and inserting 303(e) ; and in paragraph (2)(B), by striking 303(h) and inserting 303(i) . Title V of the Public Health Service Act ( 42 U.S.C. 290aa et seq.) is amended— in section 520E–4(c) (42 U.S.C. 290bb–36d(c)), by striking 303(g)(2)(B) and inserting 303(h)(2)(B) ; and in section 544(a)(3) ( 42 U.S.C. 290dd–3(a)(3) ), by striking 303(g) and inserting 303(h) .

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