88 FR 197 pgs. 71021-71022 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
Type: NOTICEVolume: 88Number: 197Pages: 71021 - 71022
Pages: 71021, 71022Docket number: [Docket No. DEA-1280]
FR document: [FR Doc. 2023-22627 Filed 10-12-23; 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-1280]
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Chattem Chemicals, Inc., 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 December 12, 2023. Such persons may also file a written request for a hearing on the application on or before December 12, 2023.
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 July 14, 2023, Chattem Chemicals, Inc. 3801 Saint Elmo Avenue, Chattanooga, Tennessee 37409, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
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| Controlled substance | Drug code | Schedule |
|---|---|---|
| Gamma Hydroxybutyric Acid | 2010 | I |
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
| 4-Methoxyamphetamine | 7411 | I |
| Dihydromorphine | 9145 | I |
| Amphetamine | 1100 | II |
| Methamphetamine | 1105 | II |
| Lisdexamfetamine | 1205 | II |
| Methylphenidate | 1724 | II |
| Cocaine | 9041 | II |
| Codeine | 9050 | II |
| Dihydrocodeine | 9120 | II |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Ecgonine | 9180 | II |
| Hydrocodone | 9193 | II |
| Levorphanol | 9220 | II |
| Methadone | 9250 | II |
| Methadone intermediate | 9254 | II |
| Morphine | 9300 | II |
| Oripavine | 9330 | II |
| Thebaine | 9333 | II |
| Oxymorphone | 9652 | II |
| Noroxymorphone | 9668 | II |
| Alfentanil | 9737 | II |
| Remifentanil | 9739 | II |
| Sufentanil | 9740 | II |
| Tapentadol | 9780 | II |
| Fentanyl | 9801 | II |
The company plans to bulk manufacture the listed controlled substances in bulk for distribution and sale to its customers. In reference to drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as a synthetic. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the manufacturing of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-22627 Filed 10-12-23; 8:45 am]
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