; or (ii) is exempt from the provisions of section 505 of such Act relating to new drugs because— (I) it is intended solely for investigational use as described in section 505(i) of such Act; and (II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application. . (b) Clarification To Import and Export statute Section 1010 of the Controlled Substances Import and Export Act ( 21 U.S.C. 960 ) is amended, in subsection (a)(1), by inserting 305, before 1002 . (c) Civil penalties Section 402 of the Controlled Substances Act ( 21 U.S.C. 842 ) is amended— (1) in subsection (a)— (A) in paragraph (15), by striking or at the end; (B) in paragraph (16), by striking the period at the end and inserting ; or ; and (C) by inserting, after paragraph (16), the following: (17) to violate subsection (f) of section 825 of this title. ; and (2) in subsection (c)(1)— (A) by inserting, in subparagraph (A), after subparagraph (B), (C), striking or (D) and inserting the following: , (D), (E), or (F)