82 FR 13135 - Importer of Controlled Substances Application: Meridian Medical Technologies
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 45 (March 9, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 45 (March 9, 2017)
| Page Range | 13135-13136 | |
| FR Document | 2017-04647 |
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)] [Notices] [Pages 13135-13136] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04647] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Meridian Medical Technologies 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 1301.34(a) on or before April 10, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 10, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 1301.34(a), this is notice that on December 29, 2016, Meridian Medical Technologies, 2555 Hermelin Drive, Saint Louis, Missouri 63144 applied to be registered as an importer of morphine (9300), a basic class of controlled substance listed in schedule II. The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM for use as reference standards. [[Page 13136]] This is the sole purpose for which the company will be authorized by the DEA to import morphine. Louis J. Milione, Assistant Administrator. [FR Doc. 2017-04647 Filed 3-8-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 13135
DATES: Registered bulk manufacturers of 8701 Morrissette Drive, Springfield, incident to the registration of
the affected basic classes, and Virginia 22152. All requests for hearing manufacturers, distributors, dispensers,
applicants therefore, may file written should also be sent to: (1) Drug importers, and exporters of controlled
comments on or objections to the Enforcement Administration, Attn: substances (other than final orders in
issuance of the proposed registration in Hearing Clerk/LJ, 8701 Morrissette connection with suspension, denial, or
accordance with 21 CFR 1301.34(a) on Drive, Springfield, Virginia 22152; and revocation of registration) has been
or before April 10, 2017. Such persons (2) Drug Enforcement Administration, redelegated to the Assistant
may also file a written request for a Attn: DEA Federal Register Administrator of the DEA Diversion
hearing on the application pursuant to Representative/DRW, 8701 Morrissette Control Division (‘‘Assistant
21 CFR 1301.43 on or before April 10, Drive, Springfield, Virginia 22152.
Administrator’’) pursuant to section 7 of
2017. SUPPLEMENTARY INFORMATION: The
28 CFR part 0, appendix to subpart R.
ADDRESSES: Written comments should Attorney General has delegated his
be sent to: Drug Enforcement authority under the Controlled In accordance with 21 CFR
Administration, Attention: DEA Federal Substances Act to the Administrator of 1301.34(a), this is notice that on
Register Representative/DRW, 8701 the Drug Enforcement Administration November 11, 2016, Myoderm, 48 East
Morrissette Drive, Springfield, Virginia (DEA), 28 CFR 0.100(b). Authority to Main Street, Norristown, Pennsylvania
22152. All requests for hearing must be exercise all necessary functions with 19401 applied to be registered as an
sent to: Drug Enforcement respect to the promulgation and importer of the following basic classes
Administration, Attn: Administrator, implementation of 21 CFR part 1301, of controlled substances:
Controlled substance Drug code Schedule
Amphetamine ............................................................................................................................................................. 1100 II
Lisdexamfetamine ...................................................................................................................................................... 1205 II
Methylphenidate ......................................................................................................................................................... 1724 II
Nabilone ..................................................................................................................................................................... 7379 II
Oxycodone ................................................................................................................................................................. 9143 II
Hydromorphone .......................................................................................................................................................... 9150 II
Hydrocodone .............................................................................................................................................................. 9193 II
Morphine .................................................................................................................................................................... 9300 II
Oxymorphone ............................................................................................................................................................. 9652 II
Fentanyl ...................................................................................................................................................................... 9801 II
The company plans to import the or before April 10, 2017. Such persons substances (other than final orders in
listed controlled substances in finished may also file a written request for a connection with suspension, denial, or
dosage form for clinical trials, research, hearing on the application pursuant to revocation of registration) has been
and analytical purposes. 21 CFR 1301.43 on or before April 10, redelegated to the Assistant
The import of the above listed basic 2017. Administrator of the DEA Diversion
classes of controlled substances will be ADDRESSES: Written comments should Control Division (‘‘Assistant
granted only for analytical testing, be sent to: Drug Enforcement Administrator’’) pursuant to section 7 of
research, and clinical trials. This Administration, Attention: DEA Federal 28 CFR part 0, appendix to subpart R.
authorization does not extend to the Register Representative/DRW, 8701
import of a finished FDA approved or In accordance with 21 CFR
Morrissette Drive, Springfield, Virginia
non-approved dosage form for 1301.34(a), this is notice that on
22152. All requests for hearing must be
commercial sale. sent to: Drug Enforcement December 29, 2016, Meridian Medical
Administration, Attn: Administrator, Technologies, 2555 Hermelin Drive,
Louis J. Milione, Saint Louis, Missouri 63144 applied to
Assistant Administrator.
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing be registered as an importer of morphine
[FR Doc. 2017–04646 Filed 3–8–17; 8:45 am] (9300), a basic class of controlled
should also be sent to: (1) Drug
BILLING CODE 4410–09–P
Enforcement Administration, Attn: substance listed in schedule II.
Hearing Clerk/LJ, 8701 Morrissette The company manufactures a product
Drive, Springfield, Virginia 22152; and containing morphine in the United
DEPARTMENT OF JUSTICE
(2) Drug Enforcement Administration, States. The company exports this
Drug Enforcement Administration Attn: DEA Federal Register product to customers around the world.
Representative/DRW, 8701 Morrissette The company has been asked to ensure
[Docket No. DEA–392] Drive, Springfield, Virginia 22152. that its product, which is sold to
SUPPLEMENTARY INFORMATION: The European customers, meets the
Importer of Controlled Substances
Application: Meridian Medical Attorney General has delegated his standards established by the European
Technologies authority under the Controlled Pharmacopeia, administered by the
Substances Act to the Administrator of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Directorate for the Quality of Medicines
ACTION: Notice of application. the Drug Enforcement Administration (EDQM). In order to ensure that its
(DEA), 28 CFR 0.100(b). Authority to product will meet European
DATES: Registered bulk manufacturers of exercise all necessary functions with
specifications, the company seeks to
the affected basic classes, and respect to the promulgation and
import morphine supplied by EDQM for
applicants therefore, may file written implementation of 21 CFR part 1301,
comments on or objections to the incident to the registration of use as reference standards.
issuance of the proposed registration in manufacturers, distributors, dispensers,
accordance with 21 CFR 1301.34(a) on importers, and exporters of controlled
VerDate Sep<11>2014 18:42 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/82_FR_13180/page/1.svg)
![13136 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices
This is the sole purpose for which the DATES: Registered bulk manufacturers of respect to the promulgation and
company will be authorized by the DEA the affected basic classes, and implementation of 21 CFR part 1301,
to import morphine. applicants therefore, may file written incident to the registration of
comments on or objections to the manufacturers, distributors, dispensers,
Louis J. Milione,
issuance of the proposed registration in importers, and exporters of controlled
Assistant Administrator. accordance with 21 CFR 1301.33(a) on substances (other than final orders in
[FR Doc. 2017–04647 Filed 3–8–17; 8:45 am] or before May 8, 2017. connection with suspension, denial, or
BILLING CODE 4410–09–P revocation of registration) has been
ADDRESSES: Written comments should
be sent to: Drug Enforcement redelegated to the Assistant
Administration, Attention: DEA Federal Administrator of the DEA Diversion
DEPARTMENT OF JUSTICE
Register Representative/DRW, 8701 Control Division (‘‘Assistant
Drug Enforcement Administration Morrissette Drive, Springfield, Virginia Administrator’’) pursuant to section 7 of
22152. 28 CFR part 0, appendix to subpart R.
[Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The In accordance with 21 CFR
Attorney General has delegated his 1301.33(a), this is notice that on
Bulk Manufacturer of Controlled authority under the Controlled November 14, 2016, Mallinckrodt, LLC,
Substances Application: Mallinckrodt, Substances Act to the Administrator of 3600 North Second Street, Saint Louis,
LLC the Drug Enforcement Administration Missouri 63147 applied to be registered
(DEA), 28 CFR 0.100(b). Authority to as a bulk manufacturer of the following
ACTION: Notice of application.
exercise all necessary functions with 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-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
Oxymorphone ............................................................................................................................................................. 9652 II
Noroxymorphone ........................................................................................................................................................ 9668 II
Alfentanil ..................................................................................................................................................................... 9737 II
Remifentanil ............................................................................................................................................................... 9739 II
Sufentanil ................................................................................................................................................................... 9740 II
Tapentadol ................................................................................................................................................................. 9780 II
Fentanyl ...................................................................................................................................................................... 9801 II
asabaliauskas on DSK3SPTVN1PROD with NOTICES
VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/82_FR_13180/page/2.svg)
Document Created: 2017-03-09 04:58:35
Document Modified: 2017-03-09 04:58:35
| 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 1301.34(a) on or before April 10, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 10, 2017. | |
| FR Citation | 82 FR 13135 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR