[Federal Register Volume 87, Number 167 (Tuesday, August 30, 2022)]
[Notices]
[Page 53009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18739]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1061]


Bulk Manufacturer of Controlled Substances Application: Purisys, 
LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Purisys, LLC, has applied to be registered as a bulk 
manufacturer 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 
October 31, 2022. Such persons may also file a written request for a 
hearing on the application on or before October 31, 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 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on June 6, 2022, Purisys, LLC, 1550 Olympic Drive, 
Athens, Georgia 30601-1602, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Ibogaine...............................     7260  I
5-Methyoxy-N,N-diisopropyltryptamine...     7439  I
Cocaine................................     9041  II
Ecgonine...............................     9180  II
Meperidine.............................     9230  II
Meperidine intermediate-A..............     9232  II
Meperidine intermediate-B..............     9233  II
Meperidine intermediate-C..............     9234  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for the production of active pharmaceutical ingredients 
(API) and analytical reference standards for sale to its customers. The 
company plans to manufacture the above listed controlled substances as 
clinical trial and starting materials to make compounds for 
distribution to its customers. No other activities for these drug codes 
are authorized for this registration.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-18739 Filed 8-29-22; 8:45 am]
BILLING CODE 4410-09-P