80 FR 46323 - Manufacturer of Controlled Substances Registration: Sigma Aldrich Research Biochemicals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 149 (August 4, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 149 (August 4, 2015)
| Page Range | 46323-46324 | |
| FR Document | 2015-19166 |
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)] [Notices] [Pages 46323-46324] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19166] ----------------------------------------------------------------------- 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
![Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices 46323
Respondent is without authority to maintains her DEA registration.2 of certain duration, the practitioner no
prescribe, administer, or dispense Pursuant to 21 U.S.C. 823(f), only a longer meets the statutory definition of
controlled substances in the State of ‘‘practitioner’’ may receive a DEA a practitioner.’’ 6 In this case,
Illinois. In its Exhibit One attachment, registration. Under 21 U.S.C. 802(21), a Respondent’s state controlled substance
the Government provided evidence that ‘‘practitioner’’ must be ‘‘licensed, registration has been suspended for an
the State of Illinois, the jurisdiction registered, or otherwise permitted, by indefinite duration. As detailed above,
where she is licensed to practice the United States or the jurisdiction in only a ‘‘practitioner’’ may receive a DEA
medicine and where Respondent is which he practices or does research, to registration. Therefore, I will
registered with the DEA, considers her distribute [or] dispense . . . controlled recommend the revocation of
license ‘‘Not Renewed’’ with an substance[s.]’’ Given this statutory Respondent’s DEA registration.
expiration date of July 31, 2014. language, the DEA Administrator does
Additionally, the Government in its not have the authority under the Order Granting the Government’s
Exhibit Two attachment provided a Controlled Substances Act to maintain a Motion for Summary Disposition and
sworn declaration of Laura Forester, practitioner’s registration if that Recommendation
Chief of Medical Prosecutions for the practitioner is not authorized to I find there is no genuine dispute
Illinois Department of Financial and dispense controlled substances.3 regarding whether Respondent is a
Professional Regulation, stating that Respondent correctly argues in her ‘‘practitioner’’ as that term is defined by
Respondent is not currently authorized response that a final disposition has not 21 U.S.C. 802(21), and that based on the
under Illinois law to handle controlled been made regarding her controlled record the Government has established
substances. Based on this status, the substance registration in Illinois’s that Respondent is not a practitioner
Government moved for a summary administrative proceedings. However, and is not authorized to dispense
disposition of these proceedings as well Respondent mischaracterizes the controlled substances in the state in
as a stay of these proceedings pending Government’s Motion for Summary which she seeks to practice with a DEA
resolution of its Motion for Summary Disposition when alleging that the Certificate of Registration. I find no
Disposition. Finding good cause was Government is arguing that a final other material facts at issue.
shown, I granted an Order Staying disposition had occurred. The Accordingly, I GRANT the
Proceedings with the exception of the Government is only arguing that Government’s Motion for Summary
March 24, 2015 deadline for Respondent is currently without Disposition.
Respondent’s response to the authority to handle controlled Upon this finding, I ORDER that this
Government’s Motion for Summary substances in Illinois. To emphasize this case be forwarded to the Administrator
Disposition. point, the Government cites to the case for final disposition and I recommended
Respondent filed a timely response to of Roger A. Rodriguez, M.D. to that Respondent’s DEA Certificate of
the Government’s Motion for Summary demonstrate that even a temporary Registration should be REVOKED and
Disposition on March 24, 2015. In her suspension warrants revocation.4 As any pending application for the renewal
response, Respondent states that her DEA Administrator Michele M. or modification of the same should be
Illinois State medical license case is Leonhart previously stated in James L. DENIED.
pending appeal and is therefore not a Hooper, M.D., ‘‘the controlling question
Dated: March 25, 2015
final disposition. Respondent further is not whether a practitioner’s license to
attached an affidavit affirming that she practice medicine in the state is Christopher B. McNeil,
has a case pending before the Illinois suspended or revoked; rather, it is Administrative Law Judge.
Administrative Law Court that is whether the Respondent is currently [FR Doc. 2015–19122 Filed 8–3–15; 8:45 am]
pending appeal. She also attached authorized to handle controlled BILLING CODE 4410–09–P
‘‘Exhibit B’’ containing a statement from substances in the state.’’ 5 In Hooper,
Lillian Walanka, who is representing Administrator Leonhart concluded that
Respondent before the Illinois ‘‘even where a practitioner’s state DEPARTMENT OF JUSTICE
Administrative Law Court. Ms. Walanka license has been suspended for a period
again confirms that the case is pending Drug Enforcement Administration
final action by Illinois authorities. Ms. 2 See 21 U.S.C. 801(21), 823(f), 824(a)(3); see also [Docket No. DEA–392]
Walanka states that although House of Medicine, 79 FR 4959, 4961 (DEA Jan. 30,
2014); Deanwood Pharmacy, 68 FR 41662–01 (DEA
Respondent filed a timely renewal July 14, 2003); Wayne D. Longmore, M.D., 77 FR Manufacturer of Controlled
application of her controlled substances 67669–02 (DEA Nov. 13, 2012); Alan H. Olefsky, Substances Registration: Sigma
license, her controlled substances M.D., 72 FR 42127–01 (DEA Aug. 1, 2007); Layfe Aldrich Research Biochemicals, Inc.
license was not renewed pending a Robert Anthony, M.D., 67 FR 15811 (DEA May 20,
2002); George Thomas, PA–C, 64 FR 15811–02 ACTION: Notice of registration.
Notice of Intent to Refuse to Renew by (DEA Apr. 1, 1999); Shahid Musud Siddiqui, M.D.,
authorities in Illinois. 61 FR 14818–02 (DEA April 4, 1996); Michael D.
The substantial issue raised by the Lawton, M.D., 59 FR 17792–01 (DEA Apr. 14, 1994);
SUMMARY: Sigma Aldrich Research
Government rests on an undisputed fact. Abraham A. Chaplan, M.D., 57 FR 55280–03 (DEA Biochemicals, Inc. applied to be
The Government asserts that
Nov. 24, 1992). See also Bio Diagnosis Int’l, 78 FR registered as a manufacturer of certain
39327–03, 39331 (DEA July 1, 2013) (distinguishing basic classes of controlled substances.
Respondent’s DEA Certificate of distributor applicants from other ‘‘practitioners’’ in
Registration must be revoked because the context of summary disposition analysis). The Drug Enforcement Administration
Respondent does not have an active 3 See Abraham A. Chaplan, M.D., 57 FR 55280– (DEA) grants Sigma Aldrich Research
controlled substance registration issued 03, 55280 (DEA Nov. 24, 1992), and cases cited Biochemicals, Inc. registration as a
therein. In Chaplan, DEA Administrator Robert C. manufacturer of those controlled
tkelley on DSK3SPTVN1PROD with NOTICES
by the state in which she practices. Bonner adopts the ALJ’s opinion that ‘‘the DEA
Under DEA precedent, a practitioner’s lacks statutory power to register a practitioner
substances.
DEA Certificate of Registration for unless the practitioner holds state authority to SUPPLEMENTARY INFORMATION: By notice
handle controlled substances.’’ Id.
controlled substances must be 4 Roger A. Rodriguez, M.D., 70 FR 33206, 33,207
dated April 14, 2015, and published in
summarily revoked if the applicant is (DEA June 7, 2005). the Federal Register on April 22, 2015,
not authorized to handle controlled 5 James L. Hooper, M.D.; Decision and Order, 76
substances in the state in which she FR 71371–01, 71371 (DEA Nov. 17, 2011). 6 Id. at 71372.
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![46324 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
80 FR 22557, Sigma Aldrich Research Research Biochemicals, Inc. to company’s compliance with state and
Biochemicals, Inc., 1–3 Strathmore manufacture the basic classes of local laws, and reviewing the company’s
Road, Natick, Massachusetts 01760– controlled substances is consistent with background and history.
2447 applied to be registered as a the public interest and with United Therefore, pursuant to 21 U.S.C.
manufacturer of certain basic classes of States obligations under international
823(a), and in accordance with 21 CFR
controlled substances. No comments or treaties, conventions, or protocols in
1301.33, the above-named company is
objections were submitted for this effect on May 1, 1971. The DEA
investigated the company’s maintenance granted registration as a bulk
notice.
The DEA has considered the factors in of effective controls against diversion by manufacturer of the basic classes of
21 U.S.C. 823(a) and determined that inspecting and testing the company’s controlled substances listed:
the registration of Sigma Aldrich physical security systems, verifying the
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) (7540) ....................................................................................................................... I
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 DEPARTMENT OF JUSTICE filed exceptions to the Recommended
reference standards. Decision.
Drug Enforcement Administration
Dated: July 29, 2015. Having reviewed the record in its
Joseph T. Rannazzisi, entirety, I adopt the CALJ’s findings of
[Docket No. 15–16] fact,1 conclusions of law, and
Deputy Assistant Administrator.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2015–19166 Filed 8–3–15; 8:45 am] Pedro E. Lopez, M.D.; Decision and 1 I take official notice of the fact that, according
BILLING CODE P Order
to the registration records of the Agency,
Respondent retains an active registration as of this
On March 20, 2015, Chief date. Pursuant to 21 CFR 1316.59(e), Respondent
Administrative Law Judge (CALJ) John J. may controvert this finding by filing a properly
Mulrooney, II, issued the attached supported motion, no later than 10 days from the
Recommended Decision. Neither party date of this Order.
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Document Created: 2015-12-18 14:51:34
Document Modified: 2015-12-18 14:51:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of registration. | |
| FR Citation | 80 FR 46323 |
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