H & R Corporation; Denial of Application, 30168-30172 [06-4838]
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and directed him to immediately
surrender his license to practice
medicine. There is no evidence before
the Deputy Administrator that the
Consent Agreement has been modified,
lifted or stayed or that Dr. Brockbank’s
Arizona medical license has been
renewed or reinstated.
Pursuant to 21 U.S.C. 824(a)(3), the
Deputy Administrator may revoke a
DEA Certificate of Registration if she
finds the registrant has had his state
license revoked and is no longer
authorized to dispense controlled
substances in the jurisdiction of
registration. Alternatively, revocation is
authorized if the registrant has
committed such acts as would render
his registration contrary to the public
interest, as determined by factors listed
in 21 U.S.C. 823(f). See Thomas B.
Pelkowski, D.D.S., 57 FR 28,538 (1992).
Nevertheless, despite Dr. Brockbank’s
egregious prescribing activities, his
grossly inappropriate conduct with
female patients and the public interest
factors that are implemented by such
unprofessional and unlawful conduct,
his lack of state authorization to handle
controlled substances is dispositive of
this matter.
DEA does not have statutory authority
under the Controlled Substances Act to
issue or maintain a registration if the
applicant or registrant is without state
authority to handle controlled
substances in the state in which he
conducts business. See 21 U.S.C.
802(21), 823(f) and 824(a)(3). This
prerequisite has been consistently
upheld. See Rory Patrick Doyle, M.D., 69
FR 11,655 (2004); Dominick A. Ricci,
M.D., 58 FR 51,104 (1993); Bobby Watts,
M.D., 53 FR 11,919 (1988).
Here, it is clear Dr. Brockbank
surrendered his medical license and it
is reasonable to infer that he is currently
not authorized to handle controlled
substances in Arizona and is therefore
not entitled to a DEA registration in that
state. As a result of the finding that Dr.
Brockbank lacks any state authorization
to handle controlled substances, the
Deputy Administrator concludes it is
unnecessary to address further whether
his DEA registration should be revoked
based upon the public interest grounds
asserted in the Order to Show Cause and
Immediate Suspension of Registration.
See Gilbert C. Aragon, Jr., D.O., 69 FR
58,536 (2004); Samuel Silas Jackson,
D.D.S., 67 FR 65,145 (2002); NathanielAikens-Afful, M.D., 62 FR 16,871
(1997); Sam F. Moore, D.V.M., 58 FR
14,428 (1993).
Accordingly, the Deputy
Administrator of the Drug Enforcement
Administration, pursuant to the
authority vested in her by 21 U.S.C. 823
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and 824 and 28 CFR 0.100(b) and 0.104,
hereby orders that DEA Certificate of
Registration, AB2053027, issued to
Kevin Dean Brockbank, M.D., be, and it
hereby is, revoked. The Deputy
Administrator further orders that any
pending applications for renewal or
modification of such registration be, and
they hereby are, denied. This order is
effective June 26, 2006.
Dated: May 5, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 06–4837 Filed 5–24–06; 8:45am]
BILLING CODE 4410–09–M
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 03–26]
H & R Corporation; Denial of
Application
On April 7, 2003, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA) issued an Order
to Show Cause to H & R Corporation
(Respondent H & R) proposing to deny
its application for a DEA Certificate of
Registration as a distributor of list I
chemicals. The Order to Show Cause
alleged in substance that granting
Respondent’s application to distribute
list I chemicals to what DEA has
identified as the ‘‘gray market,’’ would
be inconsistent with the public interest,
as that term is used in 21 U.S.C. 823(h)
and 824(a).
Respondent, through counsel,
requested a hearing on the issues raised
by the Order to Show Cause and the
matter was docketed before
Administrative Law Judge Mary Ellen
Bittner. Following prehearing
procedures, a hearing was held in
Atlanta, Georgia on October 28, 2003. At
the hearing, both parties called
witnesses to testify and introduced
documentary evidence. Subsequently,
both parties filed Proposed Findings of
Fact, Conclusions of Law, and
Argument.
On December 3, 2004, Judge Bittner
issued her Opinion and Recommended
Ruling, Findings of Fact, Conclusions of
Law, and Decision of the Administrative
Law Judge (Opinion and Recommended
Ruling), recommending that
Respondent’s application for a
Certificate of Registration as a
distributor of listed chemical products
be denied. Neither party filed
exceptions to the Opinion and
Recommended Ruling and on January
11, 2005, judge Bittner transmitted the
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record of these proceedings to the
Deputy Administrator.
The Deputy Administrator has
considered the record in its entirety and
pursuant to 21 CFR 1316.67, hereby
issues her final order based upon
findings of fact and conclusions of law
hereinafter set forth. The Deputy
Administrator adopts, in full, the
Opinion and Recommended Ruling of
the Administrative Law Judge. Her
adoption is in no manner diminished by
any recitation of facts, issues and
conclusions herein, or any failure to
mention a matter of fact or law.
In April 2002, Respondent, a
Tennessee corporation owned by
members of the Patel family, submitted
an application for DEA Certificate of
Registration as a distributor of list I
chemicals, seeking authority to
distribute pseudoephedrine, ephedrine
and phenylpropanolamine. Mr. Ramu
Patel (Mr. Patel) owns 50 per cent of the
business and the remainder is owned by
R. Patel’s uncle, Hasmukh Patel (H.
Patel) and his brothers, Mahendra and
Kantibhai Patel. Mr. Patel and H. Patel
are Respondent’s only employees.
H & R also does business under the
name ‘‘Tri-State Wholesale,’’ a name
used previously used by Elk
International, Inc. (Elk International)
when that company was operating out
of the Chattanooga-area premises where
H & R is now located. On May 1, 2001,
Elk International filed an application for
DEA registration as a distributor of list
I chemicals. An Order to Show Cause
was issued proposing to deny Elk
International’s application and H & R
subsequently purchased the right to use
the name ‘‘Tri-State Wholesale’’ from
the company, along with its customer
list. The Elk International matter was
administratively closed as it was no
longer in business at the location and
H & R ultimately then submitted its
application for registration, which is the
subject of these proceedings.
H & R is a wholesale supplier of
tobacco products, hair products and
paper supplies to tobacco and
convenience stores and what Mr. Patel
referred to as ‘‘mom and pop’’ stores.
Mr. Panel testified that he and his uncle
previously owned retail tobacco stores/
outlets in Dalton and Chickamauga,
Georgia and his store had sold MiniThins and ephedrine products, along
with tobacco products and other
sundries.
List I chemicals are those that may be
used in the manufacture of a controlled
substance in violation of the Controlled
Substances Act. 21 U.S.C. 802(34); 21
CFR 1310.02(a). Pseudoephedrine and
ephedrine are list I chemicals which are
legitimately manufactured and
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distributed in single entity and
combination forms as decongestants and
bronchodilators, respectively. Both are
used as precursor chemicals in the illicit
manufacture of methamphetamine and
amphetamine.
Phenylpropanolamine, also a list I
chemical, is a legitimately manufactured
and distributed product used to provide
relief of the symptoms resulting from
inflammation of the sinus, nasal and
upper respiratory tract tissues and for
weight control. Phenylpropanolamine is
also used as a precursor in the illicit
manufacture of methamphetamine and
amphetamine. See, Gazaly Trading, 69
FR 22561 (2004). In November 2000, the
United States Food and Drug
Administration issued a public health
advisory requesting drug companies to
discontinue marketing products
containing phenylpropanolamine, due
to risk of hemorrhagic stroke. As a
result, many pharmaceutical companies
have stopped using
phenylpropanolamine as an active
ingredient.
As testified to by government
witnesses and as addressed in previous
DEA final orders, methamphetamine is
an extremely potent central nervous
system stimulant and its abuse is a
persistent and growing problem in the
United States. See e.g., Direct
Wholesale, 69 FR 11654 (2004); Branex,
Inc., 69 FR 8682 (2004); Yemen
Wholesale Tobacco and Candy Supply,
Inc., 67 FR 9997 (2002); Denver
Wholesale, 67 FR 99986 (2002).
A Special Agent from DEA’s
Chattanooga, Tennessee, Resident Office
testified regarding the rapid
proliferation of clandestine
methamphetamine laboratories in
Tennessee and its adjoining states and
described prevalent methods of local
production. He also described the
multiple health hazards and social costs
stemming from the production and
abuse of methamphetamine in
Southeastern Tennessee. In sum, he
deemed it ‘‘more than a legal issue; it is
a terrible social issue.’’
As recognized in recent published
final orders, Tennessee has led the DEA
Atlanta Region in the number of
clandestine laboratories seized. See
Prachi Enterprises, Inc., 69 FR 69407
(2004); CWK Enterprises, Inc., 69 FR
69400 (2004). Further, the Chattanooga/
Eastern Tennessee area, where H & R
seeks to distribute chemicals, has a
‘‘substantial’’ methamphetamine abuse
problem and it has been recognized that
local ‘‘[d]istributors or retailers serving
the illicit methamphetamine trade
observe no borders and trade across
state lines.’’ Id., 69 FR at 69401.
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The Special Agent estimated that 80
to 90 percent of ephedrine and
pseudoephedrine used by area
methamphetamine manufacturers was
obtained from convenience stores. More
often than not, the ephedrine and
pseudoephedrine products were ‘‘off
name’’ brands, with Max Brand the most
prevalent encountered at illicit
laboratories. He also sees products at
these sites with brand names such as
Mini-Thins, Mini-Tabs, Pseudo-60’s and
Z-60’s and the preferred
pseudoephedrine is of 60 mg. strength.
The Special Agent testified that
convenience stores are readily able to
purchase ephedrine and
pseudoephedrine and may use several
distributors simultaneously for these
products. Further, persons seeking to
buy ephedrine and pseudoephedrine
from convenience stores for illicit
manufacturing typically go to many
stores and buy small quantities from
each, or recruit four or five people, who
each purchase chemicals from a single
store. Often store personnel allow the
same individual to complete multiple
purchases in a short period of time and
some convenience stores even cater to
manufacturers, selling other products
used in the manufacturing process such
as coffee filters, antifreeze, and Heet fuel
which, for certain customers were even
packaged in manufacturing ‘‘kits.’’
Diversion Investigators testified that,
in general, persons purchasing
pseudoephedrine and ephedrine for
legitimate therapeutic purposes bought
their products, packaged in blister packs
and in smaller dosage units and
strengths, at traditional drug stores,
grocery stores and large discount stores.
By written declaration, a DEA
Diversion Investigator contrasted the
‘‘traditional’’ market for list I chemicals
with what DEA has termed the ‘‘gray
market’’ for these products. The
traditional market, characterized by a
short distribution chain from
manufacturer to distributor to retailer,
typically includes large chain grocery
stores, chain pharmacies, large
convenience stores and large discount
stores. The gray market is characterized
by additional layers of distribution and
includes such non-traditional retailers
as small convenience stores, gas stations
and other retail establishments where
customers do not usually purchase overthe-counter medications. These nontraditional retailers typically sell higherstrength products in large package sizes,
such as 100 or 120 count bottles of 60
mg. pseudoephedrine. The Diversion
Investigator also identified the brand
names found at clandestine laboratory
seizures in disproportionate numbers.
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They included Max Brand, Mini Two
Way, MiniThin and Action-Pseudo.
A Group Supervisor from DEA’s
Nashville office testified that, in his
view, the demand for pseudoephedrine
and ephedrine for legitimate medical
purposes did not justify the supply and
much of these chemicals were being
diverted at the convenience store level.
By declaration, the Government
introduced evidence regarding
ephedrine and pseudoephedrine sales
and the convenience store market from
Mr. Jonathan Robbin, a consultant in
marketing information systems and
databases, who is an expert in statistical
analysis and quantitative marketing
research.
Using the 1997 United States
Economic Census of Retail Trade, Mr.
Robbin tabulated data indicating that
over 97% of all sales of non-prescription
drug products, including nonprescription cough, cold and nasal
congestion remedies, occur in drug
stores and pharmacies, supermarkets,
large discount merchandisers, mailorder houses and through electronic
shopping. He characterized these five
retail industries as the traditional
marketplace where such goods are
purchased by ordinary customers.
Analyzing national sales data specific
to over-the-counter, non-prescription
drugs containing pseudoephedrine, Mr.
Robbin’s research and analysis showed
that a very small percentage of the sales
of such goods occur in convenience
stores—only about 2.6% of the HABC
[Health and Beauty Care] category of
merchandise or 0.05% of total in-store
(non-gasoline) sales. He determined that
the normal expected retail sales of
pseudoephedrine tablets in a
convenience store would range between
$10.00 and $30.00 per month, with an
average monthly sales figure of about
$20.00 and the sales of more than
$100.00 in a month would be expected
to occur in a random sampling about
once in one million to the tenth power,
a number he characterized as nearly
equivalent to the number of atoms in the
universe. He further stated that the
current convenience store gross margin
in the health and beauty care category
is about 40 percent, so that such a store
could be expected to spend an average
of $12.00 per month acquiring its
inventory of pseudoephedrine products
from a distributor.
In October 2002, a pre-registration
inspection was performed at H & R’s
facility by a DEA Diversion Investigator.
Mr. Patel advised the Diversion
Investigator that H & R had purchased
its customer list from Elk International
and its customers were mainly
convenience stores and gasoline stations
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located within 30 miles of Chattanooga.
He identified several listed products H
& R intended to sell which are normally
sold in the traditional market. Of
concern, he also advised the Diversion
Investigator that the company would
carry whatever products its customers
wanted to buy. At the hearing, Mr. Patel
then testified that customers had
brought him samples of products they
wanted and specifically asked for Max
Brand Pseudo 60s. However, he had not
yet identified a supplier for that
product.
Max Brand Pseudo 60s has been
identified by DEA as ‘‘the precursor
product predominantly encountered
and seized at clandestine
methamphetamine laboratories’’ and
convenience stores are the ‘‘primary
source’’ for the purchase of ‘‘Max Brand
products, which are the preferred brand
for use by illicit methamphetamine
producers * * *.’’ Express Wholesale,
69 FR 62086, 62087 (2004); see also
RAM, Inc. d/b/a/ American Wholesale
Distribution Corp., 70 FR 11693 (2005).
The Diversion Investigator found
Respondent’s physical security adequate
and its monitoring, storage and
recordkeeping systems an improvement
over Elk International’s systems.
At the time of the hearing, Mr. Patel
testified H & R then had about 385
customers. He also provided a list of 459
businesses, not all of whom were actual
customers. At least 27 of these
customers were located in cities some
distance from Chattanooga, including
Knoxville and Nashville, Tennessee;
Atlanta, Summerville, Americus,
Griffin, Rome, Tucker and Lakeland,
Georgia; Huntsville, Chickasaw, Decatur
and Mobile, Alabama; Myrtle Beach and
Greenville, South Carolina; Gainsville,
Florida; Kansas City, Missouri; and
Woodstock, Illinois.
While Mr. Patel testified H & R would
not sell listed chemicals to customers in
Mobile, Woodstock and Gainesville, he
did not specify whether he would sell
to the customers at other distant
locations on the list. He further testified
H & R delivered to local customers but
others, including those from nashville
and Atlanta, would have to come to the
Chattanooga facility to pick up orders.
A DEA Special Agent testified he
recognized at least ten names on
Respondent’s customer list as being
under investigation by DEA, state or
local law enforcement agencies for
involvement in distribution of
ephedrine or other chemicals associated
with methamphetamine manufacturing.
A Supervisory Investigator testified that
Respondent’s customer list also
included distributors who were already
registered to sell list I chemicals.
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Mr. Patel testified he would not sell
over-threshold quantities of list I
chemicals to customers, but he could
not say how much he would sell. He
estimated that in addition to other
products, he expected an average
convenience store to order one or two
dozen bottles of Mini Thins per month,
which would probably retail at $6.99
per bottle.
H. Patel did not testify, but submitted
a post-hearing affidavit in which he
stated that if Respondent’s application
were granted, they were willing to
‘‘work with DEA to limit the amount of
ephedrine and single ingredient
pseudoephedrine products we sell’’ and
would not sell to customers being
investigated by DEA. He also stated that
H & R’s customers requested that it carry
listed chemicals, as they wanted to
make their purchases from one
distributor. H. Patel admitted having no
experience selling listed chemicals at
the wholesale level and did not know
how much of these products H & R’s
customers might buy.
Mr. Patel testified that neither he nor
his uncle had criminal records and the
Government offered no evidence to the
contrary.
Pursuant to 21 U.S.C. 823(h), the
Deputy Administrator may deny an
application for a Certificate of
Registration if she determines that
granting the registration would be
inconsistent with the public interest, as
determined under that section. Section
823(h) requires the following factors be
considered in determining the public
interest:
(1) Maintenance of effective controls
against diversion of listed chemicals
into other than legitimate channels;
(2) Compliance with applicable
Federal, State, and local law;
(3) Any prior conviction record under
Federal or State laws relating to
controlled substances or to chemicals
controlled under Federal or State law;
(4) Any past experience in the
manufacture and distribution of
chemicals; and
(5) Such other factors as are relevant
to and consistent with the public health
and safety.
As with the public interest analysis
for practitioners and pharmacies
pursuant to subsection (f) of section 823,
these factors are to be considered in the
disjunctive; the Deputy Administrator
may rely on any one or combination of
factors, and may give each factor the
weight she deems appropriate in
determining whether a registration
should be revoked or an application for
registration denied. See, e.g., Direct
Wholesale, 69 FR 11654 (2004); Energy
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Outlet, 64 FR 14269 (1999); Henry J.
Schwartz, Jr., M.D., 54 FR 16422 (1989).
As to factor one, maintenance by the
applicant of effective controls against
diversion, the Deputy Administrator
agrees with Judge Bittner that H & R’s
proposed physical security and
recordkeeping arrangements were
adequate. Judge Bittner also found that
Respondent did not disput the
Government’s evidence that
convenience stores are a major source of
diversion of list I chemicals.
Judge Bittner phrased the key issue in
factor one as whether Respondent
would sell listed chemicals to retailers
who were likely to divert them. In
concluding this factor weighed against
registration, Judge Bittner took
particular note that Mr. Patel’s estimates
of anticipated sales were several times
larger than what Mr. Robbin’s research
indicated a convenience store would
legitimately sell.
Additionally, at least ten customers
on Respondent’s list were under
investigation for involvement in the
distribution of chemicals associated
with illicit methamphetamine
manufacturing. Red flags were further
raised by Mr. Patel’s failure to
specifically testify whether he would
refuse to sell listed chemicals to
customers located substantial distances
from H & R’s Chattanooga facility.
The Deputy Administrator is
particularly concerned with Mr. Patel’s
willingness to sell ‘‘whatever’’ products
his customers wanted. Coupled with the
specific requests from its gray market
customers that the company carry Max
Brand Pseudo 60’s, the preferred
precursor of illicit manufacturers, the
risk of diversion should the application
be approved, is apparent. See, RAM,
Inc. d/b/a American Wholesale
Distribution Corp., supra, 70 FR 11693,
11694.
Judge Bittner acknowledged
applicability of a previously published
DEA final order in which registration
was denied an applicant who, much like
Respondent, was seeking registration to
distribute list I chemicals in the gray
market. In that case, Xtreme Enterprises,
Inc., 67 FR 76195 (2002), there was no
evidence the applicant’s owner had
failed to comply with Federal, State or
local law or that she had any prior
convictions relating to controlled
substances or chemicals. Further, she
was willing to provide adequate security
for the listed chemicals.
However, the Deputy Administrator
found the applicant’s owner had only a
rudimentary knowledge of what would
constitute a suspicious order and no
experience in the manufacture or
distribution of listed chemicals. Most
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significant, for purposes of this and
similar cases, the Deputy Administrator
also found that ‘‘[v]irtually all of the
Respondent’s customers, consisting of
gas station and convenience stores, are
considered part of the grey market, in
which large amounts of listed chemicals
are diverted to the illicit manufacture of
amphetamine and methamphetamine.’’
Xtreme Enterprises, Inc., supra, 67 FR at
76197.
Citing Xtreme Enterprises, Judge
Bittner concluded that factor one
(maintenance of controls against
diversion), weighed against granting H &
R’s application. The Deputy
Administrator agrees, noting DEA has
applied this analysis in numerous final
orders published after Xtreme
Enterprises was decided. See, e.g.,
Express Wholesale, supra, 69 FR 62086;
Value Wholesale, 69 FR 58548 (2004); K
& Z Enterprises, Inc., 69 FR 51475
(2004); William E. ‘‘Bill’’ Smith d/b/a B
& B Wholesale, 69 FR 22559 (2004);
Branex Incorporated, supra, 69 FR 8682:
Shop It for Profit, 69 1,311 (2003); Shani
Distributors, 68 FR 62324 (2003).
Judge Bittner found Respondent had
complied with applicable Federal, State
and local laws and its owners have not
been convicted of any crimes relating to
controlled substances or listed
chemicals. Thus, she concluded that
factors two and three weigh in favor of
registration. Based on the record that
was before the Administrative Law
Judge, the Deputy Administrator agrees.
However, as discussed in depth under
factor five, after the Opinion and
Recommended Ruling was issued, state
legislation was enacted making it illegal
to sell tableted pseudoephedrine
products in Tennessee, outside of
licensed pharmacies. Thus, to the extent
that Respondent’s Tennessee gray
market customer base is no longer
authorized to sell those products under
state law, factor two is adversely
impacted and weighs against
registration.
With regard to factor four, the
applicant’s past experience in
distributing listed chemicals, Judge
Bittner found that while Mr. Patel had
previously sold listed chemical
products in his retail tobacco outlet,
neither of H & R’s owners/employees
had experience selling listed chemicals
at the wholesale level. Judge Bittner
therefore found this factor weighed in
favor of a finding that H & R’s
registration would be inconsistent with
the public interest. The Deputy
Administrator agrees with that
conclusion.
With regard to factor five, other
factors relevant to public health and
safety, Judge Bittner was ‘‘not persuaded
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that Respondent will limit its sales of
listed chemicals to the quantities that
convenience stores are likely to sell to
legitimate customers.’’ She thus found
this factor also weighed against
registration. The Deputy Administrator
concurs.
Unlawful methamphetamine
production and use is a growing public
health and safety concern throughout
the United States and specificially in
the localities where Respondent intends
to do business. Pseudoephedrine and
ephedrine are the precursor products
used to manufacture methamphetamine
and area laboratory operators
predominantly acquire their precursor
chemicals from the customer base
Respondent seeks to serve. While the
Patels indicated some intent to avoid
contributing to this scourge, the risk of
diversion once listed chemicals enter
the gray market is real, substantial and
compelling.
The Deputy Administrator concludes
Judge Bittner correctly applied DEA
precedent. As in Xtreme Enterprise,
supra, the Respondent’s owners’ lack of
criminal records, their previous
compliance with the law and any
professed willingness to comply with
regulations and guard against diversion,
are far outweighed by the intent to sell
ephedrine and pseudoephedrine, almost
exclusively, in the gray market.
This reasoning has been consistently
applied by the Deputy Administrator in
a series of recently published final
orders denying registration to potential
gray market distributors. See, RAM, Inc.
d/b/a American Wholesale Distribution
Corp., supra, 70 FR 11693; Al-Alousi,
Inc., 70 FR 3561 (2005); Volusia
Wholesale, supra, 69 FR 69409; Prachi
Enterprises, Inc., supra, 69 FR 69407;
CWK Enterprises, Inc., 69 FR 69400
(2004); J & S Distributors, 69 FR 62089
(2004); Express Wholesale, supra, 69 FR
62086; Absolute Distributing, Inc., 69
FR 62078 (2004); Value Wholesale,
supra, 69 FR 58548 (2004); John E.
McRae d/b/a J & H Wholesale, 69 FR
51480 (2004).
While not addressed in the Opinion
and Recommended Ruling, the Deputy
Administrator notes that state
legislatures throughout the United
States are actively considering
legislation designed to impede the ready
availability of precursor chemicals.
Many of these proposals are similar to
legislation enacted by the State of
Oklahoma, titled the ‘‘Oklahoma
Methamphetamine Reduction Act of
2004.’’ Under that measure, as of April
6, 2004, pseudoephedrine tablets were
designated as Schedule V controlled
substances and may be sold only from
licensed pharmacies within that state.
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As a result, it is prohibited in
Oklahoma to sell these products from
gray market establishments, such as
independent convenience stores, which
have contributed so much to the scourge
of methamphetamine abuse. See, e.g.,
Express Wholesale, supra, 69 FR at
62809 [denying DEA registration to an
Oklahoma gray market distributor, in
part, because of new state restrictions].
A review of data for 2004 reveals the
Oklahoma law has resulted in an
apparent reduction in the number of
seizures involving clandestine
methamphetamine laboratories in that
state. These developments are
encouraging and represent an important
step in the ongoing battle to curb
methamphetamine abuse in the United
States. State legislation, such as
Oklahoma’s, reflects a positive trend
and growing recognition that the
diversion of precursor chemicals
through the gray market insidiously
impacts public health and safety. See,
e.g., Tysa Management,
d/b/a Osmani Lucky Wholesale, 70 FR
12732, 12734 (2005) [denying
registration to intended Oklahoma
distributor, in part, on basis of
enactment of recent state legislation];
Express Wholesale, supra, 69 FR at
62089.
Of particular consequence to H & R
and similarly situated Tennessee
applicants and registrants, after Judge
Bittner signed her Opinion and
Recommended Ruling, legislation was
enacted by the State of Tennessee that
is patterned after the Oklahoma
initiative. That legislation (Senate Bill
2318/House Bill 2334), collectively
known as the ‘‘Meth-Free Tennessee Act
of 2005,’’ was signed into law by
Governor Phil Bredeson on March 31,
2005, and makes it unlawful for
establishments, other than licensed
pharmacies, to sell tableted
pseudoephedrine products in Tennessee
after April 1, 2005. This includes both
name brand and off-name brand
products.
Accordingly, Respondent’s entire
intended Tennessee customer base is
now prohibited by state law from selling
the pseudoephedrine products H & R
seeks DEA registration to distribute.
This adversely implicates factors five
and two and weighs heavily against
registration. See, Tysa Management, d/
b/a Osmani Lucky Wholesale, supra, 70
FR at 12734; Express Wholesale, supra,
69 FR at 62089.
Factor five is also relevant to H & R’s
proposal to distribute chemicals to
customers under criminal investigation.
The conduct of a potential customer has
previously been deemed a relevant
consideration under factor five. See,
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Federal Register / Vol. 71, No. 101 / Thursday, May 25, 2006 / Notices
Gazaly Trading, supra, 69 FR 22561;
Shani Distributors, supra, 68 FR 62326.
Finally, it is noted that Respondent
seeks to distribute
phenylpropanolamine. Accordingly, the
Deputy Administrator finds factor five
relevant to H & R’s request to distribute
phenylpropanolamine and the apparent
lack of safety associated with the use of
that product. DEA has previously
determined that an applicant’s request
to distribute phenylpropanolamine
constitutes a ground under factor five
for denial of an application for
registration. See, J & S Distributors,
supra, 69 FR 62089; Gazaly Trading,
supra, 69 FR 22561; William E. ‘‘Bill’’
Smith d/b/a B & B Wholesale, supra, 69
FR 22559; Shani Distributors, supra, 68
FR 62324.
Based on the foregoing, the Deputy
Administrator concludes that granting
Respondent’s pending application
would be inconsistent with the public
interest.
Accordingly, the Deputy
Administrator of the Drug Enforcement
Administration, pursuant to the
authority vested in her by 21 U.S.C. 823
and CFR 0.100(b) and 0.104, hereby
orders that the pending application for
a DEA Certificate of Registration,
previously submitted by H & R
Corporation, be, and it hereby is,
denied. This order is effective June 26,
2006.
Dated: May 5, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 06–4838 Filed 5–24–06; 8:45am]
BILLING CODE 4410–09–M
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
cchase on PROD1PC60 with NOTICES
Sidney S. Loxley, M.D.; Revocation of
Registration
On January 25, 2005, the Deputy
Administrator of the Drug Enforcement
Administration (DEA) issued an Order
to Show Cause and Immediate
Suspension of Registration to Sidney S.
Loxley, M.D. (Dr. Loxley) of
Chesapeake, Virginia. Dr. Loxley was
notified of an opportunity to show cause
as to why DEA should not revoke his
DEA Certificate of Registration,
AL6366428, as a practitioner, and deny
any pending applications for renewal or
modification of that registration
pursuant to 21 U.S.C. 823(f) and
824(a)(4) on the basis that his continued
registration would be inconsistent with
the public interest. Dr. Loxley was
further notified that pursuant to 21
U.S.C. 824(d), his DEA registration was
VerDate Aug<31>2005
16:42 May 24, 2006
Jkt 208001
being immediately suspended as an
imminent danger to the public health
and safety.
The Order to Show Cause and
Immediate Suspension of Registration
alleged that Dr. Loxley had been the
subject of two prior disciplinary
proceedings before the Virginia Board of
Medicine (Virginia Board). In June 1993,
his medical license had been suspended
for 16 months as a result of his abusing
the patient-doctor relationship by
engaging in a sexual relationship with a
minor and for a related misdemeanor
conviction of contributing to the
delinquency of a minor. His state
license was reinstated in October 1994
but in a subsequent disciplinary
proceeding occurring in October 2003, it
was placed on probation for a period of
not less than three years. At that time
the Virginia Board found, along with
several controlled substance
recordkeeping violations reflecting gross
incompetence, that Dr. Loxley had
improperly prescribed controlled
substances to his wife, who was not his
patient and was chemically dependent.
As a condition of his probation, Dr.
Loxley was directed to complete a Board
approved course in the proper
prescribing of controlled substances.
The Order to Show Cause and
Immediate Suspension of Registration
alleged, in sum, that Dr. Loxley had
been issuing prescriptions for large
amounts of controlled substances to
individuals without the physical
examinations, testing or evaluations
which are consistent with a legitimate
doctor-patient relationship. These
prescriptions were not issued for
legitimate medical purposes or in the
usual course of professional treatment,
thus violating 21 CFR 1306.04 and 21
U.S.C. 841(a). It was further alleged that
between September 2003 and May 2004,
on ten separate occasions Dr. Loxley
issued prescriptions under these
circumstances to a DEA Special Agent
and a confidential source who had been
posing undercover as patients. Profiles
obtained from area pharmacies covering
the period between August and
December 2004 indicated he was
continuously prescribing large
quantities of controlled narcotic
substances, primarily oxycodone and
hydrocodone, in 120 tablet quantities to
patients without apparent legitimate
medical reasons and supplier records
shows that Dr. Loxley was the largest
orderer of Demerol (meperidine), among
all orthopedic surgeons in the Virginia
Tidewater area.
Finally, it was alleged that four
patients of Dr. Loxley had died while
under his care as a result of possible
excessive prescribing, that he prescribed
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
controlled substances while under the
influence of alcohol and had recently
been convicted of driving while
intoxicated in state court.
According to the investigative file, the
Order to Show Cause and Immediate
Suspension of Registration was
personally served on Dr. Loxley by a
DEA Diversion Investigator on January
27, 2005. More than thirty days have
passed since service of the Order to
Show Cause and Immediate Suspension
of Registration and DEA has not
received a request for hearing or any
other reply from Dr. Loxley or anyone
purporting to represent him in this
matter.
Therefore, the Deputy Administrator
of DEA, finding that (1) thirty days
having passed since the delivery of the
Order to Show Cause and Immediate
Suspension of Registration to Dr.
Loxley, and (2) not request for hearing
having been received, concludes that Dr.
Loxley is deemed to have waived his
hearing right. See David W. Linder, 67
FR 12579 (2002). After considering
material from the investigative file in
this matter, the Deputy Administrator
now enters her final order without a
hearing pursuant 21 CFR 1301.43(d) and
(e) and 1301.46.
The Deputy Administrator finds the
Dr. Loxley is currently registered with
DEA as a practitioner under DEA
Certificate of Registration AL 6366424.
According to information in the
investigative file, on January 20, 2005,
and indictment was unsealed by order
of the United States District court,
Eastern District of Virginia (Norfolk),
charging Dr. Loxley with 91 felony
counts relating to the unlawful
distribution and dispensing of
controlled substances without a
legitimate medical purpose under 21
U.S.C. 841(a)(1) and (b)(1)C). The
indictment includes four counts alleging
that a death had resulted from Dr.
Loxley’s unlawful distribution and
dispensing. On the date the indictment
was unsealed, Dr. Loxley was arrested
and he remains in custody pending trial
in the matter of USA v. Sidney Loxley
(Case No. 2:04–cr–00236–WDK–JEB–
ALL).
On February 25, 2005, the Virginia
Board notified Dr. Loxley that an
informal conference had been scheduled
to address allegations of multiple
violations of state laws and regulations
governing the practice of medicine and
surgery and an allegation that he was
unfit for the performance of his
professional obligations and duties and
unable to practice medicine with
reasonable skill and safety. In response,
Dr. Loxley advised the Virginia Board
that he was currently unable to address
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[Federal Register Volume 71, Number 101 (Thursday, May 25, 2006)]
[Notices]
[Pages 30168-30172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4838]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 03-26]
H & R Corporation; Denial of Application
On April 7, 2003, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA) issued an
Order to Show Cause to H & R Corporation (Respondent H & R) proposing
to deny its application for a DEA Certificate of Registration as a
distributor of list I chemicals. The Order to Show Cause alleged in
substance that granting Respondent's application to distribute list I
chemicals to what DEA has identified as the ``gray market,'' would be
inconsistent with the public interest, as that term is used in 21
U.S.C. 823(h) and 824(a).
Respondent, through counsel, requested a hearing on the issues
raised by the Order to Show Cause and the matter was docketed before
Administrative Law Judge Mary Ellen Bittner. Following prehearing
procedures, a hearing was held in Atlanta, Georgia on October 28, 2003.
At the hearing, both parties called witnesses to testify and introduced
documentary evidence. Subsequently, both parties filed Proposed
Findings of Fact, Conclusions of Law, and Argument.
On December 3, 2004, Judge Bittner issued her Opinion and
Recommended Ruling, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge (Opinion and Recommended Ruling),
recommending that Respondent's application for a Certificate of
Registration as a distributor of listed chemical products be denied.
Neither party filed exceptions to the Opinion and Recommended Ruling
and on January 11, 2005, judge Bittner transmitted the record of these
proceedings to the Deputy Administrator.
The Deputy Administrator has considered the record in its entirety
and pursuant to 21 CFR 1316.67, hereby issues her final order based
upon findings of fact and conclusions of law hereinafter set forth. The
Deputy Administrator adopts, in full, the Opinion and Recommended
Ruling of the Administrative Law Judge. Her adoption is in no manner
diminished by any recitation of facts, issues and conclusions herein,
or any failure to mention a matter of fact or law.
In April 2002, Respondent, a Tennessee corporation owned by members
of the Patel family, submitted an application for DEA Certificate of
Registration as a distributor of list I chemicals, seeking authority to
distribute pseudoephedrine, ephedrine and phenylpropanolamine. Mr. Ramu
Patel (Mr. Patel) owns 50 per cent of the business and the remainder is
owned by R. Patel's uncle, Hasmukh Patel (H. Patel) and his brothers,
Mahendra and Kantibhai Patel. Mr. Patel and H. Patel are Respondent's
only employees.
H & R also does business under the name ``Tri-State Wholesale,'' a
name used previously used by Elk International, Inc. (Elk
International) when that company was operating out of the Chattanooga-
area premises where H & R is now located. On May 1, 2001, Elk
International filed an application for DEA registration as a
distributor of list I chemicals. An Order to Show Cause was issued
proposing to deny Elk International's application and H & R
subsequently purchased the right to use the name ``Tri-State
Wholesale'' from the company, along with its customer list. The Elk
International matter was administratively closed as it was no longer in
business at the location and H & R ultimately then submitted its
application for registration, which is the subject of these
proceedings.
H & R is a wholesale supplier of tobacco products, hair products
and paper supplies to tobacco and convenience stores and what Mr. Patel
referred to as ``mom and pop'' stores. Mr. Panel testified that he and
his uncle previously owned retail tobacco stores/outlets in Dalton and
Chickamauga, Georgia and his store had sold Mini-Thins and ephedrine
products, along with tobacco products and other sundries.
List I chemicals are those that may be used in the manufacture of a
controlled substance in violation of the Controlled Substances Act. 21
U.S.C. 802(34); 21 CFR 1310.02(a). Pseudoephedrine and ephedrine are
list I chemicals which are legitimately manufactured and
[[Page 30169]]
distributed in single entity and combination forms as decongestants and
bronchodilators, respectively. Both are used as precursor chemicals in
the illicit manufacture of methamphetamine and amphetamine.
Phenylpropanolamine, also a list I chemical, is a legitimately
manufactured and distributed product used to provide relief of the
symptoms resulting from inflammation of the sinus, nasal and upper
respiratory tract tissues and for weight control. Phenylpropanolamine
is also used as a precursor in the illicit manufacture of
methamphetamine and amphetamine. See, Gazaly Trading, 69 FR 22561
(2004). In November 2000, the United States Food and Drug
Administration issued a public health advisory requesting drug
companies to discontinue marketing products containing
phenylpropanolamine, due to risk of hemorrhagic stroke. As a result,
many pharmaceutical companies have stopped using phenylpropanolamine as
an active ingredient.
As testified to by government witnesses and as addressed in
previous DEA final orders, methamphetamine is an extremely potent
central nervous system stimulant and its abuse is a persistent and
growing problem in the United States. See e.g., Direct Wholesale, 69 FR
11654 (2004); Branex, Inc., 69 FR 8682 (2004); Yemen Wholesale Tobacco
and Candy Supply, Inc., 67 FR 9997 (2002); Denver Wholesale, 67 FR
99986 (2002).
A Special Agent from DEA's Chattanooga, Tennessee, Resident Office
testified regarding the rapid proliferation of clandestine
methamphetamine laboratories in Tennessee and its adjoining states and
described prevalent methods of local production. He also described the
multiple health hazards and social costs stemming from the production
and abuse of methamphetamine in Southeastern Tennessee. In sum, he
deemed it ``more than a legal issue; it is a terrible social issue.''
As recognized in recent published final orders, Tennessee has led
the DEA Atlanta Region in the number of clandestine laboratories
seized. See Prachi Enterprises, Inc., 69 FR 69407 (2004); CWK
Enterprises, Inc., 69 FR 69400 (2004). Further, the Chattanooga/Eastern
Tennessee area, where H & R seeks to distribute chemicals, has a
``substantial'' methamphetamine abuse problem and it has been
recognized that local ``[d]istributors or retailers serving the illicit
methamphetamine trade observe no borders and trade across state
lines.'' Id., 69 FR at 69401.
The Special Agent estimated that 80 to 90 percent of ephedrine and
pseudoephedrine used by area methamphetamine manufacturers was obtained
from convenience stores. More often than not, the ephedrine and
pseudoephedrine products were ``off name'' brands, with Max Brand the
most prevalent encountered at illicit laboratories. He also sees
products at these sites with brand names such as Mini-Thins, Mini-Tabs,
Pseudo-60's and Z-60's and the preferred pseudoephedrine is of 60 mg.
strength.
The Special Agent testified that convenience stores are readily
able to purchase ephedrine and pseudoephedrine and may use several
distributors simultaneously for these products. Further, persons
seeking to buy ephedrine and pseudoephedrine from convenience stores
for illicit manufacturing typically go to many stores and buy small
quantities from each, or recruit four or five people, who each purchase
chemicals from a single store. Often store personnel allow the same
individual to complete multiple purchases in a short period of time and
some convenience stores even cater to manufacturers, selling other
products used in the manufacturing process such as coffee filters,
antifreeze, and Heet fuel which, for certain customers were even
packaged in manufacturing ``kits.''
Diversion Investigators testified that, in general, persons
purchasing pseudoephedrine and ephedrine for legitimate therapeutic
purposes bought their products, packaged in blister packs and in
smaller dosage units and strengths, at traditional drug stores, grocery
stores and large discount stores.
By written declaration, a DEA Diversion Investigator contrasted the
``traditional'' market for list I chemicals with what DEA has termed
the ``gray market'' for these products. The traditional market,
characterized by a short distribution chain from manufacturer to
distributor to retailer, typically includes large chain grocery stores,
chain pharmacies, large convenience stores and large discount stores.
The gray market is characterized by additional layers of distribution
and includes such non-traditional retailers as small convenience
stores, gas stations and other retail establishments where customers do
not usually purchase over-the-counter medications. These non-
traditional retailers typically sell higher-strength products in large
package sizes, such as 100 or 120 count bottles of 60 mg.
pseudoephedrine. The Diversion Investigator also identified the brand
names found at clandestine laboratory seizures in disproportionate
numbers. They included Max Brand, Mini Two Way, MiniThin and Action-
Pseudo.
A Group Supervisor from DEA's Nashville office testified that, in
his view, the demand for pseudoephedrine and ephedrine for legitimate
medical purposes did not justify the supply and much of these chemicals
were being diverted at the convenience store level.
By declaration, the Government introduced evidence regarding
ephedrine and pseudoephedrine sales and the convenience store market
from Mr. Jonathan Robbin, a consultant in marketing information systems
and databases, who is an expert in statistical analysis and
quantitative marketing research.
Using the 1997 United States Economic Census of Retail Trade, Mr.
Robbin tabulated data indicating that over 97% of all sales of non-
prescription drug products, including non-prescription cough, cold and
nasal congestion remedies, occur in drug stores and pharmacies,
supermarkets, large discount merchandisers, mail-order houses and
through electronic shopping. He characterized these five retail
industries as the traditional marketplace where such goods are
purchased by ordinary customers.
Analyzing national sales data specific to over-the-counter, non-
prescription drugs containing pseudoephedrine, Mr. Robbin's research
and analysis showed that a very small percentage of the sales of such
goods occur in convenience stores--only about 2.6% of the HABC [Health
and Beauty Care] category of merchandise or 0.05% of total in-store
(non-gasoline) sales. He determined that the normal expected retail
sales of pseudoephedrine tablets in a convenience store would range
between $10.00 and $30.00 per month, with an average monthly sales
figure of about $20.00 and the sales of more than $100.00 in a month
would be expected to occur in a random sampling about once in one
million to the tenth power, a number he characterized as nearly
equivalent to the number of atoms in the universe. He further stated
that the current convenience store gross margin in the health and
beauty care category is about 40 percent, so that such a store could be
expected to spend an average of $12.00 per month acquiring its
inventory of pseudoephedrine products from a distributor.
In October 2002, a pre-registration inspection was performed at H &
R's facility by a DEA Diversion Investigator. Mr. Patel advised the
Diversion Investigator that H & R had purchased its customer list from
Elk International and its customers were mainly convenience stores and
gasoline stations
[[Page 30170]]
located within 30 miles of Chattanooga. He identified several listed
products H & R intended to sell which are normally sold in the
traditional market. Of concern, he also advised the Diversion
Investigator that the company would carry whatever products its
customers wanted to buy. At the hearing, Mr. Patel then testified that
customers had brought him samples of products they wanted and
specifically asked for Max Brand Pseudo 60s. However, he had not yet
identified a supplier for that product.
Max Brand Pseudo 60s has been identified by DEA as ``the precursor
product predominantly encountered and seized at clandestine
methamphetamine laboratories'' and convenience stores are the ``primary
source'' for the purchase of ``Max Brand products, which are the
preferred brand for use by illicit methamphetamine producers * * *.''
Express Wholesale, 69 FR 62086, 62087 (2004); see also RAM, Inc. d/b/a/
American Wholesale Distribution Corp., 70 FR 11693 (2005).
The Diversion Investigator found Respondent's physical security
adequate and its monitoring, storage and recordkeeping systems an
improvement over Elk International's systems.
At the time of the hearing, Mr. Patel testified H & R then had
about 385 customers. He also provided a list of 459 businesses, not all
of whom were actual customers. At least 27 of these customers were
located in cities some distance from Chattanooga, including Knoxville
and Nashville, Tennessee; Atlanta, Summerville, Americus, Griffin,
Rome, Tucker and Lakeland, Georgia; Huntsville, Chickasaw, Decatur and
Mobile, Alabama; Myrtle Beach and Greenville, South Carolina;
Gainsville, Florida; Kansas City, Missouri; and Woodstock, Illinois.
While Mr. Patel testified H & R would not sell listed chemicals to
customers in Mobile, Woodstock and Gainesville, he did not specify
whether he would sell to the customers at other distant locations on
the list. He further testified H & R delivered to local customers but
others, including those from nashville and Atlanta, would have to come
to the Chattanooga facility to pick up orders.
A DEA Special Agent testified he recognized at least ten names on
Respondent's customer list as being under investigation by DEA, state
or local law enforcement agencies for involvement in distribution of
ephedrine or other chemicals associated with methamphetamine
manufacturing. A Supervisory Investigator testified that Respondent's
customer list also included distributors who were already registered to
sell list I chemicals.
Mr. Patel testified he would not sell over-threshold quantities of
list I chemicals to customers, but he could not say how much he would
sell. He estimated that in addition to other products, he expected an
average convenience store to order one or two dozen bottles of Mini
Thins per month, which would probably retail at $6.99 per bottle.
H. Patel did not testify, but submitted a post-hearing affidavit in
which he stated that if Respondent's application were granted, they
were willing to ``work with DEA to limit the amount of ephedrine and
single ingredient pseudoephedrine products we sell'' and would not sell
to customers being investigated by DEA. He also stated that H & R's
customers requested that it carry listed chemicals, as they wanted to
make their purchases from one distributor. H. Patel admitted having no
experience selling listed chemicals at the wholesale level and did not
know how much of these products H & R's customers might buy.
Mr. Patel testified that neither he nor his uncle had criminal
records and the Government offered no evidence to the contrary.
Pursuant to 21 U.S.C. 823(h), the Deputy Administrator may deny an
application for a Certificate of Registration if she determines that
granting the registration would be inconsistent with the public
interest, as determined under that section. Section 823(h) requires the
following factors be considered in determining the public interest:
(1) Maintenance of effective controls against diversion of listed
chemicals into other than legitimate channels;
(2) Compliance with applicable Federal, State, and local law;
(3) Any prior conviction record under Federal or State laws
relating to controlled substances or to chemicals controlled under
Federal or State law;
(4) Any past experience in the manufacture and distribution of
chemicals; and
(5) Such other factors as are relevant to and consistent with the
public health and safety.
As with the public interest analysis for practitioners and
pharmacies pursuant to subsection (f) of section 823, these factors are
to be considered in the disjunctive; the Deputy Administrator may rely
on any one or combination of factors, and may give each factor the
weight she deems appropriate in determining whether a registration
should be revoked or an application for registration denied. See, e.g.,
Direct Wholesale, 69 FR 11654 (2004); Energy Outlet, 64 FR 14269
(1999); Henry J. Schwartz, Jr., M.D., 54 FR 16422 (1989).
As to factor one, maintenance by the applicant of effective
controls against diversion, the Deputy Administrator agrees with Judge
Bittner that H & R's proposed physical security and recordkeeping
arrangements were adequate. Judge Bittner also found that Respondent
did not disput the Government's evidence that convenience stores are a
major source of diversion of list I chemicals.
Judge Bittner phrased the key issue in factor one as whether
Respondent would sell listed chemicals to retailers who were likely to
divert them. In concluding this factor weighed against registration,
Judge Bittner took particular note that Mr. Patel's estimates of
anticipated sales were several times larger than what Mr. Robbin's
research indicated a convenience store would legitimately sell.
Additionally, at least ten customers on Respondent's list were
under investigation for involvement in the distribution of chemicals
associated with illicit methamphetamine manufacturing. Red flags were
further raised by Mr. Patel's failure to specifically testify whether
he would refuse to sell listed chemicals to customers located
substantial distances from H & R's Chattanooga facility.
The Deputy Administrator is particularly concerned with Mr. Patel's
willingness to sell ``whatever'' products his customers wanted. Coupled
with the specific requests from its gray market customers that the
company carry Max Brand Pseudo 60's, the preferred precursor of illicit
manufacturers, the risk of diversion should the application be
approved, is apparent. See, RAM, Inc. d/b/a American Wholesale
Distribution Corp., supra, 70 FR 11693, 11694.
Judge Bittner acknowledged applicability of a previously published
DEA final order in which registration was denied an applicant who, much
like Respondent, was seeking registration to distribute list I
chemicals in the gray market. In that case, Xtreme Enterprises, Inc.,
67 FR 76195 (2002), there was no evidence the applicant's owner had
failed to comply with Federal, State or local law or that she had any
prior convictions relating to controlled substances or chemicals.
Further, she was willing to provide adequate security for the listed
chemicals.
However, the Deputy Administrator found the applicant's owner had
only a rudimentary knowledge of what would constitute a suspicious
order and no experience in the manufacture or distribution of listed
chemicals. Most
[[Page 30171]]
significant, for purposes of this and similar cases, the Deputy
Administrator also found that ``[v]irtually all of the Respondent's
customers, consisting of gas station and convenience stores, are
considered part of the grey market, in which large amounts of listed
chemicals are diverted to the illicit manufacture of amphetamine and
methamphetamine.'' Xtreme Enterprises, Inc., supra, 67 FR at 76197.
Citing Xtreme Enterprises, Judge Bittner concluded that factor one
(maintenance of controls against diversion), weighed against granting H
& R's application. The Deputy Administrator agrees, noting DEA has
applied this analysis in numerous final orders published after Xtreme
Enterprises was decided. See, e.g., Express Wholesale, supra, 69 FR
62086; Value Wholesale, 69 FR 58548 (2004); K & Z Enterprises, Inc., 69
FR 51475 (2004); William E. ``Bill'' Smith d/b/a B & B Wholesale, 69 FR
22559 (2004); Branex Incorporated, supra, 69 FR 8682: Shop It for
Profit, 69 1,311 (2003); Shani Distributors, 68 FR 62324 (2003).
Judge Bittner found Respondent had complied with applicable
Federal, State and local laws and its owners have not been convicted of
any crimes relating to controlled substances or listed chemicals. Thus,
she concluded that factors two and three weigh in favor of
registration. Based on the record that was before the Administrative
Law Judge, the Deputy Administrator agrees. However, as discussed in
depth under factor five, after the Opinion and Recommended Ruling was
issued, state legislation was enacted making it illegal to sell
tableted pseudoephedrine products in Tennessee, outside of licensed
pharmacies. Thus, to the extent that Respondent's Tennessee gray market
customer base is no longer authorized to sell those products under
state law, factor two is adversely impacted and weighs against
registration.
With regard to factor four, the applicant's past experience in
distributing listed chemicals, Judge Bittner found that while Mr. Patel
had previously sold listed chemical products in his retail tobacco
outlet, neither of H & R's owners/employees had experience selling
listed chemicals at the wholesale level. Judge Bittner therefore found
this factor weighed in favor of a finding that H & R's registration
would be inconsistent with the public interest. The Deputy
Administrator agrees with that conclusion.
With regard to factor five, other factors relevant to public health
and safety, Judge Bittner was ``not persuaded that Respondent will
limit its sales of listed chemicals to the quantities that convenience
stores are likely to sell to legitimate customers.'' She thus found
this factor also weighed against registration. The Deputy Administrator
concurs.
Unlawful methamphetamine production and use is a growing public
health and safety concern throughout the United States and
specificially in the localities where Respondent intends to do
business. Pseudoephedrine and ephedrine are the precursor products used
to manufacture methamphetamine and area laboratory operators
predominantly acquire their precursor chemicals from the customer base
Respondent seeks to serve. While the Patels indicated some intent to
avoid contributing to this scourge, the risk of diversion once listed
chemicals enter the gray market is real, substantial and compelling.
The Deputy Administrator concludes Judge Bittner correctly applied
DEA precedent. As in Xtreme Enterprise, supra, the Respondent's owners'
lack of criminal records, their previous compliance with the law and
any professed willingness to comply with regulations and guard against
diversion, are far outweighed by the intent to sell ephedrine and
pseudoephedrine, almost exclusively, in the gray market.
This reasoning has been consistently applied by the Deputy
Administrator in a series of recently published final orders denying
registration to potential gray market distributors. See, RAM, Inc. d/b/
a American Wholesale Distribution Corp., supra, 70 FR 11693; Al-Alousi,
Inc., 70 FR 3561 (2005); Volusia Wholesale, supra, 69 FR 69409; Prachi
Enterprises, Inc., supra, 69 FR 69407; CWK Enterprises, Inc., 69 FR
69400 (2004); J & S Distributors, 69 FR 62089 (2004); Express
Wholesale, supra, 69 FR 62086; Absolute Distributing, Inc., 69 FR 62078
(2004); Value Wholesale, supra, 69 FR 58548 (2004); John E. McRae d/b/a
J & H Wholesale, 69 FR 51480 (2004).
While not addressed in the Opinion and Recommended Ruling, the
Deputy Administrator notes that state legislatures throughout the
United States are actively considering legislation designed to impede
the ready availability of precursor chemicals. Many of these proposals
are similar to legislation enacted by the State of Oklahoma, titled the
``Oklahoma Methamphetamine Reduction Act of 2004.'' Under that measure,
as of April 6, 2004, pseudoephedrine tablets were designated as
Schedule V controlled substances and may be sold only from licensed
pharmacies within that state.
As a result, it is prohibited in Oklahoma to sell these products
from gray market establishments, such as independent convenience
stores, which have contributed so much to the scourge of
methamphetamine abuse. See, e.g., Express Wholesale, supra, 69 FR at
62809 [denying DEA registration to an Oklahoma gray market distributor,
in part, because of new state restrictions].
A review of data for 2004 reveals the Oklahoma law has resulted in
an apparent reduction in the number of seizures involving clandestine
methamphetamine laboratories in that state. These developments are
encouraging and represent an important step in the ongoing battle to
curb methamphetamine abuse in the United States. State legislation,
such as Oklahoma's, reflects a positive trend and growing recognition
that the diversion of precursor chemicals through the gray market
insidiously impacts public health and safety. See, e.g., Tysa
Management, d/b/a Osmani Lucky Wholesale, 70 FR 12732, 12734 (2005)
[denying registration to intended Oklahoma distributor, in part, on
basis of enactment of recent state legislation]; Express Wholesale,
supra, 69 FR at 62089.
Of particular consequence to H & R and similarly situated Tennessee
applicants and registrants, after Judge Bittner signed her Opinion and
Recommended Ruling, legislation was enacted by the State of Tennessee
that is patterned after the Oklahoma initiative. That legislation
(Senate Bill 2318/House Bill 2334), collectively known as the ``Meth-
Free Tennessee Act of 2005,'' was signed into law by Governor Phil
Bredeson on March 31, 2005, and makes it unlawful for establishments,
other than licensed pharmacies, to sell tableted pseudoephedrine
products in Tennessee after April 1, 2005. This includes both name
brand and off-name brand products.
Accordingly, Respondent's entire intended Tennessee customer base
is now prohibited by state law from selling the pseudoephedrine
products H & R seeks DEA registration to distribute. This adversely
implicates factors five and two and weighs heavily against
registration. See, Tysa Management, d/b/a Osmani Lucky Wholesale,
supra, 70 FR at 12734; Express Wholesale, supra, 69 FR at 62089.
Factor five is also relevant to H & R's proposal to distribute
chemicals to customers under criminal investigation. The conduct of a
potential customer has previously been deemed a relevant consideration
under factor five. See,
[[Page 30172]]
Gazaly Trading, supra, 69 FR 22561; Shani Distributors, supra, 68 FR
62326.
Finally, it is noted that Respondent seeks to distribute
phenylpropanolamine. Accordingly, the Deputy Administrator finds factor
five relevant to H & R's request to distribute phenylpropanolamine and
the apparent lack of safety associated with the use of that product.
DEA has previously determined that an applicant's request to distribute
phenylpropanolamine constitutes a ground under factor five for denial
of an application for registration. See, J & S Distributors, supra, 69
FR 62089; Gazaly Trading, supra, 69 FR 22561; William E. ``Bill'' Smith
d/b/a B & B Wholesale, supra, 69 FR 22559; Shani Distributors, supra,
68 FR 62324.
Based on the foregoing, the Deputy Administrator concludes that
granting Respondent's pending application would be inconsistent with
the public interest.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in her by 21 U.S.C.
823 and CFR 0.100(b) and 0.104, hereby orders that the pending
application for a DEA Certificate of Registration, previously submitted
by H & R Corporation, be, and it hereby is, denied. This order is
effective June 26, 2006.
Dated: May 5, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 06-4838 Filed 5-24-06; 8:45am]
BILLING CODE 4410-09-M