00-000375 Department Of Health, Board Of Pharmacy vs. Azubueze Ikejiani Status: Closed Recommended Order on Friday, June 16, 2000.

Summary: Pharmacist had a pharmacy balance, but not the required weights; his stock had expired drugs on the shelves; he did not have a controlled substance inventory; and there was a monthly, rather than daily, certified log of deliveries and prescriptions.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) Case No. 00-0375

)

AZUBUEZE IKEJIANI, )

)

Respondent. )

________________________________)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held in this case

on March 24, 2000, at Miami, Florida, before Susan B. Kirkland, a

designated Administrative Law Judge of the Division of

Administrative Hearings.

APPEARANCES

For Petitioner: Lawrence F. Kranert, Jr., Esquire

Agency for Health Care Administration

Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent: Azubueze Ikejiani, pro se

2321 Dunhill Avenue

Hollywood, Florida 33025-3815

STATEMENT OF THE ISSUES

Whether Respondent violated Sections 465.016(1)(e), 465.018,

and 893.07(1)(b), Florida Statutes, and Rules 64B16-28.107(2)(b),

64B16-28.110, and 64B16-28.140(3)(c), (d), and (e), Florida

Administrative Code, and if so, what penalty should be imposed.

PRELIMINARY STATEMENT

On September 24, 1998, Petitioner, Department of Health

(Department), filed an Administrative Complaint against

Respondent, Azubueze Ikejiani ( Ikejiani), alleging that he

violated Rule 64B16-28.107(2)(b), Florida Administrative Code, by

failing to ensure that the prescription department had one set of

prescription weights in good condition; that he violated

Rule 64B16-28.110, Florida Administrative Code, by failing to

ensure that outdated pharmaceuticals were removed from the

pharmacy; that he violated Section 893.07(1)(b), Florida

Statutes, by failing to have available for inspection a biennial

controlled substance inventory; and that he violated

Rule 64B16-28.104(3)(c), (d), and (e), Florida Administrative

Code, by failing to maintain a certified daily log or printout of

dispensed medications. Ikejiani requested an administrative

hearing, and the case was forwarded to the Division of

Administrative Hearings for assignment to an Administrative Law

Judge.

At the final hearing Petitioner called Ikejiani and Harold

Gluck as its witnesses. Petitioner's Exhibit 1 was entered into

evidence. Respondent testified in his own behalf and presented

no exhibits.

Official recognition was taken of Sections 455.594, 455.621,

455.624, 455.681, 465.016-465.019, 465.0193, 465.0196, 465.015,

465.0155, 465,156, 465.009, 465.012, and 465.008, Florida

Statutes, and Rules 64B16-28.110, 64B16-28.109, 64B16-28.101,

64B16-28.107, 64B16-28.140, 64B16-28.404, 64B16-26.103,

64B16-26.603, and 64B16-26.606 and Chapter 64B16-30, Florida

Administrative Code.

At the final hearing the parties agreed to file proposed

recommended orders within ten days of the filing of the

Transcript, which was filed on April 13, 2000. The time for

filing proposed recommended orders was extended to June 9, 2000.

Neither Petitioner nor Respondent filed a proposed recommended

order.

FINDINGS OF FACT

1. Ikejiani has held a pharmacist license since 1987. In

February 1997, Ikejiani was the owner and pharmacy manager of

Makgoni Pharmaceuticals, which was doing business as Citadel

Pharmacy (Citadel). The business was located at 5301 Northeast

2nd Avenue, Miami, Florida. Citadel is a community pharmacy.

2. The posted pharmacy hours for Citadel were 10 :00 a.m. to

6:00 p.m. Monday through Friday, and 10:00 a.m. to 4:00 p.m. on

Saturday.

3. On February 14, 1997, Harold Gluck ( Gluck), an inspector

for the Department, visited Citadel at 12:10 p.m. There was a

sign in the pharmacy area, indicating that the pharmacy portion

of the business was closed. There was no pharmacist on duty.

Ikejiani was a few doors down visiting a doctor. Although there

was a clerk on duty at the business, she did not advise Gluck of

the whereabouts of Ikejiani.

4. On February 17, 1997, Gluck returned to Citadel at

10:45 a.m. to inspect the pharmacy. Again, no pharmacist was

present, and there was a "Closed" sign in the pharmacy area.

5. On February 18, 1997, Gluck visited Citadel at 1:20 p.m.

No pharmacist was present, and the pharmacy was closed.

6. On February 26, 1997, Gluck returned to Citadel, where

Ikejiani was present and the pharmacy was open for business.

Gluck inspected the premises and found a pharmacy balance but no

weights. Each pharmacy is required to have a balance and weights

to be used when there is a prescription which requires that the

ingredients be measured.

7. Gluck found approximately 70 bottles of expired legend

drugs on the pharmacy shelves. The 70 bottles were not located

in a section for expired drugs, but were interspersed with the

regular drugs. No evidence was presented as to the expiration

dates of the 70 bottles. In the refrigerator among the regular

drugs, he found five pints of erythromycin, which had expired

approximately five months before the inspection.

8. Gluck observed other expired medications which were in

boxes on the floor of the pharmacy. These medications were not

with the regular merchandize and were to be shipped by the

manufacturer for a refund.

9. Ikejiani did not have a controlled substance inventory.

He did have controlled III and IV substances on the shelves,

including such things as cough syrup made with a codeine

preparation, and sleeping pills.

10. Ikejiani was maintaining his certified log of

deliveries and prescriptions of legend and controlled substances

on a monthly basis, rather than on a daily basis.

CONCLUSIONS OF LAW

11. The Division of Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceeding. Section 120.57(1), Florida Statutes.

12. In Count I of the Administrative Complaint,

the Department alleged that Ikejiani violated

Rule 64B16-28.107(2)(b), Florida Administrative Code, which

provides that the prescription department of a pharmacy shall

have the following items:

(2) The prescription department of any

pharmacy permittee unless otherwise required

by these rules shall have such other

equipment as is necessary to meet the needs

of the professional practice of pharmacy

including:

* * *

(b) One set of prescription weights in

good condition;

13. Ikejiani violated Rule 64B16-28.107(2)(b), Florida

Administrative Code, by failing to have a set of prescription

weights for the prescription department of Citadel.

14. In Count II of the Administrative Complaint, the

Department alleged that Ikejiani violated Rule 64B16-28.110,

Administrative Code, which provides:

Persons qualified to do so shall examine

the stock of the prescription department of

each pharmacy at a minimum interval of four

months, and shall remove all deteriorated

pharmaceuticals, or pharmaceuticals which

bear upon the container an expiration date

which date has been reached, and under no

circumstances will pharmaceuticals or devices

which bear upon the container an expiration

date which has been reached be sold or

dispensed to the public.

15. Ikejiani violated 64B16-28.110, Florida Administrative

Code, by having five pints of erythromycin, which had been

expired for five months, in with the regular pharmaceuticals.

Rule 64B16-28.110, Florida Administrative Code, requires the

stock to be examined every four months at a minimum. Thus, it is

possible to have expired medications on the shelves which have

been expired less than four months and still not be in violation

of the rule. There was no evidence presented to indicate how

long the 70 bottles of medicine pulled from the shelves had been

expired. No evidence was presented to show that Ikejiani had

sold or dispensed medications which had expired.

16. The Department has alleged that Respondent violated

Section 465.016(1)(e), Florida Statutes, which provides that the

following acts shall be grounds for Disciplinary action:

(e) Violating any of the requirements of

this chapter; or if licensed as a

practitioner in this or any other state,

violating any of the requirements of their

respective practice act or violating chapter

499; 21 U.S.C. ss. 301-392, known as the

Federal Food, Drug, and Cosmetic Act; 21

U.S.C. ss. 821 et seq., known as the

Comprehensive Drug Abuse Prevention and

Control Act; or chapter 893.

17. In Count III of the Administrative Complaint, the

Department alleges that Ikejiani violated Sections 465.016(1)(e)

and 893.07(1)(b), Florida Statutes, which provide:

(1) Every person who engages in the

manufacture, compounding, mixing,

cultivating, growing, or by any other process

producing or preparing, or in the dispensing,

importation, or, as a wholesaler,

distribution, of controlled substances shall:

* * *

(b) On and after January 1, 1974,

maintain, on a current basis, a complete and

accurate record of each substance

manufactured, received, sold, delivered, or

otherwise disposed of by him or her, except

that this subsection shall not require the

maintenance of a perpetual inventory.

Compliance with the provisions of federal law

pertaining to the keeping of records of

controlled substances shall be deemed a

compliance with the requirements of this

subsection.

18. Ikejiani violated Section 893.07(1)(b), Florida

Statutes, because he failed to maintain an inventory of

controlled substances.

19. In Count IV of the Administrative Complaint, the

Department alleges that Ikejiani violated

Rule 64B16-28.140(3)(c), (d), and (e), Florida Administrative

Code, which pertains to records of dispensing prescriptions and

provides:

(c) The daily hard-copy printout shall be

produced within 72 hours of the date on which

the prescription drug orders were dispensed

and shall be maintained in a separate file at

the pharmacy. Records of controlled

substances shall be readily retrievable from

records of non-controlled substances.

(d) Each individual pharmacist who

dispenses or refills a prescription drug

order shall verify that the data indicated on

the daily hard-copy printout is correct, by

dating and signing such document in the same

manner as signing a check or legal document

(e.g., J. H. Smith, or John H. Smith) within

seven days from the date of dispensing.

(e) In lieu of producing the printout

described in subparagraphs (b) and (c) of

this section, the pharmacy shall maintain a

log book in which each individual pharmacist

using the data processing system shall sign a

statement each day, attesting to the fact

that the information entered into the data

processing system that day has been reviewed

by him or her and is correct as entered.

Such log book shall be maintained at the

pharmacy employing such a system for a period

of two years after the date of dispensing

provided, however, that the data processing

system can produce the hard-copy printout on

demand by an authorized agent of the

Department of Health. If no printer is

available on site, the hard-copy printout

shall be available within 48 hours with a

certification by the individual providing the

printout, which states that the printout is

true and correct as of the date of entry and

such information has not been altered,

amended or modified.

20. Ikejiani violated Rule 64B16-28.140(3)(c), (d), and

(e), Florida Administrative Code, because he was maintaining his

dispensing records on a monthly basis rather than a daily basis

as required.

21. Rule 64B16-30.001, Florida Administrative Code,

provides disciplinary guidelines, including a range of penalties

for violations of Chapter 465, Florida Statutes, and the rules

promulgated thereto. The penalty range for violations of Rules

64B16-28.107 and 64B16-28.110, Florida Administrative Code, is a

$500 fine to one-year probation and $1,000 fine. The penalty

range for a violation of Section 893.07(1)(b), Florida Statues,

is a $1,000 fine and one-year probation to revocation. No

penalty range could be found for a violation of Rule 64B16-

28.140.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that a final order be entered finding that

Azubueze Ikejiani violated Rules 64B16-28.107(2)(b), 64B16-

28.110, and 64B16-28.140(3)(c), (d), and (c), Florida

Administrative Code, and Section 893.07(1)(b), Florida Statutes,

and imposing a $500 fine for the violation of Rule 64B16-28.107,

Florida Administrative Code, a $1,000 fine for the violation of

Rule 64B16-28.110, Florida Administrative Code, a $1,000 fine and

one-year probation for violation of Section 893.07(1)(b), Florida

Statutes, and a $500 fine for violation of Rule 64B16-28.140,

Florida Administrative Code.

DONE AND ENTERED this 16th day of June, 2000, in

Tallahassee, Leon County, Florida.

___________________________________

SUSAN B. KIRKLAND

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 16th day of June, 2000.

COPIES FURNISHED:

Lawrence F. Kranert, Jr., Esquire

Agency for Health Care Administration

Post Office Box 14229

Tallahassee, Florida 33217-4229

Azubueze Ikejiani

2321 Dunhill Avenue

Hollywood, Florida 33025-3815

John Taylor, Executive Director

Board of Pharmacy

Department of Health

1940 North Monroe Street

Tallahassee, Florida 32399-0750

Amy M. Jones, General Counsel

Department of Health

Bin A02

2020 Capital Circle, Southeast

Tallahassee, Florida 32399-1701

Angela T. Hall, Agency Clerk

Department of Health

Bin A02

2020 Capital Circle, Southeast

Tallahassee, Florida 32399-1703

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within 15

days from the date of this Recommended Order. Any exceptions to

this Recommended Order should be filed with the agency that will

issue the Final Order in this case.