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Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City

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 furth...

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Department of Justice
Drug Enforcement Administration
  1. [Docket No. DEA-1402]

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 7, 2024. Such persons may also file a written request for a hearing on the application on or before October 7, 2024.

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 June 18, 2024, 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 code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration.

Marsha L. Ikner,

Acting Deputy Assistant Administrator.

[FR Doc. 2024-17613 Filed 8-7-24; 8:45 am]

BILLING CODE 4410-09-P

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89 FR 64955

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“Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City,” thefederalregister.org (August 8, 2024), https://thefederalregister.org/documents/2024-17613/bulk-manufacturer-of-controlled-substances-application-cambrex-charles-city.