Notice2021-14530
Importer of Controlled Substances Application: Aspen API, Inc.
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 8, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Aspen API, 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.
Full Text
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<title>Federal Register, Volume 86 Issue 128 (Thursday, July 8, 2021)</title>
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[Federal Register Volume 86, Number 128 (Thursday, July 8, 2021)]
[Notices]
[Page 36160]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14530]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-862]
Importer of Controlled Substances Application: Aspen API, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Aspen API, 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 August 9, 2021.
Such persons may also file a written request for a hearing on the
application on or before August 9, 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 May 5, 2021, Aspen API, Inc., 2136 Wolf Road, Des
Plaines, Illinois 60018, 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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Remifentanil.................................... 9739 II
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The company plans to import the listed controlled substance as a
bulk active pharmaceutical ingredient (API) for distribution to
manufacturers of finished dosage prescription drugs. 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.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-14530 Filed 7-7-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on July 8, 2021.
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