21 CFR 1307.11 - Distribution by dispenser to another practitioner

Cite as21 CFR 1307.11
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19 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
    ...to distribute)'' a controlled substance to ``a reverse distributor who is registered to receive such controlled substances.'' 21 CFR 1307.11(a). Thus, this provision would seem to grant authority to a practitioner to dispose of his excess controlled substances by shipping them to a reverse ......
  • Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy; Decision and Order
    • United States
    • Federal Register March 13, 2018
    • March 13, 2018
    ...it filled ``the prescriptions alleged'' in the Show Cause Order, Respondent argued that its actions were ``legal and proper'' under 21 CFR 1307.11(a), the called 5% Rule. Resp. Br., at 15-16. Since I find that the Government did not allege a legal basis for the ``office use'' allegation, I ......
  • Disposal of Controlled Substances
    • United States
    • Federal Register December 21, 2012
    • December 21, 2012
    ...from the relevant SAC. --------------------------------------------------------------------------- \41\ Current DEA regulations at 21 CFR 1307.11(a)(2) discuss practitioner distribution of controlled substances to a reverse distributor. DEA proposes to clarify that provision at the proposed......
  • Davis v. Shoop, Case No. 2:16-cv-495
    • United States
    • United States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio
    • June 16, 2020
    ...regulations when used for executions. Id. at PageID 8821-23, citing 21 U.S.C. §§ 331(a), 355(a), 393(b)(2), 841(a); 21 C.F.R. §§ 1301.22, 1307.11; Ohio Rev. Code §§ 4729.01(I), 4765.39(C)(1). Davis claims that human execution is not, and can never be, a valid "off-label" use of the executio......
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2 cases
  • Davis v. Shoop, Case No. 2:16-cv-495
    • United States
    • United States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio
    • June 16, 2020
    ...regulations when used for executions. Id. at PageID 8821-23, citing 21 U.S.C. §§ 331(a), 355(a), 393(b)(2), 841(a); 21 C.F.R. §§ 1301.22, 1307.11; Ohio Rev. Code §§ 4729.01(I), 4765.39(C)(1). Davis claims that human execution is not, and can never be, a valid "off-label" use of the executio......
  • Wedgewood Village Pharmacy v. D.E.A., No. 06-1156.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • December 11, 2007
    .... . for [his] own ingestion.'"10 Id. at 21 (JA 952). The ALJ also focused on the so-called "5% Rule." Id. at 28-29 (JA 959-60). Under 21 C.F.R. § 1307.11, a practitioner "may dispense controlled substances to another registered entity, provided the total number of dosage units thus dispense......
1 firm's commentaries
  • FDA and State Boards of Pharmacy React to COVID-19 – April 20, 2020 Update
    • United States
    • JD Supra United States
    • April 21, 2020
    ...rule.” For the duration of the public health emergency, “A DEA-registered practitioner that complies fully with all other requirements of 21 CFR 1307.11 may now distribute controlled substances beyond five percent of the total number of dosage units of controlled substances distributed and ......
1 provisions
  • HB 178 – Pharmacy Practice Modifications
    • United States
    • Utah Session Laws
    • January 1, 2021
    ...drugs does not exceed 5% of the facility's total prescription drug sales; and (B) the distribution otherwise complies with 21 C.F.R. Sec. 1307.11. (48) "Pharmacist" means an individual licensed by this state to engage in the practice of (49) "Pharmacist-in-charge" means a pharmacist current......

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