Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute SRI Montana Satellite Laboratory
Scottsdale Research Institute SRI Montana Satellite Laboratory has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supple...
Scottsdale Research Institute SRI Montana Satellite Laboratory 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 October 26, 2026. Such persons may also file a written request for a hearing on the application on or before October 26, 2026.
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
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
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 17, 2026, Scottsdale Research Institute SRI Montana Satellite Laboratory, 426 Deer Creek Road, Lakeside, Montana 59922, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
Controlled substance
Drug code
Schedule
Ibogaine
7260
I
3,4-Methylenedioxymethamphetamine
7405
I
The company plans to bulk manufacture the listed controlled substances as Active Pharmaceutical Ingredients (API) to support internal research and clinical trials, while also supplying other schedule I researchers who are collaborating on clinical trials. No other activities for these drug codes are authorized for this registration.
Use this for formal legal and research references to the published document.
91 FR 54883
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute SRI Montana Satellite Laboratory,” thefederalregister.org (August 25, 2026), https://thefederalregister.org/documents/2026-17282/bulk-manufacturer-of-controlled-substances-application-scottsdale-research-institute-sri-montana-satellite-laboratory.
www.regulations.gov
21 CFR 1301.33(a)