83 FR 49579 - Importer of Controlled Substances Registration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 191 (October 2, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 191 (October 2, 2018)
| Page Range | 49579-49580 | |
| FR Document | 2018-21354 |
[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)] [Notices] [Pages 49579-49580] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21354] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances. [[Page 49580]] SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as importers of various basic classes of controlled substances. Information on previously published notices are listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for these notices. ------------------------------------------------------------------------ Company FR Docket Published ------------------------------------------------------------------------ AMRI Rensselaer, Inc.......... 83 FR 15176 April 9, 2018. S&B Pharma, Inc............... 83 FR 31421 July 5, 2018. Cerilliant Corporation........ 83 FR 32906 July 16, 2018. Shertech Laboratories, LLC.... 83 FR 34879 July 23, 2018. Fresenius Kabi USA, LLC....... 83 FR 34878 July 23, 2018. VHG Labs DBA LGC Standards.... 83 FR 34875 July 23, 2018. Catalent Pharma Solutions, LLC 83 FR 34874 July 23, 2018. Fisher Clinical Services, Inc. 83 FR 34879 July 23, 2018. Anderson Brecon, Inc.......... 83 FR 37525 August 1, 2018. ------------------------------------------------------------------------ The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I or II controlled substances to the above listed companies. Dated: September 20, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-21354 Filed 10-1-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Notices 49579
as a bulk manufacturer of the following Dated: September 20, 2018. SUMMARY: Registrants listed below have
basic classes of controlled substances: John J. Martin, applied for and been granted
Assistant Administrator. registration by the Drug Enforcement
Drug [FR Doc. 2018–21348 Filed 10–1–18; 8:45 am] Administration (DEA) as bulk
Controlled substance Schedule
code manufacturers of various classes of
BILLING CODE 4410–09–P
Methylphenidate ....... 1724 II
schedule I and II controlled substances.
Levomethorphan ...... 9210 II SUPPLEMENTARY INFORMATION: The
DEPARTMENT OF JUSTICE
Levorphanol .............. 9220 II companies listed below applied to be
Thebaine .................. 9333 II Drug Enforcement Administration registered as bulk manufacturers of
Remifentanil ............. 9739 II various basic classes of controlled
Tapentadol ............... 9780 II [Docket No. DEA–392]
substances. Information on previously
Bulk Manufacturer of Controlled published notices is listed in the table
The company plans to manufacture Substances Registration below. No comments or objections were
the listed controlled substances in bulk submitted for these notices.
for distribution to its customers. ACTION: Notice of registration.
Company FR docket Published
American Radiolabeled Chem ................................................................................................................................. 83 FR 28664 June 20, 2018.
Cerilliant Corporation ............................................................................................................................................... 83 FR 28664 June 20, 2018.
The DEA has considered the factors in issuance of the proposed registration on Controlled substance Drug code Schedule
21 U.S.C. 823(a) and determined that or before December 3, 2018.
Codeine .......................... 9050 II
the registration of these registrants to ADDRESSES: Written comments should Oxycodone ..................... 9143 II
manufacture the applicable basic classes be sent to: Drug Enforcement Hydromorphone .............. 9150 II
of controlled substances is consistent Administration, Attention: DEA Federal Hydrocodone .................. 9193 II
with the public interest and with United Register Representative/DPW, 8701 Morphine ........................ 9300 II
Oripavine ........................ 9330 II
States obligations under international Morrissette Drive, Springfield, Virginia Thebaine ........................ 9333 II
treaties, conventions, or protocols in 22152. Opium extracts ............... 9610 II
effect on May 1, 1971. The DEA Opium fluid extract ......... 9620 II
SUPPLEMENTARY INFORMATION: The Opium tincture ................ 9630 II
investigated each of the company’s
Attorney General has delegated his Opium, powdered ........... 9639 II
maintenance of effective controls
authority under the Controlled Oxymorphone ................. 9652 II
against diversion by inspecting and Noroxymorphone ............ 9668 II
Substances Act to the Administrator of
testing each company’s physical Fentanyl .......................... 9801 II
the Drug Enforcement Administration
security systems, verifying each
(DEA), 28 CFR 0.100(b). Authority to
company’s compliance with state and The company plans to manufacture
exercise all necessary functions with
local laws, and reviewing each the listed controlled substances in bulk
respect to the promulgation and
company’s background and history. for conversion to other controlled
implementation of 21 CFR part 1301,
Therefore, pursuant to 21 U.S.C. substances and sale to its customers, for
incident to the registration of
823(a), and in accordance with 21 CFR dosage form development, for clinical
manufacturers, distributors, dispensers,
1301.33, the DEA has granted a trials, and for use in stability
importers, and exporters of controlled
registration as a bulk manufacturer to qualification studies.
substances (other than final orders in
the above listed companies. Dated: September 20, 2018.
connection with suspension, denial, or
Dated: September 20, 2018. revocation of registration) has been John J. Martin,
John J. Martin, redelegated to the Assistant Assistant Administrator.
Assistant Administrator. Administrator of the DEA Diversion [FR Doc. 2018–21351 Filed 10–1–18; 8:45 am]
[FR Doc. 2018–21353 Filed 10–1–18; 8:45 am] Control Division (‘‘Assistant BILLING CODE 4410–09–P
BILLING CODE 4410–09–P Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE 1301.33(a), this is notice that on June 8,
2018, Cambrex Charles City, 1205 11th Drug Enforcement Administration
Drug Enforcement Administration Street, Charles City, Iowa 50616 applied
to be registered as a bulk manufacturer [Docket No. DEA–392]
[Docket No. DEA–392] of the basic classes of controlled
substances: Importer of Controlled Substances
Bulk Manufacturer of Controlled Registration
Substances Application: Cambrex Controlled substance Drug code Schedule
Charles City ACTION: Notice of registration.
amozie on DSK3GDR082PROD with NOTICES1
Gamma Hydroxybutyric 2010 I
Acid.
ACTION: Notice of application. Amphetamine ................. 1100 II SUMMARY: Registrants listed below have
Lisdexamfetamine .......... 1205 II applied for and been granted
DATES: Registered bulk manufacturers of Methylphenidate ............. 1724 II registration by the Drug Enforcement
4-Anilino-N-phenethyl-4- 8333 II
the affected basic classes, and piperidine (ANPP).
Administration (DEA) as importers of
applicants therefore, may file written Phenylacetone ................ 8501 II various classes of schedule I or II
comments on or objections to the Cocaine .......................... 9041 II controlled substances.
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![49580 Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Notices
SUPPLEMENTARY INFORMATION: The classes of controlled substances. comments or objections were submitted
companies listed below applied to be Information on previously published and no requests for hearing were
registered as importers of various basic notices are listed in the table below. No submitted for these notices.
Company FR Docket Published
AMRI Rensselaer, Inc ............................................................................................................................................. 83 FR 15176 April 9, 2018.
S&B Pharma, Inc .................................................................................................................................................... 83 FR 31421 July 5, 2018.
Cerilliant Corporation .............................................................................................................................................. 83 FR 32906 July 16, 2018.
Shertech Laboratories, LLC .................................................................................................................................... 83 FR 34879 July 23, 2018.
Fresenius Kabi USA, LLC ....................................................................................................................................... 83 FR 34878 July 23, 2018.
VHG Labs DBA LGC Standards ............................................................................................................................. 83 FR 34875 July 23, 2018.
Catalent Pharma Solutions, LLC ............................................................................................................................ 83 FR 34874 July 23, 2018.
Fisher Clinical Services, Inc .................................................................................................................................... 83 FR 34879 July 23, 2018.
Anderson Brecon, Inc ............................................................................................................................................. 83 FR 37525 August 1, 2018.
The DEA has considered the factors in DEPARTMENT OF JUSTICE Representative/DPW, 8701 Morrissette
21 U.S.C. 823, 952(a) and 958(a) and Drive, Springfield, Virginia 22152.
determined that the registration of the Drug Enforcement Administration Comments and requests for hearings on
listed registrants to import the [Docket No. DEA–392] applications to import narcotic raw
applicable basic classes of schedule I or material are not appropriate. 72 FR
II controlled substances is consistent Importer of Controlled Substances 3417, (January 25, 2007).
with the public interest and with United Application: R & D Systems, Inc. SUPPLEMENTARY INFORMATION: The
States obligations under international Attorney General has delegated his
ACTION: Notice of application.
treaties, conventions, or protocols in authority under the Controlled
effect on May 1, 1971. DATES: Registered bulk manufacturers of Substances Act to the Administrator of
The DEA investigated each company’s the affected basic classes, and the Drug Enforcement Administration
maintenance of effective controls applicants therefore, may file written (DEA), 28 CFR 0.100(b). Authority to
against diversion by inspecting and comments on or objections to the exercise all necessary functions with
testing each company’s physical issuance of the proposed registration on respect to the promulgation and
or before November 1, 2018. Such implementation of 21 CFR part 1301,
security systems, verifying each
persons may also file a written request incident to the registration of
company’s compliance with state and
for a hearing on the application on or manufacturers, distributors, dispensers,
local laws, and reviewing each
before November 1, 2018. importers, and exporters of controlled
company’s background and history. substances (other than final orders in
ADDRESSES: Written comments should
Therefore, pursuant to 21 U.S.C. be sent to: Drug Enforcement connection with suspension, denial, or
952(a) and 958(a), and in accordance Administration, Attention: DEA Federal revocation of registration) has been
with 21 CFR 1301.34, the DEA has Register Representative/DPW, 8701 redelegated to the Assistant
granted a registration as an importer for Morrissette Drive, Springfield, Virginia Administrator of the DEA Diversion
schedule I or II controlled substances to 22152. All requests for hearings must be Control Division (‘‘Assistant
the above listed companies. sent to: Drug Enforcement Administrator’’) pursuant to section 7 of
Administration, Attn: Administrator, 28 CFR part 0, appendix to subpart R.
Dated: September 20, 2018.
8701 Morrissette Drive, Springfield, In accordance with 21 CFR
John J. Martin,
Virginia 22152. All requests for hearings 1301.34(a), this is notice that on April
Assistant Administrator. should also be sent to: (1) Drug 9, 2018, R & D Systems, Inc., 614
[FR Doc. 2018–21354 Filed 10–1–18; 8:45 am] Enforcement Administration, Attn: McKinley Place NE, Minneapolis,
BILLING CODE 4410–09–P Hearing Clerk/LJ, 8701 Morrissette Minnesota 55413–5541 applied to be
Drive, Springfield, Virginia 22152; and registered as an importer of the
(2) Drug Enforcement Administration, following basic classes of controlled
Attn: DEA Federal Register substances:
Controlled substance Drug code Schedule
Mephedrone (4-Methyl-N-methylcathinone) .................................................................................................................... 1248 I
JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) .............................................................................. 7118 I
CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) ................................................................. 7297 I
Marihuana ........................................................................................................................................................................ 7360 I
Tetrahydrocannabinols .................................................................................................................................................... 7370 I
4-Bromo-2,5-dimethoxyamphetamine ............................................................................................................................. 7391 I
3,4-Methylenedioxymethamphetamine ............................................................................................................................ 7405 I
Dimethyltryptamine .......................................................................................................................................................... 7435 I
amozie on DSK3GDR082PROD with NOTICES1
Psilocyn ........................................................................................................................................................................... 7438 I
Pentobarbital .................................................................................................................................................................... 2270 II
Phencyclidine ................................................................................................................................................................... 7471 II
Cocaine ............................................................................................................................................................................ 9041 II
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Document Created: 2018-10-02 01:18:34
Document Modified: 2018-10-02 01:18:34
| 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 registration. | |
| FR Citation | 83 FR 49579 |
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