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Notice

Bulk Manufacturer of Controlled Substances Application: Purisys, LLC

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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.

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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 substanceDrug codeSchedule
Gamma-hydroxybutyic acid2010I
Marihuana Extract7350I
Marihuana7360I
Tetrahydrocannabinols7370I
Codeine-N-Oxide9053I
Dihydromorphine9145I
Hydromorphinol9301I
Nabilone7379II
Codeine9050II
Dihydrocodeine9120II
Oxycodone9143II
Hydromorphone9150II
Hydrocodone9193II
Levorphanol9220II
Morphine9300II

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.

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William T. McDermott,

Assistant Administrator.

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[FR Doc. 2020-14781 Filed 7-8-20; 8:45 am]

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