Importer of Controlled Substances Application: Novitium Pharma LLC, 27245-27246 [2020-09705]

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 27246 Federal Register / Vol. 85, No. 89 / Thursday, May 7, 2020 / Notices 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 March 2, 2020, Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as an importer of the following basic class(es) of controlled substances: Controlled substance Drug code Schedule Lisdexamfetamine .... 1205 II The company plans to import the listed controlled substance as a raw material for drug product development and research. The company may import Active Pharmaceutical Ingredients (API) for research purposes only but not for the manufacturing of Food and Drug Administration-approved products. Approval of permit applications will occur only when the registrant’s activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). William T. McDermott, Assistant Administrator. [FR Doc. 2020–09705 Filed 5–6–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration khammond on DSKJM1Z7X2PROD with NOTICES Michael Thomas Watkins, M.D.; Decision and Order On November 4, 2019, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Michael Thomas Watkins, M.D. (hereinafter, Registrant) of Boston, Massachusetts. OSC, at 1. The OSC proposed the revocation of Registrant’s Certificate of Registration No. BW0913132 and the denial of ‘‘any applications for renewal or modification of such registration and any applications for any other DEA registrations.’’ Id. It alleged that Registrant is ‘‘without authority to handle controlled substances in the Commonwealth of Massachusetts, the state in which . . . [he is] registered with the DEA.’’ Id. at 2 (citing 21 U.S.C. 824(a)(3); 21 CFR 1301.37(b)). Specifically, the OSC alleged that, ‘‘[o]n or about May 30, 2019, the Massachusetts Board of Registration in Medicine . . . ratified a ‘Voluntary Agreement Not to Practice Medicine’ VerDate Sep<11>2014 16:45 May 06, 2020 Jkt 250001 that . . . [Registrant] signed on May 22, 2019, in which . . . [he] agreed to ‘cease . . . [his] practice of medicine in the Commonwealth of Massachusetts effective immediately.’’’ OSC, at 1. The OSC further alleged that Registrant’s ‘‘Massachusetts Controlled Substances License was terminated due to the Board action’’ and, ‘‘[t]hus, . . . [he is] currently without authority to handle controlled substances in . . . the state in which . . . [he is] registered with the DEA.’’ Id. at 2. The OSC concluded that ‘‘DEA must revoke . . . [Registrant’s] DEA registration based on . . . [his] lack of authority to handle controlled substances in the Commonwealth of Massachusetts.’’ Id. The OSC notified Registrant of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. (citing 21 CFR 1301.43). The OSC also notified Registrant of the opportunity to submit a corrective action plan. OSC, at 3 (citing 21 U.S.C. 824(c)(2)(C)). Adequacy of Service In a Declaration dated February 24, 2020, a Diversion Investigator (hereinafter, DI) assigned to the New England Division, stated that she and another DI traveled to the address her investigation identified to be Registrant’s home on November 12, 2019. Request for Final Agency Action dated February 26, 2020 (hereinafter, RFAA), Exhibit (hereinafter, EX) 4 (Declaration of Service of Order to Show Cause dated February 24, 2020), at 1. The DI stated that she and the other DI showed their credentials to the ‘‘woman who answered the door’’ and asked if Registrant was ‘‘available.’’ Id. The woman, according to the DI’s Declaration, responded that Registrant ‘‘was not home.’’ Id. After verifying the woman’s identity as Registrant’s spouse, DI ‘‘explained . . . that Registrant was being served with the . . . [OSC] and handed the . . . [OSC] to . . . [the woman] to give to Registrant.’’ Id. The woman signed a receipt for the OSC. Id.; see also id. at EX 4B (signed DEA–12 receipt dated November 12, 2019), at 1. According to the DI’s Declaration, the woman ‘‘stated that she would give the documents to Registrant.’’ Id. at EX 4, at 1. The Government forwarded its RFAA, along with the evidentiary record, to this office on February 26, 2020. In its RFAA, the Government represented that ‘‘[a]t least 30 days have passed since the time the Order was served on Registrant. Registrant has not requested a hearing PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 and has not otherwise corresponded or communicated with DEA regarding the Order . . . including the filing of any written statement in lieu of a hearing.’’ RFAA, at 2. The Government requested that Registrant’s registration be revoked, based on his having ‘‘no valid medical license in Massachusetts’’ and his being ‘‘without state authority to handle controlled substances in Massachusetts, the state where he is registered with DEA.’’ Id. at 3. Based on the DI’s Declaration, the Government’s written representations, and my review of the record, I find that the Government accomplished service of the OSC on Registrant on November 12, 2019. Dale L. Taylor, M.D., 72 FR 30,855, 30,855 (2007) (concluding that service was sufficient when OSC and Immediate Suspension Order were left at registrant’s residence with his wife); Sajjan Gangappa Chikkannaiah, M.D., 54 FR 8608, 8608 (1989) (noticing OSC and Immediate Suspension Order to registrant through the Federal Register when family, wife, and staff were unable to provide any information on registrant’s whereabouts); Fredric J. Sloan, M.D., 52 FR 10,957, 10,957 (1987) (serving registrant’s wife with OSC at their residence was sufficient notice to registrant). I also find that more than thirty days have now passed since the Government accomplished service of the OSC. Further, based on the Government’s written representations and my review of the record, I find that neither Registrant, nor anyone purporting to represent Registrant, requested a hearing, submitted a written statement while waiving Registrant’s right to a hearing, or submitted a corrective action plan. Accordingly, I find that Registrant has waived the right to a hearing and the right to submit a written statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.43(e). Findings of Fact Registrant’s DEA Registration Registrant is the holder of DEA Certificate of Registration No. BW0913132 at the registered address of Dept. of Surgery-Vascular-MGH, 15 Parkman Street, ACC 440, Boston, MA 02114. RFAA, EX 1 (Certification of Registration Status for DEA No. BW0913132 dated December 4, 2019), at 1. Pursuant to this registration, Registrant is authorized to dispense controlled substances in schedules II E:\FR\FM\07MYN1.SGM 07MYN1

Agencies

[Federal Register Volume 85, Number 89 (Thursday, May 7, 2020)]
[Notices]
[Pages 27245-27246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09705]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-638]


Importer of Controlled Substances Application: Novitium Pharma 
LLC

ACTION: Notice of application.

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DATES: 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,

[[Page 27246]]

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 March 2, 2020, Novitium Pharma LLC, 70 Lake Drive, 
East Windsor, New Jersey 08520, applied to be registered as an importer 
of the following basic class(es) of controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Lisdexamfetamine.....................       1205   II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance as a 
raw material for drug product development and research.
    The company may import Active Pharmaceutical Ingredients (API) for 
research purposes only but not for the manufacturing of Food and Drug 
Administration-approved products. Approval of permit applications will 
occur only when the registrant's activity is consistent with what is 
authorized under 21 U.S.C. 952(a)(2).

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-09705 Filed 5-6-20; 8:45 am]
 BILLING CODE 4410-09-P