21 CFR 1304.04 - Maintenance of records and inventories

Cite as21 CFR 1304.04
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51 practice notes
  • Perry County Food & Drug Decision and Order
    • United States
    • Federal Register November 12, 2015
    • November 12, 2015
    ...ALJ EX. 15, at 2. More specifically, DEA regulations require that paper prescriptions be maintained at the registered location. See 21 CFR 1304.04(h)(2) (``Paper prescriptions for Schedule II controlled substances shall be maintained at the registered location in a separate prescription fil......
  • Jeffery J. Becker, D.D.S., and Jeffery J. Becker, D.D.S., Affordable Care Decision and Order
    • United States
    • Federal Register December 05, 2012
    • December 5, 2012
    ...those records in a manner that is ``readily retrievable,'' upon demand of those DEA officials charged with conducting inspections. See 21 CFR 1304.04(g) & (f)(2) (2011); see 21 CFR 1304.03 (requiring recordkeeping set forth in Sec. 1304.04 for dispensing physicians). Readily retrievable......
  • JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp; Decision and Order
    • United States
    • Federal Register May 19, 2015
    • May 19, 2015
    ...(27) prescriptions for controlled substances'' from November 2009 through November 2011 in violation of 21 U.S.C. 827(b)(1) and 21 CFR 1304.04.\7\ --------------------------------------------------------------------------- \7\ ALJ Ex. 1, at The Government alleges that the granting of the CO......
  • Howard N. Robinson, M.D.; Decision and Order
    • United States
    • Federal Register April 08, 2014
    • April 8, 2014
    ...to maintain inventories and records of Schedule I and II controlled substances separately from all other records,'' in violation of 21 CFR 1304.04(f)(1); (3) the Respondent ``failed to properly record on a DEA Form 222, the number of Schedule II commercial or bulk containers and the dates o......
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9 cases
  • United States v. Ruan, No. 17-12653
    • United States
    • U.S. Court of Appeals — Eleventh Circuit
    • July 10, 2020
    ...Similarly, federal law requires pharmacies to keep copies of filled controlled substances prescriptions for at least two years. 21 C.F.R. § 1304.04(a), (h)(2), (h)(4) ; see 21 U.S.C. § 828.Access to the PDMP database is limited. Ala. Code § 20-2-214. Pharmacists and doctors can see informat......
  • 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
    ...substance must 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......
  • United States v. Jonas, 19-1243
    • United States
    • United States Courts of Appeals. United States Court of Appeals (1st Circuit)
    • January 27, 2022
    ...substance must 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 State......
  • Kelleher v. Fred Meyer Stores, Inc., No. CV-13-3108-SMJ
    • United States
    • United States District Courts. 9th Circuit. Eastern District of Washington
    • January 28, 2015
    ...from ordinary business records of the pharmacy. All recordkeeping requirements for controlled substances must be complied with."); 21 CFR 1304.04(h) ("Each registered pharmacy shall maintain the inventories and records of controlled substances as follows. . ."); WAC 246-869-0......
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3 firm's commentaries
  • Record Retention and Destruction for Idaho Healthcare Entities
    • United States
    • JD Supra United States
    • February 6, 2019
    ...guidelines Credentialing file Medical Staff Office 30 years AHIMA guidelines PHARMACY Controlled substances dispensed Pharmacy 2 years 21 CFR § 1304.04(a) 21 USC § 827(b) RESEARCH RECORD RETENTION AND DESTRUCTION FOR IDAHO HEALTHCARE ENTITIES 10 COPYRIGHT © 2018, HOLLAND & HART LLP HEALTHCA......
  • Record Retention and Destruction for Utah Healthcare Entities
    • United States
    • JD Supra United States
    • February 6, 2019
    ...INDUSTRY Record Description Department Retention Recommendations Authority/Comment Controlled substances dispensed Pharmacy 2 years 21 CFR § 1304.04(a) 21 USC § 827(b) RESEARCH Institutional review board (IRB) for clinical devices IRB 2 years after later of the termination of the investigat......
  • Record Retention and Destruction for Wyoming Healthcare Entities
    • United States
    • JD Supra United States
    • February 6, 2019
    ...guidelines Credentialing file Medical Staff Office 30 years AHIMA guidelines PHARMACY Controlled substances dispensed Pharmacy 2 years 21 CFR § 1304.04(a) 21 USC § 827(b) RESEARCH Institutional review board (IRB) for clinical devices IRB 2 years after later of the termination of the investi......

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