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

Importers Notice of Application - 2020

[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Page 21890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08270]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-609]

Importer 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 May 20, 2020. Such persons may also file a written request for a hearing on the application on or before May 20, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on January 30, 2020, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia 30601-1602 applied to be registered as an importer of the following basic class(es) of controlled substances:

Controlled Substance Drug Code Schedule
Marihuana Extract 7350 I
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Nabilone 7379 II
Phenylacetone 8501 II
Levorphanol 9220 II
Thebaine 9333 II
Poppy Straw Concentrate 9670 II
Tapentadol 9780 II

The company plans to import drug code 8501, Phenylacetone and drug code 9670, Poppy Straw Concentrate to bulk manufacture other controlled substances for distribution to its customers. The company plans to import impurities of buprenorphine that have been determined by DEA to be captured under drug code 9333, Thebaine. In reference to drug codes 7360, Marihuana and 7370, Tetrahydrocannabinols the company plans to import a Synthetic Cannabidiol and a Synthetic Tetrahydrocannabinol. No other activity for these drug codes is authorized for this registration. Placement of these drugs codes on the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.

[FR Doc. 2020-08270 Filed 4-17-20; 8:45 am]

BILLING CODE 4410-09-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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