82 FR 43570 - Bulk Manufacturer of Controlled Substances Application: Specgx LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 179 (September 18, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 179 (September 18, 2017)
| Page Range | 43570-43571 | |
| FR Document | 2017-19786 |
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)] [Notices] [Pages 43570-43571] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19786] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Specgx LLC ACTION: Notice of application. ----------------------------------------------------------------------- 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 in accordance with 21 CFR 1301.33(a) on or before November 17, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. 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 1301.33(a), this is notice that on August 9, 2017, Specgx LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid.......... 2010 I Tetrahydrocannabinols.............. 7370 I Codeine-N-oxide.................... 9053 I Dihydromorphine.................... 9145 I Difenoxin.......................... 9168 I Morphine-N-oxide................... 9307 I Normorphine........................ 9313 I Norlevorphanol..................... 9634 I Acetyl Fentanyl (N-(1- 9821 I phenethylpiperidin-4-yl)-N- phenylacetamide). Butyryl Fentanyl................... 9822 I Amphetamine........................ 1100 II Methamphetamine.................... 1105 II Lisdexamfetamine................... 1205 II Methylphenidate.................... 1724 II Nabilone........................... 7379 II 4-Anilino-N-phenethyl-4-piperidine 8333 II (ANPP). Codeine............................ 9050 II Dihydrocodeine..................... 9120 II Oxycodone.......................... 9143 II Hydromorphone...................... 9150 II Diphenoxylate...................... 9170 II Ecgonine........................... 9180 II Hydrocodone........................ 9193 II Levorphanol........................ 9220 II Meperidine......................... 9230 II Methadone.......................... 9250 II Methadone intermediate............. 9254 II Dextropropoxyphene, bulk (non- 9273 II dosage forms). Morphine........................... 9300 II Oripavine.......................... 9330 II Thebaine........................... 9333 II Opium tincture..................... 9630 II Opium, powdered.................... 9639 II Oxymorphone........................ 9652 II Noroxymorphone..................... 9668 II Alfentanil......................... 9737 II Remifentanil....................... 9739 II Sufentanil......................... 9740 II Tapentadol......................... 9780 II Fentanyl........................... 9801 II ------------------------------------------------------------------------ [[Page 43571]] The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers. Dated: September 13, 2017 Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017-19786 Filed 9-15-17; 8:45 am] BILLING CODE 4410-09-P
![43570 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
Controlled substance Drug Schedule DEPARTMENT OF JUSTICE the Drug Enforcement Administration
code (DEA), 28 CFR 0.100(b). Authority to
Gamma Hydroxybutyric Acid ... 2010 I
Drug Enforcement Administration exercise all necessary functions with
Marihuana Extract .................... 7350 I [Docket No. DEA–392] respect to the promulgation and
Marihuana ................................ 7360 I implementation of 21 CFR part 1301,
Bulk Manufacturer of Controlled incident to the registration of
The company plans to import finished Substances Application: Specgx LLC
dosage unit products containing gamma- manufacturers, distributors, dispensers,
hydroxybutryic acid and cannabis importers, and exporters of controlled
ACTION: Notice of application.
extracts for clinical trial studies. substances (other than final orders in
These cannabis extracts compounds DATES: Registered bulk manufacturers of connection with suspension, denial, or
are listed under drug code 7350. No the affected basic classes, and revocation of registration) has been
other activity for these drug codes is applicants therefore, may file written redelegated to the Assistant
authorized for this registration. comments on or objections to the Administrator of the DEA Diversion
Approval of permit applications will issuance of the proposed registration in Control Division (‘‘Assistant
occur only when the registrant’s accordance with 21 CFR 1301.33(a) on Administrator’’) pursuant to section 7 of
business activity is consistent with what or before November 17, 2017. 28 CFR part 0, appendix to subpart R.
is authorized under 21 U.S.C. 952(a)(2). ADDRESSES: Written comments should In accordance with 21 CFR
Authorization will not extend to the be sent to: Drug Enforcement 1301.33(a), this is notice that on August
import of FDA approved or non- Administration, Attention: DEA Federal
approved finished dosage forms for 9, 2017, Specgx LLC, 3600 North
Register Representative/DRW, 8701 Second Street, Saint Louis, Missouri
commercial sale. Morrissette Drive, Springfield, Virginia 63147 applied to be registered as a bulk
Dated: September 11, 2017. 22152. manufacturer of the following basic
Demetra Ashley, SUPPLEMENTARY INFORMATION: The classes of controlled substances:
Acting Assistant Administrator. Attorney General has delegated his
[FR Doc. 2017–19833 Filed 9–15–17; 8:45 am] authority under the Controlled
BILLING CODE 4410–09–P Substances Act to the Administrator of
Controlled substance Drug code Schedule
Gamma Hydroxybutyric Acid ........................................................................................................................................... 2010 I
Tetrahydrocannabinols .................................................................................................................................................... 7370 I
Codeine-N-oxide .............................................................................................................................................................. 9053 I
Dihydromorphine ............................................................................................................................................................. 9145 I
Difenoxin .......................................................................................................................................................................... 9168 I
Morphine-N-oxide ............................................................................................................................................................ 9307 I
Normorphine .................................................................................................................................................................... 9313 I
Norlevorphanol ................................................................................................................................................................ 9634 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ............................................................................... 9821 I
Butyryl Fentanyl ............................................................................................................................................................... 9822 I
Amphetamine ................................................................................................................................................................... 1100 II
Methamphetamine ........................................................................................................................................................... 1105 II
Lisdexamfetamine ............................................................................................................................................................ 1205 II
Methylphenidate .............................................................................................................................................................. 1724 II
Nabilone ........................................................................................................................................................................... 7379 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 8333 II
Codeine ........................................................................................................................................................................... 9050 II
Dihydrocodeine ................................................................................................................................................................ 9120 II
Oxycodone ....................................................................................................................................................................... 9143 II
Hydromorphone ............................................................................................................................................................... 9150 II
Diphenoxylate .................................................................................................................................................................. 9170 II
Ecgonine .......................................................................................................................................................................... 9180 II
Hydrocodone ................................................................................................................................................................... 9193 II
Levorphanol ..................................................................................................................................................................... 9220 II
Meperidine ....................................................................................................................................................................... 9230 II
Methadone ....................................................................................................................................................................... 9250 II
Methadone intermediate .................................................................................................................................................. 9254 II
Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. 9273 II
Morphine .......................................................................................................................................................................... 9300 II
Oripavine ......................................................................................................................................................................... 9330 II
Thebaine .......................................................................................................................................................................... 9333 II
Opium tincture ................................................................................................................................................................. 9630 II
Opium, powdered ............................................................................................................................................................ 9639 II
sradovich on DSKBBY8HB2PROD with NOTICES
Oxymorphone .................................................................................................................................................................. 9652 II
Noroxymorphone ............................................................................................................................................................. 9668 II
Alfentanil .......................................................................................................................................................................... 9737 II
Remifentanil ..................................................................................................................................................................... 9739 II
Sufentanil ......................................................................................................................................................................... 9740 II
Tapentadol ....................................................................................................................................................................... 9780 II
Fentanyl ........................................................................................................................................................................... 9801 II
VerDate Sep<11>2014 16:54 Sep 15, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\18SEN1.SGM 18SEN1](https://thefederalregister.org/doc/82_FR_43749/page/1.svg)
![Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices 43571
The company plans to manufacture Administrator’’) pursuant to section 7 of Register Representative/DRW, 8701
bulk active pharmaceutical ingredients 28 CFR part 0, appendix to subpart R. Morrissette Drive, Springfield, Virginia
(APIs) for distribution to its customers. In accordance with 21 CFR 22152.
Dated: September 13, 2017 1301.34(a), this is notice that on August SUPPLEMENTARY INFORMATION: The
9, 2017, Specgx LLC, 3600 North Attorney General has delegated his
Demetra Ashley,
Second Street, Saint Louis, Missouri authority under the Controlled
Acting Assistant Administrator.
63147 applied to be registered as an Substances Act to the Administrator of
[FR Doc. 2017–19786 Filed 9–15–17; 8:45 am] importer of the following basic classes
BILLING CODE 4410–09–P
the Drug Enforcement Administration
of controlled substances: (DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
Drug
DEPARTMENT OF JUSTICE Controlled substance code Schedule respect to the promulgation and
implementation of 21 CFR part 1301,
Drug Enforcement Administration Marihuana ....................... 7360 I incident to the registration of
Phenylacetone ................ 8501 II manufacturers, distributors, dispensers,
[Docket No. DEA–392] Coca Leaves .................. 9040 II importers, and exporters of controlled
Opium, raw ..................... 9600 II substances (other than final orders in
Importer of Controlled Substances Poppy Straw Con- 9670 II connection with suspension, denial, or
Application: Specgx LLC centrate. revocation of registration) has been
redelegated to the Assistant
ACTION: Notice of application. The company plans to import the Administrator of the DEA Diversion
listed controlled substances to bulk Control Division (‘‘Assistant
DATES: Registered bulk manufacturers of manufacture into Active Pharmaceutical Administrator’’) pursuant to section 7 of
the affected basic classes, and Ingredients for distribution to its 28 CFR part 0, appendix to subpart R.
applicants therefore, may file written customers. In reference to drug code In accordance with 21 CFR
comments on or objections to the 7360 (marihuana) the company plans to 1301.33(a), this is notice that on July 11,
issuance of the proposed registration in import a synthetic cannabidiol. No other 2017, Halo Pharmaceutical, Inc., 30
accordance with 21 CFR 1301.34(a) on activity for this drug code is authorized North Jefferson Road, Whippany, New
or before October 18, 2017. Such for this registration. Placement of these Jersey 07981 applied to be registered as
persons may also file a written request drug codes onto the company’s a bulk manufacturer the following basic
for a hearing on the application registration does not translate into classes of controlled substances:
pursuant to 21 CFR 1301.43 on or before automatic approval of subsequent
October 18, 2017. permit applications to import controlled Drug
Controlled substance Schedule
ADDRESSES: Written comments should substances. Approval of permit code
be sent to: Drug Enforcement applications will occur only when the
registrant’s business activity is Dihydromorphine .......... 9145 I
Administration, Attention: DEA Federal Hydromorphone ............ 9150 II
Register Representative/DRW, 8701 consistent with what is authorized
Morrissette Drive, Springfield, Virginia under 21 U.S.C. 952(a)(2). Authorization The company plans to manufacture
22152. All requests for hearing must be will not extend to the import of FDA Hydromorphone (9150) for distribution
sent to: Drug Enforcement approved or non-approved finished to its customers. Dihydromorphine
Administration, Attn: Administrator, dosage forms for commercial sale. (9145) is an intermediate in the
8701 Morrissette Drive, Springfield, Dated: September 11, 2017. manufacture of Hydromorphone and is
Virginia 22152. All request for hearing Demetra Ashley, not for commercial distribution.
should also be sent to: (1) Drug Acting Assistant Administrator. Dated: September 11, 2017.
Enforcement Administration, Attn: [FR Doc. 2017–19784 Filed 9–15–17; 8:45 am] Demetra Ashley,
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
BILLING CODE 4410–09–P Acting Assistant Administrator.
(2) Drug Enforcement Administration, [FR Doc. 2017–19834 Filed 9–15–17; 8:45 am]
Attn: DEA Federal Register DEPARTMENT OF JUSTICE
BILLING CODE P
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152. Drug Enforcement Administration
DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION: The [Docket No. DEA–392]
Attorney General has delegated his Drug Enforcement Administration
authority under the Controlled Bulk Manufacturer of Controlled
Substances Act to the Administrator of [Docket No. DEA–392]
Substances Application: Halo
the Drug Enforcement Administration Pharmaceutical, Inc. Importer of Controlled Substances
(DEA), 28 CFR 0.100(b). Authority to Application: Unither Manufacturing
exercise all necessary functions with ACTION: Notice of application.
LLC
respect to the promulgation and
implementation of 21 CFR part 1301, DATES: Registered bulk manufacturers of ACTION: Notice of application.
incident to the registration of the affected basic classes, and
manufacturers, distributors, dispensers, applicants therefore, may file written DATES: Registered bulk manufacturers of
sradovich on DSKBBY8HB2PROD with NOTICES
importers, and exporters of controlled comments on or objections to the the affected basic classes, and
substances (other than final orders in issuance of the proposed registration in applicants therefore, may file written
connection with suspension, denial, or accordance with 21 CFR 1301.33(a) on comments on or objections to the
revocation of registration) has been or before November 17, 2017. issuance of the proposed registration in
redelegated to the Assistant ADDRESSES: Written comments should accordance with 21 CFR 1301.34(a) on
Administrator of the DEA Diversion be sent to: Drug Enforcement or before October 18, 2017. Such
Control Division (‘‘Assistant Administration, Attention: DEA Federal persons may also file a written request
VerDate Sep<11>2014 16:54 Sep 15, 2017 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\18SEN1.SGM 18SEN1](https://thefederalregister.org/doc/82_FR_43749/page/2.svg)
Document Created: 2017-09-16 00:52:39
Document Modified: 2017-09-16 00:52:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of application. | |
| 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 in accordance with 21 CFR 1301.33(a) on or before November 17, 2017. | |
| FR Citation | 82 FR 43570 |
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