Importer of Controlled Substances Application: Purisys, LLC

Primary source

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Published

March 23, 2023

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

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.

Full Text

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<title>Federal Register, Volume 88 Issue 56 (Thursday, March 23, 2023)</title>
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[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Page 17627]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05939]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1169]


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 
April 24, 2023. Such persons may also file a written request for a 
hearing on the application on or before April 24, 2023.

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 February 15, 2023, 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):

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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
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
------------------------------------------------------------------------

    The company plans to import Opium, Raw (9600), Opium, Powered 
(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. 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. 2023-05939 Filed 3-22-23; 8:45 am]
BILLING CODE P


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