# Bulk Manufacturer of Controlled Substances Application: SpecGx LLC
**AGENCY:**
Drug Enforcement Administration, Justice.
**ACTION:**
Notice of application.
**SUMMARY:**
SpecGx LLC 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 submit electronic comments on or objections to the issuance of the proposed registration on or before June 27, 2022. Such persons may also file a written request for a hearing on the application on or before June 27, 2022.
**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 January 26, 2022, SpecGx LLC, 3600 North Second Street, Saint Louis, Missouri 63147-3457, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Gamma Hydroxybutyric Acid | 2010 | I |
| Tetrahydrocannabinols | 7370 | I |
| Codeine-N-oxide | 9053 | I |
| Noroxymorphone | 9145 | I |
| Difenoxin | 9168 | I |
| Morphine-N-oxide | 9307 | I |
| Normorphine | 9313 | I |
| Alphamethadol | 9605 | I |
| Betamethadol | 9609 | I |
| Norlevorphanol | 9634 | I |
| Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) | 9821 | I |
| Butyryl Fentanyl | 9822 | I |
| Fentanyl related-compounds as defined in 21 CFR 1308.11(h) | 9850 | I |
| Amphetamine | 1100 | II |
| Methamphetamine | 1105 | II |
| Lisdexamfetamine | 1205 | II |
| Methylphenidate | 1724 | II |
| Nabilone | 7379 | II |
| ANPP (4-Anilino-N-phenethyl-4-piperidine) | 8333 | II |
| Phenylacetone | 8501 | II |
| Codeine | 9050 | II |
| Dihydrocodeine | 9120 | II |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Diphenoxylate | 9170 | 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 | 9254 | II |
| Dextropropoxyphene, bulk (non-dosage forms) | 9273 | II |
| Morphine | 9300 | II |
| Oripavine | 9330 | II |
| Thebaine | 9333 | II |
| Opium tincture | 9630 | II |
| Opium, powdered | 9639 | II |
| Oxymorphone | 9652 | II |
| Noroxymorphone | 9668 | II |
| Alfentanil | 9737 | II |
| Remifentanil | 9739 | II |
| Sufentanil | 9740 | II |
| Tapentadol | 9780 | II |
| Fentanyl | 9801 | II |
The company plans to bulk manufacture the listed controlled substances for the internal use intermediates or for sale to its customers. In reference to dug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.