[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Page 34720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12197]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1021]


Bulk Manufacturer of Controlled Substances Application: Pisgah 
Laboratories Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Pisgah Laboratories Inc. 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 
August 8, 2022. Such persons may also file a written request for a 
hearing on the application on or before August 8, 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 March 9, 2022, Pisgah Laboratories Inc., 3222 Old 
Hendersonville Highway, Pisgah Forest, North Carolina 28768, applied to 
be registered as a bulk manufacturer of the following basic class(es) 
of controlled substance(s):

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         Controlled substance           Drug code         Schedule
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4-Bromo-2,5-dimethoxyphenethylamine..        7392  I
Methylone (3,4-Methylenedioxy-N-             7540  I
 methylcathinone).
Difenoxin............................        9168  I
Diphenoxylate........................        9170  II
Levorphanol..........................        9220  II
Meperidine...........................        9230  II
Methadone............................        9250  II
Remifentanil.........................        9739  II
Tapentadol...........................        9780  II
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    The company plans to bulk manufacture the above-listed controlled 
substances in bulk for distribution to its customers. No other 
activities for these drug codes are authorized for this registration.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-12197 Filed 6-6-22; 8:45 am]
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