83 FR 54611 - Importer of Controlled Substances Application: United States Pharmacopeial Convention
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Federal Register Volume 83, Issue 210 (October 30, 2018)
| Page Range | 54611-54612 | |
| FR Document | 2018-23701 |
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)] [Notices] [Pages 54611-54612] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23701] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: United States Pharmacopeial Convention 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 on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 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 August 17, 2018, United States Pharmacopeial [[Page 54612]] Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1717, applied to be registered as an importer of the following basic class of the controlled substance: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Oxymorphone.......................... 9652 II ------------------------------------------------------------------------ The company plans to import the bulk controlled substance for distribution of analytical reference standards to its customers for research and analytical purposes. Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-23701 Filed 10-29-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices 54611
Dated: October 11, 2018. DEPARTMENT OF JUSTICE Dated: October 22, 2018.
John J. Martin, John J. Martin,
Assistant Administrator. Drug Enforcement Administration Assistant Administrator.
[FR Doc. 2018–23684 Filed 10–29–18; 8:45 am] [FR Doc. 2018–23696 Filed 10–29–18; 8:45 am]
BILLING CODE 4410–09–P [Docket No. DEA–392] BILLING CODE 4410–09–P
Bulk Manufacturer of Controlled
DEPARTMENT OF JUSTICE Substances Application: Insys DEPARTMENT OF JUSTICE
Manufacturing, LLC
Drug Enforcement Administration Drug Enforcement Administration
ACTION: Notice of application. [Docket No. DEA–392]
[Docket No. DEA–392]
DATES: Registered bulk manufacturers of Importer of Controlled Substances
Bulk Manufacturer of Controlled the affected basic classes, and Application: United States
Substances Registration applicants therefore, may file written Pharmacopeial Convention
comments on or objections to the
ACTION: Notice of registration. issuance of the proposed registration on ACTION: Notice of application.
or before December 31, 2018.
SUMMARY: Registrants listed below have DATES: Registered bulk manufacturers of
applied for and been granted ADDRESSES: Written comments should the affected basic classes, and
registration by the Drug Enforcement be sent to: Drug Enforcement applicants therefore, may file written
Administration (DEA) as bulk Administration, Attention: DEA Federal comments on or objections to the
manufacturers of various classes of Register Representative/DPW, 8701 issuance of the proposed registration on
schedule I and II controlled substances. Morrissette Drive, Springfield, Virginia or before November 29, 2018. Such
SUPPLEMENTARY INFORMATION: The 22152. persons may also file a written request
companies listed below applied to be for a hearing on the application on or
SUPPLEMENTARY INFORMATION: The before November 29, 2018.
registered as bulk manufacturers of Attorney General has delegated his
various basic classes of controlled ADDRESSES: Written comments should
authority under the Controlled
substances. Information on previously Substances Act to the Administrator of be sent to: Drug Enforcement
published notices is listed in the table the Drug Enforcement Administration Administration, Attention: DEA Federal
below. No comments or objections were (DEA), 28 CFR 0.100(b). Authority to Register Representative/DPW, 8701
submitted for these notices. exercise all necessary functions with Morrissette Drive, Springfield, Virginia
respect to the promulgation and 22152. All requests for hearing must be
Company FR docket Published sent to: Drug Enforcement
implementation of 21 CFR part 1301,
incident to the registration of Administration, Attn: Administrator,
Johnson Matthey 83 FR June 13, 8701 Morrissette Drive, Springfield,
Pharmaceutical 27632. 2018. manufacturers, distributors, dispensers,
Materials Inc. importers, and exporters of controlled Virginia 22152. All requests for hearing
Alcami Wisconsin 83 FR June 13, substances (other than final orders in should also be sent to: (1) Drug
Corporation. 27628. 2018. connection with suspension, denial, or Enforcement Administration, Attn:
revocation of registration) has been Hearing Clerk/OALJ, 8701 Morrissette
The DEA has considered the factors in redelegated to the Assistant Drive, Springfield, Virginia 22152; and
21 U.S.C. 823(a) and determined that Administrator of the DEA Diversion (2) Drug Enforcement Administration,
the registration of these registrants to Control Division (‘‘Assistant Attn: DEA Federal Register
manufacture the applicable basic classes Administrator’’) pursuant to section 7 of Representative/DPW, 8701 Morrissette
of controlled substances is consistent 28 CFR part 0, appendix to subpart R. Drive, Springfield, Virginia 22152.
with the public interest and with United SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR
States obligations under international The Attorney General has delegated
1301.33(a), this is notice that on August
treaties, conventions, or protocols in his authority under the Controlled
22, 2018, Insys Manufacturing, LLC,
effect on May 1, 1971. The DEA Substances Act to the Administrator of
2700 Oakmont Drive, Round Rock,
investigated each of the company’s the Drug Enforcement Administration
Texas 78665–1019 applied to be
maintenance of effective controls (DEA), 28 CFR 0.100(b). Authority to
registered as a bulk manufacturer of the
against diversion by inspecting and exercise all necessary functions with
following basic classes of controlled
testing each company’s physical respect to the promulgation and
substances:
security systems, verifying each implementation of 21 CFR part 1301,
company’s compliance with state and Controlled sub- incident to the registration of
local laws, and reviewing each Drug code Schedule manufacturers, distributors, dispensers,
stance
company’s background and history. importers, and exporters of controlled
Therefore, pursuant to 21 U.S.C. Marihuana ......... 7360 I substances (other than final orders in
Tetrahydrocann- 7370 I connection with suspension, denial, or
823(a), and in accordance with 21 CFR
abinols. revocation of registration) has been
1301.33, the DEA has granted a
redelegated to the Assistant
khammond on DSK30JT082PROD with NOTICES
registration as a bulk manufacturer to
the above listed companies. The company plans to manufacture Administrator of the DEA Diversion
bulk synthetic active pharmaceutical Control Division (‘‘Assistant
Dated: October 22, 2018. ingredients (APIs) for product Administrator’’) pursuant to section 7 of
John J. Martin, development and distribution to its 28 CFR part 0, appendix to subpart R.
Assistant Administrator. customers. No other activity for these In accordance with 21 CFR
[FR Doc. 2018–23698 Filed 10–29–18; 8:45 am] drug codes are authorized for this 1301.34(a), this is notice that on August
BILLING CODE 4410–09–P registration. 17, 2018, United States Pharmacopeial
VerDate Sep<11>2014 17:34 Oct 29, 2018 Jkt 247001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/83_FR_54821/page/1.png)
![54612 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
Convention, 12601 Twinbrook Parkway, respect to the promulgation and Administration, Attention: DEA Federal
Rockville, Maryland 20852–1717, implementation of 21 CFR part 1301, Register Representative/DPW, 8701
applied to be registered as an importer incident to the registration of Morrissette Drive, Springfield, Virginia
of the following basic class of the manufacturers, distributors, dispensers, 22152. All requests for hearing must be
controlled substance: importers, and exporters of controlled sent to: Drug Enforcement
substances (other than final orders in Administration, Attn: Administrator,
Controlled Drug code Schedule connection with suspension, denial, or 8701 Morrissette Drive, Springfield,
substance revocation of registration) has been Virginia 22152. All requests for hearing
redelegated to the Assistant should also be sent to: (1) Drug
Oxymorphone ......... 9652 II
Administrator of the DEA Diversion
Enforcement Administration, Attn:
Control Division (‘‘Assistant
The company plans to import the bulk Hearing Clerk/OALJ, 8701 Morrissette
Administrator’’) pursuant to section 7 of
controlled substance for distribution of Drive, Springfield, Virginia 22152; and
28 CFR part 0, appendix to subpart R.
analytical reference standards to its (2) Drug Enforcement Administration,
In accordance with 21 CFR
customers for research and analytical Attn: DEA Federal Register
1301.34(a), this is notice that on August
purposes. 30, 2018, Sharp (Bethlehem), LLC, 2400 Representative/DPW, 8701 Morrissette
Dated: October 22, 2018. Baglyos Circle, Bethlehem, Drive, Springfield, Virginia 22152.
John J. Martin, Pennsylvania 18020, applied to be SUPPLEMENTARY INFORMATION: The
Assistant Administrator. registered as an importer of the Attorney General has delegated his
[FR Doc. 2018–23701 Filed 10–29–18; 8:45 am] following basic class of controlled authority under the Controlled
substances:
BILLING CODE 4410–09–P Substances Act to the Administrator of
Controlled the Drug Enforcement Administration
Drug code Schedule (DEA), 28 CFR 0.100(b). Authority to
substance
DEPARTMENT OF JUSTICE
exercise all necessary functions with
Gamma Hydrox- 2010 I respect to the promulgation and
Drug Enforcement Administration ybutyric Acid. implementation of 21 CFR part 1301,
[Docket No. DEA–392] incident to the registration of
The company plans to import dosage
manufacturers, distributors, dispensers,
Importer of Controlled Substances forms of the listed controlled substances
to conduct clinical trials. importers, and exporters of controlled
Application: Sharp (Bethlehem), LLC
Approval of permit applications will substances (other than final orders in
ACTION: Notice of application. occur only when the registrant’s activity connection with suspension, denial, or
is consistent with what is authorized revocation of registration) has been
DATES: Registered bulk manufacturers of under to 21 U.S.C. 952 (a)(2). redelegated to the Assistant
the affected basic classes, and Authorization will not extend to the Administrator of the DEA Diversion
applicants therefore, may file written import of FDA approved or non- Control Division (‘‘Assistant
comments on or objections to the approved finished dosage forms for Administrator’’) pursuant to section 7 of
issuance of the proposed registration on commercial sale. 28 CFR part 0, appendix to subpart R.
or before November 29, 2018. Such Dated: October 22, 2018. In accordance with 21 CFR
persons may also file a written request 1301.34(a), this is notice that on August
John J. Martin,
for a hearing on the application on or
Assistant Administrator. 17, 2018, Fisher Clinical Services Inc.,
before November 29, 2018.
[FR Doc. 2018–23705 Filed 10–29–18; 8:45 am] 7554 Schantz Road, Allentown,
ADDRESSES: Written comments should Pennsylvania 18106, applied to be
BILLING CODE 4410–09–P
be sent to: Drug Enforcement registered as an importer of the
Administration, Attention: DEA Federal following basic classes of controlled
Register Representative/DPW, 8701 DEPARTMENT OF JUSTICE substances:
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be Drug Enforcement Administration Controlled
sent to: Drug Enforcement Drug code Schedule
substance
Administration, Attn: Administrator, [Docket No. DEA–392]
8701 Morrissette Drive, Springfield, Importer of Controlled Substances Psilocybin ......... 7437 I
Virginia 22152. All requests for hearing Application: Fisher Clinical Services,
Methylphenidate 1724 II
should also be sent to: (1) Drug Inc.
Levorphanol ...... 9220 II
Enforcement Administration, Attn: Noroxymorphon- 9668 II
Hearing Clerk/OALJ, 8701 Morrissette ACTION: Notice of application. e.
Drive, Springfield, Virginia 22152; and Tapentadol ........ 9780 II
(2) Drug Enforcement Administration, DATES: Registered bulk manufacturers of
Attn: DEA Federal Register the affected basic classes, and The company plans to import the
Representative/DPW, 8701 Morrissette applicants therefore, may file written listed controlled substances for clinical
Drive, Springfield, Virginia 22152. comments on or objections to the trials.
khammond on DSK30JT082PROD with NOTICES
SUPPLEMENTARY INFORMATION: issuance of the proposed registration on
Dated: October 22, 2018.
The Attorney General has delegated or before November 29, 2018. Such
persons may also file a written request John J. Martin,
his authority under the Controlled
Substances Act to the Administrator of for a hearing on the application on or Assistant Administrator.
the Drug Enforcement Administration before November 29, 2018. [FR Doc. 2018–23702 Filed 10–29–18; 8:45 am]
(DEA), 28 CFR 0.100(b). Authority to ADDRESSES: Written comments should BILLING CODE 4410–09–P
exercise all necessary functions with be sent to: Drug Enforcement
VerDate Sep<11>2014 19:27 Oct 29, 2018 Jkt 247001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/83_FR_54821/page/2.png)
Document Created: 2018-10-30 00:43:07
Document Modified: 2018-10-30 00:43:07
| 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 on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. | |
| FR Citation | 83 FR 54611 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR