82 FR 214 pgs. 51642-51643 - Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Type: NOTICEVolume: 82Number: 214Pages: 51642 - 51643
Pages: 51642, 51643Docket number: [Docket No. DEA-392]
FR document: [FR Doc. 2017-24201 Filed 11-6-17; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
ACTION:
Notice of application.
DATES:
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with on or before January 8, 2018.
ADDRESSES:
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import raw material are not appropriate. 72 FR 3417 (January 25, 2007).
SUPPLEMENTARY INFORMATION:
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division ("Assistant Administrator") pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on June 12, 2017, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Gamma Hydroxybutyric Acid | 2010 | I |
| Amphetamine | 1100 | II |
| Lisdexamfetamine | 1205 | II |
| Methylphenidate | 1724 | II |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) | 8333 | II |
| Phenylacetone | 8501 | II |
| Cocaine | 9041 | II |
| Codeine | 9050 | II |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Hydrocodone | 9193 | 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 listed controlled substances in bulk for sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies.
Dated: October 30, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-24201 Filed 11-6-17; 8:45 am]
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