<NOTICE>
DEPARTMENT OF JUSTICE
<SUBAGY>Drug Enforcement Administration</SUBAGY>
<DEPDOC>[Docket No. DEA-1640]</DEPDOC>
<SUBJECT>Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC</SUBJECT>
<HD SOURCE="HED">AGENCY:</HD>
Drug Enforcement Administration, Justice.
<HD SOURCE="HED">ACTION:</HD>
Notice of application.
<SUM>
<HD SOURCE="HED">SUMMARY:</HD>
IsoSciences LLC 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.
</SUM>
<DATES>
<HD SOURCE="HED">DATES:</HD>
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 February 20, 2026. Such persons may also file a written request for a hearing on the application on or before February 20, 2026.
</DATES>
<HD SOURCE="HED">ADDRESSES:</HD>
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
<E T="03">https://www.regulations.gov</E>
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
<E T="03">https://www.regulations.gov.</E>
If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment.
<SUPLINF>
<HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
In accordance with 21 CFR 1301.33(a), this is notice that on November 18, 2025, IsoSciences, LLC, 340 Mathers Road, Ambler, Pennsylvania 19002-3420, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
<GPOTABLE COLS="3" OPTS="L2,nj,tp0,i1" CDEF="s200,9,xls36">
<TTITLE> </TTITLE>
<CHED H="1">Controlled substance</CHED>
<CHED H="1">Drug code</CHED>
<CHED H="1">Schedule</CHED>
<ROW>
<ENT I="01">Cathinone</ENT>
<ENT>1235</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Methcathinone</ENT>
<ENT>1237</ENT>
<ENT I="01">Lysergic acid diethylamide</ENT>
<ENT>7315</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Marihuana</ENT>
<ENT>7360</ENT>
<ENT I="01">3,4-Methylenedioxyamphetamine</ENT>
<ENT>7400</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">3,4-Methylenedioxy-N-ethylamphetamine</ENT>
<ENT>7404</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">3,4-Methylenedioxymethamphetamine</ENT>
<ENT>7405</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">5-Methoxy-N-N-dimethyltryptamine</ENT>
<ENT>7431</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Alpha-methyltryptamine</ENT>
<ENT>7432</ENT>
<ENT I="01">5-Methoxy-N,N-diisopropyltryptamine</ENT>
<ENT>7439</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Dihydromorphine</ENT>
<ENT>9145</ENT>
<ENT I="01">Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide)</ENT>
<ENT>9811</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Para-Fluorofentanyl</ENT>
<ENT>9812</ENT>
<ENT I="01">Acetyl-alpha-methylfentanyl</ENT>
<ENT>9815</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide</ENT>
<ENT>9816</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)</ENT>
<ENT>9821</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Butyryl Fentanyl</ENT>
<ENT>9822</ENT>
<ENT I="01">4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide)</ENT>
<ENT>9824</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide</ENT>
<ENT>9825</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Beta-hydroxyfentanyl</ENT>
<ENT>9830</ENT>
<ENT I="01">Beta-hydroxy-3-methylfentanyl</ENT>
<ENT>9831</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Alpha-methylthiofentanyl</ENT>
<ENT>9832</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">3-Methylthiofentanyl</ENT>
<ENT>9833</ENT>
<ENT I="01">Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide)</ENT>
<ENT>9834</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Thiofentanyl</ENT>
<ENT>9835</ENT>
<ENT I="01">Beta-hydroxythiofentanyl</ENT>
<ENT>9836</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide</ENT>
<ENT>9843</ENT>
<ENT>I</ENT>
</ROW>
<ROW>
<ENT I="01">Amphetamine</ENT>
<ENT>1100</ENT>
<ENT I="01">Levo-alphacetylmethadol</ENT>
<ENT>9648</ENT>
<ENT>II</ENT>
</ROW>
<ROW>
<ENT I="01">Oxymorphone</ENT>
<ENT>9652</ENT>
The company plans to bulk manufacture the listed controlled substances to be used in analytical testing. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.
<SIG>
<NAME>Thomas Prevoznik,</NAME>
Deputy Assistant Administrator.
</SIG>
</SUPLINF>
<FRDOC>[FR Doc. 2025-23621 Filed 12-19-25; 8:45 am]</FRDOC>
</NOTICE>
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