U.S. Code » Title 21 » Chapter CHAPTER 13— DRUG ABUSE PREVENTION AND CONTROL › Subchapter SUBCHAPTER I— CONTROL AND ENFORCEMENT › Part Part B— Authority To Control; Standards and Schedules

21 U.S.C. § 3

EMERGENCY SCHEDULING OF GAMMA HYDROXYBUTYRIC ACID AND LISTING OF GAMMA BUTYROLACTONE AS LIST I CHEMICAL.

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“(a)Emergency Scheduling of GHB.—“(1)In general.—The Congress finds that the abuse of illicit gamma hydroxybutyric acid is an imminent hazard to the public safety. Accordingly, the Attorney General, notwithstanding sections 201(a), 201(b), 201(c), and 202 of the Controlled Substances Act [21 U.S.C. 811(a)–(c), 812], shall issue, not later than 60 days after the date of the enactment of this Act [Feb. 18, 2000], a final order that schedules such drug (together with its salts, isomers, and salts of isomers) in the same schedule under section 202(c) of the Controlled Substances Act as would apply to a scheduling of a substance by the Attorney General under section 201(h)(1) of such Act (relating to imminent hazards to the public safety), except as follows:“(A) For purposes of any requirements that relate to the physical security of registered manufacturers and registered distributors, the final order shall treat such drug, when the drug is manufactured, distributed, or possessed in accordance with an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i)] (whether the exemption involved is authorized before, on, or after the date of the enactment of this Act [Feb. 18, 2000]), as being in the same schedule as that recommended by the Secretary of Health and Human Services for the drug when the drug is the subject of an authorized investigational new drug application (relating to such section 505(i)). The recommendation referred to in the preceding sentence is contained in the first paragraph of the letter transmitted on May 19, 1999, by such Secretary (acting through the Assistant Secretary for Health) to the Attorney General (acting through the Deputy Administrator of the Drug Enforcement Administration), which letter was in response to the letter transmitted by the Attorney General (acting through such Deputy Administrator) on September 16, 1997. In publishing the final order in the Federal Register, the Attorney General shall publish a copy of the letter that was transmitted by the Secretary of Health and Human Services.“(B) In the case of gamma hydroxybutyric acid that is contained in a drug product for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (whether the application involved is approved before, on, or after the date of the enactment of this Act [Feb. 18, 2000]), the final order shall schedule such drug in the same schedule as that recommended by the Secretary of Health and Human Services for authorized formulations of the drug. The recommendation referred to in the preceding sentence is contained in the last sentence of the fourth paragraph of the letter referred to in subparagraph (A) with respect to May 19, 1999.“(2)Failure to issue order.—If the final order is not issued within the period specified in paragraph (1), gamma hydroxybutyric acid (together with its salts, isomers, and salts of isomers) is deemed to be scheduled under section 202(c) of the Controlled Substances Act [21 U.S.C. 812(c)] in accordance with the policies described in paragraph (1), as if the Attorney General had issued a final order in accordance with such paragraph.”
Notes of Decisions
Cited in 9 cases, 1930–2015 · leading case: In Re Cryomedical Sciences, Inc. Sec. Litig., 884 F. Supp. 1001 (D. Maryland 1995).
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In Re Cryomedical Sciences, Inc. Sec. Litig., 884 F. Supp. 1001 (D. Maryland 1995). “” 21 U.S.C. § 3«Xj)(l); 21 C.F.R. § 807.20 (a).”
Ranbaxy Labs., Ltd. v. Burwell, 82 F. Supp. 3d 159 (D.D.C. 2015). “” 21 U.S.C. § 3 55 (j)(5)(D)(i)(IV) (emphasis supplied); My-lan Labs, 910 F.”
Knapp v. Callaway, 52 F.2d 476 (S.D.N.Y. 1931). “*477 Section 3 (21 USCA § 3) provides that the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce shall make uniform rules and regulations for carrying out these provisions.”
United States v. King & Howe, Inc., 78 F.2d 693 (2d Cir. 1935). “” The appellant argues that within the definition of “adulteration in drugs,” as stated in section 7 of the act (21 USCA § 8) and the regulations adopted pursuant to section 3 thereof (21 USCA § 3), a drug is not adulterated, even though it deviates from the standard set out in…”
Ambruster v. Mellon, 41 F.2d 430 (D.C. Cir. 1930). “Section 3 (21 USCA § 3), provides that the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce, shall make uniform rules and regulations for carrying out the provisions of the act.”
Arkansas Carpenters Health & Welfare Fund v. Bayer AG, 544 F.3d 1323 (Fed. Cir. 2008). “21 U.S.C. § 3 5 5 (j) (2) (A) (vii) (IV).”
Limitations on Presidential Auth. to Control Exp. of Certain Hazardous Substances (OLC 1980). “If 21 U.S.C. § 3 8 1 (d X l) had the effect that the M em orandum contends it has, § 6 (0 w ould have been either om itted as unnecessary o r at least phrased w ith reference to § 381(d)(1) 807 controls under the EAA become important for reasons of national security, foreign…”
Rapken & Co. v. United States, 25 C.C.P.A. 268 (C.C.P.A. 1938). “Also in prohibition matters (27 USCA § 4) and in pure food and drug matters (21 USCA § 3 and Regulation 25 (a) for enforcement of Pure Food and Drug Act, 1930) the volume standard is provided.”
United States v. Centralia Dairy Co., 60 F.2d 141 (W.D. Wash. 1932). “” (21USCA§3). This reference to section 3 shows that the sentence last quoted from paragraph third of section 10 is no part of the definition of the offense but is a direction as to the exercise of administrative power.”
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