Manufacturer of Controlled Substances; Notice of Registration, 44359 [2011-18751]
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Federal Register / Vol. 76, No. 142 / Monday, July 25, 2011 / Notices
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.
Dated: July 19, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–18750 Filed 7–22–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
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By Notice dated April 11, 2011, and
published in the Federal Register on
April 19, 2011, 76 FR 21916,
Mallinckrodt Inc., 3600 North Second
Street, St. Louis, Missouri 63147, made
application by letter to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
4–Anilino-N-Phenethyl-4-Piperidine
(8333), a basic class of controlled
substance listed in schedule II.
The company plans to use this
controlled substance in the manufacture
of another controlled substance.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Mallinckrodt, Inc., to manufacture the
listed basic class of controlled substance
is consistent with the public interest at
this time. DEA has investigated
Mallinckrodt, Inc., to ensure that the
company’s registration is consistent
with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 823,
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic class of controlled substance
listed.
Dated: July 19, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–18751 Filed 7–22–11; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09–51]
Paul Weir Battershell, N.P.;
Suspension Of Registration
On May 8, 2009, the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Paul Weir Battershell,
N.P. (‘‘Respondent’’), of Caldwell and
Meridian, Idaho. The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificates of
Registration MB1090670 (for his
Caldwell registered location) and
MB1294711 (for his Meridian registered
location), and the denial of any pending
applications to renew or modify either
registration, on the ground that his
‘‘continued registration is inconsistent
with the public interest, as that term is
defined in 21 U.S.C. § 823(f).’’ ALJ Ex.
1, at 1.
The Show Cause Order specifically
alleged that from ‘‘July 2005 through at
least August 2006,’’ Respondent
‘‘prescribed and dispensed Human
Growth Hormone and controlled
substances, including anabolic steroids,
to individuals for no legitimate medical
purpose and outside the course of
professional practice’’ in violation of 21
U.S.C. §§ 333(e) and 841(a)(1), as well as
21 CFR 1306.04(a). Id. at 1.
The Order further alleged that from
September 2005 through August 2006,
Respondent ‘‘failed to maintain proper
security over [his] controlled substances
by not maintaining a proper key control
system, failing to maintain adequate
supervision over fellow employees who
handle[d] [his] controlled substances
and failing to monitor the distribution of
[his] controlled substances in violation
of 21 CFR 1301.71.’’ Id. The Order also
alleged that ‘‘[i]n August 2005,’’
Respondent ‘‘failed to record the
transfer of another practitioner’s
controlled substances into [his]
inventory, when that practitioner left
the clinic where [Respondent] was
employed,’’ id. at 2 (citing 21 U.S.C.
§ 827(a)(3) and 21 CFR 1304.21); that
‘‘[i]n November and December 2005,’’
he ‘‘failed to keep records of controlled
substances [he] received, specifically
Phentermine 30 mg’’; and that ‘‘during
calendar year 2005,’’ Respondent further
‘‘failed to properly record the date on
[his] dispensing records.’’ Id. (citing 21
U.S.C. § 827(a)(3) and 21 CFR 1304.21 &
1304.22).
Finally, the Show Cause Order alleged
that ‘‘[d]uring 2005 and 2006,’’
Respondent ‘‘accepted controlled
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44359
substances from non-DEA registered
sources (patients) in violation of 21
U.S.C. § 844(a) and redistributed those
illicitly obtained controlled substances
to other patients in violation of 21
U.S.C. § 841(a)(1).’’ Id.
On June 5, 2009, counsel for
Respondent timely requested a hearing,
and the matter was placed on the docket
of the Agency’s Administrative Law
Judges (ALJs). ALJ Ex. 2. Following prehearing procedures, an ALJ conducted a
hearing in Boise, Idaho on December 1–
2, 2009. At the hearing, both parties
called witnesses to testify and
introduced documentary evidence.
Following the hearing, both parties
submitted post-hearing briefs.
On April 9, 2010, the ALJ issued her
Recommended Decision (also ALJ).
Therein, the ALJ, after considering the
five public interest factors, see 21 U.S.C.
§ 823(f), recommended that Respondent
be granted a restricted registration and
be admonished.
As to the first factor—the
recommendation of the appropriate state
licensing board—the ALJ found that
while the Idaho Board of Pharmacy
(Board) had previously placed
Respondent on probation, there was ‘‘no
pending action[] against’’ him and ‘‘the
Board has made no recommendations
with regards to his registration.’’ ALJ at
34. As to the second factor—
Respondent’s experience in dispensing
controlled substances—the ALJ found
that ‘‘Respondent’s actions as well as
his own statements suggest that at the
time of these infractions in 2006,
[Respondent] was inexperienced, or at
least unaware of numerous regulations
relating to the security and inventory
requirements for controlled substances
under the [Controlled Substances Act].’’
Id. at 34–35. She further found that
while Respondent claimed that he had
‘‘sought guidance but did not receive it
* * * in some instances, when [he] did
receive such guidance, he was still
unable to follow it.’’ Id. at 35. The ALJ
thus concluded that ‘‘the record
demonstrates that [Respondent’s] past
practices demonstrate a lack of
knowledgeable experience in handling
controlled substances.’’ Id.
As to factor three—Respondent’s
conviction record for offenses related to
the distribution or dispensing of
controlled substances—the ALJ found
that the ‘‘record contains no evidence of
any convictions related to the handling
of controlled substances.’’ Id. The ALJ
thus concluded that ‘‘this factor does
not fall in favor of revocation.’’ Id.
With respect to the fourth factor—
Respondent’s compliance with
applicable State, Federal or local laws
related to controlled substances—the
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[Federal Register Volume 76, Number 142 (Monday, July 25, 2011)]
[Notices]
[Page 44359]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18751]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated April 11, 2011, and published in the Federal
Register on April 19, 2011, 76 FR 21916, Mallinckrodt Inc., 3600 North
Second Street, St. Louis, Missouri 63147, made application by letter to
the Drug Enforcement Administration (DEA) to be registered as a bulk
manufacturer of 4-Anilino-N-Phenethyl-4-Piperidine (8333), a basic
class of controlled substance listed in schedule II.
The company plans to use this controlled substance in the
manufacture of another controlled substance.
No comments or objections have been received. DEA has considered
the factors in 21 U.S.C. 823(a) and determined that the registration of
Mallinckrodt, Inc., to manufacture the listed basic class of controlled
substance is consistent with the public interest at this time. DEA has
investigated Mallinckrodt, Inc., to ensure that the company's
registration is consistent with the public interest. The investigation
has included inspection and testing of the company's physical security
systems, verification of the company's compliance with state and local
laws, and a review of the company's background and history. Therefore,
pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the
above named company is granted registration as a bulk manufacturer of
the basic class of controlled substance listed.
Dated: July 19, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2011-18751 Filed 7-22-11; 8:45 am]
BILLING CODE 4410-09-P
