[Federal Register: January 8, 2004 (Volume 69, Number 5)]
[Notices]
[Page 1307-1310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja04-36]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 02-11]
Marlou D. Davis, M.D.; Revocation of Registration
On October 12, 2001, the Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause to Marlou D. Davis,
M.D. (Respondent). The show cause order proposed the revocation of DEA
Certificate of Registration AD7084217 pursuant to 21 U.S.C. 824(a), and
denial of any pending applications for renewal or modification of such
registration for reason that such registration was deemed inconsistent
with the public interest pursuant to 21 U.S.C. 823(f). The Order to
Show Cause alleged in substantive part, the following:
1. On November 25, 2000, the Respondent notified the Missouri
Bureau of Narcotics and Dangerous Drugs (``BNDD'') that he was moving
his office/practice from his registered location in Bridgeton, Missouri
to a new location in St. John, Missouri.
2. On December 7, 2000, BNDD notified the Respondent by certified
mail that his Missouri controlled substance registration was valid only
for his registered location in Bridgeton, Missouri. The letter
referenced 19 CSR 30-1.030(1)(J), which states, in part, that ``the
registration of any person shall terminate if and when that person
changes his/her address as shown on the certificate of registration.''
The Respondent was also notified in the letter that he did not
currently have a registration and therefore did not have authority to
order, stock, dispense, prescribe or administer controlled substances
in the State of Missouri. Ref. 19 CSR 30-1.030(1)(E) 1 (``Any person
who is required to be registered and who is not so registered shall not
engage in any activity for which registration is required, until the
application is granted and a certificate of registration is issued by
the Board of Health'').
3. Effective December 20, 2000, the Respondent's Missouri State
Controlled Substances Registration was terminated. Therefore, the
Respondent lacked authority under Missouri state law to prescribe,
dispense and/or administer controlled substances. Consequently, the
Respondent was not authorized to possess a Federal controlled
substances registration.
4. In addition, on October 18, 2000, the Respondent was arrested by
the St. Louis Division Tactical Diversion Squad and charged at the
state felony level with 14 counts of attempt to deliver a controlled
substance and three (3) counts of delivery of a controlled substance.
One of the conditions of the Respondent's release on bond by a St.
Louis County Circuit Judge was that the Respondent would be prohibited
from writing controlled substance prescriptions until his criminal case
was concluded.
5. On April 27, 2001, DEA became aware that the Respondent wrote
two (2) prescriptions for controlled substances for patient B.F. The
first prescription, dated April 23, 2001, was for Triazolam, .25 mg
30, a Schedule IV controlled substance, and Fioricet,
100, a non-controlled substance. The second prescription,
dated May 29, 2001, was for Triazolam, .25 mg, 30.
By letter dated November 12, 2002, the Respondent, acting pro se,
timely requested a hearing. The matter was subsequently assigned to
Administrative Law Judge Gail A. Randall (Judge Randall) and on January
11, 2002, Judge Randall issued to the Government and the Respondent an
Order for Prehearing Statements.
In lieu of filing a prehearing statement, the Government filed
Government's Request for Stay of Proceedings and Motion for Summary
Judgment. The Government argued that the Respondent was without
authorization to handle controlled substances in Missouri, and as a
result, further proceedings in the matter were not required. Attached
to the Government's motion was a copy of a letter dated December 7,
2000, from the Administrator of the Missouri Department of Narcotics
and Dangerous Drugs (``BNDD'') to the Respondent. The letter notified
the Respondent that as a result of his changing the location of his
medical practice, and because his controlled substance registration was
valid only for his registered practice location, the Respondent's
Missouri controlled substance registration was terminated. While the
BNDD letter informed the Respondent that he lacked state authority to
handle controlled substances in Missouri, the Respondent was
nevertheless provided an opportunity to apply for a new Missouri state
certificate of registration at his new business address.
[[Page 1308]]
The Government also attached to its motion a declaration dated
January 25, 2002, from the Assistant Bureau Chief of the Missouri
Department of Health and Senior Services' Bureau of Narcotics and
Dangerous Drugs. The declaration corroborated information regarding the
termination of the Respondent's state controlled substance authority,
and further asserted that he had not submitted an application for a new
state controlled substance registration.
In his reply to the Government's motion, the Respondent
acknowledged that he had closed his Bridgeton office on December 1,
2000, and was informed by a BNDD representative that his state
controlled substance license terminated upon closure of that office.
The Respondent further acknowledged that as of July 1, 2001, his DEA
and BNDD licenses ceased to exist, and that a hearing was not necessary
in this matter. The Respondent subsequently argued that his DEA
registration remained valid pending a resolution of these proceedings.
On March 13, 2002, Judge Randall issued an ``Order of
Clarification'' requesting that the parties explain: (1) The status of
the Respondent's current medical practice, (2) his authorization to
handle controlled substances at this St. John, Missouri address, and
(3) whether or not the Respondent had a viable DEA Certificate of
Registration to revoke. In its March 19, 2002 response, the Government
proffered that DEA had not modified the Respondent's place of business;
the Respondent had abandoned his DEA registered location and
established a new practice in St. John, Missouri; was without state
authority to handle controlled substances in the state; and that the
Respondent had a viable DEA registration to revoke. The Government
again requested that its Motion for Summary Disposition be granted.
In his April 11, 2002, response to the Order for Clarification, the
Respondent argued that following his review of federal statutes, he
discovered that the grounds for revocation provided for under 21 U.S.C.
824(a) were not applicable in this matter. Specifically, the Respondent
argued that his state license had never been suspended or revoked by
competent state authority, but rather, had been ``administratively
dissolved'' as a result of relocating his medical practice.
By Memorandum of Order dated April 22, 2002, Judge Randall denied
the Government's Motion for Summary Disposition. In denying the
Government's motion, Judge Randall found that pursuant to the plain
language of 21 U.S.C. 824(a)(3), revocation of the Respondent's
Certificate of Registration was not authorized. In addition, Judge
Randall found that in this case, DEA had an avenue for terminating, as
opposed to revoking, the Respondent's DEA registration. She further
outlined the distinction between the termination and revocation of a
DEA registration, and found that a revocation results in a ``stigma''
with more significant consequence upon the Respondent than a mere
termination. Judge Randall concluded that since the State of Missouri
had not taken or attempted to take any adverse action against the
Respondent's state registration, the statutory provisions authorizing
revocation of a DEA registration had not been met.
On May 6, 2002, the Government filed a Motion for Reconsideration,
Or in the Alternative, Request for Authorization to File Interlocutory
Appeal, and Motion for Stay of Proceedings. In its motion, the
Government renewed its Motion for Summary Disposition. On July 3, 2002,
the Administrative Law Judge issued a Memorandum and Order, again
denying the Government's Motion for Summary Disposition and Granting
the Government's Motion for Authorization to File Interlocutory Appeal.
Accordingly, on July 24, 2002, the Government filed an interlocutory
appeal with the then-Deputy Administrator of the Drug Enforcement
Administration.
By Order dated November 14, 2002, the then-Deputy Administrator
found that pursuant to 21 U.S.C. 823(a)(3), and where as in the instant
matter a practitioner's state controlled substance authority has
terminated by operation of law and not adverse state action, revocation
of a DEA registration is warranted. The Order further remanded the
matter to the Administrative Law Judge for disposition consistent with
the then-Deputy Administrator's ruling.
On November 21, 2002, Judge Randall issued Opinion, Order and
Recommended Decision of the Administrative Law Judge (Opinion and
Recommended Decision) in which she granted the Government's motion for
summary disposition and found that the Respondent lacked authorization
to handle controlled substances in the State of Missouri. In granting
the Government's motion, Judge Randall also recommended that the
Respondent's DEA registration be revoked and any pending applications
for renewal be denied. Neither party filed exceptions to her Opinion
and Recommended Decision, and on January 21, 2003, Judge Randall
transmitted the record of these proceedings to the Office of the Deputy
Administrator.
The Acting Deputy Administrator has considered the record in its
entirety and pursuant to 21 CFR 1316.67, hereby issues her final order
based upon findings of fact and conclusions of law as hereinafter set
forth. The Acting Deputy Administrator adopts, in full, both the
November 14, 2002 Order of the then-Deputy Administrator with respect
to the Government's interlocutory appeal, as well as the Opinion and
Recommended Decision of the Administrative Law Judge.
As noted above, in her March 13, 2002, ``Order for Clarification''
Judge Randall requested the parties to apprise of whether or not the
Respondent had a viable DEA Certificate of Registration to revoke. The
Acting Deputy Administrator's review of the record reveals that the
Respondent's DEA Certificate of Registration was due to expire on June
30, 2003. There is no evidence in the record that a renewal application
has been submitted on behalf of the Respondent. DEA has previously held
that ``[i]f a registrant has not submitted a timely renewal application
prior to the expiration date, then the registration number expires and
there is nothing to revoke.'' Ronald J. Riegel, D.V.M., 63 FR 67132
(1998). However, because the record in these proceedings was
transmitted to the Office of Deputy Administrator prior to the
expiration date of the Respondent's DEA Certificate of Registration,
the Acting Deputy Administrator will address this matter on its merits,
specifically, the status of the Respondent's DEA Certificate of
Registration.
In his Order of November 14, 2002 (Interlocutory Order), the then-
Deputy Administrator found that the following matters were not in
dispute: (1) The Respondent held DEA Certificate of Registration
AD7084217, as a practitioner; (2) he relocated his medical practice
from his registered location in Bridgeton, Missouri to an office
location in St. John. Missouri; (3) pursuant to Missouri law (19 CSR
30-1.030(1)(J) the controlled substance registration of any person
terminates if and when that person changes his/or her address as shown
on the certificate of registration; (4) the Respondent had not obtained
state authorization to handle controlled substances at his St. John
location; (5) the Respondent's Missouri controlled substance
registration had not been suspended or revoked by any authority in that
state nor has such action been recommended; (6) according to the
Missouri Department of Health, the Respondent was without authorization
[[Page 1309]]
to handle controlled substances in Missouri, the state in which he held
a DEA registration.
While there was no dispute that the Respondent lacked state
authorization to handle controlled substances, the then-Deputy
Administrator found that the primary issues for resolution of the
interlocutory appeal were (1) whether DEA has statutory authority under
the Controlled Substances Act to revoke a Certificate of Registration
when the lack of state authority arose by operation of law and not
adverse action; (2) whether 21 U.S.C. 824(a)(3) authorizes revocation
of a registration regardless of the manner in which the practitioner's
state authority was terminated; and (3) whether DEA should avail itself
the avenue of terminating as opposed to revoking the Respondent's
Certificate of Registration.
21 U.S.C. 824(a), provides in pertinent that:
(a) A registration pursuant to section 823(f) of this title to
manufacture, distribute, or dispense controlled substances or a list I
chemical may be suspended or revoked by the Attorney General upon a
finding that the registrant--
(3) has had his State license or registration suspended, revoked,
or denied by competent State authority and is no longer authorized by
State law to engage in the manufacturing, distribution, or dispensing
of controlled substances or list I chemicals or has had the suspension,
revocation, or denial of his registration recommended by competent
State authority.
21 CFR 1301.52(a) provides in pertinent part:
``* * * the registration of any person shall terminate if and when
such person dies, ceases legal existence, or discontinues business or
professional practice.''
21 CFR 1301.12(a) states:
``A separate registration is required for each principal place of
business or professional practice at one general physical location
where controlled substances are manufactured, distributed, imported, or
dispensed by a person.''
In support of its Motion for Summary Disposition, and as a basis
for filing the interlocutory appeal, the Government recited well-
settled DEA authority that the agency cannot register a practitioner to
handle controlled substances who is without authority to handle
controlled substances in the state in which he practices. With respect
to the termination of the Respondent's state controlled substance
authority, the Government argued that pursuant to DEA precedent, the
method by which a state terminates such authority is unimportant, and
that DEA has no discretion in this regard other than to revoke a DEA
registration: Javen Shah, 59 FR 4103 (1993); Cornelius Beukenkamp, 58
FR 28415 (1993); Samuel Brint, 51 FR 45067 (1986); and Trinidad
Bascara, 51 FR 37090 (1986). The then-Deputy Administrator also
incorporated in his Interlocutory Order additional DEA cases cited by
the Government: George P. Gotsis, M.D., 49 FR 33,750 (1984); Henry
Weitz, M.D., 46 FR 34,858 (1981); and Sam Misasi, D.O., 50 FR 11,469
(1985).
With respect to the Shah, Judge Randall in her July 3, 2002
Memorandum and Order noted that the Deputy Administrator in that matter
did not rely solely upon the provisions of 21 U.S.C. 824(a)(3) as the
basis for the revocation decision; rather, the Deputy Administrator
relied upon the public interest provisions of 21 U.S.C. 823(f) and
824(a)(4). Judge Randall further noted that the State of Illinois took
an adverse action against the registrant prior to DEA's final order in
the matter.
Similarly, with respect to the Brint, and Bascara, Judge Randall
found that the relevant medical boards had taken adverse actions
against the two Respondents prior to DEA revocation actions. The then-
Deputy Administrator concurred with Judge Randall's finding that each
of the above cited cases were distinguishable from matters raised in
the interlocutory appeal, and these matters did not address one of the
predominant issues of that appeal, namely, whether or not DEA may
revoke a registration in a situation where removal of state authority
occurred by operation of law and not by adverse state action.
The Government cited three additional DEA final orders where the
agency held that revocation of a Certificate of Registration was
appropriate even where the practitioner's state registration merely
expired of its own terms and the registrant had not reapplied for state
registration: Mark L. Beck, D.D.S., 64 FR 40,899 (1999); William D.
Levitt, D.O., 64 FR 49,822 (1999); and Charles H. Ryan, M.D., 58 FR
14,430 (1993). Judge Randall observed however, that ``[r]egrettably
these * * * Final Orders defy the plain language of the statutory
provisions, for in neither of these * * * cases does the Final Order
recount adverse action either taken or initiated by the state licensing
authority.'' In comparing the findings of Beck, Levitt and Ryan to the
instant matter, Judge Randall concluded that the Government failed to
meet the requirement of 21 U.S.C. 824(a)(3) because the record
contained no evidence that the State of Missouri had acted to suspend,
revoke, or deny the Respondent's authority to handle controlled
substances, nor had the State recommended such action be taken.
Nevertheless, the then-Deputy Administrator expressed a reluctance
to ``accord such a narrow interpretation to section 824(a)(3),'' and
instead concluded that it was ``clear from the precedent cited by the
Government that DEA has broadly construed section 824(a)(3), and
extended its provisions beyond situations involving adverse actions
taken or initiated by state licensing authorities. Such interpretation
is consistent with the doctrine [outlined in] Chevron U.S.A. v. Natural
Resources Defense Council, 467 U.S. 837, 842-43, 81 L. Ed. 2D 694, 104
S. Ct. 2778 (1984), where it was held that administrative agencies are
given broad discretion to construe their own regulations and
authorizing statutes.'' See, e.g. Culbertson v. United States
Department of Agriculture, 69 F. 3d 465 (10th Cir. 1995); Valley Comp.
of Utah, Inc. v. Babbitt, 24 F3d 1263, 1267 (10th Cir. 1994).
The then-Deputy Administrator noted that the above principle
governing broad administrative discretion in statutory interpretation
is supported by a number of policies, including, but not limited to the
following: (1) Agencies tend to be familiar with, and sophisticated
about, the statutes they administer, in other words, agencies
understand the relationships among various provisions, and the
practical implications of adopting one interpretation as opposed to
another. (2) As unforeseen problems develop in the administration of a
complex regulatory scheme, the agency needs flexibility if it is to
make the program function effectively. Gellhorn & Levin, Administrative
Law and Process, 4th Edition at p. 81-2 (1997).
The then-Deputy Administrator further noted that pursuant to the
holding in Levitt, state authorization was clearly intended to be a
prerequisite to DEA registration, and Congress could not have intended
for DEA to maintain a registration if a registrant is no longer
authorized by the state in which he practices to handle controlled
substances. In the instant proceeding, the then-Deputy Administrator
found that DEA precedent allowed for a liberal construction of section
824(a)(3), and also found it reasonable for DEA to interpret that
section as allowing for the revocation of a DEA Certificate of
Registration where, as here, the respondent's authorization under
Missouri law had terminated.
[[Page 1310]]
As noted above, Judge Randall also based, in part, the denial of
the Government's January 28, 2002, Motion for Summary Disposition upon
the proposition that DEA ``had an avenue for terminating, as opposed to
revoking, the Respondent's authority for handling controlled
substances.'' Judge Randall also noted that the distinction between the
termination and revocation of a DEA registration had significance,
since revocation has a more severe consequence upon the Respondent, and
thus, a ``stigma'' with consequences attached to the act of revoking a
registration. However, the then-Deputy Administrator rejected the
Administrative Law Judge's finding, and instead concluded that any
``stigma'' attendant to the revocation of a DEA registration was
speculative, and if any exists, such stigma is secondary to public
interest considerations in ensuring full and truthful responses on DEA
registration applications. The then-Deputy Administrator also found
that the termination provision under 21 CFR 1301.52 was inapplicable
since the only relevant issue in the instant matter was whether the
Respondent was currently authorized to handle controlled substances.
Levitt at 49822.
Consistent with the Interlocutory order of the then-Deputy
Administrator, Judge Randall recommended the revocation of the
Respondent's DEA Certificate of Registration, and denial of any pending
applications for renewal of such registration based on the Respondent's
lack of authority to handle controlled substances in Missouri. There is
no evidence before the Acting Deputy Administrator that the
Respondent's Missouri state controlled substance privileges have been
reinstated.
DEA does not have statutory authority under the Controlled
Substances Act to issue or maintain a registration if the applicant or
registrant is without state authority to handle controlled substances
in the state in which he conducts business. See 21 U.S.C. 802(21),
823(f) and 824(a)(3). This prerequisite has been consistently upheld.
See Karen Joe Smiles, M.D., 68 FR 48944 (2003), Dominick A. Ricci,
M.D., 58 FR 51104 (1993); Bobby Watts, M.D., 53 FR 11919 (1988).
Here, it is clear that the Respondent is not currently authorized
to handle controlled substances in the State of Missouri, where he is
registered with DEA. Therefore, he is not entitled to maintain that
registration. Because the Respondent is not entitled to a DEA
registration in Missouri due to his lack of state authorization to
handle controlled substances, the Acting Deputy Administrator concludes
that it is unnecessary to address whether the Respondent's registration
should be revoked based upon the other grounds asserted in the Order to
Show Cause. See Fereida Walker-Graham, M.D., 68 FR 24761 (2003);
Nathaniel-Aikens-Affud, M.D., 62 FR 16871 (1997); Sam F. Moore, D.V.M.,
58 FR 14428 (1993).
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in her by
21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that
DEA Certificate of Registration, AD7084217, issued to Marlou D. Davis,
M.D., be, and it hereby is, revoked. The Acting Deputy Administrator
further orders that any pending applications for renewal of such
registration be, and they hereby are, denied. This order is effective
February 9, 2004.
Dated: December 18, 2003.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 04-343 Filed 1-7-04; 8:45 am]
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