Importer of Controlled Substances Application: Adiramedica, LLC
| Published date | 11 June 2021 |
| Citation | 86 FR 31344 |
| Record Number | 2021-12290 |
| Section | Notices |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 86 Issue 111 (Friday, June 11, 2021)
[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31344-31345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12290]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-848]
Importer of Controlled Substances Application: Adiramedica, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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[[Page 31345]]
SUMMARY: Adiramedica, LLC. has applied to be registered as an importer
of basic class(es) of controlled substance(s). Refer to Supplementary
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 July 12, 2021.
Such persons may also file a written request for a hearing on the
application on or before July 12, 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
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 May 17, 2021, Adiramedica, LLC., 585 Turner
Industrial Way, Aston, Pennsylvania 19014, 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
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Tapentadol..................................... 9780 II
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The company plans to import Tapentadol (9780) in dosage form for
clinical trials. No other activity for this drug code 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. 2021-12290 Filed 6-10-21; 8:45 am]
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