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

Federal law — U.S. Code and appendices · legal_authorities

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

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Source file: Laws/federal/codes/united-states-code/title-21/section-825-labeling-and-packaging--bdb7a921e4.md
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Source location: Title 21, Chapter 13, § 825; chapter-013-drug-abuse-prevention-and-control.md

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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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/k&num=0&edition=prelim)) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/m&num=0&edition=prelim)) 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** The Secretary shall prescribe regulations under [section 353(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) 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)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim), (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.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 801 — Congressional findings and declarations: controlled substances

The Congress makes the following findings and declarations: (1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people. (2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people. (3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because— (A) after manufacture, many controlled substances are transported in interstate commerce, (B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and (C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession. (4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances. (5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate. (6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 842 — Prohibited acts B

**(a) Unlawful acts** It shall be unlawful for any person— (1) who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of [section 829 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section829&num=0&edition=prelim); (2) who is a registrant to distribute or dispense a controlled substance not authorized by his registration to another registrant or other authorized person or to manufacture a controlled substance not authorized by his registration; (3) who is a registrant to distribute a controlled substance in violation of [section 825 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section825&num=0&edition=prelim); (4) to remove, alter, or obliterate a symbol or label required by [section 825 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section825&num=0&edition=prelim); (5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II; (6) to refuse any entry into any premises or inspection authorized by this subchapter or subchapter II; (7) to remove, break, injure, or deface a seal placed upon controlled substances pursuant to section 824(f) or 881 of this title or to remove or dispose of substances so placed under seal; (8) to use, to his own advantage, or to reveal, other than to duly authorized officers or employees of the United States, or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection authorized by this subchapter concerning any method or process which

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

Page 30 TITLE 21—FOOD AND DRUGS § 301 Sec. 398. Notices to States regarding imported food. 399. Grants to enhance food safety. 399a. Office of the Chief Scientist. 399b. Office of Women’s Health. 399c. Improving the training of State, local, terri- torial, and tribal food safety officials. 399d. Employee protections. 399e. Nanotechnology. 399f. Ensuring adequate information regarding pharmaceuticals for all populations, par- ticularly underrepresented subpopulations, including racial subgroups. 399g. Food and Drug Administration Intercenter Institutes. 399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufac- turing. 399i. Food and Drug Administration Working Cap- ital Fund. SUBCHAPTER I—SHORT TITLE § 301. Short title This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. (June 25, 1938, ch. 675, § 1, 52 Stat. 1040.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro- vided that: ‘‘[SEC. 1] (a) The effective date of the following provi- sions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this title]. ‘‘(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940[,] the ef- fective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. **(b) Filing application; contents** (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approv

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

Page 186 TITLE 21—FOOD AND DRUGS § 355 § 355. New drugs (a) Necessity of effective approval of application No person shall introduce or deliver for intro- duction into interstate commerce any new drug, unless an approval of an application filed pursu- ant to subsection (b) or (j) is effective with re- spect to such drug. (b) Filing application; contents (1)(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the ap- plication— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as compo- nents of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the arti- cles used as components thereof as the Sec- retary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 355c of this title; and (viii) the patent number and expiration date of each patent for which a claim of patent in- fringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug sub- stance (active ingredient) patent or a drug product (formulation or composition) pat- ent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an a

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Federal law — U.S. Code and appendices · legal_authorities

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

Page 822 TITLE 21—FOOD AND DRUGS § 825 the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables. Subchapter II, referred to in subsecs. (a)(1), (2) and (d)(2), was in the original ‘‘title III’’, meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables. AMENDMENTS 2022—Subsec. (a). Pub. L. 117–328, § 1262(b)(1), which di- rected substitution of ‘‘823(g)’’ for ‘‘823(g)(1)’’ in two places in concluding provisions, could not be executed because of the intervening amendment by Pub. L. 117–215, § 103(b)(1)(C). See Amendment note below. Pub. L. 117–215, in concluding provisions, substituted ‘‘823(h)(1)’’ for ‘‘823(g)(1)’’ in two places. Subsec. (d)(1). Pub. L. 117–328, § 1262(b)(1), which di- rected substitution of ‘‘823(g)’’ for ‘‘823(g)(1)’’, could not be executed because of the intervening amendment by Pub. L. 117–215, § 103(b)(1)(C). See Amendment note below. Pub. L. 117–215 substituted ‘‘823(h)(1)’’ for ‘‘823(g)(1)’’. 2021—Subsec. (h). Pub. L. 117–36 added subsec. (h). 2016—Subsec. (c). Pub. L. 114–145, § 2(b), struck out ‘‘The order to show cause shall contain a statement of the basis thereof and shall call upon the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but in no event less than thirty days after the date of receipt of the order. Proceedings to deny, revoke, or suspend shall be con- ducted pursuant to this section in accordance with sub- chapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecu- tions or other proceeding

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