[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52135-52136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21319]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Noramco, Inc.
ACTION: Notice of application.
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DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before October 31, 2019.
Such persons may also file a written request for a hearing on the
application on or before October 31, 2019.
[[Page 52136]]
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
requests 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. Comments and requests for hearings on
applications to import narcotic raw material are not appropriate. 72 FR
3417 (January 25, 2007).
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on July 18, 2019, Noramco Inc., 1550 Olympic Drive,
Athens, Georgia 30601 applied to be registered as an importer of the
following basic classes of controlled substances:
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Drug
Controlled substance code Schedule
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Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
Nabilone................................ 7379 II
Phenylacetone........................... 8501 II
Thebaine................................ 9333 II
Poppy Straw Concentrate................. 9670 II
Tapentadol.............................. 9780 II
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The company plans to import phenylacetone (8501), and poppy straw
concentrate (9670) to bulk manufacture other controlled substances for
distribution to its customers. The company plans to import an
intermediate form of tapentadol (9780) to bulk manufacture tapentadol
(9780) for distribution to its customers.
The company plans to import impurities of buprenorphine that have
been determined by DEA to be captured under drug code (9333) thebaine.
In reference to drug codes 7360 and 7370, the company plans to
import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No
other activity for these drug codes is authorized for this
registration. 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 under 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.
Dated: September 23, 2019.
Thomas W. Prevoznik,
Acting Assistant Administrator Deputy Assistant Administrator.
[FR Doc. 2019-21319 Filed 9-30-19; 8:45 am]
BILLING CODE 4410-09-P