[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13954-13955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06852]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: SpecGx LLC
ACTION: Notice of application.
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DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written
[[Page 13955]]
comments on or objections to the issuance of the proposed registration
on or before May 8, 2019. Such persons may also file a written request
for a hearing on the application on or before May 8, 2019.
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 materials are not appropriate. 72
FR 3417 (January 25, 2007).
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or revocation of registration) has been redelegated
to the Assistant Administrator of the DEA Diversion Control Division
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0,
appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on
February 1, 2019, SpecGx LLC, 3600 North Second Street, Saint Louis,
Missouri 63147 applied to be registered as an importer of the following
basic classes of controlled substances:
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Controlled substance Drug code Schedule
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Marihuana............................ 7360 I
Phenylacetone........................ 8501 II
Coca Leaves.......................... 9040 II
Opium, raw........................... 9600 II
Poppy Straw Concentrate.............. 9670 II
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The company plans to import the listed controlled substances to
bulk manufacture into Active Pharmaceutical Ingredients (API) for
distribution to its customers. In reference to drug code 7360
(marihuana), the company plans to import synthetic cannabidiol. No
other activity for this drug code is authorized for this registration.
Placement of these 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: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06852 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P