85 FR 132 pg. 41244 - Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
Type: NOTICEVolume: 85Number: 132Page: 41244
Page: 41244Docket number: [Docket No. DEA-674]
FR document: [FR Doc. 2020-14781 Filed 7-8-20; 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-674]
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 September 8, 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 May 14, 2020, 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 substances:
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Gamma-hydroxybutyic acid | 2010 | I |
| Marihuana Extract | 7350 | I |
| Marihuana | 7360 | I |
| Tetrahydrocannabinols | 7370 | I |
| Codeine-N-Oxide | 9053 | I |
| Dihydromorphine | 9145 | I |
| Hydromorphinol | 9301 | I |
| Nabilone | 7379 | II |
| Codeine | 9050 | II |
| Dihydrocodeine | 9120 | II |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Hydrocodone | 9193 | II |
| Levorphanol | 9220 | II |
| Morphine | 9300 | II |
The company plans to manufacture 7360, 7370, and 7379 as bulk active pharmaceutical ingredients and manufacture the remaining above-listed controlled substances as analytical reference standards for distribution to customers. The company also plans to use these substances for lab scale research and development activities. In reference to drug codes 7360 and 7370, the company plans to bulk manufacture these as synthetic. No other activities for these drug codes are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-14781 Filed 7-8-20; 8:45 am]
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