Notices. Notice of application
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/register/2022/08/10/2022-17175A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-1048] Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of application. SUMMARY: Cambrex Charles City 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 submit electronic comments on or objections to the issuance of the proposed registration on or before October 11, 2022.
Such persons may also file a written request for a hearing on the application on or before October 11, 2022. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to *https://www.regulations.gov* and follow the online instructions at that site for submitting comments.
Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on *https://www.regulations.gov.* If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on May 9, 2022, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616-3466, 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 Tetrahydrocannabinols 7370 I Amphetamine 1100 II Lisdexamfetamine 1205 II Methylphenidate 1724 II ANPP (4-Anilino-N-phenethyl-4-piperidine) 8333 II Phenylacetone 8501 II Codeine 9050 II Oxycodone 9143 II Hydromorphone 9150 II Hydrocodone 9193 II Methadone 9250 II Morphine 9300 II Oripavine 9330 II Thebaine 9333 II Opium extracts 9610 II Opium fluid extract 9620 II Opium tincture 9630 II Opium, powdered 9639 II Oxymorphone 9652 II Noroxymorphone 9668 II Fentanyl 9801 II The company plans to manufacture the listed controlled substances in bulk for conversion to other controlled substances and sales to its customers for dosage form development, clinical trials and use in stability qualification studies.
In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Kristi O'Malley, Assistant Administrator. [FR Doc. 2022-17175 Filed 8-9-22; 8:45 am]
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