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[Federal Register Volume 90, Number 29 (Thursday, February 13, 2025)]
[Notices]
[Pages 9554-9555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02600]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1491]

Importer of Controlled Substances Application: Purisys, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Purisys, 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 submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
March 17, 2025. Such persons may also file a written request for a 
hearing on the application on or before March 17, 2025.

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 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 10, 2024, Purisys, LLC, 1550 Olympic Drive, 
Athens, Georgia 30601-1602, applied to be registered as an importer of 
the following basic class(es) of controlled substance(s):

[[Page 9555]]

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                                           Drug
          Controlled substance             code          Schedule
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Marihuana Extract.......................    7350  I
Marihuana...............................    7360  I
Tetrahydrocannabinols...................    7370  I
Nabilone................................    7379  II
Phenylacetone...........................    8501  II
Ecgonine................................    9180  II
Levorphanol.............................    9220  II
Methadone...............................    9250  II
Thebaine................................    9333  II
Opium, raw..............................    9600  II
Opium, powdered.........................    9639  II
Opium, granulated.......................    9640  II
Noroxymorphone..........................    9668  II
Poppy Straw Concentrate.................    9670  II
Tapentadol..............................    9780  II
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    The company plans to import Opium, Raw (9600), Opium, Powdered 
(9639) and Opium, Granulated (9640) to manufacture an Active 
Pharmaceutical Ingredient (API) only for distribution to its customers. 
The company plans to import Phenylacetone (8501) and Poppy Straw 
Concentrate (9670), to bulk manufacture other controlled substances for 
distribution to its customers. The company plans to import impurities 
of buprenorphine that have been determined by DEA to be captured under 
Thebaine (9333). In reference to Marihuana Extract (7350), Marihuana 
(7360), and Tetrahydrocannabinols (7370), the company plans to import 
as synthetic. The company plans to import an isomer of methadone (9250) 
not currently available domestically to manufacture a non-controlled 
substance. No other activities for these drug codes are 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. 2025-02600 Filed 2-12-25; 8:45 am]
BILLING CODE P
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