[Federal Register Volume 61, Number 238 (Tuesday, December 10, 1996)]
[Notices]
[Pages 65079-65081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31253]
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DEPARTMENT OF JUSTICE
[Docket No. 95-4]
Roger Pharmacy; Revocation of Registration
On October 7, 1994, the Deputy Assistant Administrator. Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to show Cause to Roger Pharmacy (Respondent) of Gahanna, Ohio,
notifying the pharmacy of an opportunity to show cause as to why DEA
should not revoke its DEA Certificate of Registration, BR1448655, 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 the public interest
pursuant to 21 U.S.C. 824(a)(4).
On November 2, 1994, the Respondent, through counsel, filed a
timely request for a hearing, and following prehearing procedures, a
hearing was held in Cleveland, Ohio on June 27, 1995, before
Administrative Law Judge Mary Ellen Bittner. At the hearing, both
parties called witnesses to testify, and the Government introduced
documentary evidence. After the hearing, counsel for both parties
submitted proposed findings of fact, conclusions of law and argument.
On April 9, 1996, 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 May 10, 1996, Judge
Bittner transmitted the record of these proceedings to the 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 Findings of
Fact, Conclusions of Law, 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 Jon R. Martin, R.Ph.
purchased Respondent pharmacy, located in Gahanna Ohio, in the late
1980's. Respondent is a high volume drug store that employees 10 to 15
individuals, and provides services not generally available from chain
pharmacies, such as charge accounts and deliveries to the elderly.
In November 1990, a detective with the Narcotics Bureau of the
Columbus, Ohio Police Department conducted a routine inspection of
Respondent pharmacy and its exempt narcotics log book. Under both
Federal and state law a prescription is not required to purchase
certain Schedule V cough syrups, however a log book must be maintain
containing the name and address of the purchaser, the name and quantity
of the controlled substance purchased, the date of purchase, and the
name of the dispensing pharmacist. In addition, there is a limit on the
amount of cough syrup that may be purchased by an individual within a
48 hour period. The inspection revealed that on 11 occasions, between
February 1989 and November 1990, individuals had purchased Schedule V
exempt narcotic cough syrups from Respondent more than once in a 48
hour period in violation of both Federal and state law. Further
examination of Respondent's exempt narcotic log book revealed that
certain individuals bought exempt narcotics from Respondent frequently
and over an extended period of time. Specifically, between February 20,
1989 and November 18, 1990, an individual purchased exempt narcotics
from Respondent on 126 occasions; between March 24, 1989 and February
7, 1990, an individual purchased exempt narcotics from Respondent on 63
occasions; another individual purchased exempt narcotics from
Respondent on 97 occasions between January 2, 1989 and February 3,
1991; between January 15, 1989 and December 29, 1990, an individual
purchased exempt narcotics from Respondent on 104 occasion; an
individual purchased exempt narcotics on 87 occasions between January
16, 1989 and February 10, 1991; and another individual purchased exempt
narcotics from Respondent on 34 occasions between August 25, 1990 and
February 2, 1991.
The detective interviewed three of these individuals who all
admitted purchasing exempt narcotics from Respondent. One stated that
when he went to Respondent, there would be a bottle of cough syrup
waiting for him by the time he reached the pharmacy counter. Another
individual admitted to signing the log book using different names.
On January 30, 1991, the detective interviewed Jon Martin,
Respondent's owner and pharmacist, and asked him how long it would take
someone to become addicted to codeine if he/she drank a bottle of cough
syrup every day or every other day. Mr. Martin stated that in his
opinion it would take approximately 60 days. The detective then asked
Mr. Martin why he continued to sell cough syrup to the same
individuals. Mr. Martin replied that as long as customers stayed within
the 48 hour rule, he would sell the cough syrup to them because if he
did not, they would just buy it elsewhere. Mr. Martin went on to state
that the pharmacy business is a tough business and he might as well
make money.
In April 1991, the Columbus Police Department informed DEA of the
results of its investigation of Respondent. DEA compared the amount of
exempt narcotics sold by Respondent with the amount sold by the other
five pharmacies located in Gahanna, Ohio, and discovered that during an
average month in 1991, Respondent sold twice the quantity of exempt
narcotic products as all the other local pharmacies combined. On April
18, 1991, DEA went to Respondent pharmacy to evaluate its compliance
with the Controlled Substances Act. It was discovered that Respondent
did not have a biennial inventory as required by Federal regulations.
At the hearing before Judge Bittner, when asked about this Respondent
stated that, ``I suspect it was just a matter of being a little lax on
getting things done. It was nothing intentional. There's a lot of
things for me to do. * * * Some of them are nit-picky things I
neglected doing. I'm sorry.'' The DEA investigators also discovered
that Respondent could not account for 18 of the 126 Schedule II order
forms that it had been issued by DEA between January 1989 and April
1991. Respondent testified at the hearing before Judge Bittner that he
was surprised that the order forms were missing, and that ``paperwork
has not always been one of (his) strong suits.''
As part of its investigation, DEA conducted an accountability audit
at Respondent pharmacy of eight controlled substances. The audit
revealed both overages and shortages of all but one of the audited
substances. For example, Respondent pharmacy could account for 164
tablets of Dilaudid 2 mg. (a Schedule II controlled substances) more
than it was accountable, and could not account for 1,160 tablets of
APAP with codeine (a Schedule III controlled substance) for
[[Page 65080]]
which it was accountable. At the hearing before Judge Bittner, Mr.
Martin stated that had he been informed of the shortages at the time of
the investigation, he probably could have accounted for the shortages.
However, both the DEA investigator that testified at the hearing and
Mr. Martin testified that at the time of the accountability audit, the
investigator asked Mr. Martin several times if he had given or shown
the investigator all of the pharmacy's controlled substances and
records.
The DEA investigator returned to Respondent pharmacy on April 25,
1991, to verify refill information, and discovered that Respondent's
records did not indicate dates of refills or verification by the
dispensing pharmacist. The investigator also discovered that
Respondent's records of oral prescriptions did not include information
required by Federal regulations. The investigator seized seven
controlled substance prescriptions issued to an individualy purportedly
by one doctor. On April 30, 1991, the investigator met with the doctor
who advised the investigator that he had not authorized one of the
prescriptions at all and that another prescription that he had issued
had been refilled five times, when he had only authorized one refill.
As a result of the investigation by the Columbus Police Department,
the Ohio State Board of Pharmacy (Board) found that on nine occasions
between March 1989 and November 1990, Mr. Martin had violated the 48
hour rule regarding the dispensing of exempt narcotics, and that he had
sold codeine cough syrup for other than a legitimate medical purpose.
The Board concluded that Mr. Martin was guilty of gross immorality,
dishonesty and unprofessional conduct in the practice of pharmacy, and
on August 11, 1992, suspended his license to practice pharmacy for one
year, fined him $5,000.00, but permitted the pharmacy to continue
operating without restriction.
Mr. Martin pled guilty in the United States District Court for the
Southern District of Ohio to one misdemeanor count of unlawful
distribution of a codeine-based exempt narcotic, and in September 1993,
he was placed on probation for one year, fined $2,500.00 and ordered to
perform 50 hours of community service. Mr. Martin paid the fine, but
was excused from performing some of the community service, and his
probation was terminated early.
Both the Columbus detective and the DEA investigator testified at
the hearing in this matter that they have not received any complaints
regarding Respondent's controlled substance dispensing since the
investigation in 1991. Mr. Martin testified at the hearing that he
assumes full responsibility for what happened at Respondent pharmacy,
and that he has instituted procedural changes so nothing like it will
happen again. The pharmacy no longer sells exempt narcotics without a
prescription even though a prescription is not required by Federal or
state law. Mr. Martin has hired a pharmacist to be responsible for all
controlled substance inventories, Schedule II order forms, and other
DEA requirements. It is now the pharmacy's policy to call prescribing
doctors to verify refill information, and to note that information on
the prescription and in the computer.
However, Mr. Martin admitted at the hearing that he was aware that
certain individuals came to his pharmacy to buy Schedule V cough syrup
because he always sold it to them. When asked why the pharmacy stopped
selling exempt narcotics without a prescription, Mr. Martin testified,
``it's cost me a lot of money and a lot of time and a lot of anguish in
my life that I really don't need. And besides that, I certainly wasn't
helping the people.''
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 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). In this case, factors one, two, three and four are relevant in
determining the public interest.
As to factor one, ``recommendation of the appropriate licensing
board * * *'' in 1992, the Ohio State Board of Pharmacy found that Mr.
Martin had dispensed coedine cough syrup for no legitimate medical
purpose and in violation of the prohibition against dispensing more
than once in a 48 hour period to the same individual. As a result, the
Board suspended Mr. Martin's license to practice pharmacy for one year.
Mr. Martin's license to practice pharmacy and Respondent's license are
currently unrestricted. While it is relevant that Respondent and its
owner possess unrestricted state authorization to handle controlled
substances, the Acting Deputy Administrator does not find it
dispositive of whether Respondent's continued registration is in the
public interest.
As to factor two, the Respondent's ``experience in dispensing * * *
controlled substances,'' the Acting Deputy Administrator concurs with
the Administrative Law Judge that ``this factor strongly weighs in
favor of finding that Respondent's registration would not be in the
public interest.'' In the case of Schedule V exempt narcotic cough
syrups dispensed without a prescription, the responsibility to ensure
that these substances are dispensed for a legitimate medical purpose
rests solely with the pharmacist. See Arthur Sklar, R.Ph., d/b/a/ King
Pharmacy, 54 FR 34,623 (1989). The Ohio State Board of Pharmacy found
that Mr. Martin dispensed exempt narcotics to certain individuals for
no legitimate medical purpose. Mr. Martin admitted that he was aware
that certain individuals came to his pharmacy to buy Schedule V cough
syrup for no legitimate medical purpose, because he always sold it to
them. He stated that if he didn't sell it to them, they'd just go buy
it elsewhere. He violated the prohibitions against dispensing exempt
narcotics to the same individual more than once in a 48 hour period. It
was Mr. Martin's opinion that an individual who took Schedule V cough
syrup every day or every other day, could become addicted within 60
days, yet he continued to dispense these substances to individuals on a
regular basis over several years. The Acting Deputy Administrator
agrees with Judge Bittner's finding that ``Mr. Martin abrogated his
professional and legal responsibilities with respect to dispensing
controlled substances.''
Regarding factor three, it is uncontested that in September 1993,
Mr. Martin pled guilty in the United States District Court for the
Southern District of Ohio to one misdemeanor count of unlawful
distribution of a codeine-based exempt narcotic, and he
[[Page 65081]]
was placed on probation for one year, fined $2,500.00 and ordered to
perform 50 hours of community service.
As to factor four, the Respondent's ``[c]ompliance with applicable
State, Federal, or local laws relating to controlled substances,'' the
evidence presented at the hearing in this matter clearly supports the
conclusion that Respondent committed numerous violations of applicable
laws and regulations. Respondent failed to maintain complete and
accurate records of its controlled substances as required by 21 U.S.C.
827 and 21 CFR 1304.21, as evidenced by the results of the
accountability audit. Respondent failed to conduct a biennial inventory
of its controlled substances as required by 21 CFR 1304.13. Pursuant to
21 CFR 1305.13, Respondent was required to preserve all Schedule II
order forms. Its inability to account for 18 of its order forms
indicates a violation of this regulation.
Respondent's maintenance of records regarding oral prescriptions
and prescriptions refills was also deficient. Under 21 CFR 1306.21, a
pharmacist may dispense a Schedule III or IV controlled substance
pursuant to an oral prescription that is promptly reduced to writing by
the pharmacist. The writing must contain all of the information
required for a written prescription, including the date of issuance,
the name and address of patient, and the name, address, and
registration number of the prescribing practitioner. Respondent's oral
prescription information failed to include the name and address of both
the patient and the practitioner. Respondent's prescription refill
records failed to include the date of the refill or verification
information by the dispensing pharmacist, in violation of 21 CFR
1306.22(b) (1) and (3).
Respondent violated Section 3719.16 of the Ohio Revised Code and 21
CFR 1306.32 by selling codeine cough syrup on 11 occasions to the same
individual more than once within a 48 hour period.
Of considerable concern to the Acting Deputy Administrator is
Respondent's violation of 21 CFR 1306.04(a), which provides that:
A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice. The responsibility for the proper prescribing and
dispensing of controlled substances is upon the prescribing
practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription * * *
Accordingly, in situations where a prescription for a controlled
substance is issued, both the prescribing practitioner and the
dispensing pharmacist have the responsibility to ensure that the
substances are being dispensed for a legitimate medical purpose. In
this case, however, there is no prescribing practitioner. Therefore,
the dispensing pharmacist bears the sole responsibility for evaluating
the purpose and necessity for the dispensing of controlled substances.
Mr. Martin himself admits that he ignored his responsibilities and
dispensed the Schedule V cough syrups for no legitimate medical
purpose. He attempted to justify his behavior by stating that if he did
not sell the cough syrup, the customers would just go elsewhere. His
only concern was to make money. Based upon these numerous violations of
Federal and state laws and regulations relating to the dispensing of
controlled substances, factor four is extremely significant in
evaluating the public interest in this case.
Like Judge Bittner, the Acting Deputy Administrator notes Mr.
Martin's testimony regarding the procedural changes that he has
instituted to ensure that Respondent would comply with applicable laws
and regulations in the future. However, he has delegated most of the
responsibility concerning compliance to a pharmacist at Respondent. As
the owner of Respondent, Mr. Martin is ultimately responsible for
compliance, and by his own admission, he has not spent much time at
Respondent recently.
The Acting Deputy Administrator concludes that regardless of
whether Mr. Martin is present at the pharmacy or not, Respondent's
continued registration is inconsistent with the public interest. Judge
Bittner found that ``Mr. Martin displayed a total disregard for federal
and State laws and regulations, and for his responsibilities as a
licensed pharmacist and owner of a DEA registrant.'' The Acting Deputy
administrator concurs with Judge Bittner's assertion that ``Mr. Martin
testified that he accepted responsibility for his misconduct and
recognized that he used poor judgment; however, his expression of
regret was directed more to the consequences to himself of his action--
the aggravation and loss of time and money--than to the conduct
itself.'' Mr. Martin turned a blind eye to his duty as a DEA registrant
to ensure that controlled substances were dispensed for a legitimate
medical purpose. He characterized many of the registration requirements
as ``nit-picky things.'' Those requirements are in place to guard
against the diversion of controlled substances. To minimize these
requirements demonstrates a lack of appreciation for the
responsibilities of a DEA registrant. Consequently, the Acting Deputy
administrator concludes that Respondent's continued registration is
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 BR1448655, issued to Roger Pharmacy,
be, and it hereby is revoked and any pending applications for renewal
of such registration, be, and they hereby are, denied. This order is
effective January 9, 1997.
Dated: December 2, 1996.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 96-31253 Filed 12-9-96; 8:45 am]
BILLING CODE 4410-09-M