; or (ii) is exempt from the provisions of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) relating to new drugs because— (I) the SARM or product containing a SARM is intended solely for investigational use as described in subsection (i) of that section; and (II) the SARM or product containing a SARM is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application. . (2) Clarification regarding felony drug offenses Section 102(44) of the Controlled Substances Act (21 U.S.C. 802(44)) is amended by inserting SARMs, after anabolic steroids, . (3) Civil penalties Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended— (A) in subsection (a)(16)— (i) by inserting or (f) after subsection (e) ; and (ii) by striking 825 and inserting 305 ; and (B) in subsection (c)(1)(D), by inserting or a SARM after an anabolic steroid . 3. Amendments to the Federal Food, Drug, and Cosmetic Act Section 413(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b(c)) is amended— (1) in paragraph (1), by striking an anabolic steroid or an analogue of an anabolic steroid and inserting an anabolic steroid, a SARM, an analogue of an anabolic steroid, or an analogue of a SARM ; and (2) in paragraph (2)— (A) in subparagraph (A), by striking and at the end; (B) in subparagraph (B), by striking the period at the end and inserting a semicolon; and (C) by adding at the end the following: (C) the term analogue of a SARM means a substance that has a chemical structure that is substantially similar to the chemical structure of a SARM; and (D) the term SARM has the meaning given the term in section 102(57) of the Controlled Substances Act (21 U.S.C. 802(57)). .