Importers Notice of Application - 2020
[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14605]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-672]
Importer of Controlled Substances Application: Lipomed
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 August 6, 2020. Such persons may also file a written request for a hearing on the application on or before August 6, 2020.
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 June 4, 2020, Lipomed, 150 Cambridgepark Drive, Suite 705, Cambridge, Massachusetts 02140, applied to be registered as an importer of the following basic class(es) of controlled substances:
|Controlled Substance||Drug Code||Schedule|
|Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido) 3,3-dimethylbutanoate)||7036||I|
The company plans to import the above controlled substances as analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized in 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration (FDA)-approved or non-approved finished dosage forms for commercial sale.
William T. McDermott,
[FR Doc. 2020-14605 Filed 7-6-20; 8:45 am]
BILLING CODE P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).