§207.13. Who is exempt from the registration and listing requirements? — Inbound Citations

(1) Domestic manufacturers, domestic repackers, domestic relabelers and domestic salvagers, not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or § 207.13, regardless of whether their drugs enter interstate commerce;

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

(l) The exemptions provided in paragraphs (a) through (k) of this section do not apply to such persons if they:

(1) Manufacture (as defined in § 207.1), repack, relabel, or salvage compounded positron emission tomography drugs as defined in section 201(ii) of the Federal Food, Drug, and Cosmetic Act;

(2) Manufacture (as defined in § 600.3(u) of this chapter) a human biological product subject to licensing under section 351 of the Public Health Service Act; or

Except as provided in § 207.13(l), the following classes of persons are exempt from registration and drug listing in accordance with section 510(g) of the Federal Food, Drug, and Cosmetic Act or because FDA has determined, under section 510(g)(5) of the Federal Food, Drug, and Cosmetic Act, that their registration is not necessary for the protection of the public health. This exemption is limited to establishment registration and drug listing requirements and does not relieve a person from other statutory or regulatory obligations.