Sylvester A. Nathan; Dismissal of Proceeding, 17516-17517 [E9-8625]
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Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices
that Respondent had violated its
corresponding responsibility under
Federal law by filling prescriptions
which were not issued for a legitimate
medical purpose by a practitioner acting
in the usual course of professional
practice. Id. More specifically, the Order
alleged that Respondent had ‘‘acquired
over 15 million dosage units of’’ such
drugs as Didrex and phentermine,
which are schedule III and IV controlled
substances respectively, and that
Respondent was dispensing ‘‘huge
amounts of dosage units to persons
who’’ obtained prescriptions through
the Internet and ‘‘who [were] never
actually seen or examined by a
physician.’’ Id. at 8.
Respondent timely requested a
hearing. The matter was placed on the
docket of the Agency’s Administrative
Law Judges (ALJ), and a hearing was
held on March 27 through 29, 2006, at
which both parties elicited the
testimony of witnesses and introduced
various documents into evidence.
Following the hearing, both parties
submitted briefs containing their
proposed findings of fact, conclusions of
law, and argument. Moreover, on
October 11, 2007, the ALJ invited the
parties to submit additional briefs in
light of my decision in United
Prescription Services, Inc., 72 FR 50397
(2007); both parties did so.
Thereafter, on March 10, 2008, the
ALJ issued her recommended decision.
In her decision, the ALJ found that
Respondent and its owner had
repeatedly violated Federal law by
filling prescriptions for controlled
substances which it had reason to know
were unlawful. ALJ at 64–69. The ALJ
also found that Respondent’s owner had
failed to accept responsibility for her
misconduct. Id. at 70. The ALJ thus
concluded that ‘‘Respondent’s
continued registration would be
inconsistent with the public interest,’’
and recommended that I revoke its
registration and deny any pending
applications. Id.
On May 2, 2008, Respondent filed
exceptions to the ALJ decision. Shortly
thereafter, the record was forwarded to
me for final agency action.
During the course of reviewing the
record, my office determined that on
August 12, 2008, Respondent had been
acquired by Walgreens. On the same
day, Respondent also surrendered its
registration certificate, as well as its
order forms (DEA Form 222), to the
Agency’s Philadelphia Field Division
Office. Letter of Charlotte J. Lopacki,
R.Ph., to DEA Philadelphia Field Div.
Office (August 12, 2008). There is,
however, no evidence that Respondent
completed a voluntary surrender form.
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16:44 Apr 14, 2009
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Based on these acts, I find that
Respondent has discontinued business.
Under 21 CFR 1301.52(a), ‘‘the
registration of any person shall
terminate if and when such person
* * * discontinues business or
professional practice.’’ Accordingly, I
will declare that Respondent’s
registration has terminated with an
effective date of August 12, 2008. And
because there are no pending
applications before the Agency, I further
hold that the Show Cause proceeding is
now moot.2
Order
Pursuant to the authority vested in me
under 5 U.S.C. 554(e), as well as 28 CFR
0.100(b) & 0.104, I hereby declare
terminated as of August 12, 2008, DEA
Certificate of Registration, BB5209223,
issued to Budget Pharmacy and
Wellness Center, of Feasterville,
Pennsylvania. Pursuant to the authority
vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) &
0.104, I further order that the Order to
Show Cause issued to Budget Pharmacy
and Wellness Center be, and it hereby
is, dismissed. This Order is effective
immediately.
Dated: April 3, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–8617 Filed 4–14–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08–50]
Sylvester A. Nathan; Dismissal of
Proceeding
On June 25, 2008, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Sylvester A. Nathan,
M.D. (Respondent), of Woodridge,
Illinois. The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificate of
Registration, AN1430343, which
authorized him to dispense controlled
substances as a practitioner, and the
denial of any pending applications to
renew or modify the registration, on the
ground that the Illinois Department of
Professional Regulation had suspended
2 While I have raised the issue of Respondent’s
registration status sua sponte, in the event
Respondent seeks to refute the factual basis upon
which I rely, it may do so by filing a motion for
reconsideration within fifteen days of the date of
service of this Order, which shall begin on the date
the Order is mailed.
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Respondent’s ‘‘state license to handle
controlled substances,’’ and that
Respondent is therefore without
authority to dispense controlled
substances in the State in which he
holds his registration. Id. at 1.
Respondent timely requested a
hearing on the allegations and sought a
five-month long continuance of the
proceeding. Thereafter, the Government
moved to deny Respondent’s request for
a continuance and for summary
disposition. The basis for the summary
disposition motion was that
Respondent’s state medical license had
been suspended. As support for the
motion, the Government attached: (1) A
copy of a July 25, 2007 order of the
Illinois Department of Financial and
Professional Regulation (IDFPR), which
indefinitely suspended Respondent’s
Illinois Physician and Surgeon’s
Certificate until he provided proof that
he has passed the Special Purpose
Examination (SPEX); and (2) a July 8,
2008 printout of Respondent’s Physician
Profile from the IDFPR’s Web site,
which indicated that the status of
Respondent’s license was ‘‘suspended.’’
Thereafter, the ALJ issued an Order
for Respondent’s Response. On August
11, 2008, Respondent submitted his
response in which he acknowledged
that since July 25, 2007, he ‘‘has no
authority to prescribe, handle or
[d]ispense any [c]ontrolled medical
substances in the state’’ of Illinois. With
the submission, Respondent also
enclosed his DEA Certificate of
Registration but indicated on the
document that it was being ‘‘returned
under protest.’’
Shortly thereafter, the ALJ granted the
Government’s motion for summary
disposition. ALJ at 6. The ALJ noted that
there was no dispute that ‘‘Respondent
is not authorized to practice medicine in
Illinois’’ and thus could not ‘‘prescribe
controlled substance in that State.’’ Id.
at 5. Applying the Agency’s
longstanding interpretation that the
Controlled Substances Act precludes the
continuation of a registration if the
practitioner no longer holds authority to
dispense controlled substances in the
State in which he practices medicine,
id. (collecting cases); the ALJ granted
the Government’s motion and
recommended that Respondent’s
registration be revoked and that any
pending application be denied.
Respondent did not file exceptions to
the ALJ’s decision. On September 11,
2008, the record was forwarded to me
for final agency action. Having
considered the entire record and having
taken official notice of the registration
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Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices
records of this Agency,1 I find that
Respondent’s registration expired on
October 31, 2008, and that Respondent
has not submitted a renewal
application, let alone a timely one
(which would have kept his registration
in effect pending the issuance of this
decision).
It is well settled that ‘‘[i]f a registrant
has not submitted a timely renewal
application prior to the expiration date,
then the registration expires and there is
nothing to revoke.’’ Ronald J. Riegel, 63
FR 67132, 67133 (1998); see also
William W. Nucklos, 73 FR 34330
(2008). Because Respondent’s
registration has expired and there is no
pending application to act upon, I
conclude that this case is now moot.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a), as well as
28 CFR 0.100(b) and 0.104, I hereby
order that the Order to Show Cause
issued to Sylvester A. Nathan, M.D., be,
and it hereby is, dismissed.
Dated: April 3, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–8625 Filed 4–14–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 05–43]
Gregg & Son Distributors; Grant of
Conditional Registration
rwilkins on PROD1PC63 with PROPOSALS
On August 3, 2005, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Gregg & Son Distributors
(Respondent), of Powell, Tennessee. The
Show Cause Order proposed the
revocation of, and the denial of its
pending application to renew,
Respondent’s DEA Certificate of
Registration, which authorizes it to
distribute the List I chemicals
pseudoephedrine and ephedrine, on the
ground that its registration ‘‘is
1 Under the Administrative Procedure Act (APA),
an agency ‘‘may take official notice of facts at any
stage in a proceeding-even in the final decision.’’
U.S. Dept. of Justice, Attorney General’s Manual on
the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance
with the APA and DEA’s regulations, Respondent
is ‘‘entitled on timely request, to an opportunity to
show to the contrary.’’ 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). Respondent can dispute these facts
by filing a properly supported motion for
reconsideration within fifteen days of service of this
order, which shall begin on the date this order is
mailed.
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16:44 Apr 14, 2009
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inconsistent with the public interest.’’
Order to Show Cause at 1.
More specifically, the Show Cause
Order alleged that Respondent’s
customers for List I chemical products
‘‘are almost exclusively * * * entities
such as convenience stores and small
independent grocery stores,’’ and that
these retailers are a primary source for
the diversion of these products into the
illicit manufacture of
methamphetamine, a schedule II
controlled substance. Id. at 1–2. The
Order further alleged that Respondent
was selling ‘‘products that are not sold
in traditional retail outlets, including
over one dozen ephedrine products and
various pseudoephedrine products,’’ id.
at 2–3, that according to an expert
utilized by the Agency, ‘‘the average
small store could expect to sell monthly
only about $ 10.00 to $ 30.00 worth of
pseudoephedrine products,’’ and ‘‘that
the potential for sales of combination
ephedrine products [was] about only
one-fourth of [these] sales levels.’’ Id. at
4. Relatedly, the Order alleged that ‘‘it
is highly unlikely that [Respondent’s
customers] would sell a large volume of
List I chemical products for legitimate
uses,’’ that Respondent’s ‘‘sales of
combination ephedrine products and
pseudoephedrine products are
inconsistent with the known legitimate
market and known end-user demand for
products of this type,’’ and that
Respondent ‘‘is serving an illegitimate
market for these products.’’ Id. at 4–5.
The Show Cause Order further alleged
that in March 2005, DEA Investigators
conducted an inspection of Respondent.
Id. at 2. According to the allegations, the
Investigators conducted an audit of six
ephedrine products distributed by
Respondent between December 27,
2003, and March 15, 2005, and found
‘‘substantial underages and overages for
these products.’’ Id. at 3.
The Order also alleged that during the
inspection, the Investigators discovered
that Respondent sold ‘‘‘lovers’ roses,’
devices with small roses contained
inside a glass vial cylinder,’’ and that
‘‘[t]hese products are considered drug
paraphernalia because the vials are used
to smoke methamphetamine and [crack]
cocaine.’’ Id. The Order further alleged
that Mr. Dennis Gregg, Respondent’s
owner, ‘‘acknowledged that he was
aware of the illicit use of lovers’ roses.’’
Id.
Finally, the Order alleged that after
the inspection, Investigators visited
three of Respondent’s customers and
obtained information which indicated
that Respondent’s products were being
diverted. Id. at 3. More specifically, the
Order alleged that at the first store, one
customer purchased two (forty-eight
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17517
count) bottles each day, and that at a
second store, the manager stated that
she had only a few customers who
purchased the products but that they
did so regularly, and ‘‘that she believed
that most of the List I chemical products
sold in her store went to ‘meth labs.’’’
Id. at 3. Finally, the Order alleged that
at the third store, the owner stated ‘‘that
he was a former law enforcement
officer’’ and that ‘‘he was certain that
most or all of the ephedrine sold at his
store [was] used for illicit
methamphetamine production.’’ Id. at
3–4.
On or about August 30, 2005,
Respondent requested a hearing on the
allegations; the matter was placed on
the docket of the Agency’s
Administrative Law Judges (ALJ). On
April 18 and 19, 2006, a hearing was
held in Nashville, Tennessee, at which
both parties called witnesses to testify
and submitted documentary evidence.
Following the hearing, both parties
submitted briefs containing their
proposed findings of fact, legal
conclusions, and argument.
On February 29, 2008, nearly twentytwo months after the hearing, the ALJ
issued her recommended decision (ALJ).
Because Respondent’s sales levels of
ephedrine products ‘‘far exceed the
expected legitimate market demand,’’
the ALJ concluded that the Government
had established its prima facie case that
its continued registration is inconsistent
with the public interest. ALJ at 41. The
ALJ reasoned, however, that a sanction
less severe than revocation was
warranted because Tennessee had
recently enacted legislation that ‘‘placed
extensive limits upon the products
[Respondent could] sell,’’ that
Respondent was in ‘‘compliance with
the Act,’’ id., and that the Agency had
not provided evidence that its sales of
gel cap products were excessive. Id. at
39. The ALJ further concluded that there
was a ‘‘lack of evidence in [the] record
showing that soft-gel listed chemical
products have actually been made into
methamphetamine at illicit
laboratories.’’ Id. at 41.
The Government filed exceptions to
the ALJ’s decision, and Respondent
filed a Response to the Government’s
exceptions.1 Thereafter, the record was
forwarded to me for final agency action.
1 Therein, the Government argued that the record
not only showed that listed chemical products in
gel cap form have been diverted, but that in various
decisions I have previously rejected the ALJ’s
reasoning that the Agency cannot revoke a
registration until the actual diversion of gel cap
products is substantiated. Exceptions at 2–3 (citing
Holloway Distributing, 72 FR 42118 (2007), T.
Young Associates, 71 FR 60567 (2006)).
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Agencies
[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17516-17517]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8625]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08-50]
Sylvester A. Nathan; Dismissal of Proceeding
On June 25, 2008, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Sylvester A. Nathan, M.D. (Respondent), of Woodridge,
Illinois. The Show Cause Order proposed the revocation of Respondent's
DEA Certificate of Registration, AN1430343, which authorized him to
dispense controlled substances as a practitioner, and the denial of any
pending applications to renew or modify the registration, on the ground
that the Illinois Department of Professional Regulation had suspended
Respondent's ``state license to handle controlled substances,'' and
that Respondent is therefore without authority to dispense controlled
substances in the State in which he holds his registration. Id. at 1.
Respondent timely requested a hearing on the allegations and sought
a five-month long continuance of the proceeding. Thereafter, the
Government moved to deny Respondent's request for a continuance and for
summary disposition. The basis for the summary disposition motion was
that Respondent's state medical license had been suspended. As support
for the motion, the Government attached: (1) A copy of a July 25, 2007
order of the Illinois Department of Financial and Professional
Regulation (IDFPR), which indefinitely suspended Respondent's Illinois
Physician and Surgeon's Certificate until he provided proof that he has
passed the Special Purpose Examination (SPEX); and (2) a July 8, 2008
printout of Respondent's Physician Profile from the IDFPR's Web site,
which indicated that the status of Respondent's license was
``suspended.''
Thereafter, the ALJ issued an Order for Respondent's Response. On
August 11, 2008, Respondent submitted his response in which he
acknowledged that since July 25, 2007, he ``has no authority to
prescribe, handle or [d]ispense any [c]ontrolled medical substances in
the state'' of Illinois. With the submission, Respondent also enclosed
his DEA Certificate of Registration but indicated on the document that
it was being ``returned under protest.''
Shortly thereafter, the ALJ granted the Government's motion for
summary disposition. ALJ at 6. The ALJ noted that there was no dispute
that ``Respondent is not authorized to practice medicine in Illinois''
and thus could not ``prescribe controlled substance in that State.''
Id. at 5. Applying the Agency's longstanding interpretation that the
Controlled Substances Act precludes the continuation of a registration
if the practitioner no longer holds authority to dispense controlled
substances in the State in which he practices medicine, id. (collecting
cases); the ALJ granted the Government's motion and recommended that
Respondent's registration be revoked and that any pending application
be denied.
Respondent did not file exceptions to the ALJ's decision. On
September 11, 2008, the record was forwarded to me for final agency
action. Having considered the entire record and having taken official
notice of the registration
[[Page 17517]]
records of this Agency,\1\ I find that Respondent's registration
expired on October 31, 2008, and that Respondent has not submitted a
renewal application, let alone a timely one (which would have kept his
registration in effect pending the issuance of this decision).
---------------------------------------------------------------------------
\1\ Under the Administrative Procedure Act (APA), an agency
``may take official notice of facts at any stage in a proceeding-
even in the final decision.'' U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA's regulations, Respondent is ``entitled on timely request, to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). Respondent can dispute these facts by filing a
properly supported motion for reconsideration within fifteen days of
service of this order, which shall begin on the date this order is
mailed.
---------------------------------------------------------------------------
It is well settled that ``[i]f a registrant has not submitted a
timely renewal application prior to the expiration date, then the
registration expires and there is nothing to revoke.'' Ronald J.
Riegel, 63 FR 67132, 67133 (1998); see also William W. Nucklos, 73 FR
34330 (2008). Because Respondent's registration has expired and there
is no pending application to act upon, I conclude that this case is now
moot.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order that the
Order to Show Cause issued to Sylvester A. Nathan, M.D., be, and it
hereby is, dismissed.
Dated: April 3, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-8625 Filed 4-14-09; 8:45 am]
BILLING CODE 4410-09-P