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70788 Federal Register / Vol. 71, No.

234 / Wednesday, December 6, 2006 / Notices

submissions with the Secretary by TIME AND DATE: December 15, 2006 at 11 may be carried over to the agenda of the
facsimile or electronic means only to the a.m. following meeting.
extent permitted by section 201.8 of the PLACE: Room 101, 500 E Street SW., By order of the Commission.
rules (see Handbook for Electronic Washington, DC 20436. Telephone: Issued: December 4, 2006.
Filing Procedures, ftp://ftp.usitc.gov/ (202) 205–2000. Marilyn R. Abbott,
pub/reports/ STATUS: Open to the public.
electronic_filing_handbook.pdf). Secretary to the Commission.
Persons with questions regarding Matters To Be Considered [FR Doc. 06–9579 Filed 12–4–06; 11:43 am]
electronic filing should contact the 1. Agenda for future meetings: none. BILLING CODE 7020–02–P
Secretary (202–205–2000 or 2. Minutes.
edis@usitc.gov). 3. Ratification List.
Any submissions that contain INTERNATIONAL TRADE
4. Inv. Nos. 701–TA–444–446 and COMMISSION
confidential business information must 731–TA–1107–1109
also conform with the requirements of (Preliminary)(Coated Free Sheet Paper [USITC SE–06–061]
section 201.6 of the Commission’s Rules from China, Indonesia, and Korea)—
of Practice and Procedure (19 CFR briefing and vote. (The Commission is Sunshine Act Meeting Notice
201.6). Section 201.6 of the rules currently scheduled to transmit its
requires that the cover of the document AGENCY HOLDING THE MEETING: United
determination to the Secretary of
and the individual pages be clearly States International Trade Commission.
Commerce on December 15, 2006;
marked as to whether they are the Commissioners’ opinions are currently TIME AND DATE: December 14, 2006 at 11
‘‘confidential’’ or ‘‘nonconfidential’’ scheduled to transmit its determination a.m.
version, and that the confidential to the Secretary of Commerce on or PLACE: Room 101, 500 E Street SW.,
business information be clearly before December 22, 2006.). Washington, DC 20436. Telephone:
identified by means of brackets. All 5. Outstanding action jackets: none. (202) 205–2000.
written submissions, except for In accordance with Commission STATUS: Open to the public.
confidential business information, will policy, subject matter listed above, not
be made available in the Office of the disposed of at the scheduled meeting, Matters To Be Considered
Secretary to the Commission for may be carried over to the agenda of the 1. Agenda for future meetings: none.
inspection by interested parties. following meeting. 2. Minutes.
The Commission may include some or 3. Ratification List.
all of the confidential business By order of the Commission.
Issued: December 4, 2006.
4. Inv. Nos. AA1921–197, 701–TA–
information submitted in the course of 319, 320, 325–327, 348, and 350); and
this investigation in the report it sends Marilyn R. Abbott,
731–TA–573, 574, 576, 578, 582–587,
to the USTR and the President. Secretary to the Commission. 612, and 614–618 (Second Review)
However, should the Commission [FR Doc. 06–9578 Filed 12–4–06; 11:43 am] (Certain Carbon Steel Products from
publish a public version of this report, BILLING CODE 7020–02–P Australia, Belgium, Brazil, Canada,
such confidential business information Finland, France, Germany, Japan, Korea,
will not be published in a manner that Mexico, Poland, Romania, Spain,
would reveal the operations of the firm INTERNATIONAL TRADE Sweden, Taiwan, and the United
supplying the information. COMMISSION Kingdom)—briefing and vote. (The
The public record for this Commission is currently scheduled to
[USITC SE–06–060]
investigation may be viewed on the transmit its determination and
Commission’s electronic docket (EDIS) Sunshine Act Meeting Notice Commissioners’ opinions to the
at http://edis.usitc.gov. Hearing Secretary of Commerce on or before
impaired individuals may obtain AGENCY HOLDING THE MEETING: United January 17, 2007.).
information on this matter by contacting States International Trade Commission. 5. Outstanding action jackets: none.
the Commission’s TDD terminal on 202– TIME AND DATE: December 12, 2006 at 11 In accordance with Commission
205–1810. Persons with mobility a.m. policy, subject matter listed above, not
impairments who will need special PLACE: Room 101, 500 E Street SW., disposed of at the scheduled meeting,
assistance in gaining access to the Washington, DC 20436. Telephone: may be carried over to the agenda of the
Commission should contact the Office (202) 205–2000. following meeting.
of the Secretary at 202–205–2000.
STATUS: Open to the public. By order of the Commission.
By order of the Commission.
Matters To Be Considered Issued: December 4, 2006.
Issued: November 30, 2006.
Marilyn R. Abbott,
Marilyn R. Abbott, 1. Agenda for future meetings: none.
Secretary to the Commission.
Secretary to the Commission. 2. Minutes.
[FR Doc. 06–9580 Filed 12–4–06; 11:43 am]
[FR Doc. E6–20671 Filed 12–5–06; 8:45 am] 3. Ratification List.
BILLING CODE 7020–02–P
BILLING CODE 7020–02–P 4. Inv. No. 731–TA–891
(Review)(Foundry Coke from China)—
briefing and vote. (The Commission is
INTERNATIONAL TRADE currently scheduled to transmit its DEPARTMENT OF JUSTICE
COMMISSION determination and Commissioners’
Drug Enforcement Administration
PWALKER on PRODPC60 with NOTICES

opinions to the Secretary of Commerce


[USITC SE–06–062]
on or before December 29, 2006.). Mario Alberto Diaz, M.D.—Denial of
Sunshine Act Meeting Notice 5. Outstanding action jackets: none. Application
In accordance with Commission
AGENCY HOLDING THE MEETING: United policy, subject matter listed above, not On June 27, 2005, the Deputy
States International Trade Commission. disposed of at the scheduled meeting, Assistant Administrator, Office of

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Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Notices 70789

Diversion Control, Drug Enforcement customers who had received through September 12, 2003, the date
Administration, issued an Order to prescriptions for controlled substances the warrant was executed. Of these
Show Cause to Mario Alberto Diaz, M.D. that were issued by Respondent. See id. twenty thousand prescriptions,
(Respondent) of Miami, Florida. The The Show Cause Order alleged that each approximately five thousand of them
Show Cause Order proposed to deny of these customers told investigators had been filled and dispensed on behalf
Respondent’s pending application for a that before receiving controlled of Pharmacom. All of the Pharmacom
DEA Certificate of Registration as a substances, they had had no contact prescriptions were filled between
practitioner, on the ground that granting with Respondent other than by e-mail. August 18, 2003, and September 12,
Respondent a registration would be Id. The Show Cause Order thus 2003.
inconsistent with the public interest. concluded by alleging that Respondent The investigation determined that
See Show Cause Order at 1; see also 21 was ‘‘responsible for the diversion of Pharmacom was located in Miami,
U.S.C. 824(a)(4), id. § 823(f). large quantities of controlled Florida, and that it owned the domain
More specifically, the Show Cause substances,’’ and that he had name Buymeds.com and operated the
Order alleged that in May 2003, ‘‘indiscriminately dispensed large Web site http://www.buymeds.com.
Respondent, who had previously been volumes of controlled substances to Approximately 1,240 of the controlled
registered as a practitioner, entered into persons’’ he had never seen or substance prescriptions downloaded by
a contract with Pharmacom, an Internet physically examined. Id. Union Family Pharmacy from the
pharmacy, under which he agreed to On July 15, 2005, the Show Cause Pharmacom web site and filled by the
issue prescriptions online. Show Cause Order was served on Respondent by pharmacy were issued by Respondent.
Order at 5. The Show Cause Order certified mail as evidenced by the Because of unusual banking activity,
alleged that Respondent issued Return Receipt Card. Thereafter, on July Pharmacom had previously come to the
approximately 100 prescriptions per 23, 2005, Respondent submitted a letter attention of the Internal Revenue
day, and that Respondent admitted to me in which he waived his right to Service (IRS) and, on September 2,
having issued approximately twenty to a hearing and submitted a written 2003, two IRS special agents
twenty-five thousand prescriptions statement setting forth his position on interviewed Mr. Orlando Birbragher,
during the period of his employment the matters of fact and law involved. See Pharmacom’s President and CEO.
with Pharmacom. See id. 21 CFR 1301.43(c). The investigative file During the interview, the IRS special
The Show Cause Order further alleged was then forwarded to me for final agents determined that Pharmacom
that Respondent issued prescriptions for agency action. operated multiple on-line pharmacy
controlled substances based on Based on Respondent’s letter to me, I Web sites including Buymeds.com. The
questionnaires submitted by customers conclude that Respondent has waived interview determined that Pharmacom’s
over the Internet. See id. The Show his right to a hearing. Moreover, having customers submitted on-line
Cause Order alleged that the considered the record as a whole questionnaires to purchase Schedule III
questionnaire solicited from the including Respondent’s statement, I and IV controlled substances, and that
customer information regarding the conclude that granting Respondent’s Pharmacom’s doctors evaluated the
drugs the customer wished to purchase application for a new registration would questionnaires to determine whether to
and obtained the customer’s payment be inconsistent with the public interest approve or reject the order.
information and was then electronically and make the following findings. Pharmacom’s doctors did not, however,
transmitted to Respondent. See id. The conduct a physical exam of the
Show Cause Order alleged that based on Findings customer. Instead, the questionnaires
the questionnaire, Respondent would Respondent, a medical doctor with a required the patient to indicate whether
issue a prescription for a controlled specialty in anesthesiology, formerly they had been examined by a physician
substance and that the principal drugs held a DEA certificate of registration as within the past year. Mr. Birbragher
he prescribed were hydrocodone, a a practitioner under which he was further maintained that Pharmacom’s
Schedule III controlled substance, and authorized to prescribe Schedule II doctors contacted the customers and
Valium, a Schedule IV controlled through Schedule V controlled their physicians when evaluating the
substance. See id. substances. On May 20, 2004, questionnaires. Those prescriptions
The Show Cause Order also alleged Respondent surrendered his registration which were approved were then sent to
that Respondent never saw the during the execution of a search warrant a pharmacy, which filled the
customers and did not perform a at his residence/registered location, prescriptions and shipped them to the
physical exam on them, that he did not which was located in Miami, Florida. customers. Pharmacom paid both the
have a pre-existing doctor-patient On September 12, 2003, two DEA doctor who issued the prescription and
relationship with them, and that he did Diversion Investigators from the Des the pharmacy which filled it.
not create or maintain patient records Moines, Iowa office, DEA Task Force Mr. Birbragher told the IRS agents that
for them. See id. The Show Cause Order Officers, and investigators from the Iowa Respondent had started working for
further alleged that Respondent never Board of Pharmacy Examiners executed Pharmacom in March 2003.
consulted with the customers’ primary a federal search warrant at the Union Respondent’s duties involved reviewing
care physicians or obtained from them Family Pharmacy, 2541 Central Avenue, the questionnaires and determining
the customers’ medical records, and that Dubuque, Iowa. The search was whether a prescription should be
the only information he reviewed was initiated based on information that the issued. Pharmacom initially paid
the questionnaires submitted by the Union Family Pharmacy was engaged in Respondent $20 for evaluating a request
customers. See id. at 5–6. filling purported prescriptions that it for a new prescription and $10 for
The Show Cause Order additionally downloaded from an Internet site and evaluating a request for a refill. Because
PWALKER on PRODPC60 with NOTICES

alleged that many of the prescriptions that it distributed the drugs to persons of the volume of business it attracted,
written by Respondent were for minors. nationwide. Pharmacom subsequently cut its
See id. at 6. The Show Cause Order also During the search, investigators seized payment rates in half. Even at this
alleged that during its investigation of approximately twenty thousand reduced payment rate, Pharmacom paid
Pharmacom, the Iowa Board of prescriptions that the pharmacy had Respondent $218,586 between April
Pharmacy contacted approximately 20 filled and dispensed from March 2003 and August 2003. Mr. Birbragher further

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70790 Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Notices

told the IRS agents that Respondent Respondent told the investigators that a cosmetic surgery center where he
used physician assistants (PA’s) to assist customers would contact Pharmacom provided anesthesia services even
him in evaluating the patient through the Internet and fill out a though he had previously surrendered
questionnaires. Mr. Birbragher did not questionnaire provided by it. his DEA registration.
know, however, whether Respondent or Pharmacom then assigned a list of During this interview, Respondent
the PA’s actually reviewed the patients to Respondent. Respondent’s asserted that he had researched the DEA
questionnaires. job was to review the questionnaires w Web site and could not find any
Thereafter, one of the DIs reviewed and then interview the customers either statute indicating that prescribing over
prescription data obtained during the by telephone or e-mail to determine the Internet ‘‘could not be done.’’
search of the Union Family Pharmacy. whether the customers were eligible to Respondent further stated that he
More specifically, the DI reviewed the receive the drug they requested. thought the practice was similar to that
prescription data that the pharmacy Respondent stated to the investigators in an emergency room where the
downloaded from the buymeds.com that he told Pharmacom that he was patients are ‘‘unknown’’ to the
website and filled on September 7, only willing to review 100 customers a physician. Respondent again
2003. On that date, the pharmacy filled day and that he did not issue maintained that he had contacted
583 Buymeds’ prescriptions. Of the 583 prescriptions to ten to twenty-five Kanner to determine whether the
prescriptions, only 29 (4.9%) were for percent of the customers. Respondent practice was legal and had been told by
non-controlled substances. The also told the investigators that he Kanner that Pharmacom’s attorneys had
remaining prescriptions were for reviewed approximately 40 to 50 refill ‘‘stated that it was legal.’’ Respondent
controlled substances such as prescriptions a day and that he made as further stated that when he met with
hydrocodone, codeine, propoxyphene, much as $14,000 a week. Kanner and Birbragher, they told him
and Ambien (zolpidem). Respondent Respondent further told the ‘‘they were licensed in all states and
issued 146 of the 583 prescriptions that investigators that he never saw any of [that] he could make a huge amount of
were filled that day. While the the customers and that he never money.’’
investigative file does not indicate how developed a doctor/patient relationship Respondent further admitted that
many of these prescriptions were for with any of them as everything was while he limited himself to 100
controlled substances, even if done either via the Internet or by ‘‘patients’’ per day, a general
Respondent issued all of the non- telephone. According to the DI’s report, practitioner would normally see thirty
controlled substance prescriptions, he Respondent admitted that the to forty patients per day. Respondent
still would have issued 117 controlled information provided by the customers asserted that the only difference
substance prescriptions that were filled was never verified and that when he between his activities and that of a
on that day.1 interviewed customers by telephone, he general practitioner was that a ‘‘general
On May 20, 2004, investigators could not verify whom he was talking practitioner sees the patient.’’
executed a search warrant at to. Respondent added that he would review
Respondent’s residence in Miami. While When the DI asked Respondent the medical history provided by the
Respondent was not home when the whether he knew it violated the law to customer and such other information as
search commenced, his son contacted issue a prescription for a controlled the customer’s location, age, weight,
him by cell phone. Respondent spoke substance without having a legitimate height, and previous and current
with a DEA Special Agent and agreed to doctor/patient relationship, Respondent medications. Later in this interview,
return to his residence. Upon his return, did not give a specific answer. Instead, Respondent admitted that he ‘‘felt
a DI and IRS special agent interviewed Respondent asserted that whenever he uncomfortable with the number of
him. questioned the legality of the practice, patients’’ he was assigned, and that
Respondent told the investigators that Kanner or Birbragher assured him that when he telephoned patients, ‘‘some
he began working for Pharmacom in it was legal. When the DI reminded appeared to be druggies.’’ Respondent
April 2003 and quit in November 2003. Respondent that he was the doctor, also stated that as time went on, he ‘‘felt
Respondent stated that another Respondent stated, ‘‘Yes, I know that.’’ people were ordering medications for
physician had told him about Respondent also told the investigators habits or entertainment,’’ and that the
Pharmacom’s business and had that he quit Pharmacom because ‘‘types of people ordering were getting
recommended him to Marshall Kanner, sometime in September or October worse and worse.’’
one of the owners. Thereafter, 2003, Birbragher told him that all Respondent admitted that the
Respondent interviewed with Kanner customers would have to receive a customers submitted requests for
for a position with Pharmacom. Kanner physical exam and that he did not agree specific drugs, but that he would ‘‘never
told him that the position would with this policy. When questioned as to ask a patient what drug they wanted’’
involve authorizing medication over the the basis of his disagreement, because doing so would be contrary to
Internet to patients who were seeing or Respondent became vague and evasive ‘‘good medical practice.’’ He further
had seen a doctor in the past year. and would not specifically answer the stated that the ‘‘best professional care
Respondent claimed that he expressed question. Towards the end of the would be face to face.’’ He also claimed
to Kanner his concerns regarding interview, Respondent was also advised that he had quit because the physical
prescribing medicine in this manner, by the DI that having surrendered his examinations that Pharmacom had
but Kanner told him it was legal. DEA registration, he was not authorized started providing were incomplete.
According to Respondent, Kanner also to handle controlled substances in any Respondent admitted that some
told him he could authorize manner and could not possess, customers requested multiple drugs
prescriptions for customers throughout dispense, administer or prescribe them. such as hydrocodone and alprazolam.
PWALKER on PRODPC60 with NOTICES

the United States. Subsequently, on September 14, 2004, Respondent also stated that he approved
Respondent agreed to undergo a proffer between twenty and twenty-five
1 A further analysis of the computer data seized
interview at the DEA Miami field office. thousand prescriptions during the
during the search of the Union Family Pharmacy During the interview, at which he was period of his association with
found that Respondent issued 1,240 prescriptions
for controlled substances during the period August represented by counsel, Respondent Pharmacom and that the highest number
18, 2003, through September 12, 2003. stated that he was currently employed at of prescriptions he authorized in a day

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Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Notices 70791

was about 200. In response to a question should not be written without a the Administrative Procedure Act 80
regarding the danger of prescribing physical examination.’’ (1947) (Wm. W. Gaunt & Sons, Inc.,
medication without establishing a I further take official notice of the fact Reprint 1979). Therefore, pursuant to 5
doctor/patient relationship, Respondent that on May 17, 2006, the Florida U.S.C. 556(e) and 21 CFR § 1316.59(e),
stated that the ‘‘potential for killing Department of Health issued an order I hereby take official notice of the fact
people can happen in a hospital,’’ but imposing an emergency suspension of that on May 17, 2006, the Florida
that ‘‘a bigger potential [exists] over the Respondent’s state medical license. That Department of Health issued an order
Internet.’’ order remains in effect. imposing an emergency suspension of
In his written statement responding to Respondent’s state medical license.2
the Show Cause Order, Respondent Discussion
Respondent is therefore without
asserted that he ‘‘attempted to perform Section 303(f) of the Controlled authority under state law to handle
my medical functions in a professional Substances Act provides that an controlled substances in the state in
and ethical manner.’’ Respondent application for a practitioner’s which he intends to practice medicine.
further stated that he ‘‘did call the registration may be denied upon a Our precedents have repeatedly
patient to evaluate them for their determination ‘‘that the issuance of such construed the Controlled Substances
prescriptions,’’ and that he ‘‘denied a registration would be inconsistent with Act (CSA) as precluding DEA from
high percentage of the prescriptions the public interest.’’ 21 U.S.C. 823(f). In issuing a registration to an applicant
requested.’’ making the public interest who lacks authority to handle
Respondent asserted that he searched determination, the Act requires the controlled substances in the state where
the websites of both DEA and the consideration of the following factors: the applicant practices medicine. See 21
Florida Department of Health to see if U.S.C. 802(21) & 823(f); see also George
(1) The recommendation of the appropriate
there were ‘‘any laws that made this State licensing board or professional Thomas, 64 FR 15811, 15812 (1999);
business illegal.’’ Respondent also disciplinary authority. Robert E. Hales, 52 FR 17646 (1987).
stated that Pharmacom’s owners had (2) The applicant’s experience in Moreover, denial of an application is
‘‘fooled [him] into thinking that their dispensing * * * controlled substances. appropriate even ‘‘when a State license
business was legal’’ and that he ‘‘would (3) The applicant’s conviction record under has been suspended, but [there is] a
never knowingly violate any laws.’’ Federal or State laws relating to the possibility of future reactivitation.’’
Respondent further asserted that he was manufacture, distribution, or dispensing of
Alton E. Ingram, Jr., 69 FR 22562 (2004).
unaware of the statements of DEA, the controlled substances.
(4) Compliance with applicable State, Therefore, I conclude that Respondent’s
American Medical Association, the lack of state authority is reason alone to
Federal, or local laws relating to controlled
Federation of State Medical Boards, the deny his application for a registration.
substances.
Food and Drug Administration, and the (5) Such other conduct which may threaten But because the Florida Department of
National Association of Boards of the public health and safety. Health’s order is not a final decision and
Pharmacy (all of which were recited in may be rescinded, an analysis of
the Show Cause Order) and all of which Id.
Respondent’s conduct as charged in the
discuss the illegality and/or impropriety ‘‘[T]hese factors are * * * considered
Show Cause Order and his defenses is
of prescribing over the Internet without in the disjunctive,’’ Robert A. Leslie,
warranted.
establishing a bona-fide doctor-patient M.D., 68 FR 15227, 15230 (2003). I ‘‘may
relationship. rely on any one or combination of Factors Two and Four—Respondent’s
Respondent contended that as an factors, and may give each factor the Experience in Dispensing Controlled
anesthesiologist he had rarely written weight [I] deem[] appropriate in Substances and His Record of
prescriptions and that while he ‘‘knew determining whether * * * an Compliance With Applicable Laws
that a patient-doctor relationship had to application for registration [should be] The CSA’s implementing regulations
be established,’’ he ‘‘honestly believed denied.’’ Id. Moreover, case law state that for ‘‘[a] prescription for a
that having a patient fill out a establishes that I am ‘‘not required to controlled substance to be effective [it]
questionnaire about their health and make findings as to all of the factors.’’ must be issued for a legitimate medical
another dedicated section related to the Hoxie v. DEA, 419 F.3d 477, 483 (6th purpose by an individual practitioner
medication they were requesting would Cir. 2005); see also Morall v. DEA, 412 acting in the usual course of his
fulfill this criteria.’’ Respondent also F.3d 165, 173–74 (D.C. Cir. 2005). professional practice.’’ 21 CFR
maintained that he ‘‘would question the In this matter, I conclude that 1306.04(a). This regulation further
patient about any previous prescriptions multiple grounds support the denial of provides that ‘‘[a]n order purporting to
for the medication they were then Respondent’s application. Specifically, be a prescription issued not in the usual
requesting,’’ and that ‘‘[a] very large Respondent currently lacks authority course of professional treatment * * *
percentage of them had already been under Florida law to practice medicine is not a prescription within the meaning
prescribed the medication by their and therefore is not entitled to a DEA and intent of * * * 21 U.S.C. 829 * * *
family physician.’’ Respondent further registration. Moreover, even if the State and the person * * * issuing it, shall be
stated that he ‘‘did call a few of their of Florida were to rescind its order of subject to the penalties provided for
physicians in cases I suspected of emergency suspension, my analysis of
problems.’’ several other factors also demonstrates 2 In accordance with the Administrative
In his written statement, Respondent that granting his application would be Procedure Act and DEA’s regulations, Respondent
added that he resigned when he became inconsistent with the public interest. is ‘‘entitled on timely request, to an opportunity to
aware ‘‘that a physical examination was show to the contrary.’’ 5 U.S.C. 556(e). See also 21
needed to write a prescription.’’ Factor One—The Recommendation of CFR 1316.59(e). DEA’s regulations contain no
the State Licensing Board provision for requesting reconsideration of a final
PWALKER on PRODPC60 with NOTICES

Respondent also stated that he ‘‘will order. See Robert A. Leslie, M.D., 60 FR 14004,
never work for any endeavor of this type It has long been recognized that 14005 (1995). To allow Respondent the opportunity
ever again.’’ Respondent concluded by ‘‘[a]gencies may take official notice of to refute the facts of which I am taking official
notice, publication of this final order shall be
stating that he ‘‘accept[ed] that the facts at any stage in a proceeding—even withheld for a fifteen-day period, which shall begin
selling of medications over the Internet in the final decision.’’ U.S. Dept. of on the date of service by placing this order in the
is not correct and that a prescription Justice, Attorney General’s Manual on mail.

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violations of the provisions of law way to verify the information provided 5 U.S.C. 552(a)(1)(D). DEA, however,
relating to controlled substances.’’ Id. by the customers.4 took the further step of posting this
As the Supreme Court has recognized, Furthermore, while Respondent policy statement on the Office of
the CSA reflects Congress’s ‘‘intent to asserts that he asked Pharmacom’s Diversion Control’s Web page and the
limit a registered physician’s dispensing owners about the legality of issuing document is easily found by using the
authority to the course of his Internet prescriptions (who assured him Web page’s search engine.
professional practice.’’ United States v. that the practice was lawful), there were The purpose of the Notice was ‘‘to
Moore, 423 U.S. 122, 140 (1975). The numerous reasons to question its provide guidance to prescribers * * *
Court has further explained that the legality. For example, customers were and the public concerning the
CSA ‘‘reflect[s] the intent of Congress to not required to submit any application of current laws and
confine authorized medical practice documentation (other than the regulations as they relate to the use of
within accepted limits.’’ Id. at 141–42. questionnaire) regarding a medical the Internet for dispensing [and]
Thus, in Moore, the Court upheld a condition that would demonstrate the purchasing * * * controlled
criminal conviction of a physician for need for a drug.5 Moreover, Respondent substances.’’ Id. The Notice further
knowingly or intentionally distributing did not review the customer’s explained that ‘‘[w]ith the advent of
controlled substances in violation of the questionnaires and choose a drug to Internet pharmacies, DEA registrants
CSA, explaining that the physician’s prescribe based on his ‘‘diagnosis’’ of and the public have asked how these
‘‘conduct exceeded the bounds of the customer’s medical condition. Internet pharmacies fit into the
professional practice’’ when the Rather, it was the customer who requirements that currently exist for the
physician prescribed controlled requested a specific drug. Respondent prescribing and dispensing of controlled
substances and ‘‘gave inadequate admitted, however, that he would substances.’’ Thus, DEA issued this
physical examinations or none at all.’’ ‘‘never ask a patient what drug they policy statement, which was based on
Id. at 142–43. wanted’’ because doing so would be the application of existing law to the
The evidence in this case establishes contrary to ‘‘good medical practice.’’ new circumstances that arose with the
that Respondent repeatedly acted Finally, Respondent should have emergence of the Internet as a
outside the course of professional questioned why Pharmacom’s mechanism to engage in commerce.
practice and violated the CSA. customers did not submit prescriptions The Notice expressly addressed the
Respondent, while contracted to issued by their own doctors but rather potential illegality under existing law of
Pharmacom, issued between twenty and required that prescriptions be issued by prescribing a controlled substance based
twenty-five thousand prescriptions to him and the other Pharmacom doctors. on an on-line questionnaire. After
persons with whom he had no bonafide Indeed, Respondent admitted that when noting the regulation pertaining to the
doctor-patient relationship. While the he telephoned patients, ‘‘some appeared purpose of a prescription, see 21 CFR
investigative file does not establish the to be druggies,’’ and that as time went 1306.04, the Notice explained that
exact number of controlled substance on he ‘‘felt people were ordering ‘‘[u]nder Federal and state law, for a
prescriptions issued by Respondent, the medications for habits or doctor to be acting in the usual course
analysis of the 583 Buymeds.com entertainment.’’ In short, Respondent of professional practice, there must be a
prescriptions filled by Union Family had numerous indications that issuing bona fide doctor/patient relationship.’’
Pharmacy on September 7, 2003, prescriptions in this manner ‘‘exceeded 66 FR at 21182. The Notice further
establishes that at least 117 (out of a the bounds of professional practice,’’ observed that:
total of 143) prescriptions issued by Moore, 423 U.S. at 142, and violated many state authorities, with the endorsement
Respondent and filled on that date were federal law notwithstanding the of medical societies, consider the existence of
for a controlled substance.3 comments of Pharmacom’s owners. the following four elements as an indication
Furthermore, the analysis of the that a legitimate doctor/patient relationship
Respondent maintains that he visited has been established:
prescriptions filled by the Union Family the DEA and Florida Department of • A patient has a medical complaint
Pharmacy for Pharmacom between Health Web sites but could find no • A medical history has been taken
August 18, 2003, and September 12, information that the practice of Internet • A physical examination has been
2003, shows that Respondent issued prescribing was illegal. As for his effort performed; and
1240 controlled substance prescriptions. to find information on the issue at the • Some logical connection exists between
Given that this represents only a small DEA Web site, Respondent must not the medical complaint, the medical history,
portion of the period during which the physical examination, and the drug
have looked very hard. On April 27,
Respondent was engaged with prescribed.
2001, DEA published a Notice in the
Pharmacom, it is reasonable to infer that Federal Register entitled ‘‘Dispensing Id. at 21182–83.
Respondent issued many more and Purchasing Controlled Substances The Notice thus concluded that
prescriptions for controlled substances. over the Internet.’’ See 66 FR 21181. To ‘‘[c]ompleting a questionnaire that is
Respondent issued the prescriptions the extent DEA was required to give then reviewed by a doctor hired by the
notwithstanding that he did not perform notice of this policy statement, Internet pharmacy could not be
a physical exam and had no face-to-face publication in the Federal Register is all considered the basis for a doctor/patient
interaction with Pharmacom’s that was necessary to comply with the relationship. * * * It is illegal to
customers. While Respondent Administrative Procedure Act. See receive a prescription for a controlled
maintained that he called or contacted substance without the establishment of
via e-mail the customers ‘‘on a regular 4 I note, however, that Respondent does not a legitimate doctor/patient relationship,
basis’’ to discuss their questionnaires contend that he actually contacted every patient. and it is unlikely for such a relationship
and denied some percentage of the Moreover, the assembly line nature of his activity
to be formed through Internet
PWALKER on PRODPC60 with NOTICES

begs the question of what Respondent did when a


requests, Respondent admitted in the customer did not answer the phone or failed to correspondence alone.’’ 6 Id. at 21183.
interviews that there was generally no timely call him back or respond to his e-mail.
5 This is not to suggest that Respondent would 6 As the Notice explained, ‘‘[a] consumer can
3 The investigative file does not establish the have acted lawfully if he had issued prescriptions more easily provide false information in a
precise date that Respondent issued these on the basis of medical reports submitted directly questionnaire than in a face-to-face meeting with a
prescriptions. to him by customers. doctor.’’ Id. at 21183.

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Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Notices 70793

The Notice further stated that doctors that such information was readily Street, NW., Washington, DC. Requests
who issued prescriptions without available at the time Respondent for information, or advance notices of
establishing a legitimate doctor/patient commenced his contract with intention to observe an open meeting,
relationship could be subjected ‘‘to Pharmacon and therefore will not may be directed to: Administrative
criminal, civil, or administrative excuse his misconduct.7 Moreover, I Officer, Foreign Claims Settlement
actions,’’ and that ‘‘[f]or DEA registrants find that Respondent’s experience in Commission, 600 E Street, NW., Room
administrative action may include the dispensing controlled substances and 6002, Washington, DC 20579.
loss of their DEA registration.’’ Id. Thus, his record of compliance with Telephone: (202) 616–6988.
contrary to Respondent’s suggestion that applicable laws involve numerous
Mauricio J. Tamargo,
no information was publicly available violations of the CSA in that
regarding the potential illegality of the Respondent issued prescriptions Chairman.
practice, DEA had given fair warning without a legitimate medical purpose [FR Doc. 06–9568 Filed 12–4–06; 10:10 am]
that prescribing a controlled substance and that these factors demonstrate that BILLING CODE 4410–01–P
based on an on-line questionnaire and granting Respondent’s application (in
without conducting a physical exam the event the State were to rescind its
could be deemed a violation of the order) would be inconsistent with the DEPARTMENT OF LABOR
CSA’s longstanding requirement that a public interest. Having found so, it is
prescription must be issued for a unnecessary to address the remaining Office of the Secretary
legitimate medical purpose. DEA also factors. See, e.g., Hoxie, 419 F.3d at 483;
Morall, 412 F.3d at 165. Submission for OMB Review:
warned that issuing a prescription
Comment Request
without such a purpose could subject a Order
physician to criminal, civil and November 29, 2006.
administrative proceedings. Accordingly, pursuant to the
authority vested in me by 21 U.S.C. The Department of Labor (DOL) has
Moreover, in April 2002, the submitted the following public
Federation of State Medical Boards 823(f), and 28 CFR 0.100(b) and 0.104,
I hereby order that the application of information collection request (ICR) to
adopted its model guidelines for the use the Office of Management and Budget
of the Internet in medical practice. Mario Alberto Diaz for a DEA Certificate
of Registration as a Practitioner be, and (OMB) for review and approval in
Section Five of this document states that accordance with the Paperwork
‘‘[a] documented patient evaluation, it hereby is, denied. This order is
effective January 5, 2007. Reduction Act of 1995 (Pub. L. 104–13,
including history and physical 44 U.S.C. chapter 35). A copy of this
evaluation adequate to establish Dated: November 3, 2006. ICR, with applicable supporting
diagnoses and identify underlying Michele M. Leonhart, documentation, may be obtained from
conditions and/or contra-indications to Deputy Administrator. RegInfo.gov at http://www.reginfo.gov/
the treatment recommended/provided, [FR Doc. E6–20630 Filed 12–5–06; 8:45 am] public/do/PRAMain or by contacting
must be obtained prior to providing BILLING CODE 4410–09–P Darrin King on 202–693–4129 (this is
treatment, including issuing not a toll-free number)/e-mail:
prescriptions, electronically or king.darrin@dol.gov.
otherwise.’’ Federation of State Medical DEPARTMENT OF JUSTICE Comments should be sent to Office of
Boards of the U.S., Inc., Model Information and Regulatory Affairs,
Guidelines for the Appropriate Use of Foreign Claims Settlement Attn: OMB Desk Officer for the Bureau
the Internet in Medical Practice 5 (2002) Commission
of Labor Statistics (BLS), Office of
(emphasis added). [F.C.S.C. Meeting Notice No. 10–06] Management and Budget, Room 10235,
The guidelines further state that Washington, DC 20503, Telephone:
‘‘[t]reatment and consultation Sunshine Act Meeting Notice 202–395–7316 / Fax: 202–395–6974
recommendations made in an online (these are not toll-free numbers), within
setting, including issuing a prescription The Foreign Claims Settlement
Commission, pursuant to its regulations 30 days from the date of this publication
via electronic means, will be held to the in the Federal Register.
same standards of appropriate practice (45 CFR Part 504) and the Government
in the Sunshine Act (5 U.S.C. 552b), The OMB is particularly interested in
as those in traditional (face-to-face) comments which:
hereby gives notice in regard to the
settings.’’ Id. Finally, the guidelines • Evaluate whether the proposed
scheduling of meetings for the
state that ‘‘[t]reatment, including issuing collection of information is necessary
transaction of Commission business and
a prescription, based solely on an online for the proper performance of the
other matters specified, as follows:
questionnaire or consultation, does not functions of the agency, including
constitute an acceptable standard of DATE AND TIME: Thursday, December 14,
2006, at 10 a.m. whether the information will have
care.’’ Id. practical utility;
Thus, while Respondent may have SUBJECT MATTER: Issuance of Amended
Proposed Decisions and Amended Final • Evaluate the accuracy of the
lacked actual knowledge of DEA’s agency’s estimate of the burden of the
interpretation of the CSA and the Decisions in claims against Albania.
proposed collection of information,
position of other entities involved in the STATUS: Open.
including the validity of the
regulation of his profession, I conclude All meetings are held at the Foreign
methodology and assumptions used;
Claims Settlement Commission, 600 E
• Enhance the quality, utility, and
The Notice also discussed some Internet sites
which ‘‘ask[ed] patients to waive the requirement 7 I do not rely on the fact that Respondent worked clarity of the information to be
PWALKER on PRODPC60 with NOTICES

for a physical and to agree to have a physical before as an anesthesiologist after he surrendered his DEA collected; and
taking a drug they purchase via the Internet.’’ Id. registration. While the administration of anesthesia • Minimize the burden of the
In this regard, the Notice stated: ‘‘[a]n after-the-fact invariably requires the use of controlled substances collection of information on those who
physical does not take the place of establishing a and it seems highly probable that Respondent
doctor/patient relationship. The physical exam further violated the CSA by administering
are to respond, including through the
should take place before the prescription is controlled substances without a registration, this use of appropriate automated,
written.’’ Id. conduct was not alleged in the Show Cause Order. electronic, mechanical, or other

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