Importer of Controlled Substances Application: Almac Clinical Services Inc. (ACSI)

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Published

May 25, 2022

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Almac Clinical Services Inc. (ACSI) 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 101 (Wednesday, May 25, 2022)</title>
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[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Page 31902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11261]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1014]


Importer of Controlled Substances Application: Almac Clinical 
Services Inc. (ACSI)

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Almac Clinical Services Inc. (ACSI) 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 submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
June 24, 2022. Such persons may also file a written request for a 
hearing on the application on or before June 24, 2022.

ADDRESSES: The Drug Enforcement Administration 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 April 14, 2022, Almac Clinical Services Inc. (ACSI), 
25 Fretz Road, Souderton, Pennsylvania 18964, 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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Psilocybin..............................    7437  I
Oxycodone...............................    9143  II
Hydromorphone...........................    9150  II
Morphine................................    9300  II
Tapentadol..............................    9780  II
Fentanyl................................    9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances as 
finished dosage form units for clinical trials purposes only.
    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.

Kristi N. O'Malley,
Assistant Administrator.
[FR Doc. 2022-11261 Filed 5-24-22; 8:45 am]
BILLING CODE P


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