[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Pages 19599-19602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9797]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bob's Pharmacy and Diabetic Supplies; Revocation of Registration
On August 15, 2008, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Bob's Pharmacy and Diabetic Supplies
(Respondent), of Winter Haven, Florida. The Show Cause Order proposed
the revocation of Respondent's DEA Certificate of Registration,
FB0181216, as a retail pharmacy, and the denial of any pending
application to renew or modify its registration, on the ground that
Respondent has committed acts which render its ``continued registration
inconsistent with the public interest.'' Show Cause Order at 1 (citing
21 U.S.C. 824(a)(4)).
The Show Cause Order alleged that Respondent was ``knowingly
engaging in a scheme to distribute controlled substances based on * * *
prescriptions that [were] issued for other than legitimate medical
purpose and by physicians acting outside [of] the usual course of
professional practice, in violation of * * * Federal and State law.''
Id. (citing 21 CFR 1306.04; United Prescriptions Servs., Inc., 72 FR
50397 (2007)). More specifically, the Show Cause Order alleged that
Respondent was ``dispensing controlled substances into states in which
it is not licensed to do so,'' and that it was ``aiding physicians in
the unauthorized practice of medicine in those states that require
physicians to be licensed by the state before prescribing controlled
substances to state residents.'' Id. at 2 (citing United, 72 FR 50407-
08). The Show Cause Order also alleged that Respondent had ``dispensed
large quantities of controlled substances based on prescriptions
purportedly written by Sheila Soman, M.D., a physician who was not
authorized by DEA to prescribe controlled substances.'' Id. Based on
the above, I further found that there was a ``substantial likelihood
that [Respondent
[[Page 19600]]
would] continue to divert large quantities of controlled substances,''
and concluded that Respondent's continued registration during the
pendency of the proceeding ``would constitute an imminent danger to the
public health and safety.'' Id. I therefore ordered that Respondent's
registration be immediately suspended.\1\ Id.
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\1\ The Show Cause Order also informed Respondent of its right
to request a hearing on the allegations; the date, time, and place
of the hearings; its right to submit a written statement in lieu of
a hearing; and the consequences if it failed to request a hearing.
Show Cause Order at 2.
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On August 20, 2008, a DEA Investigator personally served the Order
on Respondent. Since that time neither Respondent, nor anyone
purporting to represent it, has requested a hearing. Because more than
thirty days have elapsed since Respondent was served with the Order,
and Respondent has not requested a hearing, I conclude that Respondent
has waived its right to a hearing. 21 CFR 1301.43(d). I therefore enter
this Decision and Final Order based on relevant material contained in
the investigative file and make the following findings. Id. 1301.43(e).
Findings
Respondent is the holder of DEA Certificate of Registration,
FB0181216, which authorizes it to dispense, as a retail pharmacy,
controlled substances in schedules II through V, at the registered
location of 2860 Highway 17 N., Winter Haven, Florida 33881. Respondent
was first registered with the Agency on or about March 14, 2007; its
registration does not expire until July 31, 2009. Respondent is owned
by Mr. Robert L. Grable.
In August 2007, a DEA Investigator (DI) obtained a report which
indicated that between April 15 and June 28, 2007, Respondent had
purchased 767,900 dosage units of drugs containing hydrocodone, a
controlled substance highly popular with drug abusers. Moreover,
between June 28 and September 12, 2007, Respondent ordered a further
258,000 dosage units of hydrocodone from just one of its suppliers.
Subsequent reports further showed that between April 25 and December
28, 2007, Respondent had purchased 2.3 million dosage units of drugs
containing hydrocodone, or approximately 287,000 dosage units per
month. By way of contrast, I have previously found that the national
average purchase of combination hydrocodone drugs by retail pharmacies
is approximately 6,000 dosage units. See Southwood Pharmaceuticals,
Inc., 71 FR 36487, 36490 (2007).
On January 10, 2008, the DEA Nashville Diversion Group received a
letter from the compliance officer for Top Rx, Inc., a registered
distributor. The letter indicated that Respondent had applied to become
a customer of Top Rx and had completed a questionnaire on which it
indicated that it did not dispense controlled substances through the
internet. Top Rx's compliance office determined, however, that
Respondent may have been affiliated with a Web site which provided
illegal prescriptions for controlled substances.
Approximately a week later, the DI received information from the
New York Diversion Group that Respondent had ordered 700 grams of pure
hydrocodone powder (a schedule II controlled substance) from another
distributor. Finally, in a December 27, 2007 letter, a third
distributor identified Respondent as having placed excessive orders.
On June 27, 2008, two DIs visited Respondent. During the visit, the
DIs obtained prescriptions which had been issued by two physicians (one
based in Tampa, Florida; the other based in Deridder, Louisiana) which
had been issued to persons throughout the United States, and which were
dispensed by Respondent. Ninety-seven percent of the prescriptions were
for schedule III controlled substances containing hydrocodone and were
typically for ninety tablets; some of the remaining prescriptions were
for alprazolam, a schedule IV controlled substance.
On August 20, 2008, an Administrative Inspection Warrant was served
on Respondent. Pursuant to the search, the DIs obtained numerous
prescription records. According to the sworn declaration of a DI who
reviewed the records, between May 3, 2007, and the date that the
warrant was executed, Respondent had filled in excess of 38,000
prescriptions for controlled substances, the great majority of which
were for schedule III drugs containing hydrocodone.
The DI found that Respondent had filled more than 6,000
prescriptions issued by Dr. Celeste Lujan, who was authorized to
practice medicine and prescribe controlled substances only in Louisiana
and Texas. According to the DI, most of the prescriptions were issued
to persons who resided in States where Dr. Lujan was not authorized to
practice medicine including Alaska, Alabama, Arkansas, Arizona,
California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii,
Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine,
Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New
Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania,
Rhode Island, South Carolina, South Dakota, Utah, Virginia, Washington,
Wisconsin, West Virginia, and Wyoming.
The DI further found that between January 1 and August 18, 2008,
Respondent filled more than 3,000 prescriptions which were written
under the DEA registration issued to Dr. Sheila Soman of New York, NY.
Dr. Soman had, however, previously voluntarily surrendered her
registration; on December 17, 2007, the Agency retired her
registration.
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.'' Id. Moreover, case law establishes 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
(D.C. Cir. 2005). Finally, where the Government has made out its prima
facie case, the burden shifts to the Respondent to show why its
continued registration would be consistent with the public interest.
See, e.g., Theodore Neujahr, 65 FR 5680, 5682 (2000); Service Pharmacy,
Inc., 61 FR 10791, 10795 (1996).
[[Page 19601]]
In this case, having considered all of the factors, I conclude that
the Government's evidence with respect to factors two and four
establishes a prima facie case that Respondent's continued registration
is ``inconsistent with the public interest.'' 21 U.S.C. 823(f).
Accordingly, Respondent's registration will be revoked and any pending
applications for renewal of its registration will be denied.
Factor Two--Respondent's Experience in Dispensing Controlled Substances
Under DEA's 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 long 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.' '' Medicine Shoppe-
Jonesborough, 73 FR 363, 381 (2008) (quoting Medic-Aid Pharmacy, 55 FR
30043, 30044 (1990)), aff'd Medicine Shoppe-Jonesborough v. DEA, 2008
WL 4899525 (6th Cir. 2008); 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).\2\
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\2\ The Supreme Court has recently explained that ``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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In United Prescription Services, Inc., I further held that ``[a]
physician who engages in the unauthorized practice of medicine is not a
`practitioner acting in the usual course of * * * professional
practice.' '' 21 CFR 1306.04(a). This rule derives from the text of the
CSA, which defines ``[t]he term `practitioner' [to] mean[ ] a physician
* * * licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices * * * to * * *
dispense * * * a controlled substance.'' 21 U.S.C. 802(21). See also 21
U.S.C. 823(f) (``The Attorney General shall register practitioners * *
* to dispense * * * if the applicant is authorized to dispense * * *
controlled substances under the laws of the State in which he
practices.''). As the Supreme Court has explained: ``In the case of a
physician [the CSA] contemplates that he is authorized by the State to
practice medicine and to dispense drugs in connection with his
professional practice.'' United States v. Moore, 423 U.S. 122, 140-41
(1975) (emphasis added). A controlled-substance prescription issued by
a physician who lacks the license necessary to practice medicine within
a State is therefore unlawful under the CSA. Cf. 21 CFR 1306.03(a)(1)
(``A prescription for a controlled substance may be issued only by an
individual practitioner who is * * * [a]uthorized to prescribe
controlled substances by the jurisdiction in which he is licensed to
practice his profession[.]'').
Respondent had ample reason to know that the prescriptions issued
by Dr. Lujan were unlawful under both Federal and state law. As the
California Court of Appeal has noted: The ``proscription of the
unlicensed practice of medicine is neither an obscure nor an unusual
state prohibition of which ignorance can reasonably be claimed, and
certainly not by persons * * * who are licensed health care providers.
Nor can such persons reasonably claim ignorance of the fact that
authorization of a prescription pharmaceutical constitutes the practice
of medicine.'' Hageseth v. Superior Court, 59 Cal. Rptr. 3d 385, 403
(Ct. App. 2007); \3\ see Cal. Bus. & Prof. Code Sec. 2052 (prohibiting
unlicensed practice of medicine); Cal. Health & Safety Code Sec.
11352(a) (prohibiting furnishing a controlled substance ``unless upon
the written prescription of a physician * * * licensed to practice in
this state''). See also e.g., Ala. Code Sec. 34-24-501(a) (defining
practice of medicine across state lines); id. Sec. 34-24-502(a)
(requiring special purpose license to practice medicine across state
lines); Ga. Code Ann. Sec. 43-34.31.1(a) (defining practice of
medicine to include electronic prescribing by ``[a] person who is
physically located in another state'' and requiring Georgia license);
225 Ill. Comp. Stat. Ann. Sec. 60/3 (licensure requirement); id. Sec.
60/3.5 (prohibiting unlicensed practice); id. Sec. 60/49 (listing acts
constituting holding oneself out to the public as a physician); id.
Sec. 60/49.5 (requiring persons engaged in telemedicine to hold
Illinois license); N.H. Rev. Stat. Sec. 329:1 (defining practice of
medicine); id. Sec. 329:24 (unlicensed practice).
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\3\ In Hageseth, the California Court of Appeal upheld the
State's jurisdiction to criminally prosecute an out-of-state
physician, who prescribed a drug to a California resident over the
internet, for the unauthorized practice of medicine.
Moreover, the Medical Board of California has issued numerous
Citation Orders to out-of-state physicians for internet prescribing
to state residents. See, e.g., Citation Order Harry Hoff (June 17,
2003); Citation Order Carlos Gustavo Levy (Nov. 30, 2001). It has
also issued press releases announcing its position on the issuance
of prescriptions by physicians who do not hold a California license.
See Medical Board of California, Record Fines Issued by Medical
Board to Physicians in Internet Prescribing Cases (News Release,
Feb. 10, 2003) (available at http://www.mbc.ca.gov/NR_2003_02-10_Internetdrugs.htm).
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As I have previously explained, an entity which voluntary engages
in commerce by shipping controlled substances to persons located in
other States is properly charged with knowledge of the laws regarding
both the practice of medicine and pharmacy in those States. United, 72
FR at 50408. In short, given that Dr. Lujan was licensed to practice
medicine and prescribe in only Louisiana and Texas, and yet was
prescribing to persons who did not reside in those States and lived
hundreds of--and in many instances more than a thousand--miles away,
Respondent had ample reason to know that the prescriptions were
unlawful under both the CSA and the laws of numerous States. See id. at
50409.
Moreover, under DEA regulations, a prescription for a controlled
substance can be issued only by a practitioner who holds a registration
with the Agency. 21 CFR 1306.03(a) (``A prescription for a controlled
substance may be issued only by an individual practitioner who is * * *
registered.'').\4\ Respondent thus also violated the CSA when it filled
more than 3,000 prescriptions which were purportedly issued by Dr.
Soman, a physician who had previously voluntarily surrendered her
registration.
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\4\ It is unclear whether the prescriptions issued under Dr.
Soman's expired registration were actually issued by her. What is
clear is that no prescription could be lawfully issued (or filled)
under her registration number.
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[[Page 19602]]
As the foregoing demonstrates, Respondent's experience in
dispensing controlled substances is characterized by its repeated and
flagrant violations of the CSA and state laws. Indeed, within less than
one month of obtaining its registration, Respondent proceeded to
purchase hundreds of thousands of dosage units of hydrocodone,
quantities which exceeded by nearly fifty times the average purchase of
this drug by legitimate pharmacies. As this evidence shows, Respondent
was engaged in a criminal scheme to divert controlled substances.
I therefore hold that Respondent's continued registration is
``inconsistent with the public interest'' and that its registration
should be revoked. 21 U.S.C. 823(f). For the same reasons that I
ordered the immediate suspension of Respondent's registration, I
further hold that this Order shall be effective immediately.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate of Registration, FB0181216, issued to Bob's Pharmacy and
Diabetic Supplies be, and it hereby is, revoked. I further order that
any pending applications for renewal or modification of such
registration be, and they hereby are, denied. This Order is effective
immediately.
Dated: April 3, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-9797 Filed 4-28-09; 8:45 am]
BILLING CODE 4410-09-P