Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC, 5992-5993 [2020-01960]

Download as PDF 5992 Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (hereinafter, CSA), ‘‘upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.’’ With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner’s registration. See, e.g., James L. Hooper, M.D., 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (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, M.D., 76 FR at 71371–72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby Watts, M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton, M.D., 43 FR at 27617. Under Michigan law, ‘‘a person who manufactures, distributes, prescribes, or dispenses a controlled substance in this state . . . shall obtain a license issued by the administrator.’’ Mich. Comp. Laws § 333.7303(1). Here, the 3 Registrant is also authorized as a Data-Waiver practitioner for up to 100 patients pursuant to 21 U.S.C. 823(g)(2)(a). 4 Under the Administrative Procedure Act, an agency ‘‘may take official notice of facts at any stage in a proceeding—even in the final decision.’’ United States Department of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.’’ Accordingly, Registrant may dispute my finding by filing a a practitioner.3 Registrant’s registration expires on June 30, 2020, and is ‘‘in an active pending status.’’ RFAA, EX 1 (Copy of Registrant’s Certificate of Registration). lotter on DSKBCFDHB2PROD with NOTICES The Status of Registrant’s State License On January 19, 2018, the Michigan Department of Licensing and Regulatory Affairs ‘‘executed an Order of Summary Suspension and an Administrative Complaint charging [Registrant] with violating the Public Health Code, [Mich. Comp. Laws] § 333.1101 et seq.’’ RFAA, EX 3 (Final Order of the Board of Pharmacy Disciplinary Subcommittee, Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory Affairs), at 1. On June 21, 2019, after an administrative hearing, the Michigan Board of Pharmacy issued a Final Order revoking Registrant’s controlled substance license and drug control-location licenses. Id. at 2, 4. The Final Order became effective thirty days from its signature, on July 21, 2019. RFAA, EX 3, at 4. According to Michigan’s online records, of which I take official notice,4 Registrant’s controlled substance license and drug control-location licenses remain revoked. https:// aca3.accela.com/MILARA/ GeneralProperty/PropertyLookUp.aspx (last visited January 3, 2020). Further, the Final Order states that reinstatement of Registrant’s revoked licenses ‘‘is not automatic and shall be in accordance with [Mich. Comp. Laws] §§ 333.7315–333.7316.’’ RFAA, EX 3, at 3. It is noted that pursuant to Section 333.7315, Registrant may not apply for reinstatement of his revoked licenses before the expiration of five years after the effective date of revocation. Mich. Comp. Laws § 333.7315. Accordingly, I find that Registrant currently does not possess a controlled substances license in Michigan, the State in which he is registered with the DEA. VerDate Sep<11>2014 16:47 Jan 31, 2020 Jkt 250001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 undisputed evidence in the record is that Registrant currently lacks authority to manufacture, distribute, prescribe, or dispense controlled substances in Michigan. Thus, because Registrant lacks authority to distribute, prescribe, or dispense controlled substances in Michigan, 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. FA7485027 issued to Solomon Adu-Beniako. This Order is effective March 4, 2020. Dated: January 3, 2020. Uttam Dhillon, Acting Administrator. [FR Doc. 2020–01971 Filed 1–31–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–578] Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 3, 2020. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: In accordance with 21 CFR 1301.33(a), this is notice that on November 27, 2019, IsoSciences, LLC, 340 Mathers Road, Ambler, Pennsylvania 19002–3420 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: properly supported motion for reconsideration within 15 calendar days of the date of this Order. Any such motion shall be filed with the Office of the Administrator and a copy shall be served on the Government. In the event Registrant files a motion, the Government shall have 15 calendar days to file a response. E:\FR\FM\03FEN1.SGM 03FEN1 5993 Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices Controlled substance Drug code lotter on DSKBCFDHB2PROD with NOTICES Cathinone ................................................................................................................................................................. Methcathinone ......................................................................................................................................................... Lysergic acid diethylamide ...................................................................................................................................... Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ 3,4-Methylenedioxyamphetamine ............................................................................................................................ 3,4-Methylenedioxy-N-ethylamphetamine ............................................................................................................... 3,4-Methylenedioxymethamphetamine .................................................................................................................... 5-Methoxy-N–N-dimethyltryptamine ........................................................................................................................ Alpha-methyltryptamine ........................................................................................................................................... Bufotenine ................................................................................................................................................................ Diethyltryptamine ..................................................................................................................................................... Dimethyltryptamine .................................................................................................................................................. Psilocybin ................................................................................................................................................................. Psilocyn .................................................................................................................................................................... 5-Methoxy-N,N-diisopropyltryptamine ...................................................................................................................... Dihydromorphine ...................................................................................................................................................... Heroin ...................................................................................................................................................................... Nicocodeine ............................................................................................................................................................. Nicomorphine ........................................................................................................................................................... Normorphine ............................................................................................................................................................ Thebacon ................................................................................................................................................................. Normethadone ......................................................................................................................................................... Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- ...................................................................................................... phenylacrylamide) .................................................................................................................................................... Para-Fluorofentanyl ................................................................................................................................................. 3-Methylfentanyl ....................................................................................................................................................... Alpha-methylfentanyl ............................................................................................................................................... Acetyl-alpha-methylfentanyl ..................................................................................................................................... N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide ............................................................................... Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N- ................................................................................................... phenylacetamide) ..................................................................................................................................................... Butyryl Fentanyl ....................................................................................................................................................... 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N- .................................................................................................. (1-phenethylpiperidin-4-yl)isobutyramide) ................................................................................................................ 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide ................................................................................. Beta-hydroxyfentanyl ............................................................................................................................................... Beta-hydroxy-3-methylfentanyl ................................................................................................................................ Alpha-methylthiofentanyl .......................................................................................................................................... 3-Methylthiofentanyl ................................................................................................................................................. Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran- .............................................................................. 2-carboxamide) ........................................................................................................................................................ Thiofentanyl ............................................................................................................................................................. Beta-hydroxythiofentanyl ......................................................................................................................................... N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2- ....................................................................................... carboxamide ............................................................................................................................................................ Amphetamine ........................................................................................................................................................... Methamphetamine ................................................................................................................................................... Codeine .................................................................................................................................................................... Dihydrocodeine ........................................................................................................................................................ Oxycodone ............................................................................................................................................................... Hydromorphone ....................................................................................................................................................... Hydrocodone ............................................................................................................................................................ Isomethadone .......................................................................................................................................................... Methadone ............................................................................................................................................................... Methadone intermediate .......................................................................................................................................... Morphine .................................................................................................................................................................. Thebaine .................................................................................................................................................................. Levo-alphacetylmethadol ......................................................................................................................................... Oxymorphone .......................................................................................................................................................... Thiafentanil .............................................................................................................................................................. Alfentanil .................................................................................................................................................................. Sufentanil ................................................................................................................................................................. Carfentanil ................................................................................................................................................................ Fentanyl ................................................................................................................................................................... The company plans to manufacture bulk controlled substances for use in analytical testing. In reference to drug codes 7360 (marihuana) and 7370 (Tetrahydrocannabinols), the company VerDate Sep<11>2014 16:47 Jan 31, 2020 Jkt 250001 plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. PO 00000 Fmt 4703 Sfmt 9990 1235 1237 7315 7360 7370 7400 7404 7405 7431 7432 7433 7434 7435 7437 7438 7439 9145 9200 9309 9312 9313 9315 9635 I I I I I I I I I I I I I I I I I I I I I I I 9811 9812 9813 9814 9815 9816 I I I I I I 9821 9822 I I 9824 9825 9830 9831 9832 9833 I I I I I I 9834 9835 9836 I I I 9843 1100 1105 9050 9120 9143 9150 9193 9226 9250 9254 9300 9333 9648 9652 9729 9737 9740 9743 9801 I II II II II II II II II II II II II II II II II II II II Dated: January 24, 2020. William T. McDermott, Assistant Administrator. [FR Doc. 2020–01960 Filed 1–31–20; 8:45 am] BILLING CODE 4410–09–P Frm 00067 Schedule E:\FR\FM\03FEN1.SGM 03FEN1

Agencies

[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
[Notices]
[Pages 5992-5993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01960]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-578]


Bulk Manufacturer of Controlled Substances Application: 
IsoSciences, LLC

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before April 3, 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 November 27, 2019, IsoSciences, LLC, 340 Mathers 
Road, Ambler, Pennsylvania 19002-3420 applied to be registered as a 
bulk manufacturer of the following basic classes of controlled 
substances:

[[Page 5993]]



------------------------------------------------------------------------
          Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Cathinone...............................            1235               I
Methcathinone...........................            1237               I
Lysergic acid diethylamide..............            7315               I
Marihuana...............................            7360               I
Tetrahydrocannabinols...................            7370               I
3,4-Methylenedioxyamphetamine...........            7400               I
3,4-Methylenedioxy-N-ethylamphetamine...            7404               I
3,4-Methylenedioxymethamphetamine.......            7405               I
5-Methoxy-N-N-dimethyltryptamine........            7431               I
Alpha-methyltryptamine..................            7432               I
Bufotenine..............................            7433               I
Diethyltryptamine.......................            7434               I
Dimethyltryptamine......................            7435               I
Psilocybin..............................            7437               I
Psilocyn................................            7438               I
5-Methoxy-N,N-diisopropyltryptamine.....            7439               I
Dihydromorphine.........................            9145               I
Heroin..................................            9200               I
Nicocodeine.............................            9309               I
Nicomorphine............................            9312               I
Normorphine.............................            9313               I
Thebacon................................            9315               I
Normethadone............................            9635               I
Acryl fentanyl (N-(1-phenethylpiperidin-            9811               I
 4-yl)-N-...............................
phenylacrylamide).......................
Para-Fluorofentanyl.....................            9812               I
3-Methylfentanyl........................            9813               I
Alpha-methylfentanyl....................            9814               I
Acetyl-alpha-methylfentanyl.............            9815               I
N-(2-fluorophenyl)-N-(1-                            9816               I
 phenethylpiperidin-4-yl)propionamide...
Acetyl Fentanyl (N-(1-phenethylpiperidin-           9821               I
 4-yl)-N-...............................
phenylacetamide)........................
Butyryl Fentanyl........................            9822               I
4-Fluoroisobutyryl fentanyl (N-(4-                  9824               I
 fluorophenyl)-N-.......................
(1-phenethylpiperidin-4-
 yl)isobutyramide)......................
2-methoxy-N-(1-phenethylpiperidin-4-yl)-            9825               I
 N-phenylacetamide......................
Beta-hydroxyfentanyl....................            9830               I
Beta-hydroxy-3-methylfentanyl...........            9831               I
Alpha-methylthiofentanyl................            9832               I
3-Methylthiofentanyl....................            9833               I
Furanyl fentanyl (N-(1-                             9834               I
 phenethylpiperidin-4-yl)-N-phenylfuran-
2-carboxamide)..........................
Thiofentanyl............................            9835               I
Beta-hydroxythiofentanyl................            9836               I
N-(1-phenethylpiperidin-4-yl)-N-                    9843               I
 phenyltetrahydrofuran-2-...............
carboxamide.............................
Amphetamine.............................            1100              II
Methamphetamine.........................            1105              II
Codeine.................................            9050              II
Dihydrocodeine..........................            9120              II
Oxycodone...............................            9143              II
Hydromorphone...........................            9150              II
Hydrocodone.............................            9193              II
Isomethadone............................            9226              II
Methadone...............................            9250              II
Methadone intermediate..................            9254              II
Morphine................................            9300              II
Thebaine................................            9333              II
Levo-alphacetylmethadol.................            9648              II
Oxymorphone.............................            9652              II
Thiafentanil............................            9729              II
Alfentanil..............................            9737              II
Sufentanil..............................            9740              II
Carfentanil.............................            9743              II
Fentanyl................................            9801              II
------------------------------------------------------------------------

    The company plans to manufacture bulk controlled substances for use 
in analytical testing. In reference to drug codes 7360 (marihuana) and 
7370 (Tetrahydrocannabinols), the company plans to bulk manufacture 
these drugs as synthetics. No other activities for these drug codes are 
authorized for this registration.

    Dated: January 24, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-01960 Filed 1-31-20; 8:45 am]
 BILLING CODE 4410-09-P