81 FR 27473 - Manufacturer of Controlled Substances Registration: Noramco, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 88 (May 6, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 88 (May 6, 2016)
| Page Range | 27473-27473 | |
| FR Document | 2016-10731 |
[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)] [Notices] [Page 27473] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10731] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Noramco, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Noramco, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Noramco, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated November 23, 2015, and published in the Federal Register on December 3, 2015, 80 FR 75692, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801-4417 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Noramco, Inc. to manufacture the basic classes of 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 the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Codeine-N-oxide (9053)..................... I Dihydromorphine (9145)..................... I Morphine-N-oxide (9307).................... I Amphetamine (1100)......................... II Methylphenidate (1724)..................... II Phenylacetone (8501)....................... II Codeine (9050)............................. II Dihydrocodeine (9120)...................... II Oxycodone (9143)........................... II Hydromorphone (9150)....................... II Hydrocodone (9193)......................... II Morphine (9300)............................ II Oripavine (9330)........................... II Thebaine (9333)............................ II Opium extracts (9610)...................... II Opium fluid extract (9620)................. II Opium tincture (9630)...................... II Opium, powdered (9639)..................... II Opium, granulated (9640)................... II Oxymorphone (9652)......................... II Noroxymorphone (9668)...................... II Tapentadol (9780).......................... II ------------------------------------------------------------------------ The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. Dated: April 29, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-10731 Filed 5-5-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices 27473
maintenance of effective controls manufacture the basic classes of grants Almac Clinical Services Incorp
against diversion by inspecting and controlled substances is consistent with (ACSI) registration as an importer of this
testing the company’s physical security the public interest and with United controlled substance.
systems, verifying the company’s States obligations under international SUPPLEMENTARY INFORMATION: By notice
compliance with state and local laws, treaties, conventions, or protocols in dated December 15, 2015, and
and reviewing the company’s effect on May 1, 1971. The DEA published in the Federal Register on
background and history. investigated the company’s maintenance December 24, 2015, 80 FR 80387, Almac
Therefore, pursuant to 21 U.S.C. of effective controls against diversion by Clinical Services Incorp (ACSI), 25 Fretz
952(a) and 958(a), and in accordance inspecting and testing the company’s Road, Souderton, Pennsylvania 18964
with 21 CFR 1301.34, the above-named physical security systems, verifying the applied to be registered as an importer
company is granted registration as an company’s compliance with state and of a certain basic class of controlled
importer of marihuana (7360), a basic local laws, and reviewing the company’s substance. No comments or objections
class of controlled substance listed in background and history. were submitted for this notice.
schedule I. Therefore, pursuant to 21 U.S.C. The DEA has considered the factors in
The company plans to import finished 823(a), and in accordance with 21 CFR 21 U.S.C. 823, 952(a) and 958(a) and
pharmaceutical products containing 1301.33, the above-named company is determined that the registration of
cannabis extracts in dosage form for granted registration as a bulk Almac Clinical Services Incorp (ACSI)
clinical trial studies. manufacturer of the following basic to import the basic class of controlled
This compound is listed under drug classes of controlled substances: substance is consistent with the public
code 7360. No other activity for this interest and with United States
drug code is authorized for this Controlled substance Schedule obligations under international treaties,
registration. Approval of permits conventions, or protocols in effect on
applications will occur only when the Codeine-N-oxide (9053) ............... I
Dihydromorphine (9145) ............... I May 1, 1971. The DEA investigated the
registrant’s business activity is Morphine-N-oxide (9307) ............. I company’s maintenance of effective
consistent with what is authorized Amphetamine (1100) .................... II controls against diversion by inspecting
under 21 U.S.C. 952(a)(2). Authorization Methylphenidate (1724) ................ II and testing the company’s physical
will not extend to the import of FDA Phenylacetone (8501) .................. II security systems, verifying the
approved or non-approved finished Codeine (9050) ............................. II company’s compliance with state and
dosage forms for commercial sale. Dihydrocodeine (9120) ................. II
local laws, and reviewing the company’s
Oxycodone (9143) ........................ II
Dated: April 29, 2016. Hydromorphone (9150) ................ II background and history.
Louis J. Milione, Hydrocodone (9193) ..................... II Therefore, pursuant to 21 U.S.C.
Deputy Assistant Administrator. Morphine (9300) ........................... II 952(a) and 958(a), and in accordance
[FR Doc. 2016–10728 Filed 5–5–16; 8:45 am] Oripavine (9330) ........................... II with 21 CFR 1301.34, the above-named
BILLING CODE 4410–09–P
Thebaine (9333) ........................... II company is granted registration as an
Opium extracts (9610) .................. II importer of Morphine (9300), a basic
Opium fluid extract (9620) ............ II class of controlled substance listed in
Opium tincture (9630) .................. II schedule II.
DEPARTMENT OF JUSTICE Opium, powdered (9639) ............. II The company plans to import the
Opium, granulated (9640) ............ II
Drug Enforcement Administration Oxymorphone (9652) ................... II
listed controlled substance in dosage
Noroxymorphone (9668) .............. II form for clinical trial only. Approval of
[Docket No. DEA–392]
Tapentadol (9780) ........................ II permit applications will occur only
Manufacturer of Controlled when the registrant’s business activity is
Substances Registration: Noramco, The company plans to manufacture consistent with what is authorized
Inc. the above-listed controlled substances under 21 U.S.C. 952(a)(2). Authorization
in bulk for distribution to its customers. will not extend to the import of FDA
ACTION: Notice of registration. Dated: April 29, 2016.
approved or non-approved finished
dosage forms for commercial sale.
SUMMARY: Noramco, Inc. applied to be Louis J. Milione,
Deputy Assistant Administrator. Dated: April 29, 2016.
registered as a manufacturer of certain
basic classes of controlled substances. [FR Doc. 2016–10731 Filed 5–5–16; 8:45 am] Louis J. Milione,
The Drug Enforcement Administration BILLING CODE 4410–09–P Deputy Assistant Administrator.
(DEA) grants Noramco, Inc. registration [FR Doc. 2016–10730 Filed 5–5–16; 8:45 am]
as a manufacturer of those controlled BILLING CODE 4410–09–P
substances. DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION: By notice Drug Enforcement Administration DEPARTMENT OF JUSTICE
dated November 23, 2015, and
published in the Federal Register on [Docket No. DEA–392]
Drug Enforcement Administration
December 3, 2015, 80 FR 75692,
Noramco, Inc., 500 Swedes Landing Importer of Controlled Substances [Docket No. DEA–392]
Road, Wilmington, Delaware 19801– Registration: Almac Clinical Services
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Incorp (ACSI) Importer of Controlled Substances
4417 applied to be registered as a
Registration: Noramco, Inc.
manufacturer of certain basic classes of ACTION: Notice of registration.
controlled substances. No comments or ACTION: Notice of registration.
objections were submitted for this SUMMARY: Almac Clinical Services
notice. Incorp (ACSI) applied to be registered as SUMMARY: Noramco, Inc. applied to be
The DEA has considered the factors in an importer of a certain basic class of registered as an importer of certain basic
21 U.S.C. 823(a) and determined that controlled substance. The Drug classes of controlled substances. The
the registration of Noramco, Inc. to Enforcement Administration (DEA) Drug Enforcement Administration
VerDate Sep<11>2014 17:20 May 05, 2016 Jkt 238001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\06MYN1.SGM 06MYN1](https://thefederalregister.org/doc/81_FR_27561/page/1.svg)
Document Created: 2016-05-06 00:29:32
Document Modified: 2016-05-06 00:29:32
| 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 | 81 FR 27473 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR