Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter II - Drug Enforcement Administration, Department of Justice |
Part 1309 - Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals |
Requirements for Registration |
§ 1309.28 - Exemption of distributors of regulated prescription drug products.
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(a) The requirement of registration is waived for any person who distributes a prescription drug product containing a List I chemical that is regulated pursuant to § 1310.01(f)(1)(iv) of this chapter.
(b) If any person exempted by this section also engages in the distribution, importation or exportation of a List I chemical, other than as described in paragraph (a) of this section, the person shall obtain a registration for such activities, as required by § 1309.21 of this part.
(c) The Administrator may, upon finding that continuation of the waiver granted in paragraph (a) of this section would not be in the public interest, suspend or revoke a person's waiver pursuant to the procedures set forth in §§ 1309.43 through 1309.46 and 1309.51 through 1309.57 of this part.