Notice2021-23036
Importer of Controlled Substances Application: Mycrodose Therapeutics
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
October 22, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Mycrodose Therapeutics 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 86 Issue 202 (Friday, October 22, 2021)</title>
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[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58691-58692]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23036]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-919]
Importer of Controlled Substances Application: Mycrodose
Therapeutics
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Mycrodose Therapeutics 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 file written comments on or objections to
the issuance of the proposed registration on or before November 22,
2021. Such persons may also file a written request for a hearing on the
application on or before November 22, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
request for a hearing should also 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on September 17, 2021, Mycrodose Therapeutics, 5940
Pacific Mesa Court, Suite 210, San Diego, California 92121-4317 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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Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
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[[Page 58692]]
The company plans to import the listed control substances for
clinical trials, research and development, analytical purposes, and
distribution to its customers. 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-23036 Filed 10-21-21; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on October 22, 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.