Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2021

[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Page 11558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03837]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-791]

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

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.


SUMMARY: S&B Pharma, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 26, 2021. Such persons may also file a written request for a hearing on the application on or before April 26, 2021.

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 November 11, 2020, S&B Pharma, Inc., 405 South Motor Avenue, Azusa, California 91702-3232, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s):

Controlled Substance Drug Code Schedule
Gamma Hydroxybutyric Acid 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-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 (Tetrahydrocannabinols), the company plans to bulk manufacture both as synthetic substances. No other activity for these drug codes is authorized for this registration.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2021-03837 Filed 2-24-21; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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