[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Notices]
[Page 68090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23766]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-736]


Importer of Controlled Substances Application: Mylan 
Pharmaceuticals

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Mylan Pharmaceuticals 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 November 27, 
2020. Such persons may also file a written request for a hearing on the 
application on or before November 27, 2020.

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, 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 October 7, 2020, Mylan Pharmaceuticals, Incorporated, 
3711 Collins Ferry Road, Morgantown, West Virginia 26505-2362, 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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Amphetamine.............................   1100  II
Methylphenidate.........................   1724  II
Oxycodone...............................   9143  II
Hydromorphone...........................   9150  II
Methadone...............................   9250  II
Morphine................................   9300  II
Fentanyl................................   9801  II
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    The company plans to import finished dosage forms for analytical 
testing and distribution for clinical trials. No other activity for 
these drug codes 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. 2020-23766 Filed 10-26-20; 8:45 am]
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