[Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
[Notices]
[Pages 67132-67135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32225]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 97-6]
Ronald J. Riegel, D.V.M., Revocation of Registration
On January 28, 1997, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA) issued an
Order to Show Cause to Ronald J. Riegel, D.V.M. (Respondent)
1 of Ostrander, Ohio, notifying him of an opportunity to
show cause as to why DEA should not revoke his DEA Certificate of
Registration AR1930254, and deny any pending applications for renewal
of such registration pursuant to 21 U.S.C. 824(a)(2) and (a)(4),
because he was convicted of a felony related to controlled substances
and because his continued registration would be inconsistent with the
public interest.
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\1\ The Order to Show Cause indicated that Respondent was an
``M.D.'', however Respondent identified himself as a ``D.V.M.'' in
his request for a hearing and the facsimile of Respondent's DEA
Certificate of Registration, which was introduced at the hearing as
a Government exhibit, also indicates that Respondent is a ``D.V.M.''
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By letter dated February 12, 1997, Respondent, through counsel,
filed a timely request for a hearing, and following prehearing
procedures, a hearing was held in Columbus, Ohio on August 13, 1997,
before Administrative Law Judge Gail A. Randall. At the hearing, both
parties called witnesses to testify and the Government introduced
documentary evidence. After the hearing, Government counsel submitted
proposed findings of fact, conclusions of law and argument. On March
27, 1998, Judge Randall issued her Opinion and Recommended Ruling,
recommending that Respondent's DEA registration be revoked. On April
17, 1998, the Government filed exceptions to the Opinion and
Recommended Ruling of the Administrative Law Judge, and on May 28,
1998, Judge Randall transmitted the record of these proceedings to the
Acting Deputy Administrator.
The Acting Deputy Administrator has considered the record in its
entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order
based upon findings of fact and conclusions of law as hereinafter set
forth. The Acting Deputy Administrator adopts, except as specifically
noted below, the Opinion and Recommended Ruling of the Administrative
Law Judge. His adoption is in no manner diminished by any recitation of
facts, issues and conclusions herein, or of any failure to mention a
matter of fact or law.
Respondent is a veterinarian who has been licensed to practice in
Ohio for approximately 18 years. His DEA Certificate of Registration,
that is the subject of these proceedings, expired on April 30, 1997,
and he did not submit an application for renewal of this registration.
Before reaching the merits of this case, it must be determined whether
DEA has jurisdiction to revoke this registration since it has expired
with no renewal application being filed.
After the hearing in this matter, the Government filed a Motion for
Appropriate Relief on September 3, 1997, arguing that the
Administrative Law Judge has no jurisdiction over this matter since
Respondent's registration expired before resolution of the issues
raised in the Order to Show Cause. The Government further argued that
since DEA has not received a renewal application for the registration,
``there is no registration to either suspend or revoke under 21 U.S.C.
Sec. 824.'' The Government requested that Judge Randall issue a ruling
allowing Respondent an opportunity to submit an application for
registration which would then be considered based upon the record in
these proceedings, or in the alternative if no such application is
submitted, to terminate the proceedings based upon a lack of
jurisdiction. Respondent did not file a response to the Government's
motion.
On November 7, 1997, Judge Randall issued a Memorandum and Order
regarding the jurisdictional issue. As Judge Randall noted, there is
nothing in the Controlled Substances Act or its implementing
regulations that specifically addresses the status of a registration
that expires before the resolution of show cause proceedings where no
renewal application has been filed. The Administrative Procedure Act
(APA) applies to show cause proceedings, and 5 U.S.C. 558(c) provides
that ``[w]hen the licensee has made timely and sufficient application
for a renewal or a new license in accordance with agency rules, a
license with reference to an activity of a continuing nature does not
expire until the application has been finally determined by the
agency.'' However, the APA does not specifically address what happens
to a registration when no renewal application has been filed.
Pursuant to 21 CFR 1301.36(i), a registration will be automatically
extended past its expiration date and continue in effect until a final
decision is made regarding the registration if a renewal application is
filed at least 45 days before the expiration of the registration. The
regulation also provides that:
The Administrator may extend any other existing registration
under the circumstances contemplated in this section even though the
registrant failed to apply for reregistration at least 45 days
before expiration of the existing registration, with or without
request by the registrant, if the Administrator finds that such
extension is not inconsistent with the public health and safety.
Here, no specific findings were made to extend Respondent's
registration past the expiration date and therefore, 21 CFR 1301.36(i)
does not apply to extend the registration in this proceeding.
As Judge Randall noted, in a prior DEA decision, the then-
Administrator addressed facts somewhat similar to the ones at issue in
this proceeding. See Park and King Pharmacy, 52 FR 13,136 (1987). In
that case, the pharmacy's Certificate of Registration expired by its
own terms after the Order to Show Cause was issued but before a final
order had been issued. No renewal application had been submitted, and
instead the pharmacy was sold while the show cause proceeding was
pending final agency action. The then-Administrator disagreed with the
Administrative Law Judge's finding that the pharmacy's registration
terminated pursuant to 21 CFR 1301.62 (now 21 CFR 1301.52) as a result
of the sale of the pharmacy, and that the show cause proceeding was
moot. In addition, the then-Administrator found that:
[[Page 67133]]
The practice of the Drug Enforcement Administration, as well as
its predecessor agency, since the implementation of the Controlled
Substance[s] Act has been to maintain registrations on a day-to-day
basis pending resolution of administrative proceedings seeking to
revoke such registrations. The Respondent in this matter possessed a
viable DEA registration when he received the Order to Show Cause
which initiated the proceedings. That registration remained in
effect, on a day-to-day basis, following its nominal expiration date
on March 31, 1986. The same administrative ``hold'' that prevented
the registration from expiring also prevented the Respondent from
renewing the registration. Accordingly, the Administrator concludes
that neither the nominal expiration date on the face of the
Respondent's registration nor his inability to file a renewal
application have any effect upon the matter pending before the
Administrator. Id.
As Judge Randall noted, the same rationale that applied in Park and
King Pharmacy would seem to apply in this case. ``At the time the Order
to Show Cause was issued, the Respondent held a viable Certificate of
Registration. The order placed an `administrative hold' on that
certificate, and likewise placed it in a day-to-day category. The
respondent's unilateral action of failing to file a renewal application
would not change the status of the registration.''
However, Judge Randall expressed concern that neither the
regulations nor Park and King Pharmacy provide any authority for
placing an ``administrative hold'' on a registration that expires with
no renewal application being filed in the midst of a show cause
proceeding. As Judge Randall noted, ``[t]o the contrary, the
regulations tell the registrant to file a renewal application within a
specified time to preserve his registration status.''
But Judge Randall concluded that in light of the decision in Park
and King Pharmacy, she does not have the authority to terminate these
proceedings, because to do so would ``unilaterally change agency policy
without giving this Respondent notice of such a change and an
opportunity to comply.'' Therefore, Judge Randall denied the
Government's motion, concluding that ``consistent with DEA precedent,
the Respondent's DEA Certificate of Registration is currently being
maintained on a day-to-day basis, that this proceeding is not rendered
moot by the Respondent's failure to file a renewal application, and
that jurisdiction still rests with this forum to complete these show
cause proceedings.''
The Acting Deputy Administrator agrees with Judge Randall's
decision not to terminate the proceedings and to forward this matter to
the Acting Deputy Administrator. However, the Acting Deputy
Administrator is troubled by the decision in Park and King Pharmacy.
Other than the statement that it has been DEA's practice, no authority
was cited in the final order for the position that an expired
registration can still be revoked if no renewal application has been
filed. The Acting Deputy Administrator can find nothing in the statute
or regulations nor any other notice to the public that a registration
is extended past its expiration date on a day-to-day basis pending
final resolution where no renewal application has been submitted. To
the contrary, both the APA and 21 CFR 1301.36(i) specifically state
that a registration is extended on a day-to-day basis if a timely
renewal application is filed. Consequently, it is reasonable for a
registrant to assume that its registration would no longer be subject
to adverse action once it expires and no application for renewal has
been filed regardless of whether an Order to Show Cause has been issued
or not.
Therefore, the Acting Deputy Administrator finds no authority to
support the then-Administrator's conclusion in Park and King Pharmacy
that the registration was maintained on a day-to-day basis past the
expiration date even though a renewal application had not been filed.
If 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. Accordingly, the Acting Deputy Administrator agrees
with the Government's initial position that this matter is moot because
there is no viable registration to revoke.
However, as Judge Randall noted in her November 7, 1997 Memorandum
and Order, since Respondent has participated in a hearing, it would be
unfair to now terminate the proceedings without resolution based upon a
deviation from past agency precedent. In fact the Government did not
even argue until several weeks after the hearing that Respondent did
not have a viable registration. ``Such a deviation mid-case, without
notice and opportunity to comply with the changed procedure,
specifically prejudices this Respondent.'' Therefore, the Acting Deputy
Administrator will address the merits of this case to determine whether
Respondent's registration should be revoked.
The Acting Deputy Administrator finds that in January 1995, a
cooperating individual who was renting a house from Respondent provided
DEA with a vial of etorphine, a Schedule II controlled substance,
claiming to have obtained it from Respondent. Etorphine is a strong
tranquilizer used on large animals. It is also used illegally on race
horses.
On April 5, 1995, DEA and local authorities monitored and tape
recorded a meeting between the cooperating individual and Respondent
during which the cooperating individual paid Respondent $500 for a
previously obtained vial of etorphine. At the hearing in this matter,
Respondent acknowledged receiving $500 from the cooperating individual,
but testified that the payment was for rent owed to him by the
cooperating individual.
After the initial transaction, Respondent returned to the
cooperating individual's residence that same day with a vial of
etorphine that he had apparently retrieved from his residence.
According to Respondent, the cooperating individual had told him the
day before during a telephone conversation that the cooperating
individual had stored a bottle of etorphine in Respondent's veterinary
clinic and that Respondent could sell it and keep the money from the
sale as a rent payment. Respondent also testified that during the
initial meeting on April 5, the cooperating individual had indicated
that he wanted the vial returned to him because he had located a buyer
for the etorphine. Therefore, Respondent acknowledged handing a bottle
of etorphine to the cooperating individual on April 5, but denied that
it was from his office stock. Respondent testified that he returned the
vial to the cooperating individual because he was afraid of him.
According to Respondent he had a telephone conversation with the
cooperating individual sometime between April 5 and 13, 1995, during
which the cooperating individual indicated that he would give
Respondent $1,500 that had been obtained from the sale of the etorphine
acquired on April 5. Thereafter, on April 13, 1995, during a monitored
and recorded meeting, the cooperating individual gave Respondent $1,500
for the bottle of etorphine obtained on April 5.
Respondent testified that in June of 1995, the cooperating
individual's dog developed a cough which did not get better with
prescribed antibiotics. According to Respondent, the cooperating
individual then requested some Vicodin, a Schedule III controlled
substance, stating that it had worked for his sister's dog. Respondent
testified that, ``[f]inally, because I am so busy and everything, and
just to get him off my back, I called in a prescription, but I am
suspicious of him by this time.'' Respondent indicated that in light of
his suspicions, he called in a prescription
[[Page 67134]]
for hydrocodone, the generic for Vicodin, because he ``felt [the
cooperating individual] could not resell or, you know, do anything with
[it].''
On July 13, 1995, the cooperating individual was observed by
investigators giving Respondent $75. Respondent admitted at the hearing
to accepting $75 from the cooperating individual, but testified that
the money was for rent that the cooperating individual owed him.
As a result of this investigation, Respondent was charged
criminally. Following a jury trial, the Court of Common Pleas of
Delaware County, Ohio entered judgment on February 23, 1996, finding
Respondent guilty of one count of Aggravated Trafficking, for
activities involving etorphine, and one count of Trafficking in Drugs,
for activities involving hydrocodone, both felony offenses in violation
of Ohio state law.
On February 9, 1994, the Ohio Veterinary Medical Licensing Board
(Board) issued an order suspending Respondent's license to practice
veterinary medicine for six months. The Board's order was based on a
finding that Respondent had permitted a ``graduate animal technician to
administer treatment and care to and to perform surgeries on patients
while in his employ.'' Following the rejection of Respondent's appeal
of the Board's order, the suspension was effective from September 12,
1995 to March 12, 1996. By notice dated May 16, 1996, the Board
initiated another administrative action against Respondent's veterinary
license, however, there is no evidence in the record regarding the
resolution of that action.
Pursuant to 21 U.S.C. 824(a), ``A registration pursuant to section
823 of this title to * * * dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant--* * * (2) has been convicted of a felony under this
subchapter or subchapter II of this chapter or any other law of the
United States, or of any State, relating to any substance defined in
this subchapter as a controlled substance. * * *''
In addition, pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration and deny any
pending application for renewal of such registration, if he determines
that the continued registration would be inconsistent with the public
interest. Section 823(f) requires that the following factors be
considered in determining the public interest:
(1) The recommendation of the appropriate state licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable state, federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health or
safety.
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may
give each factor the weight he deems appropriate in determining whether
a registration should be revoked or an application for registration
denied. See Henry J. Schwarz, Jr., M.D., 54 FR 16,422 (1989).
It is undisputed that Respondent was convicted on February 23,
1996, in the Court of Common Pleas of Delaware County, Ohio of two
felony counts relating to controlled substances. Therefore, grounds
exist to revoke Respondent's DEA registration under 21 U.S.C.
824(a)(2).
Next, the Acting Deputy Administrator considers whether
Respondent's continued registration would be inconsistent with the
public interest. Regarding factor one, in 1994, Respondent's veterinary
license was suspended for six months based upon a finding that he had
allowed a graduate technician to perform surgery and care for patients
in violation of Ohio law. The Board again initiated proceedings against
Respondent's license in May 1996; however, there is no evidence in the
record regarding the resolution of those proceedings. Therefore, based
upon the record before him, the Acting Deputy Administrator finds that
Respondent possesses a valid state license.
Factors two and four, Respondent's experience in dispensing
controlled substances and his compliance with applicable laws relating
to controlled substances, are clearly relevant in determining the
public interest. There is some dispute regarding the circumstances
surrounding Respondent's providing the cooperating individual with the
bottle of etorphine and the prescription for hydrocodone. But even if
the Acting Deputy Administrator were to accept Respondent's version of
events, there is still cause for concern regarding Respondent's
continued registration.
Respondent admitted at the hearing that he gave the cooperating
individual the bottle of etorphine on April 5, 1995, knowing that the
cooperating individual intended on selling it. Respondent indicated
that he did so out of fear. The Acting Deputy Administrator agrees with
Judge Randall's conclusion that ``[i]f accepted as true, the
Respondent's demonstrated susceptibility to coercion puts the public at
risk of controlled substance diversion.'' Regarding the hydrocodone
prescription, Respondent stated that he issued the prescription
``because I am so busy and everything, and just to get him off my
back,'' despite his suspicion of the cooperating individual.
However as Judge Randall noted, Respondent was convicted of
aggravated trafficking in etorphine and trafficking in drugs, to wit
hydrocodone, and it is not proper to look behind these convictions.
Therefore, the Acting Deputy Administrator concludes that there was no
legitimate medical purpose for the hydrocodone prescription in
violation of 21 U.S.C. 841(a)(1), 21 CFR 1306.04 and Ohio law, and
Respondent distributed the etorphine in violation of 21 U.S.C.
841(A)(1) and Ohio law.
As to factor three, it is undisputed that Respondent was convicted
of two felony offenses relating to controlled substances.
Regarding such other conduct as may threaten the public health and
safety, the Acting Deputy Administrator is deeply troubled by
Respondent's conduct if one assumes, as Respondent suggests, that he
was merely returning the cooperating individual's bottle of etorphine
to him on April 5, 1995. As Respondent admitted, he knew that the
cooperating individual intended on selling the etorphine, yet
Respondent did not notify DEA or the local authorities. Instead, he
just gave this potentially lethal medication to the cooperating
individual because he was afraid of him. As Judge Randall concluded,
``[s]uch behavior is a direct threat to the public safety and is not
the action of a responsible registrant.''
The Acting Deputy Administrator concludes that the Government has
presented a prima facie case for revocation of Respondent's DEA
Certificate of Registration. Further, the Acting Deputy Administrator
concurs with Judge Randall's conclusion that rather than presenting any
mitigating evidence, ``the Respondent continues to fail to take
responsibility for his actions, to show any remorse for his controlled
substance convictions, or to give any assurance that he will not
participate in such activities in the future.'' The Acting Deputy
Administrator concludes
[[Page 67135]]
that Respondent's continued registration would be inconsistent with the
public interest and therefore grounds exist to revoke his DEA
registration pursuant to 21 U.S.C. 824(a)(4).
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that
DEA Certificate of Registration AR1930254, previously issued to Ronald
J. Riegel, D.V.M., be, and it hereby is revoked. This order is
effective January 4, 1999.
Dated: November 27, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-32225 Filed 12-3-98; 8:45 am]
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