84 FR 18321 - Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.

[Federal Register Volume 84, Number 83 (Tuesday, April 30, 2019)]
[Notices]
[Pages 18321-18322]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-08702]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mylan 
Pharmaceuticals Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before May 30, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before May 30, 2019.

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 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for 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. Comments and requests for hearings on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417, (January 25, 2007).

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
November 13, 2018, Mylan Pharmaceuticals Inc., 3711 Collins Ferry Road, 
Morgantown, West Virginia 26505 applied to be registered as an importer 
of the following basic classes of controlled substances:

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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

[[Page 18322]]

 
Fentanyl...............................     9801  II
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    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically manufactured FDF to foreign 
markets. Authorization will not extend to the import of FDA approved or 
non-approved finished dosage forms for commercial use.

    Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-08702 Filed 4-29-19; 8:45 am]
 BILLING CODE 4410-09-P