FR Doc E8-21035[Federal Register: September 10, 2008 (Volume
73, Number 176)] [Notices] [Page 52689-52704] From the Federal
Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se08-68]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08-33]
Novelty Distributors, Inc.; Revocation of Registration
On January 17, 2008, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and
Immediate Suspension of Registration to Novelty Distributors,
Inc. (Respondent), of Greenfield, Indiana. The Order immediately
suspended and proposed the revocation of Respondent's DEA
Certificate of Registration, 003563NSY, as a distributor of the
list I chemicals ephedrine and pseudoephedrine, on the grounds
that its "continued registration is inconsistent with the public
interest,'' and "constitute[d] an imminent danger to public
health and safety.'' Show Cause Order at 1 (ALJ EX. 1) (citing
21 U.S.C. 823(h), 824(a)(4), and 824(d)).
More specifically, the Show Cause Order alleged that
Respondent was storing listed chemical products at, and
distributing them from, over 100 unregistered locations
throughout the United States, in violation of Federal law and
regulations. Id. (citing 21 U.S.C. 822(e), 21 CFR 1309.21 and
1309.23(a)).
Next, the Show Cause Order alleged that Respondent was
distributing quantities of listed chemical products "to small
retail outlets such as convenience stores'' in amounts "far
exceed[ing] what those retail outlets could be expected to sell
for legitimate, therapeutic purposes.'' Id. at 2. The Order thus
alleged that the "listed chemical products distributed by
[Respondent] in large quantities have been, and are likely to
continue being, diverted to the clandestine manufacture of
methamphetamine.'' Id. (citing cases). Relatedly, the Show Cause
Order alleged that some "[s]mall retail outlets that receive
large quantities of * * * listed chemical products from
[Respondent] sell such products to individuals in amounts that
cannot be attributed to legitimate individual needs,'' that "some
of the retail outlets allow customers to make multiple purchases
of scheduled listed chemical products within a single week, and
in some cases, within a single day,'' and that "[s]ome customers
of these retail outlets purchased more than 9 grams of ephedrine
or pseudoephedrine base within 30 days in violation of 21 U.S.C.
844(a).'' Id.\1\
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\1\ The Show Cause Order also alleged that "[i]n November
2002, 22 bottles of ephedrine products distributed by Novelty
were found at an illicit methamphetamine laboratory in
Connecticut.'' Show Cause Order at 2.
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The Show Cause Order further alleged that between January 1,
2007, and July 9, 2007, Respondent distributed listed chemical
products "on at least 284 occasions to 35 retail outlets,''
which had not self- certified as required under Federal law. Id.
(citing 21 U.S.C. 830(e)(1)(A)(vii)). Id. Moreover, on three
occasions subsequent to February 1, 2007, Respondent allegedly
distributed 24-count bottles of listed chemical products to
retailers in violation of Federal law, which effective April 9,
2006, required that non-liquid form products be sold only in
blister packs. Id. at 2-3 (citing 21 U.S.C. 830(d)(2)).
Relatedly, the Show Cause Order alleged that Respondent had
distributed tablet-form products to retailers in Kentucky and
North Carolina in violation of the laws of these States which "prohibit
the sale of non- liquid ephedrine and pseudoephedrine except in
a gel-cap product.'' Id. at 3.
Finally, the Show Cause Order alleged that in July 2007, DEA
had audited twenty listed chemical products which Respondent
distributed. Id. at 2. The Show Cause Order alleged that
Respondent "could not account for more than 60,000 dosage units
of two ephedrine products'' and that it also had "overages for
16 different * * * listed chemical products.'' Id. The Order
thus alleged that Respondent "failed to maintain accurate
records of its distributions and receipts of * * * listed
chemical products in violation of 21 U.S.C. 830(a) and 21 CFR
1310.04.'' Id.
[[Page 52690]]
Based on the above allegations, I made the preliminary
finding that the listed chemical products Respondent was
distributing had been, and were "likely to continue to be,
diverted into the illicit manufacture of methamphetamine.'' Id.
at 3. I also found that Respondent's "failure to maintain
effective controls against diversion, including its distribution
of large amounts of * * * listed chemical products that far
exceed legitimate demand, contribute to the illicit manufacture
of methamphetamine.'' Id. I thus came to the "preliminary
conclusion that [Respondent's] continued registration during the
pendency of these proceedings would constitute an imminent
danger to the public health and safety,'' and immediately
suspended its registration. Id.
On February 26, 2008, Respondent requested a hearing on the
allegations. ALJ Ex. 2. The matter was assigned to
Administrative Law Judge (ALJ) Gail Randall, who proceeded to
conduct pre-hearing procedures. A hearing was held on March 24
through March 28, and March 31 through April 2, 2008, at which
both parties put on extensive testimony and introduced numerous
documents into evidence. Moreover, on March 24, 2008, Respondent
filed an interlocutory appeal in which it challenged the ALJ's
denial of its motion to remove one of the Government's lawyers
from participating in the hearing, on the ground that he was a
necessary and indispensable witness to the events surrounding
the execution of an administrative search warrant which was the
subject of its motion to suppress. See ALJ Exs. 12 and 13. On
March 25, 2008, I denied Respondent's appeal on multiple
grounds.\2\ ALJ Ex. 13.
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\2\ The grounds included that Respondent had not established
that the Government's lawyer was a necessary and indispensable
witness, and that Respondent had not cited a single case to
support its contention that the conduct of the Government
lawyer--even if true--was a violation of its constitutional
rights. Denial of Interlocutory Appeal, at 2-3 (ALJ Ex. 13.) I
also noted that the Agency had previously held that the
exclusionary rule does not apply to proceedings under 21 U.S.C.
824, and that the Supreme Court had "repeatedly declined to
extend the exclusionary rule to proceedings other than criminal
trials.'' Id. (quoting Pennsylvania Bd. of Probation v. Scott,
524 U.S.C. 357, 363 (1998)).
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Following the hearing, both parties submitted briefs
containing their proposed findings, conclusions of law, and
argument. On May 21, 2008, the ALJ issued her recommended
decision (hereinafter, ALJ).\3\
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\3\ The decision was 165 pages in length.
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In her decision, the ALJ found that the Government's evidence
regarding the monthly expected sales of combination ephedrine
products at convenience stores ($14.39) to meet legitimate
demand was "flawed and not credible.'' ALJ at 97. Relatedly,
while acknowledging that "Respondent sells an approximate
monthly average of $640.00 in SLC products to its convenience
store customers,'' the ALJ observed that "there is no legitimate
sales figure in the record'' by which the excessiveness of its
sales (and the likelihood that the products were being diverted)
could be judged. Id.
Regarding the allegation that Respondent failed to maintain
accurate records of its receipts and distributions, the ALJ
concluded that the evidence pertaining to the audit did not
establish "preponderating evidence either way to assist in
analyzing the accuracy of * * * Respondent's handling'' of
listed chemical products. Id. at 88. The ALJ concluded, however,
that "Respondent's recordkeeping is not adequate to conduct an
effective audit of its SLC products.'' Id.
The ALJ also rejected the allegation that Respondent had made
numerous distributions to uncertified retailers based on
testimony and documentary evidence that one of Respondent's
officials had confirmed that these "customers were, in fact,
self-certified.'' Id. at 91. The ALJ further found unproven the
allegation that Respondent had thrice distributed listed
chemical products in bottles in violation of Federal law, noting
that Respondent had provided "documentary proof that the * * *
product * * * had not been illegally distributed.'' Id. at 86.
The ALJ also found unproven the Government's allegation that
Respondent had distributed tablet-form products to retailers in
Kentucky and North Carolina, noting that "Respondent produced
credible testimonial evidence to support a finding that these
illegal sales in fact did not happen.'' Id.
With respect to the allegation that Respondent was violating
Federal law because it was distributing from over 100 drop-off
points which were not registered, the ALJ noted that Respondent
had challenged the Agency's interpretation in Federal District
Court. Id. at 90-91. The ALJ found, however, that Respondent had
been advised by a DEA Group Supervisor (GS) that its practice of
shipping SLCs to numerous storage units which were not
registered was illegal, that it had continued do so without even
seeking clarification from the Agency, and that this conduct was
"not consistent with the requirements for a participant in a
regulated industry.'' Id. at 91. However, because Respondent's
declaratory judgment action was still "pending in federal
court,'' the ALJ "conclude[d] that [the district court was] the
proper venue for this issue'' and declined to address the
statutory question.\4\ Id. at 91 n.38.
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\4\ On August 7, 2008, the District Court granted the
Government's motion for summary judgment and denied Respondent's
cross-motion for summary judgment. See Entry on Cross Motions
for Summary Judgment, Novelty, Inc., v. Tandy, No.
1:04-cv-1502-DFH-TAB (S.D. Ind., Aug. 7, 2008). Notably, the
District Court held that the instructions in the Group
Supervisor's letter were interpretive and not legislative rules,
and were thus not subject to notice and comment rulemaking under
5 U.S.C. 553. Id. at 2. Pursuant to 5 U.S.C. 556(e), I take
official notice of the District Court's decision. I also take
official notice of the August 13, 2008 letter submitted by
Respondent's President. In his letter, Respondent's President
stated that he has ordered a change to Respondent's distribution
practices and "reiterates its previously stated commitment to
cooperate with [this Agency] and adhere to all conditions
specified by [me] for [its] continued registration.'' Letter of
Todd Green (Aug. 13, 2008).
In his letter, Respondent's CEO does not state that
Respondent's will waive its right to appeal the District Court's
decision. Moreover, I conclude that in light of the extensive
resources that have been devoted to litigating the issue of the
lawfulness of Respondent's use of unregistered locations to
store and distribute SLCs, as well as the importance of the
issue to the regulated industry, the issue should be decided.
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Finally, the ALJ also found that following the suspension
order, Respondent had attempted to enter into an agreement with
one of its suppliers (BDI), under which its salespersons would
still take orders for SLCs which would be shipped by BDI. ALJ at
92. Here again, the ALJ noted that there was no evidence that
Respondent had asked the Agency if the arrangement was lawful.
Id.
The ALJ nonetheless concluded that Respondent had "demonstrated
a willingness to comply with the laws and regulations governing
the distribution of SLC products,'' specifically noting that it
had developed a training program for its customers, had provided
them with the logbooks required by the CMEA, and lockable
display cases for its products, and had upgraded its computer
system. Id. at 98-99. The ALJ also noted that following the
implementation of the CMEA, Respondent had "acted to remove * *
* non-complying SLC products from its customers' shelves and
[to] properly dispose of'' them. Id. at 99.
With respect to the audits, the ALJ observed that while they "appeare[d]
to reveal significant overages and shortages,'' Respondent had "credibly
and adequately minimized those figures to a more acceptable
margin of inventory error after analyzing its records and making
its own audit
[[Page 52691]]
findings.'' Id. Finally, while the ALJ noted that
Respondent's continued distributions to the drop-off points "cause[s]
concern,'' she further reasoned that except for the Group
Supervisor's letter, it "had no notice from the [Agency] of any
violations until the * * * Suspension Order was served'' on it,
and that it "ha[d] not been given an opportunity to remedy the
flaws identified by the Agency [in] this action.'' Id. at 100.
Based on what she characterized as its "history of,'' and "financial
commitment to,'' compliance, the ALJ reasoned that revocation
would not be an appropriate sanction. Id. at 100-01. Instead,
the ALJ recommended that I impose compliance requirements on
Respondent to ensure that it operated in the public interest.
Id. at 101.
Thereafter, the Government filed exceptions to the ALJ's
decision. Respondent likewise filed a 140 page brief which
supported the ALJ's decision while also excepting to certain
findings and conclusions. Having considered the entire record in
this matter and all of the issues raised in the parties'
exceptions, I hereby issue this Decision and Final Order. More
specifically, I reject the allegations that Respondent
distributed SLC products in violation of the CMEA and the laws
of Kentucky and North Carolina as unsupported by substantial
evidence. With respect to the allegations that Respondent
engaged in 284 distributions to uncertified retailers, I
conclude that the evidence establishes only a single instance of
distributing to an uncertified retailer and several instances of
inaccurate recordkeeping in that Respondent's records of the
addresses for several stores did not match the actual addresses
of the stores, and that the Government has not proved by
substantial evidence that the stores were uncertified on the
date of the distributions.
With respect to the audit, I conclude that because the ALJ
found credible the testimony of one of Respondent's executives
that the Agency's investigators had excluded certain
transactions and inventory adjustments which it had provided to
them, and the Government offered no rebuttal evidence, the
allegation that Respondent had shortages and overages of various
products is not proved. I find, however, that the evidence shows
that Respondent's recordkeeping did not comply with federal law
because it failed to maintain proper records of regulated
transactions as required by Federal law and DEA regulations. See
21 U.S.C. 830(a); 21 CFR 1310.03, id. 1310.04, id. 1310.06.
Because of this, as well as evidence showing that Respondent's
list of shipments included three shipments of a product with a
date of July 16, 2007, even though it was then only July 9,
2007, I find that Respondent does not have adequate systems for
monitoring the receipt and distribution of SLCs. 21 CFR
1309.71(b).
With respect to the allegation that Respondent's sales of SLC
were excessive and consistent with diversion, I agree with the
ALJ that the Government's figure as to the expected monthly
sales range is not supported by substantial evidence. I
nonetheless conclude that Respondent does not maintain effective
controls against diversion because its own evidence shows that
it distributed SLCs to numerous stores in quantities that
dwarfed what its average customer purchases, and that it did so
even when it had previously developed concerns that a store was
purchasing excessive quantities, and that it does not even
enforce its own sales limit policies.
Next, in contrast to the ALJ, I conclude that this proceeding
is the appropriate forum to address the meaning of 21 U.S.C.
822(e) and the allegation that Respondent has repeatedly
violated Federal law by distributing from unregistered
locations. Consistent with the statutory text and purpose, I
conclude that Respondent's practice of using unregistered
self-storage units to store and distribute SLC products violated
the Controlled Substances Act and DEA's regulation.
Finally, for reasons set forth below, I reject the ALJ's
recommended sanction that Respondent's registration be continued
with conditions. As explained below, because Respondent
repeatedly violated Federal law notwithstanding that it was
advised that its use of the unregistered self-storage facilities
was unlawful, does not even enforce its own policies with
respect to limiting sales, and attempted to circumvent the
suspension order, I conclude that revocation is necessary to
protect the public interest. I make the following findings of
fact.
Findings
Respondent is a corporation which is solely owned by its
President, Mr. Todd Green. Respondent is a wholesale distributor
of various sundry items to between 10,000 and 12,000 convenience
stores throughout the United States.
Since 1998, Respondent has held DEA Certificate of
Registration, 003563NSY, which authorizes it to distribute
pseudoephedrine and ephedrine from its registered location of
351 W. Muskegon Drive, Greenfield, Indiana. GX 1. Respondent's
registration expires on October 31, 2008. Id.
Both ephedrine and pseudoephedrine have FDA approved
therapeutic uses. GX 19, at 3. Ephedrine is lawfully marketed
under the Food, Drug, and Cosmetic Act for OTC use as a
bronchodilator to treat asthma,\5\ and pseudoephedrine is
lawfully marketed for OTC use as a decongestant. Id. at 3-4.
Both substances are, however, regulated as schedule listed
chemicals under the Controlled Substances Act because they are
precursor chemicals which are frequently diverted into the
illicit manufacture of methamphetamine, a schedule II controlled
substance, a potent and highly addictive central nervous system
stimulant. See 21 U.S.C. 802(34); id. 812(c); 21 CFR 1308.12(d).
Moreover, in the course of investigating methamphetamine
trafficking, DEA has frequently found that the listed chemicals
which are used by smaller illicit labs have been sold by
convenience stores, gas stations, and other small retailers. GX
51, at 56, 59, 62, 66; GX 54, at 29-30.\6\ See also TNT
[[Page 52692]]
Distributors, 70 FR 12729, 12730 (2005) (noting testimony of
Special Agent that "80 to 90 percent of ephedrine and
pseudoephedrine being used [in Tennessee] to manufacture
methamphetamine was being obtained from convenience stores'').
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\5\ The FDA has, however, issued a notice of proposed
rulemaking which would remove combination ephedrine-guaifenesin
products from the OTC monograph on the grounds that they are not
"safe and effective for continued OTC availability.'' 70 FR
40232 (2005).
The parties also extensively litigated the medical
appropriateness of using combination ephedrine products to treat
asthma. See ALJ 43-48. I find it unnecessary to make any
findings on this issue as until the FDA issues a final rule,
combination ephedrine-guaifenesin products can be lawfully
marketed for this purpose.
\6\ Based on the testimony of a witness whose experience was
limited to the Shenandoah, Virginia valley, the ALJ found that
the street price of a gram of methamphetamine is "between $20.00
and $50.00 per gram.'' ALJ at 48-49. Based on this, as well as
evidence regarding the yield and conversion rate, the ALJ found
that "it would cost a methamphetamine cook between $50.00 and
$144.00 to produce 1 gram of methamphetamine.'' ALJ at 50. The
ALJ thus concluded that "using the Respondent's product to
manufacture methamphetamine makes little monetary sense.'' Id.
at 96.
I reject the ALJ's finding regarding the street price of
methamphetamine and her conclusion that using Respondent's
product "makes little monetary sense.'' Id. As for her findings
regarding the street price of methamphetamine, I note that it is
based on anecdotal evidence and limited to a small region of the
State of Virginia. Respondent does not, however, limit its
distribution of SLCs to this region of the country. I further
note that it runs counter to the data which this Agency obtains
on a periodic basis, and which show that in most of the country,
methamphetamine prices are substantially higher than they are in
the Shenandoah Valley. See U.S. Dep't of Justice, National
Illicit Drug Prices--December 2007, 32-37 (Mar. 2008). In
accordance with 5 U.S.C. 556(e), and 21 CFR 1316.59(e), I take
official notice of the methamphetamine street price data
contained in this publication. Moreover, the ALJ's conclusion
assumes that methamphetamine addicts engage in economically
rational behavior. There is, however, no evidence in the record
to support this assumption. I therefore reject the ALJ's
conclusion.
I also find that this witness's testimony that convenience
stores are not the source of precursors in the Shenandoah Valley
(ALJ at 49), to be anecdotal and contrary to the Agency's
experience throughout the country. I thus give it no weight.
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Prior to the suspension of its registration, Respondent sold
combination ephedrine and pseudoephedrine products under the
brand names of Double Action, Mini, and Ephedrine Plus in
package sizes of two, six, twelve and twenty-four count. Tr.
561, 692-93. Respondent sold these products to approximately
3,500 to 4,000 convenience stores in approximately thirty
different States. Id. at 80-82, 558-60. Respondent does not
carry any other OTC drug products. Id. at 552.
Respondent employs approximately 150 sales persons, who
typically visit each store every other week.\7\ Tr. 2046, 1290.
Using its own tractor-trailers, Respondent ships products
including SLCs from its Greenfield warehouse to each sales
person's "drop-off point,'' which is a unit in a commercial
self-storage facility. Id. at 73-75. According to the testimony
of Respondent's owner and CEO, Respondent was using
approximately 150 to 180 drop-off points at the time the
immediate suspension was served on it. Id. at 76. Both the
driver who delivers the product to the drop-off point and the
route sales person have keys to the storage unit. Id. While the
sales persons are notified of each arriving shipment, SLCs can
sit in the storage units for several days before the sales
person retrieves them for delivery to the stores.\8\ Id. at 534,
668. Moreover, according to one of Respondent's executives, the
SLCs can remain on the salesperson's truck for up to nine days
depending upon the demand for the product. Id. at 1282, 1421.
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\7\ Approximately 90% of the stores are on this schedule; the
remaining stores are visited either weekly or monthly. Tr. 1290.
\8\ It is undisputed that the SLCs are not shipped back to
Respondent's registered location prior to their being
distributed.
At the hearing, an executive of Respondent insisted that "we
are not storing product in * * * unregistered locations,'' and
added: "Now your coming back into the definition of what is
storage. We're not storing the product in that location,''
referring to the drop-off points. Tr. 666-67. See also id. at
668 ("We're not storing or keeping or whatever words you want to
try and use, product in these warehouses, against the law. We're
not doing it.''). The executive acknowledged, however, that
products may stay in the storage units for "a few days.'' Id. at
667. I therefore find that Respondent is storing products in the
self-storage units.
Respondent further asserted that its distribution system
provided more security than shipping the products via such
common carriers as UPS or Fed Ex. See Tr. 644-45. Yet an
executive of Respondent acknowledged that it uses temporary
drivers on a contract basis. Id. at 693, 697. Relatedly,
Respondent's CEO offered testimony as to perceived security
inadequacies at UPS, asserting that "[p]roduct delivered by UPS
could easily be stolen anywhere in the system.'' Id. at 157.
On cross-examination, however, Respondent's CEO admitted that
he had not taken a tour of a UPS facility. Id. at 161. When
asked when he had last "checked into the training that UPS
personnel have with regard to handling [SLCs]?,'' he answered: "I
assume they don't have any training, since they're not DEA
regulated facilities.'' Id. at 162. The ALJ did not address the
credibility of the CEO's testimony. As ultimate factfinder, I
reject it as lacking foundation.
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None of the drop-off points is registered with the Agency.
Tr. 1284. Moreover, the units do not have separate cages for
storing SLCs, id. at 132, and the facilities have varying
degrees of external security with some having cameras and
requiring access codes while others have no additional security.
Compare id. at 131, with id. at 538 (former salesperson
testifying that anyone could come off the road and access the
door and padlock to his route storage unit).\9\ Moreover, DEA
Investigators could not determine the addresses of thirty-four
of the drop-off points. Tr. 1196-98.\10\
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\9\ There is no dispute that the security at Respondent's
Greenfield warehouse is adequate. It is also undisputed that
following the enactment of the CMEA, Respondent prepared a
training video for its customers and supplied them with logbooks
and cases for storing SLC products. Tr. 1390 & 1422; RXs 34,
47, & 48.
\10\ On its list of shipments, Respondent used code numbers
to indicate where products were being shipped to. Tr. 1196.
Moreover, Respondent initially refused to turn over information
identifying the addresses of the drop-off points for the sales
routes, claiming that it was outside the scope of the warrant.
Id. at 1197.
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In a letter dated May 5, 2004, the Diversion Group Supervisor
of the Indianapolis, Indiana DEA District Office, advised
Respondent that "any storage at, and distribution from, a
location other than the registered location (including the use
of delivery vehicles for overnight storage) is a violation of
federal law.'' \11\ GX 100. Upon review of the letter,
Respondent sought a declaratory judgment in Federal District
Court challenging the interpretation set forth in the letter.
Tr. 652-53. At no time, however, did Respondent change its
practice of distributing to the drop-off points. Id. at 664-65.
Nor did Respondent seek a review of the letter by officials at
the Agency's headquarters. ALJ at 18.
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\11\ The letter also reviewed three scenarios "in case
[Respondent was] storing List I chemical products * * * and
distributing them from satellite locations, such as commercial
storage units, personal residences and or delivery vehicles.''
GX 100, at 1. The first two scenarios involved sales
representatives who picked up listed chemicals from a registered
location either to fill a pre-placed order or a "general
order,'' and could not return the products "to the registered
location at the end of the day.'' Id.
The third scenario was "a company [that] ships orders
containing List I chemicals to sales representatives at remote
locations.'' Id. at 2. The letter further explained that "DEA
considers this to be freight forwarding and at this time * * *
has no provisions that would permit freight forwarding for List
I chemical products.'' Id.
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The record further establishes that at the time the listed
chemical products are shipped from its Greenfield, Indiana
warehouse (which is its only registered location) to the
drop-off points, the products have not been sold to a particular
store. Tr. 2079. Indeed, the amount of SLCs to be sold to a
customer is not known until the route sales person visits the
store and determines how much product the store needs. Id. at
1282. The sales person counts the product on hand, discusses the
order with the store manager, and restocks the store. Id. at
631; 1422.
Moreover, at the time an SLC order is placed, only the
salesperson--and no one at Respondent's headquarters--knows how
much the store has purchased. Id. at 633. The salesperson is
required to enter the order information into a handheld computer
which generates an invoice; this information is later
transmitted back to Respondent's headquarters. Id. at 634. The
salesperson is also required to return a paper copy of the
invoice, as well as a shipping document which accompanies the
delivery of the SLCs from the warehouse, to headquarters. Id. at
688. Under its system, while Respondent's headquarters can
determine which salesperson has received product with a
particular lot number, it cannot identify the specific store
that obtained a particular lot number of a product. Id. at 1517.
Respondent's CEO testified that a store could purchase up to
a case of an SLC product in each "service cycle.'' \12\ Id. at
101. Accordingly, most stores could purchase two cases per month
of each product. Moreover, Respondent sold more than ten
different SLC products. Id. at 623.
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\12\ With respect to the 24-tablet products, the record
establishes that there were 144 packages in a case. Tr. 621. The
record does not, however, establish how many packages there were
in a case of the smaller size packages. Id. at 624.
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According to one of its executives, the company monitors the
sales of each SLC product at each store throughout the week to
determine whether a store "is increasing [its] inventory more
than [Respondent] expects [it] to,'' and if it is, the company
contacts the salesperson to
[[Page 52693]]
inquire further. Id. at 2061-62. This executive also asserted
that in this event, it would send in one of the salesperson's
supervisors to visit with the sales person and determine the
true inventory at a store. Id. Moreover, another executive
claimed that he "receive[s] a computer-generated report
indicating any time that more than one case has been sold to a
single retail location of a single'' product and issues a
warning letter to its salespersons. Id. at 1431. Respondent's
CEO and Owner further testified that if a customer obtained more
than a case of a product, he "would cut them off, [and] stop the
sale of product to them.'' \13\ Tr. 159. See also RX 10, at 1
(asserting that stores purchasing "unusual quantities'' would be
"monitored over the following 4 week period,'' and that "[i]f
further unusual activity is noted,'' Respondent "will
discontinue sales of all or part of the List I products sold to
the store'').
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\13\ While the ALJ credited the CEO's testimony, the e-mails
discussed in note 14 below, show otherwise. See, e.g., RX 56, at
3. Moreover, Respondent did not identify a single store which it
had refused to sell SLCs to.
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According to one of Respondent's executives, between January
17, 2007 and January 17, 2008, that there had been "approximately
35 to 45'' violations of the one case limit, and most of the
violations had occurred before July 2007, when the Agency
executed the administrative warrant. Id. at 1433. The ALJ,
however, credited the testimony of a DEA DI who reviewed
Respondent's sales records for the period between January and
July 2007, and found that its salespersons exceeded the one case
limit 85 times. Tr. 1496-1506; GX 68.
The same executive stated that Respondent had only started
issuing written warnings to its salespersons after August 2007
because of a computer "glitch'' which had resulted in the
reports not being issued as scheduled. Id. at 1435. Moreover,
while Respondent introduced into evidence a few e-mails
indicating that the company had cut off supplying 100-count
bottles to several stores, Respondent did not identify a single
store to which it had refused to sell ephedrine.\14\ Indeed,
according to its own evidence, one of the stores (BPM55), which
it had previously stopped selling 100-count products to because
of its excessive purchases, was allowed to purchase products
with a retail value of more than $7300 a month, in the three
months prior to the issuance of the suspension order. Compare RX
56, at 1, with RX 27a, at 1.
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\14\ The record contains several e-mails indicating that
Respondent directed its employees to not sell 100 count
ephedrine to several stores. See RX 56. While the e-mails
expressed concerns about the excessiveness of these stores'
sales of ephedrine products, notably, Respondent did not cut off
all sales of the products to any of the stores. See id.
Moreover, while it restricted its sales "to a maximum of [one
case] every 2 weeks'' and prohibited the sale of 100 count
ephedrine to store number BPM55, this store was its leading SLC
customer in the three months prior to the issuance of the
suspension order, during which it purchased products with an
average of retail value of $7317.77 per month. Compare RX 56, at
1, with RX 27A, at 1.
---------------------------------------------------------------------------
According to one of its executives, Respondent's SLC
customers purchased SLCs with an average retail sales value of
$640 per month, with the majority of the products containing
ephedrine. Id. at 563-64. Moreover, according to one of
Respondent's exhibits, in the three months prior to the issuance
of the suspension order, it distributed listed chemicals
products with an average monthly retail sales value greater than
$2000 to approximately 120 of its customers. RX 27A. Respondent
also distributed listed chemical products with an average
monthly retail sales value in excess of $3000 to thirty-four
customers, and product with average monthly retail sale value
greater than $4000 to nine customers. Id. Finally, Respondent
distributed to its two largest customers, products with an
average monthly retail sales value of $5056 and $7314
respectively. Id.
At the hearing, the Government put forward expert testimony
to the effect that the expected sales range of ephedrine
products at convenience stores to meet legitimate demand was
$14.39 per month. GX 25, at 8. In his declaration, the
Government's expert stated that U.S. Economic Census data show
that only about 31.5% of all convenience stores (45,077 stores)
carry non-prescription drug products. GX 99, at 7. According to
his declaration, the Government's expert then applied "these
statistics'' to the National Association of Convenience Stores
2007 Survey revenue data which show that convenience stores sold
a total of $292,000,000 of cough and cold remedies during 2006,
to calculate the annual and monthly average sale of cough and
cold products at a convenience store. Id. According to the
Government's expert, stores carrying the HBC line had average
annual sales of all cough and cold products of $4,080.18, and
average monthly sales of $340.01. Id.; see also id. at Table 2.
The Government's expert did not explain, however, why he used
the total number of stores carrying the HBC line \15\ (71,565
stores) rather than the smaller number of stores that he had
determined carried non-prescription drug products ( 45,077
stores). See id. at Table 2. Moreover, the Government did not
rebut the testimony of Respondent's expert that because of
legislation in twelve States, convenience stores can no longer
sell ephedrine products and that the stores in these States
comprise 23% of the nation's convenience stores. RX 59, at 10.
This suggests that at most, 34,709 convenience stores nationwide
carry ephedrine products. Id.\16\
---------------------------------------------------------------------------
\15\ The HBC line includes analgesics, stomach remedies,
vitamins, other OTC drugs, grooming aids, feminine hygiene,
family planning, baby care, skin care, cosmetics, and some other
unspecified products.
\16\ Respondent's expert also pointed out that some
convenience stores that carry non-prescription drug products may
not sell any ephedrine. RX 59, at 10.
---------------------------------------------------------------------------
Next, the Government's expert determined the percentage of
cough and cold remedies comprised of ephedrine products. GX 99,
at 8. According to the Government's expert, "[t]his factor was
derived from a tabulation of MRI data showing asthma remedy
usage by retail channel (in this case, convenience stores).''
Id. Based on this data, which was included at Table 1, the
Government's expert concluded that ephedrine products constitute
8.36% of cough and cold remedies sold at convenience stores. Id.
Multiplying this figure times the average monthly total sales of
cough and cold products, the Government's expert concluded that
the average monthly sale of all ephedrine products at
convenience stores selling the products was $28.43.\17\ Id.
---------------------------------------------------------------------------
\17\ As part of its case, the Government entered into
evidence a declaration prepared by its expert in another matter.
See GX 25. In this document, the expert stated that he had also
looked at data which included "cumulated observed
transactions,'' such as scanner data obtained by Information
Resources, Inc. Id. at 7. The Government's expert also testified
that in preparing GX 25, he had reviewed scanner data to
determine "the proportion of the nonprescription drug category
that included preparations for the treatment of asthma
containing ephedrine.'' Tr. 313 & 500. However, in his
rebuttal declaration, the Government's expert made no mention of
having used scanner data. See GX 99.
---------------------------------------------------------------------------
Respondent's expert stated, however, that the MRI Survey
(which is a survey of 50,000 consumers) does not provide
sufficient information to support the Government's expert's
figure that ephedrine products constitute 8.36% of cough and
cold remedies sold at convenience stores. RX 59, at 11.
Respondent's expert noted that the MRI Survey (which was
included as an attachment to RX 59) "reports absolutely no
information about any ephedrine products,'' and "reports
absolutely no information on whether consumers bought either an
asthma remedy or a cough and cold remedy from convenience
stores.'' Id. (emphasis deleted).
[[Page 52694]]
Respondent's expert further opined that the MRI Survey asks
three questions which "are inadequate to form an estimate'' of
the percentage of cough and cold remedies constituting
ephedrine. RX 59, at 11. The first question is: "How many times
in'' various time periods has the person used one of numerous
products? See Survey of the American Consumer 2-106. While the
survey includes a list of non- prescription cold, sinus, and
allergy remedies, none of the products listed contain ephedrine.
Survey at 12. Nor does it appear that an ephedrine product is
listed anywhere in the survey.
As for the remaining two questions, the survey asks whether a
person has had asthma in the last twelve months, and whether
they have used a prescription drug, a non-prescription drug, an
herbal remedy, or have not treated the condition at all. Id. at
15. The survey does not ask any further questions regarding the
use of non-prescription drugs to treat asthma.
Finally, with respect to the use of convenience stores, the
survey asks only whether the consumer has purchased a
non-prescription/OTC drug at a convenience store in the last 30
days. Id. at 43. Again, the survey does not inquire further as
to what type of drug the consumer may have purchased at a
convenience store. The Government's expert did not explain how
the data obtained in the answers to these questions supported
his conclusion that ephedrine products constitute 8.36% of the
cough and cold remedies purchased at convenience
stores.\18\
---------------------------------------------------------------------------
\18\ Respondent's expert noted that she was informed by its
executives that ephedrine products constituted 60% of its
customers' SLC sales. RX 59, at 12. Even if this is an accurate
figure with respect to its customers, Respondent does not allow
them to purchase SLCs from other suppliers, Tr. 626-27, and it
does not sell any nationally-branded OTC pseudoephedrine
remedies such as Sudafed or Claritin D. The figure is thus based
on a biased sample.
---------------------------------------------------------------------------
The Government's expert further stated that he used "[a]nother
MRI tabulation showing the route of the drug (powder, tablet,
liquid, mist, skin patch, etc., etc.), [which] enabled the
estimate to be further adjusted to reflect tablets only * * *
resulting in the final estimate of $14.78.'' Id. The
Government's expert thus concluded that 52% of ephedrine users
use tablets rather than inhalers, id. at Table 2; multiplying
this figure times the average monthly sales of $28.43, the
expert concluded that the average monthly sale of tablet-form
ephedrine products at convenience stores was $14.78. Id. at
8.\19\
---------------------------------------------------------------------------
\19\ Because the average retail price for a box of the two
leading brands of ephedrine was $7.19, the Government's expert
then further reduced the average monthly sales figure from
$14.78 to $14.39 "to reflect the purchase of exactly two boxes
of 24 count ephedrine tablets.'' Id. at 9.
---------------------------------------------------------------------------
The MRI survey asks, however, only about the mode of
administration with respect to cold, sinus and allergy remedies
and not asthma remedies. Survey, at 12. Here again, it is
unclear why this data provides a reliable basis for estimating
the percentage of asthma sufferers who use tablets versus
inhalers.
I thus agree with the ALJ that the Government has not proved
by substantial evidence that the monthly expected retail sales
value of ephedrine products at convenience stores to meet
legitimate demand is $14.39.\20\ On the other hand, it is
undisputed that no ephedrine product ranks in the top 200 of
over-the-counter and health-and-beauty care products which are
sold in drug stores, supermarkets, and mass merchandisers. See
GX 99, at 4. It is also undisputed that approximately 97% of the
sales of non-prescription drugs occurs at pharmacies,
supermarkets, warehouse clubs, department stores, electronic
shopping/mail order houses, and other general merchandise
stores. GX 25A, at C2. Moreover, convenience stores (both those
with and without gasoline) account for approximately 1.14% of
the total commerce in non-prescription drugs. Id. The
Government, however, produced no evidence as to the annual sales
of combination ephedrine products such as Primatene Tablets and
Bronkaid, which are sold at pharmacies, supermarkets, and other
large volume retailers of non- prescription drugs.
---------------------------------------------------------------------------
\20\ The Government offered evidence regarding visits or
telephone contacts made by various Diversion Investigators (DIs)
to eighteen pharmacies which were apparently located near some
of Respondent's customers. See ALJ Dec. at 23-33. At least half
the pharmacies did not carry any ephedrine products. See id. As
for the remaining pharmacies, the Government produced evidence
as to their sales levels of ephedrine products with respect to
only four of the pharmacies. This evidence showed that the
pharmacies were selling minimal quantities of tablet-form
ephedrine products, with the most that any store sold being 71
boxes in a four-and-a-half month period. See, e.g., GXs 26, 27,
28 & 29.
The Government did not establish that it used a statistically
valid sampling technique in choosing the pharmacies the DIs
interviewed. The evidence thus amounts to nothing more than a
collection of anecdotes. To the extent the evidence is offered
to show that there is little demand at pharmacies for these
products, it is of limited probative value.
---------------------------------------------------------------------------
Evidence of Diversion
In September 2002, DMD Pharmaceuticals, a supplier to
Respondent, shipped it an entire lot of sixty-count bottles of a
combination ephedrine (25 mg.) product.\21\ Tr. 1079. Two months
later, twenty-two bottles of this lot were found at an illicit
methamphetamine laboratory in Thompson, Connecticut. Id. at
1077. DEA subsequently issued a warning letter to DMD. Id. at
1077-78.
---------------------------------------------------------------------------
\21\ According to the testimony of a DI, DEA issued DMD a
warning letter. Tr. 1078. Upon receipt of the letter, DMD's
compliance manager told the DI that he would look into to whom
the product was shipped. Id. Subsequently, the DI received a
phone call from DMD's compliance manager and owner informing her
that "that entire lot had been sold to'' Respondent in September
2002. Id. at 1079. The ALJ credited this testimony, see ALJ at
13, as do I.
---------------------------------------------------------------------------
Several months later, while completing a previously-commenced
inspection of Respondent, a DI discussed the matter with two of
its executives. Id. at 1082-83. While the executives provided
the DI with the names of two salespersons whose territory
included or was near the part of Connecticut where the lab was
found, they could not identify which specific stores had
obtained the ephedrine. Id. at 1084.
As part of the investigation that gave rise to this
proceeding, DIs based in four States visited a number of
Respondent's customers. At a Roadrunner Market in Bristol,
Tennessee, a DI testified that during the "time period of July
23rd through August 23rd'' of 2007, three customers had
purchased quantities that far exceeded nine grams.\22\ Tr.
730-733. While 439 gel caps in 25 mg. strength is the dosage
form equivalent to the nine gram limit, M.W. had bought 56 boxes
totaling 1,344 gel caps or approximately 27 grams. GX 46. During
the same period, C.M. purchased 23 boxes totaling 552 gel caps
(approximately 11.3 grams), and E.B. purchased 52 boxes totaling
1,248 gel caps or approximately 25.6 grams. Id. The DI also
found other evidence of repetitive purchasing patterns at the
stores, but the logbooks were missing information such as the
number of dosage units and/or strength of the product. See GX
80.
---------------------------------------------------------------------------
\22\ It is noted that the time period which was reviewed
exceeded thirty days. Even assuming that these persons did not
violate Federal law in purchasing these products, given the
dosing instruction for these products (one tablet every four
hours and no more than six tablets every twenty-four hours),
their purchases are not consistent with the use of the products
to treat asthma. See, e.g., RX 9, at 1. Moreover, the "Drug
Facts'' warning label for Respondent's Double Action Ephedrine
(25/200 mg.) product further advises to "Stop use and ask a
doctor if * * * cough persists for more than 1 week.'' Id.
---------------------------------------------------------------------------
A different DI visited the Smoker Friendly No. 4 Store in
Little Falls, New York, and obtained the logbooks. Tr. 785-86,
791-92. The logbooks showed that between July 27, 2007, and
August
[[Page 52695]]
27, 2007, four persons had purchased more than nine grams.
K.S. bought 984 tablets of ephedrine 25 mg. (more than 20
grams), and A.P. bought 768 tablets of ephedrine 25 mg.
(approximately 15.7 grams). GX 45. Moreover, Richard and Robert
R., who had the same last name and used the same address,
respectively purchased 600 and 696 tablets of ephedrine 25 mg.
Id. These purchases amounted to 12.3 and 14.25 grams. Id.
Another DI visited the Mason of New York convenience store of
Jamestown, New York, and obtained the logbook. Tr. 1484. The
logbook entries were frequently missing information as to the
strength of the ephedrine tablets that had been purchased.
Nonetheless, the logbook showed that there were five individuals
who, even if they had purchased only 12.5 mg. ephedrine, had
nonetheless purchased more than nine grams during the period
between July 21 and August 21, 2007. More specifically, M.M.
purchased 1,368 tablets (14 grams),\23\ A.J. purchased 1,014
tablets (10.4 grams), J.B. purchased 1,548 tablets (15.9 grams),
J.H. purchased 1,068 tablets (10.9 grams), and R.B. purchased
1,002 tablets (10.3 grams).\24\ GX 49.
---------------------------------------------------------------------------
\23\ A person named Chris M. (with the same last name and
address as M.M.) purchased an additional 360 tablets. GX 49.
\24\ All of these calculations assume that these persons bought
12.5 mg. tablets; if they bought 25 mg., then the amount of
ephedrine was double. Moreover, the DI found that four other
persons had purchased quantities which would exceed nine grams
if the strength of the tablets was 25 mg.
---------------------------------------------------------------------------
A Pennsylvania-based DI likewise found evidence of purchases
that, while technically not in violation of the CMEA, raised a
strong suspicion that the ephedrine was being diverted. For
example, at the CoGo of Somerset, Pennsylvania, a DI found that
S.M. had bought 384 dosage units between August 16 and 23, 2007.
GX 75. At 12.5 mg. strength, this amounted to 3.9 grams. This
individual had also bought three twenty-four count boxes on
three consecutive days.\25\ Id. Moreover, another DI visited a
CoGos in Midland, Pennsylvania, and found evidence that a person
had bought 620 dosage units of 12.5 mg. between May 1 and May
31, 2007, and an additional 636 dosage units between June 1 and
June 15, 2007. Tr. 1486; GX 41.
---------------------------------------------------------------------------
\25\ At two stores, the DI did not find any evidence of
purchases in excess of the limit and was told by the managers
that the products were primarily purchased by hospital workers
and truck drivers who used them to stay awake on their jobs. Tr.
872-73; 886- 87.
---------------------------------------------------------------------------
The Allegation That Respondent Distributed Listed
Chemicals to Uncertified Retailers
Effective September 30, 2006, the CMEA prohibited a retailer
from selling schedule listed chemical products unless the
retailer had self- certified to the Attorney General that all "individuals
who are responsible for delivering such products into the
custody of purchasers or who deal directly with purchasers by
obtaining payment for the products * * * have * * * undergone
training provided by the seller to ensure that the individuals
understand the requirements that apply'' to the sale of the
products. 21 U.S.C. 830(e)(1)(VII). As stated above, the
Government alleged that between January 1, 2007, and July 9,
2007, Respondent made 284 distributions of listed chemical
products to thirty-five retailers who were not self-certified.
As support for the allegation, a DEA DI testified that using
a document supplied by Respondent which listed the customers by
code number, store name and address, she conducted a spot check
to see if the stores were listed in the Agency's database of
stores that had become certified. Tr. 1213-19. The DI further
testified that the results of her inquiry were reported in a
thirteen page document, which listed the distributions by
Respondent's store code number, the date, Respondent's product
code, and quantity. Id. at 1218, see also GX 40 (listing stores
and transactions).
At the hearing, Respondent produced numerous documents that
refuted the allegation. For example, the Government listed
twenty-five Speedway stores that were located in Indiana and
Kentucky which had obtained SLCs from Respondent between April
10 and July 9, 2007. GX 40, at 3, 6 & 7. Respondent,
however, introduced into evidence, a letter dated April 3, 2007
from an executive of Speedway Super America to DEA's
registration unit submitting a CD-Rom with the certification
data for the company's stores in Indiana and Kentucky. RX 57.
Respondent also submitted copies of each store's certification.
See RX 57A. While each of the certifications was dated July 5,
2007, the Government did not rebut Respondent's evidence that
the Agency considers a chain retailer who submits information on
a CD-Rom to be self-certified on the date the information is
received by the Agency. Tr. 1335-36.
At most, the evidence suggests that Respondent made a single
distribution to a single store before it obtained its
certification. Compare GX 40, at 14, with RX 57, at 18.
According to these exhibits, Respondent distributed a listed
chemical product on January 18, 2007, to an independent
convenience store located in Centreville, Virginia, prior to the
store obtaining certification on March 8, 2007.\26\
---------------------------------------------------------------------------
\26\ The store's certification shows that it was completed
online at DEA's self-certification Web page. RX 57, at 18.
---------------------------------------------------------------------------
The evidence did show, however, several instances in which
Respondent's records contained erroneous information. For
example, Respondent's records listed the address of store
XTM7480 as 1451 Dorsey Road, Hanover, Maryland. GX 39, at 100.
The store's DEA Certificate states, however, that its address is
7500 Ridge Road, Hanover, MD. RX 57, at 14. Respondent's records
likewise listed the address of store XTM7520 as 7300 Washington
Blvd., Dorsey, MD. GX 39, at 100. According to its DEA
certificate, the store's address was 7300 Washington Blvd,
Elkridge, MD. RX 57, at 15. Also, Respondent's record listed the
address of store MTO102 as 995 Old Airport Road, Bristol, TN. GX
39, at 33. The store's DEA certificate, however, gives its
address as 1001 Airport Road, Bristol, Va. RX 57, at 16.\27\
---------------------------------------------------------------------------
\27\ Likewise, Respondent's records list the address for
store BGP1 as 1699 N. Dixie Hwy, Monroe Michigan. GX 39. The
store's DEA certificate gives its address as 1488 N. Dixie Hwy.,
Monroe, Michigan. RX 57, at 21.
---------------------------------------------------------------------------
The Allegations That Respondent Distributed Products in
Forms That Could Not Be Lawfully Sold Under the CMEA and State
Laws
Effective April 9, 2006, the CMEA prohibited a retailer from
selling a listed chemical "product in nonliquid form (including
gel caps) at retail unless the product is packaged in blister
packs * * * containing not more than 2 dosage units, or where
the use of blister packs is technically infeasible, the product
is packaged in unit dose packets or pouches.'' 21 U.S.C.
830(d)(2). The Government alleged that subsequent to February 1,
2007, Respondent distributed 24-count bottles of listed chemical
product to retailers on three occasions.
In support of this allegation, the Government introduced a
document which lists three distributions of Respondent's product
17902, Mini 2 Way 25 mg. gel caps in 24 count bottles, to three
stores (PTR3295, PTR3438, and PTR3973).\28\ See GX 66 & 37.
A DI testified that the three transactions were found in
Respondent's sales records. Tr.
[[Page 52696]]
1442-45. According to Respondent's customer list, each of the
stores was owned by The Pantry chain. See GX 39.
---------------------------------------------------------------------------
\28\ According to Respondent's sales records, two of the
distributions (to stores PTR3295 and PTR3438) occurred on
February 7, 2007; the other distribution (to store PTR3973)
occurred on April 23, 2007. GX 66, Tr. 1442-43.
---------------------------------------------------------------------------
Respondent's record of shipments showed, however, that the
product had not been shipped after January 2006. RX 40, at 152.
Moreover, Respondent presented e-mail correspondence between it
and an employee of The Pantry. More specifically, Respondent
requested that The Pantry check its scanner data to determine
whether it had sold the bottled product at the three stores
after February 1, 2007. RX 46, at 2-3. In an e-mail, a Pantry
employee reported that she had checked the item number for the
three stores "from Feb. 2007-Feb. 2008 and [that] there was no
movement at any of the three locations for this item.'' RX 46,
at 1.\29\ Based on the totality of the evidence, I find that the
Government has not proved this allegation.
---------------------------------------------------------------------------
\29\ Respondent's CEO attributed the data as resulting from
its salesperson[s] having entered the wrong product code in
their computer. Tr. 68. Another of Respondent's testified that
that it had reprogrammed its computer system to prevent a
salesperson from selling an item that was prohibited. Id. at
1404. Yet even after the reprogramming, there were several
instances in which salespersons entered the codes for
discontinued products. Id. at 1405. The same executive
acknowledged that he did not know if the salespersons still had
obsolete products in their storage units. Id.
---------------------------------------------------------------------------
The Government also alleged that Respondent distributed
tablet-form products to retailers in Kentucky and North
Carolina, after these States prohibited the sale of non-liquid
products other than in gel-cap form at establishments that are
not pharmacies. In support of the allegation, the Government
introduced a document which listed four distributions of
Respondent's product 017550, Ephedrine Plus Blister 24 Count.
See GX 37 & 65. Three of the distributions were made to
three stores owned by Circle K Midwest which were located in
Kentucky (CKM 3212, CKM 3247, and CKM 3248); the other store was
owned by The Pantry and located in North Carolina (PTR3972). See
GX 39, at 10, 11 & 65. According to Respondent's records,
the distributions occurred on March 27 and 28, and July 9, 2007.
An executive of Respondent testified that its records pertaining
to the four distributions were erroneous. Tr. 1347-50. Moreover,
Respondent's records did not show any shipments of this product
after December 26, 2005. RX 40, at 159. Finally, in an e-mail,
an employee of The Pantry reported that "there was no movement''
of the product at store number 3972. RX 46, at 1.\30\ Because
the ALJ found credible Respondent's explanation and did not
produce sufficient evidence to reject this finding, I find that
Government has proved only that Respondent's records were
erroneous and that it did not violate North Carolina or Kentucky
law.
---------------------------------------------------------------------------
\30\ Respondent also submitted an e-mail from an employee of
Circle K., which states that she checked the stores' sales going
back to April 30, 2007, and that the stores had not sold the
product. RX 46, at 5. The e-mail is thus not probative of
whether Respondent distributed the products in violation of
Kentucky law.
---------------------------------------------------------------------------
The DEA Audits
On July 9, 2007, as part of an administrative inspection of
its registered location, DEA Investigators took a physical count
of Respondent's listed chemical products then on hand. Tr. 1163.
The DIs also obtained an initial inventory dated December 25,
2005, from Respondent's records. Id.; see GX 4. Both the
beginning and ending inventories were certified as correct by
Ryan Polk, Respondent's Chief Financial Officer. GX 4. Pursuant
to an agreement with the DIs, products which were stored in the
returns portion of Respondent's storage cage which included
out-of-date products, broken blister packs, and single loose
pills were not counted. Tr. 1494-95. The products had not,
however, been logged back into Respondent's records. Id.
DEA Investigators audited twenty different products by adding
Respondent's receipts (including returns, Tr. 1182) to the
beginning inventory (GX 34) \31\ and comparing this figure with
the sum of the closing inventory and Respondent's shipments to
its salespersons (GX 35) and returns to its suppliers. See GX 4,
at 3. Of further note, Respondent's list of shipments indicated
that it had made three separate shipments of product 17121
(totaling more than 2300 units \32\) to three of its
salespersons on July 16, 2007, notwithstanding that this date
was a week into the future. GX 35, at 29.
---------------------------------------------------------------------------
\31\ According to the DI, the investigators "asked to see
receipts for the products audited for a time period. And we
were, instead, given this three-page summary.'' Tr. 1170.
Relatedly, the DI testified that while Respondent gave them a
157 page list of its shipments, the document used product codes
and the Investigators had to ask several times for a document
which identified the products. Id. at 1180-81.
\32\ This product was a six-count blister pack. See GX 32, at
1.
---------------------------------------------------------------------------
According to the DIs' calculations, only one of the products
in which there was activity balanced,\33\ two of the products
had sizable shortages, and the remaining had overages. Id. More
specifically, the DI identified Respondent's product code 17902
(Mini 2-Way 25 mg. 24 count gel cap bottles) as being short
nearly 28,000 bottles. Tr. 1186. Moreover, the DI concluded that
Respondent was short 32,913 units of product code 17903 (Mini 2
Way 12.5 mg. gel cap 6 ct. blister packs). See GX 4, at 3.
---------------------------------------------------------------------------
\33\ While two other products balanced, the computation chart
indicates that there was no beginning or closing inventory of,
and no activity in, these products. GX 3, at 6.
---------------------------------------------------------------------------
The DI further testified that "because we got different
numbers when comparing [Respondent's] receipts versus their
warehouse documentation,'' Tr. 1186, she conducted an additional
audit of four products by obtaining information from
Respondent's suppliers in order to verify its receipts. Id. at
1187. According to the DI, for these four products, there were
substantial differences between the quantities that were
reported by the suppliers and the information provided by
Respondent. Id. With respect to product 17121 (Double Action 6
ct. ephedrine 25 mg. tablets), Respondent had represented that
its receipts were 656,688, but according to the DI, the
suppliers had claimed to have sold it only 429,024 units
resulting in an overage of more than 275,000 units. Tr. 1188; GX
4, at 3. The DI also found overages in the other three products
which were subject to the additional audit. GX 4, at 3. The DI
further testified that she prepared an additional document which
compared the receipt information provided on Respondent's
printouts, the hard copy invoices of Respondent's receipts, and
the quantities which the manufacturers of Respondent's products
reported to the DI. Tr. 1189-90; GX 69.
According to this document, while Respondent's printout of
its receipts for product 17103 (525,240 units of Double Action
12 ct. Blister 25 mg.) matched the quantity of the
manufacturer's report, Respondent had no hard copy invoices. GX
69. With respect to product 17131 (Double Action Pseudo tablets
12 mg.), Respondent's printout indicated it had received 404,184
units and the manufacturer reported that it had sold 403,248
units to Respondent. Id. Respondent did not, however, have any
hard copy invoices for the product. Id. With respect to product
17121 (Double Action 6 ct. ephedrine 25 mg.), Respondent's
receipts (656,688 units) matched the number reported by the
manufacturer. Id. Respondent, however, had hard copy invoices
for only 429,024 units. Id.
With respect to product 17125, Respondent's printout
indicated it had received 1,011,901 units, which matched the
total quantity reported by the two suppliers of this product.
Id. Respondent, however, had invoices only
[[Page 52697]]
for 851,671 units. Id. Apparently, Respondent was also
missing invoices for other products.\34\ Id.
---------------------------------------------------------------------------
\34\ The DI also testified that there were thirty-four sales
routes for which Respondent did not provide address information
indicating where its products were being shipped to. Tr.
1197-98, GX 67.
---------------------------------------------------------------------------
Respondent's CFO testified that upon being provided with a
copy of the Government's audit, he proceeded to conduct his own
audit. With respect to product 17902, which the Government had
concluded was short, the CFO testified that the DIs had "excluded
a transaction for 28,800 units where we sent that product back
to the original manufacturer'' because in his words, it "was an
obsolete item.'' Tr. 2036; RX 36, at 4. The ALJ further found
credible the CFO's testimony that he had provided this
information to the DIs as part of their document request. Id.;
see also ALJ at 42.\35\ Respondent also introduced into evidence
numerous documents listing inventory adjustments and data
pertaining to items that had been removed to the "obsolete
inventory area'' which its CFO asserted had been excluded by the
DIs in doing the audit. Tr. 2037; RX 36. As for Respondent's
other product ( 17903), which the Government concluded it was
short nearly 33,000 units, Respondent introduced into evidence
two documents listing various inventory adjustments which it
contended had not been considered by the Government and which
would have greatly reduced the discrepancy. GX 36, at 2. On
cross-examination, the CFO maintained that he had provided these
documents no later than July 18, 2007. Tr. 2085. Notably, the
Government did not rebut either the CFO's testimony that the
documents had been provided or that it had failed to consider
them in performing the audit.
---------------------------------------------------------------------------
\35\ The ALJ noted that this document shows a return of
57,600. ALJ at 43. That figure appears, however, to be the
amount of the credit Respondent was entitled to. RX 36, at 4.
---------------------------------------------------------------------------
Respondent's CFO also testified that the additional audit
(performed on the four products) was flawed, asserting that with
respect to two of the items (s 17121 and 17125), the Government
had "exclude[d] a very large receipt that's on the sales record
from those suppliers.'' Tr. 2038-39. With respect to product
17121, the CFO testified that the Government had excluded "227,664
units [that] were listed on the report as sold to'' it. Id. at
2039. As for product 17125, which came from two suppliers, the
CFO stated that the Government had excluded transactions
totaling 160,000 units. Id.
While the purpose of the second audit was to obtain
information from Respondent's suppliers and verify it with
Respondent's reported receipts, in fact, the audit appeared to
have been based on Respondent's actual invoices and not the
reported figures (which appear to have been used in the first
round of audits). Compare GX 69, with GX 4, at 3.\36\ In his
testimony, however, Respondent's CFO did not address the
Government's contention that Respondent was missing various
invoices of its receipts and Respondent does not cite to any
specific evidence of record rebutting the allegation. See Tr.
2042 (CFO testified that "I think in a couple of instances--I
did not include the pages in this [exhibit RX 36], for example,
Item 17121 when the Government excluded the 227,000 units.'').
Accordingly, I find that Respondent was missing numerous
invoices documenting its purchases from its suppliers.
---------------------------------------------------------------------------
\36\ For example, both Respondent and the manufacturer agreed
that Respondent had obtained 656,688 packets of product 17121,
but Respondent's invoices only added up to 429,024 units. GX 69.
In the first audit, the Government used the 656,688 figure, and
in the second audit, which was supposedly based on the
information it obtained from the manufacturer, it used the
429,024 figure. See GX 4, at 3. It did the same thing with
respect to product 17125, using the 1,011,901 figure (which
Respondent and the two manufacturers agreed with) in the first
audit. Id. Again, in the second audit, it used the 851,671
figure, the figure that was based on the actual invoices
produced by Respondent. Id.; see also GX 4, at 3.
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Respondent's Post-Suspension Conduct
Following the issuance of the suspension order, Respondent
engaged in discussions with BDI, Inc., one of its suppliers,
under which Respondent proposed to have its sales persons take
orders for SLCs, which would then be sent back to its
headquarters and forwarded on to BDI, which would fill the
orders by shipping them to its customer by UPS. GX 48; Tr.
2401-02. According to a February 8, 2008 letter which was signed
by its CEO, under the scheme, Respondent's sales persons would "still
do all reordering and stocking of the merchandise as we have in
the past,'' and when a shipment arrived at a customer, "the
manager [would] have the choice of stocking the OTC cabinet or
holding it for our sales person.'' GX 48. The letter further
stated: "This basically keeps the business the same. The only
difference is a UPS box. All invoices are from Novelty, Inc.''
Id.
Respondent's Vice President of Product justified the scheme,
reasoning that under his "definition of sales, we're not
involved in the distribution of the product. But our sales
people are in that store functioning as an agent.'' Tr. 2402.
Because BDI refused to participate, the scheme "was never
implemented.'' Id. at 2403. However, at the hearing,
Respondent's VP testified that the scheme was "[s]omething that
we're still continuing to explore.'' Id.
Discussion
Section 304(a) of the Controlled Substances Act provides that
a registration to distribute a list I chemical "may be suspended
or revoked * * * upon a finding that the registrant * * * has
committed such acts as would render [its] registration under
section 823 of this title inconsistent with the public interest
as determined under such section.'' 21 U.S.C. 824(a)(4).
Moreover, under section 303(h), "[t]he Attorney General shall
register an applicant to distribute a list I chemical unless the
Attorney General determines that registration of the applicant
is inconsistent with the public interest.'' 21 U.S.C. 823(h). In
making the public interest determination, Congress directed that
the following factors be considered:
(1) Maintenance by the applicant of effective controls
against diversion of listed chemicals into other than legitimate
channels;
(2) Compliance by the applicant with applicable Federal,
State, and local law;
(3) Any prior conviction record of the applicant 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.
Id. 823(h).
"These factors are considered in the disjunctive.'' Joy's
Ideas, 70 FR 33195, 33197 (2005). I may rely on any one or a
combination of factors, and may give each factor the weight I
deem appropriate in determining whether a registration should be
revoked or an application for a registration should be denied.
See, e.g., David M. Starr, 71 FR 39367, 39368 (2006); Energy
Outlet, 64 FR 14269 (1999). Moreover, I am "not required to make
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); Morall v. DEA, 412 F.3d 165, 173-74 (DC
Cir. 2005).
In this matter, I have considered all of the statutory
factors.\37\ While I have found that several of the Government's
allegations have not been proved, I nonetheless conclude that
Respondent does not maintain effective controls against
diversion and that its
[[Page 52698]]
distribution practices and recordkeeping did not comply with
Federal law. Moreover, while I have carefully considered the
ALJ's findings regarding Respondent's willingness to comply with
Federal law and her recommendation that I continue its
registration with conditions, I conclude that on balance, the
ALJ did not give sufficient weight to several factors including
Respondent's failure to enforce its own policies, its sustained
conduct in continuing to distribute out of unregistered storage
facilities even after being advised that its practice was
illegal, and its attempt to circumvent the suspension order.
Accordingly, Respondent's registration will be revoked.
---------------------------------------------------------------------------
\37\ I note that there is no evidence that Respondent has
been convicted of an offense related to controlled substances or
listed chemicals.
---------------------------------------------------------------------------
Factor One--Maintenance of Effective Controls Against
Diversion
Under agency decisions, this factor encompasses a variety of
considerations. Holloway Distributing, Inc., 72 FR 42118, 42123
(2007). These include the adequacy of the
registrant's/applicant's security arrangements, the adequacy of
its recordkeeping and reporting, its distribution practices, and
the occurrence of diversion. See id.; see also Rick's Picks,
L.L.C., 72 FR 18275, 18278 (2007); John J. Fotinopoulos, 72 FR
24602, 24605 (2007); D & S Sales, 71 FR 37607, 37610 (2006);
Joy's Ideas, 70 FR 33195, 33197-98 (2005).
In evaluating a registrant's security controls and
procedures, DEA regulations direct that the Agency consider the
following eight factors:
(1) The type, form, and quantity of List I chemicals handled;
(2) The location of the premises and the relationship such
location bears on the security needs;
(3) The type of building construction comprising the facility
and the general characteristics of the building or buildings;
(4) The availability of electronic detection and alarm
systems;
(5) The extent of unsupervised public access to the facility;
(6) The adequacy of supervision over employees having access
to List I chemicals;
(7) The procedures for handling business guests, visitors,
maintenance personnel, and nonemployee service personnel in
areas where List I chemicals are processed or stored;
(8) The adequacy of the registrant's or applicant's systems
for monitoring the receipt, distribution, and disposition of
List I chemicals in its operations.
21 CFR 1309.71.\38\
\38\ Under DEA regulations, "[a]ny registrant or applicant
desiring to determine whether a proposed system of security
controls and procedures is adequate may submit materials and
plans regarding the proposed security controls and procedures
either to the Special Agent in Charge in the region in which the
security controls and procedures will be used, or to the
Chemical Operations Section Office of Diversion Control'' at DEA
Headquarters. 21 CFR 1309.71(c).
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It is undisputed that Respondent maintains adequate physical
security of the list I chemicals which it stores at its
registered location. The record further establishes, however,
that Respondent then ships the SLCs to between 150 to 180
self-storage units throughout the country, where the products
may be kept for up to several days at a time before the route
sales persons retrieve them. Tr. 534 & 667-68.
As found above, Respondent disputes that this practice
constitutes storage. See Tr. 666 (Executive testifying that: "That's
a nonsense question. Now you're coming back into the definition
of what is storage. We're not storing the product in that
location.''); id. at 672 ("We are not storing or keeping or
whatever words you want to try and use, product in these
warehouses, against the law.''). Likewise, in its brief,
Respondent engages in the tortured argument that it does not
store products in the self-storage units because "[t]he
definition of 'store' focuses on future, not present use,'' and
it uses the units only for what it terms is an "immediate'' and
not a "future use.'' Resp. Br. 99.
This argument begs the question of why Respondent needs to
rent storage units if not to store products in them. Moreover,
the record is clear that the products are typically not
immediately transferred from the delivery truck to the route
salesperson and that products may remain in the storage unit for
up to several days before the route sales person retrieves them.
Respondent is therefore using the self- storage areas for
storage.
Moreover, putting aside momentarily the issue of whether
these storage units must be registered, it is unlikely that they
could meet the security requirements of this Agency. Indeed, DEA
has previously rejected applications of entities that sought to
store SLCs in public storage facilities on the ground that they
present an unacceptable risk of diversion. See Stephen J.
Heldman, 72 FR 4032, 4034 (2007); see also Sujak Distributors,
71 FR 50102, 50104 (2006).
In these decisions, I have noted a variety of security
concerns which are raised by these facilities including the
inadequacy of their construction, the lack of alarm systems, the
lack of 24 hour on-site monitoring, the ability of unauthorized
persons to gain access to the facility and the storage units,
and the fact that the tenant does not control what other tenants
the landlord rents to. See, e.g., Sujak, 71 FR at 50104. Here,
for example, a former salesperson for Respondent testified that
his storage unit was in a facility which lacked a secure
perimeter and that anyone could come off the road and gain
access to the door of his unit. Tr. 538. It also is undisputed
that the storage units did not have separate cages within them
for securing the products. Id. at 133. Finally, to this day, the
Agency does not know where thirty-four of the storage units are
located. Tr. 1196-98. Respondent's use of these storage
facilities thus does not provide adequate controls against
diversion and provides reason alone to support the finding that
its continued registration "is inconsistent with the public
interest.'' 21 U.S.C. 823(h).
The record identified a further serious deficiency in the
security of Respondent's distribution practices. As found above,
SLCs may remain on a salesperson's truck for up to nine days
before being delivered to a store. This practice presents a
serious security concern because of the risk that a thief can
steal the vehicle's cargo. Indeed, by stealing the entire
vehicle with its cargo--an act which takes but seconds to
perform--a thief does not have to spend time offloading the SLCs.
See McBride Marketing, 71 FR 35710, 35711 (2006). Moreover, the
risk posed by Respondent's distribution practice is exacerbated
by the extensive time period during which the products remain on
its trucks.
Nor are these security concerns the only manner in which
Respondent fails to maintain effective controls against
diversion. The record also supports the conclusion that
Respondent has serious recordkeeping deficiencies.
According to the manufacturer's sales journal, AAA
Pharmaceuticals made three shipments of product 17121 to
Respondent: (1) 227,664 dosage units on August 11, 2006; (2)
228,264 dosage units on September 1, 2006; and (3) 200,760
dosage units on November 14, 2006. See GX 32 at 7, 8 & 11.
Each of these shipments was also a "regulated transaction'' as
each exceeded the 1,000 gram threshold. 21 CFR
1310.04(f)(1)(ii). Respondent was thus required to keep a record
of the transaction "for 2 years after the date of the
transaction.'' Id. 1310.04(a). Yet Respondent was missing an
invoice for the August 11, 2006 shipment of 227,666 units, GX
69, and the computer-generated records which it provided to the
Agency pursuant to the warrant did not comply with Federal law
and Agency regulations because they were missing required
information such as the form of packaging and the method of
transfer. Compare GX 34,
[[Page 52699]]
with 21 U.S.C. 830(a)(2) and 21 CFR 1310.06(a). With respect
to product number 17103, Respondent acquired more than 525,000
units in seven different shipments between March 29, 2006, and
April 19, 2006. See GX 3 at 2-5.\39\ Here again, Respondent
engaged in multiple regulated transactions and was required to
keep records of them. See 21 U.S.C. 802(39); 21 U.S.C.
1310.04(f) (threshold for regulations transaction is based on "the
cumulative amount for multiple transactions within a calendar
month''). Yet it had no invoices for any of the shipments, GX
69, and the computer-generated records it provided to the Agency
likewise did not comply with the regulations.\40\ Respondent was
also missing invoices documenting its purchases of other
products. See id. Respondent's failure to maintain adequate
records for the regulated transactions it engaged in constitutes
not only a violation of Federal law, it also demonstrates that
its systems for monitoring the receipt of SLCs are inadequate.
---------------------------------------------------------------------------
\39\ On March 29, 2006, AAA shipped Respondent 15,984 and
114,480 units of product number 17103; a dosage unit of this
product contained 25 mg. of ephedrine hcl. GX 32 at 2-3. This
was followed by a shipment on April 14, 2006 of 113,856 units; a
shipment on April 17, 2006 of 113, 472 units; and three
shipments on April 18, 2006 which totaled 167,328 units. See id.
\40\ Here again, there were multiple transactions that fell
within the definition of a regulated transaction.
---------------------------------------------------------------------------
Respondent's systems for monitoring the distribution of its
products are also deficient. First, Respondent's recordkeeping
is deficient in various ways. According to the shipping records
which Respondent provided to the DIs on July 9, 2007, it shipped
more than 2300 packages of product 17121 to three different
salespersons on July 16, 2007, even though the date listed was a
week into the future.
The Government also identified several instances in which
Respondent's records indicated that it had distributed products
that could not be lawfully sold under either the CMEA or the
laws of Kentucky and North Carolina. While I have credited
Respondent's evidence that the distributions did not occur, the
evidence nonetheless points to further inadequacies in
Respondent's recordkeeping and systems for monitoring the
distribution of SLCs.\41\ Moreover, Respondent's records
contained a variety of errors related to the addresses of its
customers including the wrong street address, and in one case,
the wrong state.
---------------------------------------------------------------------------
\41\ I acknowledge the testimony of Respondent's executives
that the errors were caused by its salespersons' erroneous entry
of products codes into their computers, and that the software
has since been reprogrammed.
---------------------------------------------------------------------------
Second, Respondent's procedures for monitoring the
distribution of its products are deficient. The record
establishes that the placement of an order and the delivery of
the products occur simultaneously, and at the time, only the
salesperson knows how much the store has purchased. Tr. 633.
While Respondent asserted that it monitors its sales of SLC and
conducts an inquiry if a store has acquired more inventory than
is expected, and that another report is prepared which lists
instances in which more than one case has been sold per product
during a transaction, these procedures are wholly deficient to
protect against the diversion of SLCs. Moreover, as the evidence
with respect to the 2002 incident in which Respondent's products
were found at a meth. lab shows, under its distribution model,
it can not identify which stores receive a particular product.
Tr. 1517. Fundamental to its obligation to maintain effective
controls against diversion, a distributor must review every
order and identify suspicious transactions. Further, it must do
so prior to shipping the products. Indeed, a distributor has an
affirmative duty to forgo a transaction if, upon investigation,
it is unable to determine that the proposed transaction is for
legitimate purposes. See DEA, Chemical Handler's Manual 21
(2002).\42\ Respondent's procedure of post- transaction review
is incompatible with its obligation to identify and forgo
suspicious transactions.
---------------------------------------------------------------------------
\42\ Under the Agency's policy, this manual was provided to
all list I chemical distributors at various inspections. It is
also available through the Agency's Web site.
---------------------------------------------------------------------------
Respondent further maintains that its imposition of its one
case, per product, per service cycle limit, and its practice of
issuing warning letters to salespersons who sell over the limit,
demonstrates that it maintains effective controls against
diversion. However, the credited testimony establishes that
between January and July 2007, Respondent's sales force violated
its case limit policy some 85 times. ALJ at 12. Moreover, one of
Respondent's senior executives testified that it had only
started issuing written warnings in August 2007, which, of
course, was after the administrative inspection. Furthermore,
Respondent's policy is a meaningless measure because it sells
ten different products and most stores are serviced every two
weeks.
The inadequacy of Respondent's control measures is further
demonstrated by its own exhibit showing its sales of SLCs in the
three months prior to the issuance of the suspension order. As
found above, Respondent's CEO testified that its average
customer sold SLCs with a retail value of $640 per month. Tr.
563-64. Yet Respondent's evidence shows that during this period,
it had sold SLCs with an average monthly retail value of more
than $2000 (more than three times its average monthly sale) to
approximately 120 of its customers, and SLCs with an average
monthly retail value of more than $3000 (4.68 times its average
monthly sales) to thirty-four of its customers. RX 27A.
Moreover, Respondent sold SLCs with an average monthly retail
sales value greater than $4000 to nine customers. Id. One of
these customers was purchasing SLCs with an average monthly
retail sales value of $5056--approximately eight times its
average customer's purchase. Id. Finally, its largest customer
(Store BPM55) was purchasing SLCs with an average monthly retail
sale value of $7314--more than eleven times its average
customer's purchase--in the three months prior to the issuance
of the suspension order.
Moreover, the record establishes that Respondent had
previously determined that store BPM55 was purchasing excessive
quantities. RX 56. Yet notwithstanding this store's history,
Respondent allowed it to purchase quantities that dwarfed that
of its average customer. Furthermore, upon reviewing this
store's logbook for the period July 21 through August 21, 2007,
at least five individuals had purchased in excess of nine grams
within this period. These customers purchased quantities which
far exceeded the recommended dosing for the product's use as an
asthma treatment \43\ and are consistent with diversion.\44\
---------------------------------------------------------------------------
\43\ These five customers had purchased between 1,002 and
1,548 tablets. In contrast, Respondent's recommended dosing for
its 12.5 mg product was "2 tablets every 4 hours as needed, not
to exceed 12 tablets in 24 hours,'' and to "stop use'' and see a
doctor if "cough lasts more than 7 days.'' RX 9, at 3.
I acknowledge that Respondent cannot review the logbooks. A
registrant cannot, however, ignore other evidence which is
indicative of diversion.
\44\ At the hearing, Respondent's Expert testified that BPM55
is an outlier and that it would not be appropriate to draw "a
conclusion about [Respondent's] customers based on relying on
the . . . highest seller.'' Tr. 1722. Contrary to the
understanding of Respondent's Expert, in evaluating the
effectiveness of an entity's diversion controls, there are no
free passes. Excessive sales to a single store are sufficient by
themselves to support the conclusion that the registrant does
not maintain effective controls against diversion. Moreover, as
explained above, BPM55 had a history of excessive sales and had
previously come to the attention of Respondent. Yet Respondent
continued to sell to it, and sold massive quantities to it in
the three months which preceded the suspension.
For similar reasons, I find unpersuasive the testimony of
Respondent's Expert that it would be error to draw conclusions
from the six stores identified in Government Ex. 38 and 44. See
Tr. 1697- 1705. Indeed, with the exceptions of BPM 55 and NOC
56, it is not even clear that these stores were the largest
purchasers.
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[[Page 52700]]
Contrary to Respondent's understanding, while proof that a
distributor is selling quantities in excess of the national
monthly average for sales of SLCs by convenience stores would be
highly probative of the distributor's lack of effective controls
against diversion, it is not the sole measure for evaluating the
effectiveness of those controls. More specifically, a registrant
cannot ignore evidence that some of its customers are purchasing
quantities that greatly exceed what its typical customer buys
from it. Significantly, Respondent introduced this evidence into
the record. Although in some instances there may be a plausible
explanation for the disparity that does not involve diversion,
Respondent offered no explanation that was specific to any store
for why it was selling in such quantities.\45\
---------------------------------------------------------------------------
\45\ As noted above, there was a substantial dispute between
the parties over the various assumptions necessary to determine
what an average convenience store would sell in legitimate
commerce. Yet even indulging numerous assumptions favorable to
Respondent such as: (1) That only 31,000 stores sell the
products, (2) that ephedrine products constitute sixty percent
of the SLC market at convenience stores, and (3) that the NACS
survey has an error rate of fifty-five percent because some
stores erroneously report their sales of ephedrine as general
merchandise rather than as cold and cough products, ALJ Ex. 15;
and concluding that the average monthly sales figure is $941 a
month, more than 100 stores were selling at levels which were
statistically significant according to Respondent's expert. See
Tr. 1700 (noting that being outside of two standard deviations
is statistically significant); id. at 1704 (use of two standard
deviations is "a very appropriate number'').
I acknowledge that because two standard deviations represents
ninety-five percent of a population, by definition 2.5 % of the
stores will fall outside of this point on both sides of the
curve. In concluding that Respondent does not maintain effective
controls against diversion, I do not rely solely on the Z scores
calculated by Respondent's expert. See RX 27A. I also consider
the disparity between the size of the purchases of Respondent's
largest customers and its average customer.
---------------------------------------------------------------------------
Moreover, while Respondent's CEO testified that he would cut
off a customer who purchased more than a case of a product,
Respondent offered no evidence that it has ever refused to sell
to a customer because the customer was purchasing excessive
amounts of products. Indeed, Respondent's continued sales to
BPM55, at a rate that was more than eleven times what its
average customer was buying, amply demonstrates that its
purported written policy of monitoring those stores which
purchased "unusual quantities,'' and "[i]f further unusual
activity is noted * * *discontinu[ing] sales,'' RX 10, at 1; is
a sham.
I therefore conclude that Respondent does not maintain
effective controls against diversion. Given the variety of ways
in which Respondent's controls are deficient, this factor
strongly supports the conclusion that Respondent's continued
registration "is inconsistent with the public interest.'' 21
U.S.C. 823(h).
Factor Two--Respondent's Compliance With Applicable Laws
The Government further argues that Respondent failed to
comply with Federal law and DEA regulations by distributing SLCs
from the self- storage units because none of the units were
registered. See Gov. Exceptions 1-6. The ALJ, while noting that
the facts surrounding Respondent's use of the self-storage units
were not in dispute, declined to address the statutory issue,
reasoning that because there was then litigation pending in the
U.S. District Court, the Court, and not this proceeding, is the
proper forum for resolving the dispute. ALJ at 91 n.38.\46\ I
conclude, however, that there is no reason for the Agency to not
address this issue which involves a fundamental question as to
the scope of the CSA's registration requirements.\47\
---------------------------------------------------------------------------
\46\ The ALJ did note, however, that Respondent ignored the
letter of a DEA Group Supervisor which had informed it that its
conduct was illegal. ALJ at 91.
\47\ Ordinarily, courts defer to agencies when presented with
a legal issue that lies within the agency's primary
jurisdiction. II Richard J. Pierce, Jr., Administrative Law
Treatise 917 (4th ed. 2002). The scope of the CSA's registration
requirements is such an issue.
---------------------------------------------------------------------------
Under Federal law, "[e]very person who * * * distributes any
* * * list I chemical * * * shall obtain annually a registration
issued by the Attorney General.'' 21 U.S.C. 822(a)(1). "Persons
registered by the Attorney General * * * to distribute * * *
list I chemicals are authorized to possess [and] distribute * *
* such * * * chemicals * * * to the extent authorized by their
registration and in conformity with the other provisions of''
the CSA. Id. Sec. 822(b). The Act further provides that "[a]
separate registration shall be required at each principal place
of business * * * where the applicant * * * distributes list I
chemicals.'' Id. Sec. 822(e); see also 21 CFR 1309.23(a) ("A
separate registration is required for each principal place of
business at one general physical location where List I chemicals
are distributed, imported, or exported by a person.'').
With respect to SLC distributors, DEA has created by
regulation two limited exceptions to the requirement that each
principal place of business be registered. The first is for "[a]
warehouse where List I chemicals are stored by or on behalf of a
registered person, unless such chemicals are distributed
directly from such warehouse to locations other than the
registered location from which the chemicals were originally
delivered[.]'' 21 CFR 1309.23(b)(1).\48\ This regulation is
directly applicable to Respondent's use of the storage units.
---------------------------------------------------------------------------
\48\ The regulation also exempts from registration "[a]n
office used by agents of a registrant where sales of List I
chemicals are solicited, made, or supervised but which neither
contains such chemicals (other than chemicals for display
purposes) nor serves as a distribution point for filling such
sales orders.'' 21 CFR 1309.23(b)(2). This provision is not
applicable to Respondent's use of the self-storage units.
---------------------------------------------------------------------------
Notably, at the time this regulation was promulgated, several
commenters "objected to the requirement * * * that a separate
registration be obtained for each location at which List I
chemical activities are carried out[,]'' and "suggested that DEA
allow companies to obtain a single registration * * * for
multiple locations.'' Implementation of the Domestic Chemical
Diversion Control Act of 1993, 60 FR 32447, 32448 (1995). As DEA
then explained, "[t]he law is specific on this point. The
[Domestic Chemical Diversion Control Act] requires that a
separate registration be obtained at each location at which List
I chemicals are distributed.'' Id. (emphasis added).
Relatedly, several commenters asked "how the requirement for
separate registrations for separate locations would apply to
[independently owned] warehouses?'' Id. DEA explained that "[t]he
person who distributes List I chemicals from independently owned
warehouses must register at each location and ensure that the
other chemical control requirements, including security, record
keeping, reporting, etc., for their products are met.'' Id.
(emphasis added).
The record here clearly establishes that the SLCs which
Respondent stores in the self-storage units are not shipped back
to Respondent's registered location before being distributed.
Rather, the SLCs are distributed directly from the self-storage
units to Respondent's customers. As DEA's regulation makes
plain, Respondent's self-storage units are therefore subject to
the registration requirement. See 21 CFR 1309.23(b)(1).
As explained above, Respondent's contention that it was not
storing products at the self-storage units is
[[Page 52701]]
absurd. The units are warehouses as that term is understood
in common usage. See Webster's Third New International
Dictionary 2576 (1976) (defining warehouse as "a structure or
room for the storage of merchandise or commodities'').
Respondent nonetheless argues that the drop-off points are
not required to be registered because they are not its "principal
place of business.'' Resp. Br. at 97-98. Respondent acknowledges
that the term "principal place of business [is] not defined in
the definition section [ ] of the CSA.'' Resp. Br. at 97.
Respondent thus contends that the term should be given its "ordinary
meaning.'' Id. Relying on several cases interpreting the term "principal
place of business'' for the purpose of determining a
corporation's citizenship for the diversity jurisdiction of the
federal courts, see 28 U.S.C. 1332(c)(1), Respondent contends
that "[t]he principal place of business for a corporation is
usually its headquarters, where day-to-day business is
conducted.'' Id. (citing Heritage Educ. Trust v. Katz, 287
F.Supp.2d 34 (D.D.C. 2003) and Masterson-Cook v. Criss Bros.
Iron Works, Inc., 722 F. Supp. 810, 812 (D.D.C. 1989)).
According to Respondent, the Federal courts apply a " 'nerve
center of operation' test to establish the principal place of
business of corporations doing business in multiple states[,]''
and that " [w]hen no one state is clearly the center of
corporate activity or accounts for a majority of the company
income, the headquarters logically assumes greater importance in
determination of the principal place of business.'' Id. at 97-98
(quoting Masterson-Cook, 722 F. Supp. 812) (other citations
omitted). In Respondent's view, its Greenfield, Indiana
headquarters "is clearly the center of corporate activity,''
because "[a]ll transactions with vendors and customers are
handled through the Greenfield offices.'' Id. at 98. Relatedly,
Respondent argues that "[t]he drop off units are not the 'center
of corporate activity' nor do they 'account for a majority of
the company income.' '' Id. Respondent's arguments are not
persuasive.
It is fundamental that statutory terms take their meaning
from the context in which they are used and the statutory
purpose. See Mid-Con Freight Systems, Inc., v. Michigan Pub.
Serv. Comm'n, 545 U.S. 440, 447 (2005); Tyler v. Cain, 533 U.S.
656, 662 (2001); see also Pharmaceutical Res. & Mfr's of
America v. Thompson, 251 F.3d 219, 224 (D.C. Cir. 2001).
Respondent's reliance on cases interpreting the diversity
statute ignores the context in which the term "each principal
place of business'' is used in the CSA, as well as the CSA's
fundamentally different purpose.
Under Respondent's interpretation, an entity would be
required to obtain a registration only for a single
location--its headquarters. The text of section 822
demonstrates, however, that Congress did not limit a
registrant's obligation to obtain a registration to a single
place of business such as its corporate headquarters. Rather,
Congress imposed on a registrant the obligation to obtain a
separate registration at "each principal place of business * * *
where the applicant * * * distributes * * * List I chemicals.''
21 U.S.C. 822(e) (emphasis added).
Consistent with the underlying purposes of the CSA, the
statutory text manifests Congress's understanding that an entity
can have multiple principal places of business. A location where
List I chemicals are stored and distributed from, is a principal
place of business because it plays a "consequential'' part in
the registrant's activity of distributing. See Webster's Third
New Int'l Dictionary 1802 (1976) (defining "principal'' in part
as "consequential''). In determining whether a facility is a
principal place of business within the meaning of the CSA, the
Act looks to the nature of the activity that occurs at the
particular location and not at the dollar volume of business
that is transacted out of the facility. See 21 CFR 1309.23(b)(2)
(exempting from registration "[a]n office used by agents of a
registrant where sales of List I chemicals are solicited, made,
or supervised but which neither contains such chemicals * * *
nor serves as a distribution point for filling sales orders'').
Respondent's interpretation would clearly frustrate the
Congressional purpose. In enacting the CSA's registration
provisions, Congress' purpose was to protect against diversion
by requiring that those persons who propose to engage in the
legitimate distribution of controlled substances and listed
chemicals apply for a registration, notify this Agency of the
proposed location of their activity, and submit the facility for
inspection by the Agency to ensure that it has adequate security
controls and procedures. See, e.g., 21 U.S.C. 822(f)
(authorizing the Attorney General "to inspect the establishment
of a registrant or applicant for registration''). Indeed,
inspection by the Agency of a proposed facility is fundamental
to the CSA's mandate to protect the public interest. Id. 823(h);
see also 21 CFR 1309.41.
As the record here establishes, Respondent has never applied
for registration for any of its storage units and has never
submitted any of its storage units for inspection. Indeed,
according to the record, Respondent has yet to provide
information regarding the location of some 34 of its storage
units. As this case demonstrates, adopting Respondent's
interpretation would frustrate Congress's purpose and render the
Act a nullity.
Respondent's interpretation would also create a perverse
incentive. While it is unclear whether under its view an entity
which has only a few warehouses would have to obtain a
registration for each of them, see Resp. Br. at 97-98,\49\ what
is clear is that an interpretation which determines whether a
facility must be registered by looking to the amount of business
activity that occurs out of a facility rather than the nature of
the activity that occurs therein, would encourage an entity to
keep adding warehouses or storage facilities so that it could
eventually claim that its warehouses were no longer principal
places of business and were thus not subject to the registration
requirement. Adopting Respondent's interpretation would thus
lead to absurd results and seriously undermine the security of
the Nation's controlled substances and listed chemical supplies.
I therefore reject it.
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\49\ Respondent's argument that "the principal place of
business for a corporation is usually its headquarters,'' Resp.
Br. 98, suggests that its view is that only one registration is
required for an entity no matter the geographic scope of its
distribution activities.
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As stated above, the ALJ did not address this statutory
question. She did, however, conclude that Respondent's conduct
in continuing to store SLCs at, and distributing them from, the
self-storage units, even after receiving the Group Supervisor's
letter, was "not consistent with the requirements for a
participant in a regulated industry,'' and supported the
revocation of its registration. ALJ at 91. Respondent excepts to
the ALJ's conclusion, contending that it was placed in the "dilemma''
that if it complied with the letter, it would have to use common
carriers and that this "would increase the risk of diversion.''
Resp. Exceptions at 99. Respondent further argues that because
it "questioned the legal validity of the letter, and feared
adherence to it would cause [it] to contribute to the risk of
diversion to the illicit methamphetamine trade, it filed suit''
in federal court. Id. at 100.
Respondent's argument is patently self-serving and
unsupported by the record. As found above, Respondent's evidence
as to the perceived security inadequacies of, and increased risk
of
[[Page 52702]]
diversion when shipping via common carriers, lacked
foundation. It presented no evidence of any diversion of SLCs
when being shipped by common carriers.\50\ The argument further
ignores the significant risk of diversion posed by its own
distribution model, both through its use of the storage units
which do not provide an acceptable level of security, and its
further practice under which SLCs may be stored on a
salesperson's truck for up to nine days at a time.
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\50\ Respondent also argues that "the Raber letter would
allow reliance on a system of distribution (FedEx and UPS
unregistered locations) that present risks of diversion that
exceed those of [its] system.'' Resp. Exceptions at 101.
Congress however, has specifically exempted common carriers from
registration, see 21 U.S.C. 822(c)(2), and has concluded that
their use for shipping controlled substances and listed
chemicals poses an acceptable risk of diversion. I further note
that Respondent acknowledged in testimony that it has used
common carriers in the past.
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Finally, Respondent contends that because it was not sure
what the legal effect of the letter was, it felt obliged to
challenge the letter by filing suit. Contrary to Respondent's
view, its right to seek declaratory relief in federal court is
not at issue. Cf. id. at 100. (arguing that ALJ's decision "[c]ondemns
the exercise of'' its right to seek relief in a federal court).
Rather, what is at issue is Respondent's decision to continue to
distribute SLCs--for some forty- four months--in a manner that
violates Federal law, and its doing so even after being told
that it was violating Federal law.
Furthermore, even if there was a legitimate question as to
the legal effect of the letter, the Agency's regulation made
clear that a warehouse was not exempt from registration if the
SLCs being stored therein "are distributed directly from such
warehouse to locations other than the registered location from
which the chemicals were originally delivered.'' 21 CFR
1309.23(a)(1). I thus conclude that the Agency's regulation and
the letter provided Respondent with ample notice that its
conduct was illegal.\51\ Notwithstanding Respondent's assertion
that it is now willing to comply with Federal law, its
deliberate disregard of the warning it received and lengthy
failure to comply, strongly support the revocation of its
registration.\52\
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\51\ Nor did Respondent seek review of the Group Supervisor's
letter within the Agency.
\52\ As noted under factor one, Respondent also failed to
comply with Federal law because it did not maintain proper
records of regulated transactions.
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Factor Four--Past Experience in the Distribution of
Chemicals
In discussing this factor, the ALJ noted that Respondent has
been registered since 1998 and thus had extensive experience in
distributing SLCs. ALJ at 92-93. She further explained that
prior to the service of the Suspension Order, "Respondent had
not been informed by the [agency] of any incidents of diversion
of its SLC product,'' and that with the exception of the 2004
letter regarding its distribution practices, it was "never
informed * * * of any statutory or regulatory violations.'' Id.
at 93. Finally, the ALJ noted that the Agency had renewed "Respondent's
registration annually between 1998 and 2007.'' Id. Based on what
she characterized as Respondent's "nine year history of
compliance,'' the ALJ concluded that the evidence on this factor
"support[ed] a remedy less severe than revocation.'' Id.
The ALJ's conclusion is mistaken for several reasons. First,
the ALJ's conclusion that Respondent had not been informed by
the Agency of any incident of diversion is contrary to the
evidence, which establishes that twenty-two sixty-count bottles
of products it distributed were found at an illicit laboratory
in Connecticut and that a DI discussed the matter with its
executives. Tr. 1082-84. Whether the subject was first broached
by the DI or Respondent is beside the point, as is whether the
information was put in a formal warning letter. The fact remains
that products which it distributed were diverted. Moreover,
while Respondent provided the investigator with information as
to which of its salespersons had received the products, it could
not identify the stores to which the products were distributed.
Tr. 1517.
Second, the ALJ gave insufficient weight to Respondent's
continuation of its illegal practice of distributing out of
unregistered storage units for more than three and a half years
after having been advised of the practice's illegality. Most
significantly, at no point did Respondent voluntarily cease the
practice.
Moreover, as explained above under factor two, the
registration requirement is one of the essential features of the
CSA. Respondent's violations are not technical violations of the
Act. Respondent's conduct thus precludes a finding that
Respondent's experience establishes a "history of compliance.''
ALJ at 93. Respondent's experience thus also supports the
conclusion that its registration would be "inconsistent with the
public interest.'' 21 U.S.C. 823(h).\53\
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\53\ The ALJ's further reliance on the Agency's renewal of
Respondent's registration was in error. Under Federal
Regulations, in the event the Agency proposes the denial of a
renewal application, it must issue an Order to Show Cause. 21
CFR 1309.42(a). There are a variety of reasons why the Agency
may not be prepared to go forward with a Show Cause Proceeding
at a particular time including, inter alia, a lack of resources,
the complexity of the matters under investigation, and the need
to pursue other enforcement priorities. Moreover, field
personnel may approve the renewal of a registration based on an
erroneous understanding of the law and regulations. The decision
to renew a registration is thus not probative of a registrant's
record of compliance with Federal law and Agency regulations.
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Factor Five--Other Factors Relevant to and Consistent With
Public Health and Safety
As found above, following the service of the Immediate
Suspension, Respondent contacted one of its suppliers and
attempted to enter into a scheme under which its sales force
would continue to take orders for SLCs, which would be sent to
its headquarters and then on to the supplier, which would ship
the products. Under the scheme, Respondent's salespersons would "still
do all reordering and stocking of the merchandise as [they] have
in the past.'' GX 48.
At the hearing, one of Respondent's vice presidents attempted
to justify the scheme, explaining that under his "definition of
sales, we're not involved in the distribution of the product.
But our sales people are in that store functioning as an
agent.'' Tr. 2402. While the supplier refused to enter into the
scheme, the VP testified that it was "[s]omething that were
still continuing to explore.'' Id. at 2403.
In its Exceptions, Respondent contends that "[u]nder 21 CFR
1309.23, sales agents are not required to be registered and are
lawful.'' Resp. Exceptions at 102. Respondent further argues
that because it "only discerned select customer's interest in it
serving in this role,'' id. at 103, the ALJ's conclusion that it
"still does not seem to understand that it is working in a
highly regulated industry when it actually handles SLC
products,'' ALJ at 92, condemns it based on "the mere expression
of interest in a legal option.'' Resp. Exceptions at 103.
Respondent is correct that because it never actually entered
the scheme, there is no basis for concluding that its actions
related to the scheme demonstrate that it failed to comply with
applicable laws. See 21 U.S.C. 823(h)(2). The scope of factor
five is, however, considerably broader than factor two, and
encompasses "such other factors as are relevant to and
consistent with the public health and safety.'' Id. 823(h)(5).
Respondent's assertion that it merely expressed interest in a
legal option mischaracterizes the record. Respondent's actions
were not limited
[[Page 52703]]
to merely thinking about a legal option or seeking legal
advice about the scheme. Rather, it affirmatively sought out one
of its suppliers and attempted to induce it to enter the scheme
only to be rebuffed by the supplier.
While Respondent maintains that it was pursuing a legal
option because an agent is not required to be registered, it
ignores that this exception applies only if the "agent * * * is
acting in the usual course of [its] business.'' 21 U.S.C.
822(c)(1); 21 CFR 1309.24(a). The usual course of Respondent's
business with respect to SLCs did not, however, involve acting
as a sales agent for another registrant. Rather, the usual
course of its business was distributing SLCs for its own
account. More significantly, I further hold that an entity does
not act in the usual course of business when it engages in
distribution- related activities that it has previously been
prohibited from doing pursuant to an order suspending or
revoking its registration. It would fundamentally undermine the
CSA's purpose of protecting against diversion to allow an entity
whose registration has been suspended or revoked to subsequently
engage in the same or related activities as an agent.
Respondent's attempt to circumvent the suspension order--and
the admission of one its executives at the hearing that it was
still exploring this option--reflects adversely on its fitness
to engage in the distribution of SLCs. I thus conclude that this
factor also supports the conclusion that Respondent's
registration would be "inconsistent with the public interest.''
21 U.S.C. 823(h)(5).\54\
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\54\ As explained above at n. 5, the issue of whether there
is a legitimate medical need for over-the-counter ephedrine
products, see ALJ at 94-95, is for the FDA to decide. The issue
in this proceeding is whether Respondent's registration is
consistent with the public interest.
---------------------------------------------------------------------------
Sanction
Under DEA precedent, the Agency considers all of the facts
and circumstances in determining the appropriate sanction. See
Martha Hernandez, M.D., 62 FR 61,145 (1997). While the ALJ found
that factors one and two supported revocation, and that "Respondent's
actions appeared to blatantly disobey a DEA directive,'' she
further reasoned that except for this letter, "Respondent has
not been given an opportunity to remedy the flaws identified * *
* in this action.'' ALJ at 100. Based on what she characterized
as its "history of compliance, as evidenced by'' the Agency's
continuing its registration, as well as "its financial
commitment to compliance, as evidenced by its rework of its
hand-held computer system to better track inventory,'' the ALJ
reasoned that revocation "does not seem consistent with prior
agency action concerning this Respondent.'' ALJ at 100-101.
Based on this view of the record, the ALJ further opined "that
this is a case where teamwork between the DEA and this major
distributor would facilitate the public interest.'' Id. at 101.
The ALJ thus recommended that I continue Respondent's
registration while imposing compliance conditions.
Were the evidence limited to Respondent's recordkeeping
problems, imposing compliance conditions might well protect the
public interest. But it is not. I acknowledge that the evidence
points to some measures which Respondent voluntarily undertook
such as reprogramming its computer system,\55\ providing its
customers with materials on the CMEA and its self-certification
requirement, logbooks, and plexiglass cabinets. Its customers
could not, however, legally sell its products without
self-certifying and maintaining logbooks. Moreover, these
measures do not address the serious problems with its
distribution practices that are established by the record, and
which were either ignored, or discounted by the ALJ.
---------------------------------------------------------------------------
\55\ It is, however, unclear whether the reprogramming has
rectified the problems identified with the salespersons' entry
of product codes.
---------------------------------------------------------------------------
First, for more than three and a half years, Respondent
disregarded a DEA letter specifically warning it that its use of
the 150-180 self- storage units to store and distribute SLCs
violated Federal law. Moreover, Respondent continued to violate
Federal law up until its registration was suspended. As
explained above, these are not technical violations, but rather
transgressions of one of the CSA's fundamental provisions.
Respondent's disregard of the letter and continuation of its
practices for some forty-four months makes its conduct
especially egregious. Given the sustained nature of the
violations and Respondent's failure to voluntarily cease its
misconduct, its assertion that it is now willing to "modify[]
its existing system of distribution,'' Resp. Exc. 90, is not
persuasive. Cf. ALRA Laboratories, Inc., v. DEA, 54 F.3d 450,
452 (7th Cir. 1995) ("[a]n agency rationally may conclude that
past performance is the best predictor of future performance'');
Southwood Pharmaceuticals, Inc., 72 FR 36487, 36503 (2007)
(rejecting company's claims of reform in light of the scope and
duration of its misconduct and failure to heed information that
its activities were contributing to diversion).
Second, while Respondent asserted that it imposed sales
limits on how much of each product a store could buy in a
service cycle, and that it monitored the purchases of each
product at each store throughout the week to determine whether a
store was purchasing excessive quantities, investigated if it
was, and cutoff sales to those store which were purchasing
excessive amounts, it is clear that these policies were
frequently ignored. Putting aside the effectiveness of the one
case per product, per service cycle policy,\56\ the credited
testimony establishes that its sales force violated the policy
some 85 times in the six months preceding the July 2007
inspection. Moreover, Respondent only started issuing warning
letters to its sales force in August 2007--a month after the
warrant was executed--with one of its executives offering the
lame excuse that he had not received the reports until then
because of a computer "glitch.''
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\56\ As explained above, the policy's limit was imposed on a
per-product and per-service cycle basis. Most stores were
serviced every two weeks and some were serviced weekly.
Moreover, Respondent sold ten different products. Accordingly, a
store being serviced weekly could buy up to forty cases every
four weeks.
---------------------------------------------------------------------------
Notably, Respondent's CEO testified that if a customer
obtained more than a case of a product in a service cycle, he "would
cut them off, [and] stop the sale of product to them.'' Tr.159.
Respondent, however, produced no evidence that it had ever
entirely cut off a customer.
Indeed, Respondent's own evidence with respect to store
BPM55--a store at which five persons purchased quantities that
are grossly inconsistent with use of the products to treat
asthma and are consistent with diversion--amply demonstrates the
disingenuousness of its claim that it monitors its customers'
purchases and cuts off sales if a store is acquiring excessive
amounts. Notwithstanding that it had previously developed
concerns regarding this store's excessive purchases, in the
three months prior to the suspension order, Respondent sold to
it products with a monthly average retail value of more than
$7300, an amount more than eleven times its average customer's
purchase.\57\ Respondent's sales to this store amply demonstrate
that its policy of monitoring "unusual sales activity'' and
cutting off sales if such purchases
[[Page 52704]]
continue, RX 10, at 1, is a sham and not a legitimate effort
to control diversion.
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\57\ As found above, the record also shows numerous other
stores to which Respondent repeatedly sold quantities that
exceeded its average customer's purchases by a wide margin.
---------------------------------------------------------------------------
Respondent's failure to enforce its own policies provides
reason alone to conclude that it cannot be trusted to adhere to
compliance conditions. This conclusion is further supported by
Respondent's sustained and flagrant violations of Federal law,
as well as its attempt to circumvent the suspension order.
Indeed, as Respondent's history amply demonstrates, its
professed commitment to "teamwork'' and "to become a compliance
model for the entire industry,'' Resp. Ex. at 139, cannot be
taken seriously.\58\ I therefore conclude that imposing
compliance conditions would not adequately protect the public
interest, and reject the ALJ's recommendation.\59\
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\58\ For the same reasons, I find unpersuasive the August 13,
2008 letter from Respondent's President.
\59\ Respondent raises a plethora of claims that the Agency
or its personnel have violated its rights under the First and
Fifth Amendments, as well as statutory provisions including the
Administrative Procedure Act, the Data Quality Act, and 21 U.S.C.
880. See Resp. Br. at 114-39. For example, Respondent asserts
that the DIs violated its First Amendment rights and engaged in
a prior restraint because they refused to allow its executives
to videotape them as they reviewed Respondent's records. See id.
at 116. It also alleges that a DI committed an assault and
battery during the inspection when he grabbed a video recorder
from the hands of one of its executives who was attempting to
set up the camera in order to tape the investigators while they
reviewed Respondent's records.
While in my order denying Respondent's interlocutory appeal,
I adhered to settled Agency precedent that the exclusionary rule
does not apply in these proceedings, ALJ Ex. 13, at 3;
Respondent now contends that I should discount the testimony of
two DIs who participated in the inspection to deter future
violations. Indeed, Respondent even contends that I should
discount the testimony of these DIs based on the alleged assault
and battery of the third DI, who did not testify at the hearing.
Having considered the legal and factual bases for each of
Respondent's claims, I conclude that none of them presents a
substantial question as to the fundamental fairness of this
proceeding and none warrants further discussion.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(h)
& 824(a), as well as 28 CFR 0.100(b) & 0.104, I order
that DEA Certificate of Registration, 003563NSY, issued to
Novelty Distributors, D/B/A/ Greenfield Labs, be, and it hereby
is, revoked. I further order that any pending application of
Novelty Distributors, D/B/A Greenfield Labs, for renewal of its
registration, be, and it hereby is, denied. This order is
effective immediately.
Dated: September 3, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-21035 Filed 9-9-08; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).