21 CFR 1304.21 - General requirements for continuing records

Cite as21 CFR 1304.21
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36 practice notes
  • Moore Clinical Trials, L.L.C.; Decision and Order
    • United States
    • Federal Register July 11, 2014
    • July 11, 2014
    ...while both Page 40160 Respondent and Dr. Nichol failed to maintain dispensing records on a current basis, see 21 U.S.C. 827(a)(3); 21 CFR 1304.21(a), Ms. Moore asserted that she was not aware that Dr. Nichol was required to keep controlled substances records for the studies until August 24,......
  • Top RX Pharmacy; Decision and Order
    • United States
    • Federal Register May 03, 2013
    • May 3, 2013
    ...exported, or otherwise disposed of by it, except that no registrant shall be required to maintain a perpetual inventory.'' 21 C.F.R. Sec. 1304.21(a). Additionally, 21 C.F.R. Sec. 1304.22 requires dispensers of controlled substances to maintain records of: ``the number of units or volume of ......
  • Disposal of Controlled Substances
    • United States
    • Federal Register September 09, 2014
    • September 9, 2014
    ...1304.21(a) was updated to specifically include inner liners and mail-back packages, which were inadvertently overlooked in the NPRM. 21 CFR Sec. 1304.21(c) was updated to include the general recordkeeping requirements for collection activities as outlined in the final rule. The recordkeepin......
  • Howard N. Robinson, M.D.; Decision and Order
    • United States
    • Federal Register April 08, 2014
    • April 8, 2014
    ...audit charts throughout her career, the records that she reviewed were in violation of multiple recordkeeping requirements outlined in 21 CFR Sec. 1304.21. Tr. 124, 144.\29\ Also after the January inspection, DI McRae informed the Respondent that, ``for some unknown reason,'' Page 19361 had......
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10 cases
  • U.S. Dep't of Justice v. Jonas, 19-1243
    • United States
    • United States Courts of Appeals. United States Court of Appeals (1st Circuit)
    • January 27, 2022
    ...maintain a complete and accurate record of each such substance disposed of.17 21 U.S.C. § 827(a)(3) ; 21 C.F.R. §§ 1304.03, 1304.04(h), 1304.21(a). These records must be kept for at least two years "for inspection and copying by officers or employees of the United States authorized by the A......
  • United States v. Jonas, 19-1243
    • United States
    • United States Courts of Appeals. United States Court of Appeals (1st Circuit)
    • January 27, 2022
    ...maintain a complete and accurate record of each such substance disposed of.[17] 21 U.S.C. § 827(a)(3); 21 C.F.R. §§ 1304.03, 1304.04(h), 1304.21(a). These records must be kept for at least two years "for inspection and copying by officers or employees of the United States authorized by the ......
  • US v. Poulin, Civil A. No. 93-12265-REK.
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
    • April 19, 1996
    ...most of the missing drugs were out of date drugs that were stored in the paper bag, but, in violation of 21 U.S.C. § 842(a)(5) and 21 C.F.R. § 1304.21, he provided no record of when the drugs were last present in the In short, David Poulin and Mattapoisett Pharmacy, Inc. did not keep comple......
  • US v. Stidham, No. 95-0438-CB-C.
    • United States
    • U.S. District Court — Southern District of Alabama
    • August 16, 1996
    ...and accurate records and inventories of controlled substances dispensed or received as required by 21 U.S.C. § 842 in violation of 21 C.F.R. § 1304.21 in that they could not account for 56,000 milligrams or approximately 560 dosage units of Conclusions of Law Summary judgment should be gran......
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