2021-12817. Bulk Manufacturer of Controlled Substances Application: Organix Inc.

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Organix 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 file written comments on or objections to the issuance of the proposed registration on or before August 16, 2021. Such persons may also file a written request for a hearing on the application on or before August 16, 2021.

ADDRESSES:

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

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.33(a), this is notice that on April 27, 2021, Organix Inc., 240 Salem Street, Woburn, Massachusetts 01801-2029, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s):

Controlled substance	Drug code	Schedule
Mescaline	7381	I
3,4,5-trimethoxyamphetamine	7390	I
4-bromo-2,5-dimethoxyphenethylamine	7392	I
3,4-methylenedioxyamphetamine	7400	I
3,4-methylenedioxymethamphetamine	7405	I
2-(2,5-dimethoxyphenyl)ethanamine	7517	I
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine	7518	I

The company plans to bulk manufacture small quantities of the above controlled substances for use in clinical research. No other activities for these drug codes are authorized for this registration.

William T. McDermott,

Assistant Administrator.