[Federal Register Volume 59, Number 28 (Thursday, February 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3032]
[[Page Unknown]]
[Federal Register: February 10, 1994]
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DEPARTMENT OF JUSTICE
[Docket No. 92-63]
Vernor Prescription Center; Revocation of Registration
On June 12, 1992, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Vernor Prescription Center (Respondent), of
Detroit, Michigan, proposing to revoke Respondent's DEA Certificate of
Registration, BV1142784, and to deny any pending applications for
registration as a practitioner under 21 U.S.C. 823(f). The Order to
Show Cause alleged that Respondent's continued registration is
inconsistent with the public interest, as that term is used in 21
U.S.C. 823(f) and 824(a)(4).
Respondent, represented by its owner/operator, timely filed a
request for a hearing on the issues raised in the Order to Show Cause
and the matter was docketed before Administrative Law Judge Paul A.
Tenney. Following prehearing procedures, a hearing was held, beginning
on October 14, 1992, in Detroit, Michigan.
On January 19, 1993, Judge Tenney issued his findings of fact,
conclusions of law and recommended ruling, recommending that
Respondent's DEA Certificate of Registration be suspended for one year
with respect to dispensing, without a prescription from a physician,
controlled substances listed in Schedule V. The Government filed
exceptions pursuant to 21 CFR 1316.66. Respondent, through counsel who
was retained after the hearing, filed a response to the Government's
exceptions. The response argued that the exceptions were not timely
filed but the exceptions were filed before expiration of the 20-day
time limit provided by 21 CFR 1316.66.
On March 11, 1993, Judge Tenney transmitted the record of the
proceedings, including the Government's exceptions and Respondent's
response to the exceptions, to the Administrator. The Acting
Administrator has carefully considered the record in its entirety and
adopts, in part, the opinion and recommended decision of the
administrative law judge and makes independent findings and conclusions
of his own. Pursuant to 21 CFR 1316.67, the Acting Administrator hereby
issues his final order in this matter.
The Acting Administrator finds that Respondent stocked and sold
Schedule V cough preparations primarily over-the-counter. The
Controlled Substances Act and its attendant regulations permits a
pharmacy to dispense a Schedule V controlled substance without a
prescription issued by a practitioner, as long as the drug is dispensed
for a legitimate medical purpose. If a customer chooses to obtain a
Schedule V cough preparation over-the-counter, the pharmacy must have
the purchaser sign a logbook and record various other information
pursuant to 21 CFR 1306.32(e). An audit was conducted by DEA Diversion
Investigators of Respondent's logbook of all over-the-counter sales of
such cough preparations covering the period January 1, 1988 through
February 9, 1989. This audit revealed that on 32 occasions, Respondent
sold a Schedule V cough preparation to the same individual on
consecutive days, in violation of 21 CFR 1306.32(b).
This audit also revealed that there were 32 individuals who
purchased more than 35 bottles of Schedule V cough preparations within
the audit period. Nine of these purchasers bought the cough syrup in
excess of 100 times during the audit period. Subsequent interviews of
some of these high volume purchasers revealed that they were in fact
addicted to codeine and supported their habit by purchasing the
Schedule V cough preparations from Respondent. Significantly, one of
the persons interviewed revealed that on some occasions when he went to
Respondent to purchase the cough preparation, there were three or four
people ahead of him in line to buy these cough medicines.
Further investigation revealed that Respondent made excessive
purchases of Schedule V cough preparations from October 1988 until July
1992. For the months of October and November 1988, Respondent ordered
912 four-ounce bottles. For the months of February, March and May 1989,
Respondent purchased 1,536 bottles for an average of 512 bottles per
month for those three months. In September 1989, Respondent ordered
1,260 bottles, although the distributors actually only sold Respondent
606 bottles for that month.
For 1990, Respondent purchased an average of 149 bottles per month
over a seven month period. In 1991, Respondent ordered an average of
124.25 bottles for the months in which Respondent ordered such cough
preparations. For the months of May, June and July 1992, Respondent
purchased an average of 68 bottles per month.
The administrative law judge found that Respondent's declining
purchases of these Schedule V cough preparations were a mitigating
factor. The Acting Administrator concludes however, that the fact that
such purchases declined is not a mitigating circumstance because the
purchases remained excessive. In January 1990, a drug distributor sales
representative informed a DEA Investigator that the average pharmacy
purchased 12 to 14 bottles of Schedule V cough preparations per month
during cold and flu season. In the State of Michigan, the average
purchase by a pharmacy for these cough preparations was approximately
14 bottles per month. This figure was established in Barton Drug, Inc.,
Docket No. 91-28, 57 FR 44211 (1991) and the Acting Administrator takes
official notice of this statistic. Hence, Respondent's purchases
remained excessive.
In addition, the DEA notified wholesalers and distributors sometime
in the late 1980's to monitor the sales of these cough preparations to
pharmacies located in Michigan due to an ongoing problem of the abuse
of these products by customers of various retail pharmacies. Any
decline in purchases of these cough preparations by Respondent was in
no small part due to the monitoring by the various distributors. The
Acting Administrator also notes that the sales figures available for
1992 only included the summer months. Therefore, the average of 68
bottles a month is excessive in light of the fact that these cough
preparations were not purchased during cold and flu season.
The Acting Administrator finds that the February 9, 1989 audit
revealed that Respondent failed to provide all of his invoices for
purchases of these Schedule V cough preparations.
In evaluating whether Respondent's continued registration by the
Drug Enforcement Administration would be inconsistent with the public
interest, as that term is used in 21 U.S.C. 824(a)(4), the Acting
Administrator considers the factors enumerated in 21 U.S.C. 823(f).
They are as follows:
(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 Sate, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
In determining whether a registrant's continued registration is
inconsistent with the public interest, the Acting Administrator is not
required to make findings with respect to each of the factors listed
above. Instead, the Acting Administrator has the discretion to give
each factor the weight he deems appropriate, depending upon the facts
and circumstances of each case. See David E. Trawick, D.D.S., Docket
No. 88-69, 53 FR 5326 (1988).
The Acting Administrator concurs with the opinion and recommended
decision of the administrative law judge to the extent that factors two
and five of the public interest factors apply. Respondent not only
often dispensed Schedule V cough preparations within a 48-hour period
to the same customer in violation of 21 CFR 1306.32(b), he also
dispensed excessive amounts of these controlled substances to various
customers without a legitimate medical reason contrary to 21 U.S.C.
829(c) and 21 CFR 1306.04(a). The owner/operator, as a professional
pharmacist, should have known that many of the excessive purchases of
these controlled substances resulted in transactions to abusers of such
substances. The Acting Administrator will not permit a pharmacist to
abdicate his professional and legal responsibilities merely because a
drug is dispensed without a prescription. See Liberty Discount Drugs,
Inc., Docket No. 88-73, 54 FR 30116 (1989). Respondent also failed to
provide purchase invoices for some of these Schedule V controlled
substances in violation of 21 U.S.C. 827 and 21 CFR 1304.24.
The administrative law judge, however, did not recommend complete
revocation of Respondent's DEA Certificate of Registration. Rather he
recommended a suspension for one year of Respondent's Schedule V
dispensing privileges without a prescription. This recommendation was
based upon the fact that Respondent's purchases of Schedule V cough
preparations had declined, and because Respondent testified he had
monitored these purchases and in some cases imposed more stringent
requirements for dispensing these controlled substances than were
required by law.
The Acting Administrator cannot agree with this recommended remedy.
As noted above, Respondent's purchases remained excessive (especially
in light of the average amounts purchased by retail pharmacies),
despite the fact that an audit had been performed and that distributors
took active measures to monitor and curtail their sales to Michigan
pharmacies. Moreover, Respondent's actions belie his assertions that he
took active measures to monitor the sale of the Schedule V cough
preparations.
The Acting Administrator finds that the same remedy must be imposed
in this case as was imposed in the cases of Liberty Discount Drugs,
Inc., Docket No. 88-73, 54 FR 30116 (1989) and Barton Drug, Inc.,
Docket No. 91-28, 57 FR 44211 (1991), where the facts were virtually
indistinguishable from the facts in the present case. In these two
cases, the Administrator ordered that the pharmacies' registrations be
revoked in their entirety. To adequately protect the public interest,
the same remedy must be imposed in the present case.
Accordingly, the Acting 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), hereby orders that DEA Certificate of
Registration, BV1142784, previously issued to Vernor Prescription
Center, be, and it hereby is, revoked, and any pending applications for
the renewal of such registration, be, and they hereby are, denied. This
order is effective March 14, 1994.
Dated: February 4, 1994.
Stephen H. Greene,
Acting Administrator of Drug Enforcement.
[FR Doc. 94-3032 Filed 2-9-94; 8:45 am]
BILLING CODE 4410-09-M
