85 FR 67 pgs. 19504-19505 - Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
Type: NOTICEVolume: 85Number: 67Pages: 19504 - 19505
Pages: 19504, 19505Docket number: [Docket No. DEA-618]
FR document: [FR Doc. 2020-07273 Filed 4-6-20; 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-618]
Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
ACTION:
Notice of application.
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 May 7, 2020. Such persons may also file a written request for a hearing on the application on or before May 7, 2020.
ADDRESSES:
[top] 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
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.34(a), this is notice that on March 6, 2020, Almac Clinical Services Incorp, (ACSI) 25 Fretz Road, Souderton, Pennsylvania, 18964, applied to be registered as an importer of the following basic class(es) of controlled substances:
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Psilocybin | 7437 | I |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Morphine | 9300 | II |
| Tapentadol | 9780 | II |
| Fentanyl | 9801 | II |
The company plans to import the listed controlled substances in dosage form to conduct clinical trials.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-07273 Filed 4-6-20; 8:45 am]
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