Importer of Controlled Substances Application: Sigma Aldrich Company LLC
Sigma Aldrich Company LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further ...
Sigma Aldrich Company LLC has applied to be registered as an importer 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 April 5, 2024. Such persons may also file a written request for a hearing on the application on or before April 5, 2024.
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. All requests for a hearing must be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.34(a), this is notice that on February 7, 2024, Sigma Aldrich Company LLC, 3500 Dekalb Street, Saint Louis, Missouri 63118-4103, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
Controlled substance
Drug
code
Schedule
Cathinone
1235
I
Methcathinone
1237
I
Mephedrone (4-Methyl-N-methylcathinone)
1248
I
Gamma Hydroxybutyric Acid
2010
I
Tetrahydrocannabinols
7370
I
4-Bromo-2,5-dimethoxyamphetamine
7391
I
4-Bromo-2,5-dimethoxyphenethylamine
7392
I
2,5-Dimethoxyamphetamine
7396
I
3,4-Methylenedioxyamphetamine
7400
I
3,4-Methylenedioxy-N-ethylamphetamine
7404
I
3,4-Methylenedioxymethamphetamine
7405
I
4-Methoxyamphetamine
7411
I
Dimethyltryptamine
7435
I
N-Benzylpiperazine
7493
I
Heroin
9200
I
Normorphine
9313
I
Amobarbital
2125
II
Secobarbital
2315
II
Nabilone
7379
II
Phencyclidine
7471
II
Ecgonine
9180
II
Ethylmorphine
9190
II
Levorphanol
9220
II
Meperidine
9230
II
Thebaine
9333
II
Opium, powdered
9639
II
Levo-alphacetylmethadol
9648
II
The company plans to import the listed controlled substances for sale to research facilities for drug testing and analysis. In reference to drug code 7370 (Tetrahydrocannabinols) the company plans to import synthetic Tetrahydrocannabinols. 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 import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.