[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