[Federal Register Volume 62, Number 198 (Tuesday, October 14, 1997)]
[Notices]
[Pages 53338-53343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27144]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-47]
City Drug Company: Revocation of Registration
On August 29, 1996, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, (DEA), issued an
Order to Show Cause to City Drug Company, (Respondent) of Opp, Alabama,
notifying it of an opportunity to show cause as to why DEA should not
revoke its DEA Certificate of Registration, AC5430450, and deny any
pending
[[Page 53339]]
applications for registration under 21 U.S.C. 823(f), for reason that
its continued registration would be inconsistent with the public
interest pursuant to 21 U.S.C. 824(a)(4).
By letter dated September 19, 1996, Respondent, through counsel,
filed a request for a hearing, and following prehearing procedures, a
hearing was held in Mobile, Alabama on April 15, 1997, before
Administrative Law Judge Gail A. Randall. At the hearing, both parties
called witnesses to testify and introduced documentary evidence. After
the hearing, counsel for both parties submitted proposed findings of
fact, conclusions of law and argument. On July 24, 1997, Judge Randall
issued her Opinion and Recommended Ruling, recommending that
Respondent's DEA Certificate of Registration be revoked and any pending
applications for renewal of such registration be denied. In addition,
Judge Randall recommended that favorable consideration be given to a
new application for registration should Respondent present any
persuasive evidence of proposed procedural changes for the dispensing
of controlled substances. On August 4, 1997, Respondent filed a general
objection to the Administrative Law Judge's decision, and on August 26,
1997, Judge Randall transmitted the record of these proceedings to the
Acting Deputy Administrator.
By letter dated September 17, 1997, Judge Randall forwarded a
letter from Respondent's counsel dated September 9, 1997, that set
forth information concerning procedural changes implemented at
Respondent and continuing education received by Respondent's owner.
This letter was received by the Administrative Law Judge after the
record had closed and been transmitted to the Acting Deputy
Administrator. The Acting Deputy Administrator has not considered
Respondent's September 9, 1997 letter in rendering his decision in this
matter since it was submitted after the record had closed, and
Respondent did not offer any explanation as to why this information was
not submitted prior to the closing of the record.
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, with one noted
exception, the Opinion and Recommended Ruling of the Administrative Law
Judge, and 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.
The Acting Deputy Administrator finds that Respondent is one of
five pharmacies located in Opp, Alabama and has been in existence for
approximately 25 years. Joseph Grimes is the owner and pharmacist in
charge of Respondent.
On March 2, 1992, a search warrant was executed at Respondent
pharmacy as a result of an undercover operation conducted by a local
police department. During the search, DEA investigators conducted a
physical count of controlled substances on the premises using
Respondent's pill counting machine, and collected all relevant
controlled substance records for the period January 15, 1990 to March
2, 1992, except purchase invoices and records of controlled substances,
if any, returned to suppliers. A DEA investigator later contacted
Respondent's suppliers and obtained records of controlled substance
sales to Respondent for the period January 15, 1990 to March 2, 1992.
Alabama law requires a pharmacy to conduct an inventory of
controlled substances on the 15th day of January of each year. Included
in the records seized during execution of the search warrant were these
inventories conducted by Respondent for 1990, 1991, and 1992. Mr.
Grimes testified at the hearing in this matter that when performing an
inventory, he counts all individual dosage units of Schedule II
controlled substances, and as permitted by Federal and state law, he
estimates the quantities of Schedule III through V controlled
substances.
Using Respondent's records, records from Respondent's suppliers,
and the closing inventory conducted on March 2, 1992, DEA conducted
several accountability audits. One audit of Schedule III and IV
controlled substances was conducted using Respondent's January 15, 1990
inventory as the initial inventory figure and DEA's March 2, 1992 count
as the closing inventory. This accountability audit revealed that
Respondent could not account for 80,223 dosage units, including 18,774
dosage units of Darvocet/propoxyphene 100 mg. and 10,428 dosage units
of Darvocet/propoxyphene 65 mg. In addition, the audit revealed an
overage of 402 dosage units of hydrocodone 5 mg. (brand and generic).
An audit of the Schedule II controlled substance oxycodone 5 mg.
for the period January 15, 1990 to January 15, 1992, revealed an
overage of 859 dosage units. This unit used Respondent's January 15,
1990 inventory as the initial inventory figure, and its January 15,
1992 inventory as the closing inventory figure.
Another audit was conducted of Schedule III and IV controlled
substances using Respondent's January 15, 1990 inventory as the initial
inventory figure and its January 15, 1992 inventory as the closing
inventory figure. This audit revealed shortages totaling 13,706 dosage
units and overages totaling 705 dosage units.
Following execution of the search warrant, DEA organized
prescription records taken from Respondent according to the prescribing
doctor. Eleven of these doctors were provided copies of prescriptions
attributed to them and each doctor reviewed his patient records in the
presence of a DEA investigation to determine whether or not he had
authorized the prescriptions found at Respondent pharmacy.
Prescriptions taken from Respondent pharmacy indicated that Dr. Rex
Butler had prescribed a total of 2,427 dosage units of controlled
substances to five patients. By affidavit dated March 19, 1997, Dr.
Butler indicated that he had not authorized any of these prescriptions.
Respondent provided affidavits from two of these patients and one of
their relatives which indicated that they had witnessed Mr. Grimes
receiving authorization from Dr. Butler for controlled substance
prescriptions for them. Another of the patients indicated by affidavit
that Dr. Butler had prescribed Limbitrol DS for him on several
occasions. However, like Judge Randall, the Acting Deputy Administrator
finds these patient affidavits to be of limited value since they do not
specifically address the prescriptions at issue nor do they reference
any time period for their statements. In addition, the Acting Deputy
Administrator finds Dr. Butler's affidavit to be more reliable than the
patients' affidavits, since Dr. Butler's affidavit is based upon a
review of his patient records which were prepared and maintained during
the relevant time period, whereas the patients' affidavits are based
upon their recollection more than six years after the event.
Dr. Steven Davis declared in an affidavit dated March 3, 1997, that
after reviewing the prescriptions taken from Respondent's files that
were attributed to him and comparing them to his patient records, he
determined that he had not authorized prescriptions for 20 specifically
named patients, amounting to a total of approximately 2,650 dosage
units of controlled substances. Respondent provided affidavits from
patients or immediate family members of patients concerning Dr. Davis's
[[Page 53340]]
prescribing practices. The majority of these affidavits fail to address
the specifically questioned prescriptions or to provide relevant time
periods for their statements, and are therefore of limited value.
However, two of the patients do indicate in their affidavits that they
were prescribed the medication on the specific date at issue.
Nonetheless, the Acting Deputy Administrator finds Dr. Davis' affidavit
to be more reliable than the affidavits of these two patients since Dr.
Davis' affidavit is based upon a review of his patient records which
were prepared and maintained during the relevant time period, whereas
the patients' affidavits are based upon their recollection more then
six years after the event. As Judge Randall noted, the affidavit of the
wife of one of the patients verified that her husband was prescribed
Vicodin in December 1991 by Dr. Davis. Since Dr. Davis does not address
in his affidavit whether or not he authorized this prescription, the
Acting Deputy Administrator agrees with Judge Randall that the wife's
affidavit ``warrant[s] a belief that this December 1991 prescription
was authorized by Dr. Davis.''
Prescriptions taken from Respondent pharmacy indicated that Dr.
James Guest had prescribed a total of 1,205 dosage units of Halcion and
Xanax for one patient between June 25, 1990 and February 29, 1992. By
affidavit dated February 13, 1997, Dr. Guest stated that he had last
seen this patient on May 17, 1989, and had not authorized any of the
prescriptions taken from Respondent pharmacy that were attributed to
him. Respondent provided affidavit from the patient and her daughter
which indicated that Mr. Grimes had telephoned Dr. Guest's office for
authorization to dispense Halcion and Xanax. However, like many of the
previously discussed affidavits, these affidavits fail to address the
specific prescriptions in question or to provide any specific time
period for their statements.
Respondent's prescription records indicated that Dr. Joe Sanders
authorized the dispensing of 2,600 dosage units of propoxyphene N-100
or Darvocet N-100 to one patient between August 31, 1990 and February
1, 1992. But, in a letter dated June 4, 1993, Dr. Sanders wrote that he
had last seen the patient on May 17, 1990, and had no record or
recollection of calling in any prescriptions for the patient since that
time.
According to Respondent's records, between January 19, 1990 and
November 21, 1991, Respondent dispensed 2,280 dosage units of lorazepam
2 mg. to one patient as allegedly authorized by Dr. Kirit Joshi.
However, by affidavit dated February 18, 1997, Dr. Joshi declared that
while he has issued that patient prescriptions for other controlled
substances, he had not authorized the lorazepam prescriptions for the
patient. In an affidavit, the patient's husband stated that, ``[t]o my
knowledge Joe Grimes has phoned Dr. Kiruit [sic] Joshi's office for
lorazepam and other medication in 1990 and 1992 for my wife * * *.''
The Acting Deputy Administrator finds Dr. Joshi's affidavit to be more
reliable than the husband's affidavit, since Dr. Joshi's affidavit is
based upon a review of his patient record which was prepared and
maintained during the relevant time period, whereas the husband's
affidavit is based upon his recollection more than six years after the
event.
Respondent's records indicate that Dr. D.A. Marsh telephoned two
prescriptions to Respondent for an individual, one on November 25,
1991, for 18 dosage units of Fiorinal #3 with codeine, and the other on
December 5, 1991, for 6 dosage units of Fiorinal #3 with codeine. In an
affidavit dated February 19, 1997, Dr. Marsh declared that he did in
fact see this patient on November 19 and 25, 1991, and that he did
write her a prescription for 20 Fiorinal #3 with codeine on November
25, 1991. However, Dr. Marsh stated he did not orally authorize any
prescriptions for this individual, and specifically denied authorizing
the two prescriptions noted above. In an affidavit dated April 9, 1997,
the patient stated that, ``[p]rescriptions for Fiorinal #3 were
authorized for me by D.A. Marsh MD in November and December of 1991 and
were filled at [Respondent] * * *. Some of these prescriptions were
phoned in.'' She indicated that she was allergic to a drug prescribed
for her by Dr. Marsh and that once he was informed of this allergy,
``Dr. Marsh authorized a prescription for 6 Fiorinal with codeine
capsules for me.'' While the patient's affidavit might help explain the
prescription in Respondent's files for the six Fiorinal #3 with
codeine, it does not address the 18 dosage units allegedly dispensed
pursuant to an oral prescription, on the same day Dr. Marsh admitted
issuing the patient a written prescription for 20 dosage units.
However, as with the other affidavits, the Acting Deputy Administrator
finds Dr. Marsh's affidavit to be more reliable than that of the
patient since it is based upon a review of his patient record which was
prepared and maintained during the relevant time period, whereas the
patient's affidavit is based upon her recollection more than six years
after the event.
According to Respondent's records, between January 1, 1990 and
March 2, 1992, Dr. Donald Newman orally authorized prescriptions for
2,600 dosage units of chlordiazepoxide 10 mg. for a specific patient.
By affidavit dated February 18, 1997, Dr. Newman stated that while he
did prescribe controlled substances on occasion to this patient, it was
always in writing and he did not authorize any of the oral
prescriptions for chlordiazepoxide found in Respondent's files.
Respondent provided an affidavit from this patient dated April 9, 1997,
who stated that, ``I have witnessed Joe Grimes calling Dr. Donald
Newman's office for permission to refill Librium (chlordiazepoxide HCL)
on several occasions during the period of January 1990 to January
1991.'' However, this affidavit does not address the specific
prescriptions at issue. Again, the Acting Deputy Administrator finds
Dr. Newman's affidavit to be more reliable than that of the patient
since it based upon a review of his patient record which was prepared
and maintained during the relevant time period, whereas the patient's
affidavit is based upon her recollection more than six years after the
event.
According to Respondent's records, Dr. Steven Price authorized five
prescriptions for a total of 150 dosage units of controlled substances
to three patients. As to the first patient, Dr. Price stated in an
affidavit dated February 20, 1997, that while he had prescribed the
patient Xanax in January 1991, he did not authorize the prescription
for Xanax found in Respondent's files dated February 22, 1991.
Regarding the second patient, Dr. Price denied prescribing diazepam 5
mg. for the individual on the dates listed on the three prescriptions
found in Respondent's files. Finally, Dr. Price stated that he has no
record of the patient whose name appeared on the fifth prescription
attributed to Dr. Price. The first patient, in an affidavit dated April
9, 1997, stated that Dr. Price had prescribed Xanax for her in January
and February 1991. This affidavit confirms Dr. Price's conclusion,
after reviewing his patient's chart, that he had prescribed Xanax in
January of 1991, yet conflicts with his conclusion concerning the
February 1991 prescription. Regarding the second patient, Respondent
provided an affidavit dated April 9, 1997, from an individual who
stated that she could ``verify that [the patient] was prescribed Valium
(diazepam) by Dr. Steven Price and sometimes the prescription was
phoned into [Respondent]. I personally
[[Page 53341]]
picked up this medication on many occasions for [the patient].'' The
affidavit fails to give a time period for her statements. The Acting
Deputy Administrator finds Dr. Price's affidavit to be more reliable
than those submitted by Respondent, since it is based upon a review of
his patient records which were prepared and maintained during the
relevant time period, whereas the patients' affidavits are based upon
the recollection of individuals more than six years after the event.
During execution of the search warrant, investigators obtained from
Respondent five prescriptions allegedly authorized by Dr. B.A. Santa
Rossa for an individual for a total of 180 dosage units of
proproxyphene 65 mg. and 120 dosage units of Wygesic. In his affidavit
dated March 17, 1997, Dr. Santa Rossa stated that while he had
prescribed controlled substances for this individual in the past, he
always issued a written prescription for the drugs. In addition, a
review of his patient record revealed that he had not authorized any of
the five prescriptions attributed to him that were found in
Respondent's files. Further, in his affidavit, Dr. Santa Rossa denied
issuing a prescription to a second individual on June 8, 1991, for 30
dosage units of diazepam 10 mg. However, Respondent provided an
affidavit from this second patient who stated that, ``according to my
best judgment and recol[l]ection do attest to the fact that Joe Grimes
has called for permission to fill diazepam 10 mg. in June 1991.'' As
Judge Randall noted, ``[e]ven if this affidavit is given more
credibility than Dr. Santa Rossa's affidavit, a total of 300 dosage
units of controlled substances were dispensed, without authority, by
the Respondent's pharmacists * * *.''
According to Respondent's records, Dr. Richard Spurlin authorized
multiple prescriptions to six individuals which accounted for the
dispensation of over 12,000 dosage units of controlled substances by
Respondent. By affidavit, Dr. Spurlin stated that after reviewing his
records for these patients, he determined that while he had at various
times issued these individuals controlled substances prescriptions, he
had not authorized any of the prescriptions found in Respondent's
files. Respondent provided affidavits from four of these patients.
Three of them indicated that they had observed Mr. Grimes telephoning
Dr. Spurlin's office for authorization to fill or refill prescriptions.
Yet, none of these affidavits address the specific prescriptions at
issue nor do they provide a time period for the statements made. The
other patient's affidavit indicated that ``Dr. Spurlin has authorized
prescriptions for Xanax .25 mg. (alprazolam) and Halcion for me from
1988 to 1997.'' The Acting Deputy Administrator finds that while this
patient references a general time period, like the other patients, she
fails to address the specific prescriptions at issue. Therefore,the
Acting Deputy administrator finds Dr. Spurlin's affidavit to be more
reliable than those submitted by Respondent, since it is based upon a
review of his patient records which were prepared and maintained during
the relevant time period, whereas the patients' affidavits are based
upon their recollection more than six years after the event.
In December 1992, DEA investigators asked Dr. Reddoch Williams to
review prescriptions found in Respondent's files that indicated that
they were authorized by him. By letter dated February 26, 1997, Dr.
Williams certified that he had reviewed the original prescriptions and
his patient filed. Dr. Williams also wrote that he had not authorized
``[Respondent] or any other person or pharmacy to fill or refill the
prescriptions which are marked as `forgery' or otherwise marked as not
authorized by me.'' Some of Dr. Williams handwritten comments are
difficult to read and other comments are not definitive in nature,
being qualified with statements such as ``I believe'' or ``I think''.
Therefore, the Acting Deputy Administrator declines to find that any of
these prescriptions were unauthorized. However, in those instances
where the prescriptions are clearly marked as forgeries without any
qualifying language, the Acting Deputy Administrator finds that these
prescriptions were not authorized by Dr. Williams. These unauthorized
prescriptions accounted for the dispensation of over 1,100 dosage units
of controlled substances. Three of the patients, whose names appeared
on the prescriptions which were clearly marked as forgeries by Dr.
Williams, provided affidavits. However, these affidavits did not
provide any time period for their statements and the other only
provided a general reference to a time period, but did not specifically
reference the date of the prescription at issue. Like with the
previously discussed affidavits, the Acting Deputy Administrator finds
Dr. Williams' comments to be more reliable than the patients'
affidavits, since his comments are based upon a review of his patient
records which were prepared and maintained during the relevant time
period, whereas the patients' affidavits are based upon their
recollection more than six years after the event.
In conducting the accountability audits which revealed significant
shortages, DEA investigators included the unauthorized prescriptions as
drugs for which Respondent could account. Mr. Grimes testified at the
hearing before Judge Randall that he never filled a prescription
without a doctor's authorization, and that while he disputes the
results of the accountability audits, he does not have any explanation
for the shortages and overages revealed by the audits.
The state of Alabama has not withdrawn its licensing commission
from Respondent. In addition, while arrested and charged, Mr. Grimes
was ultimately found not guilty by a jury of all charges stemming from
the undercover operation conducted by the local police department which
led to the execution of the search warrant. Further, it is undisputed
that there have never been any complaints about Respondent or Mr.
Grimes made by any drug supplier, and no doctor or pharmacist has ever
contacted Mr. Grimes about illegal prescriptions. Finally, Respondent
introduced into evidence a letter from the co-chairman of a drug
company attesting to Mr. Grimes' honesty and integrity.
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 applications, if he determines that the continued registration
would be inconsistent with the public interest. Section 823(f) requires
that the following factors be 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 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 be
denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-42, 54 F.R.
16,422 (1989).
[[Page 53342]]
Respondent contends that the Government has not met its burden of
proof in establishing that Respondent's continued registration would be
inconsistent with the public interest. Judge Randall concluded and the
Acting Deputy Administrator concurs that all five factors are relevant
in determining the public interest in this matter.
As to factor one, it is undisputed that the State of Alabama has
not taken any action against Respondent pharmacy or its owner Mr.
Grimes. Regarding Respondent's conviction record relating to controlled
substances, it is also undisputed that neither Respondent pharmacy nor
its owner Mr. Grimes has been convicted of any such offense.
Factors two and four, Respondent's experience in dispensing
controlled substances and its compliance with state, Federal, or local
laws relating to controlled substances, are clearly relevant in
determining whether Respondent's continued registration would be
inconsistent with the public interest. The Acting Deputy Administrator
finds that Respondent pharmacy dispensed over 25,000 dosage units of
controlled substances without authorization from a physician in
violation of 21 U.S.C. 829. Respondent argues that the physicians whose
names appeared on the prescriptions at issue could have forgotten to
note in the patient chart that the telephone prescriptions had been
authorized. Respondent further argues that a patient's recollection is
more reliable, since a patient is more likely to remember what was
actually prescribed to him or her. Respondent also contends that in
instances where there was no patient affidavit, Mr. Grimes was able to
recall the circumstances of the dispensing at issue.
The Acting Deputy Administrator concludes that it is highly
unlikely that eleven different physicians forgot to note numerous
prescriptions in patient charts which accounted for the dispensing of
over 25,000 dosage units of controlled substances. Also as stated
previously, most of the patients' affidavits are of little value since
they do not address the specific prescriptions at issue nor do they
provide a time period for the statements contained in the affidavits.
In addition, the physicians' affidavits were based upon a review of
patient records prepared contemporaneously with the events at issue,
whereas the patients' affidavits and Mr. Grimes' testimony are based
upon their recollection of events which occurred over six years ago.
Therefore, the Acting Deputy Administrator finds that Respondent
pharmacy dispensed controlled substances in violation of 21 U.S.C. 829.
In addition, Mr. Grimes violated his corresponding responsibility as
set forth in 21 C.F.R. 1306.04, to ensure that controlled substances
are only prescribed and dispensed for a legitimate medical purpose.
Additionally, pursuant to 21 U.S.C. 827, a registrant must maintain
complete and accurate records of controlled substances received, sold,
delivered or otherwise disposed of by him. The Acting Deputy
Administrator finds that accountability audits of Respondent's
controlled substances handling revealed that for the period January 15,
1990 to March 1992, Respondent could not account for over 80,000 dosage
units of Schedule III and IV controlled substances. In addition, the
audits revealed overages of some audited substances, including an
overage of 859 dosage units of oxycodone 5 mg., a Schedule II
controlled substance. In conducting these audits, the investigators
included the unauthorized prescriptions in their calculation of the
total amount of controlled substances dispensed by Respondent. Had
Respondent not been given credit for these unauthorized dispensations,
the shortages would have been significantly greater.
In its post-hearing filing, Respondent proposes a number of
possible explanations for the audit discrepancies. First, Respondent
argues that as allowed, it estimated the amount of Schedule III through
V controlled substances on hand when conducting its yearly inventory,
and consequently, it is possible that the overages and shortages could
have resulted from these estimations. Respondent also argues that the
audit results were possibly the result of a review by DEA of incorrect
or incomplete receiving and/or return records. Next Respondent argues
that it is possible that the audit discrepancies were the result of
other prescription records not being examined at the time of the audit.
In support of this argument, Respondent contends that in conducting the
audit, DEA did not examine additional ledgers used by Respondent during
the audit period. Finally, Respondent argues that another possible
explanation for the audit results is that DEA's closing inventory
conducted on March 2, 1992, was inaccurate since DEA used Respondent's
pill counting machine without first verifying the accuracy of the
machine.
The Acting Deputy Administrator concurs with Judge Randall's
conclusion that these possibilities advanced by Respondent ``are mere
speculation, unsupported by the record in this case.'' Respondent did
not provide any specific evidence that would account for the over
80,000 dosage unit shortage of controlled substances. While it is
permissible to estimate Schedule III through V controlled substances
when conducting an inventory, clearly such estimations would not
account for over 80,000 dosage units. In addition, a registrant cannot
estimate Schedule II controlled substances, however, the audit revealed
a significant overage of the one Schedule II controlled substance
audited. The investigators who conducted the audits were confident that
they had obtained all of the necessary records. It is significant to
note that if one were to accept Respondent's argument that the
receiving records were incomplete, then the shortages revealed by the
audit should actually have been greater, since Respondent would have
had to account for more controlled substances. As to the prescription
ledgers that Respondent argues would have effected the audit, the
investigator testified that those ledgers were examined, however, since
they did not contain any information necessary for conducting an audit,
they were discounted. Finally, Respondent did not present any evidence
that its pill counting machine was not operating properly.
Thus, the Acting Deputy Administrator concludes that the
preponderance of the evidence supports a finding that Respondent did
not maintain complete and accurate records of controlled substances as
required by 21 U.S.C. 827, as evidenced by the results of the audits.
The Acting Deputy Administrator finds it extremely significant that had
DEA not included the unauthorized prescriptions in the audit and given
Respondent credit for those dispensations, the shortages would have
been far greater.
As to factor five, the Acting Deputy Administrator concurs with
Judge Randall's finding that Mr. Grime's failure to accept
responsibility for the significant unexplained shortages and
unauthorized dispensations of controlled substances indicates a
potential threat to the public health and safety. Previously, DEA's
then-Administrator found that a pharmacist's ``refusal to acknowledge
the impropriety of his dispensing practices * * * give[s] rise to the
inference that [he] is not likely to act more responsibly in the
future.'' Medic-Aid Pharmacy, 55 FR 30,043 (1990); see also, Rocco's
Pharmacy, 62 FR 3056 (1997).
The Administrative Law Judge concludes that ``[t]he Government has
proven by a preponderance of the evidence that the Respondent's past
[[Page 53343]]
conduct would justify revocation of its DEA Certificate of
Registration.'' Judge Randall further concluded that Respondent did not
present any mitigating or rehabilitating evidence as it relates to its
dispensing practices. Therefore, Judge Randall recommended that
Respondent's DEA Certificate of Registration be revoked. Judge Randall
further recommended however, that ``[s]ubsequently, should the
Respondent provide any evidence of proposed procedural changes for the
dispensing of controlled substances in a new application for a
Certificate of Registration, and should such evidence be persuasive,
then I would concur with a favorable decision concerning that
subsequent application.''
The Acting Deputy Administrator agrees with the Administrative Law
Judge that the Government has met its burden of proof and that
Respondent's registration should be revoked. However, the Acting Deputy
Administrator does not adopt Judge Randall's recommendation that
favorable consideration will be given to a new application for
registration should Respondent present persuasive evidence of
procedural changes regarding the dispensing of controlled substances. A
change in procedures, in and of itself, might not justify granting
Respondent a new registration, since Mr. Grimes has failed to
acknowledge that he and his pharmacy have done anything improper. An
unexplained shortage of $80,000 dosage units and the unauthorized
dispensation of over 25,000 dosage units of controlled substances are
not merely minor technical violations. The egregious nature of the
violations in this matter demonstrate that Respondent has failed
miserably in its responsibility as a DEA registrant to protect against
the diversion of controlled substances from the legitimate chain of
distribution. Respondent is certainly free to apply for a new DEA
Certificate of Registration. Any such application will be evaluated in
light of all of the relevant circumstances in existence at that time to
determine whether to grant the application.
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 AC5430450, issued to City Drug Company, be, and it
hereby is, revoked. The Acting Deputy Administrator further order that
any pending applications for renewal of such registration, be, and they
hereby are, denied. This order is effective November 13, 1997.
Dated: October 7, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-27144 Filed 10-10-97; 8:45 am]
BILLING CODE 4410-09-M