[Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Notices]
[Page 33195-33199]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn05-84]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 03-35]
Joy's Ideas, Revocation of Registration
On June 13, 2003, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Joy's Ideas (Joy's Ideas/Respondent) proposing
to revoke its DEA Certificate of Registration 003278JIY as a
distributor of list I chemicals and deny its pending application for
renewal under 21 U.S.C. 824(a)(4) and 823(h) as being inconsistent with
the public interest. The Order to Show Cause alleged, in sum, that
Respondent was distributing list I chemicals to what DEA has identified
as the ``gray market'' and that a September 2001 audit by DEA Diversion
Investigators showed the company had serious record keeping
deficiencies.
Respondent 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. Following pre-hearing procedures, a hearing was held
in Memphis, Tennessee, on March 11 and 12, 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 September 29, 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 registration to distribute pseudoephedrine and
ephedrine products be continued and its application for renewal be
granted, subject to enumerated monitoring conditions. She recommended
denying the request to distribute phenylpropanolamine. The Government
filed Exceptions to the Opinion and Recommended Ruling, to which
Respondent submitted a Reply and on November 8, 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 the
recommendation that Respondent be denied registration to distribute
phenylpropanolamine, but disagrees with Judge Randall's recommendation
that Respondent be registered to distribute ephedrine and
pseudoephedrine, even under close monitoring conditions.
Respondent is a sole proprietorship owned and operated by Ms. Joy
Carter which is located in Memphis, Tennessee. It has been a DEA
registrant since March 1998 and holds DEA Certificate of Registration
003278JIY. On November 10, 2003, Ms. Carter filed an application for
renewal of that registration, which was due to expire on December 31,
2003. In it, she sought registration to distribute list I products
[[Page 33196]]
containing pseudoephedrine, ephedrine and phenylpropanolamine. Having
filed a timely application for renewal, Respondent has been allowed to
continue distributing listed chemicals during the pendency of these
proceedings. See 21 CFR 1309.45.
In September 2001, DEA Diversion Investigators conducted a routine
regulatory investigation of Respondent and met Ms. Carter at her
residence, which is also the registered premises. The physical security
and monitoring systems were found to be adequate and Ms. Carter
testified at the hearing that she had never had any listed chemical
products stolen or lost.
As a part of their investigation, the Diversion Investigators
conducted a two day accountability audit. However, the results were
hampered by Respondent's lack of an accurate inventory and
investigators assigned a beginning inventory of zero as their starting
inventory. Ms. Carter was cooperative and provided investigators all
purchase and sales records for the period covering March 1, 2001 to
September 12, 2001. At the conclusion of the audit, investigators found
there were overages of four listed chemical products and shortages of
two such products. Ms. Carter was unable to account for 15 100-count
bottles of ``Efedrin'' and 557 60-count bottles of ``Mini-thins.'' The
overages involved 6-count packages and 60-count bottles of ``Efedrin,''
60-count bottles of ``Max Brand Two Way'' and 6-count packages of
``Mini Thins.''
Evidence was introduced that overages can be anticipated when a
zero starting inventory is used and/or they may be attributable to
improperly maintained records. Shortages can result from improperly
maintained records or from theft or loss of the product. At the
hearing, a mathematical error impacting the overage of one product was
discovered and a former DEA Diversion Investigator testified that more
often than not, these audits do not result in perfectly balanced
inventories, particularly when a zero opening balance is used.
At the hearing Ms. Carter testified that before receiving the Order
to Show Cause, she was unfamiliar with procedures for ensuring
accountability of listed chemicals or how to conduct an audit. After
receiving that Order, she began working with her attorney and certified
pubic accountant to establish procedures for accurately recording
purchase and sales data and initiated weekly physical inventories of
listed chemicals. This system was put into operation in November 2003
and records introduced at the hearing showed that Ms. Carter was
adhering to the improved accountability procedures.
The Respondent is a wholesale distributor of about 200 sundry
products to convenience stores and gas stations. Seven of her
approximately 60 customers are located in Arkansas and Mississippi and
the balance are in Memphis. Each of these customers buy listed
chemicals from Joy's Ideas, which makes up between 20 to 30 percent of
Respondent's total sales. Most customers purchase approximately $100.00
of list I chemical products from Respondent each month.
Ms. Carter, the sole employee, testified she personally delivers
the listed chemicals and places them on customer's shelves. As a
result, she believed she could monitor her customers' stocks and tell
if she was their only supplier of listed products. Affidavits from
several long term customers were also introduced which affirmed they
only purchased listed chemicals from Respondent and their retail
customers did not buy more than two weeks packets or bottles of listed
chemicals at a time. According to records introduced at the hearing,
Respondent also did not exceed the threshold quantities of sales to a
single purchaser which are established by the Comprehensive
Methamphetamine Control Act of 1996. Ms. Carter further testified that
she instructed her customers to not sell more than two bottles of
ephedrine products to any single customer.
Ms. Carter has never been charged or convicted under Federal or
state law of any crime involving controlled substances or listed
chemicals. Joy's Ideas is her only source of income and she expressed
fear that if she were not able to provide customers listed chemicals,
they would take their entire business to other wholesalers, who could
provide ``one stop'' shopping.
List I chemicals are those that may be used in the manufacture of a
controlled substance in violation of the Controlled Substance 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 chemicals, is a legitimately
manufactured and distributed product used to provide relief of 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 requesting drug
companies to discontinue marketing products containing
phenylpropanolamine, due to risk of hemorrhagic stroke. As a result,
pharmaceutical companies have stopped using phenylpropanolamine as an
active ingredient. See, Gazaly Trading, 69 FR 22,561 (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 11,654 (2004); Branex, Inc., 69 FR 8,682 (2004); Denver Wholesale,
67 FR 99,986 (2002); Yemen Wholesale Tobacco and Candy Supply, Inc., 67
FR 9,997 (2002).
The Government introduced documentary and testimonial evidence
regarding the rapid proliferation of clandestine methamphetamine
laboratories in Tennessee and its adjoining states and described local
methods of production, as well as the multiple health hazards and
social costs stemming from production and abuse of methamphetamine. As
discussed in several recently published final orders, Tennessee leads
the DEA Atlanta Region in the number of clandestine laboratories
seized. See, e.g., Elk International Inc., d.b.a. Tri City Wholesale
(Elk International), 70 FR 24,615 (2005); Prachi Enterprises, Inc., 69
FR 69,407 (2004); CWK Enterprises, Inc., 69 FR 69,400 (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 69,401.
A DEA Special Agency credibly testified that the list I chemical
product of choice found in about eighty percent of illicit laboratories
in Tennessee is distributed under the off-name brand ``Max Brand''
label and is usually obtained from convenience stores. Judge Randall
found Respondent has distributed this product. However, there was no
direct evidence showing a known diversion of Respondent's products to
illicit manufacturing.
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
[[Page 33197]]
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 60, 100 or 120-county 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.
In previous final orders DEA has identified convenience stores as
the ``primary source'' for the purchase of ``Max Brand products, which
are the preferred brand for use by illicit methamphetamine producers.*
* * '' See, Elk International, supra, 70 FR 24,615; Express Wholesale,
69 FR 62,086, 62,087 (2004); see also, RAM, Inc. d/b/a American
Wholesale Distribution Corp., 70 FR 11,693 (2005).
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 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, after evaluating Tennessee convenience
store sales data, half 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, ``[t]he implausible nature of such
exceptionally large hypothetical sales at retail leads to a virtually
incontrovertible conclusion that the goods are not actually being
purveyed at retail to ordinary customers in the store's trading area at
all, but are being diverted to some other channel `under the counter.'
'' He concluded that many small Tennessee convenience stores were not
selling pseudoephedrine and ephedrine products for their intended
purpose as non-prescription drugs in the legitimate market and the
assumption that they were supplying a ``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 and
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, supra, 69 FR 11,654; Energy Outlet, 64 FR 14,269 (1999);
Henry J. Schwartz, Jr., M.D., 54 FR 16,422 (1989).
As to factor one, maintenance by the applicant of effective
controls against diversion, the Deputy Administrator agrees with Judge
Randall that Respondent's physical security system is adequate. With
regard to the 2001 accountability audit's results, Judge Randall found
the statistics ``questionable'' and based on the statistics alone,
could not conclude that any listed chemical products distributed by
Respondent had been diverted. She also concluded that Ms. Carter had a
faulty accountability system at the time of the audit. However, that
was mitigated by the significant accountability improvements crafted by
her certified public accountant after receipt of the Order to Show
Cause. Judge Randall also found Ms. Carter had a long standing
relationship with her customers and personally delivered their listed
chemical products and placed them on the shelves, allowing her to
monitor whether or not they were obtaining listed chemicals from other
wholesalers. Judge Randall concluded this factor weighted in favor of
registration.
The Deputy Administrator agrees with the Government's Exceptions
that the shortages established by the 2001 inventory would normally
show up as overages, given that a zero opening balance was used, and
that diversion may be inferred from such shortages. However, given the
apparent good faith of Ms. Carter to avoid diversion and the inadequate
accountability systems she was using at the time of the audit, under
the facts of this case the inference of diversion attributable to the
audit is not strong.
On the other hand, given the number of Respondent's retail
customers and imprecise and unrecorded ``eyeball'' monitoring of what
is on their shelves, the Deputy Administrator has concern over Ms.
Carter's ability to know, with an acceptable degree of certainty,
whether or not her customers are obtaining products from other
distributors. DEA has previously found that gray markets 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, Elk International Inc., supra, 70 FR
24,615; Titan Wholesale, Inc., 70 FR 12,727 (2005).
Further, convenience store operators engaged in this illicit trade
could be obtaining products from other wholesalers, yet not be
displaying them on retail shelves, also compromising Ms. Carter's
efforts to ensure she was the only supplier. Accordingly, so long as
Respondent services this suspect
[[Page 33198]]
market, even the most sincere efforts by Ms. Carter to self-regulate
her customers cannot guarantee that current and/or future customers
will not be obtaining precursor chemicals from other distributors, as
well as from Respondent, and then resell them for illicit purposes.
Nevertheless, given Ms. Carter's commendable actions to improve her
accountability systems and her honest and credible desire to avoid
contributing to the scourge of methamphetamine, in a ``close call,''
the Deputy Administrator agrees with Judge Randall that factor one
weighs in favor of continued registration.
With regard to factor two, Respondent's compliance with applicable
Federal, state and local law, Judge Randall concluded this factor also
weighs in favor of registration. However, the significance for this
factor 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
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 methamphetamine abuse
problem. See, e.g., Express Wholesale, supra, 69 FR at 62,809 [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 12,732, 12,734 (2005)
[denying registration to intended Oklahoma distributor, in part, on
basis of enactment of recent state legislation]; Express Wholesale,
supra, 69 FR at 62,089.
Of particular relevance to Joy's Ideas and similarly situated
Tennessee applicants and registrants, after Judge Randall signed her
Opinion and Recommended Ruling, legislation was enacted by the State of
Tennessee 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 included both name
brand and off-name brand products. See, e.g., Elk International Inc.,
supra, 70 FR 24,615.
According to evidence introduced at the hearing, approximately 53
of Respondent's 60 customers are convenience stores and gas stations
located in Tennessee. Therefore, with only a few exceptions,
Respondent's entire customer base is now prohibited by state law from
selling the pseudoephedrine products Respondent seeks DEA registration
to distribute. Thus, factor two weighs heavily against registration.
See, Elk International, supra, 70 FR at 24,618; Tysa Management, d/b/a
Osmani Lucky Wholesale, supra, 70 FR at 12,734; Express Wholesale,
supra, 69 FR at 62,089.
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 of any prior convictions
of Respondent or its owner relating 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 Ms. Carter's
lack of knowledge concerning how to conduct accountability audits and
lack of inventory control, which were uncovered in the 2001 audit,
weighed against Respondent's continued handling of listed chemical
products. However, this was balanced by Ms. Carter's aggressive actions
to improve her inventory and accountability practices. She was also
familiar with listed chemical products, as well as her customers, and
never sold over-the threshold quantities.
The Administrative Law Judge concluded that while ``a close
matter,'' because of Ms. Carter's willingness to create and maintain a
viable inventory system and her familiarity with her customers'
operations, factor four weighed in favor of continued registration,
especially if close monitoring was maintained by DEA over Respondent.
The Deputy Administrator disagrees with this conclusion.
The evidence showed Respondent was selling most of her convenience
store customers about $100.00 of list I chemicals per month. As
established by Mr. Robbin's expert opinion evidence, this far exceeds
the amount of expected sales of these products for legitimate
therapeutic purposes. Even though, as Judge Randall concluded, there
was no direct evidence that Respondent contributed to the diversion of
listed chemical products, she did find the record contained ``abundant
statistical evidence that, without further explanation, would logically
lead to the conclusion that the Respondent distributed more listed
chemical products to its convenience store customers than could
reasonably be sold at resale for legitimate use.''
The Deputy Administrator cannot find a plausible explanation in the
record for this deviation from the expected norm, other than diversion
at the retail level. Accordingly, while Ms. Carter may have been an
unknowing and unintentional contributor to Tennessee's methamphetamine
problem, it is logical to infer that the listed products she was
distributing to area convenience stores were being diverted to illicit
purposes. Accordingly, the Deputy Administrator finds that factor four
weights against Respondent's continued registration.
With regard to factor five, other factors relevant and consistent
with the public health and safety, Judge Randall acknowledged earlier
DEA precedent applying this factor to deny registration to a gray
market distributor based on statistical evidence. See, Xtreme
Enterprises, Inc., 67 FR 76,195 (2002); Branex, Inc., supra, 69 FR
8,682, 8,693. However, based on the amounts of listed products being
distributed by Respondent, their wholesale prices and Ms. Carter's
apparent good faith and willingness to adhere to DEA requirements,
given the facts of the case, Judge Randall was unwilling to conclude
that Respondent's listed chemical products were being diverted or would
likely be diverted in the future. She therefore found factor five
weighed in favor of continued registration to distribute ephedrine and
pseudoephedrine.
In Xtreme Enterprises, the Deputy Administrator found its owner had
only a rudimentary knowledge of what
[[Page 33199]]
would constitute a suspicious order and no experience in the
manufacture or distribution of listed chemicals. While given Ms.
Carter's past experience, those findings do not apply to Respondent.
However, 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 76,197.
DEA has expansively applied Xtreme Enterprises to a multitude of
applicants and registrants seeking to do business in the gray market.
See e.g., Express Wholesale, supra, 69 FR 62,086; Value Wholesale, 69
FR 58,548 (2004); K & Z Enterprises, Inc., 69 FR 51,475 (2004); William
E. ``Bill'' Smith d/b/a B & B Wholesale, 69 FR 22,559 (2004); Branex
Incorporated, supra, 69 FR 8,682; Shop It for Profit. 69 FR 1,311
(2003); Shani Distributors, 69 FR 62,324 (2003).
As in those cases, Ms. Carter's lack of a criminal record, previous
general compliance with the law and regulations and willingness to
comply with regulations and guard against diversion, are far outweighed
by her intent to continue selling ephedrine and pseudoephedrine
exclusively in the gray market. Unlawful methamphetamine production and
use is a growing public health and safety concern throughout the United
States and specifically in the locality where Respondent does business.
Pseudoephedrine and ephedrine are the precursor products used to
manufacture methamphetamine and area laboratory operators have
predominantly acquired their precursor chemicals from the customer base
Respondent seeks to continue serving. While Ms. Carter may intend to
avoid contributing to this problem, the risk of diversion once her
listed chemicals enter the gray market is real, substantial and
compelling.
This reasoning has also been applied by the Deputy Administrator in
a series of final orders published after Judge Randall issued her
Opinion and Recommended Ruling in the matter. See, Elk International,
supra, 70 FR 24,615; TNT Distributors, Inc., supra, 70 FR 12,729; Titan
Wholesale, Inc., supra, 70 FR 12,727; RAM, Inc. d/b/a American
Wholesale Distribution Corp., supra, 70 FR 11,693; Al-Alousi, Inc., 70
FR 3,561 (2005); Volusia Wholesale, 69 FR 69,409, (2004); Prachi
Enterprises, Inc., supra, 69 FR 69,407; CWK Enterprises, Inc. 69 FR
69,400 (2004); J & S Distributors, 69 FR 62,089 (2004); Express
Wholesale, supra, 69 FR 62,086; Absolute Distributing, Inc., 69 FR
62,078 (2004).
In any event, Judge Randall's recommendation that Respondent be
allowed to continue distributing listed chemicals to convenience stores
in Tennessee, albeit with close monitoring by DEA through the
submission of a monthly log and consent to inspection without an
administrative inspection warrant, has been mooted by Tennessee's
recent enactment of legislation requiring that all pill and tablet
pseudoephedrine products, including those marketed under traditional
brand names, be sold only through registered pharmacies. As this state
statute, discussed more fully under factor two, effectively bars
distribution of those products throughout Tennessee's gray market, it
is also relevant under factor five and weighs heavily against
Respondent's continued registration. See, e.g., Elk International,
supra, 70 FR at 24,618.
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 Respondent's initial proposal to distribute that
product. DEA has previously determined that such a request constitute a
ground under factor five for denial of an application for registration.
See J & S Distributors, supra, 69 FR 62,089; Gazaly Trading supra, 69
FR 22,561; William E. ``Bill'' Smith d/b/a B & B Wholesale, supra, 69
FR 22,559; Shani Distributors, supra, 68 FR 62,324. However, it is
noted that after the hearing and the Government's filing of its
Exceptions to the Opinion and Recommended Ruling, Respondent's Reply
indicated that it did not intend to carry products containing
phenylpropanolamine.
Based on the foregoing, the Deputy Administrator concludes that
continuing Respondent's registration and granting its pending
application for renewal 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 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate
of Registration, 003278JIY, issued to Joy's Ideas, be, and it hereby
is, revoked. Further, the pending application for renewal of said
Certificate of Registration submitted by Joy's Ideas should be, and
hereby is, denied.
This order is effective July 7, 2005.
Dated: May 25, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-11249 Filed 6-6-05; 8:45 am]
BILLING CODE 4410-09-M