80 FR 57388 - Bulk Manufacturer of Controlled Substances Application: Mallinckrodt LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 184 (September 23, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 184 (September 23, 2015)
| Page Range | 57388-57388 | |
| FR Document | 2015-24125 |
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)] [Notices] [Page 57388] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24125] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Mallinckrodt 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 23, 2015. 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 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 July 21, 2015, Mallinckrodt 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 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- I yl)-N-phenylacetamide) (9821). Amphetamine (1100)......................... II Methamphetamine (1105)..................... II Lisdexamfetamine (1205).................... II Methylphenidate (1724)..................... II Nabilone (7379)............................ II 4-Anilino-N-phenethyl-4-piperidine (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) II (9273). 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 ------------------------------------------------------------------------ The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution its customers. Dated: September 16, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-24125 Filed 9-22-15; 8:45 am] BILLING CODE 4410-09-P
![57388 Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices
Therefore, pursuant to 21 U.S.C. Substances Act to the Administrator of The company plans to manufacturer
823(a), and in accordance with 21 CFR the Drug Enforcement Administration bulk active pharmaceutical ingredients
1301.33, the above-named company is (DEA), 28 CFR 0.100(b). Authority to (API) for distribution its customers.
granted registration as a bulk exercise all necessary functions with Dated: September 16, 2015.
manufacturer of the basic classes of respect to the promulgation and Joseph T. Rannazzisi,
controlled substances: implementation of 21 CFR part 1301,
Deputy Assistant Administrator.
incident to the registration of
[FR Doc. 2015–24125 Filed 9–22–15; 8:45 am]
manufacturers, distributors, dispensers,
importers, and exporters of controlled BILLING CODE 4410–09–P
Controlled substance Schedule
substances (other than final orders in
Marihuana (7360) ....................... I connection with suspension, denial, or
Tetrahydrocannabinols (7370) .... I DEPARTMENT OF JUSTICE
revocation of registration) has been
Amphetamine (1100) .................. II redelegated to the Deputy Assistant
Lisdexamfetamine (1205) ........... II Drug Enforcement Administration
Methylphenidate (1724) .............. II
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant [Docket No. DEA–392]
Pentobarbital (2270) ................... II
4-Anilino-N-phenethyl-4-piper- II Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R. Importer of Controlled Substances
idine (8333).
Registration: Fisher Clinical Services,
Meperidine (9230) ...................... II In accordance with 21 CFR
Fentanyl (9801) .......................... II Inc.
1301.33(a), this is notice that on July 21,
2015, Mallinckrodt LLC, 3600 North ACTION: Notice of registration.
The company plans to manufacture
Second Street, Saint. Louis, Missouri
bulk controlled substances for use in SUMMARY: Fisher Clinical Services, Inc.
63147 applied to be registered as a bulk
product development and for applied to be registered as an importer
manufacturer of the following basic
distribution to its customers. of certain basic classes of controlled
In reference to drug code 7360 classes of controlled substances:
substances. The Drug Enforcement
(marihuana), and 7370 (THC), the Administration (DEA) grants Fisher
Controlled substance Schedule
company plans to bulk manufacture Clinical Services, Inc. registration as an
these drugs as synthetic. No other Gamma Hydroxybutyric Acid I importer of those controlled substances.
activity for this drug code is authorized (2010). SUPPLEMENTARY INFORMATION: By notice
for this registration. Tetrahydrocannabinols (7370) ..... I
dated August 27, 2014, and published in
Dated: September 16, 2015. Codeine-N-oxide (9053) ............... I
Dihydromorphine (9145) ............... I
the Federal Register on September 4,
Joseph T. Rannazzisi, 2014, 79 FR 52762, Fisher Clinical
Difenoxin (9168) ........................... I
Deputy Assistant Administrator. Morphine-N-oxide (9307) ............. I Services, Inc., 700A–C Nestle Way,
[FR Doc. 2015–24122 Filed 9–22–15; 8:45 am] Normorphine (9313) ..................... I Breinigsville, Pennsylvania 18031–1522
BILLING CODE 4410–09–P Norlevorphanol (9634) .................. I applied to be registered as an importer
Acetyl Fentanyl (N-(1- I of certain basic classes of controlled
phenethylpiperidin-4-yl)-N- substances. No comments or objections
DEPARTMENT OF JUSTICE phenylacetamide) (9821). were submitted for this notice.
Amphetamine (1100) .................... II The DEA has considered the factors in
Drug Enforcement Administration Methamphetamine (1105) ............ II 21 U.S.C. 823, 952(a) and 958(a) and
Lisdexamfetamine (1205) ............. II determined that the registration of
[Docket No. DEA–392] Methylphenidate (1724) ................ II
Fisher Clinical Services, Inc. to import
Nabilone (7379) ............................ II
Bulk Manufacturer of Controlled 4-Anilino-N-phenethyl-4-piperidine II
the basic classes of controlled
Substances Application: Mallinckrodt (8333). substances is consistent with the public
LLC Codeine (9050) ............................. II interest and with United States
Dihydrocodeine (9120) ................. II obligations under international treaties,
ACTION: Notice of application. Oxycodone (9143) ........................ II conventions, or protocols in effect on
Hydromorphone (9150) ................ II May 1, 1971. The DEA investigated the
DATES: Registered bulk manufacturers of Diphenoxylate (9170) ................... II company’s maintenance of effective
the affected basic classes, and Ecgonine (9180) ........................... II controls against diversion by inspecting
applicants therefore, may file written Hydrocodone (9193) ..................... II and testing the company’s physical
comments on or objections to the Levorphanol (9220) ...................... II security systems, verifying the
issuance of the proposed registration in Meperidine (9230) ........................ II company’s compliance with state and
accordance with 21 CFR 1301.33(a) on Methadone (9250) ........................ II
local laws, and reviewing the company’s
or before November 23, 2015. Methadone intermediate (9254) ... II
Dextropropoxyphene, bulk (non- II background and history.
ADDRESSES: Written comments should Therefore, pursuant to 21 U.S.C.
dosage forms) (9273).
be sent to: Drug Enforcement 952(a) and 958(a), and in accordance
Morphine (9300) ........................... II
Administration, Attention: DEA Federal Oripavine (9330) ........................... II with 21 CFR 1301.34, the above-named
Register Representative/ODXL, 8701 Thebaine (9333) ........................... II company is granted registration as an
Morrissette Drive, Springfield, Virginia Opium tincture (9630) .................. II importer of the basic classes of
22152. Request for hearings should be
mstockstill on DSK4VPTVN1PROD with NOTICES
Opium, powdered (9639) ............. II controlled substances:
sent to: Drug Enforcement Oxymorphone (9652) ................... II
Administration, Attention: Hearing Noroxymorphone (9668) .............. II Controlled substance Schedule
Clerk/LJ, 8701 Morrissette Drive, Alfentanil (9737) ........................... II
Springfield, Virginia 22152. Remifentanil (9739) ...................... II Methylphenidate (1724) ................ II
SUPPLEMENTARY INFORMATION: The
Sufentanil (9740) .......................... II Levorphanol (9220) ...................... II
Tapentadol (9780) ........................ II Noroxymorphone (9668) .............. II
Attorney General has delegated her Fentanyl (9801) ............................ II Tapentadol (9780) ........................ II
authority under the Controlled
VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/80_FR_57572/page/1.svg)
Document Created: 2015-12-15 09:44:23
Document Modified: 2015-12-15 09:44:23
| 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 23, 2015. | |
| FR Citation | 80 FR 57388 |
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