RAM, INC. d/b/a American Wholesale Distribution Corp.; Denial of Registration, 11693-11695 [05-4565]
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Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Notices
remedy, the public interest and
bonding. On January 27, 2003, the
Commission issued a notice indicating
that it had determined that there is a
violation of section 337 of the Tariff Act
of 1930, as amended, and had issued a
limited exclusion order prohibiting the
importation of the infringing sortation
systems, parts and components thereof,
manufactured abroad by Vanderlande.
The Federal Circuit affirmed the
Commission’s determination on May 3,
2004. See Vanderlande Indus. v. Int’l
Trade Comm’n, 366 F.3d 1311 (Fed. Cir.
2004).
On February 2, 2005, Vanderlande
and complainants filed a joint petition
to rescind the remedial order under
Commission Rule 210.76(a)(1) on the
basis of a settlement agreement between
the parties. The parties asserted that
their settlement agreement constituted
‘‘changed conditions of fact or law’’
sufficient to justify rescission of the
order under Commission Rule
210.76(a)(1), 19 CFR 210.76(a)(1). The
IA filed a response in support of the
motion on February 14, 2005.
Having reviewed the parties’
submissions, the Commission has
determined that the settlement
agreement satisfies the requirement of
Commission Rule 210.76(a)(1), 19 CFR
210.76(a)(1), that there be changed
conditions of fact or law. The
Commission therefore has issued an
order rescinding the limited exclusion
order previously issued in this
investigation.
This action is taken under the
authority of section 337 of the Tariff Act
of 1930 (19 U.S.C. 1337) and
§ 210.76(a)(1) of the Commission’s Rules
of Practice and Procedure (19 CFR
210.76(a)(1)).
Issued: March 3, 2005.
By order of the Commission.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. 05–4570 Filed 3–8–05; 8:45 am]
2. Cancellations. ATF O 1100.9A,
Delegation Order—Designation of
Acting Supervisory Officials dated
October 7, 1980 and ATF F 1100.1,
Temporary Assignment Designation.
3. Authorities. Pursuant to authorities
vested in the Director, ATF, by Title 6
U.S.C. 531 and 28 CFR O.130–0.133.
4. Designations.
a. An official e-mail notification is
required for supervisors to designate a
subordinate employee to act in the event
of their absence or in a subordinate
supervisory position in which such
position becomes vacant. At a
minimum, the official e-mail
notification must be sent to individuals
who report directly to the supervisor;
the individual to whom the supervisor
reports; and any other individual(s) who
need to be advised. An official e-mail
notification is not required if there
exists a document or order that
designates a temporary acting official.
b. In the event of an emergency, ATF
O 1100.59G, Delegation Order—
Emergency Order of Succession and
Delegation of Authority, designates the
order of succession for Acting Director
to ensure the continuity of Bureau
functions. Under these circumstances
no e-mail notification is required.
5. Retention Requirements. Acting
designations must be retained in
accordance with ATF O 1345.1, Records
Management Program and Records
Control Schedule 101, item 2
(Headquarters) and ATF Records
Control Schedule 201, item 1 (Field).
6. Redelegation. The authority to
designate acting supervisory officials is
delegated to all Bureau personnel in
supervisory positions and may not be
redelegated.
7. Questions. Questions regarding this
delegation order may be addressed to
the Chief, Document Services Branch at
(202) 927–8930.
Dated: February 18, 2005.
Carl J. Truscott,
Director.
[FR Doc. 05–4606 Filed 3–8–05; 8:45 am]
BILLING CODE 7020–02–P
BILLING CODE 4410–FY–P
DEPARTMENT OF JUSTICE
Bureau of Alcohol, Tobacco, Firearms
and Explosives
[Docket No. ATF 17N; ATF O 1150.13]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Delegation Order—Designation of
Acting Supervisory Officials
RAM, INC. d/b/a American Wholesale
Distribution Corp.; Denial of
Registration
1. Purpose. The purpose of this
delegation order is to grant supervisors
authority to designate acting
supervisory officials of the Bureau of
Alcohol, Tobacco, Firearms and
Explosives (ATF).
On July 23, 2004, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to RAM Inc., d/b/a
American Wholesale Distribution
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11693
Corporation (RAM), proposing to deny
its June 5, 2003, application for DEA
Certificate of Registration as a
distributor of List I chemicals. The
Order to Show Cause alleged that
granting RAM’s application would be
inconsistent with the public interest, as
that term is used in 21 U.S.C. 823(h).
The order also notified RAM that should
no request for a hearing be filed within
30 days, its hearing right would be
deemed waived.
According to the DEA investigative
file, the Order to Show Cause was sent
by certified mail to RAM at its proposed
registered location at 3300 Pleasant
Valley Lane, Suite C, Arlington, Texas
76015. It was received on August 2,
2004, and DEA has not received a
request for a hearing or any other reply
from RAM or anyone purporting to
represent the company in this matter.
Therefore, the Deputy Administrator
of DEA, finding that (1) thirty days have
passed since delivery of the Order to
Show Cause, and (2) no request for a
hearing having been received, concludes
that RAM has waived its hearing right.
See Aqui Enterprises, 67 FR 12576
(2002). After considering relevant
material from the investigative file, the
Deputy Administrator now enters her
final order without a hearing pursuant
to 21 CFR 1309.53(c) and (d) and
1316.67. The Deputy Administrator
finds as follows.
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 1300.02(a). Pseudoephedrine and
ephedrine are List I chemicals
commonly used to illegally manufacture
methamphetamine, a Schedule II
controlled substance. As noted in
previous DEA 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).
The Deputy Administrator’s review of
the investigative file reveals that RAM’s
owner and only officer is Mr. Mohamad
Khorchid. On or about June 5, 2003, an
application was submitted by Mr.
Khorchid on behalf of RAM, seeking
registration to distribute ephedrine and
pseudoephedrine List I chemical
products. It identified the applicant as
‘‘RAM INC American Wholesale Dist.
Co.’’
Prior to RAM’s February 7, 2003,
incorporation, Mr. Khorchid and his
wife owned and operated American
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Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Notices
Wholesale Distribution Corporation
(AWD), also of Arlington, Texas, which
was registered as a distributor of List I
chemical products on April 15, 1999,
under DEA Certificate of Registration
004169ASY.
During AWD’s 1999 pre-registration
inspection, DEA investigators discussed
requirements for recordkeeping and
suspicious order reporting with Mr. and
Mrs. Khorchid and provided written
information regarding combination
ephedrine and pseudoephedrine drug
products used in illicitly manufacturing
methamphetamine. A juvenile employee
of AWD [John Doe] was present at this
meeting and the three were advised it
was illegal to sell List I chemical
products knowing they would be used
to manufacture illegal drugs. During this
conversation, Mr. Khorchid advised
investigators that AWD sold sundry
items to area convenience stores and
that List I chemical products would
make up about 15% of the company’s
total sales.
During a July 2001 regulatory
investigation, Mr. Khorchid advised
DEA investigators that 99% of AWD’s
customers were convenience stores and
that List I chemical products made up
about 10% of its sales. An inventory
conducted as a part of that investigation
showed AWD maintained a substantial
inventory of ephedrine and
pseudoephedrine products
manufactured or distributed by two
companies, Lannett Company, Inc.
(Lannett) and PDK Labs, Inc. (PDK). The
inventory included several Max Brand
products, which are manufactured by
PDK.
DEA is aware that Lannett and PDK’s
ephedrine and pseudoephedrine
products have been discovered by law
enforcement agencies at clandestine
methamphetamine laboratories and
other illicit sites throughout the
country. See Indace, Inc, c/o Seegott,
Inc; Malladi, Inc., (Indace), 69 FR 67951
(2004) (Suspension of Shipment of
ephedrine hydrochloride being
imported for distribution to PDK Labs,
Inc.). Further, during this period, no
other ephedrine and pseudoephedrine
manufacturers had as much diversion of
their products as Lannett and PDK. DEA
has previously found that PDK’s Max
Brand products are the precursors
‘‘predominantly encountered and seized
at clandestine methamphetamine
laboratories’’ and that ‘‘[c]onvenience
stores are also the primary source for the
purchase of the Max Brand products,
which are the preferred brand for use by
illicit methamphetamine producers, and
users.’’ See Express Wholesale, 69 FR
62086, 62087, 62089 (2004).
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In April 2002, DEA investigators
received information that AWD
employee John Doe, who had a close
personal relationship with the
Khorchids, was falsifying company
invoices to account for unlawful sales of
pseudoephedrine. On June 11, 2002, an
undercover operation was conducted
which resulted in Doe selling a case of
Action Brand PSE and four dozen
bottles of Max Brand PSE to an
undercover agent for about $1600.00,
believing the products would be used to
manufacture methamphetamine.
In July 2002, Diversion Investigators
obtained Mr. Khorchid’s consent to
perform an administrative inspection of
AWD. A review of the company’s sales
records from April 2001 through July
2002 showed AWD sold large amounts
of Lannet and PDK pseudoephedrine
and ephedrine products to numerous
area convenience stores. In many
instances, the purchases of these
products were well in excess of any
potential legitimate demand. See
Branex, Inc., supra, 69 FR at 8693
(expert testimony on the legitimacy of
selling listed chemical products in the
‘‘gray market’’); Xtreme Enterprises,
Inc., 67 FR 76195, 76197 (2002) (same);
Value Wholesale, 69 FR 58548 (2004);
see also Indace, supra, 69 FR at 67962
and cases cited therein.
On July 30, 2002, investigators
informed Mr. Khorchid about the
investigation involving John Doe and
requested surrender of the company’s
DEA registration, which was done on
October 1, 2002. The employee was
subsequently prosecuted in state
juvenile court and pled guilty to
conspiring to manufacture a controlled
substance (methamphetamine).
During DEA’s pre-registration
investigation into RAM’s pending
application, Mr. Khorchid advised
investigators that the new company’s
prospective customers would continue
to be convenience stores and he also
intended to sell PDK manufactured
pseudoephedrine and ephedrine
products.
DEA is aware that small illicit
laboratories operate with listed
chemical products often procured,
legally or illegally, from non-traditional
retailers of over-the-counter drug
products, such as gas stations and small
retail markets. Some retailers acquire
product from multiple distributors to
mask their acquisition of large amounts
of listed chemicals. In addition, some
individuals utilize sham corporations of
fraudulent records to establish a
commercial identity in order to acquire
listed chemicals.
DEA knows by experience that there
exists a gray market in which certain
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high strength, high quantity
pseudoephedrine and ephedrine
products are distributed only to
convenience stores and gas stations,
from where they have a high incidence
of diversion. These gray market
products are not sold in large discount
stores, retail pharmacies or grocery
stores, where sales of therapeutic overthe-counter drugs predominate.
DEA also knows from industry data,
market studies and statistical analysis
that over 90% of over-the-counter drug
remedies are sold in drug stores,
supermarket chains and ‘‘big box’’
discount retailers. Less than one percent
of cough and cold remedies are sold in
gas stations or convenience stores.
Studies have indicated that most
convenience stores could not be
expected to sell more than $20.00 to
$40.00 worth of products containing
pseudoephedrine per month. The
expected sales of ephedrine products
are known to be even smaller.
Furthermore, convenience stores
handling gray market products often
order more product than what is
required for the legitimate market and
obtain chemical products from multiple
distributors. See CWK Enterprises, Inc.,
69 FR 69400 (2004); Prachi Enterprises,
Inc., 69 FR 69407 (2004); Volusia
Wholesale, 69 FR 69409; Branex, Inc.,
supra, 69 FR at 8693.
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.
Section 823(h) requires that 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 of the applicant 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 a 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., Energy
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Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Notices
Outlet, 64 FR 14269 (1999). See also,
Henry J. Schwartz, Jr., M.D., 54 FR
16422 (1989).
The Deputy Administrator finds
factors one, two, three, four and five
relevant to the pending application for
registration.
As to factors one through four, RAM’s
owners and operators have a history of
distributing List I chemical products
which were then diverted while the
company operated as AWD and an
employee with a close relationship to
the Khorchids, sold listed products to
an undercover officer believing they
would be used to manufacture
methamphetamine. That employee was
subsequently convicted of a state crime
involving controlled substances. As a
result of these activities, Mr. Khorchid
surrendered AWD’s registration and
incorporated RAM only a few months
later. That company now seeks to sell
listed products to the gray market,
including those manufactured by PDK
Labs, just as it did when operating
solely under the AWD name. These four
factors weigh against granting the
pending application.
With regard to factor five, other
factors relevant to and consistent with
the public safety, the Deputy
Administrator finds this factor also
weighs heavily against granting the
application. Unlawful
methamphetamine use is a growing
public health and safety concern
throughout the United States, including
Texas. Ephedrine and pseudoephedrine
are precursor products needed to
manufacture methamphetamine and
operators of illicit methamphetamine
laboratories regularly acquire the
precursor products needed to
manufacture the drug from convenience
stores and gas stations which, in prior
DEA decisions, have been identified as
constituting the gray market for List I
chemical products. It is apparent that
Mr. Khorchid intends on again
becoming a participant in this market,
just as he did when registered under
AWD’s identity.
While there are no specific
prohibitions under the Controlled
Substances Act regarding the sale of
listed chemical products to these
entities, DEA has nevertheless found
these establishments serve as sources for
the diversion of large amounts of listed
chemical products. See, e.g., ANM
Wholesale, 69 FR 11652 (2004); Xtreme
Enterprises, Inc., supra, 67 FR 76195;
Sinbad Distributing, 67 FR 10232
(2002); K.V.M. Enterprises, 67 FR 70968
(2202).
The Deputy Administrator has
previously found that many
considerations weighed heavily against
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18:06 Mar 08, 2005
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registering a distributor of list I
chemicals because, ‘‘[v]irtually all of the
Respondent’s customers, consisting of
gas station and convenience stores, are
considered part of the gray market, in
which large mounts of listed chemicals
are diverted to the illicit manufacture of
amphetamine and methamphetamine.’’
Xtreme Enterprises, Inc., supra, 67 FR at
76197. As in Xtreme Enterprises, Inc.,
Mr. Khorchid’s personal lack of a
criminal record, his discharge of formerAWD employee John Doe and purported
intent to comply with the law and
regulations, are far outweighed by his
intent to sell pseudoephedrine products
almost exclusively to the gray market.
The Deputy Administrator is
particularly troubled by AWD’s history,
indicating its owners and operators,
now principals of RAM, cannot be
trusted to handle the responsibilities of
a registrant. Further, RAM’s continued
use of AWD’s name in a d/b/a capacity,
raises further questions about RAM’s
customer base and the risk that its
products will be sold to previous
customers of AWD and then diverted to
illegal purposes.
Based on the foregoing, the Deputy
Administrator concludes that granting
the 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 824 and 28 CFR 0.100(b) and 0.104,
hereby orders the pending application
for DEA Certificate of Registration,
submitted by RAM, Inc.
d/b/a American Wholesale Distribution
Corporation, be, and it hereby is,
denied. This order is effective April 8,
2005.
Dated: January 14, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05–4565 Filed 3–8–05; 8:45 am]
BILLING CODE 4410–09–M
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mario Avello, M.D.; Revocation of
Registration
On May 17, 2004, the Deputy
Administrator of the Drug Enforcement
Administration (DEA) issued an Order
to Show Cause and Immediate
Suspension of Registration to Mario
Avello, M.D. (Dr. Avello) of Coral
Gables, Florida. Dr. Avello was notified
of an opportunity to show cause as to
why DEA should not revoke his DEA
Certificate of Registration, AA0105747,
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11695
as a practitioner, and deny any pending
applications for renewal or modification
of such registration pursuant to 21
U.S.C. 823(f) and 824(a)(4) for reason
that his continued registration would be
inconsistent with the public interest. Dr.
Avello was further notified that his DEA
registration was immediately suspended
as an imminent danger to the public
health and safety pursuant to 21 U.S.C.
824(d).
The Order to Show Cause and
Immediate Suspension alleged in sum,
that Dr. Avello was engaged in illegally
prescribing controlled substances as
part of a scheme in which controlled
substances were dispensed by
pharmacies, based on Internet
prescriptions issued by Dr. Avello and
associated physicians, based solely on
their review on Internet questionnaires
and without personal contact,
examination or bona fide physician/
patient relationships. Such
prescriptions were not issued ‘‘in the
usual course of professional treatment’’
and violated 21 CFR 1306.04 and 21
U.S.C. 841(a). This action was part of a
nationwide enforcement operation by
DEA titled Operation Pharmnet, which
targeted online suppliers of prescription
drugs, including owners, operators,
pharmacists and doctors, who have
illegally and unethically been marketing
controlled substances via the Internet.
According to the investigative file, the
Order to Show Cause and Immediate
Suspension of Registration was
personally served upon Dr. Avello by
DEA Diversion Investigators on May 20,
2004. More than thirty days have passed
since the Order to Show Cause and
Immediate Suspension of Registration
was served and DEA has not received a
request for hearing or any other reply
from Dr. Avello 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.
Avello, and (2) no request for hearing
having been received, concludes that Dr.
Avello 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 to 21 CFR 1301.43(d)
and (e) and 1301.46.
The Deputy Administrator finds Dr.
Avello is currently registered with DEA
as a practitioner under DEA
Registration, AA0105747 for Schedule II
through V Controlled Substances. That
registration expires on June 30, 2006.
His registered address is 363 Aragon
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Agencies
[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Pages 11693-11695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4565]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
RAM, INC. d/b/a American Wholesale Distribution Corp.; Denial of
Registration
On July 23, 2004, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to RAM Inc., d/b/a American Wholesale Distribution
Corporation (RAM), proposing to deny its June 5, 2003, application for
DEA Certificate of Registration as a distributor of List I chemicals.
The Order to Show Cause alleged that granting RAM's application would
be inconsistent with the public interest, as that term is used in 21
U.S.C. 823(h). The order also notified RAM that should no request for a
hearing be filed within 30 days, its hearing right would be deemed
waived.
According to the DEA investigative file, the Order to Show Cause
was sent by certified mail to RAM at its proposed registered location
at 3300 Pleasant Valley Lane, Suite C, Arlington, Texas 76015. It was
received on August 2, 2004, and DEA has not received a request for a
hearing or any other reply from RAM or anyone purporting to represent
the company in this matter.
Therefore, the Deputy Administrator of DEA, finding that (1) thirty
days have passed since delivery of the Order to Show Cause, and (2) no
request for a hearing having been received, concludes that RAM has
waived its hearing right. See Aqui Enterprises, 67 FR 12576 (2002).
After considering relevant material from the investigative file, the
Deputy Administrator now enters her final order without a hearing
pursuant to 21 CFR 1309.53(c) and (d) and 1316.67. The Deputy
Administrator finds as follows.
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 1300.02(a). Pseudoephedrine and ephedrine are
List I chemicals commonly used to illegally manufacture
methamphetamine, a Schedule II controlled substance. As noted in
previous DEA 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).
The Deputy Administrator's review of the investigative file reveals
that RAM's owner and only officer is Mr. Mohamad Khorchid. On or about
June 5, 2003, an application was submitted by Mr. Khorchid on behalf of
RAM, seeking registration to distribute ephedrine and pseudoephedrine
List I chemical products. It identified the applicant as ``RAM INC
American Wholesale Dist. Co.''
Prior to RAM's February 7, 2003, incorporation, Mr. Khorchid and
his wife owned and operated American
[[Page 11694]]
Wholesale Distribution Corporation (AWD), also of Arlington, Texas,
which was registered as a distributor of List I chemical products on
April 15, 1999, under DEA Certificate of Registration 004169ASY.
During AWD's 1999 pre-registration inspection, DEA investigators
discussed requirements for recordkeeping and suspicious order reporting
with Mr. and Mrs. Khorchid and provided written information regarding
combination ephedrine and pseudoephedrine drug products used in
illicitly manufacturing methamphetamine. A juvenile employee of AWD
[John Doe] was present at this meeting and the three were advised it
was illegal to sell List I chemical products knowing they would be used
to manufacture illegal drugs. During this conversation, Mr. Khorchid
advised investigators that AWD sold sundry items to area convenience
stores and that List I chemical products would make up about 15% of the
company's total sales.
During a July 2001 regulatory investigation, Mr. Khorchid advised
DEA investigators that 99% of AWD's customers were convenience stores
and that List I chemical products made up about 10% of its sales. An
inventory conducted as a part of that investigation showed AWD
maintained a substantial inventory of ephedrine and pseudoephedrine
products manufactured or distributed by two companies, Lannett Company,
Inc. (Lannett) and PDK Labs, Inc. (PDK). The inventory included several
Max Brand products, which are manufactured by PDK.
DEA is aware that Lannett and PDK's ephedrine and pseudoephedrine
products have been discovered by law enforcement agencies at
clandestine methamphetamine laboratories and other illicit sites
throughout the country. See Indace, Inc, c/o Seegott, Inc; Malladi,
Inc., (Indace), 69 FR 67951 (2004) (Suspension of Shipment of ephedrine
hydrochloride being imported for distribution to PDK Labs, Inc.).
Further, during this period, no other ephedrine and pseudoephedrine
manufacturers had as much diversion of their products as Lannett and
PDK. DEA has previously found that PDK's Max Brand products are the
precursors ``predominantly encountered and seized at clandestine
methamphetamine laboratories'' and that ``[c]onvenience stores are also
the primary source for the purchase of the Max Brand products, which
are the preferred brand for use by illicit methamphetamine producers,
and users.'' See Express Wholesale, 69 FR 62086, 62087, 62089 (2004).
In April 2002, DEA investigators received information that AWD
employee John Doe, who had a close personal relationship with the
Khorchids, was falsifying company invoices to account for unlawful
sales of pseudoephedrine. On June 11, 2002, an undercover operation was
conducted which resulted in Doe selling a case of Action Brand PSE and
four dozen bottles of Max Brand PSE to an undercover agent for about
$1600.00, believing the products would be used to manufacture
methamphetamine.
In July 2002, Diversion Investigators obtained Mr. Khorchid's
consent to perform an administrative inspection of AWD. A review of the
company's sales records from April 2001 through July 2002 showed AWD
sold large amounts of Lannet and PDK pseudoephedrine and ephedrine
products to numerous area convenience stores. In many instances, the
purchases of these products were well in excess of any potential
legitimate demand. See Branex, Inc., supra, 69 FR at 8693 (expert
testimony on the legitimacy of selling listed chemical products in the
``gray market''); Xtreme Enterprises, Inc., 67 FR 76195, 76197 (2002)
(same); Value Wholesale, 69 FR 58548 (2004); see also Indace, supra, 69
FR at 67962 and cases cited therein.
On July 30, 2002, investigators informed Mr. Khorchid about the
investigation involving John Doe and requested surrender of the
company's DEA registration, which was done on October 1, 2002. The
employee was subsequently prosecuted in state juvenile court and pled
guilty to conspiring to manufacture a controlled substance
(methamphetamine).
During DEA's pre-registration investigation into RAM's pending
application, Mr. Khorchid advised investigators that the new company's
prospective customers would continue to be convenience stores and he
also intended to sell PDK manufactured pseudoephedrine and ephedrine
products.
DEA is aware that small illicit laboratories operate with listed
chemical products often procured, legally or illegally, from non-
traditional retailers of over-the-counter drug products, such as gas
stations and small retail markets. Some retailers acquire product from
multiple distributors to mask their acquisition of large amounts of
listed chemicals. In addition, some individuals utilize sham
corporations of fraudulent records to establish a commercial identity
in order to acquire listed chemicals.
DEA knows by experience that there exists a gray market in which
certain high strength, high quantity pseudoephedrine and ephedrine
products are distributed only to convenience stores and gas stations,
from where they have a high incidence of diversion. These gray market
products are not sold in large discount stores, retail pharmacies or
grocery stores, where sales of therapeutic over-the-counter drugs
predominate.
DEA also knows from industry data, market studies and statistical
analysis that over 90% of over-the-counter drug remedies are sold in
drug stores, supermarket chains and ``big box'' discount retailers.
Less than one percent of cough and cold remedies are sold in gas
stations or convenience stores. Studies have indicated that most
convenience stores could not be expected to sell more than $20.00 to
$40.00 worth of products containing pseudoephedrine per month. The
expected sales of ephedrine products are known to be even smaller.
Furthermore, convenience stores handling gray market products often
order more product than what is required for the legitimate market and
obtain chemical products from multiple distributors. See CWK
Enterprises, Inc., 69 FR 69400 (2004); Prachi Enterprises, Inc., 69 FR
69407 (2004); Volusia Wholesale, 69 FR 69409; Branex, Inc., supra, 69
FR at 8693.
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. Section 823(h) requires that 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 of the applicant 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 a 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.,
Energy
[[Page 11695]]
Outlet, 64 FR 14269 (1999). See also, Henry J. Schwartz, Jr., M.D., 54
FR 16422 (1989).
The Deputy Administrator finds factors one, two, three, four and
five relevant to the pending application for registration.
As to factors one through four, RAM's owners and operators have a
history of distributing List I chemical products which were then
diverted while the company operated as AWD and an employee with a close
relationship to the Khorchids, sold listed products to an undercover
officer believing they would be used to manufacture methamphetamine.
That employee was subsequently convicted of a state crime involving
controlled substances. As a result of these activities, Mr. Khorchid
surrendered AWD's registration and incorporated RAM only a few months
later. That company now seeks to sell listed products to the gray
market, including those manufactured by PDK Labs, just as it did when
operating solely under the AWD name. These four factors weigh against
granting the pending application.
With regard to factor five, other factors relevant to and
consistent with the public safety, the Deputy Administrator finds this
factor also weighs heavily against granting the application. Unlawful
methamphetamine use is a growing public health and safety concern
throughout the United States, including Texas. Ephedrine and
pseudoephedrine are precursor products needed to manufacture
methamphetamine and operators of illicit methamphetamine laboratories
regularly acquire the precursor products needed to manufacture the drug
from convenience stores and gas stations which, in prior DEA decisions,
have been identified as constituting the gray market for List I
chemical products. It is apparent that Mr. Khorchid intends on again
becoming a participant in this market, just as he did when registered
under AWD's identity.
While there are no specific prohibitions under the Controlled
Substances Act regarding the sale of listed chemical products to these
entities, DEA has nevertheless found these establishments serve as
sources for the diversion of large amounts of listed chemical products.
See, e.g., ANM Wholesale, 69 FR 11652 (2004); Xtreme Enterprises, Inc.,
supra, 67 FR 76195; Sinbad Distributing, 67 FR 10232 (2002); K.V.M.
Enterprises, 67 FR 70968 (2202).
The Deputy Administrator has previously found that many
considerations weighed heavily against registering a distributor of
list I chemicals because, ``[v]irtually all of the Respondent's
customers, consisting of gas station and convenience stores, are
considered part of the gray market, in which large mounts of listed
chemicals are diverted to the illicit manufacture of amphetamine and
methamphetamine.'' Xtreme Enterprises, Inc., supra, 67 FR at 76197. As
in Xtreme Enterprises, Inc., Mr. Khorchid's personal lack of a criminal
record, his discharge of former-AWD employee John Doe and purported
intent to comply with the law and regulations, are far outweighed by
his intent to sell pseudoephedrine products almost exclusively to the
gray market.
The Deputy Administrator is particularly troubled by AWD's history,
indicating its owners and operators, now principals of RAM, cannot be
trusted to handle the responsibilities of a registrant. Further, RAM's
continued use of AWD's name in a d/b/a capacity, raises further
questions about RAM's customer base and the risk that its products will
be sold to previous customers of AWD and then diverted to illegal
purposes.
Based on the foregoing, the Deputy Administrator concludes that
granting the 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 824 and 28 CFR 0.100(b) and 0.104, hereby orders the pending
application for DEA Certificate of Registration, submitted by RAM, Inc.
d/b/a American Wholesale Distribution Corporation, be, and it hereby
is, denied. This order is effective April 8, 2005.
Dated: January 14, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-4565 Filed 3-8-05; 8:45 am]
BILLING CODE 4410-09-M