Sun & Lake Pharmacy, Inc.; D/B/A the Medicine Shoppe; Revocation of Registration, 24523-24533 [2011-10506]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24523-24533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10506]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-18]


Sun & Lake Pharmacy, Inc.; D/B/A the Medicine Shoppe; Revocation 
of Registration

    On October 19, 2009, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Sun & Lake Pharmacy, Inc., d/b/a The Medicine Shoppe 
(hereinafter, Respondent) of Lakeland,

[[Page 24524]]

Florida. The Show Cause Order proposed the revocation of Respondent's 
Certificate of Registration, BS9433828, as a retail pharmacy, and the 
denial of any pending applications to renew or modify the registration, 
on the ground that its registration is ``inconsistent with the public 
interest.'' ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)).
    More specifically, the Show Cause Order alleged that Respondent had 
violated both federal and state laws by distributing controlled 
substances to persons throughout the United States ``based on purported 
prescriptions issued to hundreds of customers through Internet websites 
* * * by physicians who were not licensed to practice medicine in the 
states in which the customers resided.'' Id. at 2 (citations omitted). 
The Show Cause Order also alleged that the prescriptions violated 21 
CFR 1306.04(a) because the ``physicians failed to establish a valid 
physician-patient relationship as required by multiple state laws'' and 
were therefore issued ``for other than a legitimate medical purpose 
and/or outside the usual course of professional practice.'' Id. at 3 
(citations omitted).
    Finally, the Order alleged that Respondent filled unlawful 
prescriptions issued by one Robert Reppy, D.O., because Reppy ``issued 
* * * prescriptions for controlled substances to customers throughout 
the United States even though he was licensed to practice medicine only 
in the State of Florida'' and was therefore engaged in the unauthorized 
practice of medicine when he prescribed to persons outside of Florida. 
Id. The Order also alleged that Reppy violated Florida law by ``issuing 
prescriptions via the Internet without a documented patient evaluation 
and discussion between [him] and [the] patient regarding treatment 
options.'' Id. (citations omitted).
    On November 23, 2009, Respondent, through its counsel, requested a 
hearing on the allegations and the matter was placed on the docket of 
the DEA Administrative Law Judges (ALJs). ALJ Ex. 2. Following pre-
hearing procedures, on February 24-25, 2010, an ALJ conducted a hearing 
in Tampa, Florida. At the hearing, the Government called witnesses to 
testify and introduced extensive documentary evidence; Respondent 
called no witnesses and introduced a single exhibit. Following the 
hearing, both parties submitted briefs containing their proposed 
findings of fact, conclusions of law and argument.
    On April 8, 2010, the ALJ issued his Recommended Decision (also 
ALJ). As to factor one--the recommendation of the state licensing 
authority--the ALJ noted that there was no evidence that the State 
licensing authority had taken any action against Respondent's pharmacy 
license. ALJ at 28. The ALJ noted, however, that while state licensure 
is a necessary condition for holding a registration, Respondent's 
continued holding of its state license is not dispositive because DEA 
has an ``independent responsibility to determine whether a registration 
is in the public interest.'' Id. (citations omitted). The ALJ thus 
concluded that Respondent's licensure status neither ``weigh[s] for or 
against a determination'' that its ``continued registration * * * is 
consistent with the public interest.'' Id.
    As to factor three--Respondent's record of conviction of offenses 
related to the distribution or dispensing of controlled substances--the 
ALJ noted that while Respondent remains the subject of a criminal 
investigation, it has not been ``convicted of any crime.'' Id. The ALJ 
reasoned, however, that ``the probative value'' of this finding ``is 
somewhat diminished by the myriad of considerations that are factored 
into a decision to initiate, pursue, and dispose of criminal 
proceedings by'' the prosecuting authorities. Id. at 28. The ALJ 
apparently concluded that this factor neither supported nor refuted the 
conclusion that Respondent's continued registration is inconsistent 
with the public interest. Id. at 29.
    The ALJ considered the remaining factors--its experience in 
dispensing controlled substances (factor two), its compliance with 
applicable laws relating to controlled substances (factor four), and 
other conduct which may threaten public health and safety (factor 
five)--together. Id. at 29-48. With regard to these factors, the ALJ 
noted that there were two primary issues: (1) Whether Respondent 
complied with its ``corresponding responsibility'' under 21 CFR 
1306.04(a) to not knowingly fill a prescription which has not been 
issued for a legitimate medical purpose, and (2) whether it ``was 
authorized to dispense controlled substances to the ultimate user who 
received them where they were delivered.'' Id. at 32.
    As to the first issue, the ALJ explained that a ``pharmacy 
registrant must understand the requirements attendant upon the issuance 
of an effective prescription under the regulations.'' Id. at 33. The 
ALJ further noted that under the Controlled Substances Act, ``it is 
fundamental that a physician practitioner must have established a bona 
fide doctor-patient relationship in order to act `in the usual course 
of professional practice' and to issue a prescription `for a legitimate 
medical purpose,' '' and that at the time of the conduct at issue, 
``the CSA generally looked to state law to determine whether a bona 
fide doctor patient relationship existed.'' Id. at 33-34 (citations 
omitted). The ALJ also explained that under agency precedent, `` `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,' '' and this obligation includes `` 
`determin[ing] whether the physicians were in compliance with the 
States' licensure requirements and specific standards for issuing 
treatment recommendations and prescribing controlled substances.' '' 
Id. at 38 (quoting Bob's Pharmacy & Diabetic Supplies, 74 FR 19599, 
19601 (2009); United Prescriptions Servs., Inc., 72 FR 50397, 50408 
(2007)). Moreover, the ALJ also cited Agency precedent that, under the 
CSA, ``a physician who engages in the unauthorized practice of medicine 
under state law is not `a practitioner acting in the usual course of * 
* * professional practice,' '' and that ``a controlled-substance 
prescription issued by a physician who lacks the license or other 
authority required to practice medicine within a State is therefore 
unlawful under the CSA.'' Id. (citations omitted).
    The ALJ also concluded that Respondent had ignored evidence that 
the prescriptions were not issued pursuant to a valid doctor-patient 
relationship. The ALJ noted that a DEA Diversion Investigator (DI) had 
provided Respondent with various documents including a Guidance 
Document on Dispensing and Purchasing Controlled Substances Over the 
Internet, 66 FR 21181 (2001), which explained four widely accepted 
elements for establishing a bona fide doctor-patient relationship 
(including, inter alia, that a medical history be taken and a physical 
examination be performed) and the DEA Pharmacist's Manual. ALJ at 34-
35. The ALJ also found that Respondent's owner had expressed to the DI 
that it had been solicited to distribute drugs for an internet 
prescribing scheme but that he declined to do so because he did not 
believe there would be adequate doctor-patient relationships to support 
the prescriptions and thus he ``expressed actual understanding'' that 
``where doctor and patient are geographically isolated from each other, 
it increases the risk that the requisite doctor-patient relationship 
does not exist.'' Id. at 35.
    Noting that Respondent had filled several prescriptions which were

[[Page 24525]]

shipped to Alabama residents and which were authorized by a Dr. Flynn, 
who was located in Pennsylvania, and Dr. De LaGuardia, who was located 
Kansas, the ALJ reasoned that ``[t]he fact that the prescriptions were 
authorized by practitioners geographically isolated from Alabama made 
it unlikely that the issuing physician had the requisite doctor-patient 
relationship with the ultimate user''; he then found that Respondent 
``took no steps to resolve these red flags prior to dispensing 
controlled substances'' and thus violated ``its corresponding 
responsibility'' under Federal law. Id. at 40. The ALJ further noted 
that Respondent ``had * * * ignored similar obligations to resolve 
anomalies attendant upon remote doctor and patient locations prior to 
dispensing controlled substances prescribed by [these two doctors] to 
customers in states including, inter alia, California, Georgia, 
Illinois, Louisiana, Mississippi, North Carolina, and South Carolina.'' 
Id. at 40-41. (citing numerous State laws).
    The ALJ also noted that ``apart from the geographic separation 
between Dr. Flynn and his nationwide ultimate-user base, * * * 
Respondent * * * possess[ed] * * * documents that reflected that on 
single days, this physician issued 837, 347, 344 and 314 prescriptions, 
[and this] should have resulted in great concern [on its part] that 
this number of individuals was not being examined and treated on a 
daily basis by'' Flynn, who was ``one of [its] regular prescribing 
physicians.'' Id. at 44-45. Similarly, the ALJ noted that ``on several 
days Dr. De La Guardia, another regular prescriber, issued over 100 
prescriptions.'' Id. at 45. Because Respondent ignored both the 
geographic separation between the patients and prescribers as well as 
the high volume of their prescriptions, the ALJ concluded that it 
violated Federal and state laws related to controlled substances and 
``its obligations as a DEA registrant'' and that this ``militate[s] 
strongly in favor of revocation.'' Id. at 46.
    The ALJ further noted that ``these prescriptions were issued by 
physicians not licensed to practice in the states in which the 
customers resided'' and that this issue ``needed to be resolved [by 
Respondent] prior to the dispensing of a single controlled substance'' 
pursuant to these prescriptions. Id. at 41.
    Next the ALJ noted that ``[t]he CSA requires that a practitioner * 
* * be currently authorized to handle controlled substances in `the 
jurisdiction in which he practices' in order to maintain a DEA 
registration.'' Id. at 42 (citing 21 U.S.C. 802(21) & 823(f)). 
Reasoning that ``state authorization of the pharmacy registrant to 
dispense in the state where the controlled substance is ultimately 
dispensed stands as a fundamental condition precedent to establishing 
that a prescription has been lawfully filled,'' the ALJ, citing 
numerous state laws requiring that a pharmacy be licensed in the State 
to deliver drugs to one of its residents, concluded that Respondent's 
``filling and shipping of * * * controlled substances was done in 
direct violation of state laws relating to controlled substances.'' Id. 
at 43-44.
    Finally, the ALJ noted that Mr. Fosu ``elected not to testify'' and 
that Mrs. Fosu, who was also involved in Respondent's operations, had 
invoked the Fifth Amendment when called to testify. Id. at 47. Noting 
the Agency rule that where the Government makes out a prima facie case, 
the Respondent must accept responsibility for its misconduct, the ALJ 
concluded that the Fosus had failed ``to accept any responsibility for 
any of [Respondent's] prescription filling practices'' and that this 
``militates strongly in favor of revocation.'' Id. at 48. The ALJ thus 
concluded that Respondent had not rebutted the Government's prima facie 
case and recommended that Respondent's registration be revoked and any 
pending applications be denied. Id. at 48-49.
    Neither party filed exceptions to the ALJ's decision. Thereafter, 
the record was forwarded to me for final agency action.
    Having considered the entire record in this matter, I adopt the 
ALJ's findings of fact and conclusions of law except as specifically 
noted herein. I further adopt the ALJ's recommended sanction that 
Respondent's registration be revoked and its pending application be 
denied. I make the following findings.

Findings

    Respondent is a Florida corporation which owns and operates a 
retail pharmacy doing business under the name of The Medicine Shoppe. 
GX 2. Respondent, which first became registered on September 1, 2005, 
holds DEA Certificate of Registration BS9433828, which authorizes it to 
dispense controlled substances in schedules II through V as a retail 
pharmacy at the registered location of 1231 Lakeland Hills Blvd., 
Lakeland, Florida. Id. Respondent's registration was last renewed on 
February 15, 2008 and was not due to expire until February 28, 2011. 
Id. According to the registration records of the Agency, of which I 
take official notice, see 5 U.S.C. 556(e); on January 12, 2011, 
Respondent submitted a renewal application. I therefore find that 
Respondent's registration has remained in effect pending the issuance 
of this Decision and Final Order.\1\ See 5 U.S.C. 558(c); 21 CFR 
1301.36(i).
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    \1\ Under the Administative Procedure Act (APA), and agency 
``may take official notice of facts at ay stage in a proceeding-even 
in the final decision.'' U.S. Dept. of Justice, Attorney General's 
Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & 
Sons, Inc., Reprint 1979). In accordance with the APA and DEA's 
regulations, Respondent is ``entitled on timely request, to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). Respondent can dispute the fact of which I take 
oficial notice by filing a properly supported motion for 
reconsideration within twenty days of service of this Order, which 
shall begin on the date it is mailed.
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    Kwame Fosu, who is a registered pharmacist, is the director, 
registered agent, and owner of Respondent. ALJ Ex. 6, at 2 (stipulated 
facts); GX 7. Patricia Fosu, who is Mr. Fosu's wife, Tr. 184, is also a 
registered pharmacist in Florida. Id. at 317.
    Sometime in early 2005, DEA Investigators (DIs) with the Tampa 
Field Division started receiving a large volume of complaints about 
various Florida pharmacies from persons who had ordered drugs through 
Web sites. Id. at 29, 31. Using an agency database, the DIs determined 
that there were ``a lot of small pharmacies'' in the Tampa Bay area 
that were purchasing ``large amounts of hydrocodone,'' (a schedule III 
controlled substance as it is usually dispensed to patients), including 
some that were purchasing ``over a million dosage units'' and these 
quantities were at least twice as great as those being purchased by 
large chain drugstores such as Walgreens or CVS.\2\ Id. at 33. The DIs 
also noticed that the largest purchasers were usually pharmacies that 
had recently obtained DEA registrations. Id. at 35.
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    \2\ The DI did not clarify te time period during which these 
purchases occurred.
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    With this information, the Tampa DIs commenced visiting these 
pharmacies to determine what was going on and to educate them about 
DEA's position on the lawfulness of prescriptions originating through 
the Internet. Id. at 36 & 40. The Tampa Office also decided that every 
time they received a new application for a pharmacy registration, they 
would ``be proactive'' and visit the pharmacies and explain to them 
that prescriptions that were not issued based on ``a doctor-patient 
relationship'' were not legal and that, if the doctor was located in a 
State other than where the patient resides, ``there is no way there 
could be a doctor-patient relationship.'' \3\ Id. at 41-42.
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    \3\ The DI also testified that while some of the pharmacists 
they encountered claimed that they were just doing mail order they 
were not because in ``[m]ail order, the doctor sees the patient, the 
patient gets the prescription [and] mails the prescription into 
their pharmacy * * * This [internet prescribing] was done completely 
different.'' Tr. 42.

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[[Page 24526]]

    Pursuant to this policy, on December 5, 2005, two DIs went to 
Respondent and met with Mr. Fosu.\4\ The DIs gave Mr. Fosu a package of 
documents which included the DEA Pharmacist's Manual, the Agency's 2001 
Guidance Document entitled Dispensing and Purchasing Controlled 
Substances over the Internet \5\ along with a one page document 
summarizing some of the critical points of the Guidance Document, as 
well as documents containing Frequently Asked Questions regarding the 
dispensing and purchasing of controlled substances over the internet, 
and provisions of Florida law setting forth grounds for disciplinary 
action against a pharmacist's license (including where a pharmacist 
dispenses a drug either knowing or having reason to know that a 
prescription is not based upon a valid practitioner-patient 
relationship). GX 7. During their discussion of the use of the 
internet, the DI told Mr. Fosu that internet prescribing was illegal as 
were prescriptions that were digitally signed. Tr. 150-51, 153. Mr. 
Fosu told the DI ``that he was aware of the internet situation because 
he had been approached by an individual'' about filling prescriptions 
for an internet site, but ``he had informed that individual that he 
wasn't interested in doing internet because he did no see the doctor-
patient relationship and he didn't want to have any trouble [and] 
wasn't going to be doing [the] internet.'' Tr. 49; see also id. at 45.
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    \4\ The DI had previously gone to Respondent in October but was 
informed that Mr. Fosu was out of the country. Tr, 43. Because the 
DI wanted to discuss these issues with Mr. Fosu, she decided that 
she would revisit Respondent when he returned. Id.
    \5\ This document had previously been pubished in the Federal 
Register at 66 FR 21181. GX 8, at 2. The Guidance Document 
specifically stated that ``Federal law requires that `[a] 
prescription for a controlled substance to be effective must be 
issued for a legitimate medical purpose by an individual 
practitioner action in the usual course of his professional 
practice.' '' 66 FR at 21182 (quoting 21 CFR 1306.04(a)). The 
Guidance explained that ``[e]very state separately imposes the same 
requirement under its laws'' and that ``[u]nder Federal and state 
law, for a doctor to be acting in the usual course of professional 
practice, there must be a bona fide doctor/patient relationship. Id. 
Continuing, the Gudance exlained that ``[f]or purposes of state law, 
many state authorities, with the endorsement of medical societies, 
consider the existence of the following four elements as an 
indication that a legitimate doctor patient relationship has been 
established:''
    A patient has a medical complaint;
    A medical history has been taken;
    A physical; examination has been performed; and
    Some logical connection exists between the medical complaint, 
the medical history, the physical examination, and the drug 
prescribed.
    Id. at 21182-83.
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    The DI further testified that she had given Mr. Fosu her business 
card and that she asked him to call her if he was ever approached again 
by someone about filling internet prescriptions and to obtain as much 
information as he could to identify the person. Id. at 50 & 102. The DI 
was never subsequently contacted by Mr. Fosu. Id.
    In late January or early February 2007, another DI, who was 
assigned to the Pittsburgh, Pennsylvania Resident Office, received a 
phone call from a pharmacy owner who reported that he had been called 
by a person who represented that he worked for an entity known as 
Coralpines and who had solicited him to fill prescriptions that were 
issued over the internet. Id. at 332 & 337. The pharmacy owner stated 
that the Coralpines' representative had told him that if he agreed to 
do so, he would be given a user name and password so that he could 
access a Web site and download prescriptions which he was to fill. Id. 
at 332-33. When the pharmacy owner ``expressed [his] reservations'' to 
Coralpines' representative, it wired ``a significant amount of money'' 
to him to show its ``good faith.'' Id. at 333.
    Thereafter, the pharmacy owner accessed Coralpines' Web site and 
downloaded hundred of prescriptions that it wanted his pharmacy to 
fill. Id. Upon printing out the prescriptions, which totaled about 200, 
the pharmacy owner noted that they were issued by ``mainly three 
doctors'' and yet were for persons located throughout the country. Id. 
More specifically, the prescribing doctors were Michael Flynn, who was 
located in Wallingford, Pennsylvania; Alfredo Valdivieso, who was 
located in Puerto Rico; and Enrique De La Guardia, who was located in 
Ft. Leavenworth, Kansas. Id. at 337-38. With the exceptions of Dr. De 
La Guardia, who was licensed in both Kansas and Nebraska, the other 
doctors were licensed only in the States where they were located. Id. 
at 338-39.
    Apparently because all of the prescriptions were for controlled 
substances, the pharmacy owner decided not to do business with 
Coralpines and turned over the prescriptions to the DI. Id. at 333. 
According to the DI, the prescriptions were primarily for phentermine, 
diazepam, and alprazolam, all of which are schedule IV controlled 
substances. Id. at 335; see also 21 CFR 1308.14(c) & (e).
    According to the DI, the prescription forms were divided into three 
sections; one section contained prescription information such as the 
customer's name, address, drug, quantity, date, and a physician's 
signature; another section contained the label that goes on the 
prescription vial, and the third section contained either a UPS or Fed 
Ex shipping label with an account number, the pharmacy's name, and the 
patient's name. Id. at 334-36.
    Each prescription form also included the name of the Web site which 
the customer had accessed to order the drugs. Id. at 339-40. There were 
approximately 30 Web sites including pillforce.com, pillpush.com and 
pillroyal.com; the DI later determined that crownpills.com was also 
affiliated with Coralpines. Id. at 340-41 & 349. The DI also determined 
that Coralpines was located in Durban, South Africa. Id. at 340.
    On February 15, 2007, the DI, using an undercover name, visited 
pillpush.com and purchased alprazolam. Id. at 350 & 354. In additional 
to providing his name and address, the DI was directed to complete a 
ten-question questionnaire. Id. at 351. The DI gave a false height and 
weight, and when asked why he wanted the drug, wrote ``anxiety.'' Id. 
The DI then provided his credit card information and placed his order. 
Id.
    A week later, the DI received a package containing a drug vial 
which contained 60 tablets of alprazolam.\6\ Id. The vial label 
indicated that the prescription had been filled by Respondent and that 
the prescribing physician was Dr. Flynn. Id. at 351-52. Prior to the 
issuance of the prescription, the DI neither saw nor spoke with Dr. 
Flynn. Id. at 352. Nor, prior to his receiving the prescription, did he 
speak with anyone at Respondent. Id. at 354.
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    \6\ The DI subsequently testified that he received the drugs on 
February 23, 2007. Tr. 353. The DI also testified that the drugs 
were tested by a DEA laboratory and found to be alprazolam. Id.
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    Thereafter, a subpoena was issued to UPS for shipping records for 
the account number (which was the same number as had been on the 200 
prescriptions that were turned over to DEA by the western Pa. pharmacy 
owner) under which the alprazolam had been shipped. Id. at 354-55. UPS 
turned over the records which showed that in a one to one-and-a-half-
month time period, Respondent had made 1600 shipments to persons 
located throughout the country. Id. at 355.
    Using the UPS records, the DI contacted several persons who lived 
near Pittsburgh. Id. at 359. The DI (accompanied by another DI) 
interviewed B.F. at her residence; B.F. told them that she had ordered

[[Page 24527]]

alprazolam through a Web site (pillroyal.com), which was one of those 
known to be an affiliate of Coralpines. Id. at 359-60; GX 16, at 1. 
While B.F. related as to how she had filled out a questionnaire and 
provided credit card information, she also stated that she did not have 
to provide medical records and neither was examined by, nor spoke with 
a physician. Tr. 361. Shortly thereafter, B.F. received a bottle of 
alprazolam; its label indicated that the prescription had been filled 
by Respondent and listed Dr. Flynn as the prescribing physician. Id. at 
361-62. B.F. also printed out copies of e-mail correspondence (which 
she gave to the DIs) which had confirmed her order and the subsequent 
shipment of it. GX 16, at 1-3. The DIs subsequently confirmed that the 
e-mail address of the sender was the same as had been used by 
representatives of Coralpines in contacting the pharmacy owner who had 
declined to fill prescriptions for it. Tr. 362-63.
    The DI also interviewed C.S. Id. at 369. C.S. also related that he 
had gone to a Web site that the DIs had identified as being affiliated 
with Coralpines and ordered 90 tablets of diazepam ``merely through'' 
completing a questionnaire and providing credit card information. Id. 
at 370. C.S. ``did not have to provide any additional records'' and was 
neither examined by nor spoke ``with a doctor.'' Id. at 371 & 373. C.S. 
subsequently received a prescription which had been issued by Dr. Flynn 
and filled by Respondent. Id.; see also GX 18 (copy of March 26, 2007 
prescription for 90 tablets of diazepam 10 mg.).\7\
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    \7\ The prescription was seized from Respondent in June 2007 
during the execution of a search warrant. See GX17.
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    On June 12, 2007, a search warrant was executed at Respondent. 
During the search, the authorities seized hard copies of the controlled 
substance prescriptions Respondent had dispensed; Respondent's 
purchasing, dispensing records, and shipping documents; and various 
notes that related to the investigation of Coralpines. Tr. 381. 
Moreover, computer forensic examiners imaged the hard drives of 
Respondent's computers. Id. at 381-82.
    During the search, members of the search party (including the 
Pittsburgh-based DI) interviewed Patricia Fosu. Id. at 385. Ms. Fosu 
stated that her husband had purchased Respondent in 2005 and that she 
had initially worked there on a part-time basis; however, her hours had 
increased in the months before the warrant was executed (which 
corresponds with the period in which Respondent commenced filling 
prescriptions for Coralpines). Id. at 385-86.
    Ms. Fosu further stated that in November 2006, she and her husband 
were approached by one Gerald Wright, who identified himself as a 
pharmacist, and who solicited them to fill prescriptions issued by 
doctors who worked for Coralpines. Id. at 390. Wright, who practiced at 
CRJ Pharmacy, told the Fosus that he was personally filling 
prescriptions for Coralpines.\8\ Id. According to Ms. Fosu, while she 
and her husband had expressed their concern to Wright that the 
Coralpines' physicians were not seeing the patients, Wright stated that 
they had nothing ``to worry about because other pharmacies across the 
country'' were also filling prescriptions that were issued ``in a 
similar manner.'' Id. at 397.
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    \8\ In February 2007, I ordered that CRJ Pharmacy's DEA 
registration be immediately suspended. See 72 FR 30846 (2007). 
Subsequently, CRJ surrendered its state license and went out of 
business. Id. at 30847
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    During the interview, Ms. Fosu identified Drs. Flynn and De La 
Guardia as the prescribers of the prescriptions which Respondent filled 
for Coralpines. Id. at 396. While Ms. Fosu related that she had 
initially made a few phone calls to Dr. De La Guardia to verify that he 
had issued the prescriptions, she was never able to speak with Dr. 
Flynn, whose prescribing practices raised her concern because of the 
large number of prescriptions he was issuing. Id. Ms. Fosu further 
asserted that she and her husband became concerned that most of the 
Coralpines prescriptions were for controlled substances. Id. at 397-98. 
She further maintained that she and her husband had decided in April 
2007 to stop filling prescriptions for Coralpines because they did not 
believe that there was ``a legitimate doctor-patient relationship'' 
between the patients and Drs. Flynn or De La Guardia. Id. at 398.
    Ms. Fosu also related that in January 2007, she and her husband had 
been visited by Dr. Robert Reppy, a Tampa-area physician, who solicited 
Respondent to fill prescriptions that he would be writing for persons 
who were located throughout the United States. Id. at 399. Reppy 
``assured'' the Fosus that ``his patients would be flying in from all 
across the country to be seen by [him] at his'' Tampa office. Id.
    The Fosus agreed to fill Reppy's prescriptions and shortly 
thereafter started receiving faxed prescriptions which were ``mainly 
for hydrocodone,'' which is a schedule III narcotic. Id.; see also 21 
CFR 1308.13(e). Ms. Fosu further stated that because she and her 
husband ``were concerned about whether [Reppy] was actually seeing 
these patients,'' they made an unannounced visit to his office. Tr. 
399. Reppy assured the Fosus that ``he was actually seeing these 
patients.'' Id. at 400.
    During the course of executing the warrant, Respondent received six 
prescriptions via fax from Reppy's office. Id. The prescriptions were 
for patients who did not reside in Florida. Id. at 403. The DI did not, 
however, have any information linking Reppy to Coralpines and did not 
know if Reppy was issuing prescriptions through any other internet 
sites. Id. at 401.
    Later that morning, Mr. Fosu arrived at Respondent and agreed to be 
interviewed. Id. at 413-14. Mr. Fosu related that, in the summer of 
2006, he had received a phone call from a woman working for Coralpines 
who solicited him to fill prescriptions for it. Id. at 414-15. Mr. Fosu 
maintained that he was not comfortable with Coralpines' proposal 
because he ``didn't believe that the doctors would actually be seeing 
the patients'' and believed that there would not be ``a legitimate 
doctor-patient relationship.'' Id. at 415. Mr. Fosu claimed that he had 
called the DEA Tampa office and was told to contact the Florida Board 
of Pharmacy. Id. at 415-16. Mr. Fosu spoke with a representative of the 
Board to inquire about the legality of filling prescriptions for 
doctors who were not in the same area as their patients. Id. at 416. 
The Board's representative told Mr. Fosu not to fill the prescriptions 
if they ``were not based on a legitimate doctor-patient relationship.'' 
Id. at 416-17. Mr. Fosu then questioned the Board representative as to 
what constitutes a doctor-patient relationship and was advised to 
contact the Florida Board of Medicine for further guidance. Id. at 417.
    During the interview, Mr. Fosu corroborated that in November 2006, 
he was approached by Wright, who solicited him to fill prescriptions 
for doctors affiliated with the Pitcairn Group.\9\ Id. at 417. Wright 
told Fosu that he was filling prescriptions for Pitcairn and asked him 
if he was

[[Page 24528]]

interested in doing so. Id. at 417-18. Fosu maintained that he 
questioned Wright about whether the prescriptions were based on 
legitimate doctor-patient relationships and that Wright had told him 
not worry because other pharmacies were filling prescriptions for 
Pitcairn. Id. at 418.
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    \9\ While in this portion of his testimony, the DI referred to 
the Pitcairn Group, the evidence suggests that Pitcairn either 
changed its name to Coralpines, Tr. 420, was an entity that was 
controlled by Coralpines, or was taken over by it. GX 15, at 4 (Jan. 
30, 2007 e-mail from Coralpines Support to ``Kwamen and Pat'' 
stating in part: ``Pitcairn has a credit balance with Sunlake for 
8k. We will deduct this of [sic] next weeks report. Thanks, 
Coralpines Support.''); id. at 6 (Jan. 10, 2007 e-mail with subject 
line of ''Pitcairn migrating to Coralpines,'' and stating: ``My name 
is Justin, I will be taking over for Pitcairn as Juan has gone on 
leave.'').
---------------------------------------------------------------------------

    In the interview, Mr. Fosu maintained that during the course of his 
relationship with Coralpines, he had become ``increasing[ly] 
concerned'' that the prescriptions were only for controlled substances 
such as hydrocodone and alprazolam and that when he raised this issue 
with Coralpines, he was told that he would start seeing a ``mix of 
prescriptions.'' Id. at 420. However, Coralpines continued to send him 
alprazolam prescriptions. Id. Mr. Fosu further related that he had 
worked for Coralpines from November 2006 through April 2007, that 
Coralpines paid him $20 per prescription, and that Coralpines had paid 
him a total of between $150,000 to $250,000 for Respondent's 
services.\10\ Id. at 421. These payments came from foreign sources and 
according to Mr. Fosu, further raised his concern. Id.
---------------------------------------------------------------------------

    \10\ Various e-mails suggest that this amount was Respondent's 
compensation for filling the prescriptions and that it was also 
reimbursed for its drug costs. GX 15, at 3-14 (stating ``your 
estimated cost for my totals for week 4 & 5 was about $31,000 that 
is only my cost of drugs. My service fee is about 13,180 for 670 
script[s] filed''); id. at 17 (stating that in the ``week ending 02/
09/2007 I did 579 prescriptions my service fee is 11,580,000 [and 
my] drug cost is obout [sic] $12,000'').
---------------------------------------------------------------------------

    Mr. Fosu also admitted that he was concerned about Dr. Reppy's 
prescriptions and that this had prompted the visit to Reppy's office, 
which had occurred approximately one month before the warrant was 
executed. Id. at 422. After the visit, Respondent continued to fill 
Reppy's prescriptions. Id. at 423. However, during his interview, Mr. 
Fosu announced that from that ``day forward, [he] would no longer fill 
these prescriptions because [he] did not believe that Dr. Reppy was 
ever seeing these patients from out of state.'' Id.
    The day after the interview, Mr. Fosu called the DI and asked him 
whether he should fill the hydrocodone refills which Reppy had 
authorized on his prescriptions. Id. at 428. The DI instructed Fosu 
``to use his best judgment as a pharmacist'' and, if he did ``not 
believe that these prescriptions were issued for a legitimate medical 
purpose, then [he] shouldn't be refilling the prescriptions.'' Id. The 
DI further explained that if Reppy ``was not seeing these patients,'' 
then ``there was no doctor-patient relationship'' and he should not 
refill the prescriptions. Id. Mr. Fosu then told the DI that he would 
not refill Reppy's prescriptions. Id. at 428-29.
    As found above, during the search, the hard drives of Respondent's 
computers were imaged and subsequently analyzed by the National Drug 
Intelligence Center. Id. at 423-24. According to the DI, the analysis 
showed that between January and the June 2007, Respondent had filled 
2,400 prescriptions issued by Reppy, which were primarily for 
hydrocodone, and that the prescriptions had been sent to residents of 
46 different States. Id. at 425. However, the Government did not submit 
any report or summary providing further detail as to Reppy's 
prescribing practices. Nor did the Government submit copies of any of 
Reppy's prescriptions.
    As found above, the search party also seized numerous hard copy 
prescriptions that Respondent had filled which were issued by Drs. 
Flynn and De La Guardia. Id. at 447. The DI (along with other DEA 
employees) prepared a spreadsheet listing each doctor's prescriptions 
by date of issuance and drug prescribed; the spreadsheet also provided 
a daily total of the prescriptions. Id.; see also GXs 12 & 13.
    The Government also submitted representative samples of the 
controlled substance prescriptions issued by Drs. Flynn and De La 
Guardia which were filled by Respondent. With respect to Dr. Flynn, the 
exhibits included copies of 97 controlled substance prescriptions, see 
GX 10; with respect to Dr. De La Guardia, the exhibit included copies 
of 94 controlled substance prescriptions. See GX 11. Both of these 
exhibits included a cover page which listed the number of prescriptions 
by State of the patient. GX 10, at 1; GX 11, at 1.
    Upon reviewing Dr. Flynn's prescriptions, the DI found that on 
numerous days, Flynn had issued an extraordinary number of 
prescriptions. More specifically, on February 2, 2007, Flynn had issued 
344 prescriptions including 235 for alprazolam, 86 for diazepam, 4 for 
lorazepam, and 12 for clonazepam. GX 12, at 1. Moreover, on February 
19, 2007, Flynn had issued 837 prescriptions including 581 for 
alprazolam, 183 for diazepam, 1 for lorazepam, and 37 for clonazepam. 
Id. In addition, on February 23, Flynn issued 314 prescriptions; on 
February 28, 338 prescriptions; on March 26, 347 prescriptions, and on 
April 3, 267 prescriptions.\11\ Id. at 1-2. In addition, on February 14 
and 15, he issued 195 and 247 prescriptions respectively; \12\ there 
were also multiple other days on which he issued between 100 and 200 
prescriptions. Id. In each instance, the great majority of the 
prescriptions were for controlled substances. Between January 31 and 
April 5, Dr. Flynn wrote a total of 3,227 alprazolam prescriptions, 
1,310 diazepam prescriptions, 415 lorazepam prescriptions, and 195 
clonazepam prescriptions.\13\ Id. at 2.
---------------------------------------------------------------------------

    \11\ Flynn's February 23rd prescriptions included 84 alprazolam, 
30 for diazepam, 176 for lorazepam, and 12 for clonazepam; his 
February 28 prescriptions included 222 for alprazolam, 54 for 
diazepam, 9 for lorazepam, and 14 for clonazepam; his March 26 
prescriptions included 137 for alprazolam and 210 for diazepam, and 
his April 3 prescriptions included 136 alprazolam, 76 for diazepam, 
34 for lorazepam and 21 for clonazepam. GX12, at 1-2.
    \12\ His February 14 prescriptions included 136 for alprazolam 
and 58 for diazepam; his February 15 included 181 for alprazolam and 
64 diazepam. GX 12, at 1.
    \13\ Based on this information, in July 2007, DEA personnel 
obtained a warrant to search Dr. Flynn's registered location, which 
was also his home. Tr. 461. While Dr. Flynn was not home when the 
warrant was executed, he returned the following day and was 
interviewed by the DI and others. Id. at 463. During his interview, 
Flynn admitted that he worked for Coralpines; he further admitted 
that he would go to its website and see ``hundreds of 
questionnaires,'' that he issued prescriptions ``without talking to 
any of the customers by phone [and] without reviewing any other 
medical records.'' Id. at 464. He further admitted that ``in most 
cases * * * he didn't even review the questionnaires,'' that ``[h]e 
viewed this as an easy way to make money, and that this ``was not a 
legitimate medical practice.'' Id. at 464. Flynn also stated that 
``he was never contacted by any pharmacy to verify [his] 
prescriptions'' and was ``never questioned about'' the legitimacy of 
the prescriptions. Id. On July 30, 2007, Dr. Flynn surrendered his 
registration and eventually pled guilty to violating 21 U.S.C. 846 
Tr. 465; GXs 4 & 23.
    As for Dr. De La Guardia, the record shows that he surrendered 
his registration on August 1, 2007. GX 5.
---------------------------------------------------------------------------

    As for Dr. De La Guardia, the evidence showed that between November 
30, 2006 and February 6, 2007, Respondent filled 1,366 alprazolam 
prescriptions, 628 diazepam prescriptions, 187 lorazepam prescriptions, 
58 clonazepam prescriptions, and 64 phentermine prescriptions which he 
had issued. GX 14, at 2. While De La Guardia generally did not issue 
prescriptions at the same rate as Flynn, there were numerous days on 
which he wrote more than 50 controlled substance prescriptions and 
several days on which he wrote more than 100. Id.
    In September 2007, Mr. Fosu called the DI, who had since returned 
to the Pittsburgh office. Id. at 430. Mr. Fosu reported that he had 
been solicited by another entity to fill more internet prescriptions 
for hydrocodone, which were issued by a physician in Puerto Rico, and 
that he had been sent copies of two prescriptions, one of which was for 
a Pennsylvania resident. Id. at 430-

[[Page 24529]]

31. Mr. Fosu stated that he did not feel comfortable with the proposal 
and that he wanted to provide this information to the DI. Id. at 431.
    Mr. Fosu then told the DI that he had since met again with Dr. 
Reppy, who told him that he had ``weeded out the bad people'' and that 
Reppy had asked him to continue to fill his prescriptions. Id. Mr. Fosu 
maintained that Reppy had assured him that he was actually seeing the 
patients and that he was requiring them to provide some form of 
identification. Id. at 432. Mr. Fosu then stated that he planned on 
filling these prescriptions ``if he had some sort of identification for 
the patient to [show] that the patient was who they said they were'' 
and that ``would match what was on the'' prescription. Id.
    However, on cross-examination, the DI admitted that he did not know 
whether Reppy's patients were actually coming in to see him. Id. at 
541. Moreover, the Government offered no other evidence probative of 
whether Reppy's patients were actually seeing him. Id. The DI also 
acknowledged that he did not know whether there was anything wrong with 
Reppy's prescriptions, none of which were entered into evidence. Id. 
Indeed, the DI acknowledged that he did not know whether Respondent had 
filled any prescriptions issued by Reppy and that it was ``possible'' 
that Respondent had not even filled Reppy's prescriptions. Id. at 543.
    During their respective interviews, both Mr. and Mrs. Fosu 
acknowledged that Respondent had actually dispensed the Coralpines 
prescriptions, which had been placed in several boxes found in one of 
Respondent's back rooms. Id. 493-95, 497-500, 545. I thus find that 
Respondent filled and distributed the prescriptions identified in 
Government Exhibits 10 and 11.\14\ I further find that Government 
Exhibits 12 & 13 accurately reflect prescriptions that Drs. Flynn and 
De La Guardia issued on various dates and which were eventually filled 
by Respondent.
---------------------------------------------------------------------------

    \14\ The Government also introduced a single prescription for 
alprazolam which was written by Dr. Shabir Bhimji of Austin, Texas 
for a patient in Boulder, Colorado, and a single prescription 
written by Dr. Gerard Romain of Tampa, Florida for a patient in 
Boston, Massachusetts. GXs 19 & 21. With respect to Dr. Bhimji, the 
DI testified that he had written 100 prescriptions on a signle day 
in April 2007. Tr. 458. However, other thant the single alprazolam 
prescription, the record does not establish that any of the other 
prescriptions were for controlled substances.
    As for the prescription issued by Dr. Romain, while the DI 
testified ``that there were a number of other prescriptions from 
other physicians not previously identified as being affiliated with 
Coralpines'' and named Dr. Romain as someone who was ``allegedly 
issuing prescriptions for patients all across the United States,'' 
and that an ``examination of prescriptions [Respondent] filled * * * 
showed that there were patients all across the United States 
receiving these prescriptions,'' id. at 377-78, the DI subsequently 
admitted (on direct examination no less) that he had no information 
linking Romain to either Coralpines or any other internet 
facilitator. Tr. 407. Moreover, the Government did not produce any 
other evidence probative of whether the single Romain prescription 
laced a legitimate medical purpose and was issued outside of the 
usual course of professional practice.
---------------------------------------------------------------------------

    The Government also introduced into evidence various e-mails that 
were sent from the Fosus to Coralpines and vice versa. See GX 15. Among 
these is a February 13, 2007 e-mail from ``Kwamen and Pat'' to 
``Coralpines Support'' with the subject line of ``sun&lake costs.'' Id. 
at 20. In this e-mail, Pat Fosu wrote:


    The volume is NOT the problem but rather your erratic payments. 
Do you know the amount of drugs and boxes upon boxes of UPS bags 
that we ordered just to service your company? Do you know the risk 
that we have to take to order enough narcotic or control [sic] 
medications just to meet your client needs?
    I have gone out of my way to order huge inventory of narcotics 
plus hire additional labor to take care of your needs only to 
experince [sic] your erratic, sluggish, and when-you-like payment 
attitude.
    Just last week, the DEA confiscated all the narcotics or control 
medications in another pharmacy and I stand to lose these meds if 
they should come to my pharmacy. But you don't have anything to 
lose! And when I go through all these headaches to satisfy your 
needs then I have to put up with your PAYMENT PLAN!

Id.

    As part of its investigation, a DI sent administrative subpoenas to 
the boards of pharmacy of each State (except for Florida) and the 
District of Columbia to determine whether Respondent or each of the 
Fosus held the requisite pharmacy license. Tr. 204. The DI received a 
response from all but four States; these responses were submitted into 
the record as Government Exhibit 6. Id. at 205. According to the DI, 
neither of the Fosus was licensed in these States. Id. at 205-06. 
However, the Government did not submit a copy of the subpoenas it 
issued, and the ALJ found that the responses from the States of 
Delaware, Kansas, Missouri, New Hampshire, South Carolina, and Wyoming 
did not adequately establish ``what inquiry was made and answered or 
why the author possesses the requisite competence to provide the 
information contained therein'' and were therefore unreliable. ALJ at 9 
n.15. I agree with the ALJ's findings. I further agree with the ALJ's 
findings that Respondent did not have a state license in the remaining 
States.
    Respondent did not call any witnesses to testify on its behalf. It 
introduced but a single exhibit, which was comprised of photographs 
showing both the exterior and interior of its premises. See RX 11.

Discussion

    Section 304(a) of the Controlled Substances 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 [its] 
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.
    (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).
    The Government has the burden of proving that the Respondent has 
committed acts which render its registration inconsistent with the 
public interest. 21 CFR 1301.44(d) & (e). However, where the Government 
has made out a prima facie case, the burden shifts to the applicant to 
``present[] sufficient mitigating evidence'' to show why it can be 
entrusted with a new registration. Medicine Shoppe-Jonesborough, 73 FR 
364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) 
(quoting Leo R. Miller, 53 FR 21931, 21932 (1988))), aff'd, Medicine 
Shoppe-Jonesborough v.

[[Page 24530]]

DEA, 2008 WL 4899525 (6th Cir. 2008). ``Moreover, because `past 
performance is the best predictor of future performance,' ALRA Labs, 
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held 
that where a registrant has committed acts inconsistent with the public 
interest, the registrant must accept responsibility for [his] actions 
and demonstrate that [he] will not engage in future misconduct.'' 
Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John 
H. Kennedy, 71 FR 35705, 35709 (2006); Cuong Trong Tran, 63 FR 64280, 
62483 (1998); Prince George Daniels, 60 FR 62884, 62887 (1995).
    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.'' \15\ 21 U.S.C. 
824(a)(4). I further hold that Respondent has not rebutted the 
Government's prima facie case. Accordingly, Respondent's registration 
will be revoked and any pending applications will be denied.
---------------------------------------------------------------------------

    \15\ This Agency has repeatedly held that the possession of a 
valid state license is not dispositive of the public interest 
inquiry. See Patrick W. Stodola, 74 FR 20727, 20730 n.16 (2009); 
Robert A. Leslie, 68 FR at 15230. DEA has long held that ``the 
Controlled Substances Act requires that the Administrator * * * make 
an independent determination as to whether the granting of 
controlled substances privileges would be in the public interest.'' 
Mortimer Levin, 57 FR 8680, 8681 (1992). Nor is the lack of any 
criminal convictions related to controlled substances dispositive. 
Edmund Chein, 72 FR 6580, 6793 n.22 (2007), aff'd, Chein v. DEA, 533 
F.3d 828 (D.C. Cir. 2008). Thus, the fact that Respondent may still 
hold its Florida pharmacy license and that neither it, not its 
owners, have been convicted of a criminal offense is not 
dispositive.
---------------------------------------------------------------------------

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.' '' Medicine Shoppe-
Jonesborough, 73 FR at 381 (quoting 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).\16\
---------------------------------------------------------------------------

    \16\ 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)).
---------------------------------------------------------------------------

    Under the CSA, it is fundamental that ``a practitioner must 
establish a bona fide doctor-patient relationship in order to act `in 
the usual course of * * * professional practice' and to issue a 
prescription for a `legitimate medical purpose.' '' Patrick W. Stodola, 
74 FR 20727, 20731 (2009) (citing Moore, 423 U.S. at 141-43). At the 
time of the events at issue here, the CSA generally looked to state law 
to determine whether a doctor has established a bona fide doctor-
patient relationship with an individual.\17\ Stodola, 74 FR at 20731; 
see also Kamir Garces-Mejias, 72 FR 54931, 54935 (2007); United 
Prescription Servs., Inc., 72 FR 50397, 50407 (2007). As explained 
below, prior to the dispensings at issue here, numerous States had 
either enacted legislation or promulgated administrative rules which 
generally prohibited (except for in narrow circumstances not relevant 
here) a physician from prescribing a controlled substance to a person 
without having personally performed a physical examination.
---------------------------------------------------------------------------

    \17\ On October 15, 2008, the President signed into law the Ryan 
Haight Online Pharmacy Consumer Protection Act of 2008, Pub. L. 110-
425, 122 Stat. 4820 (2008). Section 2 of the Act prohibits the 
dispensing of a prescription controlled substance ``by means of the 
Internet without a valid prescription'' and defines, in relevant 
part, the ``[t]he term `valid prescription' [to] mean [ ] a 
prescription that is issued for a legitimate medical purpose in the 
usual course of professional practice by * * * a practitioner who 
has conducted at least 1 in-person medical evaluation of the 
patient.'' 122 Stat. 4820 (codified at 21 U.S.C. 289(e)(1) & (2)). 
Section 2 further defines ``[t]he term `in-person medical 
evaluation' [to] mean [ ] a medical evaluation that is conducted 
with the patient in the physical presence of the practitioner, 
without regard to whether portions of the evaluation are conducted 
by other health professionals.'' Id. (codified at 21 U.S.C. 
829(e)(2)(B)). These provisions do not, however, apply to 
Respondent's conduct.
---------------------------------------------------------------------------

    In United Prescription Services, I further explained that ``[a] 
physician who engages in the unauthorized practice of medicine is not a 
`practitioner acting in the usual course of * * * professional 
practice.' '' 72 FR at 50407 (citing 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 held shortly after the CSA's enactment: ``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[.]'').
    Finally, as I have previously explained, an entity which 
voluntarily engages in interstate 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 Prescription Servs., 72 FR at 50408; 
Bob's Pharmacy & Diabetic Supplies, 74 FR 19599, 19601 (2009); see also 
Hageseth v. Superior Court, 59 Cal. Rptr.3d 385, 403 (Ct. App. 2007) 
(noting that the ``proscription of the unlicensed practice of medicine 
is neither an obscure nor an unusual state prohibition of which 
ignorance can

[[Page 24531]]

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.'').\18\
---------------------------------------------------------------------------

    \18\ In Hageseth, the California Court of Appeals 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.
---------------------------------------------------------------------------

    The Fosus had ample reason to know that the prescriptions 
Respondent filled for Coralpines were issued outside of the course of 
professional practice and lacked a legitimate medical purpose for 
multiple reasons. 21 CFR 1306.04(a). First, the Fosus knew that Drs. 
Flynn and De La Guardia were prescribing controlled substances without 
establishing a valid doctor-patient relationship. Indeed, the evidence 
is clear that the Fosus knew from the outset of their agreement with 
Pitcairn/Coralpines that Drs. Flynn and De La Guardia were issuing the 
prescriptions without having performed a physical examination of the 
persons who were seeking the drugs.
    During the interviews they gave when the warrant was executed, both 
of the Fosus admitted they knew from the time they were approached by 
Mr. Wright that the Coralpines' scheme involved physicians issuing 
prescriptions for persons they never saw. Tr. 397 (DI's testimony 
regarding interview of Patricia Fosu) & 417-18 (DI's testimony 
regarding interview of Kwame Fosu). Moreover, certainly within days of 
agreeing to fill the prescriptions, the Fosus knew that, given the 
respective locations of Drs. Flynn (in Pennsylvania) and De La Guardia 
(Kansas) and the persons they were prescribing to, who were located 
throughout the country, neither doctor was performing physical 
examinations of these persons and establishing legitimate doctor-
patient relationships with Coralpines' customers. Indeed, the Fosus 
admitted as much in their respective interviews. Id. at 396-97 & 419.
    The volume of the prescriptions provided further reason to know--as 
if it was needed--that neither Dr. Flynn nor Dr. De La Guardia was 
physically examining these persons. As early as February 2, 2007, Dr. 
Flynn issued 344 prescriptions on a single day. Yet this did not lead 
the Fosus to stop filling the prescriptions. Indeed, on February 19, 
Flynn issued 837 prescriptions, a rate of nearly 35 prescriptions per 
hour had he worked around the clock. Notwithstanding their knowledge of 
Flynn's assembly line rate of prescribing, the Fosus continued to fill 
his prescriptions. While there were numerous other days on which Flynn 
wrote hundreds of prescriptions, Respondent continued to fill the 
prescriptions for several months thereafter.
    While at the time of the events at issue, the CSA did not 
explicitly require that a physician perform a physical examination 
prior to prescribing a controlled substance through the Internet,\19\ 
as DEA explained in the 2001 Guidance Document (a copy of which was 
provided to the Fosus shortly after they obtained Respondent's 
registration and which was published in the Federal Register), most 
state medical boards considered that a doctor's performance of a 
physical examination (and the taking of a medical history) to be 
essential steps in establishing a legitimate doctor-patient 
relationship. See 66 FR at 21182-83. Moreover, prior to Respondent's 
agreeing to fill the Pitcairn/Coralpines prescriptions, most States had 
enacted legislation, promulgated administrative rules, or issued policy 
statements making clear that, except for in limited circumstances not 
relevant here, a physician must physically examine a patient before 
prescribing to him/her. As licensed health care providers and 
participants in interstate commerce, the Fosus ``cannot reasonably 
claim ignorance'' of state rules and standards of medical practice 
applicable to the issuance of treatment recommendations as well as 
those prohibiting the unauthorized practice of both medicine and 
pharmacy. See United Prescription Servs., 72 FR at 50408 (quoting 
Hageseth, 59 Cal. Rptr.3d at 403).
---------------------------------------------------------------------------

    \19\ It now does. See Ryan Haight Online Pharmacy Consumer 
Protection Act of 2008, Public Law 110-425, 122 Stat. 4820 (2008). 
These provisions are codified throughout the CSA.
---------------------------------------------------------------------------

    Since January 2001, California has prohibited the prescribing or 
dispensing of a dangerous drug ``on the Internet for delivery to any 
person in this state, without an appropriate prior examination and 
medical indication therefore, except as authorized by Section 2242.'' 
Cal. Bus. & Prof. Code Sec.  2242.1. In 2003, the Medical Board of 
California made clear that ``[b]efore prescribing a dangerous drug, a 
physical examination must be performed'' by the prescribing physician. 
In re Steven Opsahl, M.D., Decision and Order, at 3 (Med. Bd. Cal. 
2003) (available by query at https://publicdocs.medbd.ca.gov/pdl/mbc.aspx). Furthermore, the Medical Board of Califo