[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