Bulk Manufacturer of Controlled Substances Registration, 8115-8116 [2019-04031]

Download as PDF 8115 Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices Company FR docket Patheon API Manufacturing, Inc. .......................................................................................................................... 83 FR 58596 Insys Manufacturing, LLC ..................................................................................................................................... 83 FR 60899 Cayman Chemical Company ................................................................................................................................ 83 FR 60900 Noramco Inc. ........................................................................................................................................................ 83 FR 60898 The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of the listed 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 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 companies. Dated: February 18, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–04033 Filed 3–5–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: 27, Notice of registration. 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company. Published October 30, 2018. Dated: February 18, 2019. John J. Martin, Assistant Administrator. The registrant listed below has applied for and has been granted a registration by the Drug Enforcement Administration (DEA) as bulk manufacturer of schedule I and II controlled substances. [FR Doc. 2019–04032 Filed 3–5–19; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: SUMMARY: The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted for this notice. Notice of registration. Company FR Docket Organix, Inc ........................................................................... 83 FR 58601 ........................................................................ Jkt 247001 27, The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for this notice. 83 FR 54611 ........................................................................ 18:35 Mar 05, 2019 27, SUPPLEMENTARY INFORMATION: Insys Manufacturing, LLC ..................................................... VerDate Sep<11>2014 20, The registrant listed below has applied for and has been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of schedule I controlled substances. FR Docket The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent November 2018. November 2018. November 2018. November 2018. SUMMARY: Company The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of the listed registrant to manufacture the applicable basic classes of schedule I and II 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 the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR Published with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Published November 20, 2018. of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and E:\FR\FM\06MRN1.SGM 06MRN1 8116 Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Notices local laws, and reviewing the 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 company. Dated: February 18, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–04031 Filed 3–5–19; 8:45 am] BILLING CODE 4410–09–P 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 May 6, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: S&B Pharma Inc. ACTION: Notice of application. 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 1301.33(a), this is notice that on February 28, 2017, S&B Pharma Inc., 405 South Motor Avenue, Azusa, California 91702–3232 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Drug code Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ Amphetamine .......................................................................................................................................................... Methamphetamine ................................................................................................................................................... Lisdexamfetamine ................................................................................................................................................... Methylphenidate ...................................................................................................................................................... Pentobarbital ........................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................. Tapentadol ............................................................................................................................................................... Fentanyl ................................................................................................................................................................... The company plans to manufacture the listed controlled substances in bulk for use in product development and for commercial sales to its customers. In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture both as synthetic substances. No other activity for these drug codes is authorized for this registration. Dated: February 18, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–04030 Filed 3–5–19; 8:45 am] BILLING CODE 4410–09–P The company listed below applied to be registered as a bulk manufacturer of various basic classes of controlled substances. Information on a previously published notice is listed below. No comments or objections were submitted for the notice. Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration Notice of registration. The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances. SUMMARY: Company FR Docket Eli-Elsohly Laboratories ........................................................ 83 FR 64159 ........................................................................ The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant 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 VerDate Sep<11>2014 18:35 Mar 05, 2019 Jkt 247001 I I II II II II II II II II SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE ACTION: 7360 7370 1100 1105 1205 1724 2270 8333 9780 9801 Schedule effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Published December 13, 2018. 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 company. E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8115-8116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04031]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: The registrant listed below has applied for and has been
granted a registration by the Drug Enforcement Administration (DEA) as
bulk manufacturer of schedule I and II controlled substances.

SUPPLEMENTARY INFORMATION: The company listed below applied to be
registered as a bulk manufacturer of various basic classes of
controlled substances. Information on the previously published notice
is listed in the table below. No comments or objections were submitted
for this notice.

----------------------------------------------------------------------------------------------------------------
Company FR Docket Published
----------------------------------------------------------------------------------------------------------------
Organix, Inc............................. 83 FR 58601................. November 20, 2018.
----------------------------------------------------------------------------------------------------------------

The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of this registrant 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 the company's maintenance of effective
controls against diversion by inspecting and testing the company's
physical security systems, verifying the company's compliance with
state and

[[Page 8116]]

local laws, and reviewing the 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 company.

Dated: February 18, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-04031 Filed 3-5-19; 8:45 am]
BILLING CODE 4410-09-P

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