[Federal Register Volume 63, Number 210 (Friday, October 30, 1998)]
[Notices]
[Pages 58418-58421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29063]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 97-23]
Bradford's Pharmacy Conditional Grant of Registration
On June 16, 1997, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Bradford's Pharmacy (Respondent) of Estill
Springs, Tennessee, notifying it of an opportunity to show cause as to
why DEA should not deny its application for registration as a retail
pharmacy pursuant to 21 U.S.C. 823(f), for reason that its registration
would be inconsistent with the public interest. By letter dated July
12, 1997, Respondent, with counsel, timely filed a request for a
hearing, and following prehearing procedures, a hearing was held in
Nashville, Tennessee on November 18, 1997, before Administrative Law
Judge Gail A. Randall. At the hearing, both parties called witnesses to
testify and introduced documentary evidence. After the hearing, both
parties submitted proposed findings of fact, conclusions of law and
argument.
On May 28, 1998, Judge Randall issued her Opinion and Recommended
Ruling, recommending that Respondent's application for registration be
granted. Neither party filed exceptions to the Administrative Law
Judge's recommended decision, and on June 29, 1998,. Judge Randall
[[Page 58419]]
transmitted the record of these proceedings to the Acting Deputy
Administrator.
The Acting Deputy Administrator has considered the record, 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, 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 James R. Bradford \1\ is
a licensed pharmacist and the owner of Respondent pharmacy. In 1989,
Mr. Bradford owned and operated Prince Drug Store in Winchester,
Tennessee. An investigation of Prince Drug Store was conducted in March
1989. During a routine compliance inspection by the Tennessee Board of
Pharmacy (Pharmacy Board), it was noted that there was an excessive
amount of telephone prescriptions for controlled substances. An
investigator contacted some of the physicians whose names appeared on
the prescriptions and learned that the physicians had not authorized
the prescriptions. As a result, Mr. Bradford was arrested on May 2,
1989.
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\1\ James R. Bradford was referred to as Dr. Bradford at various
times throughout the transcript of these proceedings and by Judge
Randall in her opinion. There is nothing in the record to indicate
that he has a degree that warrants this title, and therefore he will
be referred to as Mr. Bradford throughout this final order.
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On June 15, 1989, investigators obtained more records from
Respondent. After interviewing approximately 20 physicians, the
investigators calculated that Respondent dispensed over 60,000 dosage
units of controlled substances between January 1, 1988 and June 15,
1989, that were not authorized by a physician. Of particular note,
unauthorized prescriptions accounting for approximately 5,500 dosage
units were dated after Mr. Bradford's arrest on May 2, 1989.
Mr. Bradford was indicted in the Franklin County Circuit Court in
Tennessee on one count each of illegally dispensing drugs, failure to
keep drug records, furnishing false and fraudulent records, and
obtaining controlled substances by use of forged and altered
prescriptions. On July 28, 1989, Mr. Bradford pled guilty to all four
felony counts.
On August 3, 1989, DEA served an Order to Show Cause and Immediate
Suspension of Registration on Prince Drug Store. At that time, Mr.
Bradford voluntarily surrendered the pharmacy's DEA registration.
On September 27, 1989, Mr. Bradford, both individually and on
behalf of Prince Drug Store, entered into an Agreed Final Order with
the Pharmacy Board, whereby he agreed to the revocation of the
pharmacy's license and his pharmacist license.
On November 17, 1989, Mr. Bradford was sentenced to two years in
jail for each of the four felony counts, to be served concurrently. He
served approximately six months in jail, and was released on probation.
Mr. Bradford's probation officer testified at the hearing in this
matter that after one year of probation, Mr. Bradford was discharged
from active supervision. According to the probation officer, Mr.
Bradford was ``an exceptional probationer,'' he has been rehabilitated,
and he has not committed any further offenses.
The sheriff of Franklin County testified that while incarcerated,
Mr. Bradford served as a trustee. Trustees have work assignments and
are selected because they are believed to be trustworthy. In the
sheriff's opinion, Mr. Bradford is rehabilitated.
On September 28, 1993, the Pharmacy Board entered a Consent Order
reinstating Mr. Bradford's pharmacist license on condition that he
perform 160 hours of internship within two-months of the order and that
he complete 15 hours of continuing education. Mr. Bradford fulfilled
these conditions, and his license was reinstated and placed on
probation for five years. One term of the probation was that Mr.
Bradford could not serve as the pharmacist in charge at a pharmacy, but
after two years he could petition the Pharmacy Board to remove this
restriction.
Upon reinstatement of his pharmacist license, a pharmacy submitted
a request to DEA for a waiver of 21 CFR 1301.76(a), to permit Mr.
Bradford to work at the pharmacy with access to controlled substances.
In a letter dated February 6, 1995, this request was denied based upon
the fact that Mr. Bradford would be unsupervised while working in the
pharmacy.
On September 19, 1995, Mr. Bradford entered into another Consent
Order with the Pharmacy Board whereby the previous Consent Order was
modified and Mr. Bradford's authority to serve as a pharmacist in
charge was reinstated. On January 2, 1996, Mr. Bradford opened
Respondent and subsequently applied for a DEA registration for the
pharmacy. In the application for registration, Mr. Bradford disclosed
his criminal convictions and the actions against his previous DEA
registration and sate licenses.
At the hearing before Judge Randall, Mr. Bradford acknowledged
dispensing controlled substances without a physician's authorization
and explained that he had difficulty saying ``no'' and that he did want
to lose customers. Mr. Bradford testified that he takes full
responsibility for his actions, specifically stating that:
I left James R. Bradford of `88 and `89 in Franklin County Jail
when I was released. He is no more. I've learned from my mistakes
and I'm a different person. It just won't happen again. I realize
what is to be lost * * * I lost a thriving business. I lost my
livelihood. I lost the respect of the citizens of Franklin County. I
lost my privilege of practicing the profession that I had trained
for. I lost everything--everything except my family. And at times,
it was even hard to face them.
Mr. Bradford further testified that his practice of pharmacy is
different now than it was in the late 1980's. Judge Randall found that
he credibly testified that ``[t]he patients in the late `80s--my main
objective was filling their prescriptions, keeping them coming to my
store, and I did anything to do that. Now my main objective is the
safety and well-being of my patients.'' According to Mr. Bradford, he
now contacts physicians if he believes a patient is overutilizing drugs
and he does not prematurely refill prescriptions. Additionally, he
currently participates in managed care networks, and as a result, if he
tried to prematurely refill a prescription, the pharmacy's computer
would reject it and if he did refill the prescription, he would not
receive payment from the managed care network.
The mayor of Estill Springs testified that Respondent is the only
pharmacy in the town. The population of Estill Springs is 1,500 to
1,600 people with approximately 60 percent of the population retired.
Some in the community lack transportation to be able to frequent
pharmacies outside of Estill Springs. The mayor testified that he
considers Mr. Bradford to be an outstanding professional with the
highest integrity and honesty.
Respondent introduced into evidence the affidavit of an Estill
Springs physician who stated that he is personally familiar with Mr.
Bradford, his pharmacy practices, his conviction for controlled
substance violations, and the actions by the Pharmacy Board. It is the
physician's opinion that Mr. Bradford displays ``a high degree of
honesty, integrity and professionalism
[[Page 58420]]
in the provision of pharmacy services to patients * * * [and] in
relationships with other health care professionals.''
Both Mr. Bradford and Respondent possess state licenses issued by
the Pharmacy Board. In Tennessee, both the pharmacist and the pharmacy
are required to obtain a controlled substance registration. The
Director of the Pharmacy Board testified at one point that Mr.
Bradford's controlled substance registration was reinstated by the
Pharmacy Board with his pharmacist license. However when later asked
whether Respondent pharmacy has a Tennessee controlled substance
license, he testified that ``I'm sure they probably don't, but that's
because of the absence of the DEA waiver, and he did not request that
either.'' Further, when asked whether Mr. Bradford is licensed in the
state to handle controlled substances, the Director responded. ``He
would be, but that was not requested, I don't think. Without having his
license in front of me, I couldn't [say].''
Since there was no explanation for the discrepancy in the
Director's testimony and since the Government did not raise lack of
state authorization as an issue, Judge Randall ``assume[d] that [the
Director's] initial testimony about that the status of the state
controlled substance registration is correct * * * [and] assume[d] that
his testimony to the contrary was based on a misunderstanding of the
question.'' Therefore, Judge Randall found that Respondent pharmacy and
Mr. Bradford possess state authority to dispense controlled substances.
The Acting Deputy Administrator agrees with Judge Randall that based
upon the Pharmacy Board Director's testimony, there is confusion
regarding the status of Respondent's state authorization to handle
controlled substances. However, as will be discussed further below, the
Acting Deputy Administrator disagrees with Judge Randall's assumption
that Respondent is authorized in Tennessee to handle controlled
substances.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny any
application for a DEA Certificate of Registration if he determines that
the 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 denied. See Henry J. Schwarz, Jr., M.D., 54 FR 16,422
(1989).
As to factor one, it is undisputed that Mr. Bradford's pharmacist
license and the license of his previous pharmacy were revoked through
an Agreed Final Order on September 27, 1989. In 1993, Mr. Bradford's
pharmacist license was reinstated, but he was precluded from being the
pharmacist in charge of a pharmacy. Then, in 1995 all of Mr. Bradford's
privileges were restored and he was on probation until September 1998.
Regarding factors two and four, the applicant's experience in
dispensing controlled substances and compliance with applicable laws
relating to controlled substances, Mr. Bradford's dispensing practices
while the owner and pharmacist at Prince Drug Store are relevant to
these proceedings. DEA has consistently held that a pharmacy operates
under the control of owners, stockholders, pharmacists, or other
employees, and that the conduct of these individuals is relevant in
evaluating a pharmacy's fitness to be registered with DEA. See e.g.,
Rick's Pharmacy, 62 FR 42,595 (1997); Big T Pharmacy, Inc., 47 FR
51,830 (1982).
Mr. Bradford, the owner of Respondent, admits that he dispensed
over 60,000 dosage units of controlled substances without a physician's
authorization. As Judge Randall noted, ``[i]t is particularly troubling
that Dr. Bradford continued to dispense controlled substances without
authorization after his first arrest.'' According to Mr. Bradford, he
had trouble saying ``no'' to his customers and he did not want to lose
any business, so he dispensed drugs without authorization.
However, Mr. Bradford has accepted responsibility for his actions
and says that his main objective now is his patients' safety and well-
being. He recognizes how much he has to lose should he unlawfully
dispense controlled substances again. In addition, the mayor of Estill
Springs, the sheriff of Franklin County and Respondent's probation
officer all believe that Mr. Bradford has been rehabilitated. Further,
the Acting Deputy Administrator notes that Mr. Bradford appears to have
kept abreast of changes in DEA's regulations even though he has not
been handling controlled substances since 1989.
As to factor three, it is undisputed that Mr. Bradford was
convicted of four felony counts related to his handling of controlled
substances. Regarding factor five, the Acting Deputy Administrator
agrees with Judge Randall that the record does not indicate any
additional conduct that would threaten the public health or safety.
The Acting Deputy Administrator concludes that the Government has
presented a prima facie case for denial of Respondent's application for
registration based upon Mr. Bradford's unlawful dispensing of over
60,000 dosage units of controlled substances, his conviction, and the
action of the Pharmacy Board. However, Mr. Bradford appears to be
extremely remorseful and to be rehabilitated. He has not engaged in any
unlawful conduct since 1989. Further, He approaches the dispensing of
drugs very differently now than he did in 1989. He contacts a physician
if he believes that a patient is using too much of a drug. Also, he
participates in managed care networks which causes his computer system
to reject a prescription if he tries to refill it prematurely. Finally,
Respondent is the only pharmacy in Estill Springs which has a
population of approximately 1,500 people. Without a DEA registration,
Respondent cannot meet the needs of the community since it cannot
dispense controlled substances. Therefore, the Acting Deputy
Administrator agrees with Judge Randall that it would be in the public
interest to grant Respondent a DEA Certificate of Registration.
However, the status of Respondent's state authorization to handle
controlled substances is unclear. This is significant since DEA does
not have the statutory authority under the Controlled Substances Act to
register a practitioner unless that practitioner is authorized by the
state to handle controlled substances. See 21 U.S.C. 802(21) and
823(f). Given the Pharmacy Board Director's testimony, there is
confusion as to whether Respondent pharmacy is in fact authorized by
the State of Tennessee to handle controlled substances. Unlike Judge
Randall, the Acting Deputy Administrator does not assume that the
pharmacy is properly licensed by the state. Therefore, the Acting
Deputy Administrator concludes that Respondent pharmacy should be
issued a DEA Certificate of Registration
[[Page 58421]]
once it provides evidence to DEA that it is authorized to handle
controlled substances in Tennessee.
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 for a DEA Certificate of Registration submitted by
Bradford's Pharmacy, be, and it hereby is granted upon receipt by the
DEA Nashville office of evidence of the pharmacy's state authorization
to handle controlled substances. This order is effective November 30,
1998.
Dated: October 23, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-29063 Filed 10-29-98; 8:45 am]
BILLING CODE 4410-09-M