Purisys LLC Controlled Substance Bulk Manufacturer Registration Notice

Regulations.gov Final Notices

Published February 4th, 2026

Detected April 6th, 2026

Summary

The DEA published a notice that Purisys, LLC applied on February 4, 2026, to be registered as a bulk manufacturer of Schedule I and II controlled substances. The application covers 69 controlled substances including cocaine, fentanyl, heroin, LSD, psilocybin, and various opioids and stimulants. The DEA is soliciting electronic comments or objections from registered bulk manufacturers and other interested parties.

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What changed

The DEA published a notice that Purisys, LLC, located in Athens, Georgia, applied to be registered as a bulk manufacturer of 69 Schedule I and II controlled substances pursuant to 21 CFR 1301.33(a). The listed substances include Schedule I drugs such as LSD (7315), psilocybin (7437), marijuana (7360), and various tryptamines, as well as Schedule II drugs including cocaine (9041), fentanyl (9801), oxycodone (9143), and methamphetamine-related compounds. The company plans to use these substances for active pharmaceutical ingredient production.

Registered bulk manufacturers and interested parties may submit electronic comments or objections, or written hearing requests, on or before June 2, 2026. All submissions must be made through Regulations.gov. This is an informational notice seeking public input on the application; it does not impose compliance obligations on existing DEA registrants. Parties with knowledge relevant to whether the registration should be granted may wish to file objections before the comment deadline.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Purisys, 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.

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 June 2, 2026. Such persons may also file a written
request for a hearing on the application on or before June 2, 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 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 February 4, 2026, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia
30601-1602, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Cathinone | 1235 | I |
| Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate) | 1727 | I |
| Gamma Hydroxybutyric Acid | 2010 | I |
| Ibogaine | 7260 | I |
| Lysergic acid diethylamide | 7315 | I |
| Marihuana Extract | 7350 | I |
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
| Mescaline | 7381 | I |
| 2,5-Dimethoxyamphetamine | 7396 | I |
| 3,4-Methylenedioxyamphetamine | 7400 | I |
| 3,4-Methylenedioxy-N-ethylamphetamine | 7404 | I |
| 3,4-Methylenedioxymethamphetamine | 7405 | I |
| 5-Methoxy-N,N-dimethyltryptamine | 7431 | I |
| Diethyltryptamine | 7434 | I |
| Dimethyltryptamine | 7435 | I |
| Psilocybin | 7437 | I |
| Psilocyn | 7438 | I |
| 5-Methoxy-N,N-diisopropyltryptamine | 7439 | I |
| Methylone (3,4-Methylenedioxy-N-methylcathinone) | 7540 | I |
| Codeine-N-oxide | 9053 | I |
| Dihydromorphine | 9145 | I |
| Heroin | 9200 | I |
| Hydromorphinol | 9301 | I |
| Morphine-N-oxide | 9307 | I |
| Normorphine | 9313 | I |
| Norlevorphanol | 9634 | I |
| Fentanyl-related substances as defined in 21CFR 1308.1 (h) | 9850 | I |
| Amphetamine | 1100 | II |
| Lisdexamfetamine | 1205 | II |
| Methylphenidate | 1724 | II |
| Pentobarbital | 2270 | II |
| Nabilone | 7379 | II |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) | 8333 | II |
| Cocaine | 9041 | II |
| Codeine | 9050 | II |
| Dihydrocodeine | 9120 | II |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Ecgonine | 9180 | II |
| Hydrocodone | 9193 | II |
| Levorphanol | 9220 | II |
| Meperidine | 9230 | II |
| Meperidine intermediate-A | 9232 | II |
| Meperidine intermediate-B | 9233 | II |
| Meperidine intermediate-C | 9234 | II |
| Methadone | 9250 | II |
| Methadone intermediate (4-cyano-2-dimethylamino4,4-diphenylbutane) | 9254 | II |
| Morphine | 9300 | II |
| Oripavine | 9330 | II |
| Thebaine | 9333 | II |
| Opium tincture | 9630 | II |
| Opium, powdered | 9639 | II |
| Opium, granulated | 9640 | II |
| Oxymorphone | 9652 | II |
| Noroxymorphone | 9668 | II |
| Alfentanil | 9737 | II |
| Remifentanil | 9739 | II |
| Sufentanil | 9740 | II |
| Carfentanil | 9743 | II |
| Tapentadol | 9780 | II |
| Fentanyl | 9801 | II |
The company plans to bulk manufacture the listed controlled substances for the production of active pharmaceutical ingredients
and analytical reference standards for sale to its customers. The company plans to manufacture the above listed controlled
substances as clinical trial and starting materials to make compounds for distribution to its customers. No other activities
for these drug codes are authorized for this registration.