21 CFR 1301.11 - Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy

Cite as21 CFR 1301.11
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51 practice notes
  • Decisions and Orders:
    • United States
    • Federal Register October 03, 2011
    • 3 d1 Outubro d1 2011
    ...same penalties as those prescribed for the offense, the commission of which was the object of the attempt or conspiracy.'' \66\ See also 21 CFR 1301.11 (2010). Read together, I find as a matter of statutory construction that 21 U.S.C. 822, 841, 843 and 846 impose on a practitioner an affirm......
  • Moore Clinical Trials, L.L.C.; Decision and Order
    • United States
    • Federal Register July 11, 2014
    • 11 d5 Julho d5 2014
    ...at the April 2011 meeting, the DIs provided Ms. Moore with the Code of Federal Regulations. Among the regulations contained therein are 21 CFR 1301.11, which requires that ``every person who . . . dispenses . . . any controlled substances or who proposes to engage in the . . . dispensing of......
  • Hills Pharmacy, LLC; Decision and Order
    • United States
    • Federal Register July 28, 2016
    • 28 d4 Julho d4 2016
    ...was required to count the drugs in the ``will-call bin,'' by implication the regulation does not require counting these drugs. See 21 CFR 1301.11(a) (``Controlled substances shall be deemed `on hand' if they are . . . ordered by a customer but not yet invoiced.''). Notably, those drugs in t......
  • Part II
    • United States
    • Federal Register April 06, 2009
    • 6 d1 Abril d1 2009
    ...by means of the Internet to obtain a modification of their existing DEA registration to that of an online pharmacy (21 U.S.C. 823(f), 21 CFR 1301.11). To address this, DEA is revising its existing information collection, ``Application for Registration (DEA Form Application for Registration ......
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24 cases
  • Virtus Pharm. v. Garland, Civil Action 21-2308 (CKK)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 22 d3 Setembro d3 2021
    ...must register with [the] DEA.” Wedgewood Vill. Pharmacy v. DEA, 509 F.3d 541, 542 (D.C. Cir. 2007); see also 21 U.S.C. §§ 821, 822; 21 C.F.R. § 1301.11. Entities not properly registered with the DEA under the CSA may not manufacture, distribute, or dispense controlled substances. 21 U.S.C. ......
  • 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
    • 21 d5 Fevereiro d5 2020
    ...example, the Compliant 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 tr......
  • Morris & Dickson Co. v. Whitaker, CIVIL ACTION NO.: 18-1406
    • United States
    • United States District Courts. 5th Circuit. United States District Courts. 5th Circuit. Western District of Louisiana
    • 28 d5 Dezembro d5 2018
    ...that distribute controlled substances, such as Morris & Dickson, must annually obtain a DEA registration. 21 U.S.C. § 822(a)(1) ; 21 C.F.R. § 1301.11(a). When evaluating a distributor's application, the DEA considers whether the registration is "inconsistent with the public interest" in lig......
  • Cardinal Health, Inc. v. Holder, Civil Action No. 12–185 (RBW).
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 7 d3 Março d3 2012
    ...become involved in the production or chain of distribution of controlled substances must first register with the DEA. 21 U.S.C. § 822; 21 C.F.R. § 1301.11. Distributors of Schedule I or Schedule II drugs—controlled substances with a “high potential for abuse,” 21 U.S.C. §§ 812(b), 812(2)(A)......
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