[Federal Register Volume 61, Number 7 (Wednesday, January 10, 1996)]
[Notices]
[Pages 726-728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-338]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 94-49]
Farmacia Ortiz; Revocation of Registration
On May 6, 1994, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Farmacia Ortiz, a pharmacy owned by Wayne Ortiz
Ramirez (hereinafter ``Owner'') of San German, Puerto Rico, notifying
him of an opportunity to show cause as to why DEA should not revoke the
retail pharmacy's DEA Certificate of Registration, AF1619040
(hereinafter ``registration''), under 21 U.S.C. Secs. 824(a)(4) and
823(f), as being inconsistent with the public interest. Specifically,
the Order to Show Cause recorded ten allegations of recordkeeping
violations, of alteration of expiration dates on seven bottles of
controlled substances, of providing controlled substances to an
undercover operative without a valid prescription, of providing
controlled substances to individuals with photocopied or altered
prescriptions, of possession of controlled substances not accounted for
in its inventory, and of the owner-pharmacist's entering of a guilty
plea in Federal court to a single count of dispensing Schedule II
controlled substances without a prescription.
On May 28, 1994, the Owner, on behalf of Farmacia Ortiz, requested
a hearing, and following prehearing procedures, a hearing was held in
Hato Rey, Puerto Rico, on January 25, 1995, before Administrative Law
Judge Paul A. Tenney. At the hearing the Owner represented the
interests of the pharmacy, both parties called witnesses to testify and
introduced documentary evidence, and after the hearing, the Government
counsel submitted proposed findings of fact, conclusions of law and
argument. No post-hearing submissions were offered for the pharmacy. On
March 22, 1995, Judge
[[Page 727]]
Tenney issued his opinion and recommended ruling, recommending that the
DEA Certificate of Registration for Farmacia Ortiz be revoked. Neither
party filed exceptions to his decision, and on April 24, 1995, Judge
Tenney transmitted the record of these proceedings to the Deputy
Administrator.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR Sec. 1316.67, hereby issues his final order
based upon findings of fact and conclusions of law as hereinafter set
forth. The 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 Deputy Administrator finds that Farmacia Ortiz (hereinafter the
Pharmacy) was established over sixty years ago, and is owned by Mr.
Ortiz-Ramirez, who is also the pharmacist. The investigation of the
Pharmacy began with DEA investigators reviewing the Pharmacy's DEA 222
order forms for Schedule II controlled substances. The investigators
found a questionable purchasing pattern of Demerol injectables from
1990 to 1992, specifically, an increase from approximately 2,300 in
1990, to 5,000 in 1991, to 14,400 in 1992.
Based on this information, the investigators conducted an audit of
the Pharmacy for the period from December 31, 1990, until November 30,
1992. As evidenced by the computation chart prepared by a DEA Diversion
Investigator, the audit revealed an overage of 237 units of Demerol,
and a shortage of 400 tablets of Percocet. The audit also revealed
overages of Tylenol No. 3, Hydrocet, Valium, Xanax, and Halcion. Judge
Tenney took official notice of the facts that (1) Percocet is a brand
name for a product containing oxycodone, a Schedule II narcotic
controlled substance pursuant to 21 CFR Sec. 1308.12(b); (2) Demerol is
a brand name for a product containing meperidine, a Schedule II
narcotic controlled substance pursuant to 21 CFR Sec. 1308.12(c); (3)
Tylenol No. 3 is a brand name for a product containing codeine, a
Schedule III narcotic controlled substance pursuant to 21 CFR
Sec. 1308.13(e); (4) Valium is a brand name for a product containing
diazepam, a Schedule IV narcotic controlled substance pursuant to 21
CFR Sec. 1308.14(c); (5) Xanax is a brand name for a product containing
alprazolam, a Schedule IV controlled substance pursuant to 21 CFR
Sec. 1308.14(c); and (6) Halcion is a brand name for a product
containing triazolam, a Schedule IV controlled substance pursuant to 21
CFR Sec. 1308.14(c).
The investigators had also concluded that the Pharmacy had neither
an initial inventory nor a biennial inventory. However, at the hearing
before Judge Tenney, the Owner testified that the Puerto Rican
authorities would not give him a license unless a yearly inventory was
made, and Judge Tenney found that this assertion was not rebutted by
the Government.
Further, a review of the Pharmacy's prescription records revealed
that original prescriptions and multiple photocopies of the same
prescriptions had been filled. A DEA Diversion Investigator testified
that in February 1993, he had interviewed the doctors who purportedly
issued some of these photocopied prescriptions, and each doctor
interviewed recognized the names of the patients listed on his
prescriptions, but denied issuing the photocopied prescriptions.
The DEA investigators also found a large number of Demerol
prescriptions written by Dr. Silvestry to a single named patient. Dr.
Silvestry was interviewed, and he explained that the named patient was
a cancer patient who frequently visited the doctor, but that Dr.
Silvestry never gave this patient prescriptions for more than 75 or 100
ampules of Demerol at one time. However, DEA investigators found at the
Pharmacy multiple prescriptions for 125, 150, and 175 ampules of
Demerol written to this patient. Also in February 1993, the
investigators interviewed this patient, who denied receiving anything
greater than 100 ampules of Demerol at a time, and he denied altering
any prescriptions. However, he admitted visiting Dr. Silvestry quite
often and filling his prescriptions from Dr. Silvestry at the Pharmacy.
Investigators also interviewed a patient of Dr. Pluguez about
photocopied prescriptions found at the Pharmacy with his name. The
Pharmacy had filled a Demerol (100 mg) prescription purportedly issued
in October 1992 by Dr. Pluguez to this patient, and the instructions on
the prescription specified ``Sig. 1p.o. q 6 H.'' The DEA Investigator
testified that the instructions meant that the patient was to take
``one tablet orally every six hours.'' Both the Investigator and the
Owner testified that 100 mg of Demerol is an injectable substance that
comes in liquid form; it cannot be taken orally. Judge Tenney found the
investigator's testimony credible. Although the Owner testified that
the meaning of ``p.o.'' could differ from doctor to doctor, he did not
provide any other meaning. Also, Judge Tenney found it significant that
the Owner had not called Dr. Pluguez to ascertain his meaning of
``p.o.'' prior to filling the prescription, and ``[d]espite this
suspect prescription, [the Pharmacy] continued to fill prescriptions
for [this patient] in October and November of 1992.''
This same patient admitted to making the prescription photocopies
``so he didn't have to go back to the doctor and spend the money.'' He
also told the investigator that he took the photocopied prescriptions
to the Pharmacy because he could get them filled without question.
However, the Owner testified that in May 1993, the patient had offered
a photocopied prescription, and that then he had called the doctor to
verify the prescription. When the doctor denied issuing the
prescription in question, the Owner had refused to fill that
prescription.
Next the investigators initiated two undercover visits to the
Pharmacy, with the assistance of Dr. Pluguez's patient. During the
first visit in April 1993, a Puerto Rican police officer observed the
patient enter the Pharmacy supplied with two altered, photocopied
prescriptions, one for Demerol and one for Percocet, and receive
medication from the Owner. Shortly thereafter, the Officer and the
patient met outside the Pharmacy, and the patient handed over 10
ampules of Demerol and 80 capsules of Percocet, which he had received
from the Owner. The second visit occurred on April 21, 1993, and the
police officer, accompanied by the patient, gave the Owner altered
prescriptions. The Owner then gave the police officer Demerol and
Percocet.
Further, on May 21, 1993, investigators searched the Pharmacy,
seizing controlled substances, some of which were expired or had
altered labels. Investigators found several bottles of controlled
substances on which the expiration dates had been altered;
specifically, the year of expiration had been changed on five bottles,
and on three of those bottles, the month of expiration had been
altered. Before Judge Tenney, the Owner denied changing any of these
expiration dates.
On August 18, 1993, the Owner was indicted in the United States
District Court for the District of Puerto Rico, and pursuant to a plea
agreement, he pled guilty to violations of 21 U.S.C. Sec. 829(a),
842(a)(1), and 842(c)(2)(A), for dispensing Demerol and Percocet
``based on the photocopies of the prescriptions which had not been
prescribed on original prescriptions by
[[Page 728]]
a licensed physician.'' The Judge accepted the plea agreement and
sentenced him to probation for one year and to pay a $500.00 fine.
After the plea agreement was entered, the DEA Investigator
continued to notice that the Pharmacy still purchased large quantities
of Demerol. Based on this information, investigators conducted a second
audit of the Pharmacy of the period of May 21, 1993, through November
30, 1993, and this audit revealed that the Pharmacy had a shortage of
28 ampules of Demerol.
Pursuant to 21 U.S.C. Secs. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration 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 or
safety. These factors are to be considered in the disjunctive; the
Deputy Administrator may rely on any one or 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., Docket No. 88-42,
54 Fed. Reg. 16,422 (1989).
In this case, factors one through five are relevant in determining
whether the Pharmacy's continued registration would be inconsistent
with the public interest. As to factor one, ``recommendation of the
appropriate State licensing board,'' Judge Tenney found that there was
``no evidence to indicate that [the Pharmacy] does not hold proper
State authorization to operate a retail pharmacy and handle controlled
substances.''
As to factor two, the Respondent's ``experience in dispensing * * *
controlled substances,'' the Deputy Administrator agrees with Judge
Tenney that the evidence of numerous photocopied prescriptions filled
by the Pharmacy ``clearly demonstrated poor dispensing experience under
21 U.S.C. Sec. 823(f)(2) * * *. In addition, substantial weight must be
given to factor (2) in evaluating the public interest based upon the
dangerous trend concerning Demerol.'' Specifically, the Deputy
Administrator agrees with Judge Tenney's findings concerning the
Pharmacy's dispensing of Demeral to individuals presenting altered and
photocopied prescriptions and to individuals presenting prescriptions
with instructions that were inconsistent with the nature of the
substance prescribed. Further, the Pharmacy's inability to accurately
account for its supply of Demerol as evidenced by the overage and
shortage revealed during DEA audits, and its inability to track its
supply of various Schedule III and IV controlled substances, are all
relevant concerns under factor two. Finally, the Deputy Administrator
agrees with Judge Tenney's conclusion that ``the Government has proven
poor dispensing experience under 21 U.S.C. Sec. 823(f)(2), and this
conduct warrants serious concern by the DEA.''
As to factor three, ``the applicant's conviction record * * *
relating to the * * * distribution * * * of controlled substances,
``the evidence shows that the Owner-pharmacist working at the Pharmacy
had a conviction record related to the dispensing of controlled
substances, for in August 1993, he pled guilty to charges of violating
Federal statutes; specifically, he admitted to accepting and filling
photocopied prescriptions in violation of 21 U.S.C. Secs. 829(a),
842(a)(1) and 842(c)(2)(A). He was placed on probation for one year and
fined $500.00.
As to factor four, the Respondent's ``[c]ompliance with applicable
State, Federal, or local laws relating to controlled substances,''
there was some dispute as to the evidence presented. The record
contains testimony that the pharmacy failed to maintain an initial and
a biennial inventory as required by regulation, and yet the Owner
testified that he maintained a ``perpetual inventory,'' for the Puerto
Rican authorities would not give him a license unless a yearly
inventory was maintained. Judge Tenney found that the Owner's testimony
on this point was credible and unrebutted, and he concluded ``in light
of the weight that is attached to other factors under 21 U.S.C.
Sec. 823(f), factor (4) is not considered critical in assessing the
public interest.''
As to factor five, ``[s]uch other conduct which may threaten the
public health or safety,'' Judge Tenney agreed with the Government's
position, that ``in light of [the Owner's] past conduct * * * potential
future actions by [the Owner] may threaten the public health and safety
* * * [for] considerable weight is attached to the alterations of
expiration dates on bottles of controlled substances seized at the
[Pharmacy].'' Although the Owner testified that he was unaware of the
alterations made on the expiration dates, Judge Tenney found his
testimony on this point lacked credibility. In the alternative, Judge
Tenney also found that, as the owner and pharmacist at the Pharmacy,
``it was his responsibility to assure that such alterations did not
occur.''
The Deputy Administrator agrees with Judge Tenney's findings and
his conclusion that the Government proved, by a preponderance of the
evidence, that continued registration of the Farmacia Ortiz by the DEA
would be inconsistent with the public interest, and that any pending
applications should be denied at the present time. See Sokoloff v
Saxbe, 501 F. 2d 571, 576 (2d Cir. 1974) (stating that ``permanent
revocation'' of a DEA Certificate of Registration may be ``unduly
harsh'').
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
Secs. 823 and 824, and 28 CFR Secs. 0.100(b) and 0.104, hereby orders
that DEA Certificate of Registration AF1619040, issued to Farmacia
Ortiz, be, and it hereby is, revoked and any pending applications are
hereby denied. This order is effective February 9, 1996.
Dated: December 28, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 96-338 Filed 1-9-96; 8:45 am]
BILLING CODE 4410-09-M