85 FR 89 pg. 27245 - Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
Type: NOTICEVolume: 85Number: 89Page: 27245
Page: 27245Docket number: [Docket No. DEA-628]
FR document: [FR Doc. 2020-09706 Filed 5-6-20; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-628]
Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
ACTION:
Notice of application.
DATES:
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before July 6, 2020.
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 January 30, 2020, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia 30601, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Amphetamine | 1100 | II |
| Lisdexamfetamine | 1205 | II |
| Cathinone | 1235 | I |
| Methylphenidate | 1724 | II |
| Morphine-N-Oxide | 9307 | I |
| Normophine | 9313 | I |
| Oripavine | 9330 | II |
| Thebaine | 9333 | II |
| Opium Tincture | 9630 | II |
| Oxymorphone | 9652 | II |
| Noroxymorphone | 9668 | II |
| Alfentanil | 9737 | II |
| Sufentanil | 9740 | II |
| Carfentanil | 9743 | II |
| Tapentadol | 9780 | II |
| Fentanyl | 9801 | II |
The company plans to manufacture the above-listed controlled substances to produce active pharmaceutical ingredients (API) for their prescription drug products and manufacture analytical reference standards for distribution to customers. The company also plans to use these substances for lab scale research and development activities.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-09706 Filed 5-6-20; 8:45 am]
BILLING CODE 4410-09-P