Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC, 8245 [2016-03357]
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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
applicable state board had taken action
which rendered the practitioner without
state authority. See, e.g., Morgan, 78 FR
at 61973–74 (upholding ALJ’s granting
of government motion for summary
disposition based on physician’s loss of
state authority which occurred posthearing and holding that due process
did not require amending the show
cause order; motion for summary
disposition provided adequate notice);
Roy E. Berkowitz, 74 FR 36758, 36759–
60 (2009) (rejecting argument that
revocation based on loss of state
authority was improper based on board
action not alleged in the Show Cause
Order; ‘‘The rules governing DEA
hearings do not require the formality of
amending a show cause order to comply
with the evidence. The Government’s
failure to file an amended Show Cause
Order alleging that Respondent’s state
CDS license had expired does not
render the proceeding fundamentally
unfair.’’). See also Kamal Tiwari, et al.,
76 FR 71604 (2011); Silviu Ziscovici, 76
FR 71370 (2011); Deanwood Pharmacy,
68 FR 41662 (2003); Michael D. Jackson,
68 FR 24760; Robert P. Doughton, 65 FR
30614 (2000); Michael G. Dolin, 65 FR
5661 (2000).
Here, by virtue of my order directing
the parties to address the issues of: (1)
Whether Respondent currently
possesses authority to dispense
controlled substances, and (2) if
Respondent does not possess such
authority, what consequence attaches
for this proceeding, Respondent was
provided with a meaningful opportunity
to show that he retains his state
authority. Of consequence, Respondent
does not dispute that he no longer holds
authority to dispense controlled
substances under Michigan law, this
being the only material fact that must be
adjudicated in determining whether
Respondent’s registrations can be
revoked and his applications denied
under 21 U.S.C. 823(f) and 824(a)(3) as
well as the Agency’s precedent. That
there are no dispositive legal arguments
to preclude my reliance on this basis as
an additional ground to revoke
Respondent’s registrations and to deny
his applications is not the result of
constitutionally inadequate notice.
Rather, it is the result of the statute
itself, which makes the possession of
state authority mandatory for obtaining
and maintaining a registration and
renders irrelevant the issues of
acceptance of responsibility and the
adequacy of remedial measures.
Accordingly, I will order that
Respondent’s registrations be revoked
and that his pending applications be
denied.
VerDate Sep<11>2014
19:03 Feb 17, 2016
Jkt 238001
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a) and 28 CFR 0.100(b),
I order that DEA Certificates of
Registration BA7776353 and FA2278201
issued to Hatem M. Ataya, M.D., be, and
they hereby are, revoked. Pursuant to
the authority vested in me by 21 U.S.C.
823(f) and 28 CFR 0.100(b), I order that
all pending applications submitted by
Hatem M. Ataya, M.D. be, and they
hereby are, denied. This Order is
effective immediately.56
Dated: February 10, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–03359 Filed 2–17–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Mallinckrodt,
LLC
ACTION:
Notice of registration.
Mallinckrodt, LLC applied to
be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants
Mallinckrodt, LLC registration as a
manufacturer of those controlled
substances.
SUMMARY:
By notice
dated September 16, 2015, and
published in the Federal Register on
September 23, 2015, 80 FR 57388,
Mallinckrodt, LLC, 3600 North Second
Street, Saint Louis, Missouri 63147
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 Mallinckrodt, LLC 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
SUPPLEMENTARY INFORMATION:
56 Based on the extensive findings of egregious
misconduct by Respondent, I conclude that the
public interest necessitates that this Order be
effective immediately.
PO 00000
Frm 00073
Fmt 4703
Sfmt 9990
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 following basic
classes of controlled substances:
Controlled substance
Gamma
Hydroxybutyric
Acid
(2010).
Tetrahydrocannabinols (7370) .....
Codeine-N-oxide (9053) ...............
Dihydromorphine (9145) ...............
Difenoxin (9168) ...........................
Morphine-N-oxide (9307) .............
Normorphine (9313) .....................
Norlevorphanol (9634) ..................
Acetyl
Fentanyl
(N-(1phenethylpiperidin-4-yl)-Nphenylacetamide) (9821).
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
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
II
II
II
II
II
II
II
II
II
II
The company plans to manufacturer
bulk active pharmaceutical ingredients
(API) for distribution to its customers.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–03357 Filed 2–17–16; 8:45 am]
BILLING CODE 4410–09–P
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]]>Agencies
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Page 8245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03357]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Mallinckrodt,
LLC
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Mallinckrodt, LLC applied to be registered as a manufacturer
of certain basic classes of controlled substances. The Drug Enforcement
Administration (DEA) grants Mallinckrodt, LLC registration as a
manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and
published in the Federal Register on September 23, 2015, 80 FR 57388,
Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri
63147 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 Mallinckrodt, LLC 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 following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)........... I
Tetrahydrocannabinols (7370)............... I
Codeine-N-oxide (9053)..................... I
Dihydromorphine (9145)..................... I
Difenoxin (9168)........................... I
Morphine-N-oxide (9307).................... I
Normorphine (9313)......................... I
Norlevorphanol (9634)...................... I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4- I
yl)-N-phenylacetamide) (9821).
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Nabilone (7379)............................ II
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Codeine (9050)............................. II
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Diphenoxylate (9170)....................... II
Ecgonine (9180)............................ II
Hydrocodone (9193)......................... II
Levorphanol (9220)......................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. II
Dextropropoxyphene, bulk (non-dosage forms) II
(9273).
Morphine (9300)............................ II
Oripavine (9330)........................... II
Thebaine (9333)............................ II
Opium tincture (9630)...................... II
Opium, powdered (9639)..................... II
Oxymorphone (9652)......................... II
Noroxymorphone (9668)...................... II
Alfentanil (9737).......................... II
Remifentanil (9739)........................ II
Sufentanil (9740).......................... II
Tapentadol (9780).......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to manufacturer bulk active pharmaceutical
ingredients (API) for distribution to its customers.
Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03357 Filed 2-17-16; 8:45 am]
BILLING CODE 4410-09-P
