[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices]
[Page 24615-24619]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-104]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 03-25]
ELK International, Inc., d.b.a. Tri-City Wholesale; Denial of
Application
On April 11, 2003, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to ELK International, Inc., d/b/a Tri-City
Wholesale (Respondent/Elk) proposing to deny its application for a DEA
Certification of Registration as a distributor of list I chemicals. The
Order to Show Cause alleged, in sum that granting the 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, proceeding pro se, requested a hearing on the issues
raised by the Order to Show Cause and the matter was docketed before
Administrative Law Judge Gail A. Randall. Respondent subsequently
retained counsel and following pre-hearing procedures, a hearing was
held in Memphis, Tennessee, on March 9, 2004. 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 October 7, 2004, Judge Randall issued her Recommended Findings
of Fact, Conclusions of Law, and Decision of the Administrative Law
Judge (Opinion and Recommended Ruling), recommending that Respondent's
application to distribute pseudoephedrine and ephedrine chemical
products be granted, subject to ``close monitoring'' by DEA. She did
recommend denying ELK registration to distribute phenylpropanolamine.
The Government filed exceptions to the Opinion and Recommended Ruling
and on November 16, 2004, Judge Randall 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.
Except as otherwise set forth in this final order, the Deputy
Administrator adopts the findings of fact and conclusions of law of the
Administrative Law Judge. The Deputy Administrator agrees with
recommendation that Respondent be denied registration to distribute
phenylpropanolamine. However, she disagrees with the recommendation
that Respondent be approved to distribute ephedrine and
pseudoephedrine, even under monitored conditions.
On May 9, 2002, Respondent, a Tennessee corporation owned by Mr.
and Mrs. Nafez Elkhayyat, located in Memphis, submitted its application
for registration as a distributor of list I chemicals, seeking approval
to distribute pseudoephedrine, ephedrine and phenylpropanolamine.
Prior to moving to Memphis, the Elkhayyats had owned Tri-State
Wholesale, Elk International, Inc. (Tri-State), located in East Ridge,
Tennessee, a suburb of Chattanooga. In May 2001, Tri-State applied for
DEA registration to distribute list I chemicals in an application
signed by Mrs. Elkhayyat. During a pre-registration inspection by a
Diversion Investigator from DEA's Nashville Office, Mr. Elkhayyat was
interviewed and stated he intended to carry whatever products his
customers wanted.
Despite having operating a retail grocery store for 27 years, Mr.
Elkhayyat had little or no knowledge of listed chemicals, was unaware
that they were used in illicit methamphetamine manufacturing and could
not identify the names of products containing listed chemicals.
While Tri-State was not registered with DEA, the Diversion
Investigator found numerous name-brand products at its facility
containing listed chemicals. These included Dayquil, Nyquil, Advil Cold
and Sinus, Tylenol Cold and Sinus, Anacin Cough and Cold, Alka Seltzer
Plus and Robitussin. Mr. Elkhayyat advised he had purchased these items
from a grocery store in Texas and readily agreed to box them up and
return them to the supplier, which he did while the Diversion
Investigator was still on the premises. He was also provided materials
and a briefing regarding the dangers of diversion and the record
keeping/reporting requirements for registrants.
An Order to Show Cause proposing to deny Tri-State's application
was issued by DEA on May 21, 2002, and sent to the company's address in
East Ridge. However, by then the Elkhayyats had moved to Memphis and
sold Tri-State's assets to H & R Corporation, d.b.a. Tri-State
Wholesale (H & R). At the time, H & R was not seeking to distribute
listed chemicals and the Elkhayyats had not retained any ownership or
control over H & R. Accordingly, DEA's Office of Chief Counsel directed
that Tri-State's application be administratively withdrawn, as the
entity submitting it no longer existed.\1\
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\1\ It is noted that H & R Corporation's owners subsequently
applied for DEA registration to distribute list I chemicals. An
Order to Show Cause proposing to deny H & R registration was issued
and the matter is currently pending final agency action.
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In June 2002, a different Diversion Investigator than the one who
interviewed Mr. Elkhayyat in East Ridge a year earlier, conducted the
pre-
[[Page 24616]]
registration investigation on Elk's application. He met Mr. Elkhayyat
and his brother at the company's Memphis facility and they discussed
the problem of diversion and record keeping requirements. Despite the
information having been provided him during the first pre-registration
investigation, Mr. Elkhayyat did not indicate that he had any
familiarity with reporting requirements. He also failed to disclose
that his former company had previously applied for a DEA registration.
In general, the Diversion Investigator was satisfied with Elk's
physical security and intended policies for verifying the legitimacy of
prospective customers. While the Elkhayyats did not yet have a customer
list, they indicated they intended to sell listed chemicals on a
wholesale basis, primarily to ``convenience stores, service stations,
gasoline stations, [and] small grocery stores.''
After returning to his office, the Diversion Investigator learned
the Elkhayyats had applied for registration under the Tri-State name
and he prepared a recommendation that an Order to Show Cause be issued
to Elk based primarily on its intent to distribute list I chemicals to
what DEA has termed the ``grey market.''
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 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. In November 2000, the United States
Food and Drug Administration issued a public health advisory requestion
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. See, Gazaly Trading, 69 FR 22561 (2004).
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 8,682 (2004); Denver Wholesale, 67
FR 99986 (2002); Yemen Wholesale Tobacco and Candy Supply, Inc., 67 FR
9997 (2002).
A Diversion Control Group Supervisor and Special Agent testified at
the hearing regarding the rapid proliferation of clandestine
methamphetamine laboratories in Tennessee and its adjoining states and
described the local methods of production. They recounted the multiple
health hazards and social costs stemming from the production and abuse
of methamphetamine and testified to a dramatic increase in local
clandestine laboratories. As discussed in several recently published
final orders, Tennessee now leads the DEA Atlanta Region in the number
of clandestine laboratories seized. See, e.g., Prachi Enterprise, Inc.,
69 FR 69407 (2004); CWK Enterprises, Inc., 69 FR 69400 (2004). Further,
DEA has found 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 credibly testified that local manufacturers
typically acquired their pseudoephedrine and ephedrine precursors from
area convenience stores and small ``mom and pop'' stores and would
patronize multiple stores, in order to deflect attention from their
buying patterns. In his experience, the precursor most often found in
area laboratories was Max Brand, followed by other ``off name'' brands,
such as Mini-Thins, Pseudo-60's and Two-Ways. The preferred
pseudoephedrine strength of illicit manufacturers is 60 mg. The Special
Agent further testified that he had never personally encountered
nationally known brand names at illicit sites, such as Advil Cold and
Sinus, Tylenol Allergy and Sinus, Tylenol Sinus, Tylenol Cold, Nyquil,
Dayquil, Theraflu, BC Allergy Sinus Cold or Alka Seltzer.
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 larger
package sizes, such as 100 or 120 count bottles of 60 mg.
pseudoephedrine. The Diversion Investigator also identified the off-
name brands found in disproportionate numbers during clandestine
laboratory seizures. These included Max Brand, Mini Two Way, MiniThin
and Action-Pseudo products.
Max Brand Pseudo 60s has previously 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 * * *''
See, Express Wholesale, 69 FR 62086, 62087 (2004); see also, RAM, Inc.
d/b/a American Wholesale Distribution Corp., 70 FR 11693 (2005).
A Group Supervisor from DEA's Nashville office testified that, in
his view, the area's demand for pseudoephedrine and ephedrine for
legitimate medical purposes, did not justify the supply.
Mr. Elkhayyat testified at the hearing that he and his wife were
Elk's sole shareholders and the company sold candy, tobacco and other
sundry items on a wholesale basis to area convenience stores, service
stations and small restaurants. Judge Randall found Mr. Elkhayyat
credibly testified that, prior to Tri-State's application, he had been
a retail grocer and was unaware that a license was needed to distribute
ephedrine and pseudoephedrine products on a wholesale basis.
After selling Tri-State to H & R in 2001, the Elkhayyats moved to
Memphis and began their wholesale distribution business under Elk
International's corporate charter. Mr. Elkhayyat testified that he had
no interest in selling ``Max Brand or Mini Thins'' and would abide by
DEA regulations. He testified the company would sell only name brand
products such as Advil Cold and Sinus, Tylenol Cold and Sinus, Nyquil,
Dayquil, Theraflu, Alka Seltzer, Benadryl and Vick's Cough Medicine,
which the Special Agent had testified were rarely, if ever, found at
clandestine laboratories.
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
[[Page 24617]]
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 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 that 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.
According to Mr. Robbin, ``[h]alf of the Tennessee stores analyzed
showed implied sales over ten times expectation, with ten of them over
twenty times expectation.'' These differences were extremely
significant statistically and in his expert opinion, small Tennessee
convenience stores were not selling pseudoephedrine and ephedrine
products ``for their intended purpose as non-prescription drugs'' and
the assumption that they were supplying the gray market was
statistically supported ``many times over* * *''
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 nad
pharmacies pursuant to subsection (f) of section 823, these factors are
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
Randall that Elk's proposed physical security is adequate. With regard
to Elk's proposed monitoring and business practices, Judge Randall
noted the company's proposed practices ``seemed adequate'' and that,
while the company had yet to prove the viability of these practices,
she concluded ``such a lack would support close scrutiny by DEA, but
not* * * outright denial.'' Judge Randall therefore concluded that
factor one weighed in favor of registration.
The Deputy Administrator disagrees with that condition. As noted by
the Government in its Objections, even if Respondent was able to
monitor sales to gray market customers for excessive amonts, DEA has
previously found that grey market retailers supplying chemicals for
illicit use regularly acquire their product from multiple distributors
in order to mask their acquisition of large amounts of listed
chemicals. See, Titan Wholesale, Inc., 70 FR 12,727 92005). Thus, so
long as Elk was distributing wholesale to this suspect market, even
sincere efforts by Respondent to self-regulate its customers would not
thwart gray market retailers from obtaining precursor chemicals from
other distributors, as well as from Elk, and then reselling them for
illicit purposes.
Further, a policy of DEA Headquarters directing field offices to
provide individual registrants extraordinary scrutiny and monitoring,
simply to justify an otherwise unwarranted registration, would
ultimately have an adverse cumulative impact on the execution of DEA's
mission, given the limited assets and extraordinary demands placed upon
its personnel in the field.
In sum, the Deputy Administrator concludes that factor one weighs
against granting Respondent's application, primarily because of its
intent to participate in the gray market, See, Titan Wholesale, Inc.,
supra, 70 FR 12727; TNT Distributors, Inc., 70 FR 12729 (2005).
With regard to factor two, Respondent's compliance with applicable
Federal, state and local law, Judge Randall concluded this factor
weights in favor of registration. In doing so, she rejected the
Government's argument that Respondent's owners, while doing business as
Tri-State, had distributed brand name listed chemical products without
a registration, thus violating law and regulations. Because the
products were only found by the Diversion Investigator stocked on Tri-
State's shelves and no direct evidence was introduced showing they had
been resold, Judge Randall concluded there was insufficient evidence to
show the Elkhayyat's had, in fact, distributed the listed chemicals
products, thus triggering a registration requirement.
The Government objected to that conclusion, arguing Tri-State was
actively in business as a wholesale at the time of the pre-registration
inspection and that all of the products at its unregistered facility,
including listed chemicals, were there for distribution to retail
customers, not merely for storage. The Deputy Administrator agrees with
the Government that, under the facts of this case, it is appropriate to
infer the Elkhayyats, while operating Tri-State, distributed, attempted
to distribute or possessed with the intent to distribute, list I
chemicals without a requisite registration. However, the Deputy
Administrator considers this apparent non-compliance mitigated by Mr.
Elkhayyat's then-lack of knowledge as to what products actually
contained listed chemicals and his cooperation in immediately returning
the items to his out of state supplier.
More significant for factor two and factor five as well, 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
[[Page 24618]]
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 scourage 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 the 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 Elk and similarly situated Tennessee
applicants and registrants, after Judge Randall 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 customer base is now
prohibited by state law from selling the pseudoephedrine products Elk
seeks DEA registration to distribute. Thus, factor two 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.
As to factor three, any prior conviction record relating to listed
chemicals or controlled substances, the Deputy Administrator concurs
with Judge Randall that there is no evidence or any prior convictions
of Respondent or its owners related to listed chemicals or controlled
substances. Accordingly, this factor weighs in favor of registration.
With regard to factor four, the applicant's past experience in
distributing listed chemicals, Judge Randall found that while Elk's
owners had no prior experience in manufacturing or distributing these
products, Mr. Elkhyyat had extensive retail grocery experience and had
taken steps to improve his knowledge in this area. However, recognizing
that lack of experience in handling list I chemicals has been a factor
in prior DEA final orders denying registration, Judge Randall found
this factor weighted against registration in a ``close call.'' The
Deputy Administrator agrees. See, e.g., Direct Wholesale, supra, 69 FR
11654; ANM Wholesale, 69 FR 116522 (2004); Xtreme Enterprises, Inc., 67
FR 76195 (2002).
With regard to factor five, other factors relevant to public health
and safety, Judge Randall acknowledged DEA precedent denying
registration to grey market distributors under that factor, in
particular, Xtreme Enterprises, Inc., supra, 67 FR 76195. In that case
there was no evidence the applicant's owner had failed to comply with
Federal, State or local law or had any prior convictions relating to
controlled substance or chemicals. Further, she was willing to provide
adequate security for the listed chemicals.
However, the Deputy Administrator found Xtreme'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 significant for 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.
However, in her Opinion and Recommended Ruling, Judge Randall
distinguished the facts of Xtreme Enterprises from this matter. In
Xtreme, the respondent's supplier had received two warning letters from
DEA that its product had been found in situations indicating their use
in illicit methamphetamine manufacturing. Additionally, the applicant
had received requests for list I chemicals in packaging forms that were
not normally seen in traditional retail establishments.
In contrast, Judge Randall found Respondent in this case only
intended to distribute name brand products and did not intend to
distribute Max Brand, the precursor product most favored by illicit
manufacturers. Based on these distinctions, Judge Randall concluded
Elk's intent to distribute listed chemicals to the gray market did not
``weigh as heavily'' under factor five as it did against Xtreme
Enterprises.
DEA has expansively applied the analysis of Xtreme Enterprises to a
multitude of applicants seeking to do business in the gray market. See
e.g., Express Wholesale, supra, 69 FR 624086; Value Wholesale, 69 FR
58548 (2004); K & Z Enterprises, Inc., 69 FR 5175 (2004); William E.
``Bill'' Smith d/b/a B & B Wholesale, 69 FR 2259 (2004); Branex
Incorporated, supra, 69 FR 8682; Shop It for Profit. 69 FR 1311 (2003);
Shani Distributors, 68 FR 62324 (2003).
As in those cases, the Elkhayyats' lack of criminal records,
previous general compliance with the law and regulations and their
professed willingness to comply with regulations and guard against
diversion, are far outweighed by their intent to sell ephedrine and
pseudoephedrine, almost exclusively, in the gray market.
This reasoning has also been consistently applied by the Deputy
Administrator in a series of final orders published after Judge Randall
issued her Opinion and Recommended Ruling in this matter. See, TNT
Distributors, Inc., supra, 70 FR 12729; Titan Wholesale, Inc., supra,
70 FR 1227; 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).
In any event, Judge Randall's reason for not giving Xtreme
Enterprises more weight in this matter, i.e., Respondent's intent to
carry only brand name products, has been mooted by Tennessee's new
requirement that all pill and tablet pseudoephedrine products,
including those marketed under traditional brand names, be sold only
through registered pharmacies. As this statute, addressed more fully
under factor two, effectively bars distribution of these products
though Tennessee's gray market establishments, it is also relevant
under factor five and weighs heavily against Respondent's registration.
The Deputy Administrator also notes with concern Mr. Elkhayyat's
initially
[[Page 24619]]
professed willingness to sell his customers whatever products they
wanted and his apparent lack of candidness with investigators, when he
failed to reveal that his former company had applied for registration
to distribute listed chemicals.
Finally, as recommended by Judge Randall, due to the apparent lack
of safety associated with the use of phenylpropanolamine, factor five
is also relevant to Elk's proposal to distribute that product. DEA has
previously determined that such a request 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 28 C.F.R. 0.100(b) and 0.104, hereby orders that the pending
application for a DEA Certificate of Registration, previously submitted
by Elk International, Inc., d.b.a. Tri-City Wholesale, be, and it
hereby is, denied. This order is effective June 9, 2005.
Dated: May 2, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-9251 Filed 5-9-05; 8:45 am]
BILLING CODE 4410-09-M