Notices. Notice of application
309 words·~1 min read·
/register/2022/01/31/2022-01816·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-947] Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of application. SUMMARY: Siegfried USA, LLC. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary 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 1, 2022 Such persons may also file a written request for a hearing on the application on or before April 1, 2022.
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 December 8, 2021, Siegfried USA, LLC., 33 Industrial Park Road, Pennsville, New Jersey 08070-3244, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
Controlled substance Drug code Schedule Gamma Hydroxybutyric Acid 2010 I Dihydromorphine 9145 I Hydromorphinol 9301 I Amphetamine 1100 II Lisdexamfetamine 1205 II Methylphenidate 1724 II Amobarbital 2125 II Pentobarbital 2270 II Secobarbital 2315 II Phenylacetone 8501 II Codeine 9050 II Oxycodone 9143 II Hydromorphone 9150 II Hydrocodone 9193 II Methadone 9250 II Methadone intermediate 9254 II Morphine 9300 II Oripavine 9330 II Thebaine 9333 II Opium tincture 9630 II Oxymorphone 9652 II Tapentadol 9780 II The company plans to manufacture the above-listed controlled substance in bulk for development of a new active pharmaceutical ingredient
(API)and validation for a Drug Master File submission to the Food and Drug Administration. No other activity for this drug code is authorized for this registration. Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2022-01816 Filed 1-28-22; 8:45 am]
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Notices
Notice of application
Cites 1Cited by 0 across 0 sources