(a) It shall be unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, an anabolic steroid or product containing an anabolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC).

(b)(1) A product described in paragraph (b)(2) of this section is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this section if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(2) A product is described in this paragraph (b)(2) if the product—

(i) Is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (j)); or

(ii) Is exempt from the provisions of section 505 of the Federal Food, Drug, and Cosmetic Act relating to new drugs because—

(A) It is intended solely for investigational use as described in section 505(i) of the Federal Food, Drug, and Cosmetic Act; and

(B) Such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.

[88 FR 50040, Aug. 1, 2023]