[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