88 FR 33 pgs. 10382-10383 - Importer of Controlled Substances Application: Mylan Inc.

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Type: NOTICEVolume: 88Number: 33Pages: 10382 - 10383

Docket number: [Docket No. 1140]

FR document: [FR Doc. 2023-03395 Filed 2-16-23; 8:45 am]

Agency: Justice Department

Sub Agency: Drug Enforcement Administration

Official PDF Version: PDF Version

Pages: 10382, 10383

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 1140]

Importer of Controlled Substances Application: Mylan Inc.

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Mylan Inc. 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 March 20, 2023. Such persons may also file a written request for a hearing on the application on or before March 20, 2023.

ADDRESSES:

[top] The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal,

which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on http://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.34(a), this is notice that on December 2, 2022, Mylan Inc., 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):

Controlled substance	Drug code	Schedule
Amphetamine	1100	II
Methylphenidate	1724	II
Oxycodone	9143	II
Hydromorphone	9150	II
Methadone	9250	II
Morphine	9300	II
Fentanyl	9801	II

The company plans to import bulk active pharmaceutical ingredients for internal testing purposes only and 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 the Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

Matthew Strait,

Deputy Assistant Administrator.

[FR Doc. 2023-03395 Filed 2-16-23; 8:45 am]

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