Lincoln Pharmacy; Revocation of Registration, 65667-65668 [2010-27026]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 75, Number 206 (Tuesday, October 26, 2010)]
[Notices]
[Pages 65667-65668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27026]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Lincoln Pharmacy; Revocation of Registration

    On March 26, 2010, I, the Deputy Administrator of the Drug 
Enforcement Administration, issued an Order to Show Cause and Immediate 
Suspension of Registration (Order) to Lincoln Pharmacy (Respondent), of 
Edison, New Jersey. The Order proposed the revocation of Respondent's 
DEA Certificate of Registration, BL4082222, and the denial of any 
pending applications to renew or modify its registration, on the ground 
that Respondent's ``continued registration is inconsistent with the 
public interest.'' Order at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)).
    The Order alleged that Respondent ``routinely filled fraudulent 
prescriptions for highly addictive and abused controlled substances'' 
and therefore violated 21 U.S.C. 841(a)(1) and 21 CFR 1306.04. Id. More 
specifically, the Order alleged that Respondent had filled six 
fraudulent prescriptions for Roxicodone and oxycodone, which are 
schedule II controlled substances, in exchange for cash on multiple 
occasions to wit: (1) On January 14, 2010, it filled three 
prescriptions totaling 540 dosage units of Roxicodone (30 mg.) for $975 
in cash; (2) on January 21, 2010, it filled one prescription totaling 
120 dosage units of oxycodone (30 mg.) for $215 in cash; and (3) on 
January 28, 2010, it filled two prescriptions totaling 360 tablets of 
oxycodone for $650 in cash. Id. at 1-2.
    Based on the above, I concluded that Respondent's ``continued 
registration during the pendency of these proceedings would constitute 
an imminent danger to the public health and safety.'' Id. at 2. I 
therefore exercised my authority under 21 U.S.C. 824(d) and immediately 
suspended Respondent's registration. Id.
    On April 6, 2010, the Order, which also notified Respondent of its 
right to request a hearing on the allegations or to submit a written 
statement in lieu of a hearing, the procedures for doing so, and the 
consequence of failing to do so, was served on it. Id. at 2-3 (citing 
21 CFR 1301.43(a), (c), (d) & (e)). Since that time, neither 
Respondent, nor anyone purporting to represent it, has either 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 
conclude that Respondent 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 retail pharmacy located at 52 Lincoln Highway, 
Edison, New Jersey, which is owned and operated by Mr. Vincent Hsia, a 
registered pharmacist. Respondent is the holder of Certificate of 
Registration, BL4082222, which authorizes it to dispense controlled 
substances in schedules II through V as a retail pharmacy. Respondent's 
registration does not expire until March 31, 2012.
    On January 14, 2010, at shortly after 7 p.m., a cooperating source 
(CS) went to Respondent and presented three prescriptions to Mr. Hsia. 
Each of the prescriptions was for 180 tablets of Roxicodone (oxycodone) 
30 mg., contained dosing instructions, stated ``chronic intractable 
pain,'' and was signed. While it is unclear whether the prescriptions 
the CS presented contained a patient name, the evidence which includes 
three cash-register receipts, the vials and the drugs, shows that at 
approximately 7:17 through 7:22 p.m., Hsia delivered the three vials, 
each containing 180 tablets of Roxicodone 30 mg. (for a total of 540 
tablets), to the CS and charged him $325 in cash for each vial for a 
total of $975. The prescriptions listed the patients as Chris DiMarco 
of Clark, NJ; Rudy Lore, also purportedly of Clark; and Paul Smith of 
Rahway, NJ.
    On January 21, 2010, at 7:45 p.m., the CS returned to Respondent 
and presented a prescription for 180 tablets of oxycodone 30 mg. This 
prescription listed the patient as Michael Williams of Newark, NJ. 
According to the transcript of a recording of the CS's conversation 
with Mr. Hsia, at one point the CS asked: ``Quick questions. Since I'm 
moving [expletive deleted] moving these things really fast, is there 
any way you could write for more than 180? There isn't, right?'' Hsia 
replied: ``I don't really even like filling for 180.'' The CS then 
mentioned that an associate had told him that ``you could get 240 all 
the time or somethin[g].'' Hsia replied: ``I can't even give you 180. I 
have to give you 120. Cause it doesn't say chronic intractable pain.'' 
Hsia subsequently distributed 120 tablets of oxycodone 30 mg. to the 
CS.
    On January 27, 2010, the CS called Hsia to ask him what phrase 
needed to be on the prescription to justify dispensing the larger 
quantity. Hsia told him ``chronic intractable pain.'' The following 
day, the CS returned to Respondent and presented two more prescriptions 
for 180 tablets of oxycodone 30 mg. which appear to have included the 
notation of ``chronic intractable pain.'' One of the prescriptions 
listed the patient as Paul Fusatola of Belleville, NJ; the other as 
Rachel Billis of Nutley, NJ. The CS paid $325 in cash for each 
prescription and Hsia distributed two vials, each containing 180 
tablets of oxycodone 30 mg., to the CS.

Discussion

    Section 304(a) of the Controlled Substances 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)(4). In determining the public interest in the case of a 
practitioner, 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.

[[Page 65668]]

    (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 (D.C. 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 any pending 
applications 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).\1\
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    \1\ 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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    The evidence here shows that on multiple occasions, Respondent 
violated Federal law by dispensing prescriptions for oxycodone 30 mg., 
a schedule II controlled substance (see 21 CFR 1308.12(b)), which Mr. 
Hsia, its owner and pharmacist in charge, knew were not ``issued for a 
legitimate medical purpose'' by a ``practitioner acting in the usual 
course of his professional practice.'' Id. 1306.04(a); see also 21 
U.S.C. 841(a)(1) (``Except as authorized by this subchapter, it shall 
be unlawful for any persons knowingly or intentionally * * * to 
distribute[] or dispense * * * a controlled substance.'').
    More specifically, the evidence shows that on January 14, 2010, a 
CS simultaneously presented three prescriptions, each for 180 tablets 
of Roxicodone (oxycodone) 30 mg., to Hsia. Hsia then proceeded to fill 
the prescriptions and distributed the drugs to the CS from whom he 
received $975 in cash. Hsia clearly knew that the prescriptions were 
unlawful as the CS presented all three prescriptions (all of which for 
the same drug and quantity) at the same time and Hsia used three 
different patient names (Chris DeMarco, Rudy Lore and Paul Smith) on 
the prescription labels so as to hide the fact (in the event he was 
inspected) that he had distributed the drugs to a single person. In 
short, Hsia knowingly engaged in a drug deal. 21 U.S.C. Sec.  
841(a)(1).
    The evidence further shows that on January 21, 2010, Hsia again 
unlawfully distributed 120 tablets of oxycodone 30 mg. to the CS in 
exchange for $215 in cash. Moreover, at the time the CS presented the 
prescription (which was in the name of Michael Williams) to Hsia, the 
CS told Hsia that he was re-selling the drugs, explaining that they 
were ``moving these things really fast'' and asked if he could get more 
than 180 tablets. While on this occasion Hsia only distributed 120 
tablets to the CS (apparently because the prescription did not state 
``chronic intractable pain''), he clearly knew that the CS was seeking 
the drugs for an illegal purpose and not to treat a legitimate medical 
condition. Hsia thus again violated 21 U.S.C. Sec.  841(a)(1).
    Finally, on January 28, 2010, the CS presented two more 
prescriptions to Hsia; the prescriptions listed two different persons 
(Paul Fusatola and Rachel Billis) as the patients. Each prescription 
was for 180 tablets of oxycodone 30 mg. and indicated that it was for 
``chronic intractable pain.'' Hsia again distributed both prescriptions 
to the CS from whom he received $650 in cash, knowing that the CS was 
seeking the drugs for an illegal purpose. Hsia thus committed two 
additional violations of the CSA by unlawfully distributing controlled 
substances in violation of 21 U.S.C. Sec.  841(a)(1).
    As the forgoing demonstrates, Respondent's owner Mr. Hsia has used 
its registration to engage in blatant drug dealing. I therefore hold 
that Respondent has committed multiple 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 
any pending application will be denied. For the same reasons that I 
immediately suspended Respondent's registration, I conclude that public 
interest requires that this Order 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, BL4082222, issued to Lincoln Pharmacy, be, 
and it hereby is, revoked. I further order that any pending application 
of Lincoln Pharmacy for renewal or modification of its registration be, 
and it hereby is, denied. This Order is effective immediately.

    Dated: October 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-27026 Filed 10-25-10; 8:45 am]
BILLING CODE 4410-09-P