21 CFR 1301.34 - Application for importation of Schedule I and II substances

Cite as21 CFR 1301.34
    • This document is available in original version only for vLex customers

      View this document and try vLex for 7 days
    • TRY VLEX
1062 practice notes
  • Edge Pharmacy; Decision and Order
    • United States
    • Federal Register October 19, 2016
    • October 19, 2016
    ...the same basic substance, and upon request of such manufacturer or applicant, the Agency ``shall hold a hearing on the application.'' 21 CFR 1301.34(a). While the Government does not initiate the proceeding, it may intervene in the proceeding as a ``person entitled to participate in a heari......
  • Richard J. Settles, D.O.; Decision and Order
    • United States
    • Federal Register September 21, 2016
    • September 21, 2016
    ...the same basic substance, and upon request of such manufacturer or applicant, the Agency ``shall hold a hearing on the application.'' 21 CFR 1301.34(a). While Government does not initiate the proceeding, it may intervene in the proceeding as a ``person entitled to participate in a hearing.'......
  • Penick Corp., Inc. v. Drug Enforcement Admin., No. 06-1105.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • June 26, 2007
    ...of Delaware, Inc. (Noramco) and Mallinckrodt, Inc. (Mallinckrodt), all of which requested a hearing on Chattem's application under 21 C.F.R. § 1301.34(a).2 At 491 F.3d 487 the time of Chattem's application, Noramco and Mallinckrodt were the only registered importers of NRMs, a group that Pe......
  • Lannett Company, Inc.; Grant of Registration To Import Schedule I Substance
    • United States
    • Federal Register October 22, 2013
    • October 22, 2013
    ...bulk manufacturer of THC and is therefore ``among the category of firms entitled to a hearing on the proposed registration pursuant to 21 CFR 1301.34(a).'' ALJ Ex. 2, at 1-2. Rhodes further explained that it sought ``to be heard on the issue of whether . . . the proposed registration of App......
  • Request a trial to view additional results
2 cases
  • Penick Corp., Inc. v. Drug Enforcement Admin., No. 06-1105.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • June 26, 2007
    ...of Delaware, Inc. (Noramco) and Mallinckrodt, Inc. (Mallinckrodt), all of which requested a hearing on Chattem's application under 21 C.F.R. § 1301.34(a).2 At 491 F.3d 487 the time of Chattem's application, Noramco and Mallinckrodt were the only registered importers of NRMs, a group that Pe......
  • Noramco of Delaware v. Drug Enforcement Admin., No. 02-1211.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • July 23, 2004
    ...registration, effective diversion controls are in place. 9. The ALJ analyzed the adequacy of competition under the factors set out in 21 C.F.R. § 1301.34(d), which (d) In determining whether competition among the domestic manufacturers of a controlled substance is adequate within the meanin......

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT