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Notice

Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals

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Start Preamble

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 on or before January 8, 2019.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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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 August 2, 2018, Chattem Chemicals, 3801 Saint Elmo Avenue, Chattanooga, Tennessee 37409-1237 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substanceDrug codeSchedule
Gamma Hydroxybutyric Acid2010I
Marihuana7360I
Tetrahydrocannabinols7370I
4-Methoxyamphetamine7411I
Dihydromorphine9145I
Amphetamine1100II
Methamphetamine1105II
Lisdexamfetamine1205II
Methylphenidate1724II
Codeine9050II
Dihydrocodeine9120II
Oxycodone9143II
Hydromorphone9150II
Hydrocodone9193II
Levorphanol9220II
Methadone9250II
Methadone intermediate9254II
Morphine9300II
Oripavine9330II
Thebaine9333II
Oxymorphone9652II
Noroxymorphone9668II
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Tapentadol9780II
Fentanyl9801II

The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers.

In reference to drug code 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.

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Dated: October 25, 2018.

John J. Martin,

Assistant Administrator.

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[FR Doc. 2018-24485 Filed 11-8-18; 8:45 am]

BILLING CODE 4410-09-P