[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Notices]
[Page 19973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
https://www.regulations.gov 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 https://www.regulations.gov. 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]
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