21 U.S.C. § 825

Labeling and packaging

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(a) Symbol

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 section 321(k) of this title) 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

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

The Secretary shall prescribe regulations under section 353(b) of this title 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.(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 NotesReferences in Text

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

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

Amendments

2014—Subsec. (e). Pub. L. 113–260 added subsec. (e).

Statutory Notes and Related SubsidiariesEffective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, 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 section 704(c) of Pub. L. 91–513, set out as a note under section 801 of this title.

Identification and Publication of List of Products Containing Anabolic Steroids

Pub. L. 113–260, § 4, Dec. 18, 2014, 128 Stat. 2932, provided that:“(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.”

Notes of Decisions

Cited in 11 cases (2 in the last 5 years), 1976–2026 · leading case: Hi-Tech Pharmaceuticals, Inc. v. Hodges Consulting, Inc.

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Hi-Tech Pharmaceuticals, Inc. v. Hodges Consulting, Inc. (2016) gand “If SOS-500 did contain Halovar and did not disclose of that fact on its label, Hodges may also have violated 21 U.S.C. § 825 (e)(1), which states: "It shall be unlawful to import, export, manufacture, distribute, [or] dispense .”

Edward Lee Wright v. United States (1980) ca5 “On October 23, 1964, Wright was indicted and charged with four counts of illegally selling heroin under the statutory predecessor of 21 U.S.C. §§ 825 and 828. At the arraignment on November 4 of that year, the prosecutor apprised him that the maximum sentence for the final count…”

United States v. De La Cruz (2021) ca1 “§ 960 (a) (2018) (listing 21 U.S.C. §§ 825 , 952, 953, 955, 957, and 959 as unlawful conduct for purposes of § 960).”

White v. Weiner (1989) pa “According to federal law all prescription drugs must be labeled according to Food, Drug and Cosmetic Act requirements, 21 U.S.C.S. § 825 . Suppliers of bulk drugs are specifically exempted from these labeling requirements of the Food, Drug and Cosmetic Act, 21 U.”

United States v. Akinyoyenu (2016) dcd “§ 812 ], the drugs set forth in paragraph (b) of this section have been excepted by the Director from application of [ 21 U.S.C. §§ 825 , 827-29, 952-54] for administrative purposes only.”

Fisher v. Professional Compounding Centers of America, Inc. (2004) nvd “21 U.S.C. § 825 . Suppliers of bulk pharmaceutical ingredients are specifically exempted from these labeling requirements.”

David Roberto Alvarez v. United States of America (1976) ca5 “§§ 952 , 960, 963, and 21 U.S.C. §§ 825 , 828, and 829, respectively.”

United States v. Bozo Kelava and Mile Kodzoman (1979) ca7 “§ 4704 (a) (now 21 U.S.C. § 825 (a)), which prohibited sales except in the original stamped package.”

United States v. Espinal-Mieses (2018) usdistct “§ 960 (a) : Any person who- (1) contrary to section 305, 1002, 1003, or 1007 [21 USCS § 825, 952, 953 or 957 ], knowingly or intentionally imports or exports a controlled substance, (2) contrary to section 1005 [21 USCS § 955 ], knowingly or intentionally brings or possesses on…”

Norwich Eaton Pharmaceuticals, Inc. v. Bowen (1986) ohsd “57(h)(1); 21 U.S.C. § 825 . D. Defendant’s decision that December 29, 1981 was the effective date for approval of the Buprenex NDA is not substantiated in the administrative record and is not in accordance with FDA regulations.”

Express Scripts v. Anne Arundel Cnty. (2026) md “Part 1306, the CSA and implementing regulations establish oversight over registrants, including provisions for labeling and packaging, such as warnings to patients, 21 U.S.C. § 825 ; 21 C.F.R. Part 1302; recordkeeping and reporting requirements, 21 U.”

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