21 CFR 1304.33 - Reports to Automation of Reports and Consolidated Orders System (ARCOS)

Cite as21 CFR 1304.33
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31 practice notes
  • Masters Pharmaceuticals, Inc.; Decision and Order
    • United States
    • Federal Register September 15, 2015
    • September 15, 2015
    ...\137\ The Government's printout of ARCOS data would not have included schedule IV drugs such as alprazolam. 21 CFR 1304.33(d). Nor would it have included drugs such as tramadol and carisoprodol, which were subject to the As for Respondent's distributions to Medical Plaza, Ms. Seiple's decla......
  • Edge Pharmacy; Decision and Order
    • United States
    • Federal Register October 19, 2016
    • October 19, 2016
    ...report to the Agency both acquisition and distribution transactions for various controlled substances included all schedule II drugs. 21 CFR 1304.33(c). The information was compiled in the document found at GE 6, at 1-5, which lists each filled schedule II order by distributor, transaction ......
  • Disposal of Controlled Substances
    • United States
    • Federal Register December 21, 2012
    • December 21, 2012
    ...inventoried, or otherwise discerned. DEA is also proposing in section 1317.50 that collectors be exempt from the ARCOS requirements in 21 CFR 1304.33 and the order form requirements in 21 CFR part 1305 only when they collect controlled substances from ultimate users or other authorized non-......
  • Superior Pharmacy I and Superior Pharmacy II Decision and Order
    • United States
    • Federal Register May 18, 2016
    • May 18, 2016
    ...95 percent of the purchase data. Id. at 402-04. --------------------------------------------------------------------------- \42\ See 21 CFR 1304.33 (setting forth ARCOS reporting obligations imposed on manufacturers and The Government called another DI, who testified regarding the execution......
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3 cases
  • United States v. Rattini, Case No. 1:19-cr-81
    • United States
    • United States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio
    • March 5, 2021
    ...all transactions related to the acquisition and distribution of Schedule II and III narcotic substances. (Id. at ¶ 10, citing, 21 C.F.R. § 1304.33.) Miami-Luken is also required to maintain "effective controls against diversion of particular controlled substances into other than legitimate ......
  • In re Nat'l Prescription Opiate Litig., MDL No. 2804
    • United States
    • United States District Courts. 6th Circuit. United States District Court of Northern District of Ohio
    • July 26, 2018
    ...is a creature of federal law, maintained by the DEA in accordance with 21 U.S.C. §§ 827, 831, 958 ; 5 U.S.C. §§ 552 and 552a ; 21 C.F.R. §§ 1304. It is "an automated comprehensive drug reporting system which monitors the flow" of certain controlled substances, including opioids, "from their......
  • Easy Returns Worldwide, Inc v. U.S., No. 4:03 CV 555HEA.
    • United States
    • United States District Courts. 8th Circuit. United States District Court (Eastern District of Missouri)
    • May 19, 2003
    ...controlled substances listed in Schedules III and IV with the DEA's Automation of Reports and Consolidated Orders System (ARCOS). 21 C.F.R. § 1304.33(c); 21 U.S.C. 827(d). These reports must be filed every quarter not later than the 15th day of the month succeeding the quarter for which it ......

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