21 USC 825 - Labeling and packaging

U.S Code last checked for updates: Feb 21, 2025

§ 825.

Labeling and packaging

(a)

Symbol

(b)

Unlawful distribution without identifying symbol

(c)

Warning on label

(d)

Containers to be securely sealed

(e)

False labeling of anabolic steroids

(1)

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).

(2)

(A)

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

(B)

A product is described in this subparagraph 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 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.

(Pub. L. 91–513, title II, § 305, Oct. 27, 1970, 84 Stat. 1256; Pub. L. 113–260, § 3(a), Dec. 18, 2014, 128 Stat. 2931.)

cite as: 21 USC 825