Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia, LLC, 32284 [2021-12812]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 32284 Federal Register / Vol. 86, No. 115 / Thursday, June 17, 2021 / Notices 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, the DEA has held repeatedly that revocation of a practitioner’s registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the state in which he practices. See, e.g., James L. Hooper, 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, 43 FR at 27,617. Under Nebraska law, ‘‘[d]ispense means to deliver a controlled substance to an ultimate user or a research subject pursuant to a medical order issued by a practitioner authorized to prescribe, including the packaging, labeling, or compounding necessary to prepare the controlled substance for such delivery.’’ Neb. Rev. Stat. § 28–401(8) (Westlaw, Current through legislation effective May 6, 2021). Further, ‘‘[p]ractitioner means a physician . . . or any other person licensed, registered, or otherwise permitted to distribute, dispense, prescribe, conduct research with respect to, or administer a controlled substance in the course of practice or research in this state . . . .’’ Id. at § 28–401(21). Because Registrant is not currently licensed as a physician, or otherwise licensed, in Nebraska, he is not authorized to dispense controlled substances in Nebraska. Here, the undisputed evidence in the record is that Registrant currently lacks authority to practice medicine in Nebraska. As already discussed, a physician must be a licensed practitioner to dispense a controlled substance in Nebraska. Thus, because Registrant lacks authority to practice medicine in Nebraska and, therefore, is VerDate Sep<11>2014 18:41 Jun 16, 2021 Jkt 253001 not authorized to handle controlled substances in Nebraska, Registrant is not 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. FK4149882 issued to Tareq A. Khedir Al-Tiae, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending application of Tareq A. Khedir Al-Tiae, M.D., to renew or modify this registration, as well as any other pending application of Tareq A. Khedir Al-Tiae M.D., for additional registration in Nebraska. This Order is effective July 19, 2021. D. Christopher Evans, Acting Administrator. [FR Doc. 2021–12755 Filed 6–16–21; 8:45 am] BILLING CODE 4410–09–P North Normandy Drive, Petersburg, Virginia 23805–2380, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Methylphenidate ........... Levomethorphan ........... Levorphanol .................. Morphine ....................... Thebaine ....................... Noroxymorphone .......... Tapentadol .................... Drug code 1724 9210 9220 9300 9333 9668 9780 Schedule II II II II II II II The company plans to bulk manufacture the listed controlled substances for the internal use intermediates or for sale to its customers. The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. No other activities for these drug codes are authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2021–12812 Filed 6–16–21; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE P Drug Enforcement Administration NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Docket No. DEA–852] Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Notice of Intent To Grant an Exclusive, Co-Exclusive or Partially Exclusive Patent License National Aeronautics and Space Administration. ACTION: Notice of intent to grant exclusive, co-exclusive or partially exclusive patent license. AGENCY: AMPAC Fine Chemicals Virginia, LLC. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. 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 August 16, 2021. Such persons may also file a written request for a hearing on the application on or before August 16, 2021. 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 May 5, 2021, AMPAC Fine Chemicals Virginia, LLC., 2820 SUMMARY: [Notice: (21–035)] NASA hereby gives notice of its intent to grant an exclusive, coexclusive or partially exclusive patent license to practice the inventions described and claimed in the patents and/or patent applications listed in SUPPLEMENTARY INFORMATION below. DATES: The prospective exclusive, coexclusive or partially exclusive license may be granted unless NASA receives written objections including evidence and argument, no later than July 2, 2021 that establish that the grant of the license would not be consistent with the requirements regarding the licensing of federally owned inventions as set forth in the Bayh-Dole Act and implementing regulations. Competing applications completed and received by NASA no later than July 2, 2021 will also be treated as objections to the grant of the contemplated exclusive, co-exclusive or SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 86, Number 115 (Thursday, June 17, 2021)]
[Notices]
[Page 32284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12812]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-852]


Bulk Manufacturer of Controlled Substances Application: AMPAC 
Fine Chemicals Virginia, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: AMPAC Fine Chemicals Virginia, LLC. has applied to be 
registered as a bulk manufacturer of basic class(es) of controlled 
substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for 
further drug information.

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 August 16, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before August 16, 2021.

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 May 5, 2021, AMPAC Fine Chemicals Virginia, LLC., 
2820 North Normandy Drive, Petersburg, Virginia 23805-2380, applied to 
be registered as a bulk manufacturer of the following basic class(es) 
of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Methylphenidate........................     1724  II
Levomethorphan.........................     9210  II
Levorphanol............................     9220  II
Morphine...............................     9300  II
Thebaine...............................     9333  II
Noroxymorphone.........................     9668  II
Tapentadol.............................     9780  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for the internal use intermediates or for sale to its 
customers. The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers. No other 
activities for these drug codes are authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-12812 Filed 6-16-21; 8:45 am]
BILLING CODE P
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