Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Importers Notice of Application - 2021

[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11558-11559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03919]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA798]

Importer of Controlled Substances Application: Myonex Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.


SUMMARY: Myonex 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 29, 2021. Such persons may also file a written request for a hearing on the application on or before March 29, 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, Virginia 22152. All request 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 January 6, 2021, Myonex Inc., 48 East Main Street, Norristown, Pennsylvania 19401-4915, 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
Lisdexamfetamine 1205 II
Methylphenidate 1724 II
Nabilone 7379 II
Oxycodone 9143 II
Hydromorphone 9150 II
Hydrocodone 9193 II
Morphine 9300 II
Oxymorphone 9652 II
Fentanyl 9801 II

[[Page 11559]]

The company plans to import the listed controlled substances for clinical trials, research, and analytical purposes. 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 (FDA)-approved or non-approved finished dosage forms for commercial sale. No other activity for these drug codes is authorized for this registration.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2021-03919 Filed 2-24-21; 8:45 am]

BILLING CODE P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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