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21 U.S. Code § 823. Registration requirements
(a) Manufacturers of controlled substances in schedule I or IIThe Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered:
(1)
maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule I or II 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;
(2)
compliance with applicable State and local law;
(3)
promotion of technical advances in the art of manufacturing these substances and the development of new substances;
(4)
prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;
(5)
past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and
(6)
such other factors as may be relevant to and consistent with the public health and safety.
(b) Distributors of controlled substances in schedule I or IIThe Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered:
(1)
maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
(2)
compliance with applicable State and local law;
(3)
prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
(4)
past experience in the distribution of controlled substances; and
(5)
such other factors as may be relevant to and consistent with the public health and safety.
(c) Manufacturers of marijuana for research purposes
(1)
(A) As it relates to applications to manufacture marijuana for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities registered under this chapter to manufacture marijuana 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—
(i)
approve the application; or
(ii)
request supplemental information.
(B) For purposes of subparagraph (A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following:
(i)
The requirements designated in the notice in the Federal Register are satisfied.
(ii)
The requirements under this chapter are satisfied.
(iii) The applicant will limit the transfer and sale of any marijuana manufactured under this subsection—
(I)
to researchers who are registered under this chapter to conduct research with controlled substances in schedule I; and
(II)
for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 355(i) [1] of this title.
(iv)
The applicant will transfer or sell any marijuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General.
(v)
The applicant has completed the application and review process under subsection (a) for the bulk manufacture of controlled substances in schedule I.
(vi)
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 Medical Marijuana and Cannabidiol Research Expansion Act.
(vii)
The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture marijuana, if that State requires such a license.
(C)
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.
(2)
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.