21 CFR 1301.71 - Security requirements generally

Cite as21 CFR 1301.71
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148 practice notes
  • Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II
    • United States
    • Federal Register August 22, 2014
    • August 22, 2014
    ...orders of unusual frequency. Id. Part of the due diligence associated with that requirement, as well as the general requirement under 21 CFR 1301.71(a) for registrants to ``provide effective controls and procedures to guard against theft and diversion of controlled substances,'' is to ``kno......
  • Part II
    • United States
    • Federal Register April 06, 2009
    • April 6, 2009
    ...distributors have a duty to maintain effective controls against diversion of controlled substances. 21 U.S.C. 823(b)(1), 823(e)(1); 21 CFR 1301.71(a). As part of this responsibility, all distributors must design and operate a system to disclose to the registrant suspicious orders of control......
  • 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
    ...to secure controlled substances properly at the Avon Office, in violation of 21 CFR 1301.75(b). ALJ Ex. 1. With regard to security, 21 CFR 1301.71(a) provides, in relevant part, that ``all applicants and registrants shall provide effective controls and procedures to guard against theft and ......
  • Masters Pharmaceuticals, Inc.; Decision and Order
    • United States
    • Federal Register September 15, 2015
    • September 15, 2015
    ...Against Diversion Into Other Than Legitimate Channels and Past Experience in the Distribution of Controlled Substances Pursuant to 21 CFR 1301.71(a), ``all applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substance......
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29 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
    ...all registrants to "provide effective controls and procedures to guard against theft and diversion of controlled substances." 21 C.F.R. § 1301.71(a). The DEA Administrator also promulgated § 1301.74(b), which imposes a legal obligation on non-practitioner registrants—manufacturers and distr......
  • De Villers v. County of San Diego, No. D048974.
    • United States
    • California Court of Appeals
    • October 19, 2007
    ...physical and other security requirements imposed on registrants may be "deemed sufficient" to satisfy the registrant's obligations. (21 C.F.R. § 1301.71(b).) Indeed, plaintiffs' expert conceded that neither of the measures he specified as complying with the regulations (e.g. limiting keys t......
  • San Mateo Union High Sch. Dist. v. Cnty. of San Mateo, A134543
    • United States
    • California Court of Appeals
    • January 31, 2013
    ...examiner (OME), " 'shall provide effective controls and procedures to guard against theft and diversion of controlled substances.' (21 C.F.R. § 1301.71(a).)" (Id. at p. 257, fn. omitted.) The court noted that "the Legislature's use of mandatory language (while necessary) is not the disposit......
  • Cleveland Bakers & Teamsters Health & Welfare Fund 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
    • February 21, 2020
    ...describes 440 F.Supp.3d 813 pharmacies' and pharmacists' duties to prevent diversion as CSA registrants. See 21 C.F.R. §§ 1301.11, 1301.71(a), 1306.04(a) ; Doc. #: 3031 at ¶ 575. It alleges the Pharmacies, in contravention of these duties, failed to: (i) adequately train pharmacists and tec......
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