[Federal Register Volume 86, Number 7 (Tuesday, January 12, 2021)]
[Notices]
[Pages 2456-2457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00353]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-763]


Importer of Controlled Substances Application: Medi-Physics, Inc. 
dba GE Healthcare

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Medi-Physics, Inc. dba GE Healthcare has applied to be 
registered as an importer of basic class(es) of controlled 
substance(s). Refer to Supplemental Information listed below for 
further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before February 11, 
2021. Such persons may also file a written request for a hearing on the 
application on or before February 11, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield,

[[Page 2457]]

Virginia 22152. All requests for a hearing should also be sent to: (1) 
Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug 
Enforcement Administration, Attn: DEA Federal Register Representative/
DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on December 15, 2020, Medi-Physics, Inc. dba GE 
Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004-
1412, applied to be registered as an importer of the following basic 
class(es) of controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Cocaine................................     9041  II
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    The company plans to import small quantities of Ioflupane, in the 
form of three separate analogues of Cocaine, to validate production and 
quality control systems, for a reference standard, and for producing 
material for a future investigational new drug submission. Supplies of 
this particular controlled substance are not available in the form 
needed within the current domestic supply of the United States. No 
other activity for this drug code is authorized for this registration.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-00353 Filed 1-11-21; 8:45 am]
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