Notice2021-15920
Bulk Manufacturer of Controlled Substances Application: Novitium Pharma, 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
July 27, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Novitium Pharma, 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 86 Issue 141 (Tuesday, July 27, 2021)</title>
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[Federal Register Volume 86, Number 141 (Tuesday, July 27, 2021)]
[Notices]
[Page 40211]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15920]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-867]
Bulk Manufacturer of Controlled Substances Application: Novitium
Pharma, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Novitium Pharma, 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 September 27,
2021. Such persons may also file a written request for a hearing on the
application on or before September 27, 2021.
ADDRESS: 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 June 17, 2021, Novitium Pharma, LLC., 70 Lake Drive,
East Windsor, New Jersey 08520, 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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Psilocybin.............................. 7347 I
Psilocyn................................ 7348 I
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The company plans to bulk manufacture the above controlled
substances to produce Active Pharmaceutical Ingredient (API) and
finished dosage forms for clinical trial purposes. No other activities
for these drug codes are authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-15920 Filed 7-26-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on July 27, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.