U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— DRUGS AND DEVICES › Part Part A— Drugs and Devices

21 U.S.C. § 360a

Clinical trial guidance for antibiotic drugs

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(a) In general

Not later than 1 year after September 27, 2007, the Secretary shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidance shall indicate the appropriate models and valid surrogate markers.

(b) Review

Not later than 5 years after September 27, 2007, the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.

(June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.)Editorial NotesPrior Provisions

A prior section 360a, act June 25, 1938, ch. 675, § 511, as added July 15, 1965, Pub. L. 89–74, § 3(b), 79 Stat. 227; amended Oct. 24, 1968, Pub. L. 90–639, § 2(a), 82 Stat. 1361, regulated the manufacture, compounding, and processing of depressant and stimulant drugs and their sale, delivery, disposal, possession, and recordkeeping activities connected therewith, prior to repeal by Pub. L. 91–513, title II, §§ 701(a), 704, Oct. 27, 1970, 84 Stat. 1281, 1284, effective on the first day of the seventh calendar month that began after Oct. 26, 1970.

Notes of Decisions
Cited in 42 cases, 1968–2007 · leading case: Woods & Rohde, Inc. v. State, Dep't of Labor, 565 P.2d 138 (Alaska 1977).
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Woods & Rohde, Inc. v. State, Dep't of Labor, 565 P.2d 138 (Alaska 1977). · cites it 2× “The district court granted the defendant's motion to suppress the evidence obtained in the warrantless search made pursuant to 21 U.S.C. § 360a(d). The court distinguished Biswell on the ground that the inspection in Anile was prompted by complaints, making it reasonable "to…”
United States v. Robert Cerrito, 413 F.2d 1270 (7th Cir. 1969). · cites it 3× “21 U.S.C. § 360a. 3 The Congressional findings furnish a basis for determining that the challenged statutes are constitutional.”
Dennis C. Deyo v. United States, 396 F.2d 595 (9th Cir. 1968). · cites it 4× “*597 21 U.S.C.A. § 360a Note. 3 There Congress found a clear danger of national proportions in unregulated traffic of depressant and stimulant drugs necessitating its action respecting interstate traffic in such drugs; 4 that since interstate traffic cannot be distinguished from…”
Russell W. White v. United States, 399 F.2d 813 (8th Cir. 1968). · cites it 2× “” and from 21 U.S.C.A. § 360a (a) (4), describing the persons to whom the Act does not apply,- reading: “(4) Practitioners licensed by law to prescribe or administer depressant or stimulant drugs, while acting in the course of their professional practice.”
United States v. Alois Peter Warren, 453 F.2d 738 (2d Cir. 1972). · cites it 2× “” 21 U.S.C. § 360a(b) (Supp. V 1969). The government attempted to prove at trial that the sales alleged in the indictment had no medical basis and were economically motivated retail sales rather than treatments given in the course of a physician-patient relationship.”
United States v. Owsley Stanley, Robert W. Massey, William A. Spires & Robert D. Thomas, 427 F.2d 1066 (9th Cir. 1970). · cites it 7× “§ 333 (a) ; 21 U.S.C. § 360a (a-e) ; and 21 CFR 166.3(c) (3).”
In Re Dr. John Doe, M.D., a Witness Before the January 1982 Additional Grand Jury. Dr. John Doe, M.D. v. United States, 711 F.2d 1187 (2d Cir. 1983). “) (record keeping required under 21 U.S.C. § 360a(d) for certain controlled substances held to be part of a regulatory scheme), cert.”
In re Neurontin Mktg. & Sale Practices Litig., 244 F.R.D. 89 (D. Mass. 2007). “2001) (citing The Food and Drug Administration Modernization Act of 1997 (“FDAMA”), 21 U.S.C. § 360a, et seq.); see also Washington Legal Found v.”
United States v. Kuch, 288 F. Supp. 439 (D.D.C. 1968). “21 U.S.C. § 360a (f) (1) of the Act reads as follows: “The Secretary may by regulation exempt any depressant or stimulant drug from the application of all or part of this section when he finds that regulation of its manufacture, ■compounding, processing, possession, and…”
United States v. Clarence Arnold, 425 F.2d 204 (10th Cir. 1970). “The judgment is reversed and remanded for a new trial. 1 . The crime charged does not apply to “[plersons who use depressant or stimulant drugs in research, teaching, or ehemieal analysis and not for sale.”
Carter-Wallace, Inc. v. John W. Gardner, Sec'y of Health, Educ., & Welfare, & James L. Goddard, Comm'r of Food & Drugs, 417 F.2d 1086 (4th Cir. 1969). · cites it 2× “21 U.S.C. § 360a; H.R.Rep. No. 130, 89th Cong.”
United States v. Terry Lee Schafer, 461 F.2d 856 (9th Cir. 1972). “This is an appeal by Terry Lee Schafer from a judgment convicting her of unlawfully possessing a “depressant stimulant drug,” namely Lysergic Acid Die-thylamide (LSD) in violation of 21 U.S. C. § 360a(c) (1), 21 U.S.C. § 331 (q) (3) (A).”
Show all 42 citing cases →
— 21 U.S.C. § 360a(a) — 5 cases
United States v. Clarence Arnold, 425 F.2d 204 (10th Cir. 1970). “The judgment is reversed and remanded for a new trial. 1 . The crime charged does not apply to “[plersons who use depressant or stimulant drugs in research, teaching, or ehemieal analysis and not for sale.”
United States v. Robert Cerrito, 413 F.2d 1270 (7th Cir. 1969). “21 U.S.C. § 360a. 3 The Congressional findings furnish a basis for determining that the challenged statutes are constitutional.”
United States v. Stephen L. Soltow, 444 F.2d 59 (10th Cir. 1971).
United States v. Owsley Stanley, Robert W. Massey, William A. Spires & Robert D. Thomas, 427 F.2d 1066 (9th Cir. 1970). “§ 333 (a) ; 21 U.S.C. § 360a (a-e) ; and 21 CFR 166.3(c) (3).”
United States v. Carl Oslin Ramzy, Jr., 446 F.2d 1184 (5th Cir. 1971).
— 21 U.S.C. § 360a(a)(4) — 1 case
United States v. Nazir, 211 F. Supp. 2d 1372 (S.D. Fla. 2002).
— 21 U.S.C. § 360a(b) — 11 cases
Russell W. White v. United States, 399 F.2d 813 (8th Cir. 1968). “” and from 21 U.S.C.A. § 360a (a) (4), describing the persons to whom the Act does not apply,- reading: “(4) Practitioners licensed by law to prescribe or administer depressant or stimulant drugs, while acting in the course of their professional practice.”
United States v. Alois Peter Warren, 453 F.2d 738 (2d Cir. 1972). “” 21 U.S.C. § 360a(b) (Supp. V 1969). The government attempted to prove at trial that the sales alleged in the indictment had no medical basis and were economically motivated retail sales rather than treatments given in the course of a physician-patient relationship.”
United States v. Sidney B. Rowlette & Robert Vecelli, A/K/A Robert Savio, United States of Am. v. Robert Vecelli, A/K/A Robert Savio, 397 F.2d 475 (7th Cir. 1968).
United States v. Angelo v. Graci, 504 F.2d 411 (3rd Cir. 1974).
Dennis C. Deyo v. United States, 396 F.2d 595 (9th Cir. 1968). “*597 21 U.S.C.A. § 360a Note. 3 There Congress found a clear danger of national proportions in unregulated traffic of depressant and stimulant drugs necessitating its action respecting interstate traffic in such drugs; 4 that since interstate traffic cannot be distinguished from…”
— 21 U.S.C. § 360a(c) — 7 cases
United States v. Terry Lee Schafer, 461 F.2d 856 (9th Cir. 1972). “This is an appeal by Terry Lee Schafer from a judgment convicting her of unlawfully possessing a “depressant stimulant drug,” namely Lysergic Acid Die-thylamide (LSD) in violation of 21 U.S. C. § 360a(c) (1), 21 U.S.C. § 331 (q) (3) (A).”
United States v. Owsley Stanley, Robert W. Massey, William A. Spires & Robert D. Thomas, 427 F.2d 1066 (9th Cir. 1970). “§ 333 (a) ; 21 U.S.C. § 360a (a-e) ; and 21 CFR 166.3(c) (3).”
Dennis C. Deyo v. United States, 396 F.2d 595 (9th Cir. 1968). “*597 21 U.S.C.A. § 360a Note. 3 There Congress found a clear danger of national proportions in unregulated traffic of depressant and stimulant drugs necessitating its action respecting interstate traffic in such drugs; 4 that since interstate traffic cannot be distinguished from…”
United States v. David Valdez Rodriguez, 438 F.2d 1164 (9th Cir. 1971).
State v. Miller, 185 N.W.2d 872 (Minn. 1971).
— 21 U.S.C. § 360a(c)(2) — 1 case
Hess v. Orton, 303 F. Supp. 1178 (D. Colo. 1969).
— 21 U.S.C. § 360a(d) — 11 cases
Woods & Rohde, Inc. v. State, Dep't of Labor, 565 P.2d 138 (Alaska 1977). “The district court granted the defendant's motion to suppress the evidence obtained in the warrantless search made pursuant to 21 U.S.C. § 360a(d). The court distinguished Biswell on the ground that the inspection in Anile was prompted by complaints, making it reasonable "to…”
In Re Dr. John Doe, M.D., a Witness Before the January 1982 Additional Grand Jury. Dr. John Doe, M.D. v. United States, 711 F.2d 1187 (2d Cir. 1983). “) (record keeping required under 21 U.S.C. § 360a(d) for certain controlled substances held to be part of a regulatory scheme), cert.”
United States v. Alois Peter Warren, 453 F.2d 738 (2d Cir. 1972). “” 21 U.S.C. § 360a(b) (Supp. V 1969). The government attempted to prove at trial that the sales alleged in the indictment had no medical basis and were economically motivated retail sales rather than treatments given in the course of a physician-patient relationship.”
United States v. Bill Lee Cummings, Etc., 468 F.2d 274 (9th Cir. 1972).
Young v. Bd. of Pharmacy, 462 P.2d 139 (N.M. 1969).
— 21 U.S.C. § 360a(f) — 1 case
Carter-Wallace, Inc. v. John W. Gardner, Sec'y of Health, Educ., & Welfare, & James L. Goddard, Comm'r of Food & Drugs, 417 F.2d 1086 (4th Cir. 1969). “21 U.S.C. § 360a; H.R.Rep. No. 130, 89th Cong.”
— 21 U.S.C. § 360a(g) — 1 case
Hoffmann-La Roche, Inc. v. Kleindienst, 464 F.2d 1068 (3rd Cir. 1972).
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