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24622 Federal Register / Vol. 70, No.

89 / Tuesday, May 10, 2005 / Notices

Dated: May 2, 2005. The Deputy Administrator finds that hereby orders that the application for
Michele M. Leonhart, on July 2, 2004, Dr. Jones applied for DEA Certificate of Registration
Deputy Administrator. DEA registration to handle Schedule II submitted by Stephen K. Jones, M.D.,
[FR Doc. 05–9252 Filed 5–9–05; 8:45 am] through IV controlled substances. His be, and it hereby is, denied. This order
BILLING CODE 4410–09–M
proposed registered address was at the is effective June 9, 2005.
LDS Hospital, 8th Avenue & C Street, Dated: May 2, 2005.
Salt Lake City, Utah 84143. The
Michele M. Leonhart,
DEPARTMENT OF JUSTICE application indicated Dr. Jones was
Deputy Administrator.
previously disciplined by the Iowa
Drug Enforcement Administration Board of Medical Examiners which, in [FR Doc. 05–9246 Filed 5–9–05; 8:45 am]
April 2004, had suspended his Iowa BILLING CODE 4410–09–M
Stephen K. Jones, M.D.; Denial of license to practice medicine for 30 days
Registration and placed it in a probationary status
upon his completion of a two month DEPARTMENT OF JUSTICE
On November 10, 2004, the Deputy
Assistant Administrator, Office of residential treatment program for opioid
Drug Enforcement Administration
Diversion Control, Drug Enforcement dependency.
According to information in the
Administration (DEA), issued an Order [Docket No. 04–56]
investigative file, on July 27, 2004, a
to Show Cause to Stephen K. Jones,
Diversion Investigator conducting an
M.D. (Dr. Jones) who was notified of an inquiry into Dr. Jones application was Michael J. Millette, M.D.; Revocation of
opportunity to show cause as to why advised by the Utah Department of Registration
DEA should not deny his application for Commerce, Division of Occupational
DEA Certificate Registration as a On May 17, 2004, the Deputy
and Professional Licensing, that he did Administrator of the Drug Enforcement
practitioner to handle controlled not hold a Utah Physician and Surgeon
substances, pursuant to 21 U.S.C. 823 Administration (DEA) issued an Order
License or state Controlled Substance to Show Cause and Immediate
and 824. License. Further, there is no evidence
The Order to Show Cause alleged in Suspension of Registration to Michael J.
before the Deputy Administrator Millette, M.D. (Dr. Millette) of Crystal
relevant part, that Dr. Jones was not showing that Dr. Jones has since been
licensed to practice medicine or handle Lake, Illinois and Elizabethtown,
granted a license to practice medicine or Kentucky. Dr. Millette was notified of
controlled substances in Utah, the state handle controlled substance in that
in which he was applying for an opportunity to show cause as to why
state.
registration and intended to practice. DEA should not revoke his DEA
DEA does not have statutory authority
Secondarily, the Order alleged Dr. Jones under the Controlled Substances Act to Certificates of Registration, BM2349012
had previously been disciplined in issue or maintain a registration if the and BM8086236, as a practitioner, and
Iowa, where he currently lives and applicant or registrant is without state deny any pending applications for
practices, for personal drug abuse, authority to handle controlled renewal or modification of such
signing a fraudulent prescription and substances in the state in which he registrations pursuant to 21 U.S.C.
diverting controlled substances. The conducts business. See 21 U.S.C. 823(f) and 824(a)(4) for reason that his
Order to Show Cause also notified Dr. 802(21), 823(f) and 824(a)(3). This continued registration would be
Jones that should no request for a prerequisite has been consistently inconsistent with the public interest. Dr.
hearing be filed within 30 days, his upheld. See Rory Patrick Doyle, M.D., Millette was further notified that his
hearing right would be deemed waived. 69 FR 11,655 (2004); Dominick A. Ricci, DEA registrations were immediately
The Order to Show Cause was sent by M.D., 58 FR 51,104 (1993); Bobby Watts, suspended as an imminent danger to the
certified mail to Dr. Jones Residence at M.D., 53 FR 11,919 (1988). public health and safety pursuant to 21
3525 Mayfield Road, Iowa City, Iowa Here, it is clear Dr. Jones is not U.S.C. 824(d).
and to his proposed registered location licensed to practice medicine in Utah, The Order to Show Cause and
in Salt Lake City, Utah. According to his state of applied-for-registration and Immediate Suspension alleged in sum,
certified mail receipt records, the Order practice, and he is not authorized to that Dr. Millette was engaged in illegally
to Show Cause sent to his residence was handle controlled substances in that prescribing controlled substances as
received by Dr. Jones on December 10, jurisdiction. Therefore, is not entitled to part of a scheme in which controlled
2004. DEA has not received a request for a DEA registration in that state. As a substances were dispensed by
hearing or any other reply from Dr. result of the finding that Dr. Jones lacks pharmacies, based on Internet
Jones or anyone purporting to represent state authorization to handle controlled prescriptions issued by Dr. Millette and
him in this matter. substances in his state of applied-for- associated physicians, based solely on
Therefore, the Deputy Administrator registration, the Deputy Administrator their review of Internet questionnaires
of DEA, finding that (1) thirty days concludes it is unnecessary to address and without personal contact,
having passed since the delivery of the further whether his application should examination or bona fide physician/
Order to Show Cause to the applicant’s be denied based upon the public patient relationships. Such
home and address of record, and (2) no interest grounds asserted in the Order to prescriptions were not issued ‘‘in the
request for hearing having been Show Cause. See Samuel Silas Jackson, usual course of professional treatment’’
received, concludes that Dr. Jones is D.D.S., 67 FR 67,145 (2002); Nathaniel- and violated 21 CFR 1306.04 and 21
deemed to have waived his wearing Aikens-Afful, M.D., 62 FR 16,871 U.S.C. 841(a). This action was part of a
right. See David W. Linder, 67 FR (1997); Sam F. Moore, D.V.M., 58 FR nationwide enforcement operation by
12,579 (2002). After considering 14,428 (1993). DEA titled Operation Pharmnet, which
material from the investigate file in this Accordingly, the Deputy targeted online suppliers of prescription
matter, the Deputy Administrator now Administrator of the Drug Enforcement drugs, including owners, operators,
enters her final order without a hearing Administration, pursuant to the pharmacists and doctors, who have
pursuant to 21 CFR 1301.43(d) and (e) authority vested in her by 21 U.S.C. 823 illegally and unethically been marketing
and 1301.46. and 824 and 28 CFR 0.100(b) and 0.104, controlled substances via the Internet.

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Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices 24623

According to the investigative file, the prescription as follows: ‘‘A prescription electronic means, will be held to the same
Order to Show Cause and Immediate for a controlled substance to be effective standards of appropriate practice as those in
Suspension of Registration was must be issued for a legitimate medical traditional (face-to-face) settings. Treatment,
personally served upon Dr. Millette by purpose by an individual practitioner including issuing a prescription, based solely
on an online questionnaire or consultation
DEA Diversion Investigators on May 19, acting in the usual course of his does not constitute an acceptable standard of
2004. Through counsel, Dr. Millette professional practice.’’ 21 CFR care.
filed a timely request for a hearing and 1306.04(a).
the matter was docketed before Prescriptions issued not in the ‘‘usual The CSA regulations establish certain
Administrative Law Judge Mary Ellen course of professional treatment’’ are responsibilities not only on individual
Bittner. On June 22, 2004, Judge Bittner not ‘‘prescriptions’’ for purposes of the practitioners who issue prescriptions for
issued an Order for Prehearing CSA and individuals issuing and filing controlled substances, but also on
Statements directing Dr. Millette to file such purported prescriptions are subject pharmacists who fill them. A
a prehearing statement no later than to the penalties for violating the CSA’s pharmacist’s ‘‘corresponding
August 4, 2004. controlled substances provisions. responsibility’’ regarding the proper
On August 18, 2004, as a result of Dr. In United States v. Moore, 423 U.S. dispensing of controlled substances is
Millette’s failure to file a prehearing 122 (1975), the Supreme Court held explicitly described in 21 CFR
statement, Judge Bittner issued an Order that, ‘‘Implicit in the registration of a 1306.04(a). It provides:
Terminating Proceeding. In that Order, physician is the understanding that he A prescription for a controlled substance to
Judge Bittner concluded that by his is authorized only to act ‘as a be effective must be issued for a legitimate
inactivity, Dr. Millette had waived his physician.’ ’’ Id., at 141. In Moore the medical purpose by an individual
right to a hearing and she ordered the court implicitly approved a jury practitioner acting in the usual course of his
proceeding terminated so it could be instruction that acting ‘‘as a physician’’ professional practice. The responsibility for
presented to the Deputy Administrator is acting ‘‘in the usual course of a the proper prescribing and dispensing of
for issuance of a final order. On professional practice and in accordance controlled substances is upon the prescribing
February 17, 2005, the investigative file with a standard of medical practice practitioner, but a corresponding
was forwarded by the DEA Office of responsibility rests with the pharmacists who
generally recognized and accepted in fills the prescription.
Chief Counsel to the Deputy the United States.’’ Id., at 138–139; see,
Administrator for final agency action. United States v. Norris, 780 F.2d 1207, In an April 21, 2001, policy statement,
Accordingly, the Deputy 1209 (5th Cir. 1986). entitled, Dispensing and Purchasing
Administrator finds that Dr. Millette is Responsible professional Controlled Substances Over the Internet,
deemed to have waived his right to a organizations have issued guidance in 66 FR 21,181 (2001), DEA delineated
hearing and after considering material this area. The American Medical certain circumstances in which
from the investigative file in this matter, Association’s guidance for physicians prescribing over the Internet is
now enters her final order without a on the appropriate use of the Internet in unlawful. The policy provides, inter
hearing pursuant to 21 CFR 1301.43(d) prescribing medication (H–120.949 alia, that a controlled substance should
and (e) and 1301.46. Guidance for Physicians on Internet not be issued or dispensed unless there
While some consumers use Internet Prescribing) states: was a bona fide doctor/patient
pharmacies for convenience, privacy
and cost savings, others, including Physicians who prescribe medications via relationship. Such a relationship
minor children, use the anonymity of the Internet shall establish, or have requires that the patient have a medical
the Internet to procure controlled established, a valid patient-physician complaint, a medical history taken, a
relationship, including, but not limited to, physical examination performed and
substances illegally. The role of a the following components. The physician
legitimate online pharmacist is to some logical connection between the
shall: medical complaint, the medical history,
dispense prescription medications and i. Obtain a reliable medical history and
to counsel patients about the proper use the physical examination and the drug
perform a physical examination of the
of these medications, not to write or patient, adequate to establish the diagnosis prescribed. The policy statement
originate prescriptions. Internet for which the drug is being prescribed and specifically explains that the
profiteers are online suppliers of to identify underlying conditions and/or completion of ‘‘a questionnaire that is
prescription drugs, be they owners, contraindications to the treatment then reviewed by a doctor hired by the
operators, pharmacists, or doctors, who recommended/provided; Internet pharmacy could not be
ii. have sufficient dialogue with the patient considered the basis for a doctor/patient
illegally and unethically market
regarding treatment options and the risks and relationship * * *’’ Id., at 21,182–83.
controlled substances via the Internet benefits of treatment(s);
for quick profit. Operation PHARMNET, iii. as appropriate, follow up with the Rogue Internet pharmacies bypass a
which this Order to Show Cause and patient to assess the therapeutic outcome; legitimate doctor-patient relationship,
Immediate Suspension of Registration is iv. maintain a contemporaneous medical usually by use of a cursory and
a part of, is a nationwide action by the record that is readily available to the patient incomplete online questionnaire or
DEA to disrupt and dismantle this and, subject to the patient’s consent, to his perfunctory telephone ‘‘consult’’ with a
illegal and dangerous cyberspace threat or her other health care professionals; and doctor, who usually has a contractual
to the public health and safety. v. include the electronic prescription arrangement with the online pharmacy
The Controlled Substances Act (CSA) information as part of the patient medical and is often paid on the basis of
record.
establishes a ‘‘closed system’’ of prescription issued. The Food and Drug
distribution regulating the movement of In April 2000, the Federation of State Administration (FDA) considers the
controlled medications from their Medical Boards adopted Model questionnaire, in lieu of face-to-face
importation or manufacture, through Guidelines for the Appropriate Use of interaction, to be a practice that
delivery to the ultimate user patient, the Internet in Medical Practice, which undermines safeguards of direct medical
pursuant to a lawful order of a state, in pertinent part, that: supervision and amounts to substandard
practitioner. The regulations Treatment and consultation medical care. See U.S. Food and Drug
implementing the CSA explicitly recommendations made in an online setting, Administration, Buying Medicines and
describe the parameters of a lawful including issuing a prescription via Medical Products Online, General

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24624 Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices

FAQ’s (http://fda.gov/oc/buyonline/ BM8086236 for Schedule II through V renewal of such registration, if she
default.htm). Controlled Substances. Their respective determines that the continued
The National Association of Boards of registered addresses are in Crystal Lake, registration would be inconsistent with
Pharmacy considers Internet pharmacies Illinois and Elizabethtown, Kentucky the public interest. Section 823(f)
to be suspect if: and they expire on January 31, 2005 and requires that the following factors be
They dispense prescription medications January 31, 2006. considered in determining the public
without requiring the consumer to mail in a While Dr. Millette had a medical interest:
prescription, and if they dispense office, his main occupation was issuing (1) The recommendation of the
prescription medications and do not contact controlled substance prescriptions to appropriate state licensing board or
the patient’s prescriber to obtain a valid patients (hereinafter ‘‘customers’’) professional disciplinary authority.
verbal prescription. Further, online through the Internet company E.V.A. (2) The applicant’s experience in
pharmacies are suspect if they dispense Global, Inc., and others doing business
prescription medications solely based upon
dispensing or conducting research with
under a number of names. Customers respect to controlled substances.
the consumer completing an online accessing Web sites owned by these
questionnaire without the consumer having a (3) The applicant’s conviction record
pre-existing relationship with a prescriber
companies would complete cursory under federal or state laws relating to
and the benefit of an in-person physical questionnaires and indicate what drugs the manufacture, distribution, or
examination. State boards of pharmacy, were wanted and a method of payment. dispensing of controlled substances.
boards of medicine, the FDA, as well as the The questionnaires would be (4) Compliance with applicable state,
AMA, condemn this practice and consider it electronically forwarded to Dr. Millette federal, or local laws relating to
to be unprofessional. and, based solely on the answers, he controlled substances.
See, National Association of Boards of would issue prescriptions for controlled (5) Such other conduct which may
Pharmacy, VIIPS Program, Most substance. These prescriptions would threaten the public health or safety.
Frequently Asked Questions (http:// then be dispensed by participating These factors are to be considered in
www.nabp.net/vipps/consumer/ pharmacies and sent to customers by the disjunctive; the Deputy
faq.asp). such means as FedEx and the U.S. Administrator may rely on any one or a
Rogue Internet pharmacies often use Postal Service.
combination of factors and may give
persons with limited or no knowledge of On six different occasions between
each factor the weight she deems
medications and standard pharmacy March 2003 and April 2004, DEA
investigators acting in an undercover appropriate in determining whether a
practices to fill prescriptions, do not registration should be revoked or an
advertise the availability of pharmacists capacity went online to order controlled
substances from five Internet company application for registration denied. See
for medication consultation, and focus Henry J. Schwartz, Jr., M.D., 54 FR
on select medications, usually lifestyle, Web sites: Clickhererx.com,
Activeliferx.com, Dietdrugs.com, 16,422 (1989).
obesity and pain medications. Rogue In this case, the Deputy Administrator
Internet pharmacies generally do not IntegraRX.com and RX-MAX.com In
each instance, investigators filled out finds factors two, four and five relevant
protect the integrity of original faxed to the determination of whether Dr.
prescriptions by requiring that they be online questionnaires and ordered drugs
such as Bontril and Phentermine which Millette’s continued registration
received directly from the prescriber remains consistent with the public
(not the patient) and do not verify the are, respectively, Schedule III and IV
controlled substances. These controlled interest.
authenticity of suspect prescriptions. With regards to factor one, the
When the established safeguards of an substances were then shipped to the
addresses provided and were received recommendation of the appropriate state
authentic doctor-patient relationship are licensing board or professional
lacking, controlled substance by investigators. Each of the labels on
the bottles identified Dr. Millette as the disciplinary authority, there is no
prescription drugs can not only be evidence in the investigative file that Dr.
misused, but also present potentially prescribing physician. Other than
initially filling out e-mail Millette has yet been the subject of a
serious health risks to patients. Rogue state disciplinary proceeding, nor is
Internet pharmacies facilitate the easy questionnaires, the investigators had no
communications with Dr. Millette or the there evidence demonstrating that his
circumvention of legitimate medical state medical licenses or state controlled
pharmacies before the prescriptions
practice. The FDA has stated: substance authorities are currently
were issued or dispensed.
We know that adverse events are under- On March 9, 2004 Dr. Millette was restricted in any form. Nevertheless,
reported and we know from history that interviewed by DEA Diversion state licensure is a necessary, but not
tolerating the sale of unproven, fraudulent, or Investigators. He admitted prescribing sufficient condition for registration, and
adulterated drugs results in harm to the therefore, this factor is not dispositive.
controlled substances over the Internet
public health. It is reasonable to expect that
for several companies since October or See e.g., Mario Avello, M.D., 70 FR
the illegal sales of drugs over the Internet and
the number of resulting injuries will increase November 2002 and estimated that on 11,695 (2005); Wesley G. Harline, M.D.,
as sales on the Internet grow. Without clear an average day, he issued a ‘‘couple 65 FR 5,665–01 (2000); James C. LaJevic,
and effective law enforcement, violators will hundred’’ prescriptions without any D.M.D., 64 FR 55,962 (1999).
have not reason to stop their illegal practices. personal contact with the customers. Dr. With regard to factors two and four,
Unless we begin to act now, unlawful Millette admitted being compensated the Deputy Administrator finds the
conduct and the resulting harm to consumers based on the number of questionnaires primary conduct at issue in this
most likely will increase. he reviewed and records seized from proceeding (i.e., the unlawful
See U.S. Food and Drug Administration, E.V.A. Global, Inc. covering an eight prescribing and dispensing of controlled
Buying Medicines and Medical Products month period during 2004, indicated Dr. substance prescriptions for use by
Online, General FAQs (http://fda.gov/ Millette was paid over $175,000.00 for Internet customers) relates to Dr.
oc/buyonline/default.htm). assisting in this scheme. Millette’s experience in prescribing
The Deputy Administrator finds Dr. Pursuant to 21 U.S.C. 823(f) and controlled substances, as well as his
Millette is currently registered with 824(a)(4), the Deputy Administrator may compliance with applicable state,
DEA as a practitioner under DEA revoke a DEA Certificate of Registration federal, or local laws relating to
Registrations BM2349012 and and deny any pending application for controlled substances.

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Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices 24625

A DEA registration authorizes a course of professional practice and he individuals can easily acquire
physician to prescribe or dispense knowingly participated in this scheme. controlled substances without regard to
controlled substances only within the With regard to factor three, Dr. age or health status. Such lack of
usual course of his or her professional Millette’s conviction record under oversight describes Dr. Millette’s
practice. For a prescription to have been federal or state laws relating to the practice of issuing prescriptions for
issued within the course of a dispensing of controlled substances, the controlled substances to indistinct
practitioner’s professional practice, it record does not reflect that he has yet Internet customers which were then
must have been written for a legitimate been convicted of a crime related to filled by pharmacies participating in the
medical purpose within the context of a controlled substances. scheme. Such conduct contributes to the
valid physician-patient relationship. See Regarding factor five, such other abuse of controlled substances by Dr.
Mario Avello, M.D., supra, 70 FR conduct which may threaten the public Millette’s customers and is relevant
11,695; Mark Wade, M.D., 69 FR 7,018 health or safety, the Deputy under factor five, further supporting
(2004). Legally, there is absolutely no Administrator finds this factor revocation of his DEA Certificates of
difference between the sale of an illicit particularly relevant. Registration.
drug on the street and the illicit The Deputy Administrator has Dr. Millette also continued
dispensing of a licit drug by means of previously expressed her deep concern prescribing to Internet customers after
a physician’s prescription. See Floyd A. about the increased risk of diversion issuance of policy statements designed
Santner, M.D., 55 FR 37,581 (1990). which accompanies Internet controlled to assist licensed practitioners and
The Deputy Administrator concludes substance transactions. Given the pharmacists in the proper prescribing
from a review of the record that Dr. nascent practice of cyber-distribution of and dispensing of dangerous controlled
Millette did not establish valid controlled drugs to faceless individuals, drugs. Apparently motivated purely by
physician-patient relationships with the where interaction between individuals financial gain, Dr. Millette has
Internet customers to whom he is limited to information on a computer demonstrated a cavalier disregard for
prescribed controlled substances. DEA screen or credit card, it is virtually controlled substance laws and
has previously found that prescriptions impossible to insure that these highly regulations and a disturbing
issued through Internet Web sites under addictive, and sometimes dangerous indifference to the health and safety of
these circumstances are not considered products will reach the intended individuals purchasing dangerous drugs
as having been issued in the usual recipient, and if so, whether the person through the Internet. Such lack of
course of medical practice, in violation purchasing these products has an actual character and flaunting of the
of 21 CFR 1306.04 and has revoked DEA need for them. The ramifications of responsibilities inherent with a DEA
registrations of several physicians for obtaining dangerous and highly registration show, in no uncertain terms,
participating in Internet prescribing addictive drugs with the ease of logging that Dr. Millette’s continued registration
schemes similar to or identical to that of on to a computer and the use of a credit would be inconsistent with the public
Dr. Millette. See, Mario Avello, M.D., card are disturbing and immense, interest.
supra, 70 FR 11,695; Marvin L. Gibbs, particularly when one considers the Accordingly, the Deputy
Jr., M.D., 69 FR 11,658 (2004); Mark growing problem of the abuse of Administrator of the Drug Enforcement
Wade, M.D., supra, 69 FR 7,018; Ernesto prescription drugs in the United States. Administration, pursuant to the
A. Cantu, M.D., 69 FR 7,014–02 (2004); See, Mario Avello, M.D., supra, 70 FR authority vested in her by 21 U.S.C. 823
Rick Joe Nelson, M.D., 66 FR 30,752 11,695; EZRX, supra, 60 FR at 63,181; and 824 and 28 CFR 0.100(b) and 0.104,
(2001). Mark Wade, M.D., supra, 69 FR 7,018. hereby orders that DEA Certificates of
Similarly, DEA has issued orders to The Deputy Administrator has also Registration BM2349012 and
show cause and subsequently revoked previously found that in a 2001 report, BM8086236, issued to Michael J.
DEA registrations of pharmacies which the National Clearinghouse for Alcohol Millette, M.D., be, and hereby are,
have failed to fulfill their corresponding and Drug Information estimated that 4 revoked. The Deputy Administrator
responsibilities in Internet prescribing million Americans ages 12 and older further orders that any pending
operations similar to, or identical to that had acknowledged misusing applications for renewal or modification
of Dr. Millette. See, EZRX, L.L.C. prescription drugs. That accounts for of such registrations be, and they hereby
(EZRX), 69 FR 63,178 (2004); 2% to 4% of the population—a rate of are, denied. This order is effective June
Prescriptiononline.com, 69 FR 5,583 abuse that has quadrupled since 1980. 9, 2005.
(2004). Prescription drug abuse—typically of
In the instant case, Dr. Millette and painkillers, sedatives and mood-altering Dated: May 2, 2005.
other practitioners associated with this drugs—accounts for one-third of all Michele M. Leonhart,
Internet scheme, authorized illicit drug use in the United States. See, Deputy Administrator.
prescriptions for controlled substances Mario Avello, M.D., supra, 70 FR [FR Doc. 05–9249 Filed 5–9–05; 8:45 am]
without the benefit of face-to-face 11,695; EZRX, supra, 69 FR at 63,181– BILLING CODE 4410–09–M
physician-patient contact, physical 82; Mark Wade, M.D., supra, 69 FR
exam or medical tests. Beyond a couple 7,018.
of rare direct e-mail contacts with The Deputy Administrator finds that DEPARTMENT OF JUSTICE
customers, there is no information in with respect to Internet transactions
the investigative file demonstrating that involving controlled substances, the Drug Enforcement Administration
Dr. Millette and other issuing horrific untold stories of drug abuse,
Thomas J. Mulhearn, III, M.D.;
physicians even took time to corroborate addiction and treatment are the
Revocation of Registration
responses to the questionnaires unintended, but foreseeable
submitted by the customers. Here, it is consequence of providing highly On August 20, 2004, the Deputy
clear the issuance of controlled addictive drugs to the public without Assistant Administrator, Office of
substance prescriptions to persons oversight. The closed system of Diversion Control, Drug Enforcement
whom Dr. Millette had not established distribution, brought about by the Administration (DEA), issued an Order
a valid physician-patient relationship is enactment of the Controlled Substances to Show Cause to Thomas J. Mulhearn,
a radical departure from the normal Act, is completely compromised when III, M.D. (Dr. Mulhearn) of Monroe,

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