Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2020

[Federal Register Volume 85, Number 132 (Thursday, July 9, 2020)]
[Notices]
[Page 41244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14781]


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]

BILLING CODE P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

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