§ 1318.05. Application of the public interest factors.
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/us/cfr/t21/s§ 1318.05·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)In accordance with section 303(a) of the Act (21 U.S.C. 823(a)), the Administrator shall consider the public interest factors set forth in paragraphs (a)(1) through
(6)of this section:
(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)The Administrator's determination of which applicants to select will be consistent with the public interest factors set forth in section 303(a), with particular emphasis on the following criteria:
(1)Whether the applicant has demonstrated prior compliance with the Act and this chapter;
(2)The applicant's ability to consistently produce and supply cannabis of a high quality and defined chemical composition; and (3)(i) In determining under section 303(a)(1) of the Act (21 U.S.C. 823(a)(1)) the number of qualified applicants necessary to produce an adequate and uninterrupted supply of cannabis under adequately competitive conditions, the Administrator shall place particular emphasis on the extent to which any applicant is able to supply cannabis or its derivatives in quantities and varieties that will satisfy the anticipated demand of researchers and other registrants in the United States who wish to obtain cannabis to conduct activities permissible under the Act, as demonstrated through a bona fide supply agreement with a registered researcher or manufacturer as defined in this subpart.
(ii)If an applicant seeks registration to grow cannabis for its own research or product development, the applicant must possess registration as a schedule I researcher with respect to marihuana under § 1301.32 of this chapter. As specified in § 1301.13 of this chapter, chemical analysis and preclinical research (including quality control analysis) are not coincident activities of a manufacturing registration for schedule I substances, including cannabis. In determining under section 303(a)(1) of the Act (21 U.S.C. 823(a)(1)) the number of qualified applicants necessary to produce an adequate and uninterrupted supply of cannabis under adequately competitive conditions, the Administrator shall consider the holding of an approved marihuana research protocol by a registered schedule I researcher seeking to grow cannabis for its own research or product development as evidence of the necessity of the applicant's registration under this factor.
(c)Applications accepted for filing after January 19, 2021 will not be considered pending for purposes of paragraph
(a)of this section until all applications accepted for filing on or before January 19, 2021 have been granted or denied by the Administrator. Where an application is subject to section 303(i) of the Act (21 U.S.C. 823(i)), that section shall apply in lieu of this paragraph (c).
(d)In determining the legitimate demand for cannabis and its derivatives in the United States, the Administrator shall consult with the U.S. Department of Health and Human Services, including its components.
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