87 FR 49 pg. 14290 - Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc.
Type: NOTICEVolume: 87Number: 49Page: 14290
Page: 14290Docket number: [Docket No. DEA-982]
FR document: [FR Doc. 2022-05314 Filed 3-11-22; 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-982]
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc.
AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Janssen Pharmaceuticals Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental 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 May 13, 2022. Such persons may also file a written request for a hearing on the application on or before May 13, 2022.
ADDRESSES:
DEA 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 December 10, 2021, Janssen Pharmaceuticals Inc., 1440 Olympic Drive Athens, Georgia 30601-1645, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Methylphenidate | 1724 | II |
| Hydromorphone | 9150 | II |
| Hydrocodone | 9193 | II |
| Oripavine | 9330 | II |
| Thebaine | 9333 | II |
| Tapentadol | 9780 | II |
The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. No other activities for these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-05314 Filed 3-11-22; 8:45 am]
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