21 CFR 1304.04 - Maintenance of records and inventories

Cite as21 CFR 1304.04
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51 practice notes
  • Registration revocations, restrictions, denials, reinstatements: Chein, Edmund, MD,
    • United States
    • Federal Register February 12, 2007
    • February 12, 2007
    ...for the purchase of controlled substance were not on-site, but rather were at the office of the clinic's accountant. This violated 21 CFR 1304.04(a). Moreover, the inventory records and dispensing logs were stored in a computer system and no one was present at the clinic who could access th......
  • 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......
  • Jones Total Health Care Pharmacy, L.L.C., and SND Health Care, L.L.C.; Decision and Order
    • United States
    • Federal Register November 10, 2016
    • November 10, 2016
    ...and CIII-V should be marked if filed with noncontrols sic and must be readily retrievable from all other records.'' Id. Of note, under 21 CFR 1304.04(h)(1), ``inventories and records of all controlled substances listed in schedule I and II shall be maintained separately from all other recor......
  • Mark P. Koch, D.O.; Decision and Order
    • United States
    • Federal Register April 03, 2014
    • April 3, 2014
    ...``may apply to modify his/her registration . . . or to change his/her name or address . . . by submitting a letter'' to the DEA). \112\ 21 CFR 1304.04. \113\ 21 CFR In the absence of authorization to handle controlled substances, it is ``unlawful for any person knowingly or intentionally to......
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8 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......
  • 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 States aut......
  • 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 246-869-070 (The "'respo......
  • Norman Bridge Drug Co. v. Banner, Nos. 74--3877 and 75--1962
    • United States
    • United States Courts of Appeals. United States Court of Appeals (5th Circuit)
    • April 5, 1976
    ...to maintain records of receipts and records of prescriptions of controlled substances in a readily retrievable manner, in violation of 21 CFR 1304.04(d)(1); (5) That Norman Bridge Drug Company had filled prescriptions which had been issued in a manner violative of 21 CFR (6) That Norman Bri......
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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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