[Federal Register Volume 69, Number 5 (Thursday, January 8, 2004)]
[Notices]
[Pages 1307-1310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-343]


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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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