86 FR 36 pgs. 11558-11559 - Importer of Controlled Substances Application: Myonex Inc
Type: NOTICEVolume: 86Number: 36Pages: 11558 - 11559
Pages: 11558, 11559Docket number: [Docket No. DEA798]
FR document: [FR Doc. 2021-03919 Filed 2-24-21; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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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):
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| 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 |
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]
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