ACTION:
Notice of application.
DATES:
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before August 5, 2019.
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 February 1, 2019, SpecGx LLC, 3600 North 2nd Street, Saint Louis, Missouri 63147 applied to be registered as a bulk manufacturer of the following basic class of controlled substances:
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Gamma Hydroxybutyric Acid | 2010 | I |
| Tetrahydrocannabinols | 7370 | I |
| Codeine-N-oxide | 9053 | I |
| Dihydromorphine | 9145 | I |
| Difenoxin | 9168 | I |
| Morphine-N-oxide | 9307 | I |
| Normorphine | 9313 | 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 |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) | 8333 | 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 |
| 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 manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers.
Dated: May 23, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-11877 Filed 6-5-19; 8:45 am]
BILLING CODE 4410-09-P