[Federal Register Volume 72, Number 69 (Wednesday, April 11, 2007)]
[Notices]
[Pages 18273-18274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6760]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 06-68]


Bourne Pharmacy, Inc.; Revocation of Registration

    On July 26, 2006, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Bourne Pharmacy, Inc., (Respondent) of Buzzards Bay, 
Massachusetts. The Show Cause Order proposed the revocation of 
Respondent's DEA Certificate of Registration, AB2802468, as a retail 
pharmacy, and to deny any pending applications for renewal or 
modification of the registration, on the ground that Respondent's 
continued registration would be inconsistent with the public interest. 
Show Cause Order at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)).
    The Show Cause Order alleged that on September 21, 2005, 
investigators from DEA and the Massachusetts Board of Pharmacy had 
executed an administrative inspection warrant at Respondent and found 
it to be in violation of various federal regulations. See id. at 2. 
Specifically, the Show Cause Order alleged that: (1) Respondent had 
failed to maintain a biennial inventory as required by 21 CFR 
1304.11(c) and 1304.21, (2) had failed to maintain drug destruction 
records as required by 21 CFR 1304.21(a), (3) was storing controlled 
substances at a non-registered location in violation of 21 CFR 1304.04, 
and (4) was improperly storing order forms for Schedule II controlled 
substances. Show Cause Order at 2.
    The Show Cause Order further alleged that on August 22, 2005, Dr. 
Michael Brown, a Massachusetts based physician, was arrested and 
charged with various drug offenses under state law, including 
conspiracy to violate drug laws and possession of various categories of 
controlled substances with the intent to distribute. See id. at 2. 
According to the Show Cause Order, investigators further determined 
that during the calendar year 2005, forty-five percent of the 
prescriptions for Schedule II controlled substances filled by 
Respondent were written by Dr. Brown; in the month of April 2005 alone, 
92 of 168 Schedule II prescriptions filled by Respondent were written 
by Dr. Brown. Id. at 2-3.
    Finally, the Show Cause Order alleged that on October 25, 2005, the 
Massachusetts Board of Pharmacy had issued a ``Final Order of Summary 
Suspension,'' which suspended Respondent's state pharmacy permit and 
controlled substance registration, and that these suspensions remain in 
effect. Id. at 3. The Show Cause Order thus alleged that Respondent 
lacked authority under state law to handle controlled substances and 
that this authority is ``a necessary prerequisite for DEA 
registration.'' Id.
    Respondent, through its counsel, requested a hearing; the matter 
was assigned to Administrative Law Judge (ALJ) Mary Ellen Bittner. 
Shortly thereafter, the Government moved for summary disposition on the 
ground that the Massachusetts Board of Pharmacy had issued a Final 
Order of Summary Suspension against Respondent's state pharmacy permit 
and the pharmacist's license of its owner (Mr. Gerald Liberfarb) and 
pharmacist in charge. Mot. for Summ. Disp. at 2. Attached to the 
Government's motion was the State's summary suspension order, as well 
as a copy of Respondent's DEA registration (which does not expire until 
July 31, 2008). See Attachments 1 & 2 to Mot. for Summ. Disp.
    Respondent opposed the Government's motion. Respondent contended 
that ``on October 24, 2005, [it] had already voluntarily surrendered 
its [state] registered drug store certificate'' and controlled 
substance registration to the Massachusetts Department of Public 
Health, ``to be held in escrow pending a hearing on the merits to be 
held * * * before the Board of Registration in Pharmacy.'' Resp. Opp. 
at 1. Respondent also argued that the Massachusetts Board ``has never 
implemented or executed the Final Order of Summary Suspension,'' and 
that it has meritorious defenses to the DEA Show Cause Order. Id. 
Finally, Respondent contended that it was ``both premature and unduly 
prejudicial to act upon the Government's Motion * * * until after [the] 
state agency'' held its hearing and made a decision. Id. at 2.
    In support of its contention, Respondent's counsel attached a 
letter he had written to an attorney for the State Board memorializing 
the fact that Respondent had delivered its state registration and 
certificates to be held by the State ``in escrow until a final decision 
is issued on the merits.'' Ex. 1 to Resp. Opp. Respondent also attached 
other documents including a ``Notice of Fourth Rescheduled Hearing,'' 
Ex. 2 to

[[Page 18274]]

Resp. Opp., and a ``Rescheduled Second Pre-Hearing Conference Order.'' 
Ex. 3 to Resp. Opp.
    The ALJ granted the Government's motion. The ALJ found that there 
was no material factual dispute regarding whether Respondent currently 
has authority under Massachusetts law to handle controlled substances. 
ALJ Dec. at 3. The ALJ specifically rejected Respondent's contention 
that its state controlled substance registration had not been 
suspended, but rather, was being held in escrow by the Massachusetts 
Board pending a final decision. Id. Relatedly, the ALJ also dismissed 
Respondent's argument that the State never implemented the summary 
suspension order, reasoning that ``whether the license is suspended 
pending a hearing on the merits, or is held in escrow,'' is irrelevant, 
because ``[i]n either event, Respondent is without authority to handle 
controlled substances in Massachusetts.'' Id. The ALJ thus held that 
Respondent is not entitled to maintain its DEA registration and 
recommended that I revoke Respondent's registration. The ALJ then 
forwarded the record to me for final agency action.
    Having considered the record as a whole, I adopt the ALJ's holding 
that Respondent is currently without authority to handle controlled 
substances in Massachusetts and is therefore not entitled to maintain 
its DEA registration. Here, the State's ``Final Order of Summary 
Suspension,'' which is signed by the Board's President, clearly ordered 
the suspension, effective October 23, 2005, of Respondent's state 
controlled substance registration ``pending a final decision on the 
merits.''
    Respondent's assertion that the State ``has never executed or 
implemented the Final Order of Summary Suspension'' does not raise a 
genuine issue of fact that requires a hearing to resolve. Respondent's 
evidence--i.e., a letter to the Board's lawyer discussing an agreement 
to surrender its state registration to be held in escrow pending a 
final decision--does not create a factual dispute as to whether 
Respondent's state registration has been suspended. As a leading 
authority explains, ``evidence in opposition to the motion that is 
clearly without any force is insufficient to raise a genuine issue.'' 
Charles Allen Wright, et al., Federal Practice and Procedure section 
2727 (3d. ed. 2006).\1\ In short, this letter contains nothing that 
refutes the Government's assertion that Respondent's state controlled 
substance registration has been suspended.
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    \1\ Respondent's other evidence likewise does not create a 
factual dispute as to whether its state controlled substance 
registration has been suspended.
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    Under the Controlled Substances Act (CSA), it is irrelevant that 
Respondent's state registration is being held in escrow pending state 
proceedings. Under the Act, a practitioner must be currently authorized 
to handle controlled substances in ``the jurisdiction in which [it] 
practices'' in order to maintain its DEA registration. See 21 U.S.C. 
802(21) (``[t]he term `practitioner' means a * * * pharmacy * * * 
licensed, registered, or otherwise permitted, by * * * the jurisdiction 
in which [it] practices * * * to * * * dispense * * * a controlled 
substance in the course of professional practice''). See also id. 
section 823(f) (``The Attorney General shall register practitioners * * 
* if the applicant is authorized to dispense * * * controlled 
substances under the laws of the State in which [it] practices.'').
    Furthermore, in section 304, Congress expressly authorized the 
revocation of a DEA registration issued to a registrant whose ``State 
license or registration [has been] suspended * * * by competent State 
authority and is no longer authorized by State law to engage in the * * 
* dispensing of controlled substances.'' Id. section 824(a)(3). By 
definition, a suspension is of a finite duration. See Merriam-Webster's 
Collegiate Dictionary 1187 (10th ed. 1998) (defining ``suspend'' as 
``to debar temporarily from a privilege * * * or function''). Under the 
CSA, it does not matter whether the suspension is for a fixed term or 
for a duration which has yet to be determined because it is continuing 
pending the outcome of a state proceeding. Rather, what matters--as DEA 
has repeatedly held--is whether Respondent is without authority under 
Massachusetts law to dispense a controlled substance. See Oakland 
Medical Pharmacy, 71 FR 50100, 50,102 (2006) (``a registrant may not 
hold a DEA registration if it is without appropriate authority under 
the laws of the state in which it does business''); Accord Rx Network 
of South Florida, LLC, 69 FR 62,093 (2004); Wingfield Drugs, Inc., 52 
FR 27,070 (1987).
    Because the State suspended its controlled substances registration, 
Respondent clearly lacks authority under Massachusetts law to handle 
controlled substances. Therefore, it is not entitled to maintain its 
DEA registration.

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) and 0.104, I hereby order that DEA 
Certificate of Registration, AB2802468, issued to Bourne Pharmacy, 
Inc., 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 May 11, 2007.

    Dated: March 30, 2007.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E7-6760 Filed 4-10-07; 8:45 am]
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