Manufacturer of Controlled Substances Registration: Sigma Aldrich Research Biochemicals, Inc., 46323-46324 [2015-19166]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices Respondent is without authority to prescribe, administer, or dispense controlled substances in the State of Illinois. In its Exhibit One attachment, the Government provided evidence that the State of Illinois, the jurisdiction where she is licensed to practice medicine and where Respondent is registered with the DEA, considers her license ‘‘Not Renewed’’ with an expiration date of July 31, 2014. Additionally, the Government in its Exhibit Two attachment provided a sworn declaration of Laura Forester, Chief of Medical Prosecutions for the Illinois Department of Financial and Professional Regulation, stating that Respondent is not currently authorized under Illinois law to handle controlled substances. Based on this status, the Government moved for a summary disposition of these proceedings as well as a stay of these proceedings pending resolution of its Motion for Summary Disposition. Finding good cause was shown, I granted an Order Staying Proceedings with the exception of the March 24, 2015 deadline for Respondent’s response to the Government’s Motion for Summary Disposition. Respondent filed a timely response to the Government’s Motion for Summary Disposition on March 24, 2015. In her response, Respondent states that her Illinois State medical license case is pending appeal and is therefore not a final disposition. Respondent further attached an affidavit affirming that she has a case pending before the Illinois Administrative Law Court that is pending appeal. She also attached ‘‘Exhibit B’’ containing a statement from Lillian Walanka, who is representing Respondent before the Illinois Administrative Law Court. Ms. Walanka again confirms that the case is pending final action by Illinois authorities. Ms. Walanka states that although Respondent filed a timely renewal application of her controlled substances license, her controlled substances license was not renewed pending a Notice of Intent to Refuse to Renew by authorities in Illinois. The substantial issue raised by the Government rests on an undisputed fact. The Government asserts that Respondent’s DEA Certificate of Registration must be revoked because Respondent does not have an active controlled substance registration issued by the state in which she practices. Under DEA precedent, a practitioner’s DEA Certificate of Registration for controlled substances must be summarily revoked if the applicant is not authorized to handle controlled substances in the state in which she VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 maintains her DEA registration.2 Pursuant to 21 U.S.C. 823(f), only a ‘‘practitioner’’ may receive a DEA registration. Under 21 U.S.C. 802(21), a ‘‘practitioner’’ must be ‘‘licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute [or] dispense . . . controlled substance[s.]’’ Given this statutory language, the DEA Administrator does not have the authority under the Controlled Substances Act to maintain a practitioner’s registration if that practitioner is not authorized to dispense controlled substances.3 Respondent correctly argues in her response that a final disposition has not been made regarding her controlled substance registration in Illinois’s administrative proceedings. However, Respondent mischaracterizes the Government’s Motion for Summary Disposition when alleging that the Government is arguing that a final disposition had occurred. The Government is only arguing that Respondent is currently without authority to handle controlled substances in Illinois. To emphasize this point, the Government cites to the case of Roger A. Rodriguez, M.D. to demonstrate that even a temporary suspension warrants revocation.4 As DEA Administrator Michele M. Leonhart previously stated in James L. Hooper, M.D., ‘‘the controlling question is not whether a practitioner’s license to practice medicine in the state is suspended or revoked; rather, it is whether the Respondent is currently authorized to handle controlled substances in the state.’’ 5 In Hooper, Administrator Leonhart concluded that ‘‘even where a practitioner’s state license has been suspended for a period 2 See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also House of Medicine, 79 FR 4959, 4961 (DEA Jan. 30, 2014); Deanwood Pharmacy, 68 FR 41662–01 (DEA July 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669–02 (DEA Nov. 13, 2012); Alan H. Olefsky, M.D., 72 FR 42127–01 (DEA Aug. 1, 2007); Layfe Robert Anthony, M.D., 67 FR 15811 (DEA May 20, 2002); George Thomas, PA–C, 64 FR 15811–02 (DEA Apr. 1, 1999); Shahid Musud Siddiqui, M.D., 61 FR 14818–02 (DEA April 4, 1996); Michael D. Lawton, M.D., 59 FR 17792–01 (DEA Apr. 14, 1994); Abraham A. Chaplan, M.D., 57 FR 55280–03 (DEA Nov. 24, 1992). See also Bio Diagnosis Int’l, 78 FR 39327–03, 39331 (DEA July 1, 2013) (distinguishing distributor applicants from other ‘‘practitioners’’ in the context of summary disposition analysis). 3 See Abraham A. Chaplan, M.D., 57 FR 55280– 03, 55280 (DEA Nov. 24, 1992), and cases cited therein. In Chaplan, DEA Administrator Robert C. Bonner adopts the ALJ’s opinion that ‘‘the DEA lacks statutory power to register a practitioner unless the practitioner holds state authority to handle controlled substances.’’ Id. 4 Roger A. Rodriguez, M.D., 70 FR 33206, 33,207 (DEA June 7, 2005). 5 James L. Hooper, M.D.; Decision and Order, 76 FR 71371–01, 71371 (DEA Nov. 17, 2011). PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 46323 of certain duration, the practitioner no longer meets the statutory definition of a practitioner.’’ 6 In this case, Respondent’s state controlled substance registration has been suspended for an indefinite duration. As detailed above, only a ‘‘practitioner’’ may receive a DEA registration. Therefore, I will recommend the revocation of Respondent’s DEA registration. Order Granting the Government’s Motion for Summary Disposition and Recommendation I find there is no genuine dispute regarding whether Respondent is a ‘‘practitioner’’ as that term is defined by 21 U.S.C. 802(21), and that based on the record the Government has established that Respondent is not a practitioner and is not authorized to dispense controlled substances in the state in which she seeks to practice with a DEA Certificate of Registration. I find no other material facts at issue. Accordingly, I GRANT the Government’s Motion for Summary Disposition. Upon this finding, I ORDER that this case be forwarded to the Administrator for final disposition and I recommended that Respondent’s DEA Certificate of Registration should be REVOKED and any pending application for the renewal or modification of the same should be DENIED. Dated: March 25, 2015 Christopher B. McNeil, Administrative Law Judge. [FR Doc. 2015–19122 Filed 8–3–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Sigma Aldrich Research Biochemicals, Inc. ACTION: Notice of registration. Sigma Aldrich Research Biochemicals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Sigma Aldrich Research Biochemicals, Inc. registration as a manufacturer of those controlled substances. SUMMARY: By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, SUPPLEMENTARY INFORMATION: 6 Id. at 71372. E:\FR\FM\04AUN1.SGM 04AUN1 46324 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices 80 FR 22557, Sigma Aldrich Research Biochemicals, Inc., 1–3 Strathmore Road, Natick, Massachusetts 01760– 2447 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Sigma Aldrich Research Biochemicals, Inc. to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed: Controlled substance Schedule Cathinone (1235) ......................................................................................................................................................................................... Methcathinone (1237) .................................................................................................................................................................................. Mephedrone (4-Methyl-N-methylcathinone) (1248) .................................................................................................................................... Aminorex (1585) .......................................................................................................................................................................................... Alpha-ethyltryptamine (7249) ...................................................................................................................................................................... Lysergic acid diethylamide (7315) ............................................................................................................................................................... Tetrahydrocannabinols (7370) ..................................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (7391) .............................................................................................................................................. 4-Bromo-2,5-dimethoxyphenethylamine (7392) .......................................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine (7395) .............................................................................................................................................. 2,5-Dimethoxyamphetamine (7396) ............................................................................................................................................................ 3,4-Methylenedioxyamphetamine (7400) .................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine (7402) .................................................................................................................................. 3,4-Methylenedioxy-N-ethylamphetamine (7404) ........................................................................................................................................ 3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................ Dimethyltryptamine (7435) .......................................................................................................................................................................... Psilocybin (7437) ......................................................................................................................................................................................... 5-Methoxy-N,N-diisopropyltryptamine (7439) .............................................................................................................................................. 1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................... N-Benzylpiperazine (7493) .......................................................................................................................................................................... MDPV (3,4-Methylenedioxypyrovalerone) (7535) ....................................................................................................................................... Methylone (3,4-Methylenedioxy-N-methylcathinone) (7540) ....................................................................................................................... Heroin (9200) ............................................................................................................................................................................................... Normorphine (9313) .................................................................................................................................................................................... Amphetamine (1100) ................................................................................................................................................................................... Methamphetamine (1105) ........................................................................................................................................................................... Nabilone (7379) ........................................................................................................................................................................................... 1-Phenylcyclohexylamine (7460) ................................................................................................................................................................. Phencyclidine (7471) ................................................................................................................................................................................... Cocaine (9041) ............................................................................................................................................................................................ Codeine (9050) ............................................................................................................................................................................................ Ecgonine (9180) .......................................................................................................................................................................................... Levomethorphan (9210) .............................................................................................................................................................................. Levorphanol (9220) ..................................................................................................................................................................................... Meperidine (9230) ....................................................................................................................................................................................... Metazocine (9240) ....................................................................................................................................................................................... Methadone (9250) ....................................................................................................................................................................................... Morphine (9300) .......................................................................................................................................................................................... Thebaine (9333) .......................................................................................................................................................................................... Levo-alphacetylmethadol (9648) ................................................................................................................................................................. Remifentanil (9739) ..................................................................................................................................................................................... Sufentanil (9740) ......................................................................................................................................................................................... Carfentanil (9743) ........................................................................................................................................................................................ Fentanyl (9801) ........................................................................................................................................................................................... tkelley on DSK3SPTVN1PROD with NOTICES The company plans to manufacture reference standards. Dated: July 29, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 15–16] [FR Doc. 2015–19166 Filed 8–3–15; 8:45 am] BILLING CODE P Pedro E. Lopez, M.D.; Decision and Order On March 20, 2015, Chief Administrative Law Judge (CALJ) John J. Mulrooney, II, issued the attached Recommended Decision. Neither party VerDate Sep<11>2014 18:45 Aug 03, 2015 Jkt 235001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 I I I I I I I I I I I I I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II filed exceptions to the Recommended Decision. Having reviewed the record in its entirety, I adopt the CALJ’s findings of fact,1 conclusions of law, and 1 I take official notice of the fact that, according to the registration records of the Agency, Respondent retains an active registration as of this date. Pursuant to 21 CFR 1316.59(e), Respondent may controvert this finding by filing a properly supported motion, no later than 10 days from the date of this Order. E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46323-46324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19166]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Sigma Aldrich 
Research Biochemicals, Inc.

ACTION: Notice of registration.

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

SUMMARY: Sigma Aldrich Research Biochemicals, Inc. applied to be 
registered as a manufacturer of certain basic classes of controlled 
substances. The Drug Enforcement Administration (DEA) grants Sigma 
Aldrich Research Biochemicals, Inc. registration as a manufacturer of 
those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and 
published in the Federal Register on April 22, 2015,

[[Page 46324]]

80 FR 22557, Sigma Aldrich Research Biochemicals, Inc., 1-3 Strathmore 
Road, Natick, Massachusetts 01760-2447 applied to be registered as a 
manufacturer of certain basic classes of controlled substances. No 
comments or objections were submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Sigma Aldrich Research 
Biochemicals, Inc. to manufacture the basic classes of controlled 
substances is consistent with the public interest and with United 
States obligations under international treaties, conventions, or 
protocols in effect on May 1, 1971. The DEA investigated the company's 
maintenance of effective controls against diversion by inspecting and 
testing the company's physical security systems, verifying the 
company's compliance with state and local laws, and reviewing the 
company's background and history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the basic classes of controlled substances listed:

------------------------------------------------------------------------
               Controlled substance                       Schedule
------------------------------------------------------------------------
Cathinone (1235).................................  I
Methcathinone (1237).............................  I
Mephedrone (4-Methyl-N-methylcathinone) (1248)...  I
Aminorex (1585)..................................  I
Alpha-ethyltryptamine (7249).....................  I
Lysergic acid diethylamide (7315)................  I
Tetrahydrocannabinols (7370).....................  I
4-Bromo-2,5-dimethoxyamphetamine (7391)..........  I
4-Bromo-2,5-dimethoxyphenethylamine (7392).......  I
4-Methyl-2,5-dimethoxyamphetamine (7395).........  I
2,5-Dimethoxyamphetamine (7396)..................  I
3,4-Methylenedioxyamphetamine (7400).............  I
N-Hydroxy-3,4-methylenedioxyamphetamine (7402)...  I
3,4-Methylenedioxy-N-ethylamphetamine (7404).....  I
3,4-Methylenedioxymethamphetamine (7405).........  I
Dimethyltryptamine (7435)........................  I
Psilocybin (7437)................................  I
5-Methoxy-N,N-diisopropyltryptamine (7439).......  I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470).....  I
N-Benzylpiperazine (7493)........................  I
MDPV (3,4-Methylenedioxypyrovalerone) (7535).....  I
Methylone (3,4-Methylenedioxy-N-methylcathinone)   I
 (7540).
Heroin (9200)....................................  I
Normorphine (9313)...............................  I
Amphetamine (1100)...............................  II
Methamphetamine (1105)...........................  II
Nabilone (7379)..................................  II
1-Phenylcyclohexylamine (7460)...................  II
Phencyclidine (7471).............................  II
Cocaine (9041)...................................  II
Codeine (9050)...................................  II
Ecgonine (9180)..................................  II
Levomethorphan (9210)............................  II
Levorphanol (9220)...............................  II
Meperidine (9230)................................  II
Metazocine (9240)................................  II
Methadone (9250).................................  II
Morphine (9300)..................................  II
Thebaine (9333)..................................  II
Levo-alphacetylmethadol (9648)...................  II
Remifentanil (9739)..............................  II
Sufentanil (9740)................................  II
Carfentanil (9743)...............................  II
Fentanyl (9801)..................................  II
------------------------------------------------------------------------

    The company plans to manufacture reference standards.

    Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19166 Filed 8-3-15; 8:45 am]
BILLING CODE P