2020-08270. 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.