Registrant Actions - 2010
FR Doc 2010-20193[Federal Register: August 16, 2010 (Volume 75, Number 157)]
[Notices]
[Page 49991-49992]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au10-103]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-26]
Beverley P. Edwards, M.D.; Revocation of Registration
On January 21, 2010, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Beverly P. Edwards, M.D. (Respondent), of
Indianapolis, Indiana. The Show Cause Order proposed the revocation of
Respondent's DEA Certificate of Registration, BE8619667, and the denial
of any pending applications to renew or modify her registration, on the
ground that Respondent's "continued registration is inconsistent with
the public interest, as that term is defined in 21 U.S.C. 823(f)."
Show Cause Order at 1 (citing 21 U.S.C. 824(a)(4)).
The Show Cause Order specifically alleged that Respondent was
prescribing controlled substances over the Internet based on "online
questionnaires and/or webcam consultations and without first conducting
an in person physical examination" and that she lacked a "legitimate
medical purpose" and acted "outside the usual course of professional
practice" in issuing the prescriptions in violation of 21 CFR
1306.04(a) and 21 U.S.C. 841(a)(1). Id. at 2. Next, the Order alleged
that while Respondent is licensed to practice medicine in only the
States of Indiana, California and New York, she was prescribing
controlled substances to persons throughout the United States from her
residence in Texas, where she is not licensed, and was engaged in the
unauthorized practice of medicine in violation of the laws of Texas, as
well as the various States where the patients resided. Id. (citations
omitted). Relatedly, the Order alleged that Respondent was using her
"DEA registration to prescribe controlled substances from locations
outside of the State [Indiana] where [she is] registered with DEA, in
violation of 21 CFR 1301.12(a) & (b)(3)." Id. Finally, the Show Cause
Order alleged that Respondent was authorizing refills of schedule II
controlled substances in violation of 21 U.S.C. 829(a). Id.
Based on the above, I concluded that Respondent's continued
registration during the pendency of the proceeding would "constitute[]
an imminent danger to the public health and safety." Id. I therefore
invoked my authority under 21 U.S.C. 824(d) and immediately suspended
Respondent's registration. Id. at 2-3.
On January 25, 2010, Respondent requested a hearing on the
allegations and the matter was placed on the docket of the Agency's
Administrative Law Judges. Thereafter, on February 2, 2010, the
Government moved for summary disposition contending that on January 29,
2010, the State of Indiana had summarily suspended Respondent's state
medical license effective January 28, 2010, as well as her state
controlled substances registration. Mot. for Summary Disp. at 1. The
Government also noted that on February 2, the State had issued an
amended order which summarily suspended her state medical license,
which was also effective on January 28, 2010.\1\ Id. As support for its
motion, the Government attached copies of the various state suspension
orders as well as other documents. Based on Respondent's lack of
authority under state law to dispense controlled substances in Indiana,
the State in which she holds her DEA registration, the Government
requested that the ALJ issue a decision recommending that Respondent's
registration be revoked. Id. at 2-3.
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\1\ Apparently, the amended summary suspension order was issued
to extend the length of the suspension from 90 days (as provided in
the initial order) "until the date of the final hearing in this
matter." Compare Mot. for Summary Disp. Attachment 1, at 2, with
Attachment 2, at 2.
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Thereafter, the ALJ issued an Order for Respondent's Response to
the Government's Motion and gave Respondent until February 10, 2010 to
file a response. Subsequently, on Respondent's motion, the ALJ granted
her an extension until February 22 to file her pleading.
On February 18, Respondent filed her Response. Therein, Respondent
did not dispute that she "currently lacks the authority to handle
controlled substances in the State of Indiana, the jurisdiction in
which until February 2, 2010 she was duly licensed." Response to Gov.
Mot. for Summ. Disp. at 1. Respondent argued, however, that the
Government's request was "premature" because the Medical Licensing
Board of Indiana had not issued a final decision and that "any attempt
to seek revocation at this time is without basis and premature." Id.
On February 19, the ALJ issued her decision (also ALJ). Therein,
the ALJ noted that the State of Indiana has suspended Respondent's
medical license and that she had admitted "that she no longer has
authority to handle controlled substances in Indiana." ALJ at 4.
Noting that DEA does not have "authority under the Controlled
Substances Act to maintain a controlled substances registration if the
registrant is without state authority to handle controlled substances
in the state in which she practices medicine," and that "revocation
is * * * appropriate [even] when a state license has been suspended * *
* with the possibility of future reinstatement," the ALJ concluded
that there was no dispute over the material fact that Respondent
"lacks authority to handle controlled substances in Indiana." ALJ at
5 (citations omitted). The ALJ thus held that "DEA lacks authority to
continue * * * Respondent's DEA registration," granted the
Government's motion, and recommended that Respondent's registration be
revoked and that any pending applications be denied. Id. at 5-6.
While neither party would file exceptions to the ALJ's decision, on
February 24, Respondent filed a motion to stay the ALJ's decision
"until such time as the matter before the Medical Licensing Board of
Indiana can be resolved." Motion to Stay Decision at 1. Respondent
also noted that the State hearing had been set for March 25, 2010. Id.
The Government opposed the motion.
On March 12, the ALJ denied the motion noting that Respondent had
"offered no evidence suggesting that the circumstances have changed or
that she currently has authority to handle controlled substances in
Indiana." Order Denying Respondent's Motion to Stay Decision at 2. On
March 19, the ALJ forwarded the record to me for final agency action.
Thereafter, the Government filed a motion to supplement the record.
Therein, the Government noted that on March 30, 2010, the Medical
Licensing Board of Indiana had issued a final order permanently
revoking Respondent's medical license. Mot. to Supplement at 1. The
Government attached a copy of the state order, which included extensive
findings of fact and conclusions of law (many of which Respondent
apparently stipulated to). See In re Edwards, No. 2009 MLB 0024 (Med.
Lic. Bd. Ind., Mar 30, 2010) (final order). The findings established
numerous instances in which Respondent, who "is only licensed to
practice medicine in the States of
[[Page 49992]]
Indiana, New York and California," id. at 1, and is only registered by
DEA at two addresses in Indiana, id. at 2, issued controlled substance
prescriptions (and frequently with multiple refills) to residents of
Oklahoma, Colorado, Ohio, Illinois, Texas, Georgia, and North Carolina
without having performed a physical examination of them. Id. at 2-13.
Many of the prescriptions were for a combination drug containing 15
milligrams of hydrocodone and 80 milligrams of acetaminophen and were
for as many as 360 tablets per each dispensing; other prescriptions
were for hydrocodone/acetaminophen (10/325), oxycodone/acetaminophen
(7.5/500) and Xanax. See id.
Moreover, the State found, with respect to one patient (Patient D),
that his wife had called Respondent and told her that he had been using
30-40 pills a day and was in a treatment program for overusing opioids.
Id. at 6-7. The State found that two weeks after being informed of
this, Respondent nonetheless issued Patient D a prescription for 360
tablets of hydrocodone/acetaminophen (15/80) with five refills. Id. at
7. Moreover, Respondent issued Patient D additional prescriptions for
360 tablets of hydrocodone/acetaminophen (15/80) on two occasions
thereafter, as well as other prescriptions for hydrocodone/
acetaminophen (10/325). Id.
The State further found that Respondent's conduct constituted
multiple violations of Indiana law. Id. at 13-17. Among her violations
were those of the State's rules which prohibit prescribing a drug
without "[a] documented patient evaluation, including history and
physical evaluation adequate to establish diagnosis and identify
underlying conditions or contraindications to the treatment recommended
or provided," 844 Ind. Admin. Code 5-3-2, and prescribing "any
controlled substances to a person who the physician has never
personally physically examined and diagnosed." 844 Ind. Admin. Code 5-
4-1(a); see also In re Edwards, at 16-17.
Discussion
Under the Controlled Substances Act (CSA), a practitioner must be
currently authorized to handle controlled substances in "the
jurisdiction in which he practices" in order to maintain a DEA
registration. See 21 U.S.C. 802(21) ("[t]he term `practitioner' means
a physician * * * licensed, registered, or otherwise permitted, by * *
* the jurisdiction in which he practices * * * to distribute, dispense,
[or] administer * * * a controlled substance in the course of
professional practice"). See also id. Sec. 823(f) ("The Attorney
General shall register practitioners * * * if the applicant is
authorized to dispense * * * controlled substances under the laws of
the State in which he practices."). As these provisions make plain,
possessing authority under State law to handle controlled substances is
an essential condition for holding a DEA registration.
Accordingly, DEA has held repeatedly that the CSA requires the
revocation of a registration issued to a practitioner whose state
license has been suspended or revoked. David W. Wang, 72 FR 54297,
54298 (2007); Sheran Arden Yeates, 71 FR 39130, 39131 (2006); Dominick
A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920
(1988). See also 21 U.S.C. 824(a)(3) (authorizing the revocation of a
registration "upon a finding that the registrant * * * has had his
State license or registration suspended [or] revoked * * * and is no
longer authorized by State law to engage in the * * * distribution [or]
dispensing of controlled substances").
As found above, the Medical Licensing Board has issued a final
order "permanently revoke[ing]" Respondent's Indiana medical license.
In re Edwards, at 18. Respondent therefore lacks authority under
Indiana law to dispense controlled substances in Indiana, the State in
which she holds her DEA registration. Because Respondent is no longer
entitled to maintain her DEA registration, her registration will be
revoked and any pending applications will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) & 0.104, I grant the Government's
motion to supplement the record. I order that DEA Certificate of
Registration, BE8619667, issued to Beverly P. Edwards, M.D., be, and it
hereby is, revoked. I further order that any pending applications of
Beverly P. Edwards, M.D., to renew or modify her registration, be, and
they hereby are, denied. This Order is effective September 15, 2010.
Dated: July 30, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-20193 Filed 8-13-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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