Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA, LLC, 80159 [2020-27240]

Download as PDF 80159 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices substance within this State . . . shall obtain a registration issued by the division in accordance with rules and regulations promulgated by it.’’). New Jersey statute defines ‘‘practitioner’’ as a ‘‘physician.’’ N.J. Stat. Ann. § 24:21–2 (West, current with laws through L. 2020, c. 109 and J.R. No. 2). It defines ‘‘physician’’ as ‘‘a physician authorized by law to practice medicine in this or any other state.’’ Id. Here, the weight of the evidence in the record is that Registrant’s license to practice medicine is currently suspended and that her CDS registration is inactive. In New Jersey, as already discussed, a ‘‘practitioner’’ must be a physician authorized by law to practice medicine. Id. As such, she is not a ‘‘physician’’ or a ‘‘practitioner’’ as New Jersey statute defines those terms. Id. Thus, since Registrant lacks authority to practice medicine in New Jersey and does not have an active New Jersey CDS registration, she is not eligible to dispense controlled substances in that state. N.J. Stat. Ann. § 24:21–11(c). As such, based on the overwhelming record evidence and the law in New Jersey, I find that Registrant is not authorized to dispense controlled substances in New Jersey. 21 U.S.C. 824(a)(3). 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. FN5040136 issued to Anindita Nandi, M.D. This Order is effective January 11, 2021. In accordance with 21 CFR 1301.33(a), this is notice that on August 24, 2020, Sterling Pharma USA, LLC, 1001 Sheldon Drive, Suite 101, Cary, North Carolina 27513–2079, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Tetrahydrocannabinols .. Drug code 7370 Schedule I The company plans to manufacture in bulk drug code 7370 (Tetrahydrocannabinols) exclusively from hemp extract, for distribution and sale to its customers. No other activities for this drug code is authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2020–27240 Filed 12–10–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Timothy J. Shea, Acting Administrator. Drug Enforcement Administration [FR Doc. 2020–27235 Filed 12–10–20; 8:45 am] BILLING CODE 4410–09–P [Docket No. DEA–752] Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc. [Docket No. DEA–748] AGENCY: DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. ACTION: Notice of application. Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA, LLC Sterling Pharma USA, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and SUMMARY: VerDate Sep<11>2014 00:32 Dec 11, 2020 Jkt 253001 Johnson Matthey, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental 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 February 9, 2021. Such persons may also file a written request SUMMARY: Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: jbell on DSKJLSW7X2PROD with NOTICES applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before February 9, 2021. Such persons may also file a written request for a hearing on the application on or before February 9, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. PO 00000 Frm 00170 Fmt 4703 Sfmt 4703 for a hearing on the application on or before February 9, 2021. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on November 2, 2020, Johnson Matthey, Inc., 2003 Nolte Drive West Deptford, New Jersey 08066–1742, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Gamma Hydroxybutyric Acid. Marihuana ...................... Tetrahydrocannabinols .. Dihyromorphine ............. Difenoxin ........................ Amphetamine ................ Methamphetamine ......... Lisdexamfetamine ......... Methylphenidate ............ Nabilone ........................ Norfentanyl .................... Cocaine ......................... Codeine ......................... Dihydrocodeine .............. Oxycodone .................... Hydromorphone ............. Diphenoxylate ................ Ecgonine ........................ Hydrocodone ................. Levorphanol ................... Meperidine ..................... Methadone ..................... Methadone intermediate Morphine ........................ Thebaine ........................ Opium tincture ............... Oxymorphone ................ Noroxymorphone ........... Alfentanil ........................ Remifentanil ................... Sufentanil ....................... Tapentadol ..................... Fentanyl ......................... Drug code Schedule 2010 I 7360 7370 9145 9168 1100 1105 1205 1724 7379 8366 9041 9050 9120 9143 9150 9170 9180 9193 9220 9230 9250 9254 9300 9333 9630 9652 9668 9737 9739 9740 9780 9801 I I I I II II II II II II II II II II II II II II II II II II II II II 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. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2020–27241 Filed 12–10–20; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Page 80159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27240]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-748]


Bulk Manufacturer of Controlled Substances Application: Sterling 
Pharma USA, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Sterling Pharma USA, LLC has applied to be registered as a 
bulk manufacturer of basic class(es) of controlled substance(s). Refer 
to Supplemental 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 February 9, 
2021. Such persons may also file a written request for a hearing on the 
application on or before February 9, 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 August 24, 2020, Sterling Pharma USA, LLC, 1001 
Sheldon Drive, Suite 101, Cary, North Carolina 27513-2079, applied to 
be registered as a bulk manufacturer of the following basic class(es) 
of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols..................     7370  I
------------------------------------------------------------------------

    The company plans to manufacture in bulk drug code 7370 
(Tetrahydrocannabinols) exclusively from hemp extract, for distribution 
and sale to its customers. No other activities for this drug code is 
authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-27240 Filed 12-10-20; 8:45 am]
BILLING CODE 4410-09-P