Notice2022-07207
Importer of Controlled Substances Application: Meridian Medical Technologies
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
April 6, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Meridian Medical Technologies 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.
Full Text
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<title>Federal Register, Volume 87 Issue 66 (Wednesday, April 6, 2022)</title>
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[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Notices]
[Page 19973]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07207]
[[Page 19973]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 950]
Importer of Controlled Substances Application: Meridian Medical
Technologies
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Meridian Medical Technologies 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 May 6, 2022.
Such persons may also file a written request for a hearing on the
application on or before May 6, 2022.
ADDRESSES: The DEA 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 6, 2021, Meridian Medical Technologies, 2555
Hermelin Drive, Saint Louis, Missouri 63144, applied to be registered
as an importer of the following basic class(es) of controlled
substance(s):
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Drug
Controlled substance code Schedule
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Morphine............................... 9300 II
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The company manufactures a product containing morphine in the
United States. The company exports this product to customers around the
world. The company has been asked to ensure that its product, which is
sold to European customers, meets the standards established by the
European Pharmacopeia, administered by the Directorate for the quality
of Medicines (EDQM). In order to ensure that its product will meet
European specifications, the company seeks to import morphine supplied
by EDQM for use as reference standards. 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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-07207 Filed 4-5-22; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on April 6, 2022.
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