Notice2022-01816
Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 31, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Siegfried USA, 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.
Full Text
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<title>Federal Register, Volume 87 Issue 20 (Monday, January 31, 2022)</title>
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[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Page 4941]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01816]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-947]
Bulk Manufacturer of Controlled Substances Application: Siegfried
USA, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Siegfried USA, 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 file written comments on or objections to
the issuance of the proposed registration on or before April 1, 2022
Such persons may also file a written request for a hearing on the
application on or before April 1, 2022.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on December 8, 2021, Siegfried USA, LLC., 33 Industrial
Park Road, Pennsville, New Jersey 08070-3244, applied to be registered
as a bulk manufacturer of the following basic class(es) of controlled
substance(s):
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Drug
Controlled substance code Schedule
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Gamma Hydroxybutyric Acid............... 2010 I
Dihydromorphine......................... 9145 I
Hydromorphinol.......................... 9301 I
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Methylphenidate......................... 1724 II
Amobarbital............................. 2125 II
Pentobarbital........................... 2270 II
Secobarbital............................ 2315 II
Phenylacetone........................... 8501 II
Codeine................................. 9050 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Methadone............................... 9250 II
Methadone intermediate.................. 9254 II
Morphine................................ 9300 II
Oripavine............................... 9330 II
Thebaine................................ 9333 II
Opium tincture.......................... 9630 II
Oxymorphone............................. 9652 II
Tapentadol.............................. 9780 II
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The company plans to manufacture the above-listed controlled
substance in bulk for development of a new active pharmaceutical
ingredient (API) and validation for a Drug Master File submission to
the Food and Drug Administration. No other activity for this drug code
is authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01816 Filed 1-28-22; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on January 31, 2022.
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