[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33358-33359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13252]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-857]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
Charles City

AGENCY: Drug Enforcement Administration, Justice.

[[Page 33359]]


ACTION: Notice of application.

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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 file written comments on or objections to 
the issuance of the proposed registration on or before August 23, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before August 23, 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 May 6, 2021, 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):

------------------------------------------------------------------------
                                                       Drug
                Controlled substance                   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
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    The company plans to manufacture the above-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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-13252 Filed 6-23-21; 8:45 am]
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