21 U.S.C. § 825 | Labeling and packaging

(a)

Symbol

section 321(k) of this titleIt shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in ) containing an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of controlled substances.

(b)

Unlawful distribution without identifying symbol

section 321(m) of this titleIt shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling (as defined in ) of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under subsection (a).

(c)

Warning on label

section 353(b) of this titleThe Secretary shall prescribe regulations under which shall provide that the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient.

(d)

Containers to be securely sealed

It shall be unlawful to distribute controlled substances in schedule I or II, and narcotic drugs in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General.

(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)

21 U.S.C. 301 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 [ et seq.].

(B)

A product is described in this subparagraph if the product—

(i)

21 U.S.C. 355(b) is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act [, (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, § 305Oct. 27, 197084 Stat. 1256 Pub. L. 113–260, § 3(a)Dec. 18, 2014128 Stat. 2931(, , ; , , .)

Editorial Notes

References in Text

section 812(c) of this titleSchedules I, II, III, and IV, referred to in subsecs. (c) and (d), are set out in .

act June 25, 1938, ch. 675 52 Stat. 1040 section 301 of this titleThe Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(2)(A), is , , which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see and Tables.

Amendments

Pub. L. 113–2602014—Subsec. (e). added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date

Oct. 26, 1970section 704(c) of Pub. L. 91–513 section 801 of this titleSection effective on first day of seventh calendar month that begins after , but with Attorney General authorized to postpone such effective date for such period as he might determine to be necessary for the efficient administration of this subchapter, see , set out as a note under .

Identification and Publication of List of Products Containing Anabolic Steroids

Pub. L. 113–260, § 4Dec. 18, 2014128 Stat. 2932

“(a)

In General .—

section 1 of Pub. L. 113–260 section 801 of this titleThe Attorney General may, in the Attorney General’s discretion, collect data and analyze products to determine whether they contain anabolic steroids and are properly labeled in accordance with this Act [see , set out as a Short Title of 2014 Amendment note under ] and the amendments made by this Act. The Attorney General may publish in the Federal Register or on the website of the Drug Enforcement Administration a list of products which the Attorney General has determined, based on substantial evidence, contain an anabolic steroid and are not labeled in accordance with this Act and the amendments made by this Act.

“(b)

Absence From List .—

The absence of a product from the list referred to in subsection (a) shall not constitute evidence that the product does not contain an anabolic steroid.”

, , , provided that: