Alra Laboratories, Inc. v. Drug Enforcement Admin., No. 94-3585

CourtUnited States Courts of Appeals. United States Court of Appeals (7th Circuit)
Writing for the CourtBefore CUMMINGS, EASTERBROOK, and RIPPLE; EASTERBROOK
Citation54 F.3d 450
Docket NumberNo. 94-3585
Decision Date19 May 1995
PartiesALRA LABORATORIES, INC., Petitioner, v. DRUG ENFORCEMENT ADMINISTRATION, Respondent.

Page 450

54 F.3d 450
ALRA LABORATORIES, INC., Petitioner,
v.
DRUG ENFORCEMENT ADMINISTRATION, Respondent.
No. 94-3585.
United States Court of Appeals,
Seventh Circuit.
Argued April 7, 1995.
Decided May 19, 1995.

Steven M. Kowal, Richard O. Wood (argued), Burditt & Radzius, Chicago, IL, for Alra Laboratories.

Janet Reno, U.S. Atty. Gen., Philip Eric Urofsky (argued), U.S. Dept. of Justice, Narcotic & Dangerous Drug Section, Stephen H.

Page 451

Green, Drug Enforcement Admin., Washington, DC, for Stephen H. Green.

Philip Eric Urofsky, Jo Ann Harris, Theresa VanVliet, U.S. Dept. of Justice, Narcotic & Dangerous Drug Section, Washington, DC, for Drug Enforcement Admin.

Before CUMMINGS, EASTERBROOK, and RIPPLE, Circuit Judges.

EASTERBROOK, Circuit Judge.

Between 1982 and 1989 Alra Laboratories held a license to manufacture and distribute "controlled substances"--principally drugs containing opiates or classed with them in the administrative pharmacopeia. Licensed firms must submit to periodic inspections to confirm their compliance with manufacturing and record-keeping rules. An inspection in 1990 revealed that Alra had neglected to apply for an extension of its license; by operating without a license, Alra violated innumerable statutes and regulations. The DEA seized Alra's inventory of 178,000 doses of clorazepate dipotassium, a Schedule IV controlled substance. Alra ceased making controlled substances (though it continued manufacturing other drugs) and applied for a new license. After an administrative process that lasted four years, the Drug Enforcement Administration said "no," 59 Fed.Reg. 50620 (Oct. 4, 1994), and Alra seeks review under 21 U.S.C. Sec. 877.

An evidentiary hearing on Alra's application revealed that the firm had long been out of compliance with the recordkeeping and reporting requirements applicable to manufacturers of controlled substances. In 1987 the DEA had issued a letter of admonition to Alra because of these problems and its failure to maintain effective controls against the diversion of regulated substances. During the 1990 inspection that revealed the firm's unlicensed status, the inspectors also found that Alra was improperly storing controlled and uncontrolled substances together. Alra had even more serious problems with statutes and regulations under acts administered by the Food and Drug Administration, which repeatedly had cited Alra for bad manufacturing practices and recordkeeping. Alra's entire...

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53 practice notes
  • Decisions and Orders:
    • United States
    • Federal Register October 03, 2011
    • 3 Octubre 2011
    ...and dangerous identity verification practices if permitted to maintain his registration in the future. See Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995) (an ``agency rationally may conclude that past performance is the best predictor of future performance''). Respondent's......
  • John Doe, Inc. v. Drug Enforcement Admin., No. 06-1270.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 27 Abril 2007
    ...Fry v. DEA, 353 F.3d 1041, 1042-44 (9th Cir. 2003); Humphreys v. DEA, 96 F.3d 658, 659-60 (3d Cir.1996); Alra Labs., Inc. v. DEA, 54 F.3d 450, 451 (7th Cir.1995); Nutt v. DEA, 916 F.2d 202, 203 (5th Cir. 1990); Reckitt & Colman, Ltd. v. Adm'r, DEA, 788 F.2d 22, 23 (D.C.Cir.1986). And, in th......
  • Cardinal Health, Inc. v. Holder, Civil Action No. 12–185 (RBW).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 7 Marzo 2012
    ...a backdrop to the events that culminated [846 F.Supp.2d 222]in the DEA's issuance of the Suspension Order.”); cf. Alra Labs. Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995) (“An agency rationally may conclude that past performance is the best predictor of future performance.”). Cardinal also a......
  • Holiday CVS, L.L.C. v. Holder, Civil Action No. 12–191 (RBW).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 16 Marzo 2012
    ...whom the DEA interviewed in October 2011 remained employed at the two stores. See Leonhart Decl. ¶ 19; cf. Alra Labs. Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995) (“An agency rationally may conclude that past performance is the best predictor of future performance.”). 11. The plaintiffs als......
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7 cases
  • John Doe, Inc. v. Drug Enforcement Admin., No. 06-1270.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 27 Abril 2007
    ...Fry v. DEA, 353 F.3d 1041, 1042-44 (9th Cir. 2003); Humphreys v. DEA, 96 F.3d 658, 659-60 (3d Cir.1996); Alra Labs., Inc. v. DEA, 54 F.3d 450, 451 (7th Cir.1995); Nutt v. DEA, 916 F.2d 202, 203 (5th Cir. 1990); Reckitt & Colman, Ltd. v. Adm'r, DEA, 788 F.2d 22, 23 (D.C.Cir.1986). And, in th......
  • Cardinal Health, Inc. v. Holder, Civil Action No. 12–185 (RBW).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 7 Marzo 2012
    ...a backdrop to the events that culminated [846 F.Supp.2d 222]in the DEA's issuance of the Suspension Order.”); cf. Alra Labs. Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995) (“An agency rationally may conclude that past performance is the best predictor of future performance.”). Cardinal also a......
  • Holiday CVS, L.L.C. v. Holder, Civil Action No. 12–191 (RBW).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 16 Marzo 2012
    ...whom the DEA interviewed in October 2011 remained employed at the two stores. See Leonhart Decl. ¶ 19; cf. Alra Labs. Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995) (“An agency rationally may conclude that past performance is the best predictor of future performance.”). 11. The plaintiffs als......
  • Cardinal Health, Inc. v. Holder, Civil Action No. 12-185 (RBW)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 7 Marzo 2012
    ...violations serve as a backdrop to the events that culminated in the DEA's issuance of the Suspension Order."); cf Alra Labs. Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995) ("An agency rationally may conclude that past performance is the best predictor of future performance."). Cardinal also ......
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