[Federal Register: June 16, 2004 (Volume 69, Number 115)]
[Notices]
[Page 33666-33667]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn04-83]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 03-48]
Deborah Y. Strauss, D.V.M., Revocation of Registration
On August 1, 2003, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Deborah Y. Strauss, D.V.M. (Respondent)
notifying her of an opportunity to show cause as to why DEA should not
revoke her Certificate of Registration, BS6351821, and deny any pending
applications for renewal or modification of such registration pursuant
to 21 U.S.C. 824(a)(3) and (a)(4). Specifically, the Order to Show
alleged that the Respondent's State controlled substances registration
has been suspended and her continued registration would be inconsistent
with the public interest based on matters concerning her purported
issuance of prescriptions for Demerol, a Schedule II controlled
substance, for no legitimate medical purpose. The Order to Show Cause
further alleged that as a result of an accountability audit, the
Respondent was unable to account for over 10,000 mg. of injectible
Demerol, and her records involving the Schedule IV controlled substance
diazepam, were not complete or accurate in violation of DEA
regulations.
[[Page 33667]]
By letter dated September 3, 2003, the Respondent, through her
legal counsel, timely requested a hearing in response to the show cause
order. On September 29, 2003, the presiding Administrative Law Judge
Mary Ellen Bittner (Judge Bittner) issued to the Government as well as
the Respondent an Order for Prehearing Statements.
In lieu of filing a pre-hearing statement, counsel for DEA filed
Government's Motion for Summary Disposition. In its motion, the
Government asserted that the Respondent is without authorization to
handle controlled substances in the State of Iowa, and as a result,
further proceedings in the matter were not required. Attached to the
Government's motion was an Order of Immediate Suspension of Controlled
Substance Registration issued by the Board of Pharmacy Examiners of the
State of Iowa (Pharmacy Board), dated May 9, 2003.
On October 17, 2003, the Respondent filed a reply brief with the
caption, ``Resistance to Government's Motion for Summary Disposition.''
In its brief, the Respondent argued, inter alia, that she is entitled
to due process of law; she has been wrongfully accused of having a
controlled substance abuse problem; a requested hearing before the
Pharmacy Board will clarify the issue and should result in the
reinstatement of Respondent's State controlled substance registration;
the Pharmacy Board arrived at an ``incorrect decision'' in suspending
Respondent's State controlled substance registration; and, there is no
compelling need for DEA to proceed with summary disposition in this
proceeding when matters involving Respondent's State controlled
substance registration are under review. The Respondent however,
concedes that she is currently without authorization to handle
controlled substances in Iowa.
On December 8, 2003, Judge Bittner issued her Opinion and
Recommended Decision of the Administrative Law Judge (Opinion and
Recommended Decision). As part of her recommended ruling, Judge Bittner
granted the Government's Motion for Summary Disposition and found that
Respondent lacked authorization to handle controlled substances in
Iowa, the jurisdiction where Respondent holds a DEA registration. In
granting the Government's motion, Judge Bittner also recommended that
the Respondent's DEA registration be revoked and any pending
applications for modification or renewal be denied. No exceptions were
filed by either party to Judge Bittner's Opinion and Recommended
Decision, and on January 16, 2004, the record of these proceedings were
transmitted to the Office of the DEA Deputy Administrator.
The 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 Deputy Administrator adopts, in full, the Opinion and Recommended
Decision of the Administrative Law Judge.
The Deputy Administrator finds that the Respondent currently
possesses DEA Certificate of Registration BS6351821, and is registered
to handle controlled substances in Iowa. The record before the Deputy
Administrator reveals that on May 9, 2003, the Iowa Pharmacy Board
issued an order suspending the Respondent's State controlled substance
registration, effective immediately.
In reaching its decision, the Pharmacy Board found that during a
thirteen-month period, Respondent wrote 176 prescriptions for Demerol,
purportedly for animal patients. Several of the animal patients were
owned by the Respondent. The Pharmacy Board found however, that the
Respondent did not administer Demerol to her patients, but instead,
obtained the drug for her personal use. The Pharmacy Board also found
that the Respondent did not maintain required records for the
dispensing of controlled substances. There is no evidence before the
Deputy Administrator that the Pharmacy Board's order has been stayed or
rescinded, or that Respondent's State controlled substance privileges
have otherwise been reinstated.
Pursuant to 21 U.S.C. 824(a), the Deputy Administrator may revoke a
DEA Certificate of Registration if she finds that the registrant has
had his State license revoked and is no longer authorized to dispense
controlled substances or has committed such acts as would render his
registration contrary to the public interest as determined by factors
listed in 21 U.S.C. 823(f). Thomas B. Pelkowski, D.D.S., 57 FR 28538
(1992). Nevertheless, despite the Pharmacy Board's findings regarding
the Respondent's inappropriate handling of controlled substances, and
notwithstanding the other public interest factors for the revocation of
her DEA registration asserted herein, the more relevant consideration
here is the present status of the Respondent's State authorization to
handle controlled substances.
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 Stephen J. Graham, M.D., 69 FR 11661 (2004); Dominick A. Ricci,
M.D., 58 FR 51104 (1993); Bobby Watts, M.D., 53 FR 11919 (1988).
Here, it is clear that Respondent's Iowa controlled substance
license has been suspended, and as a result, she is not licensed under
Iowa law to handle these products. Therefore, she is not entitled to a
DEA registration in that state. As a result of a finding that
Respondent lacks State authorization to handle controlled substances,
the Deputy Administrator concludes that it is unnecessary to address
further whether Respondent's DEA registration should be revoked based
upon the public interest grounds asserted in the Order to Show Cause.
See Samuel Silas Jackson, D.D.S., 67 FR 65145 (2002); Nathaniel-Aikens-
Afful, M.D., 62 FR 16871 (1997); Sam F. Moore, D.V.M, 58 FR 14428
(1993).
Accordingly, the 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, BS6351821, issued to Deborah Y. Strauss,
D.V.M., be, and it hereby is, revoked. The Deputy Administrator further
orders that any pending applications for renewal or modification of
such registration be, and they hereby are, denied. This order is
effective July 16, 2004.
Dated: May 17, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-13534 Filed 6-15-04; 8:45 am]
BILLING CODE 4410-09-M