Memphis Wholesale Company; Declaratory Order Terminating Exemption From Registration, 16713-16715 [E8-6378]
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Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Notices
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 classes of controlled
substances listed.
Dated: March 19, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–6389 Filed 3–27–08; 8:45 am]
Dated: March 19, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–6386 Filed 3–27–08; 8:45 am]
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
sroberts on PROD1PC70 with NOTICES
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated December 17, 2007,
and published in the Federal Register
on December 27, 2007, (72 FR 73358),
GE Healthcare, 3350 North Ridge
Avenue, Arlington Heights, Illinois
60004–1412, made application to the
Drug Enforcement Administration
(DEA) to be registered as a bulk
manufacturer of Cocaine (9041), a basic
class of controlled substance listed in
schedule II.
The company plans to manufacture a
radioactive product used in diagnostic
imaging in the diagnosis of Parkinson’s
Disease and for manufacture in bulk for
investigational new drug (IND)
submission and clinical trials.
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 GE
Healthcare to manufacture the listed
basic class of controlled substance is
consistent with the public interest at
this time. DEA has investigated GE
Healthcare 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.
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DEPARTMENT OF JUSTICE
Manufacturer of Controlled
Substances; Notice of Registration
BILLING CODE 4410–09–P
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BILLING CODE 4410–09–P
By Notice dated December 20, 2007,
and published in the Federal Register
on December 31, 2007, (72 FR 74331),
Chattem Chemicals, Inc., 3801 St. Elmo
Avenue, Building 18, Chattanooga,
Tennessee 37409, made application by
letter to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of Oripavine
(9330), a basic class of controlled
substance listed in schedule II.
The company plans to manufacture
the listed controlled substance in bulk
for sale to its customers.
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
Chattem Chemicals, Inc. to manufacture
the listed basic class of controlled
substance is consistent with the public
interest at this time. DEA has
investigated Chattem Chemicals, 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: March 19, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E8–6412 Filed 3–27–08; 8:45 am]
BILLING CODE 4410–09–P
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16713
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 05–38]
Memphis Wholesale Company;
Declaratory Order Terminating
Exemption From Registration
On July 12, 2005, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Memphis Wholesale
Company (Respondent) of Memphis,
Tennessee. Show Cause Order at 1. The
Show Cause Order proposed the denial
of what it referred to as Respondent’s
‘‘application’’ for a registration as a
distributor of the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine (PPA), and to
revoke any exemption from registration,
on the ground that its registration ‘‘is
inconsistent with the public interest.’’
Id.
The Show Cause Order specifically
alleged that ‘‘[o]n July 29, 1997,
Memphis Wholesale Company, by its
owner, Neal Abodabba,’’ applied for a
DEA Certificate of Registration, that a
control number was assigned to its
application ‘‘permitting the firm to
temporarily operate under the
regulatory exemption [provided] at 21
CFR 1309.25, pending agency action on
the application.’’ Id. at 2. The Show
Cause Order alleged that in ‘‘April 1999,
Memphis Wholesale Company was
incorporated in the State of Tennessee
by Neal Abodabba and Shawkat
Abodabba, without notification to DEA
that the form of ownership, and thus the
registered person, had changed.’’ Id.
The Show Cause Order next alleged
that on August 10, 2000, DEA
investigators conducted an inspection of
Respondent. Id. The Order alleged that
during the inspection, Mr. Neal
Abodabba told investigators ‘‘that 7.8%
of his total sales were for ‘energy’
products, which included Max Brand
and Mini-Thins,’’ which are listed
chemical products. Id. The Order also
alleged that Mr. Abodabba also told
investigators that his customers
included approximately 200 to 300
convenience stores and gas stations,
which were located in Tennessee,
Arkansas, and northern Mississippi, and
that most of these customers purchased
listed chemical products from him. Id.
The Show Cause Order further alleged
that ‘‘in July 2000, Memphis Wholesale
had begun consolidating its deliveries in
the Nashville area by shipping to [an]
unlicensed distributor, Nashville
Wholesale, for further distribution to
retailers * * * in violation of 21 U.S.C.
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841(f) and 843(a)(9).’’ Id. Finally, with
respect to the August 2000 inspection,
the Show Cause Order alleged that DEA
investigators conducted an
accountability audit for the period
February 1, 2000, through August 10,
2000, and found overages in various
products. Id. at 2–3.
The Show Cause Order next alleged
that on May 16, 2002, DEA investigators
conducted another inspection of
Respondent. Id. at 3. According to the
Show Cause Order, during the
inspection, ‘‘Mr. Mohammed Issa
represented himself as the owner of
Memphis Wholesale,’’ and subsequently
the investigators were informed by Mr.
Abodabba ‘‘that he had ‘sold his shares’
in [the firm] to Mohammed Issa.’’ Id.
Relatedly, the Show Cause Order
alleged that Respondent ‘‘is now
improperly operating as a chemical
distributor under the control of Mr.
Issa,’’ and that ‘‘[n]either Mr. Abodabba
nor Mr. Issa notified DEA of any
corporate ownership changes.’’ 1 Id.
Following service of the Show Cause
Order, Respondent requested a hearing
on the allegations and the matter was
assigned to Administrative Law Judge
(ALJ) Mary Ellen Bittner. Counsel for
both parties agreed, however, that in
lieu of a hearing at which witnesses
would be called, they would submit
affidavits, proffers of testimony, and
other evidence. ALJ at 4. Neither party
objected to any of the evidence or
proffers submitted. After both parties
submitted briefs, the ALJ issued her
recommended decision.
In her decision, the ALJ found that
Respondent was not entitled to operate
under the temporary exemption from
registration authorized under 21 CFR
1309.25, because neither Respondent,
which was incorporated in 1998, nor
Mr. Issa (the corporation’s current
owner), ‘‘was the same ‘person’ that
applied for registration in 1997.’’ ALJ at
21. The ALJ thus reasoned that
Respondent was ‘‘not entitled to operate
under the exemption granted to the
business that Mr. Abodabba owned in
1997.’’ Id. The ALJ further found that
‘‘since 1998, Respondent has been
distributing listed chemical products
without being registered to do so, in
violation of 21 U.S.C. 822(a)(1).’’ Id.
‘‘In light of these findings,’’ the ALJ
concluded that ‘‘a further finding would
be warranted that there is no viable
application pending.’’ Id. She
nonetheless concluded that it was
1 The Show Cause Order also raised various
allegations related to the diversion of ephedrine and
pseudoephedrine from non-traditional retailers into
the illegal manufacture of methamphetamine, a
schedule II controlled substance. Show Cause Order
at 1–2; see also 21 CFR 1308.12(d).Id.
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appropriate to make findings under the
public interest factors (see 21 U.S.C.
823(h)) because ‘‘the parties have
devoted substantial resources to this
case.’’ ALJ at 21. Upon analyzing the
factors, the ALJ concluded that
Respondent’s registration would be
inconsistent with the public interest.
ALJ at 24.
Having considered the record as a
whole, I hereby issue this declaratory
order. See 5 U.S.C. 554(e). I conclude
that the original exemption from
registration obtained by Mr. Abodabba
terminated no later than the date he
transferred his ownership interest in
Respondent to Mr. Issa. I further
conclude that while the application
which Mr. Abodabba submitted on July
29, 1997, listed ‘‘Memphis Wholesale
Company’’ as the applicant, because the
entity was not then incorporated it did
not have independent legal capacity to
seek a registration and the application is
therefore personal to Mr. Abodabba.
While the evidence establishes that Mr.
Abodabba has long since sold his
interest in Respondent and is not in
business at the proposed registered
location, to the extent this proceeding
seeks to adjudicate his application, the
Government has known since 2002 that
Mr. Abodabba was no longer at that
location and has not properly served
him.2 To the extent Respondent (under
its new owner) seeks to adjudicate its
entitlement to a registration,
Respondent has never submitted an
application. Accordingly, there is no
pending application to act upon. I make
the following findings.
Findings
On July 29, 1997, Neal S. Abodabba,
submitted an application for a
registration to distribute the list I
chemicals, ephedrine, pseudoephedrine,
and phenylpropanolamine. GX 1. On
the application, Mr. Abodabba indicated
that Memphis Wholesale Company was
the applicant. Id. However, the business
was not then incorporated and did not
file its charter with the Tennessee
Secretary of State until April 14, 1998.
GX 36, at 2.
On May 16, 2002, DEA investigators
went to Respondent to conduct an
inspection. On that date, Mr.
Mohammed Issa told investigators that
he owned Respondent. Gov’t Proffer of
Testimony at 6. Moreover, in its proffer,
Respondent stated that ‘‘Mr. Issa would
testify that he is the majority
stockholder of Memphis Wholesale
2 See Nashville Wholesale Company, Inc., 71 FR
52159, 52160 (2006) (noting that Mr. Abodabba was
served at the proposed registered location of
Nashville Wholesale Company).
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Company and that he became majority
stockholder on July 16, 2001.’’
Respondent’s Summary of Position at 2.
Furthermore, on July 17, 2002,
Respondent filed its annual report with
the Tennessee Secretary of State which
stated that Mohammed Issa was the
corporation’s president, Sameer Issa was
its secretary, and Bill Miller was its
treasurer.3 GX 36, at 10. The report
further indicated that its board of
directors was comprised of the same
three individuals.4 Id.
Respondent submitted into evidence a
compilation and serial listing of its sales
of listed chemical products for the
period January through December 2004.
According to a table which is attached
to this document, during 2004,
Respondent had sales of all products
totaling $4,134,004.28; its list I chemical
products constituted 7.09 percent of its
sales. The document (which is 143
pages in length) then lists by product,
numerous instances in which
Respondent sold ephedrine and
pseudoephedrine products to gas
stations and convenience stores. See
generally Memphis Wholesale
Company, Inc., Sales by Item Detail, at
1–143. According to the list, during
2004, Respondent’s sales of these
products totaled $225,167.30. See id. at
143.
Discussion
Under 21 U.S.C. 822(a)(1), ‘‘[e]very
person who * * * distributes any * * *
list I chemical, or who proposes to
engage in the * * * distribution of any
* * * list I chemical, shall obtain
annually a registration issued by the
Attorney General in accordance with the
rules and regulations promulgated by
him.’’ 5 Furthermore, ‘‘[p]ersons
registered by the Attorney General
* * * to distribute * * * list I
chemicals are authorized to possess
[and] distribute * * * such * * *
chemicals * * * to the extent
authorized by their registration and in
conformity with the other provisions of’’
Subchapter I of the Controlled
Substances Act. Id. 822(b). DEA
regulations further provide that ‘‘[n]o
person required to be registered shall
engage in any activity for which
registration is required until the
application for registration is approved
3 On April 16, 2001, Respondent filed its annual
report which indicated that Neal Abodabba was its
president and Shawkat Abodabba was its Secretary.
4 On its annual report which it submitted on May
10, 2004, Respondent no longer listed Mr. Miller as
either a corporate officer or director. Instead, the
report listed ‘‘K. Issa’’ as an officer and director. GX
36, at 12.
5 Ephedrine, pseudoephedrine and
phenylpropanolamine are list I chemicals. See 21
U.S.C. 802(34).
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and a Certificate of Registration is
issued by the Administrator to such
person.’’ 21 CFR 1309.31(a).
In 1996, Congress enacted the
Comprehensive Methamphetamine
Control Act of 1996, which, for the first
time, subjected distributors of
pseudoephedrine,
phenylpropanolamine, and combination
ephedrine products to the registration
requirements. See 62 FR 52254 (1997)
(final rule). To prevent disruption of the
legitimate commerce in these products,
DEA enacted a temporary exemption
from registration for distributors of these
products. See 62 FR at 5915 (interim
rule).
Accordingly, with respect to
distributors of combination ephedrine
products, the exemption applies to
‘‘each person required’’ to be registered,
‘‘provided that the person submit[ted] a
proper application for registration on or
before July 12, 1997.’’ 21 CFR
1309.25(a). The regulation further
provides that ‘‘[t]he exemption will
remain in effect for each person who has
made such application until the
Administration has approved or denied
that application.’’ Id. DEA applied the
same rule to distributors of
pseudoephedrine and
phenylpropanolamine, the only
difference being that the application had
to be submitted ‘‘on or before October 3,
1997.’’ Id. 1309.25(b).6
As found above, on July 29, 1997, Mr.
Neil S. Abodabba applied for a
registration to distribute ephedrine,
pseudoephedrine, and
phenylpropanolamine. GX 1. While Mr.
Abodabba listed Memphis Wholesale
Company as the applicant, the firm did
not file its charter of incorporation with
the Tennessee Secretary of State until
April 14, 1998. GX 36, at 4; GX 30. As
Memphis Wholesale did not exist as an
independent legal entity until more than
eight months later, the application
submitted on July 29, 1997, is personal
to Mr. Abodabba. Moreover, there is no
evidence that Memphis Wholesale
Company, Incorporated, has ever
submitted an application for a DEA
registration either under its original
owner (Mr. Abodabba), or under its new
owner (Mr. Issa). Likewise, there is no
evidence that the application was
amended to reflect that Memphis
Wholesale Company, Inc., was the
applicant.
While the evidence indicates that Mr.
Issa disclosed to agency investigators
during the 2002 inspection that he was
6 DEA regulations defined ‘‘[t]he term person [as]
includ[ing] any individual, corporation,
government or governmental subdivision or agency,
business trust, partnership, association, or other
legal entity.’’ 21 CFR 1300.01(b)(34).
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17:57 Mar 27, 2008
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Respondent’s owner, the firm did not
have authority to distribute under the
temporary exemption because it was not
the ‘‘person’’ who applied for
registration in July 1997. See, e.g., 21
CFR 1309.25(a). As the regulation makes
plain: [e]ach person required by [21
U.S.C. 822] to obtain a registration to
distribute * * * a combination
ephedrine product is temporarily
exempted from the registration
requirement, provided that the person
submits a proper application for
registration on or before July 12, 1997.’’
Id. (emphasis added).7 Moreover, the
authority Mr. Abodabba obtained to
distribute (which was limited to
pseudoephedrine and
phenylpropanolamine) was not lawfully
transferred to either the corporation or
to its new owners) because the written
consent of the Agency was never
obtained. See id. 1309.63 (‘‘No
registration or any authority conferred
thereby shall be assigned or otherwise
transferred except upon such conditions
as the Administrator may specifically
designate and then only pursuant to his
written consent.’’).
Accordingly, I hold that Respondent
has been without authority to distribute
list I chemicals since July 16, 2001
(when Mr. Issa became its owner), and
that all distributions it has made since
that date (including all those listed in
the compilation of its 2004 sales) have
been in violation of federal law.8 See 21
U.S.C. 822(a). I further hold that
Respondent does not have an
application pending before the agency.
Order
Pursuant to the authority vested in me
under 5 U.S.C. 554(e) and 28 CFR
0.100(b) & 0.104, I hereby declare that
since July 16, 2001, Memphis Wholesale
7 While Respondent relies on Mr. Abodabba’s
application, it ignores that under 21 CFR
1309.25(a), this application was not timely
submitted with respect to combination ephedrine
products and thus, not even Mr. Abodabba was not
entitled to the exemption. See GX 1 (application
dated July 29, 1997).
8 Mr. Abodabba is not a party to this proceeding,
and I conclude that it is not necessary to decide
whether Respondent’s activities under his
ownership were lawful. Moreover, to the extent this
proceeding was brought to deny Mr. Abodabba’s
application, which is the only application in the
record, see GX 1, service has not been properly
effectuated. See Jones v. Flowers, 547 U.S. 220, 230
(2006) (‘‘[T]he government’s knowledge that notice
pursuant to the normal procedure was ineffective
triggered an obligation on the government’s part to
take additional steps to effect notice.’’); see also id.
at 232 (discussing Robinson v. Hanrahan, 409 U.S.
38, 39–40 (1972) (per curiam) (even though state
law required vehicle owner to register his address
with the state, ‘‘we found that the State had not
provided constitutionally sufficient notice, despite
having followed its reasonably calculated scheme,
because it knew that [the owner] could not be
reached at his address of record’’).
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16715
Company, Incorporated, has not had
authority under 21 CFR 1309.25 to
distribute pseudoephedrine,
combination ephedrine, and
phenylpropanolamine. This Order is
effective immediately.
Dated: March 17, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8–6378 Filed 3–27–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Hi-Tech Pharmaceutcals, Inc.; Denial
of Applications
On August 16, 2007, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Hi-Tech
Pharmaceuticals, Inc. (Respondent), of
Norcross, Georgia. The Show Cause
Order proposed the denial of
Respondent’s pending applications for
DEA Certificates of Registration to
import and manufacture ephedrine, a
list I chemical, on the ground that its
‘‘registrations would be inconsistent
with the public interest.’’ Show Cause
Order at 1 (citing 21 U.S.C. 824(a)(4) &
958(c)).
The Show Cause Order specifically
alleged that both Respondent’s owner,
Mr. Jared Wheat, and its Vice-President,
Mr. Stephen D. Smith, had previously
been convicted of controlled-substance
felony offenses. Id. The Show Cause
Order next alleged that on February 23,
2006, agents of the U.S. Customs Service
and the Food Drug Administration
(FDA) executed a search warrant at
Respondent and seized various products
containing ephedrine alkaloids that the
company was manufacturing and
distributing, as well as the raw materials
used to manufacture these products. Id.
at 2.
The Show Cause Order further alleged
that Respondent operated several
websites which represented that they
offered controlled substances for sale
from Canada and that the ‘‘drugs were
made using good manufacturing
practices in Canada,’’ when, in fact, ‘‘HiTech manufactured many of these
drugs, including various Schedule III
and IV controlled substances, in the
country of Belize and unlawfully
imported them into the United States
without a DEA registration’’ in violation
of 21 U.S.C. 957(a) and 21 CFR 1301.11.
Id. at 2. Relatedly, the Show Cause
Order alleged that on September 7,
2006, a federal grand jury indicted
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[Federal Register Volume 73, Number 61 (Friday, March 28, 2008)]
[Notices]
[Pages 16713-16715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6378]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 05-38]
Memphis Wholesale Company; Declaratory Order Terminating
Exemption From Registration
On July 12, 2005, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Memphis Wholesale Company (Respondent) of Memphis,
Tennessee. Show Cause Order at 1. The Show Cause Order proposed the
denial of what it referred to as Respondent's ``application'' for a
registration as a distributor of the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine (PPA), and to revoke any
exemption from registration, on the ground that its registration ``is
inconsistent with the public interest.'' Id.
The Show Cause Order specifically alleged that ``[o]n July 29,
1997, Memphis Wholesale Company, by its owner, Neal Abodabba,'' applied
for a DEA Certificate of Registration, that a control number was
assigned to its application ``permitting the firm to temporarily
operate under the regulatory exemption [provided] at 21 CFR 1309.25,
pending agency action on the application.'' Id. at 2. The Show Cause
Order alleged that in ``April 1999, Memphis Wholesale Company was
incorporated in the State of Tennessee by Neal Abodabba and Shawkat
Abodabba, without notification to DEA that the form of ownership, and
thus the registered person, had changed.'' Id.
The Show Cause Order next alleged that on August 10, 2000, DEA
investigators conducted an inspection of Respondent. Id. The Order
alleged that during the inspection, Mr. Neal Abodabba told
investigators ``that 7.8% of his total sales were for `energy'
products, which included Max Brand and Mini-Thins,'' which are listed
chemical products. Id. The Order also alleged that Mr. Abodabba also
told investigators that his customers included approximately 200 to 300
convenience stores and gas stations, which were located in Tennessee,
Arkansas, and northern Mississippi, and that most of these customers
purchased listed chemical products from him. Id.
The Show Cause Order further alleged that ``in July 2000, Memphis
Wholesale had begun consolidating its deliveries in the Nashville area
by shipping to [an] unlicensed distributor, Nashville Wholesale, for
further distribution to retailers * * * in violation of 21 U.S.C.
[[Page 16714]]
841(f) and 843(a)(9).'' Id. Finally, with respect to the August 2000
inspection, the Show Cause Order alleged that DEA investigators
conducted an accountability audit for the period February 1, 2000,
through August 10, 2000, and found overages in various products. Id. at
2-3.
The Show Cause Order next alleged that on May 16, 2002, DEA
investigators conducted another inspection of Respondent. Id. at 3.
According to the Show Cause Order, during the inspection, ``Mr.
Mohammed Issa represented himself as the owner of Memphis Wholesale,''
and subsequently the investigators were informed by Mr. Abodabba ``that
he had `sold his shares' in [the firm] to Mohammed Issa.'' Id.
Relatedly, the Show Cause Order alleged that Respondent ``is now
improperly operating as a chemical distributor under the control of Mr.
Issa,'' and that ``[n]either Mr. Abodabba nor Mr. Issa notified DEA of
any corporate ownership changes.'' \1\ Id.
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\1\ The Show Cause Order also raised various allegations related
to the diversion of ephedrine and pseudoephedrine from non-
traditional retailers into the illegal manufacture of
methamphetamine, a schedule II controlled substance. Show Cause
Order at 1-2; see also 21 CFR 1308.12(d).Id.
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Following service of the Show Cause Order, Respondent requested a
hearing on the allegations and the matter was assigned to
Administrative Law Judge (ALJ) Mary Ellen Bittner. Counsel for both
parties agreed, however, that in lieu of a hearing at which witnesses
would be called, they would submit affidavits, proffers of testimony,
and other evidence. ALJ at 4. Neither party objected to any of the
evidence or proffers submitted. After both parties submitted briefs,
the ALJ issued her recommended decision.
In her decision, the ALJ found that Respondent was not entitled to
operate under the temporary exemption from registration authorized
under 21 CFR 1309.25, because neither Respondent, which was
incorporated in 1998, nor Mr. Issa (the corporation's current owner),
``was the same `person' that applied for registration in 1997.'' ALJ at
21. The ALJ thus reasoned that Respondent was ``not entitled to operate
under the exemption granted to the business that Mr. Abodabba owned in
1997.'' Id. The ALJ further found that ``since 1998, Respondent has
been distributing listed chemical products without being registered to
do so, in violation of 21 U.S.C. 822(a)(1).'' Id.
``In light of these findings,'' the ALJ concluded that ``a further
finding would be warranted that there is no viable application
pending.'' Id. She nonetheless concluded that it was appropriate to
make findings under the public interest factors (see 21 U.S.C. 823(h))
because ``the parties have devoted substantial resources to this
case.'' ALJ at 21. Upon analyzing the factors, the ALJ concluded that
Respondent's registration would be inconsistent with the public
interest. ALJ at 24.
Having considered the record as a whole, I hereby issue this
declaratory order. See 5 U.S.C. 554(e). I conclude that the original
exemption from registration obtained by Mr. Abodabba terminated no
later than the date he transferred his ownership interest in Respondent
to Mr. Issa. I further conclude that while the application which Mr.
Abodabba submitted on July 29, 1997, listed ``Memphis Wholesale
Company'' as the applicant, because the entity was not then
incorporated it did not have independent legal capacity to seek a
registration and the application is therefore personal to Mr. Abodabba.
While the evidence establishes that Mr. Abodabba has long since sold
his interest in Respondent and is not in business at the proposed
registered location, to the extent this proceeding seeks to adjudicate
his application, the Government has known since 2002 that Mr. Abodabba
was no longer at that location and has not properly served him.\2\ To
the extent Respondent (under its new owner) seeks to adjudicate its
entitlement to a registration, Respondent has never submitted an
application. Accordingly, there is no pending application to act upon.
I make the following findings.
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\2\ See Nashville Wholesale Company, Inc., 71 FR 52159, 52160
(2006) (noting that Mr. Abodabba was served at the proposed
registered location of Nashville Wholesale Company).
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Findings
On July 29, 1997, Neal S. Abodabba, submitted an application for a
registration to distribute the list I chemicals, ephedrine,
pseudoephedrine, and phenylpropanolamine. GX 1. On the application, Mr.
Abodabba indicated that Memphis Wholesale Company was the applicant.
Id. However, the business was not then incorporated and did not file
its charter with the Tennessee Secretary of State until April 14, 1998.
GX 36, at 2.
On May 16, 2002, DEA investigators went to Respondent to conduct an
inspection. On that date, Mr. Mohammed Issa told investigators that he
owned Respondent. Gov't Proffer of Testimony at 6. Moreover, in its
proffer, Respondent stated that ``Mr. Issa would testify that he is the
majority stockholder of Memphis Wholesale Company and that he became
majority stockholder on July 16, 2001.'' Respondent's Summary of
Position at 2. Furthermore, on July 17, 2002, Respondent filed its
annual report with the Tennessee Secretary of State which stated that
Mohammed Issa was the corporation's president, Sameer Issa was its
secretary, and Bill Miller was its treasurer.\3\ GX 36, at 10. The
report further indicated that its board of directors was comprised of
the same three individuals.\4\ Id.
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\3\ On April 16, 2001, Respondent filed its annual report which
indicated that Neal Abodabba was its president and Shawkat Abodabba
was its Secretary.
\4\ On its annual report which it submitted on May 10, 2004,
Respondent no longer listed Mr. Miller as either a corporate officer
or director. Instead, the report listed ``K. Issa'' as an officer
and director. GX 36, at 12.
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Respondent submitted into evidence a compilation and serial listing
of its sales of listed chemical products for the period January through
December 2004. According to a table which is attached to this document,
during 2004, Respondent had sales of all products totaling
$4,134,004.28; its list I chemical products constituted 7.09 percent of
its sales. The document (which is 143 pages in length) then lists by
product, numerous instances in which Respondent sold ephedrine and
pseudoephedrine products to gas stations and convenience stores. See
generally Memphis Wholesale Company, Inc., Sales by Item Detail, at 1-
143. According to the list, during 2004, Respondent's sales of these
products totaled $225,167.30. See id. at 143.
Discussion
Under 21 U.S.C. 822(a)(1), ``[e]very person who * * * distributes
any * * * list I chemical, or who proposes to engage in the * * *
distribution of any * * * list I chemical, shall obtain annually a
registration issued by the Attorney General in accordance with the
rules and regulations promulgated by him.'' \5\ Furthermore,
``[p]ersons registered by the Attorney General * * * to distribute * *
* list I chemicals are authorized to possess [and] distribute * * *
such * * * chemicals * * * to the extent authorized by their
registration and in conformity with the other provisions of''
Subchapter I of the Controlled Substances Act. Id. 822(b). DEA
regulations further provide that ``[n]o person required to be
registered shall engage in any activity for which registration is
required until the application for registration is approved
[[Page 16715]]
and a Certificate of Registration is issued by the Administrator to
such person.'' 21 CFR 1309.31(a).
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\5\ Ephedrine, pseudoephedrine and phenylpropanolamine are list
I chemicals. See 21 U.S.C. 802(34).
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In 1996, Congress enacted the Comprehensive Methamphetamine Control
Act of 1996, which, for the first time, subjected distributors of
pseudoephedrine, phenylpropanolamine, and combination ephedrine
products to the registration requirements. See 62 FR 52254 (1997)
(final rule). To prevent disruption of the legitimate commerce in these
products, DEA enacted a temporary exemption from registration for
distributors of these products. See 62 FR at 5915 (interim rule).
Accordingly, with respect to distributors of combination ephedrine
products, the exemption applies to ``each person required'' to be
registered, ``provided that the person submit[ted] a proper application
for registration on or before July 12, 1997.'' 21 CFR 1309.25(a). The
regulation further provides that ``[t]he exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied that application.'' Id. DEA
applied the same rule to distributors of pseudoephedrine and
phenylpropanolamine, the only difference being that the application had
to be submitted ``on or before October 3, 1997.'' Id. 1309.25(b).\6\
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\6\ DEA regulations defined ``[t]he term person [as] includ[ing]
any individual, corporation, government or governmental subdivision
or agency, business trust, partnership, association, or other legal
entity.'' 21 CFR 1300.01(b)(34).
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As found above, on July 29, 1997, Mr. Neil S. Abodabba applied for
a registration to distribute ephedrine, pseudoephedrine, and
phenylpropanolamine. GX 1. While Mr. Abodabba listed Memphis Wholesale
Company as the applicant, the firm did not file its charter of
incorporation with the Tennessee Secretary of State until April 14,
1998. GX 36, at 4; GX 30. As Memphis Wholesale did not exist as an
independent legal entity until more than eight months later, the
application submitted on July 29, 1997, is personal to Mr. Abodabba.
Moreover, there is no evidence that Memphis Wholesale Company,
Incorporated, has ever submitted an application for a DEA registration
either under its original owner (Mr. Abodabba), or under its new owner
(Mr. Issa). Likewise, there is no evidence that the application was
amended to reflect that Memphis Wholesale Company, Inc., was the
applicant.
While the evidence indicates that Mr. Issa disclosed to agency
investigators during the 2002 inspection that he was Respondent's
owner, the firm did not have authority to distribute under the
temporary exemption because it was not the ``person'' who applied for
registration in July 1997. See, e.g., 21 CFR 1309.25(a). As the
regulation makes plain: [e]ach person required by [21 U.S.C. 822] to
obtain a registration to distribute * * * a combination ephedrine
product is temporarily exempted from the registration requirement,
provided that the person submits a proper application for registration
on or before July 12, 1997.'' Id. (emphasis added).\7\ Moreover, the
authority Mr. Abodabba obtained to distribute (which was limited to
pseudoephedrine and phenylpropanolamine) was not lawfully transferred
to either the corporation or to its new owners) because the written
consent of the Agency was never obtained. See id. 1309.63 (``No
registration or any authority conferred thereby shall be assigned or
otherwise transferred except upon such conditions as the Administrator
may specifically designate and then only pursuant to his written
consent.'').
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\7\ While Respondent relies on Mr. Abodabba's application, it
ignores that under 21 CFR 1309.25(a), this application was not
timely submitted with respect to combination ephedrine products and
thus, not even Mr. Abodabba was not entitled to the exemption. See
GX 1 (application dated July 29, 1997).
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Accordingly, I hold that Respondent has been without authority to
distribute list I chemicals since July 16, 2001 (when Mr. Issa became
its owner), and that all distributions it has made since that date
(including all those listed in the compilation of its 2004 sales) have
been in violation of federal law.\8\ See 21 U.S.C. 822(a). I further
hold that Respondent does not have an application pending before the
agency.
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\8\ Mr. Abodabba is not a party to this proceeding, and I
conclude that it is not necessary to decide whether Respondent's
activities under his ownership were lawful. Moreover, to the extent
this proceeding was brought to deny Mr. Abodabba's application,
which is the only application in the record, see GX 1, service has
not been properly effectuated. See Jones v. Flowers, 547 U.S. 220,
230 (2006) (``[T]he government's knowledge that notice pursuant to
the normal procedure was ineffective triggered an obligation on the
government's part to take additional steps to effect notice.''); see
also id. at 232 (discussing Robinson v. Hanrahan, 409 U.S. 38, 39-40
(1972) (per curiam) (even though state law required vehicle owner to
register his address with the state, ``we found that the State had
not provided constitutionally sufficient notice, despite having
followed its reasonably calculated scheme, because it knew that [the
owner] could not be reached at his address of record'').
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Order
Pursuant to the authority vested in me under 5 U.S.C. 554(e) and 28
CFR 0.100(b) & 0.104, I hereby declare that since July 16, 2001,
Memphis Wholesale Company, Incorporated, has not had authority under 21
CFR 1309.25 to distribute pseudoephedrine, combination ephedrine, and
phenylpropanolamine. This Order is effective immediately.
Dated: March 17, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-6378 Filed 3-27-08; 8:45 am]
BILLING CODE 4410-09-P