Manufacturer of Controlled Substances Registration: Sigma Aldrich Research Biochemicals, Inc., 46323-46324 [2015-19166]
Download as PDF
<![CDATA[
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]
-----------------------------------------------------------------------
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
