[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Notices]
[Pages 8477-8480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4201]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-6]
Townwood Pharmacy; Revocation of Registration
On October 31, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Townwood Pharmacy (Respondent) of Houston,
Texas, notifying the pharmacy of an opportunity to show cause as to why
DEA should not revoke its DEA Certificate of Registration, AT8866468,
and deny any pending applications for renewal of such registration as a
retail pharmacy under 21 U.S.C. 823(f), for reason that the pharmacy's
continued registration would be inconsistent with
[[Page 8478]]
the public interest pursuant to 21 U.S.C. 824(a)(4).
By letter dated November 15, 1995, Respondent, through counsel,
timely filed a request for a hearing, and following prehearing
procedures, a hearing was held in San Antonio, Texas on October 16,
1996, before Administrative Law Judge Mary Ellen Bittner. At the
hearing, both parties called witnesses to testify and introduced
documentary evidence. After the hearing, Government counsel submitted
proposed findings of fact, conclusions of law and argument. Respondent
did not submit any posthearing filing. On November 10, 1997, Judge
Bittner issued her Opinion and Recommended Ruling, Findings of Fact,
Conclusions of Law and Decision, recommending that Respondent's DEA
Certificate of Registration be revoked. Neither party filed exceptions
to her decision, and on December 12, 1997, 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, 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 a retail
pharmacy located in Houston, Texas. A.B. Hurd, has been a licensed
pharmacist for 25 years and has been Respondent's owner and operator
for 17 years. In late 1992, DEA received information from the Houston
Police Department that Respondent pharmacy had a reputation for
diverting controlled substances.
As a result of this information, DEA initiated an investigation of
Respondent, which included five undercover visits between December 17,
1992 and July 9, 1993. The purpose of these visits was to determine
whether Respondent would dispense controlled substances for no
legitimate medical purpose. DEA obtained a total of nine controlled
substance prescriptions written by a local Houston orthopedic physician
for a Symone Williams to be used in the undercover investigation. Five
of these prescriptions were for various quantities of Tylenol #4 with
codeine, a Schedule III controlled substance, and four were for various
quantities of Valium 10 mg., a Schedule IV controlled substance.
However, none of the prescriptions were for an excessive quantity of
either drug, given that each undercover visit was made more than a
month after the previous visit. The prescriptions did not contain the
patient's address or the date of issuance. Four out of the five visits
were conducted by an undercover agent posing as Symone Williams and the
fifth visit was conducted by an undercover agent posing as Ms.
Williams' boyfriend.
On each occasion, the undercover agent had a conversation with Mr.
Hurd while he was filling the prescriptions. At least four of these
visits were tape recorded and transcripts of these recordings are in
evidence in this proceeding. During the course of these visits, the
undercover agents made a number of statements to Mr. Hurd in an attempt
to indicate to him that the controlled substances were not going to be
used for a legitimate medical purpose. For instance, during the first
visit, the undercover agent told Mr. Hurd, ``I just tell my doctor to
write 'em, I don't tell him anything''; ``I like the brand, `cause
that's what my boyfriend likes''; and ``He's gonna have some alcohol
with it anyway.'' During the second visit, the undercover agent told
Mr. Hurd, ``Me and my boyfriend used [the controlled substances,] they
worked good''; and ``take that with a little bit of Crown,'' referring
to alcohol. On another occasion, the agent made the following comments
to Mr. Hurd: ``I go back to my doctor and * * * I told him I'm feeling
bad, and he just give it to me''; and ``[Y]ep, we'll get high. That's
right, some Crown and some Tylenol.'' During several of these visits,
the undercover agent posing as Symone Williams kept talking about
``partying'' with Mr. Hurd. Throughout the transcripts of these visits,
almost all of Mr. Hurd's comments, especially those in response to the
above statements, were unintelligible. Mr. Hurd filled all of the
prescriptions presented to him by the undercover agents. The
prescriptions for Valium were filled with its generic equivalent
diazepam.
Following the undercover visits, the undercover agent telephoned
Mr. Hurd on September 27, and October 12, 1993, in an attempt to obtain
controlled substances without presenting a prescription. Mr. Hurd did
not agree to dispense any more controlled substances to the undercover
agent. At the hearing, Mr. Hurd testified that he denied the undercover
agent's telephone requests because there were no refills listed on the
previously presented prescriptions and the agent had not authorized Mr.
Hurd to contact the doctor to request a refill.
Mr. Hurd testified at the hearing before Judge Bittner that he did
not recall any of the undercover agent's comments about using the
controlled substances with alcohol or sharing them with her boyfriend.
In addition, there was testimony that there was music or a television
playing in the background during these visits: that the undercover
agent and Mr. Hurd were approximately two arms' length apart during the
transactions; that the undercover agent was also having conversations
with the pharmacy's clerk; and that the undercover agent was not
standing directly in front of Mr. Hurd when she was making conversation
with him.
In addition, Mr. Hurd testified that he was familiar with the
doctor who purportedly issued the prescriptions; that the doctor has a
good reputation in the Houston area; and that Respondent pharmacy had
never had any problems with the doctor's prescriptions in the past. Mr.
Hurd further testified that the prescriptions appeared to be facially
valid to him; that the quantities prescribed and the frequency of the
prescriptions did not raise suspicions; and that Tylenol # 4 with
codeine and Valium are commonly prescribed by orthopedic physicians. He
also testified that he cannot determine whether or not a customer has
pain and/or anxiety simply from looking at the individual. Mr. Hurd
testified that he observed the undercover agent and that she had a
professional appearance, her eyes were not red, and her speech was not
slurred.
Mr. Hurd testified that he concluded that the prescriptions were
valid, and that had he suspected that the prescriptions were invalid,
he would not have filled them. Instead, he would have reported the
prescriptions to the appropriate authorities and/or called the
prescribing physician for verification.
Another area pharmacist testified at the hearing before Judge
Bittner on behalf of Respondent. He stated that he has worked as a
retail pharmacist in Houston for 27 years and has known Mr. Hurd since
1967. Like Mr. Hurd, this pharmacist testified that he is familiar with
the physician who issued the prescriptions used in the undercover
operation; that the physician has a good reputation; and that so long
as the physician's prescriptions met the legal requirements, he would
fill them. This pharmacist also testified that his practice is similar
to that of Respondent and that it is not at all unusual for customers
to strike up a conversation with him while he is filling a
prescription, but that he does not pay too much attention to what a
customer
[[Page 8479]]
says because his main objective is to fill the prescription. However,
the pharmacist conceded on cross-examination that he would be concerned
if a customer represented that he was going to take the prescribed
controlled substance with alcohol.
After the completion of the undercover investigation, DEA conducted
an accountability audit of ten controlled substances at Respondent. The
audit covered the period February 26, 1993 to January 25, 1994, and
revealed discrepancies for nine of the audited substances. Of
particular note, Respondent could not account for 5,363 dosage units of
diazepam 10 mg., 1,077 dosage units of hydrocodone 7.5/500, and 6,207
dosage units of APAP with codeine 60 mg. During the course of
conducting the audit, it was discovered that Respondent did not
maintain copies of 12 prescriptions and 6 purchase invoices. Respondent
was nonetheless given credit for these dispensations and purchases by
the investigators conducting the audit. Following the audit, the
results were discussed with Mr. Hurd and he was given the opportunity
to provide any additional records. Mr. Hurd subsequently provided the
investigators with copies of additional prescriptions, however the
prescriptions did not change the audit results because they were either
not for the audited substances or were outside of the audit period. In
addition, Mr. Hurd subsequently informed the investigators that he had
discovered another bottle of diazepam, which the investigators counted
and included in the audit calculations.
At the hearing in this matter, Mr. Hurd indicated that when
conducting Respondent's yearly inventory to satisfy state requirements,
he estimates the number of Schedule III through V controlled substances
on hand. Respondent's February 26, 1993 inventory was used as the
initial inventory for DEA's accountability audit.
Following the audit of Respondent, DEA was contacted by an
individual who stated that her daughter had a drug problem, was
currently in drug rehabilitation, and previously had overdosed
approximately four to five times on prescription drugs that she had
been getting from an employee of Respondent. DEA investigators later
spoke to the daughter who confirmed that she had been getting her
supply of controlled substances from Respondent's employee. Both of
these individuals provided DEA investigators with a bag of drugs. A DEA
investigator testified at the hearing that there were in fact some
valid prescriptions for the individual on file at Respondent, but that
the individual claimed that she also obtained controlled substances
from Respondent without a prescription. The investigator further
testified however that the drugs the individual actually presented to
DEA had another pharmacy's label on the bottles.
DEA investigators never spoke to Respondent's employee about the
individual, however Mr. Hurd testified that he spoke with the employee
and the employee never admitted to giving the individual any drugs
without a prescription. Mr. Hurd nonetheless instructed the employee
not to fill any more prescriptions for the individual.
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 law
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 any 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, there is no evidence that any action has been
taken against Respondent's state license. As Judge Bittner notes
however, since ``state licensure is a necessary but not sufficient
condition for DEA registration, * * * this factor is not dispositive.''
The Acting Deputy Administrator finds that factors two and four,
Respondent's experience in dispensing controlled substances and its
compliance with applicable laws relating to controlled substances, are
extremely relevant in determining the public interest in this matter.
Under the Controlled Substances Act and its implementing regulations,
pharmacists have a corresponding responsibility to ensure that
controlled substances are prescribed and dispensed for a legitimate
medical purpose. 21 CFR 1306.04(a). The Government contends that
Respondent dispensed controlled substances to the undercover agents
knowing that the drugs were not for a legitimate medical purpose.
However, the Acting Deputy Administrator agrees with Judge Bittner's
conclusion that, ``[i]t is not clear from the record whether or not Mr.
Hurd filled the prescriptions knowing that [the undercover agent]
intended to use the drugs for no medical purposes.'' While the
undercover agents' statements indicating a nonmedical purpose for the
drugs are clearly reflected in the transcripts of the visits, Mr.
Hurd's responses are unintelligible and Mr. Hurd testified that he did
not hear the undercover agents make these statements. In addition, no
testimony was elicited from either the undercover agent or the
investigator who was monitoring the undercover visits as to what Mr.
Hurd's responses were to the undercover agents' statements.
Judge Bittner does point out however, that on one occasion, the
transcript indicates that Mr. Hurd asked the undercover agent when she
was going to ``party'' with him, and therefore, Mr. Hurd was somewhat
aware of the undercover agent's statements. Also at the hearing, Mr.
Hurd testified that he dismissed the undercover agent's comment that
``My doctor writes anything I want,'' because he was familiar with the
prescribing doctor and felt that the doctor would not prescribe
improperly. This testimony by Mr. Hurd indicates that he in fact heard
the undercover agent's statement.
The Acting Deputy Administrator finds that the record does not
clearly establish whether Respondent dispensed controlled substances to
the undercover agent for no legitimate medical purpose. But, like Judge
Bittner, the Acting Deputy Administrator concludes that ``in light of
the discussion below,* * * it [is] unnecessary to decide whether the
record establishes that Mr. Hurd's filling of the prescriptions for
Symone Williams would, standing alone, warrant revocation of
Respondent's registration.''
The Acting Deputy Administrator finds that the record is clear that
Respondent has failed, at the very least, to comply with the
recordkeeping requirements of both Federal and state law as evidenced
by the violations revealed by the accountability audit. Respondent
failed to maintain complete
[[Page 8480]]
and accurate records of controlled substances in violation of 21 U.S.C.
827 and 21 CFR 1304.21, as evidenced by the audit discrepancies. For
less than a one year period of time, Respondent could not account for
over 13,500 dosage units of controlled substances. Respondent did not
actually offer any explanation for its failure to account for these
drugs. Instead, Mr. Hurd seemed to suggest that the discrepancies were
caused by the compounding over time of his estimates of Schedule III
through V drugs on hand when conducting his yearly inventory. The
Acting Deputy Administrator recognizes that it is permissible to
estimate Schedule III through V controlled substances when-conducting
controlled substance inventories. See 21 CFR 1304.11(e)(3). However,
such estimations would not compound over time. Instead, for each
inventory, Respondent would estimate what it had on hand on that date.
It was Respondent's estimated inventory taken on February 26, 1993,
that was used as the initial inventory for DEA's accountability audit.
It is inconceivable that Respondent's estimations on that date were off
by over 13,500 dosage units. Therefore, the Acting Deputy Administrator
concludes that Respondent did not offer any plausible explanation
whatsoever for the tremendous shortages revealed during the audit.
Respondent's failure to maintain 6 purchase invoices and 12
prescriptions is further evidence of its failure to maintain complete
and accurate records of controlled substances as required by 21 U.S.C.
827. This failure to keep accurate records also violated the Texas
Controlled Substances Act, title 6 Tex. Health & Safety Code Secs.
13.6(d) & 13.64(b).
While the Acting Deputy Administrator has concluded that it is
unnecessary to determine whether or not Respondent dispensed controlled
substances to the undercover agents for no legitimate medical purpose,
its dispensing of controlled substances pursuant to the prescriptions
presented nonetheless violated 21 CFR 1306.05(a). This regulation
imposes a ``corresponding liability [on] the pharmacist who fills a
prescription not prepared in the form prescribed by these
regulations.'' Pursuant to 21 CFR 1306.05(a), a prescription must
contain, among other things, the date of issuance and the address of
the patient. The prescriptions filled for the undercover agents did not
contain this information. Additionally, Respondent's filling of these
prescriptions violated the Texas Controlled Substances Act, Title 6,
Tex. Health & Safety Code Sec. 481.074(k)(2) & (3).
Regarding factor three, as Judge Bittner found, ''[t]here is no
evidence that Mr. Hurd or any other officer or agent of Respondent has
ever been convicted under State or Federal laws relating to controlled
substances.'' As to factor five, the Acting Deputy Administrator agrees
with Judge Bittner's assessment that the allegation that Respondent
dispensed controlled substances without a prescription to the
individual who overdosed is entitled to little weight. No corroborating
evidence was presented to support the allegation.
Judge Bittner concluded that ``Respondent offers little in the way
of an explanation for the serious shortages in inventory and there is
no suggestion in this record that Respondent is likely to be more
responsible in the future.'' Consequently, Judge Bittner found that
Respondent's continued registration would be inconsistent with the
public interest, and therefore recommended that its registration be
revoked. The Acting Deputy Administrator agrees with Judge Bittner.
Respondent's failure to account for over 13,500 dosage units of
controlled substances over an approximately one year period of time, is
extremely troublesome. At the very least, the shortages indicate that
respondent has failed miserably in complying with the requirement that
it maintain complete and accurate records of its controlled substance
handling. These requirements are in place in order to prevent and
detect the diversion of these potentially dangerous substances.
Respondent's failure to recognize the seriousness of the shortages,
does not bode well for its future compliance with the laws and
regulations relating to controlled substances. See Rocco's Pharmacy, 62
FR 3056 (1997). Therefore, the Acting Deputy Administrator concludes
that Respondent's continued registration would be inconsistent with the
public interest.
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 AT8866468, previously issued to
Townwood Pharmacy, be, and it hereby is, revoked. The Acting Deputy
Administrator further orders that any pending applications for the
renewal of such registration, be, and they hereby are, denied. This
order is effective March 23, 1998.
Dated: February 12, 1998.
Peter F. Gruden,
Acting Deputy Administrator.
[FR Doc. 98-4201 Filed 2-18-98; 8:45 am]
BILLING CODE 4401-09-M