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§1318.05. Application of the public interest factors. — Inbound Citations

21 C.F.R. § 1318.05

Cited by 6 regulations in release Current.

Citations to §1318.05(a)(1)

  • (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.

Citations to §1318.05(a)(2)

  • (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.

Citations to §1318.05(a)(3)

  • (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.

Citations to §1318.05(a)(4)

  • (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.

Citations to §1318.05(a)(5)

  • (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.

Citations to §1318.05(a)(6)

  • (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.