[Federal Register Volume 63, Number 54 (Friday, March 20, 1998)]
[Notices]
[Pages 13687-13689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7188]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-27]
Anant N. Mauskar, M.D.; Grant of Restricted Registration
On March 27, 1996, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Anant N. Mauskar, M.D. (Respondent), of Houston,
Texas, notifying him of an opportunity to show cause as to why DEA
should not deny his application for registration as a practitioner
under 21 U.S.C. 823(f), for reason that he is without authority to
handle controlled substances in the State of Texas, and that his
registration would be inconsistent with the public interest.
By letter dated April 15, 1996, Respondent, through counsel, filed
a request for a hearing, and the matter was docketed before
Administrative Law Judge Mary Ellen Bittner. During prehearing
procedures, the Government filed a Motion for Summary Disposition
alleging that Respondent was not entitled to a DEA registration in the
State of Texas since he was without authority to handle controlled
substances in the State. However, on May 29, 1996, the Texas Department
of Public Safety reissued Respondent's Department of Public Safety
Registration Certificate enabling him to handle controlled substances
in Texas. As a result, Judge Bittner denied the Government's Motion for
Summary Disposition on July 25, 1996.
A hearing was then held on November 13, 1996, in San Antonio, Texas
on the remaining issue raised in the Order to Show Cause. At the
hearing, Respondent testified on his own behalf and both parties
introduced documentary evidence. After the hearing, the Government
submitted proposed findings of fact, conclusions of law and argument.
Respondent did not submit a posthearing filing. On January 13, 1998,
Judge Bittner issued her Opinion and Recommended Ruling, Findings of
Fact, Conclusions of Law and Decision, recommending that Respondent's
application for a DEA Certificate of Registration should be granted in
Schedules II through V, excluding Schedule II narcotic controlled
substances, subject to the maintenance of a log of his handling of
controlled substances. Neither party filed exceptions to the Opinion
and Recommended Ruling of Judge Bittner, and on February 17, 1998,
Judge Bittner 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, in full, the Opinion and
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
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 of law.
The Acting Deputy Administrator finds that Respondent attended
medical school in Pune, India, and as of the date of the hearing had
been practicing family medicine in Harris County, Texas for 16 years.
Respondent previously possessed DEA Certificate of Registration
AM9760338.
On June 18, 1992, an Order to Show Cause was issued to Respondent
proposing to revoke his previous DEA Certificate of Registration,
alleging that his continued registration would be inconsistent with the
public interest. Following a hearing before Administrative Law Judge
Paul A. Tenney, the then-Administrator revoked Respondent's DEA
registration effective November 1, 1993. See, Anant N. Mauskar, M.D.,
58 FR 51,385 (October 1, 1993).
[[Page 13688]]
In the prior proceeding, the then-Administrator found that on
December 5, 1990, July 22, 1991, and August 29, 1991, Respondent issued
prescriptions for the Schedule III controlled substance Tylenol #4 with
codeine (Tylenol #4), and the Schedule IV controlled substance Xanax to
an undercover law enforcement officer for no legitimate medical
purpose. The undercover officer indicated that the Tylenol #4 made him
feel good, yet on two occasions, Respondent falsified the patient
record indicating that the ``patient'' was suffering from pain, even
though the undercover officer made no such complaint.
Based upon these findings, the then-Administrator concluded that
Respondent's continued registration would be inconsistent with the
public interest, and revoked Respondent's previous DEA Certificate of
Registration. Id. Subsequently, Respondent filed a petition for review
of the then-Administrator's final order revoking his DEA registration.
On August 25, 1994, the United States Court of Appeals for the Fifth
Circuit found that the then-Administrator's findings of fact were
supported by substantial evidence and affirmed his final order. Mauskar
v. Drug Enforcement Administration, No. 93-5437, slip op. (5th Cir.
Aug. 25, 1994).
On October 21, 1994, Respondent submitted an application for a new
DEA registration in Schedules II through V. That application is the
subject of these proceedings. At the hearing in this matter, Respondent
argued that he should be allowed to relitigate the underlying facts
which led to the revocation of his previous DEA registration, since he
did not testify at the previous proceeding because there were pending
criminal charges against him. Respondent presented evidence that
sometime after February 1993, Respondent was found not guilty of some
unspecified charge following a bench trial in the 183rd District Court
of Harris County, Texas. Also, in June 1995, Respondent was again found
not guilty following a July trial on an unspecified charge based on the
same facts as those which were addressed in the previous administrative
proceeding.
The Administrative Law Judge found however, that the then-
Administrator's final order published in the Federal Register on
October 1, 1993, regarding Respondent is res judicata for purposes of
this proceeding. See, Liberty Discount Drugs, Inc., 57 FR 2788 (1992)
(where the findings in a previous revocation proceeding were held to be
res judicata in a subsequent administrative proceeding.) The Acting
Deputy Administrator agrees with Judge Bittner. The then-
Administrator's determination of the facts relating to the previous
revocation of the Respondent's DEA registration is conclusive.
Accordingly, the Acting Deputy Administrator adopts the then-
Administrator's 1993 final order in its entirety. The Acting Deputy
Administrator concludes that the critical issue in this proceeding is
whether the circumstances, which existed at the time of the prior
proceeding, have changed sufficiently to support a conclusion that
Respondent's registration would be in the public interest.
At the hearing before Judge Bittner, Respondent maintained that he
never prescribed controlled substances for other than legitimate
medical purposes, including those prescribed for the undercover
officer. Respondent asserted that he is able to identify persons
addicted to controlled substances because they ``look different,''
usually ask directly for a controlled substance but do not want to
submit to a physical examination, and appear to be in a hurry.
Respondent testified that since the previous proceeding, he has
taken various courses to maintain his continuing medical education
requirements, including courses in pain management which addressed the
proper handling of controlled substances. Respondent testified that
these courses instruct physicians, ``[d]on't be scared of DEA,'' and
``be very aggressive in treating the pain.'' However, Respondent stated
that if granted a DEA registration, he does not intend to prescribe
controlled substances very often, because there are now effective non-
controlled pain relievers.
The Government argues that it has presented a prima facie case for
the denial of Respondent's application for registration based upon the
previous revocation of his DEA registration and the fact that he has
not taken responsibility for the acts which led to the revocation.
Nevertheless, the Government notes that Respondent's wrongdoing was
limited to three instances of misprescribing in 1990 and 1991, and
therefore, it may be appropriate to grant him a restricted
registration. Respondent asserts that if granted a DEA registration, he
would not prescribe controlled substances very often.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an
application for a DEA Certificate of Registration if he determines that
such registration would be inconsistent with the public interest. In
determining the public interest, the following factors are considered:
(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 and
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 be denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-
42, 54 FR 16,422 (1989).
Regarding factor one, the Acting Deputy Administrator notes that
Respondent was without authority to handle controlled substances in the
State of Texas for a period of time. However, it appears that the state
took action against Respondent's Texas registration to handle
controlled substances in light of the revocation of his previous DEA
registration. On May 29, 1996, the Texas Department of Public Safety
reissued Respondent his state controlled substance privileges in
Schedules II nonnarcotic, III, IV and V. However, as Judge Bittner
noted, ``inasmuch as state licensure is a necessary but not sufficient
condition for DEA registration, * * * this factor is not dispositive.''
As to factors two and four, Respondent's experience in dispensing
controlled substances and his compliance with controlled substance
laws, it was found in the previous proceeding that Respondent
prescribed controlled substance on three occasions in 1990 and 1991 to
an undercover officer for no legitimate medical purpose, and therefore
violated 21 CFR 1306.04. The Acting Deputy Administrator finds it
troubling that Respondent continues to maintain that he did nothing
wrong, and as the Government notes, this ``calls into question his
commitment to comply with controlled substance laws in the future.''
Respondent testified that since the revocation of his previous DEA
registration, he has taken courses that have dealt with the handling of
controlled substances. Yet, as Judge Bittner notes, ``(it appears that
these)
[[Page 13689]]
courses did not emphasize regulatory requirements and how to ensure
that one's practices comply with them.'' Instead, Respondent testified
that the courses encouraged doctors to not be scared of DEA and to take
an aggressive approach to pain management. Nevertheless, Respondent
testified that if granted a DEA registration, he would not prescribe
controlled substances very often since safer noncontrolled substances
are now available.
The Acting Deputy Administrator finds that there was no evidence
presented relevant to factor three or factor five.
The Acting Deputy Administrator concludes that in light of
Respondent's prescribing of controlled substances for no legitimate
medical purpose and his failure to accept responsibility for his
actions, the Government has established a prima facie case for the
denial of Respondent's application for registration. However, as both
Government counsel and Judge Bittner note, Respondent's wrongdoing is
limited to three instances of prescribing controlled substances without
a valid medical purpose in 1990 and 1991. Therefore, Judge Bittner
recommended that Respondent be granted a restricted DEA Certificate of
Registration. But, while Respondent has applied for a DEA registration
in Schedules II through V, DEA has consistently held that it can only
register a practitioner to handle controlled substances to the extent
that he is authorized by the state. See, e.g., Romeo J. Perez. M.D., 62
FR 16,193 (1997); Demetris A. Green, M.D., 61 FR 60,728 (1996);
Dominick A. Ricci, M.D. 58 FR 51,104 (1993). Since the record indicates
that Texas has not issued Respondent privileges in Schedule II
narcotic, Respondent is not entitled to a DEA registration in Schedule
II narcotic. Judge Bittner further recommended that Respondent be
required to ``submit quarterly logs of all his handling of controlled
substances to the appropriate DEA Special Agent in Charge or his
designee, for the term of his registration.''
The Acting Deputy Administrator agrees that a restricted
registration is appropriate under the facts and circumstances of this
case. While Respondent's wrongdoing occurred a number of years ago and
was limited in nature, it is in the public interest to monitor
Respondent's handling of controlled substances, in light of his failure
to acknowledge responsibility for his actions. Therefore, the Acting
Deputy Administrator finds it in the public interest to grant
Respondent a DEA registration in Schedules II through V, excluding
Schedule II narcotic, subject to the following condition:
For three years from the date of issuance of the DEA Certificate
of Registration, Respondent shall maintain a log of all controlled
substances that he prescribes, administers or dispenses. At a
minimum, the log shall indicate the date that the controlled
substance was prescribed, administered or dispensed, the name of the
patient, and the name, dosage and quantity of the controlled
substance prescribed, administered or dispensed. The log shall be
submitted on a quarterly basis to the Special Agent in Charge of the
DEA Houston Field Division, or his designee. Should Respondent not
prescribe, administer or dispense any controlled substances during a
given quarter, he shall so indicate to the Special Agent in Charge
of the DEA Houston Field Division, or his designee.
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
the application dated October 2, 1994, submitted by Anant N. Mauskar,
M.D., be, and it hereby is, granted in Schedules II through V,
excluding Schedule II narcotic, subject to the above described
restriction. This order is effective April 20, 1998.
Dated: March 6, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-7188 Filed 3-19-98; 8:45 am]
BILLING CODE 4410-09-M
