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28574 Federal Register / Vol. 70, No.

95 / Wednesday, May 18, 2005 / Notices

from where they have a high incidence Henry J. Schwartz, Jr., M.D., 54 FR comply with the law and regulations are
of diversion. These grey market 16,422 (1989). far outweighed by A–1’s lack of
products are not sold in large discount The Deputy Administrator finds experience and the company’s intent to
stores, retail pharmacies or grocery factors four and five relevant to the sell ephedrine and pseudoephedrine
stores, where sales of therapeutic over- pending application for registration. primarily to the gray market. See also,
the-counter drugs predominate. ‘‘Two- With regard to factor four, the CWK, supra, 69 FR 69,400; Prachi,
way’’ ephedrine and single entity applicant’s past experience in the supra, 69 FR 69,407.
pseudoephedrine products are prime distribution of chemicals, the Deputy Based on the foregoing, the Deputy
products in this gray market industry Administrator finds this factor relevant Administrator concludes that granting
and are rarely found in any retail store based on Mr. and Mrs. Smith’s lack of the pending application would be
serving the traditional therapeutic knowledge and experience regarding the inconsistent with the public interest.
market. laws and regulations governing Accordingly, the Deputy
DEA also knows from industry data, handling of list I chemical products. In Administrator of the Drug Enforcement
market studies and statistical analysis prior DEA decisions, this lack of Administration, pursuant to the
that over 90% of over-the-counter drug experience in handling list I chemical authority vested in her by 21 U.S.C. 823
remedies are sold in drug stores, products has been a factor in denying and 824 and 28 CFR 0.100(b) and 0.104,
supermarket chains and ‘‘big box’’ pending applications for registration. hereby orders the pending application
discount retailers. Less than one percent See, e.g., CWK, supra, 69 FR 69,400; for DEA Certificate of Registration,
of cough and cold remedies are sold in Prachi, supra, 69 FR 69,407; Direct previously submitted by A–1
gas stations or convenience stores. Wholesale, supra, 69 FR 11,654; ANM Distribution Wholesale, be, and it
Studies have indicated that most Wholesale, 69 FR 11,652 (2004); Xtreme hereby is, denied. This order is effective
convenience stores could not be Enterprises, Inc., 67 FR 76,195 (2002). June 17, 2005.
With regard to factor five, other
expected to sell more than $20.00 to Dated: May 9, 2005.
factors relevant to and consistent with
$40.00 worth of products containing Michele M. Leonhart,
the public safety, the Deputy
pseudoephedrine per month. The Deputy Administrator.
Administrator finds this factor weighs
expected sales of ephedrine products [FR Doc. 05–9833 Filed 5–17–05; 8:45 am]
heavily against granting the application.
are known to be even smaller. Most
Unlawful methamphetamine use is a BILLING CODE 4410–09–M
convenience stores handling gray
growing public health and safety
market products often order more
concern throughout the United States
product than what is required for the DEPARTMENT OF JUSTICE
and Southeast. Ephedrine and
legitimate market and obtain chemical pseudoephedrine are precursor products
products from multiple distributors. needed to manufacture Drug Enforcement Administration
Pursuant to 21 U.S.C. 823(h), the methamphetamine and operators of
Deputy Administrator may deny an Robert A. Burkich, M.D.; Revocation of
illicit methamphetamine laboratories Registration
application for a Certificate of regularly acquire the precursor products
Registration if she determines that needed to manufacture the drug from On August 23, 2004, the Deputy
granting the registration would be convenience stores and gas stations Assistant Administrator, Office of
inconsistent with the public interest. which, in prior DEA decisions, have Diversion Control, Drug Enforcement
Section 823(h) requires that the been identified as constituting the grey Administration (DEA), issued an Order
following factors be considered in market for list I chemical products. It is to Show Cause to Robert A. Burkich,
determining the public interest: apparent that A–1 intends on being a M.D. (Dr. Burkich) of Nashville,
(1) Maintenance of effective controls participant in this market. Tennessee, notifying him of an
against diversion of listed chemicals While there are no specific opportunity to show cause as to why
into other than legitimate channels; prohibitions under the Controlled DEA should not revoke his DEA
(2) Compliance with applicable Substances Act regarding the sale of Certificate of Registration BB4812043, as
Federal, State and local law; listed chemical products to these a practitioner, under 21 U.S.C. 824(a)(3)
(3) Any prior conviction record under entities, DEA has nevertheless found and deny any pending applications for
Federal or State laws relating to these establishments serve as sources for renewal or modification of that
controlled substances or to chemicals the diversion of large amounts of listed registration pursuant to 21 U.S.C. 823(f).
controlled under Federal or State law; chemical products. See, e.g., ANM As a basis for revocation, the Order to
(4) Any past experience of the Wholesale, supra, 69 FR 11,652; Xtreme Show Cause alleged that Dr. Burkich is
applicant in the manufacture and Enterprises, Inc., 67 FR 76,195; Sinbad not currently authorized to practice
distribution of chemicals; and Distributing, 67 FR 10,232 (2002); medicine or handle controlled
(5) Such other factors as are relevant K.V.M. Enterprises, 67 FR 70,968 (2002). substances in Tennessee, his state of
to and consistent with the public health The Deputy Administrator has registration and practice.
and safety. previously found that many On September 15, 2004, Dr. Burkich,
As with the public interest analysis considerations weighed heavily against acting pro se, filed a Waiver of Hearing
for practitioners and pharmacies registering a distributor of list I and Written statement (Written
pursuant to subsection (f) of section 823, chemicals because, ‘‘[v]irtually all of the Statement) with the Hearing Clerk of the
these factors are to be considered in the Respondent’s customers, consisting of DEA Office of Administrative Law
disjunctive; the Deputy Administrator gas station and convenience stores, are Judges. The investigative file and
may rely on any one of a combination considered part of the grey market, in Written Statement were than forwarded
of factors and may give each factor the which large amounts of listed chemicals to the Deputy Administrator for her
weight she deems appropriate in are diverted to the illicit manufacture of final order.
determining whether a registration amphetamine and methamphetamine.’’ The Deputy Administrator finds Dr.
should be revoked or an application for Xtreme Enterprises, Inc., supra, 67 FR at Burkich waived his right to a hearing
registration denied. See, e.g., Energy 76,197. As in Xtreme Enterprises, Inc., and, in lieu of a hearing, submitted a
Outlet, 64 FR 14,269 (1999). See also, lack of a criminal record and intent to Written Statement regarding his

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Federal Register / Vol. 70, No. 95 / Wednesday, May 18, 2005 / Notices 28575

position on the matters of fact and law authorized to practice medicine in the DeFrank was further notified that his
that are involved in this proceeding. States of Tennessee and Georgia. As a DEA registration was immediately
Accordingly, after considering material result, it is reasonable to infer he is also suspended as an imminent danger to the
from the investigative file and Dr. without authorization to handle public health and safety pursuant to 21
Burkich’s Written Statement, the Deputy controlled substances in either state. U.S.C. 824(d).
Administrator now enters her final DEA does not have statutory authority The Order to Show Cause and
order without a hearing pursuant to 21 under the Controlled Substances Act to Immediate Suspension of Registration
CFR 1301.43(c) and (e) and 1301.46. issue or maintain a registration if the alleged in sum, that Dr. DeFrank was
The Deputy Administrator finds Dr. applicant or registrant is without state illegally prescribing controlled
Burkich currently possesses DEA authority to handle controlled substances over the Internet without
Certificate of Registration BB4812043, substances in the state in which he personal contacts, examinations or bona
which expires on July 31, 2005. The conducts business. See 21 U.S.C. fide physician/patient relationships
Deputy Administrator further finds that 802(21), 823(f) and 824(a)(3). This with the customers ordering the
on March 17, 2004, Tennessee Board of prerequisite has been consistently medications. These prescriptions were
Medical Examiners (Tennessee Board) upheld. See Stephen J. Graham, M.D., not issued ‘‘in the usual course of
issued a Final Order revoking Dr. 69 FR 11661 (2004); Dominick A. Ricci, professional treatment’’ and violated 21
Burkich’s license to practice medicine M.D., 58 FR 51104 (1993); Bobby Watts, CFR 1306.04 and 21 U.S.C. 841(a).
in Tennessee. The Tennessee Board’s M.D., 53 FR 11919 (1988). According to the investigative file, the
action was based upon its findings of Here, it is clear Dr. Burkich’s order to Show Cause and Immediate
fact that Dr. Burkich had been convicted Tennessee medical license has been Suspension of Registration was
in the United States District Court for revoked and he is not currently licensed personally accepted on Dr. DeFrank’s
the Eastern District of Tennessee of one to handle controlled substances in that behalf by his attorney in Carrolltown,
felony count of mail fraud (18 U.S.C. state, where he is registered with DEA. Texas, on November 4, 2004. More than
1341) and that the Georgia Composite Therefore, he is not entitled to a DEA thirty days have passed since service of
State Board of Medical Examiners registration in Tennessee. the Order to show Cause and Immediate
(Georgia Board) had revoked Dr. Accordingly, the Deputy Suspension of Registration and DEA has
Burkich’s license to practice medicine Administrator of the Drug Enforcement not received a request for hearing or any
in Georgia, as a result of that conviction. Administration, pursuant to the other reply from Dr. DeFrank or anyone
In his Written Statement, Dr. Burkich authority vested in her by 21 U.S.C. 823 purporting to represent him in this
concedes he pled guilty to the criminal and 824 and 28 CFR 0.100(b) and 0.104, matter.
charge. However, he alleges he had a hereby orders that DEA Certificate of Therefore, the Deputy Administrator
viable defense of entrapment and only Registration BB4812043, issued to of DEA, finding that (1) thirty days
pled guilty after being misadvised by his Robert A. Burkich, M.D., be, and it having passed since the delivery of the
retained defense counsel who, Dr. hereby is, revoked. The Deputy Order to Show Cause and Immediate
Burkich asserts, was ineffective and had Administrator further orders that any Suspension of Registration to Dr.
a conflict of interest. Attached to his pending applications for renewal or DeFrank’s attorney, and (2) no request
Written Statement is a Motion for a modification of such registration be, and for hearing having been received,
Certificate of Appealability, which Dr. they hereby are, denied. This order is concludes that Dr. DeFrank is deemed to
Burkich filed in the United States Court effective June 17, 2005. have waived his hearing right. See
of Appeals for the Sixth Circuit (Case David W. Linder, 67 FR 12579 (2002).
Dated: May 9, 2005.
No. 04–6027). In that Motion, Dr. After considering material from the
Burkich asserts in detail the factual and Michele M. Leonhart, investigative file in this matter, the
legal basis for the claims in his Written Deputy Administrator. Deputy Administrator now enters her
Statement. [FR Doc. 05–9836 Filed 5–17–05; 8:45 am] final order without a hearing pursuant
The Deputy Administrator has BILLING CODE 4410–09–M to 21 CFR 1301.43(d) and (e) and
determined that on November 23, 2004, 1301.46.
the court of Appeals issued an Order While some consumers use Internet
denying Dr. Burkich’s Motion for a DEPARTMENT OF JUSTICE pharmacies for convenience, privacy
Certificate of Appealability. He and cost savings, others, including
Drug Enforcement Administration minor children, use the anonymity of
subsequently filed a Petition for an En
Banc Rehearing which has not yet been the Internet to procure controlled
Salvatore DeFrank, D.P.M. Revocation
acted upon by the Court. Accordingly, substances illegally. The role of a
of Registration
the federal conviction which was the legitimate online pharmacist is to
underlying basis for Dr. Burkich’s On October 28, 2004, the Deputy dispense prescription medications and
license revocation remains a valid Administrator of the Drug Enforcement to counsel patients about the proper use
judgment. Administration (DEA) issued an Order of these medications, not to write or
More significantly for purposes of this to Show Cause and Immediate originate prescriptions. Internet
proceeding, Dr. Burkich does not Suspension of Registration to Salvatore profiteers are online suppliers of
contend in either his Written Statement DeFrank, D.P.M. (Dr. DeFrank) of Dallas, prescription drugs, be they owners,
or the accompanying Motion, that the Texas. Dr. DeFrank was notified of an operators, pharmacists, or doctors, who
Tennessee Board’s Final Order has been opportunity to show cause as to why illegally and unethically market
stayed, modified or terminated or that DEA should not revoke his DEA controlled substances via the Internet
either of his state medical licenses have Certificate of Registration, BD8259346, for quick profit. Operation PHARMNET,
been reinstated. Further, there is no as a practitioner, and deny any pending which this Order to show Cause and
evidence in the investigative file applications for renewal or modification Immediate Suspension of Registration is
indicating the Tennessee Board’s Final of such registration pursuant to 21 a part of, is a nationwide action by the
Order is no longer in effect. U.S.C. 823(f) and 824(a)(4) for reason DEA to disrupt and dismantle this
Therefore, the Deputy Administrator that his continued registration would be illegal and dangerous cyberspace threat
finds Dr. Burkich is not currently inconsistent with the public interest. Dr. to the public health and safety.

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