[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]
BILLING CODE 4410-09-M