[Federal Register Volume 74, Number 44 (Monday, March 9, 2009)]
[Notices]
[Pages 10073-10076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4909]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Meetinghouse Community Pharmacy, Inc.; Affirmance of Suspension
Order
On October 31, 2008, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Meetinghouse Community Pharmacy, Inc.
(Respondent), of Dorchester, Massachusetts. The Order proposed the
revocation of Respondent's DEA Certificate of Registration, BM3972747,
which authorized it to dispense controlled substances in schedules II
through IV as a retail pharmacy, and the denial of any pending
application to renew or modify the registration on the ground that its
``continued registration is 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 Respondent was distributing ``a
large volume of controlled substances pursuant to * * * prescriptions
that it knows, or should know, [were] issued by practitioners not
acting in the usual course of professional practice or that [were]
issued for other than a legitimate medical purpose in violation of 21
CFR 1306.04(a).'' Id. The Order specifically alleged that Respondent
was filling controlled-substance prescriptions issued by physicians who
were not licensed in the States where Respondent's customers were
located and thus lacked authority to prescribe to them and violated
both State and Federal law. Id. at 1-2. (citing United Prescription
Servs., Inc., 72 FR 50397 (2007)).
Based on the above, I further concluded that Respondent's continued
registration during the pendency of this proceeding would ``constitute
an imminent danger to the public health and safety.'' Id. at 2 (citing
21 U.S.C. 824(d)). I therefore ordered the immediate suspension of
Respondent's registration.\1\ Id. at 2 (citing 21 U.S.C. 824(d)).
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\1\ I further ordered that the controlled substances in
Respondent's possession be either placed under seal or removed for
safekeeping. The Order further informed Respondent of its right to
request a hearing on the allegations; gave the date, time and place
of the hearing; explained the procedure for requesting a hearing or
to submit a written statement of position in lieu of a hearing; and
explained the consequences if Respondent failed to request a
hearing. Show Cause Order at 2-3.
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On November 1, 2008, the Order was served on Respondent. Since
then, neither Respondent's owner, nor anyone else purporting to
represent it, has requested a hearing on its behalf. Because more than
thirty days have passed since service of the Order, and the Agency has
not received a request for 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.
Findings
In 1994, Respondent was first registered with the Agency.
Respondent held DEA Certificate of Registration, BM3972747, which
authorized it to dispense controlled substances in schedules II through
IV as a retail pharmacy at the registered location of 248 Bowdoin St.,
Dorchester, Massachusetts. Respondent's registration expired, however,
on January 31, 2009, and it has not filed a renewal application.
Respondent is owned and managed by Baldwin Ihenacho. Mr. Ihenacho
held a Massachusetts pharmacist license, which was suspended on
November 1, 2008, and which expired on December 31, 2008. Respondent
holds both a Massachusetts Retail Drug Store Permit and a Massachusetts
Controlled Substances License, both of which do not expire until
December 31, 2009. These licenses were, however, suspended on November
1 and 6, 2008, respectively.
On November 1, 2008, law enforcement authorities executed a search
warrant and served the Immediate Suspension Order on Respondent. During
the search, the authorities also arrested Mr. Ihenacho. Mr. Ihenacho
was taken to a unit of the Boston Police Department. After being given
the Miranda warnings, Mr. Ihenacho agreed to an interview.
During the interview, Mr. Ihenacho stated that several years
earlier he had received a fax from Jack, an individual in the Dominican
Republic who solicited him to fill prescriptions which were being
issued through Web sites. Ihenacho called Jack and entered into an oral
agreement with him under which he was paid a dispensing fee of $5.75
for each prescription Respondent filled.\2\ Mr. Ihenacho stated that at
one point he was receiving approximately 100 prescriptions a day from
Jack and had to tell him that he could not fill that many scripts
because it was interfering with his local business. According to Mr.
Ihenacho, he received approximately $100,000 for filling the
prescriptions from Jack and was owed an additional $145,000.
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\2\ The Web site operator also reimbursed Respondent for the
cost of the drugs.
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According to Mr. Ihenacho, the customers would either go to a Web
site or call the company to order a drug and provide their medical
history. The company would then provide the customer's purported
medical history to a physician, who would decide whether to issue a
prescription. The approved prescriptions would then be entered into a
zip file and sent electronically to his pharmacy. Most of the
controlled-substance prescriptions were for phentermine and alprazolam,
which are schedule IV controlled substances. See 21 CFR 1308.14.
Mr. Ihenacho stated that he did not fill Internet prescriptions for
customers who lived in Massachusetts. Mr. Ihenacho asserted that there
were some States he did not ship to, and that an employee with the
Massachusetts Board of Pharmacy had told him that some States
prohibited the shipments.
When asked if he was concerned about the prescriptions being issued
by doctors to patients who lived in different States, Mr. Ihenacho
answered that he was concerned, but maintained that he had asked the
doctors about the prescriptions and they were convincing. According to
Mr. Ihenacho, when he would call a doctor, the doctor would tell him
that he had been talking to the patient for years so he filled the
prescriptions.
Mr. Ihenacho further stated that he had visited Jack at his office
in the Dominican Republic, and had been introduced to Jack's cousin.
The cousin told Mr. Ihenacho that he wanted to start his own Internet
pharmacy business; Mr. Ihenacho started filling prescriptions for the
cousin as well. According to Mr. Ihenacho, the cousin had paid him
approximately $100,000 for a one-year period and owed him another
$40,000. Mr. Ihenacho also told investigators that he had filled
prescriptions for the owners of several other Internet schemes, two of
whom paid him a fee of $10,000 a week. Moreover, at the time of his
arrest, Mr. Ihenacho stated that he was currently filling approximately
150 Internet prescriptions per day; he also claimed
[[Page 10074]]
that the majority of his business was for non-controlled drugs.
Investigators determined that Respondent was shipping 4,000 to
5,000 prescriptions a month to customers located in approximately 46
States. The Investigators also obtained several e-mails which Mr.
Ihenacho had sent to Jack. In an e-mail sent on September 29, 2006, Mr.
Ihenacho wrote:
Now, my concerns. I want to do business with you and I want to
do it the right way. As a pharmacist trained here in the USA, I know
that the Federal USA law concerning the prescribing of controlled
substances by any doctor requires that the doctor be licensed and
registered in any state where that doctor wants to practice. My
observation so far is that it is only one doctor who is writing for
everything for every patient, no matter which state the patient is
located [in]. Could it be that this doctor is registered in all USA
states? Please clarify this to me and if so, I would like to see
such a blanket registration and license of the doctor.
The following week, Mr. Ihenacho reiterated his concern. In an
October 5, 2006 e-mail to Jack, Mr. Ihenacho:
You did not send me any information as to which states that we
cannot ship to. Please furnish me with this information ASAP so that
we can be more careful here. If I ship to any state that I am not
supposed to, it might cost me my license. * * * Also, I really need
to speak with the Doctor directly. * * * I must have to speak with
him so that I can make sure that every thing is alright with his
prescribing abilities in the states that he is prescribing. This is
very important.
Five months later, the issue apparently had still not been
resolved. In a March 8, 2007 e-mail, Mr. Ihenacho wrote:
Again, you have not addressed all of the issue[s] that I raised
in my letter to you. * * * Do you understand how much trouble that I
will be in if and when the DEA comes to me? I don't think that you
understand, making money is good but I believe that it must be made
in a good and honest manner with great respect to the law. I do have
an issue with the doctors who are writing for your clients.
Yesterday, you said something about hiring some nurses to get
involved in screening patients and that you will have qualified
doctors to work with them to make sure that anyone who calls in for
any diet pill or a sedative hypnotic such as Diazepam, clonazepam,
lorazepam, etc[.,] does indeed need them. If you can establish a
good relationship between the patient and the doctor through hiring
nurses who actually go to these patient[']s homes to see them, then
I believe that is legal because the nurse will report to the doctor
wh[a]t he or she feels about the patient[']s request for the
medication. * * * I do not feel very comfortable at all feeling
[sic] medications where I know that there is really no doctor/
patient[] interaction. I have tried to get at least one patient
profile, but so far, I have not ben [sic] able to get one. I need to
have a documented history of the patients and doctors conversations
that warrants them to receive these medications through pharmacies
such as mine.
Notwithstanding the concerns he expressed in these e-mails,
Respondent proceeded to dispense controlled-substance prescriptions
which were written by doctors who were located in different States than
where the ``patients'' resided. For example, the investigative file
indicates that Respondent dispensed numerous prescriptions issued by
Dr. Onochie Aghaegbuna, a physician who was licensed in Virginia,\3\ to
patients in other States where he was not licensed. These include
prescriptions for phendimetrazine, a schedule III stimulant, which were
written for residents of Honolulu, Hawaii, and Sewell, New Jersey, as
well as residents of Pasadena and Placerville, California. Respondent
also dispensed prescriptions for alprazolam issued by Dr. Aghaegbuna to
residents of Woodbridge, New Jersey, and Fort Worth, Texas, and
prescriptions for phentermine 37.5 mg. to residents of Myrtle Beach,
South Carolina, and West Babylon, New York.
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\3\ On March 31, 2008, Dr. Aghaegbuna entered into a consent
order with the Virginia Board of Medicine under which the Board
found that he had prescribed without establishing valid-doctor
relationships and Dr. Aghaegbuna surrendered his State license.
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As part of the various Internet prescribing schemes, Respondent
also filled the prescriptions issued by other physicians. For example,
Dr. Lynnea N. Burr of San Antonio, Texas, issued a prescription for
phendimetrazine to a resident of Glencoe, Illinois; a prescription for
diazepam 10 mg., to a resident of St. Louis Park, Minnesota; a
prescription for phentermine 37.5 mg., to residents of St. Louis,
Missouri; Portsmouth, New Hampshire, South Park, Pennsylvania; Bernice,
Oklahoma; and Dearborn, Michigan; and prescriptions for alprazolam 2
mg., to residents of Shelton, Connecticut and Morrisville,
Pennsylvania.
Discussion
Section 304(a) of the Controlled Substance Act (CSA) 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, the CSA directs that the
following factors be considered:
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\4\ Section 304(d) further provides that ``[t]he Attorney
General may, in his discretion, suspend any registration
simultaneously with the institution of proceedings under this
section, in cases where he finds that there is an imminent danger to
the public health or safety.'' 21 U.S.C. 824(d).
(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. 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'' is consistent with
the public interest and whether a registrant has committed acts which
warranted the suspension of his/her registration. Id. Moreover, 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).
As explained below, the investigative file amply demonstrates that
Respondent's experience in dispensing controlled substances and
compliance record is characterized by its repeated filling of unlawful
prescriptions under both Federal and State laws. Moreover, I further
note that the State of Massachusetts has suspended Respondent's
pharmacy license and controlled substances registration.\5\
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\5\ While Respondent's DEA registration expired on January 31,
2009, and there is no evidence that Respondent has filed a renewal
application, I conclude that this case is not moot. This case began
with an immediate suspension, Respondent has not surrendered its
state licenses, and there is no evidence that Respondent has gone
out of business. See William Lockridge, 77791, 77797 (2006) (noting
case is not moot where order creates collateral consequences or
where conduct is capable of repetition yet evading review); RX
Direct Pharmacy, Inc., 72 FR 54070 (2007). Furthermore, in executing
the Suspension Order, Respondent's controlled substances were
seized. Under 21 U.S.C. 824(f), ``upon a revocation order becoming
final,'' any controlled substances which were seized ``shall be
forfeited to the United States,'' and ``[a]ll right, title, and
interest in [the] controlled substances * * * shall vest in the
United States.'' As I have previously recognized, a litigant cannot
defeat the effect of this provision by simply allowing its
registration to expire. Moreover, it is unclear whether Respondent
has been indicted, and if so, whether forfeiture of the controlled
substances has been sought in that proceeding. I thus conclude that
this case remains a live controversy.
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[[Page 10075]]
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Laws
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).\6\
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\6\ 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 the ``[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[.]'').
As found above, Respondent's owner knew that the Internet
prescriptions he filled were unlawful. Indeed, as Mr. Ihenacho wrote in
an e-mail to the owner of one of the schemes: ``As a pharmacist trained
here in the USA, I know that the Federal USA law concerning the
prescribing of controlled substances by any doctor requires that the
doctor be licensed and registered in any state where that doctor wants
to practice. * * * My observation * * * is that it is only one doctor
who is writing for everything for every patient, no matter [where] the
patient is located.'' Moreover, in a further e-mail, Mr. Ihenacho wrote
that he needed to speak with the doctor who was prescribing in Jack's
scheme so he could ``make sure that every thing is alright with his
prescribing abilities in the state that he is prescribing.''
Mr. Ihenacho was thus well aware of the legal requirements for a
valid prescription. In any event, state prohibitions against the
unlicensed practice of medicine are a common feature of the regulation
of medical practice, and those who practice the profession of pharmacy
are obligated to know these rules.\7\ See, e.g., Cal. Bus. & Prof. Code
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''); Haw. Rev. Stat. 453-1 (defining
practice of medicine); id. 453-2 (requiring license to practice); 225
Ill. Comp. Stat. Ann. 60/3 (licensure requirement); id. 60/3.5
(prohibiting unlicensed practice); id. 60/49 (listing acts constituting
holding oneself out to the public as a physician); id. 60/49.5
(requiring persons engaged in telemedicine to hold Illinois license);
Mich. Comp. Laws 333.17001 (defining practice of medicine), id.
17011(1) (requiring license to practice); id. 333.7303 (requiring
controlled substance registration to dispense); N.H. Rev. Stat. Ann.
329:1 (defining practice of medicine); id. 329:24 (unlicensed
practice); Tex. Occ. Code 155.001; see also id. 151.056(a) (``A person
who is physically located in another jurisdiction but who, through the
use of any medium, including an electronic medium, performs an act that
is part of a patient care service initiated in this state, * * * and
that would affect the diagnosis or treatment of the patient, is
considered to be engaged in the practice of medicine in this state and
is subject to appropriate regulations by the board.''); 22 Tex. Admin.
Code 174.4(c) (``Physicians who treat and prescribe through the
Internet are practicing medicine and must possess appropriate licensure
in all jurisdictions where patients reside.''); Tex. Health & Safety
Code 481.061(a) (requiring state registration to dispense controlled
substance); id. 481.063(d) (requiring as a condition for registration
that ``a
[[Page 10076]]
practitioner [be] licensed under the laws of this State'').
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\7\ Even if there was no direct evidence of Mr. Ihenacho's
knowledge, I would still hold that he had reason to know the
prescriptions were illegal. 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).
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 voluntarily 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. Aghaegbuna was licensed to
practice medicine in Virginia, and yet was prescribing to persons who
did not reside in that State and who frequently lived hundreds of--and
in many instances more than a thousand--miles away,\8\ 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.\9\
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\8\ In particular, I rely on the prescriptions Dr. Aghaegbuna
issued to residents of California, Hawaii, and Texas. In preparing
this Order, I have visited the Web sites of the medical licensing
authorities of these States and verified that Dr. Aghaegbuna was not
licensed by them.
I have also visited the Web sites of the respective State
authorities of Illinois, Michigan, and New Hampshire, and determined
that Dr. Burr was not licensed in these States. Respondent
nonetheless dispensed prescriptions issued by Dr. Burr for residents
of these States in violation of state and Federal laws.
\9\ Respondent also had ample reason to know that prescriptions
were unlawful because he knew that the prescribers were not
physically examining the patients. As Mr. Ihenacho wrote in a March
8, 2007 e-mail, ``I do not feel very comfortable at all feeling
[sic] medications where I know that there is really no doctor/
patient interaction.'' Indeed, under numerous State medical practice
standards, with only limited exceptions, a physician must take a
medical history and physically examine a patient in order to
properly diagnose the patient and recommend treatment options
including prescribing a drug. See, e.g., N.J. Admin. Code 13:35-
7.1A(a); S.C. Code Regs. 81-28.
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As the forgoing demonstrates, Respondent knowingly violated Federal
law in dispensing thousands of prescriptions which lacked a legitimated
purpose and were issued by practitioners acting outside of the usual
course of professional practice. 21 CFR 1306.04(a). Respondent's
experience in dispensing controlled substances is thus characterized by
its repeated and flagrant violations of both the CSA and State laws;
the scope of its illegal dispensings clearly establish that its
continued registration was ``inconsistent with the public interest,''
and posed ``an imminent danger to the public health or safety'' which
warranted the immediate suspension of its registration.\10\ 21 U.S.C.
824(a) & (d).
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\10\ To make clear, I would have revoked Respondent's
registration had it not expired prior to the issuance of this Order.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 824, as well as
28 CFR 0.100(b) & 0.104, I affirm my order which immediately suspended
the now-expired DEA Certificate of Registration, BM3972747, issued to
Meetinghouse Community Pharmacy, Inc. This order is effective
immediately.
Dated: February 26, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-4909 Filed 3-6-09; 8:45 am]
BILLING CODE 4410-09-P