Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc., 64949 [2016-22737]
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Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
if the applicant is authorized to
dispense . . . controlled substances
under the laws of the State in which he
practices.’’); 21 U.S.C. 802(21) (‘‘[t]he
term ‘practitioner’ means a physician
. . . licensed, registered, or otherwise
permitted, by . . . the jurisdiction in
which he practices . . . to distribute,
dispense, [or] administer . . . a
controlled substance in the course of
professional practice’’).25
While the Show Cause Order did not
assert this as a ground for denial of his
application (because it occurred
subsequent to the issuance of the
Order), the Government did serve a
copy of its Addendum which presented
this development to me, on Respondent.
In response to this filing, Respondent
has raised no objection.26 In any event,
there are two other independent and
legally sufficient bases to deny his
application. Accordingly, I will deny his
application.
ORDER
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
I order that the application of Richard
J. Settles, for a DEA Certificate of
Registration as a practitioner be, and it
hereby is, denied. This Order is effective
immediately.
Dated: September 13, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–22680 Filed 9–20–16; 8:45 am]
accordance with 21 CFR 1301.33(a) on
or before November 21, 2016.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The
Attorney General has delegated her
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
December 18, 2015, Nanosyn, Inc.,
Nanoscale Combinatorial Synthesis,
3331–B Industrial Drive, Santa Rosa,
California 95403 applied to be registered
as a bulk manufacturer the of following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
Controlled substance
Drug
code
Oxymorphone ...........
Fentanyl ....................
9652 .......
9801 .......
Schedule
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Nanosyn, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
mstockstill on DSK3G9T082PROD with NOTICES
DATES:
25 See also Rezik A. Saqer, 81 FR 22122, 22125–
27 (2016); Sheran Arden Yeates, 71 FR 39130,
39131 (2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR 11919, 11920
(1988).
26 DEA has previously held that ‘‘[t]he 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 has
expired does not render the proceeding
fundamentally unfair.’’ Roy E. Berkowitz, 74 FR
36758, 36759–60 (2009); see also Hatem M. Ataya,
81 FR 8221, 8245 (2016) (collecting cases).
VerDate Sep<11>2014
18:19 Sep 20, 2016
Jkt 238001
II
II
The company is a contract
manufacturer. At the request of the
company’s customers, it manufacturers
derivatives of controlled substances in
bulk form.
Dated: September 15, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–22737 Filed 9–20–16; 8:45 am]
64949
(R.D.).1 Therein, the CALJ found that it
is undisputed that Respondent is
currently without authority to handle
controlled substances in New York, the
State in which he holds DEA
Registration FL2580163. R.D. at 4. The
CALJ thus granted the Government’s
Motion for Summary Disposition and
recommended that I revoke
Respondent’s registration and deny any
pending applications.
Neither party filed exceptions to the
Recommended Decision. Having
reviewed the record, I adopt the CALJ’s
finding that Respondent lacks state
authority to handle controlled
substances in New York, the State in
which he is registered. ‘‘State
authorization to dispense or otherwise
handle controlled substances is a
prerequisite to the issuance and
maintenance of a Federal controlled
substances registration.’’ Frederick
Marsh Blanton, 43 FR 27616, 27617
(1978). See also Rezik A. Saqer, 81 FR
22122, 22124–127 (2016). Thus, once
the Government establishes that an
applicant for a practitioner’s registration
or a practitioner-registrant does not
possess state authority, there are no
further facts to be considered and
revocation is the mandatory sanction
that must be entered under the
Controlled Substances Act. Accordingly,
I will also adopt the CALJ’s
recommendation that I revoke
Respondent’s registration and deny any
pending application to renew or modify
his registration.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration FL2580163
issued to Kevin L. Lowe, M.D., be, and
it hereby is, revoked. I further order that
any pending application of Kevin L.
Lowe, M.D., to renew or modify the
above registration, be, and it hereby is,
denied. This Order is effective
immediately.2
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Kevin L. Lowe, M.D.; Decision and
Order
On May 18, 2016, Chief
Administrative Law Judge John J.
Mulrooney, II (CALJ), issued the
attached Recommended Decision
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
1 All citations to the Recommended Decision are
to the slip opinion issued by the CALJ.
2 Based on Respondent’s acknowledgment that he
has been convicted of conspiring to unlawfully
distribute controlled substances, see Resp.’s Hrng.
Req., at 1–2, I find that the public interest
necessitates that this Order be effective
immediately. 21 CFR 1316.67.
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Page 64949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22737]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Nanosyn,
Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration in accordance with 21 CFR
1301.33(a) on or before November 21, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or revocation of registration) has been redelegated
to the Deputy Assistant Administrator of the DEA Office of Diversion
Control (``Deputy Assistant Administrator'') pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on
December 18, 2015, Nanosyn, Inc., Nanoscale Combinatorial Synthesis,
3331-B Industrial Drive, Santa Rosa, California 95403 applied to be
registered as a bulk manufacturer the of following basic classes of
controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Oxymorphone....................... 9652............. II
Fentanyl.......................... 9801............. II
------------------------------------------------------------------------
The company is a contract manufacturer. At the request of the
company's customers, it manufacturers derivatives of controlled
substances in bulk form.
Dated: September 15, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22737 Filed 9-20-16; 8:45 am]
BILLING CODE 4410-09-P
