81 FR 95641 - Bulk Manufacturer of Controlled Substances Registration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 249 (December 28, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 249 (December 28, 2016)
| Page Range | 95641-95641 | |
| FR Document | 2016-31280 |
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)] [Notices] [Page 95641] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31280] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances. SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. ---------------------------------------------------------------------------------------------------------------- Company FR docket Published ---------------------------------------------------------------------------------------------------------------- National Center for Natural Products 80 FR 78766................. December 17, 2015. Research (NIDA MPROJECT). Cambrex Charles City..................... 81 FR 46956................. July 19, 2016. Chemtos, LLC............................. 81 FR 54604................. August 16, 2016. Stepan Company........................... 81 FR 54849................. August 17, 2016. Chattem Chemicals........................ 81 FR 57932................. August 24, 2016. ---------------------------------------------------------------------------------------------------------------- The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each of the company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed persons. Dated: December 19, 2016. Louis J. Milione, Assistant Administrator. [FR Doc. 2016-31280 Filed 12-27-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices 95641
Lower Ferry Road, Ewing, New Jersey a bulk manufacturer of the following
08618–1414 applied to be registered as basic classes controlled substances:
Controlled substance Drug code Schedule
Pentobarbital .................................................................................................................................................................... 2270 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 8333 II
Remifentanil ..................................................................................................................................................................... 9739 II
Fentanyl ........................................................................................................................................................................... 9801 II
The company plans to initially to DEPARTMENT OF JUSTICE Administration (DEA) as bulk
manufacture API quantities of the listed manufacturers of various classes of
controlled substances for validation Drug Enforcement Administration controlled substances.
purposes and FDA approval, then
[Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The
eventually up FDA approval to produce
commercial size batches for distribution companies listed below applied to be
Bulk Manufacturer of Controlled registered as manufacturers of various
to dosage form manufacturers. Substances Registration basic classes of controlled substances.
Dated: December 19, 2016.
ACTION: Notice of registration. Information on previously published
Louis J. Milione, notices is listed in the table below. No
Assistant Administrator. SUMMARY: Registrants listed below have comments or objections were submitted
[FR Doc. 2016–31282 Filed 12–27–16; 8:45 am] applied for and been granted for these notices.
BILLING CODE 4410–09–P registration by the Drug Enforcement
Company FR docket Published
National Center for Natural Products Research (NIDA MPROJECT) .............. 80 FR 78766 ............................................ December 17, 2015.
Cambrex Charles City ....................................................................................... 81 FR 46956 ............................................ July 19, 2016.
Chemtos, LLC .................................................................................................... 81 FR 54604 ............................................ August 16, 2016.
Stepan Company ............................................................................................... 81 FR 54849 ............................................ August 17, 2016.
Chattem Chemicals ........................................................................................... 81 FR 57932 ............................................ August 24, 2016.
The DEA has considered the factors in DEPARTMENT OF JUSTICE Substances Act to the Administrator of
21 U.S.C. 823(a) and determined that the Drug Enforcement Administration
the registration of these registrants to Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to
manufacture the applicable basic classes [Docket No. DEA–392] exercise all necessary functions with
of controlled substances is consistent respect to the promulgation and
with the public interest and with United Bulk Manufacturer of Controlled implementation of 21 CFR part 1301,
States obligations under international Substances Application: Synthcon, incident to the registration of
treaties, conventions, or protocols in LLC manufacturers, distributors, dispensers,
effect on May 1, 1971. The DEA importers, and exporters of controlled
investigated each of the company’s ACTION: Notice of application. substances (other than final orders in
maintenance of effective controls
DATES: Registered bulk manufacturers of connection with suspension, denial, or
against diversion by inspecting and
testing each company’s physical the affected basic classes, and revocation of registration) has been
security systems, verifying each applicants therefore, may file written redelegated to the Assistant
company’s compliance with state and comments on or objections to the Administrator of the DEA Diversion
local laws, and reviewing each issuance of the proposed registration in Control Division (‘‘Assistant
company’s background and history. accordance with 21 CFR 1301.33(a) on Administrator’’) pursuant to section 7 of
Therefore, pursuant to 21 U.S.C. or before February 27, 2017. 28 CFR part 0, appendix to subpart R.
823(a), and in accordance with 21 CFR ADDRESSES: Written comments should In accordance with 21 CFR
1301.33, the DEA has granted a be sent to: Drug Enforcement 1301.33(a), this is notice that on
registration as a bulk manufacturer to Administration, Attention: DEA Federal December 16, 2015, Synthcon, LLC, 770
the above listed persons. Register Representative/DRW, 8701 Wooten Road, Unit 101, Colorado
Dated: December 19, 2016. Morrissette Drive, Springfield, Virginia Springs, Colorado 80915 applied to be
Louis J. Milione, 22152. registered as a bulk manufacturer of the
Assistant Administrator. SUPPLEMENTARY INFORMATION: following basic classes of controlled
[FR Doc. 2016–31280 Filed 12–27–16; 8:45 am] The Attorney General has delegated substances:
BILLING CODE 4410–09–P her authority under the Controlled
sradovich on DSK3GMQ082PROD with NOTICES
Controlled substance Drug code Schedule
3-Fluoro-N-methylcathinone (3–FMC) ............................................................................................................................. 1233 I
Cathinone ........................................................................................................................................................................ 1235 I
Methcathinone ................................................................................................................................................................. 1237 I
4-Fluoro-N-methylcathinone (4–FMC) ............................................................................................................................. 1238 I
Pentedrone (a-methylaminovalerophenone) ................................................................................................................... 1246 I
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Document Created: 2016-12-28 02:16:58
Document Modified: 2016-12-28 02:16:58
| 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 registration. | |
| FR Citation | 81 FR 95641 |
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