Bulk Manufacturer of Controlled Substances Application: S&B Pharma Inc., 8116 [2019-04030]

Download as PDF 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]
[Page 8116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04030]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: S&B 
Pharma Inc.

ACTION: Notice of application.

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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 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.

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 1301.33(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           Schedule
------------------------------------------------------------------------
Marihuana.......................            7360  I
Tetrahydrocannabinols...........            7370  I
Amphetamine.....................            1100  II
Methamphetamine.................            1105  II
Lisdexamfetamine................            1205  II
Methylphenidate.................            1724  II
Pentobarbital...................            2270  II
4-Anilino-N-phenethyl-4-                    8333  II
 piperidine (ANPP).
Tapentadol......................            9780  II
Fentanyl........................            9801  II
------------------------------------------------------------------------

    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