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Bourne Pharmacy, Inc.; Revocation of Registration
FR Doc E7-6760 [Federal Register: April 11, 2007 (Volume 72, Number 69)]
[Notices] [Page 18273-18274] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ap07-121]
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]
BILLING CODE 4410-09-P
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