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

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Federal RegisterNov 22, 2019
84 Fed. Reg. 64563 (Nov. 22, 2019)

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 on or before January 21, 2020.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.33(a), this is notice that on October 4, 2019, S & B Pharma, Inc., DBA Norac Pharma, 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
Gamma Hydroxybutyric Acid 7360 I
Telrahydrocannabinois 7370 I
Amphetamine 1100 II
Methamphetamine 1105 II
Lisdexamfetamine 1205 II
Methylphenidate 1724 II
Pentobarbital 2270 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) 8333 II
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 code 7360 (marihuana) and 7370 (tetrahydrocannabinois), the company plans to bulk manufacture both as synthetic substances. No other activity for these dug codes is authorized for this registration.

Dated: November 5, 2019.

William T. McDermott,

Assistant Administrator.

[FR Doc. 2019-25402 Filed 11-21-19; 8:45 am]

BILLING CODE 4410-09-P