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21 USC § 825 - Labeling and packaging

---
identifier: "/us/usc/t21/s825"
source: "usc"
legal_status: "official_prima_facie"
title: "21 USC § 825 - Labeling and packaging"
title_number: 21
title_name: "FOOD AND DRUGS"
section_number: "825"
section_name: "Labeling and packaging"
chapter_number: 13
chapter_name: "DRUG ABUSE PREVENTION AND CONTROL"
subchapter_number: "I"
subchapter_name: "CONTROL AND ENFORCEMENT"
part_number: "C"
part_name: "Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances"
positive_law: false
currency: "119-84"
last_updated: "2026-04-17"
format_version: "1.1.0"
generator: "[email protected]"
source_credit: "(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.)"
---

# § 825. Labeling and packaging

**(a)** **Symbol** section 321(k) of this title

It 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 title

It 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 title

The 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)** 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.

---

**Source Credit**: (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.)

## Editorial Notes

### References in Text

Schedules I, II, III, and IV, referred to in subsecs. (c) and (d), are set out in .

The 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

2014—Subsec. (e).  added subsec. (e).

## Statutory Notes and Related Subsidiaries

### Effective Date

Section 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

> **“(a)** **In General.—** The 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 section 1 of Pub. L. 113–260, set out as a Short Title of 2014 Amendment note under section 801 of this title] 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: