80 FR 75691 - Bulk Manufacturer of Controlled Substances Application: Organix, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 232 (December 3, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 232 (December 3, 2015)
| Page Range | 75691-75692 | |
| FR Document | 2015-30554 |
[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)] [Notices] [Pages 75691-75692] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30554] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Organix, Inc. 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 February 1, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to [[Page 75692]] 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy 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 September 7, 2015, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid (2010)........... I Lysergic acid diethylamide (7315).......... I Marihuana (7360)........................... I Tetrahydrocannabinols (7370)............... I Psilocybin (7437).......................... I Psilocyn (7438)............................ I Heroin (9200).............................. I Morphine (9300)............................ II ------------------------------------------------------------------------ The company plans to manufacture reference standards for distribution to its research and forensics customers. In reference to drug codes 7360 (marihuana) and 7370 (THC) the company plans to manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Dated: November 27, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015-30554 Filed 12-2-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices 75691
DEPARTMENT OF JUSTICE Directorate for the Quality of Medicines In accordance with 21 CFR
(EDQM). In order to ensure that its 1301.34(a), this is notice that on October
Drug Enforcement Administration product will meet European 12, 2015, Mylan Pharmaceuticals, Inc.,
[Docket No. DEA–392] specifications, the company seeks to 781 Chestnut Ridge Road, Morgantown,
import morphine supplied by EDQM for West Virginia 26505 applied to be
Importer of Controlled Substances use as reference standards. registered as an importer of the
Application: Meridian Medical This is the sole purpose for which the following basic classes of controlled
Technologies company will be authorized by the DEA substances:
to import morphine.
ACTION: Notice of application. Dated: November 27, 2015. Controlled substance Schedule
Louis J. Milione, Amphetamine (1100) .................... II
DATES: Registered bulk manufacturers of
Deputy Assistant Administrator. Methylphenidate (1724) ................ II
the affected basic class, and applicants
[FR Doc. 2015–30553 Filed 12–2–15; 8:45 am] Oxycodone (9143) ........................ II
therefore, may file written comments on Hydromorphone (9150) ................ II
or objections to the issuance of the BILLING CODE 4410–09–P
Methadone (9250) ........................ II
proposed registration in accordance Morphine (9300) ........................... II
with 21 CFR 1301.34(a) on or before Fentanyl (9801) ............................ II
DEPARTMENT OF JUSTICE
January 4, 2016. Such persons may also
file a written request for a hearing on Drug Enforcement Administration The company plans to import the
the application pursuant to 21 CFR listed controlled substances in finished
1301.43 on or before January 4, 2016. [Docket No. DEA–392] dosage form (FDF) from foreign sources
ADDRESSES: Written comments should for analytical testing and clinical trials
Importer of Controlled Substances in which the foreign FDF will be
be sent to: Drug Enforcement Application: Mylan Pharmaceuticals,
Administration, Attention: DEA Federal compared to the company’s own
Inc. domestically-manufactured FDF. This
Register Representative/OD/D, 8701
Morrissette Drive, Springfield, Virginia ACTION: Notice of application. analysis is required to allow the
22152. Request for hearings should be company to export domestically-
sent to: Drug Enforcement DATES: Registered bulk manufacturers of manufactured FDF to foreign markets.
Administration, Attention: Hearing the affected basic classes, and Dated: November 23, 2015.
Clerk/LJ, 8701 Morrissette Drive, applicants therefore, may file written Louis J. Milione,
Springfield, Virginia 22152. comments on or objections to the Deputy Assistant Administrator.
SUPPLEMENTARY INFORMATION: The issuance of the proposed registration in [FR Doc. 2015–30549 Filed 12–2–15; 8:45 am]
Attorney General has delegated her accordance with 21 CFR 1301.34(a) on
BILLING CODE 4410–09–P
authority under the Controlled or before January 4, 2016. Such persons
Substances Act to the Administrator of may also file a written request for a
the Drug Enforcement Administration hearing on the application pursuant to DEPARTMENT OF JUSTICE
(DEA), 28 CFR 0.100(b). Authority to 21 CFR 1301.43 on or before January 4,
exercise all necessary functions with 2016. Drug Enforcement Administration
respect to the promulgation and ADDRESSES: Written comments should
[Docket No. DEA–392]
implementation of 21 CFR part 1301, be sent to: Drug Enforcement
incident to the registration of Administration, Attention: DEA Federal Bulk Manufacturer of Controlled
manufacturers, distributors, dispensers, Register Representative/OD/D, 8701 Substances Application: Organix, Inc.
importers, and exporters of controlled Morrissette Drive, Springfield, Virginia
substances (other than final orders in 22152. Request for hearings should be ACTION: Notice of application.
connection with suspension, denial, or sent to: Drug Enforcement
revocation of registration) has been Administration, Attention: Hearing DATES: Registered bulk manufacturers of
redelegated to the Deputy Assistant Clerk/LJ, 8701 Morrissette Drive, the affected basic classes, and
Administrator of the DEA Office of Springfield, Virginia 22152. applicants therefore, may file written
Diversion Control (‘‘Deputy Assistant SUPPLEMENTARY INFORMATION: The comments on or objections to the
Administrator’’) pursuant to section 7 of Attorney General has delegated her issuance of the proposed registration in
28 CFR part 0, appendix to subpart R. authority under the Controlled accordance with 21 CFR 1301.33(a) on
In accordance with 21 CFR Substances Act to the Administrator of or before February 1, 2016.
1301.34(a), this is notice that on October the Drug Enforcement Administration ADDRESSES: Written comments should
20, 2015, Meridian Medical (DEA), 28 CFR 0.100(b). Authority to be sent to: Drug Enforcement
Technologies, 2555 Hermelin Drive, exercise all necessary functions with Administration, Attention: DEA Federal
Saint Louis, Missouri 63144 applied to respect to the promulgation and Register Representative/ODXL, 8701
be registered as an importer of morphine implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia
(9300), a basic class of controlled incident to the registration of 22152. Request for hearings should be
substance listed in schedule II. manufacturers, distributors, dispensers, sent to: Drug Enforcement
The company manufactures a product importers, and exporters of controlled Administration, Attention: Hearing
containing morphine in the United substances (other than final orders in Clerk/LJ, 8701 Morrissette Drive,
Lhorne on DSK5TPTVN1PROD with NOTICES
States. The company exports this connection with suspension, denial, or Springfield, Virginia 22152.
product to customers around the world. revocation of registration) has been SUPPLEMENTARY INFORMATION: The
The company has been asked to ensure redelegated to the Deputy Assistant Attorney General has delegated her
that its product, which is sold to Administrator of the DEA Office of authority under the Controlled
European customers, meets the Diversion Control (‘‘Deputy Assistant Substances Act to the Administrator of
standards established by the European Administrator’’) pursuant to section 7 of the Drug Enforcement Administration
Pharmacopeia, administered by the 28 CFR part 0, appendix to subpart R. (DEA), 28 CFR 0.100(b). Authority to
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![75692 Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
exercise all necessary functions with Administration, Attention: DEA Federal DEPARTMENT OF JUSTICE
respect to the promulgation and Register Representative/OD/D, 8701
implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia Drug Enforcement Administration
incident to the registration of 22152. Request for hearings should be
manufacturers, distributors, dispensers, sent to: Drug Enforcement [Docket No. DEA–392]
importers, and exporters of controlled Administration, Attention: Hearing
substances (other than final orders in Clerk/LJ, 8701 Morrissette Drive, Importer of Controlled Substances
connection with suspension, denial, or Springfield, Virginia 22152. Registration: Catalent CTS, LLC
revocation of registration) has been
SUPPLEMENTARY INFORMATION: The ACTION: Notice of registration.
redelegated to the Deputy Assistant
Attorney General has delegated her
Administrator of the DEA Office of
authority under the Controlled SUMMARY: Catalent CTS, LLC applied to
Diversion Control (‘‘Deputy Assistant
Substances Act to the Administrator of be registered as an importer of a certain
Administrator’’) pursuant to section 7 of
the Drug Enforcement Administration basic class of controlled substance. The
28 CFR part 0, appendix to subpart R.
(DEA), 28 CFR 0.100(b). Authority to Drug Enforcement Administration
In accordance with 21 CFR
exercise all necessary functions with (DEA) grants Catalent CTS, LLC
1301.33(a), this is notice that on
respect to the promulgation and registration as an importer of this
September 7, 2015, Organix, Inc., 240
implementation of 21 CFR part 1301, controlled substance.
Salem Street, Woburn, Massachusetts
incident to the registration of
01801 applied to be registered as a bulk SUPPLEMENTARY INFORMATION: By notice
manufacturers, distributors, dispensers,
manufacturer of the following basic dated August 21, 2015, and published in
importers, and exporters of controlled
classes of controlled substances: the Federal Register on August 31,
substances (other than final orders in
2015, 80 FR 52509, Catalent CTS, LLC,
connection with suspension, denial, or
Controlled substance Schedule 10245 Hickman Mills Drive, Kansas
revocation of registration) has been
City, Missouri 64137 applied to be
Gamma Hydroxybutyric Acid I redelegated to the Deputy Assistant
registered as an importer of a certain
(2010). Administrator of the DEA Office of
basic class of controlled substance. No
Lysergic acid diethylamide (7315) I Diversion Control (‘‘Deputy Assistant
Marihuana (7360) ......................... I comments or objections were submitted
Administrator’’) pursuant to section 7 of
Tetrahydrocannabinols (7370) ..... I for this notice.
28 CFR part 0, appendix to subpart R.
Psilocybin (7437) .......................... I The DEA has considered the factors in
Psilocyn (7438) ............................. I In accordance with 21 CFR 21 U.S.C. 823, 952(a) and 958(a) and
Heroin (9200) ............................... I 1301.33(a), this is notice that on October determined that the registration of
Morphine (9300) ........................... II 6, 2015, Noramco, Inc., 500 Swedes Catalent CTS, LLC to import the basic
Landing Road, Wilmington, Delaware class of controlled substance is
The company plans to manufacture 19801–4417 applied to be registered as consistent with the public interest and
reference standards for distribution to a bulk manufacturer of the following with United States obligations under
its research and forensics customers. In basic classes of controlled substances: international treaties, conventions, or
reference to drug codes 7360 protocols in effect on May 1, 1971. The
(marihuana) and 7370 (THC) the Controlled substance Schedule DEA investigated the company’s
company plans to manufacture these maintenance of effective controls
drugs as synthetic. No other activities Codeine-N-oxide (9053) ............... I
Dihydromorphine (9145) ............... I against diversion by inspecting and
for these drug codes are authorized for Morphine-N-oxide (9307) ............. I testing the company’s physical security
this registration. Amphetamine (1100) .................... II systems, verifying the company’s
Dated: November 27, 2015. Methylphenidate (1724) ................ II compliance with state and local laws,
Louis J. Milione, Phenylacetone (8501) .................. II and reviewing the company’s
Codeine (9050) ............................. II background and history.
Deputy Assistant Administrator.
Dihydrocodeine (9120) ................. II
[FR Doc. 2015–30554 Filed 12–2–15; 8:45 am] Therefore, pursuant to 21 U.S.C.
Oxycodone (9143) ........................ II
BILLING CODE 4410–09–P Hydromorphone (9150) ................ II 952(a) and 958(a), and in accordance
Hydrocodone (9193) ..................... II with 21 CFR 1301.34, the above-named
Morphine (9300) ........................... II company is granted registration as an
DEPARTMENT OF JUSTICE Oripavine (9330) ........................... II importer of marihuana (7360), a basic
Thebaine (9333) ........................... II class of controlled substance listed in
Drug Enforcement Administration Opium extracts (9610) .................. II schedule I.
Opium fluid extract (9620) ............ II The company plans to import finished
[Docket No. DEA–392] Opium tincture (9630) .................. II pharmaceutical products containing
Opium, powdered (9639) ............. II
Bulk Manufacturer of Controlled Opium, granulated (9640) ............ II
cannabis extracts in dosage form for
Substances Application: Noramco, Inc. Oxymorphone (9652) ................... II clinical trial studies.
Noroxymorphone (9668) .............. II This compound is listed under drug
ACTION: Notice of application. Tapentadol (9780) ........................ II code 7360. No other activity for this
drug code is authorized for this
DATES: Registered bulk manufacturers of registration. Approval of permits
The company plans to manufacture
the affected basic classes, and applications will occur only when the
the above-listed controlled substances
Lhorne on DSK5TPTVN1PROD with NOTICES
applicants therefore, may file written registrant’s business activity is
in bulk for distribution to its customers.
comments on or objections to the consistent with what is authorized
issuance of the proposed registration in Dated: November 23, 2015.
under to 21 U.S.C. 952(a)(2).
accordance with 21 CFR 1301.33(a) on Louis J. Milione, Authorization will not extend to the
or before February 1, 2016. Deputy Assistant Administrator. import of FDA approved or non-
ADDRESSES: Written comments should [FR Doc. 2015–30550 Filed 12–2–15; 8:45 am] approved finished dosage forms for
be sent to: Drug Enforcement BILLING CODE 4410–09–P commercial sale.
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Document Created: 2015-12-14 13:51:40
Document Modified: 2015-12-14 13:51:40
| 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 February 1, 2016. | |
| FR Citation | 80 FR 75691 |
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