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 proceedings under this subchapter or any other law of the United States.’’ after ‘‘denied, revoked, or suspended.’’, designated existing provisions as par. (1), and added pars. (2) to (5). Subsec. (d). Pub. L. 114–145, § 2(a)(2), designated exist- ing provisions as par. (1) and added par. (2). 2000—Subsec. (a). Pub. L. 106–310, § 3502(b)(1), sub- stituted ‘‘section 823(g)(1) of this title’’ for ‘‘section 823(g) of this title’’ in two places in concluding provi- sions. Subsec. (d). Pub. L. 106–310, § 3502(b)(2), substituted ‘‘section 823(g)(1) of this title’’ for ‘‘section 823(g) of this title’’. 1994—Subsec. (g). Pub. L. 103–322 inserted ‘‘or chem- ical’’ after ‘‘such substance’’ in last sentence. 1993—Subsec. (a). Pub. L. 103–200, § 3(d)(1), inserted ‘‘or a list I chemical’’ after ‘‘controlled substance’’ in introductory provisions and par. (2) and inserted ‘‘or list I chemicals’’ after ‘‘controlled substances’’ in par. (3). Subsec. (b). Pub. L. 103–200, § 3(d)(2), inserted ‘‘or list I chemical’’ after ‘‘controlled substance’’. Subsec. (f). Pub. L. 103–200, § 3(d)(3), inserted ‘‘or list I chemicals’’ after ‘‘controlled substances’’ wherever appearing. Subsec. (g). Pub. L. 103–200, § 3(d)(4), inserted ‘‘or list I chemicals’’ after ‘‘controlled substances’’ in two places and ‘‘or list I chemical’’ after ‘‘controlled sub- stance’’ wherever appearing. 1987—Subsec. (a)(5). Pub. L. 100–93 added par. (5). 1984—Subsec. (a)(3). Pub. L. 98–473, § 512(1), inserted provisions relating to suspension, etc., recommended by competent State authority. Subsec. (a)(4). Pub. L. 98–473, § 512(2), added par. (4). Subsec. (f). Pub. L. 98–473, § 304, inserted provisions relating to vesting of right, title, and interest in the United States. Subsec. (g). Pub. L. 98–473, § 513, added subsec. (g). 1974—Subsec. (a). Pub. L. 93–281, § 4(a), provided for revocation or suspension of a registration pursuant to section 823(g) of this title for failure of a registrant to comply with standards referred to in such section 823(g). Subsec. (d). Pub. L. 93–281, § 4(b), substituted ‘‘A sus- pension under this subsection’’ for ‘‘Such suspension’’ in third sentence. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1994 AMENDMENT Amendment by Pub. L. 103–322 effective 120 days after Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set out as a note under section 802 of this title. EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 of this title. EFFECTIVE DATE OF 1987 AMENDMENT Amendment by Pub. L. 100–93 effective at end of four- teen-day period beginning Aug. 18, 1987, and inappli- cable to administrative proceedings commenced before end of such period, see section 15(a) of Pub. L. 100–93, set out as a note under section 1320a–7 of Title 42, The Public Health and Welfare. EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title. PROVISIONAL REGISTRATION Applicability of this section to provisional registra- tions, see section 703 of Pub. L. 91–513, set out as a note under section 822 of this title. § 825. Labeling and packaging (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 de- fined in section 321(k) of this title) containing an identifying symbol for such substance in ac- cordance with such regulations. A different sym- bol shall be required for each schedule of con- trolled substances. (b) Unlawful distribution without identifying symbol It shall be unlawful for the manufacturer of any controlled substance to distribute such sub- stance unless the labeling (as defined in section 321(m) of this title) of such substance contains, when and as required by regulations of the At- torney General, the identifying symbol required under subsection (a). (c) Warning on label The Secretary shall prescribe regulations under section 353(b) of this title which shall pro- vide that the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a pa- tient, 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 regula- tions of the Attorney General. (e) False labeling of anabolic steroids (1) It shall be unlawful to import, export, man- ufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense, Page 823 TITLE 21—FOOD AND DRUGS § 826 an anabolic steroid or product containing an an- abolic steroid, unless the steroid or product bears a label clearly identifying an anabolic steroid or product containing an anabolic ster- oid by the nomenclature used by the Inter- national 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 require- ment of this subsection if such product is la- beled 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 subpara- graph if the product— (i) is the subject of an approved application as described in section 505(b) or (j) of the Fed- eral 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 Notes REFERENCES 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 Subsidiaries EFFECTIVE 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 sec- tion 704(c) of Pub. L. 91–513, set out as a note under sec- tion 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, pro- vided 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 Reg- ister or on the website of the Drug Enforcement Ad- ministration a list of products which the Attorney Gen- eral has determined, based on substantial evidence, contain an anabolic steroid and are not labeled in ac- cordance 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 con- stitute evidence that the product does not contain an anabolic steroid.’’ § 826. Production quotas for controlled sub- stances (a) Establishment of total annual needs (1) The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the estab- lishment and maintenance of reserve stocks. Ex- cept as provided in paragraph (2), production quotas shall be established in terms of quan- tities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance. (2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a con- trolled substance, establish an aggregate or in- dividual production quota under this subsection, or a procurement quota established by the At- torney General by regulation, in terms of phar- maceutical dosage forms prepared from or con- taining the controlled substance. (b) Individual manufacturing quotas; revised quotas The Attorney General shall limit or reduce in- dividual manufacturing quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under subsection (a). The quota of each reg- istered manufacturer for each basic class of con- trolled substance in schedule I or II or for ephed- rine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas. However, if any registrant, before the issuance of a limitation or reduction in quota, has manufactured in excess of his revised quota, the amount of the excess shall be subtracted from his quota for the following year. (c) Manufacturing quotas for registered manu- facturers On or before December 1 of each year, upon ap- plication therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled sub- stances in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine that the manufacturer seeks to produce. The quota shall be subject to the provisions of subsections (a) and (b) of this section. In fixing such quotas, the Attorney General shall determine the manu- facturer’s estimated disposal, inventory, and other requirements for the calendar year; and, in making his determination, the Attorney Gen- eral shall consider the manufacturer’s current