84 FR 8116 - Bulk Manufacturer of Controlled Substances Application: S&B Pharma Inc.

[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Page 8116]
From the Federal Register Online  [www.thefederalregister.org]
[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:

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      Controlled substance           Drug code           Schedule
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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
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    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