Bulk Manufacturer of Controlled Substances Application: Purisys, LLC, 27245 [2020-09706]

Download as PDF 27245 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 85, No. 89 / Thursday, May 7, 2020 / Notices denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978). This rule derives from the text of two provisions of the CSA. First, Congress defined the term ‘‘practitioner’’ to mean ‘‘a physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, . . . [or] administer . . . a controlled substance in the course of professional practice.’’ 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner’s registration, Congress directed that ‘‘[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.’’ 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the CSA, DEA has held repeatedly that revocation of a practitioner’s registration is the appropriate sanction whenever she is no longer authorized to dispense controlled substances under the laws of the state in which she practices. See, e.g., James L. Hooper, M.D., 76 FR at 71,371–72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, M.D., 43 FR at 27,617. According to Nevada statute, ‘‘[e]very person desiring to practice medicine must, before beginning to practice, procure from the Board a license authorizing the person to practice.’’ Nev. Rev. Stat. § 630.160(1) (Westlaw, current through the end of the 80th Regular Session (2019)). Further, the phrase ‘‘practice medicine’’ includes prescribing ‘‘for any human disease.’’Nev. Rev. Stat. § 630.020(1) (Westlaw, current through the end of the 80th Regular Session (2019)). As already discussed, Registrant’s medical license is currently revoked. Thus, Registrant currently is not authorized to practice medicine, including to prescribe controlled substances, in Nevada. Nevada statute requires that ‘‘[e]very practitioner . . . who dispenses any controlled substance within this State . . . shall obtain biennially a registration issued by the Board in accordance with its regulations.’’ Nev. Rev. Stat. § 453.226(1) (Westlaw, current through the end of the 80th Regular Session (2019)). ‘‘Practitioner’’ means ‘‘a physician . . . who holds a license to practice his or her profession in this State and is registered pursuant to [the Uniform Controlled Substances Act].’’ VerDate Sep<11>2014 16:45 May 06, 2020 Jkt 250001 Nev. Rev. Stat. § 453.126(1) (Westlaw, current through the end of the 80th Regular Session (2019)). ‘‘Dispense’’ means ‘‘to deliver a controlled substance to an ultimate user . . ., including the prescribing . . . for that delivery.’’ Nev. Rev. Stat. § 453.056(1) (Westlaw, current through the end of the 80th Regular Session (2019)). As already discussed, Registrant’s Nevada medical license is currently revoked. Thus, Registrant is not a ‘‘practitioner’’ under Nevada law and, therefore, he is not eligible to dispense or prescribe a controlled substance in Nevada. Here, the undisputed evidence in the record is that Registrant is not currently authorized to practice medicine or to prescribe controlled substances in Nevada. Registrant, therefore, is not currently eligible to maintain a DEA registration. Accordingly, I will order that Registrant’s DEA registration be revoked. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. BH7844500 issued to Isaac J. Hearne, M.D. This Order is effective June 8, 2020. Controlled substance Drug code Amphetamine ......... Lisdexamfetamine .. Cathinone ............... Methylphenidate ..... Morphine-N-Oxide .. Normophine ............ Oripavine ................ Thebaine ................. Opium Tincture ....... Oxymorphone ......... Noroxymorphone .... Alfentanil ................. Sufentanil ................ Carfentanil .............. Tapentadol .............. Fentanyl .................. 1100 1205 1235 1724 9307 9313 9330 9333 9630 9652 9668 9737 9740 9743 9780 9801 Schedule II II I II I I II II II II II II II II II II The company plans to manufacture the above-listed controlled substances to produce active pharmaceutical ingredients (API) for their prescription drug products and manufacture analytical reference standards for distribution to customers. The company also plans to use these substances for lab scale research and development activities. William T. McDermott, Assistant Administrator. [FR Doc. 2020–09706 Filed 5–6–20; 8:45 am] BILLING CODE 4410–09–P Uttam Dhillon, Acting Administrator. [FR Doc. 2020–09722 Filed 5–6–20; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–638] DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–628] ACTION: Bulk Manufacturer of Controlled Substances Application: Purisys, LLC ACTION: Notice of application. 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 July 6, 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 January 30, 2020, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia 30601, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: DATES: PO 00000 Frm 00042 Fmt 4703 Importer of Controlled Substances Application: Novitium Pharma LLC Sfmt 4703 Notice of application. Registered bulk manufacturer 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 June 8, 2020. Such persons may also file a written request for a hearing on the application on or before June 8, 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 requests 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, DATES: E:\FR\FM\07MYN1.SGM 07MYN1

Agencies

[Federal Register Volume 85, Number 89 (Thursday, May 7, 2020)]
[Notices]
[Page 27245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09706]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-628]


Bulk Manufacturer of Controlled Substances Application: Purisys, 
LLC

ACTION: Notice of application.

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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 July 6, 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 January 30, 2020, Purisys, LLC, 1550 Olympic Drive, 
Athens, Georgia 30601, applied to be registered as a bulk manufacturer 
of the following basic class(es) of controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Amphetamine..........................        1100  II
Lisdexamfetamine.....................        1205  II
Cathinone............................        1235  I
Methylphenidate......................        1724  II
Morphine-N-Oxide.....................        9307  I
Normophine...........................        9313  I
Oripavine............................        9330  II
Thebaine.............................        9333  II
Opium Tincture.......................        9630  II
Oxymorphone..........................        9652  II
Noroxymorphone.......................        9668  II
Alfentanil...........................        9737  II
Sufentanil...........................        9740  II
Carfentanil..........................        9743  II
Tapentadol...........................        9780  II
Fentanyl.............................        9801  II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances to produce active pharmaceutical ingredients (API) for their 
prescription drug products and manufacture analytical reference 
standards for distribution to customers. The company also plans to use 
these substances for lab scale research and development activities.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-09706 Filed 5-6-20; 8:45 am]
 BILLING CODE 4410-09-P