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Department of Justice Drug Enforcement Administration [Docket No. DEA-545] ACTION: Notice of application. DATES: Registered bulk manufacturers of the affected basic classes, and...
Notice of application.
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.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
In accordance with 21 CFR 1301.33(a), this ( printed page 64564) 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
Legal Citation
Use this for formal legal and research references to the published document.
84 FR 64563
Web Citation
Use this when citing the archival web version of the document.
“Bulk Manufacturer of Controlled Substances Application: S&B Pharma, Inc.,” thefederalregister.org (November 22, 2019), https://thefederalregister.org/documents/2019-25402/bulk-manufacturer-of-controlled-substances-application-s-and-b-pharma-inc.
21 CFR 1301.33(a)