Registrant Actions - 2011
[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 20039-20042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8542]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
The Medicine Dropper; Revocation of Registration
On January 29, 2010, I, the then Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration (Order) to The Medicine Dropper
(Respondent), of Greenwood, South Carolina. The Order proposed the
revocation of Respondent's DEA Certificate of Registration, BT2981214,
as a retail pharmacy, and the denial of any pending applications to
renew or modify its registration, on the ground that its "continued
registration is inconsistent with the public interest." Order, at 1.
More specifically, the Order alleged that, on March 18, 2009,
Respondent's owner had entered into a Settlement Agreement with the
United States Attorney for the District of South Carolina under which
he agreed to a policy "to prevent the use of [his] pharmacy for
'doctor shopping' and [to] provide quarterly reports of all Schedule II
controlled substances [it] dispensed." Id. at 1-2. The Order also
alleged that in the settlement, Respondent's owner "agreed to 'fill
prescriptions using the correct DEA number for the physician and [to]
ensure that all required elements of the prescriptions are present
prior to dispensing,' " as well as to comply with Federal and State
laws related to the dispensing of controlled substances. Id.
The Order alleged that, after executing the Settlement Agreement,
Respondent's owner continued to dispense prescriptions for schedule III
controlled substances containing hydrocodone to L.P, even though she
submitted similar prescriptions from three different physicians between
June and November of 2009. Id. With respect to L.P., the Order further
alleged that Respondent had "dispensed an excessive amount of
hydrocodone," and that "[b]ased on Respondent's own calculations for
what constitutes a 'day's supply' of hydrocodone for L.P., Respondent
dispensed the equivalent of 709 'day's supplies' during the period
between September 22, 2008 and September 1, 2009," and that "[t]his
resulted in dispensing more than twice the recommended amount of
hydrocodone that L.P. should have received." Id.
Next, the Order alleged that in January and February 2009,
Respondent distributed Lyrica, a schedule V controlled substance, "to
T.M. without a valid prescription in violation of 21 U.S.C. Sec.
841(a)," and that it "also furnished false or fraudulent material
information regarding T.M.'s Lyrica prescriptions in violation of 21
U.S.C. Sec. 843(a)(4)(A) and mislabeled T.M.'s Lyrica prescription in
violation of 21 CFR 1306.24(a)." Id. The Order further alleged that on
September 14, 2009, Respondent completed filling a prescription for
Dilaudid (hydromorphone), a schedule II controlled substance, which
T.M. had presented to it in August 2009, thereby
[[Page 20040]]
violating 21 CFR 1306.13(a), which requires that a partially-filled
prescription for a schedule II controlled substance be completely
filled within 72 hours of the partial filling. Id. With respect to
T.M., the Order also alleged that in September 2009, Respondent
provided false information regarding his prescriptions to an inspector
from the South Carolina Department of Health and Environmental Control.
Id.
The Order further alleged that in September 2009, Respondent
violated 21 CFR 1306.11(d)(4), when it "filled an 'emergency' oral
call-in prescription for" MS Contin, a schedule II controlled
substance, "for patient D.S. without notifying DEA that no written
order was ever received." Id. The Order also alleged that Respondent
violated South Carolina law by filling two prescriptions for schedule
II controlled substances "that were more than 90 days old." Id. at 3.
Finally, the Order alleged that "[s]ince March 2009, Respondent
has repeatedly violated the terms of the Settlement Agreement" by
"permitt[ing] doctor shopping, fill[ing] prescriptions for controlled
substances without a legitimate medical purpose," and violating other
Federal and State laws in filling various prescriptions. Id. The Order
further alleged that Respondent had violated the Settlement Agreement
because it had "failed to provide DEA with quarterly reports of all
schedule II controlled substances [it] dispensed." Id.
Based on the above, I concluded that Respondent's continued
registration during the pendency of the proceeding "constitutes an
imminent danger to the public health and safety." Id. Pursuant to my
authority under 21 U.S.C. 824(d), I therefore immediately suspended
Respondent's registration and ordered that the suspension "remain in
effect until a final determination is reached in these proceedings."
Id.
On February 3, 2010, the Order, which also notified Respondent of
its right to a hearing to contest the allegations (as well as its right
to submit a written statement in lieu of a hearing), the procedure for
requesting a hearing, and the consequence if it failed to do so, was
served on Respondent. See id. at 3 (citing 21 CFR 1301.43(a), (c), (d)
& (e)). Since the date of service of the Order, neither Respondent, nor
anyone purporting to represent it, has requested a hearing or submitted
a written statement in lieu of a hearing. Thirty days now having passed
since the Order was served on Respondent, I find that it has waived its
right to a hearing. See 21 CFR 1301.43(b) & (d). I therefore issue this
Decision and Final Order based on the evidence contained in the
investigative record submitted by the Government. Id. 1301.43(e). I
make the following findings.
Findings
Respondent is a corporation organized under the laws of South
Carolina, which is owned by John Frank Weeks and Derrelyn B. Weeks.
Respondent operates a retail pharmacy located at 420 Epting Avenue,
Greenwood, South Carolina, and is the holder of DEA Certificate of
Registration, BT2981214, which authorizes it to dispense controlled
substances in schedules II through V as a retail pharmacy. Respondent's
registration was to expire on November 30, 2009; however, on October
16, 2009, Respondent submitted a renewal application. Accordingly,
Respondent's registration remains in effect (albeit in suspended
status) pending the issuance of this Final Order. See 5 U.S.C. 558(c).
On March 23, 2009, Respondent and its owners entered into a
Settlement Agreement with the United States of America, which was
intended to resolve the latter's civil and administrative claims based
on its contentions that, between June 14, 2002 and January 16, 2008,
Respondent violated the Controlled Substances Act and DEA regulations
"by filling prescriptions for other than legitimate medical purposes;
ignoring evidence of diversion; and dispensing excessive doses of
controlled substances." \1\ Settlement Agreement at 2. As part of the
Settlement Agreement, Respondent and its owners agreed that "as a
registrant with the DEA, they have a duty to comply with all federal
regulations governing the dispensing and distribution of controlled
substances." Id. at 8.
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\1\ The Agreement was also intended to resolve the Government's
contentions that Respondent had submitted various false claims to
the South Carolina Medicaid Program.
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Respondent and its owners further agreed that "[t]hey will adopt a
reasonable and customary policy suitable to the DEA to prevent the use
of their pharmacy for 'doctor shopping' and will provide quarterly
reports of all schedule II controlled substances dispensed in such a
form as reasonably required by the DEA." Id. at 9. In addition,
Respondent and its owners agreed that "[t]hey will fill prescriptions
using the correct DEA number for the physician and ensure that all
required elements of the prescription are present prior to dispensing"
and that "[t]hey will comply with State and Federal law pertaining to
the dispensing of controlled substances." Id.
According to the affidavit of a DEA Diversion Investigator,
notwithstanding Respondent's (and its owner's) promise to adopt a
policy to prevent doctor shopping, between June 2009 and November 2009,
Respondent dispensed ten prescriptions for schedule III controlled
substances containing hydrocodone to L.P., which were issued by three
different doctors. Affidavit at 3-4. Moreover, according to
Respondent's records, in most instances, the quantity dispensed was
intended to be a thirty-day supply, yet in several instances Respondent
dispensed an additional thirty-day supply well before the prescription
it had previously dispensed would have run out and frequently did so
weeks early, and in one instance, nearly four weeks early. More
specifically, Respondent's records show that, based on prescriptions
issued by a Dr. B., Respondent dispensed a thirty-day supply to L.P. on
April 9 and 24, May 2, 5, and 22, June 1 and 20, and July 1, 2009.
In his affidavit, the DI further stated that Respondent had
dispensed prescriptions for Lyrica, a schedule V controlled substance
to T.M., which were purportedly called in by a Dr. M. Affidavit at 5-6.
However, in a letter, Dr. M. stated that he had discharged T.M. from
his clinic on October 29, 2008, and that the last prescription he had
authorized was on October 22, 2008. Included in the record are five
"TELEPHONE PRESCRIPTION" forms, attached to which are the stickers
indicating the actual dispensing of 90 tablets of Lyrica 150 mg. and
listing Dr. M. as the prescriber. According to these documents,
Respondent dispensed Lyrica to T.M. on November 28, 2008, January 6,
May 1, June 2 and July 8, 2009, well after Dr. M. had discharged her.
Subsequently, Mr. Weeks (Respondent's owner) wrote a letter to
Lauren Patton, an Inspector with the South Carolina Department of
Health and Environmental Control. Affidavit at 5. Therein, Mr. Weeks
asserted that he had reviewed the actual prescription-fill information,
and that subsequent to November 28, 2008, Respondent did not dispense
any more Lyrica to T.M. because she was placed on hold while the
pharmacy waited for her to bring in an actual prescription. Id.
However, other records of Respondent show that it billed T.M.'s
insurance company for Lyrica prescriptions attributed to Dr. M. which
were dispensed on January 6, February 6, March 5, April 3, May 1, June
2, July 8, and August 7, 2009. In addition, the record includes a
photograph of a drug vial; the vial bears the label of Respondent's
pharmacy and indicates that on May 1, 2009, it dispensed 60 tablets of
Lyrica to T.M.,
[[Page 20041]]
that T.M. was owed 30 tablets of the authorized quantity and lists Dr.
M. as the prescriber. According to the DI's affidavit, during an
interview, T.M. showed them two vials for Lyrica which listed Dr. M. as
the prescriber and which were dispensed to her by Respondent on January
6 and May 1, 2009.\2\
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\2\ The Government also alleged that Respondent violated 21 CFR
1306.13(a) because it did not fill the remainder of a prescription
for Dilaudid (hydromorphone, a schedule II drug) until well after 72
hours of its having partially filled the prescriptions. The
Government's evidence does not, however, establish this violation.
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Other evidence shows that while Respondent repeatedly dispensed
prescriptions for hydromorphone (a schedule II controlled substance),
which were purportedly authorized by Dr. M., a pain management
specialist, and did so through May 1, 2009, on multiple occasions
during this period it also dispensed hydrocodone to T.M. based on
prescriptions issued by other practitioners. Indeed, on May 1, 2009,
Respondent dispensed to T.M. 240 tablets of hydromorphone purportedly
authorized by Dr. M. and 90 tablets of hydrocodone authorized by J.B.,
a Family Nurse Practitioner. Moreover, other documents establish that
Dr. M. and J.B. did not work in the same practice.
The record also includes a copy of a "Telephoned Prescription"
dated "09/03/09" for 28 tablets of "MSCOTIN [sic] 30 mg." for
patient D.S. According to the DI's affidavit, "no subsequent written
order was ever received and Respondent did not notify DEA" as required
under 21 CFR 1306.11(d)(4). Affidavit at 6. However, there is no
evidence such as prescription labels or a dispensing log establishing
that the prescription was ever actually dispensed.
The record also contains two prescriptions which were issued on
March 6, 2009, by Dr. S. to J.W. for 60 tablets of MS Contin (morphine
sulfate) 100 mg. and 180 tablets Roxicodone (oxycodone) 30 mg., both of
which are schedule II controlled substances under the CSA and South
Carolina law. The record further establishes that the prescriptions
were dispensed on August 7, 2009, approximately five months after they
were issued.
Finally, while the Settlement Agreement requires that Respondent
submit to DEA each quarter a report of the schedule II controlled
substances it dispensed, according to the DI, it has never done so. Id.
at 7.
Discussion
Section 304(a) of the Controlled Substance Act provides that "[a]
registration * * * to * * * dispense a controlled substance * * * may
be suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section." 21 U.S.C. 824(a).
In determining the public interest, the Act directs that the Attorney
General consider the following factors:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id. Sec. 823(f).
"[T]hese factors are * * * considered in the disjunctive." Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). 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
and/or an application should be denied. Id. Moreover, it is well
settled that I am "not required to make findings as to all of the
factors." Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also
Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005). However, the
Government has the burden of proof. 21 CFR 1301.44(d) & (e).
Having considered all of the factors, I conclude that the evidence
pertinent to factors two and four makes out a prima facie showing that
Respondent "has committed such acts as would render [its] registration
* * * inconsistent with the public interest." 21 U.S.C. 824(a)(4).
Accordingly, Respondent's registration will be revoked and its pending
application to renew its registration will be denied.
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Relating to Controlled
Substances
Under a longstanding DEA regulation, a prescription for a
controlled substance is unlawful unless it has been "issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice." 21 CFR 1306.04(a). The
regulation further provides that while "[t]he responsibility for the
proper prescribing and dispensing of controlled substances is upon the
prescribing practitioner, * * * a corresponding responsibility rests
with the pharmacist who fills the prescription." Id. (emphasis added).
Continuing, the regulation states that "the person knowingly filling
such a purported prescription, as well as the person issuing it, [is]
subject to the penalties provided for violations of the provisions of
law relating to controlled substances." Id.
DEA has consistently interpreted this provision as prohibiting a
pharmacist from filling a prescription for a controlled substance when
he either "knows or has reason to know that the prescription was not
written for a legitimate medical purpose." Medic-Aid Pharmacy, 55 FR
30043, 30044 (1990); see also Frank's Corner Pharmacy, 60 FR 17574,
17576 (1995); Ralph J. Bertolino, 55 FR 4729, 4730 (1990); United
States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980). This Agency has
further held that "[w]hen prescriptions are clearly not issued for
legitimate medical purposes, a pharmacist may not intentionally close
his eyes and thereby avoid [actual] knowledge of the real purpose of
the prescription." Bertolino, 55 FR at 4730 (citations omitted).\3\
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\3\ As the Supreme Court recently explained, "the prescription
requirement * * * ensures patients use controlled substances under
the supervision of a doctor so as to prevent addiction and
recreational abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those prohibited
uses." Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United
States v. Moore, 423 U.S. 122, 135 (1975)).
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As the evidence shows, Respondent violated this regulation on
multiple occasions when it dispensed prescriptions for schedule III
controlled substances containing hydrocodone to L.P., notwithstanding
that L.P. was filling the prescriptions weeks before a previously
filled prescription would have run out. More specifically, pursuant to
prescriptions issued by a Dr. B., Respondent dispensed 90 tablets of
hydrocodone to L.P. on April 9 and 24, May 2, 5, and 22, June 1 and 20,
and July 1, 2009. According to Respondent's records, each of these
prescriptions provided a thirty-day supply to L.P. Yet Respondent
repeatedly filled subsequent prescriptions weeks early. Indeed, even
ignoring the April prescriptions, the May 5 prescription, which
followed a prescription filled three days earlier, was filled nearly
four weeks early. Given the dates on when L.P. presented the
prescriptions, I conclude that Respondent and its employees clearly had
reason to know
[[Page 20042]]
that the prescriptions were unlawful. I thus hold that Respondent
violated its corresponding responsibility under Federal law and DEA's
regulation by filling prescriptions which it had reason to know were
not legitimate. 21 CFR 1306.04(a); Bertolino, 55 FR at 4730. It is also
clear that Respondent has breached the Settlement Agreement by failing
to comply with Federal law and DEA regulations and by failing to
institute a policy to prevent the filling of unlawful prescriptions.
The evidence also supports the conclusion that Respondent violated
Federal law when it dispensed numerous prescriptions for Lyrica to T.M.
which were purportedly authorized by Dr. M. by telephone. The evidence
shows that the prescriptions were fraudulent because Dr. M. had
previously discharged T.M. from his practice and ceased writing
prescriptions for her. The evidence also shows that Mr. Weeks falsely
represented to a State inspector that Respondent had not dispensed
Lyrica after November 28, 2008, when, in fact, it had dispensed the
drug multiple times to her. At a minimum, Mr. Weeks' willingness to lie
about this issue (coupled with his failure to submit any evidence
rebutting the allegation) supports the inference that he and Respondent
had reason to know that the prescriptions were fraudulent and yet
dispensed them anyway. See 21 U.S.C. 841(a)(1) and 843(a)(3); 21 CFR
1306.04(a).
In addition, the evidence shows that Respondent repeatedly
dispensed narcotic drugs such as hydromorphone (also purportedly
authorized by Dr. M) to T.M. for more than six months after she had
been discharged by him, and that during this time period, it also
repeatedly dispensed hydrocodone based on prescriptions which were
issued by J.B. (a nurse practitioner). Dr. M. and J.B. did not,
however, practice together. Yet Respondent repeatedly dispensed both
drugs to T.M. and even dispensed both drugs to her on the same day (May
1, 2009). Once again, it is clear that Respondent violated its
corresponding responsibility under 21 CFR 1306.04(a) and the Settlement
Agreement on numerous occasions.
The record further establishes that Respondent violated South
Carolina law when, on August 7, 2009, it dispensed 180 tablets of
Roxicodone (oxycodone) 30 mg. and 60 tablets of MS Contin (morphine
sulfate) 100 mg. to J.W. based on prescriptions which were dated March
6, 2009. Both drugs are schedule II controlled substances under South
Carolina law (as they are under the CSA). See S.C. Code Sec. 44-53-
210(a). Under South Carolina law, "[p]rescriptions for Schedule II
substances must be dispensed within ninety days of the date of issue,
after which time they are void." Id. Sec. 44-53-360(e). However, on
the date Respondent dispensed these two prescriptions, they were more
than five months old and were void. I thus conclude that Respondent
violated South Carolina law by dispensing these prescriptions.
Finally, the Settlement Agreement clearly required that Respondent
submit "quarterly reports of all schedule II controlled substances
[it] dispensed." As found above, the DI's affidavit establishes that
Respondent has never submitted such a report. Respondent is therefore
in violation of the Settlement Agreement for this reason as well.
I therefore find that Respondent has committed acts which render
its registration "inconsistent with the public interest." 21 U.S.C.
824(a)(4). Accordingly, Respondent's registration will be revoked and
its pending application to renew its registration will be denied. For
the same reasons which led me to order the immediate suspension of
Respondent's registration, I conclude that this Order shall be
effective immediately.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order that DEA
Certificate of Registration, BT2981214, issued to The Medicine Dropper,
be, and it hereby is, revoked. I further order that any pending
application of The Medicine Dropper for renewal or modification of its
registration be, and it hereby is, denied. This Order is effective
immediately.
Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-8542 Filed 4-8-11; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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