86 FR 234 pg. 70147 - Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
Type: NOTICEVolume: 86Number: 234Page: 70147
Page: 70147Docket number: [Docket No. DEA-938]
FR document: [FR Doc. 2021-26678 Filed 12-8-21; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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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.
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):
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Psilocybin | 7437 | I |
| Psilocyn | 7438 | I |
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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