[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Page 70147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26678]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-938]


Importer of Controlled Substances Application: Catalent Pharma 
Solutions, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Catalent Pharma Solutions, LLC has applied to be registered as 
an importer of basic class(es) of controlled substance(s). Refer to 
Supplemental 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 January 10, 
2022. Such persons may also file a written request for a hearing on the 
application on or before January 10, 2022.

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 10, 2021, Catalent Pharma Solutions LLC, 
3031 Red Lion Road, Philadelphia, Pennsylvania 19114, 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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    The company plans to import the above controlled substances as 
finished dosage unit products for clinical trials, research, and 
analytical activities. 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. 2021-26678 Filed 12-8-21; 8:45 am]
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