82_FR_23165 82 FR 23069 - Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc.

82 FR 23069 - Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 96 (May 19, 2017)

Page Range23069-23070
FR Document2017-10234

Federal Register, Volume 82 Issue 96 (Friday, May 19, 2017) 
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23069-23070]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10234]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research, Inc.

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic class, and 
applicants

[[Page 23070]]

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 June 19, 2017. Such persons may also file a written request for 
a hearing on the application pursuant to 21 CFR 1301.43 on or before 
June 19, 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 
request 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 of subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
November 10, 2016, Galephar Pharmaceutical Research, Inc., #100 Carr 
198, Industrial Park, Juncos, Puerto Rico 00777-3873 applied to be 
registered as an importer of hydromorphone (9150), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, research and analytical 
purposes.
    The import of this class of controlled substance will be granted 
only for analytical testing, research, and clinical trials. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form for commercial sale.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10234 Filed 5-18-17; 8:45 am]
BILLING CODE 4410-09-P

Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 23069 Controlled substance Drug code Schedule JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ....................................................................................................................... 7019 I JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) .............................................................................. 7118 I JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) ...................................................................................................... 7122 I UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .................................................................. 7144 I JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ........................................................................................................................ 7173 I Lysergic acid diethylamide .............................................................................................................................................. 7315 I 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7) .............................................................................................. 7348 I 3,4-Methylenedioxyamphetamine .................................................................................................................................... 7400 I 3,4-Methylenedioxy-N-ethylamphetamine ....................................................................................................................... 7404 I 3,4-Methylenedioxymethamphetamine ............................................................................................................................ 7405 I MDPV (3,4-Methylenedioxypyrovalerone) ....................................................................................................................... 7535 I Methylone (3,4-Methylenedioxy-N-methylcathinone) ...................................................................................................... 7540 I Desomorphine ................................................................................................................................................................. 9055 I Norlevorphanol ................................................................................................................................................................ 9634 I Phencyclidine ................................................................................................................................................................... 7471 II Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. 9273 II Noroxymorphone ............................................................................................................................................................. 9668 II Sufentanil ......................................................................................................................................................................... 9740 II Tapentadol ....................................................................................................................................................................... 9780 II Fentanyl ........................................................................................................................................................................... 9801 II The company plans to manufacture DATES: Registered bulk manufacturers of implementation of 21 CFR part 1301, small quantities of the listed controlled the affected basic classes, and incident to the registration of substances in bulk for distribution to its applicants therefore, may file written manufacturers, distributors, dispensers, customers. comments on or objections to the importers, and exporters of controlled Dated: May 15, 2017. issuance of the proposed registration in substances (other than final orders in Louis J. Milione, accordance with 21 CFR 1301.33(a) on connection with suspension, denial, or or before July 18, 2017. revocation of registration) has been Assistant Administrator. [FR Doc. 2017–10231 Filed 5–18–17; 8:45 am] ADDRESSES: Written comments should redelegated to the Assistant be sent to: Drug Enforcement Administrator of the DEA Diversion BILLING CODE 4410–09–P Administration, Attention: DEA Federal Control Division (‘‘Assistant Register Representative/DRW, 8701 Administrator’’) pursuant to section 7 of DEPARTMENT OF JUSTICE Morrissette Drive, Springfield, Virginia 28 CFR part 0, appendix to subpart R. 22152. In accordance with 21 CFR Drug Enforcement Administration 1301.33(a), this is notice that on SUPPLEMENTARY INFORMATION: The [Docket No. DEA–392] Attorney General has delegated his September 26, 2016, Johnson Matthey authority under the Controlled Pharmaceutical Materials, Inc., Bulk Manufacturer of Controlled Substances Act to the Administrator of Pharmaceutical Service, 25 Patton Road, Substances Application: Johnson the Drug Enforcement Administration Devens, Massachusetts 01434 applied to Matthey Pharmaceutical Materials, Inc. (DEA), 28 CFR 0.100(b). Authority to be registered as a bulk manufacturer of exercise all necessary functions with the following basic classes controlled ACTION: Notice of application. respect to the promulgation and substances: Controlled substance Drug code Schedule Amphetamine ................................................................................................................................................................... 1100 II Methylphenidate .............................................................................................................................................................. 1724 II Nabilone ........................................................................................................................................................................... 7379 II Hydrocodone ................................................................................................................................................................... 9193 II Alfentanil .......................................................................................................................................................................... 9737 II Remifentanil ..................................................................................................................................................................... 9739 II Sufentanil ......................................................................................................................................................................... 9740 II The company plans to utilize this Dated: May 15, 2017. DEPARTMENT OF JUSTICE facility to manufacture small quantities Louis J. Milione, of the listed controlled substances in Assistant Administrator. Drug Enforcement Administration bulk for distribution to its customers as [FR Doc. 2017–10233 Filed 5–18–17; 8:45 am] [Docket No. DEA–392] asabaliauskas on DSK3SPTVN1PROD with NOTICES well as to conduct analytical testing in BILLING CODE 4410–09–P support of the company’s primary Importer of Controlled Substances manufacturing facility in West Deptford, Application: Galephar Pharmaceutical New Jersey. Research, Inc. ACTION: Notice of application. DATES: Registered bulk manufacturers of the affected basic class, and applicants VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1

23070 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices therefore, may file written comments on Dated: May 15, 2017. Administrator’’) pursuant to section 7 of or objections to the issuance of the Louis J. Milione, 28 CFR part 0, appendix to subpart R. proposed registration in accordance Assistant Administrator. In accordance with 21 CFR with 21 CFR 1301.34(a) on or before [FR Doc. 2017–10234 Filed 5–18–17; 8:45 am] 1301.34(a), this is notice that on October June 19, 2017. Such persons may also BILLING CODE 4410–09–P 16, 2015, Whatever LLC, 4370 N. file a written request for a hearing on Randall Street, Flagstaff, Arizona 86004 the application pursuant to 21 CFR applied to be registered as an importer 1301.43 on or before June 19, 2017. DEPARTMENT OF JUSTICE of opium poppy (9650), a basic class of controlled substance listed in schedule ADDRESSES: Written comments should Drug Enforcement Administration II. be sent to: Drug Enforcement The company plans to import opium Administration, Attention: DEA Federal poppy (9650), for dried floral decorative Register Representative/DRW, 8701 [Docket No. DEA–392] arrangements. Approval of permit Morrissette Drive, Springfield, Virginia application will occur only when the 22152. All requests for hearing must be Importer of Controlled Substances Application: Whatever LLC registrant’s business activity is sent to: Drug Enforcement consistent with what is authorized Administration, Attn: Administrator, ACTION: Notice of application. under to 21 U.S.C. 952(a)(2). 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing Dated: May 15, 2017. DATES: Registered bulk manufacturers of Louis J. Milione, should also be sent to: (1) Drug the affected basic class, and applicants Enforcement Administration, Attn: Assistant Administrator. therefore, may file written comments on Hearing Clerk/LJ, 8701 Morrissette or objections to the issuance of the [FR Doc. 2017–10243 Filed 5–18–17; 8:45 am] Drive, Springfield, Virginia 22152; and proposed registration in accordance BILLING CODE 4410–09–P (2) Drug Enforcement Administration, with 21 CFR 1301.34(a) on or before Attn: DEA Federal Register June 19, 2017. Such persons may also Representative/DRW, 8701 Morrissette DEPARTMENT OF JUSTICE file a written request for a hearing on Drive, Springfield, Virginia 22152. the application pursuant to 21 CFR Drug Enforcement Administration SUPPLEMENTARY INFORMATION: The 1301.43 on or before June 19, 2017. Attorney General has delegated his [Docket No. DEA–392] ADDRESSES: Written comments should authority under the Controlled be sent to: Drug Enforcement Bulk Manufacturer of Controlled Substances Act to the Administrator of Administration, Attention: DEA Federal Substances Application: American the Drug Enforcement Administration Register Representative/DRW, 8701 Radiolabeled Chemicals (DEA), 28 CFR 0.100(b). Authority to Morrissette Drive, Springfield, Virginia exercise all necessary functions with 22152. All requests for hearing must be ACTION: Notice of application. respect to the promulgation and sent to: Drug Enforcement implementation of 21 CFR part 1301, Administration, Attn: Administrator, DATES: Registered bulk manufacturers of incident to the registration of 8701 Morrissette Drive, Springfield, the affected basic classes, and manufacturers, distributors, dispensers, Virginia 22152. All requests for hearing applicants therefore, may file written importers, and exporters of controlled should also be sent to: (1) Drug comments on or objections to the substances (other than final orders in Enforcement Administration, Attn: issuance of the proposed registration in connection with suspension, denial, or Hearing Clerk/LJ, 8701 Morrissette accordance with 21 CFR 1301.33(a) on revocation of registration) has been Drive, Springfield, Virginia 22152; and or before July 18, 2017. redelegated to the Assistant (2) Drug Enforcement Administration, ADDRESSES: Written comments should Administrator of the DEA Diversion Attn: DEA Federal Register be sent to: Drug Enforcement Control Division (‘‘Assistant Representative/DRW, 8701 Morrissette Administration, Attention: DEA Federal Administrator’’) pursuant to section 7 of Drive, Springfield, Virginia 22152. Register Representative/DRW, 8701 28 CFR part 0, appendix of subpart R. Comments and requests for hearing on Morrissette Drive, Springfield, Virginia In accordance with 21 CFR applications to import narcotic raw 22152. 1301.34(a), this is notice that on material are not appropriate. 72 FR 3417 SUPPLEMENTARY INFORMATION: The November 10, 2016, Galephar (January 25, 2007). Attorney General has delegated his Pharmaceutical Research, Inc., #100 SUPPLEMENTARY INFORMATION: The authority under the Controlled Carr 198, Industrial Park, Juncos, Puerto Attorney General has delegated his Substances Act to the Administrator of Rico 00777–3873 applied to be authority under the Controlled the Drug Enforcement Administration registered as an importer of Substances Act to the Administrator of (DEA), 28 CFR 0.100(b). Authority to hydromorphone (9150), a basic class of the Drug Enforcement Administration exercise all necessary functions with controlled substance listed in schedule (DEA), 28 CFR 0.100(b). Authority to respect to the promulgation and II. exercise all necessary functions with implementation of 21 CFR part 1301, The company plans to import the respect to the promulgation and incident to the registration of listed controlled substance in finished implementation of 21 CFR part 1301, manufacturers, distributors, dispensers, dosage form for clinical trials, research incident to the registration of importers, and exporters of controlled asabaliauskas on DSK3SPTVN1PROD with NOTICES and analytical purposes. manufacturers, distributors, dispensers, substances (other than final orders in The import of this class of controlled importers, and exporters of controlled connection with suspension, denial, or substance will be granted only for substances (other than final orders in revocation of registration) has been analytical testing, research, and clinical connection with suspension, denial, or redelegated to the Assistant trials. This authorization does not revocation of registration) has been Administrator of the DEA Diversion extend to the import of a finished FDA redelegated to the Assistant Control Division (‘‘Assistant approved or non-approved dosage form Administrator of the DEA Diversion Administrator’’) pursuant to section 7 of for commercial sale. Control Division (‘‘Assistant 28 CFR part 0, appendix to subpart R. VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1


Document Created: 2018-11-08 08:47:33
Document Modified: 2018-11-08 08:47:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered bulk manufacturers of the affected basic class, 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 June 19, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before June 19, 2017.
FR Citation82 FR 23069 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR