21 CFR 1304.22 - Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors

Cite as21 CFR 1304.22
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47 practice notes
  • 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
    ...substantially constructed cabinet, in violation of 21 CFR 1301.75(b); (2) failed to maintain proper DEA Form 222s, in violation of 21 CFR 1304.22(c); (3) distributed controlled substances to an unregistered practitioner, in violation of 21 CFR 1307.11(a); and (4) maintained an unregistered ......
  • Trinity Pharmacy II; Decision and Order
    • United States
    • Federal Register February 20, 2018
    • February 20, 2018
    ...it dispensed because they do not identify a pharmacist who filled the controlled substance prescription.'' Id. at 16-17 (citing 21 CFR 1304.22(c), 1306.06; Fla. Stat., Ch. In a letter from its counsel dated August 12, 2015, Trinity II acknowledged receipt of the Show Cause Order and request......
  • Disposal of Controlled Substances
    • United States
    • Federal Register December 21, 2012
    • December 21, 2012
    ...pertaining to the receipt and destruction of the controlled substance. These records, similar to the current requirements in 21 CFR 1304.22(e) that DEA proposes to delete, are necessary for inspection to maintain the integrity of the closed system and to assist in the detection and preventi......
  • Top RX Pharmacy; Decision and Order
    • United States
    • Federal Register May 03, 2013
    • May 3, 2013
    ...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 such finished form dispensed, in......
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9 cases
  • City of S.F. v. Purdue Pharma L.P., Case No. 3:18-cv-07591-CRB
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • September 30, 2020
    ...See In re Nat'l Prescription Opiate Litig., 2020 WL 4550400, at *12. The MDL court relied on pharmacies' record-keeping duties under 21 C.F.R. § 1304.22(c) to conclude that dispensers must monitor their records to prevent diversion. Id. at *8 ("It would undermine the entire purpose of the C......
  • City & Cnty. of S.F. v. Purdue Pharma L.P., Case No. 3:18-cv-07591-CRB
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • September 30, 2020
    ...See In re Nat'l Prescription Opiate Litig., 477 F.Supp.3d at 631. The MDL court relied on pharmacies’ record-keeping duties under 21 C.F.R. § 1304.22(c) to conclude that 491 F.Supp.3d 672 dispensers must monitor their records to prevent diversion. Id. at 627 ("It would undermine the entire ......
  • Cnty. of Lake v. Purdue Pharma, L.P. (In re Nat'l Prescription Opiate Litig.), MDL 2804
    • United States
    • United States District Courts. 6th Circuit. United States District Court of Northern District of Ohio
    • August 6, 2020
    ...typewritten name or initials of the individual who dispensed or administered the [controlled] substance on behalf of the dispenser. 21 C.F.R. § 1304.22(c). Whatever other information a pharmacy may choose to collect about its own dispensing practices, those of its stores, or those of its ph......
  • United States v. Heim, CASE NO. 5:13CV210
    • United States
    • United States District Courts. 6th Circuit. United States District Court of Northern District of Ohio
    • January 22, 2014
    ...negligently failed to make, keep, or furnish records of the controlled substance hydrocodone as required by 21 U.S.C. § 827(a)(3) and 21 C.F.R. § 1304.22(c) and prohibited by 21 U.S.C. § 842(a)(5).15. This constitutes at least fourteen separate violations of 21 U.S.C. § 842(a)(5) . . . .* *......
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1 firm's commentaries
  • DEA Releases Final Rule On Disposal Of Controlled Substances
    • United States
    • Mondaq United States
    • September 29, 2014
    ...Drug Enforcement Admin., Disposal of Controlled Substances, 79 Fed. Reg. 53520, 53521 (Sept. 9, 2014). F.R. § 1304.11. Id.; see also 21 C.F.R. § 1304.22. 16.21 C.F.R. § Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be c......

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