The Issue The question presented in this case, is whether or not the Respondent has violated the conditions of Section 465.101(1)(e) Florida Statutes, by failing to maintain on a current basis a complete and accurate record of each controlled substance controlled by Chapter 893, Florida Statutes, in particular controlled by Section 893.07, Florida Statutes. This violation is alleged to have occurred at Washington Park Pharmacy, Inc., 750 Northwest 22 Road, Ft. Lauderdale, Florida. The alleged violation was noted by V. K. Bell, agent, Florida Board of Pharmacy, based upon a drug accountability audit which covered the period from September 1, 1976 to October 3, 1977.
Findings Of Fact This cause comes on for consideration based upon the complaint and notice to show cause brought by the Petitioner, Florida Board of Pharmacy, in an action against James R. Gibbons, who is licensed to practice pharmacy by the Petitioner. The action charges that James R. Gibbons, while licensed to practice pharmacy in the State of Florida, violated the provisions of Section 465.101(1)(e), Florida Statutes. This claim of violation is premised upon the alleged failure of the Respondent, James R. Gibbons, to comply with the conditions of Section 893.07, Florida Statutes, in that the Respondent permitted the improper keeping of records, by failing to maintain on a current basis a complete and accurate record of each controlled substance controlled by Chapter 893, Florida Statutes. This failure of control was alleged to have occurred at the Washington Park Pharmacy, Inc., at 750 Northwest 22 Road, Ft. Lauderdale, Florida. The prosecution is grounded on the investigation performed by V. K. Bell, agent, of the Petitioner and specifically arises from a drug accountability audit which covered the period from September 1, 1976 till October 3, 1977. As a part of his duties, agent V. K. Bell, an employee with the Florida Board of Pharmacy, conducted an audit of the Washington Park Pharmacy, Inc., located at 750 Northwest 22 Road, Ft. Lauderdale, Florida. The period of the audit covered September 1, 1976 through October 3, 1977. An element of the audit concerned the class II drugs, Dilaudid, 4mg. tablets and Quaalude, 300mg. tablets. A synopsis or summary of the audit process pertaining to the two drugs by weight, may be found as Petitioner's Exhibit #1, admitted into evidence. In that audit report, agent Bell has broken down the amounts of the questioned drugs into categories. These categories begin with a zero initial inventory on September 1, 1976 and report the total number of tablets purchased; the amount of ending inventory; the amount of sales by prescription, both legitimate and possible forgeries; the amount of loses by theft; and the amount short, for which there is allegedly no explanation. By the figures reported by agent Bell; 59,100 Dilaudid 4mg. tablets were purchased in the audit period; 200 tablets remained as ending inventory; 49,869 tablets were reported as sales or loss by theft; and 9,031 tablets were reported short. Looking at the report rendered by agent Bell on the substance Quaalude, 300 mg. tablets, it shows a total purchase within the inventory period of 32,200; an ending inventory of 50; sales of 25,421 by prescription; and 6,729 tablets short. The Respondent has taken issue with the statistical data offered by the Petitioner. In its argument against the case of the Petitioner, the Respondent has offered Respondent's Exhibits 5 & 6, admitted into evidence. These exhibits are respectively a compilation of the sales made to the Respondent by the Gulf Drug Company and Crandon Drugs, Inc. The tapes which are attached to those exhibits act as a take-off in adding the amounts of the two questioned substances, and show that 54,200 Dilaudid 4mg. tablets were purchased during the audit period and 29,700 Quaalude 300mg. tablets were purchased during the audit period, according to the computations of the Respondent, James R. Gibbons. Gibbons also takes issue with the allegation found in the audit summary, to the effect that certain prescriptions were forged by the doctors listed. The depositions of Drs. Collier, Cohen, Morris, and Walker were taken prior to the hearing. Those depositions have been admitted into the record in lieu of testimony at the hearing. The deposition of David Collier, D.O., shows that during the audit period, he wasn't treating the patients who needed the two drugs Dilaudid and Quaalude. He did indicate that at one time he had left prescription pads in the treatment rooms where someone may have picked those prescription pads up. However, he denies signing any prescriptions which were shown to him and alleged to have been under his signature. He thereby states that those prescriptions are forgeries. He also denied that any prescription forms with the name Washington Park Pharmacy had been provided to him. Dr. Collier's partner for a time, was Bernard Cohen, D.O. Dr. Cohen states that he wrote prescriptions for Quaalude and Dilaudid in November, 1975, but not on pads from Washington Park Pharmacy. He also admitted that employees within his office other than he and Dr. Collier had access to the prescription pads. He recalls that during the audit period one patient was on Dilaudid and one patient was receiving Quaalude. The writing exemplars that were shown to him which are prescriptions allegedly written by him were felt to be forgeries, with the exception of his patients which he identified as his. From his recollection the Washington Park Pharmacy never called about any alleged forgeries that may have been received bearing his name. The deposition of William A. Morris, III, M.D. establishes that he has prescribed Dilaudid and Quaalude, but not in the amounts attributed to him in the audit. He also stated that in February, 1976, there was a "break-in" and certain prescription pads were missing. The signature on the exemplars shown to him were felt to be similar to his signature; however, he did not recognize any of the names to be his patients and therefore felt that the substance of the prescription was a forgery. The deposition of Dr. Thomas J. Walker, M.D., establishes that he was not prescribing the drugs Dilaudid and Quaalude at the time of the audit. After looking at the exemplars of the prescriptions presented him he stated that those prescriptions had not been written by him. In his estimation, the prescription pads in his office were secure during the audit period and no "break-ins" or thefts had occurred. The explanation which the Respondent gave on the question of any possible forgeries was to the effect that he has a duty to fill the prescriptions which are tendered to him by a treating physician, and further that his practice is to notify the alleged treating physician when there is some question about the authenticity of the prescription given to him by a customer. The Respondent's explanation for any shortage of prescriptions during the audit period was to the effect that either the agent for the petitioner or the representatives of the United States Drug Enforcement Authority had lost some of the records in transporting his books and records to their office for examination; or in the alternative those records still regained in his pharmacy and were undiscovered by the Petitioner's representative and representatives of the Drug Enforcement Authority. The positions of the parties should be examined in view of the requirements of the law under which the charge is brought. Section 465.101(1)(e), Florida Statutes, reads as follows: 465.101 Authority to revoke or suspend licenses.- (1) The Board of Pharmacy may revoke or sus- pend the license and registration certificate of any registered pharmacist, after giving such pharmacist reasonable notice and an opportunity to be heard, who shall have: * * * (e) Violated any of the requirements of this chapter, of chapter 500, known as the "Florida Food, Drug, and Cosmetic Law," of ss. 301 through 392 of Title 21, United States Code, known as the "Federal Food, Drug and Cosmetic Act," or of chapter 893. By this charging document, the Petitioner is claiming that the Respondents have violated Section 893.07, Florida Statutes. A portion of that section is Section 893.07(3), Florida Statutes, which calls for the record of all controlled substances sold, administered, dispensed, or otherwise disposed of to be kept; to the extent of among other things, showing the kind and quantity of controlled substances sold, administered, or dispensed. Section 893.07(4), Florida Statutes, also states that these records shall be kept and made available for a period of at least two years for inspection and copying by law enforcement officials. Section 893.07(5), Florida Statutes, calls for the maintenance of records of any substances lost, destroyed or stolen, as to the kind and quantity of such controlled substances and the date of discovery of the loss, destruction or theft. In reviewing the facts offered into evidence at the hearing, in the context of the position taken by the Petitioner at that hearing, it appears that the Petitioner is most concerned with the shortages, as opposed to the questioned prescriptions which they feel might be forgeries. Moreover, the facts establish that there was a "break-in" on August 30, 1977, in which the Respondent, James R. Gibbons' inventory showed that 128 Dilaudid 4mg. tablets were stolen or missing, for which the Petitioner gives credit in the audit process. Therefore, the analysis to be given this case will center on the "so- called" shortages of the two substances. The undersigned has reviewed the Exhibits 5 & 6 by the Respondent and finds the computations of the Respondent to be incorrect. An examination of those exhibits shows that 55,400 Dilaudid 4mg. tablets were purchased in the audit period and 30,200 Quaalude 300mg. tablets were purchased in the audit period. Using those figures, and subtracting the amount of tablets dispensed by prescriptions or lost through theft, to include questioned prescriptions, it shows 5,531 Dilaudid 4mg. tablets are short and 4,779 Quaalude 300mg. tablets are short. These shortages are shortages in which no meaningful explanation has been offered. The substances Dilaudid and Quaalude are class II drugs, for which records must be kept in a manner described above, in keeping with Section 893.07, Florida Statutes. The Respondent, James R. Gibbons, has failed to maintain the records in accordance with Section 893.07, Florida Statutes, and has thereby violated Section 465.101(1)(e), Florida Statutes.
Recommendation It is recommended that the license and registration certificate of James R. Gibbons, to be a pharmacist in the State of Florida, be revoked. DONE AND ENTERED this 5th day of April, 1977, in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Robert A. Pierce, Esquire Suite 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 W. George Allen, Esquire 116 Southeast Sixth Court Post Office Box 14738 Ft. Lauderdale, Florida 33302
The Issue The issues in this cause arise out of allegations that the Respondent violated the provisions of Chapter 466, Florida Statutes, by procuring amphetamines, procuring controlled substances for himself, procuring a controlled substance other than in the course of his dental practice, and failing to fulfill statutory record keeping requirements. At the hearing, the Petitioner called Investigator Greg P. Clift and Deputy Claude Davidson as witnesses. The Petitioner offered and had admitted two exhibits. Petitioner's Exhibit 1 is a certificate from the custodian of records for the Florida State Board of Dentistry and Exhibit No. 2 is a composite exhibit consisting of 11 D.E.A. Form 222. Respondent presented no evidence by way of live testimony and offered one composite exhibit which was admitted for the purpose of showing the character and reputation of the Respondent. That exhibit consists of eight letters from persons within the community who are familiar with the Respondent and his reputation as a dentist. Both counsel for the Petitioner and counsel for the Respondent submitted proposed recommended orders for consideration by the undersigned Hearing Officer. To the extent that the proposed findings of fact and conclusions of law contained within those proposed recommended orders are not adopted herein, they were considered and determined to be either irrelevant to the issues of this cause or not supported by the evidence.
Findings Of Fact By stipulation, it was agreed and I find that Respondent is and at all times relevant to this proceeding was a licensed dentist in the State of Florida holding License No. 0004802. During the period of May, 1979, through October, 1981, the Respondent ordered and procured the following drugs from the Interstate Drug Exchange in Plainview, New York: DATE DRUG AMOUNT 05/11/79 Quaalude 100 at 300 mg. 08/20/79 Percodan 100 at 5 mg. 11/06/79 Quaalude 500 at 300 mg. 01/08/80 Quaalude 500 at 300 mg. 01/08/80 Percodan 100 at 5 mg. 05/12/80 Quaalude 500 at 300 mg. 06/16/80 Percodan 100 at 5 mg. 08/21/80 Percodan 100 at 5 mg. 08/21/80 Quaalude 500 at 300 mg. 10/21/80 Dexedrine 100 at 15 mg. 11/17/80 Quaalude 500 at 300 mg. 02/13/81 Quaalude 500 at 300 mg. 10/05/81 Percodan 100 at 5 mg. These drugs were not procured by the Respondent for the purpose of utilizing them in the treatment of dental patients as a part of and in the course of his dental practice. The drugs were procured by the Respondent for himself for personal use, and he did, in fact, use the drugs himself. The Quaaludes and Percodan were taken by the Respondent because of problems he was having as a result of a difficult divorce that he was going through. The Dexedrine was procured by the Respondent for the purpose of losing weight, but because of the effect that it had upon him, he took only a few of the tablets and threw away the rest of the tablets. At the time the Respondent ordered and received the drugs listed in Paragraph 2 above, there was no investigative protocol contained in the records of the Florida State Board of Dentistry, nor had one been submitted regarding the prescribing, procuring, or use of amphetamines by Dr. Michael Radell, the Respondent. None of the drugs ordered were used by the Respondent in treating dental patients in the course of his dental practice. The only records maintained by Respondent with regard to those drugs listed in Paragraph 2 of this Recommended Order were the D.E.A. Form 222s which appear in Petitioner's Exhibit 2. No other records were prepared or maintained by the Respondent with regard to those drugs. The Respondent is an orthodontist and generally orthodontia does not require the use of Quaaludes. The Respondent does not use Percodan in his practice. During the course of the investigation, the Respondent was cooperative and polite at all times to Investigator Clift and Detective Davidson.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Respondent be found not guilty of Counts I, II, and III of the administrative complaint and that the charges be dismissed with prejudice. DONE and ENTERED this 6 day of May, 1983, in Tallahassee, Florida. MARVIN E. CHAVIS, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6 day of May, 1983. COPIES FURNISHED: Ms. Julie Gallager Staff Attorney 1844 Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Varn Executive Director Board of Dentistry 130 North Monroe Street Tallahassee, Florida 32301 Larry Byrd, Esquire 1844 Main Street Sarasota, Florida 33577 Mr. Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact At all times pertinent to the issues herein, the Department of Business and Professional Regulation's Division of Alcoholic Beverages and Tobacco, (Division), was the state agency responsible for regulation the wholesale and retail sales of alcoholic beverages in Florida. Respondent, Warehouse Liquors, III d/b/a Lake Avenue Liquors, held 3-PS liquor license 93-00582, for its retail liquor store located at 209 E. Lake Avenue in Tampa. The parties stipulated that the facts as alleged in paragraphs 1 - 18 of the Emergency Order of Suspension issued in this case on September 27, 1994, and Counts 1 through 11 of the Notice to Show Cause of even date are correct, and may be incorporated herein as Findings of Fact of the Hearing Officer. They are as follows: On or about April 29, 1991, Tampa City Councilman, Perry Harvey, notified the licensee's President and sole officer, Michael Kwasin, Jr., by letter, of specific public nuisance problem associated with his operation of the licensed premises. Mr. Kwasin was also given a corrective action plan to follow which included working with the Tampa Police Department, (TPD), to remedy the problem. In addition, TPD Sergeant G. Kelly contacted the licensee, through Mr. Kwasin, by telephone on several occasions in an effort to have him address the public nuisance complaints from the police Citizens Advisory Committee, made up of community leaders and city officials, relative to the licensed premises. In addition, citizens who reside in the surrounding neighborhood have met with Mr. Kwasin to voice their complaints about the drug dealing and safety problems related to his operation. Notwithstanding the repeated notices of misconduct in and around his facility given to Mr. Kwasin, the records of TPD reflect numerous complaints, incident reports and arrests associated with the licensed premises. On or about April 16, 1994, Special Agents, (SA), Hamilton and Murray went to the licensed premises as a part of an ongoing narcotics investigation. While at the premises, SA Murray observed patrons in the possession of "crack" cocaine. On or about May 19, 1994, SA Hamilton spoke with Mr. Kwasin regarding drug and loitering problems at the licensed premises. Nonetheless, TPD continued to receive complaints about the drug activity on the premises from citizens of the neighborhood. On or about June 2, 1994, SA's Hamilton, Zedell and Akins returned to the premises and while there, Zedell observed several male patrons, some of whom were conducting drug transactions, loitering in front of the licensed premises. Again, on or about July 21, 1994, SA's Maggio and Zedell returned to the licenses premises where Zedell observed patrons conducting drug transactions right in front. On or about August 25, 1994, SA's McKenzie and Zedell returned to the licensed premises and went inside where they met with the two female employees of the licensee and a male patron to arrange a purchase of marijuana. Zedell handed the male patron ten dollars and received, in exchange, a small plastic package of a substance which, when later analyzed, was determined to be marijuana. On or about August 26, 1994, SA's McKenzie and Zedell again returned to the licensed premises where Zedell observed patrons conducting drug transactions out in front. After one transaction, a patron went inside. When the agents went inside, they met with an employee, Lori, who asked the previously mentioned male patron if he had any marijuana. Thereafter, McKenzie got change from Lori from which he gave the patron ten dollars in exchange for a small plastic package containing a substance later analyzed and found to be marijuana. On or about September 1, 1994, SA's McKenzie and Zedell again returned to the licensed premises. While there they were approached by a male patron and solicited to buy marijuana. This patron thereafter directed McKenzie inside the premises to conduct the transaction because, he indicated, there were two police cars in the area. While inside, in front of employee, Lori, McKenzie gave the patron ten dollars for a small plastic bag of a substance later analyzed and determined to be marijuana. Again, on or about September 2, 1994, McKenzie and Zedell returned to the licensed premises where they observed several male patrons loitering outside. Just outside the door, McKenzie met with one of the male patrons to whom he gave ten dollars in return for a small bag containing a substance later analyzed and determined to be marijuana. On or about September 7, 1994, McKenzie and Zedell went back to the licensed premises where they were approached outside by a male patron regarding the sale of marijuana. McKenzie and the patron went inside where McKenzie handed him ten dollars in exchange for a small package containing a substance later analyzed and found to be marijuana. Later that same day, McKenzie and Zedell were again approached by the same patron regarding a sale of marijuana. McKenzie and the patron entered the premises where McKenzie again handed him ten dollars in exchange for a small plastic package containing a substance later analyzed and determined to be marijuana. This transaction was witnessed without interference by a male employee of the establishment. Again, that same day, Zedell met for a third time with that patron and gave him ten dollars in exchange for which he received a small plastic bag containing a substance later analyzed and found to be marijuana. On September 9, 1994, McKenzie and Zedell returned to the licensed premises where they were approached by another patron, different from all the previous patrons mentioned, who offered to sell them marijuana. They went with that patron inside the licensed premises where, in the presence of Respondent's employee, Jackie, McKenzie handed the patron ten dollars in exchange for which he received a small plastic bag containing a substance later analyzed and determined to be marijuana. On September 12, 1994, McKenzie and Zedell again went to the licensed premises where they were approached by yet another patron, a female this time, who offered to sell them marijuana. Again, as with prior patrons, they went inside the licensed premises where, in the presence of and with the concurrence of Respondent's employee, Lori, McKenzie handed the patron ten dollars in exchange for which he received a small plastic bag containing a substance which was later analyzed and determined to be marijuana. Two days later, on September 14, 1994, McKenzie and Zedell again went to the licensed premises where they were approached by several male patrons who were competing with one another to sell marijuana. All these patrons displayed small packages of purported marijuana and followed McKenzie into the licensed premises. Two of the patrons got into an argument about what was described as marijuana being openly displayed on the counter. Nonetheless, while inside the premises, McKenzie gave one of the patrons ten dollars in front of Jackie for which he received in return a small plastic bag containing a substance which was later analyzed and determined to be marijuana. Respondent's President, Mr. Kwasin, on the other hand, while not denying the details of the reported drug transactions which reportedly took place on the premises, denied ever being advised by his employees, the police, or his neighbors, that the situation was as bad as reported. His employee, Jacqueline Hall, (Jackie), in testimony at the hearing, indicated there was no room for drugs in the store because Mr. Kwasin has made it clear he doesn't want them there. She indicated management has also tried to get rid of the pushers outside the store as well and has cooperated with the police in all efforts to clean up the area. In her opinion, the primary responsibility lies with the police. Ms. Hall noted that she and Mr. Kwasin have gone to neighborhood meetings and have tried to implement the suggestions give by the police and others in an effort to cut down drug activities. There are only two employees at the store, she and Lori, and she has heard from law enforcement and others in the area that Respondent's policies on drugs are effective. According to her, the police have indicated that Respondent is doing all that can be done, and his efforts are appreciated. Ms. Hall has lived in that area all her life and she knows who the drug dealers are. They have come onto the licensed premises, but when they try to sell drugs inside, she sends them out. She denies having ever seen Lori selling drugs on the premises. Her testimony is patently incredible. Nonetheless, some law enforcement officers feel Respondent is being cooperative and trying to solve the drug problem. According to TPD Officer Garrett, who has spoken with Respondent Kwasin about the problem on many occasions, there has never been an instance where Kwasin has not cooperated fully with him, and Kwasin has sought suggestions from him on how to curb the drug traffic in the area. Respondent's general manager, Ms. Kennedy, has worked with him for about eight years. Approximately three years ago, the company put out a policy seeing to operate a drug-free work place. All employees are given copies of this policy. Earlier this year, Respondent's worker's compensation carrier provided her with new information to use to promote a drug free environment, which called for mandatory drug testing of employees and signed affidavits of non-use required from each employee. These new procedures have not been implemented as yet, however. Ms. Kennedy knows that Mr. Kwasin goes to the licensed premises in question each day, seven days a week. She also sees him at the location where she works, at least four hours a day the six days a week she is there. They have frequently discussed, prior to their implementation, anti-drug policies and procedures which Mr. Kwasin has brought back with him from training sessions at the IBD conventions he attends. He recognizes it to be in his best interests to conform to a no-drug policy in his stores. Ms. Kennedy is available to all Respondent's employees 24 hours a day, either at work, or on call at home. All employees go through a training program on anti-drug activity, but the drug testing and the anti-drug affidavits have not yet been implemented. Mr. Kwasin believes his efforts to curb drug activity in and around Lake Avenue Liquors had brought the problem under control. When Sgt. Hamilton spoke with him in May, 1994, he added more external lights and found that within a week of installation, all bulbs were broken. He replaced them four times, finally installing another type of bulb which is not so easily broken. He has tried to work with the police and even suggested they send in an undercover agent to work in the store as a clerk. This was not done, however. He has tried to enlarge the peep hole through which in-store activity could be monitored, but this was resisted by his employees who felt it placed them in increased danger of bodily harm. Mr. Kwasin claims he tried every way he knew to reduce the drug activity in the area because he knew it was a liability. He has taken pictures of the drug activity going on in the area outside his facility and contends they show open and unfettered drug sales going on without any interference by police. He tried to solicit suggestions from the police but nothing he tried helped. He thought his presence at the store would reduce drug dealing and when he was present, it was usually quiet. All of this related to drug activity outside the store, however. Mr. Kwasin claims to have had no knowledge at all that any drug activity was going on inside the store. He was told by his employees that they were doing what the could do and that no problem existed. It was only recently he found that his two female employees were being flattered by the male patrons who then could do what they wanted on the premises. Respondent now has a plan for new employees which includes "responsible vendor training" on anti-drug policies and procedures at the company headquarters and at the store. He had thought his prior policy was enough since no liquor was sold over the bar. At Respondent's Gandy Boulevard store, where liquor is sold by the drink, he has implemented such training, and will implement it at Lake Avenue Liquors. He will also repair and place into operation a video monitor which has been installed but not working for the past year, and he will manage the licensed premises personally until he gets proper, qualified employees in place, and he will monitor the closely after that. In short, Mr. Kwasin contends there was a tremendous breakdown in communications between him and the police and his neighbors, but denies there is any reason to fear being in the area at night. He claims he has been there at night many times. He admits his previous written policies have not worked with the employees he had. He admits his video system didn't work, and he admits that neither Jackie nor Lori was checked out on anti-drug training or tested. Notwithstanding Mr. Kwasin's denials of knowledge that any problem regarding drug sales existed inside the premises, Senator James T. Hargrett, Jr., who has lived in the area of the licensed premises for many years and who passes it frequently, has received numerous complaints from residents about the area, and as a property owner, he has made considerable effort to insure his properties are in compliance with all requirements of the law. He has observed the area at all hours and has worked with the police regarding it. Senator Hargrett believes Respondent could have done more to thwart the drug trafficking in the area. If the Senator suspected drug activity inside the premises, he would have gotten rid of those who were engaged in illegal activity; he would have worked more closely with the police; and he would have worked to get rid of loiterers. Lake Avenue Liquors has a very poor reputation in the surrounding community. It is not responsive to the neighbors' concerns about illegal activity. This facility constitutes a definite problem compared with other businesses in the neighborhood and seems to suffer from owner neglect. In Hargrett's opinion, it is incumbent upon anyone in business to supervise and audit what goes on in his business establishment and to be aware of any illegal activity. This was not done here, he feels, and this absence of proper supervision has resulted in the creation of a nuisance in the community.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that the alcoholic beverage license number 39-00583, series 3- PS, issued to Respondent, Warehouse Liquors III, Inc., d/b/a Lake Avenue Liquors, be revoked. RECOMMENDED this 17th day of November, 1994, in Tallahassee, Florida. ARNOLD H. POLLOCK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of November, 1994. APPENDIX TO RECOMMENDED ORDER The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. - 18. Accepted and incorporated herein. 19. - 29. Not Proposed Findings of Fact but restatements of the testimony of witnesses. They are, however, accepted as accurate restatements of the testimony as they support the findings made herein. FOR THE RESPONDENT: No submittal by Respondent. COPIES FURNISHED: Thomas A. Klein, Esquire Richard D. Courtemanche, Jr., Esquire Department of Business and Professional Regulation Division of Alcoholic Beverages and Tobacco 1940 North Monroe Street Tallahassee, Florida 32399-1007 Michael Kwasin, Jr., pro se Lake Avenue Liquors 4023 Gandy Boulevard Tampa, Florida 33611 John J. Harris Acting Director Division of Alcoholic Beverages and Tobacco 1940 North Monroe Street Tallahassee, Florida 32399-1007 Jack McRay General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether the Respondent committed the violations alleged in paragraphs 5 through 24 and 26 through 37 of the Corrected Second Amended Complaint, as modified, and, if so, the penalties that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency charged with the administration and enforcement of Sections 499.001 through .081. § 499.004, Fla. Stat. Worldwide Medical Supply is a prescription drug wholesaler who has been issued a permit, numbered 22:01390, to operate at 1452 North Krome Avenue, Suite 102F, Florida City, Miami-Dade County, Florida. On December 7, 2005, an inspection of Worldwide Medical Supply was conducted after a complaint against Worldwide Medical Supply was filed with the Department. Additional inspections were conducted in or about March 2006 and on May 15, 2007. During all three inspections, the Department's inspectors did not review all of the documents in Worldwide Medical Supply's files but took a sampling of the documents maintained by Worldwide Medical Supply relating to prescription drug sales and purchases. All of the drugs at issue herein are prescription drugs, also known as legend drugs. Paragraph 5 of the Corrected Second Amended Administrative Complaint, as amended; sale of prescription drugs to an unauthorized person in violation of § 499.005(15), Fla. Stat.; Petitioner's Exhibit 1.3 Petitioner's Exhibit 1 contains, in pertinent part, a Worldwide Medical Supply invoice, a Uniform Complaint Form, and a written report of an investigation conducted by the complainant, who was a drug agent. The Worldwide Medical Supply invoice, which is dated September 20, 2005, shows that five "Caverject Imp 20MCGKIT 2"4 were billed and shipped to "Health Environment" at an address in Hialeah, Florida. The Invoice includes a physician's license number and indicates that the Caverject was sent to the attention of "Amneris & Angel." The charge relating to this transaction arose out of a complaint and investigative report filed by a drug agent regarding the subject transaction, in which he reported that the physician whose number was included on the invoice was not employed by Health Environment at the time of the shipment. The Department did not present the testimony of the complaining drug agent, and the Sharon Roberts, one of the Department's inspectors who testified at the final hearing, stated that she had not conducted an investigation into the matter and had no personal knowledge of the matter beyond that which appeared on the invoice and in the report. The evidence related to the violation charged in paragraph 5 of the Corrected Second Amended Administrative Complaint is hearsay and cannot support a finding that the Caverject was delivered to an unauthorized person. See § 120.57(1)(c), Fla. Stat.( Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department is not, therefore, sufficient to establish that the Caverject was sold or transferred to a person who was not authorized to purchase or possess the prescription drug. Paragraph 6 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree in violation of §§ 499.005(14), (18), and (28) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 2. Petitioner's Exhibit 2 consists of a Picking Ticket, a Sales Order, an Invoice, and a Prescription (Legend) Drug Pedigree Form DH2129 ("Pedigree Paper")5 relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 13, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 15 12GM vials of Carimune and 35 6GM vials of Carimune. The Pedigree Paper was signed by a vice president of CT International, and the signature was dated October 10, 2005. The Pedigree Paper relates to the 35 6GM vials of Carimune sold to Worldwide Medical Supply, it identifies "ZLB" as the manufacturer, and lists "ZLB - CT International" as the "wholesaler's name." The Pedigree Paper does not identify the wholesaler that purchased the prescription drug from the manufacturer or the authorized distributor of record, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer or the authorized distributor of record. A stamp on the Pedigree Paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked much of the information that must be included in a pedigree paper, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted a failure to keep the required records of prescription drug transactions. The Department failed, however, to establish that CT International was not authorized to distribute prescription drugs in Florida. Although the records kept by prescription drug wholesalers of transactions involving prescription drugs must include the license number of the person distributing a prescription drug and the person purchasing the drug, the absence of the Florida license number of CT International constitutes an omission in the records. The omission is not, however, proof that CT International is not licensed in Florida, and the Department did not present any evidence to establish the Florida licensure status of CT International. Rather, Ms. Roberts, the Department's inspector, testified that she had no information regarding CT International's licensure status in Florida at the time of the sale of the Carimune because that "was not the issue."6 Paragraph 7 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree in violation of §§ 499.005(14), (18), and (28) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 3. Petitioner's Exhibit 3 consists of a Picking Ticket, a Sales Order, an Invoice, a Credit Memo, and a Pedigree Paper relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 17, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply seven 10ML units of Baygam intramuscular immune globulin. The Pedigree Paper was signed by a vice president of CT International, and the signature was dated October 18, 2005. The Pedigree Paper relates to the seven 10ML units of Baygam sold to Worldwide Medical Supply; lists "CT International" as the wholesaler; identifies "Bayer/Talecris" as the manufacturer; and identifies "McKesson Drug" as the wholesaler that purchased the prescription drug from the manufacturer. The Pedigree Paper does not identify the wholesaler that purchased the prescription drug from McKesson, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer by McKesson. A stamp on the pedigree paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The Baygam was returned by Worldwide Medical Supply to CT International, and a credit memo was issued to Worldwide Medical Supply refunding the cost of the drugs. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked much of the information that must be included in a pedigree paper, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. Paragraph 8 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 4. Petitioner's Exhibit 4 consists of a Picking Ticket, an Invoice, and two Pedigree Papers relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 7, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 14 6GM vials of Carimune and 15 12GM vials of Carimune. The Pedigree Papers for both the 6GM and the 12GM vials of Carimune were signed by a vice president of CT International, and the signatures were dated October 10, 2005. The Pedigree Papers identify "ZLB" as the manufacturer, and lists "ZLB - CT International" as the "wholesaler's name." The Pedigree Papers do not identify the wholesaler that purchased the prescription drugs from the manufacturer or the authorized distributor of record, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer or the authorized distributor of record. A stamp on the Pedigree Paper for the 12GM vials of Carimune indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply; there is no such stamp on the Pedigree Paper for the 6MG vials. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Papers provided by CT International and to review them for accuracy and completeness. The Pedigree Papers lacked much of the information that must be included in a pedigree paper, and they were, therefore, incomplete and could not be authenticated with the information provided. There was no indication that the Pedigree Paper relating to the 6GM vials of Carimune was reviewed for completeness, and the attestation that the Pedigree Paper relating to the 12GM vials of Carimune had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 6MG and 12MG vials of Carimune purchased by Worldwide Medical Supply from CT International were adulterated drugs in that the pedigree papers for the drugs were incomplete. Paragraph 9 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 33. Petitioner's Exhibit 33 consists of a Picking Ticket, an Invoice, and a Pedigree Paper relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 3, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 100 2ML units of Baygam intramuscular immune globulin. The Pedigree Paper was originated by First Choice Pharmaceutical Wholesalers and signed by its sales manager, with the signature dated July 18, 2005. The Pedigree Paper does not identify the manufacturer of the Baygam and no quantity of Baygam is listed; First Choice Pharmaceutical is identified as the wholesaler that purchased an unspecified quantity of Baygam from the manufacturer; and the Pedigree Paper indicates that the first subsequent wholesale distribution of the Baygam was to CT International. It appears that all of the required information is included in reference to CT International's purchase of Baygam from First Choice Pharmaceuticals, and Drew Arnold signed the Petitioner as the authenticator from CT International. Finally, the Pedigree Paper shows that the second subsequent wholesale distribution was to Worldwide Medical Supply in the amount of "100 vls." A stamp on the Pedigree Paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked the name of the manufacturer and the quantity of Baygam purchased by First Choice. The Pedigree Paper was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 100 2ML units of Baygam purchased by Worldwide Medical Supply from CT International were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 10 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 5. Petitioner's Exhibit 5 consists of a Sales Invoice and a document entitled "Pedigree" relating to a transaction between Medex BioPharm and Worldwide Medical Supply. The Invoice, which is dated August 31, 2005, indicates that Medex BioPharm shipped and billed to Worldwide Medical Supply 11 12gm units of Carimune NF. The pedigree paper is a form apparently generated by Medex BioPharm to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and it was signed by Medex BioPharm's compliance officer, with the signature dated September 6, 2005. The pedigree paper identifies the manufacturer of the Carimune as "ZLB" and indicates that Medex BioPharm purchased the Carimune as an "Authorized Distributor," but there is nothing in the pedigree paper regarding the source from which Medex BioPharm purchased the Carimune. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by Medex BioPharm, and, in addition, the pedigree paper was not issued prior to or at the same time the prescription drug was shipped. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medex BioPharm or of Worldwide Medical Supply. At the times relevant to the purchase of the Carimune by Worldwide Medical Supply, however, Medex BioPharm held two licenses in Florida, one as a pharmacy and one as a prescription drug wholesaler. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medex BioPharm and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was not sufficient to establish that Medex BioPharm was not authorized to distribute the Carimune identified in the Invoice and pedigree paper to Worldwide Medical Supply. Medex BioPharm had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Medex BioPharm's license number in the documentation of the sale constitutes only a recordkeeping error. As further proof that Worldwide Medical Supply purchased the Carimune from an unauthorized source, the Department presented the testimony of Ms. Roberts, one of the Department's inspectors. Ms. Roberts testified that she attempted to authenticate the purchase of the Carimune by Medex BioPharm and learned that Medex BioPharm was "purchasing [the Carimune] using their pharmacy license, and then, selling [the Carimune], using their wholesale license."7 According to Ms. Roberts, this practice is not permitted and renders the Carimune contraband drugs. Ms. Roberts did not, however, provide any more specific information regarding the purchase of the Carimune by Medex BioPharm. Ms. Robert's testimony is hearsay and cannot support a finding of fact that Medex BioPharm was not authorized to distribute prescription drugs to Worldwide Medical Supply. See § 120.57(1)(c), Fla. Stat. ("Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department was sufficient to establish that the 11 12gm units of Carimune NF purchased by Worldwide Medical Supply from Medex BioPharm were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 11 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 6. Petitioner's Exhibit 6 consists of a Packing Slip dated September 6, 2005, a Sales Invoice dated September 7, 2005, and a document entitled "Pedigree" relating to a transaction between Medex BioPharm and Worldwide Medical Supply. The Invoice, which is dated September 7, 2005, indicates that Medex BioPharm shipped and billed to Worldwide Medical Supply 20 2ml units of Baygam. The pedigree paper is a form apparently generated by Medex BioPharm to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and it was signed by Medex BioPharm's compliance officer, with the signature dated September 8, 2005. The pedigree paper identifies the manufacturer of the Baygam as "Talecris" and indicates that Medex BioPharm purchased the Baygam as an "Authorized Distributor," but there is nothing in the pedigree paper regarding the source from which Medex BioPharm purchased the Baygam or the date on which it was purchased. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by Medex BioPharm, and, in addition, the pedigree paper was not issued prior to or at the same time the prescription drug was shipped. A stamp on the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medex BioPharm or of Worldwide Medical Supply. At the times relevant to the purchase of the Baygam by Worldwide Medical Supply, however, Medex BioPharm held two licenses in Florida, one as a pharmacy and one as a prescription drug wholesaler. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medex BioPharm and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 33 above, the evidence presented by the Department failed to establish that Medex BioPharm was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 20 2ml units of Baygam purchased by Worldwide Medical Supply from Medex BioPharm were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 12 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 7. Petitioner's Exhibit 7 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated June 10, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 33 10gm units of Gammunex and 14 5gm units of Gammunex. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper was not signed or dated. The pedigree paper identifies the manufacturer of the Gammunex as "Bayer" and indicates that the distributor of record is "FFF" and that the Gammunex was purchased by FFF on June 8, 2005, but there is nothing in the pedigree paper regarding the source from which Medical Infusion Technologies purchased the Gammunex. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by FFF. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammunex.8 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. 48. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was not sufficient to establish that Medical Infusion Technologies was not authorized to distribute the Gammunex identified in the Invoice and pedigree paper to Worldwide Medical Supply. Medical Infusion Technologies had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Medical Infusion Technologies' license number in the documentation of the sale constitutes a recordkeeping error. The evidence presented by the Department was sufficient to establish that the 33 10gm units of Gammunex and 14 5gm units of Gammunex purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 13 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 8. Petitioner's Exhibit 8 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated June 16, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 25 units of Flebogamma. The exhibit also contains a document from Cardinal Health showing that, on June 14, 2005, it sold 25 units of Flebogamma to Medical Infusion Technologies. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is not signed or dated. It identifies the manufacturer of the Flebogamma as "Grifols" and indicates that the distributor of record is "Cardinal Health." An Invoice attached to the pedigree paper shows that the Flebogamma was sold to Medical Infusion Technologies by Cardinal Health, but the pedigree paper does not indicate the lot number and quantity of Flebogamma that Cardinal Health purchased from Grifols, nor does it or the Invoice indicate the dosage form of the Flebogamma purchased by Cardinal Health from Grifols. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Flebogamma.9 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 47 above, the evidence presented by the Department failed to establish that Medical Infusion Technologies was not authorized to distribute prescription drugs in Florida.10 The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. As further proof that Worldwide Medical Supply purchased the Flebogamma from an unauthorized source, the Department presented the testimony of Ms. Roberts that, when she attempted to authenticate the pedigree of the Flebogamma, she telephoned Cardinal Health and asked if they sold the Flebogamma to Medical Infusion Technologies: "They did confirm that they sold to Medical Infusion Technologies this product, but Cardinal explained to me that they sold to Medical Infusion Technologies as an end-user, like a pharmacy, which is not permitted for resale to a wholesaler."11 According to Ms. Robert's, an end- user may not sell a prescription drug to a wholesaler, and such a sale renders the Flebogamma contraband drugs. Ms. Roberts did not provide any more specific information regarding the purchase of the Flebogamma by Medical Infusion Technologies. Ms. Robert's testimony is hearsay and cannot support a finding of fact that Medical Infusion Technologies was not authorized to distribute prescription drugs to Worldwide Medical Supply. See § 120.57(1)(c), Fla. Stat. ("Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department was sufficient to establish that the 25 units of Flebogamma purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 14 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 9. Petitioner's Exhibit 9 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated November 8, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 100 units of Gammar P. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is not signed or dated. It identifies the manufacturer of the Gammar P as "Aventis" and indicates that the distributor of record is "Cardinal Health." The pedigree paper does not include the lot number and quantity of Gammar P that Cardinal Health purchased from Aventis, nor does it indicate the dosage form of the Gammar P purchased by Cardinal Health from Aventis. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Flebogamma.12 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 47 above, the evidence presented by the Department failed to establish that Medical Infusion Technologies was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 100 units of Gammar P purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 15 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of § 499.005(14); Petitioner's Exhibit 10. Petitioner's Exhibit 10 consists of an Order Acknowledgement, a Packing List, a Statement of Account, and an Invoice relating to a transaction between Lupin Pharmaceuticals, Inc., and Worldwide Medical Supply. The Invoice, which is dated August 16, 2004, indicates that Lupin Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply two units of Octagam 5%. Lupin Pharmaceuticals, Inc., was not required to provide a pedigree paper to Worldwide Medical Supply for the sale of the Octagam because Lupin Pharmaceuticals, Inc., is the manufacturer of the drug. It did not, however, have a manufacturer's license to ship prescription drugs to Florida from the address in Kentucky from which it shipped the Octagam to Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Octagam from an unauthorized person. Paragraph 16 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 11. Petitioner's Exhibit 11 consists of an Invoice, a copy of the same Invoice stamped "Paid," and a document entitled "Pedigree Statement" relating to a transaction between Premium Health Services and Worldwide Medical Supply. The Invoice, which is dated September 23, 2004, indicates that Premium Health Services shipped and billed to Worldwide Medical Supply 16 12gm vials of Carimune. The pedigree paper is a form apparently generated by Premium Health Services to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is signed by a "corporate officer" and dated September 23, 2004. The pedigree paper identifies the manufacturer of the Carimune as "ZLB Bioplasma" and indicates that Premium Health Services is the authorized distributor of the Carimune. The pedigree paper does not include the address, telephone number, or purchase invoice number for the purchase of the Carimune by Premium Health Services from ZLB Bioplasma.13 A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Premium Health Services or of Worldwide Medical Supply. The state database shows that Premium Health Services' Florida prescription drug wholesaler license expired on June 30, 2004. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department also was sufficient to establish that Premium Health Services was not authorized to distribute prescription drugs in Florida at the time it sold the Carimune to Worldwide Medical Supply. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 16 12gm vials of Carimune purchased by Worldwide Medical Supply from Premium Health Services were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 17 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 12. Petitioner's Exhibit 12 consists of a Packing Slip, an Invoice, a copy of the same Invoice stamped "Paid," and a Pedigree Paper relating to a transaction between Priority Pharmaceuticals and Worldwide Medical Supply. The Invoice, which is dated May 25, 2005, indicates that Priority Pharmaceuticals shipped and billed to Worldwide Medical Supply 10 10ml units of Baygam. The Pedigree Paper is signed by an individual who identifies himself as "Buyer"; the date of the signature is incomplete, giving the month but no day or year. The Pedigree Paper identifies the manufacturer of the Baygam as "Bayer" and also indicates that "Bayer" is the "authorized distributor of record" in addition to being the manufacturer. The Pedigree Paper shows a subsequent wholesale distribution to Worldwide Medical Supply, but the same individual that signed the Pedigree Paper also signed the subsequent distribution section as the "authenticator." A stamp on the Invoice marked "Paid" indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the 10 10ml units of Baygam purchased by Worldwide Medical Supply from Priority Pharmaceuticals were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 18 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 13. Petitioner's Exhibit 13 consists of five sets of documents relating to transactions between Prodigy Health Supplier Corporation and Worldwide Medical Supply on or about April 27, 2005, and May 11, 18, and 20, 2005. The Department has charged Worldwide Medical Supply in its Corrected Second Amended Administrative Complaint with four violations of Sections 499.001 through .081, Florida Statutes, each corresponding to a specific date.14 The first set of documents consists of a Picking Slip and Invoice dated April 27, 2005, together with a copy of the Picking Slip showing that it was posted April 28, 2005, and a copy of the Invoice showing that it was paid on May 11, 2005. The Invoice, which is dated May 25, 2005, indicates that Prodigy Health Supplier Corporation 30 10g vials of Gammar. No pedigree paper was included with the Invoices and Picking Slips. The evidence presented by the Department was, therefore, sufficient to establish that the 30 10g vials of Gammar were adulterated because they were not accompanied by a pedigree paper. The second set of documents consists of a Pedigree Paper dated May 17, 2005, and Picking Slip and Invoice dated May 11, 2005. The Invoice indicates that 20 6g vials and 10 3g vials of Carimune NF was sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 11, 2005. The Pedigree Paper indicates that ZLB Bioplasma is the manufacturer of the drugs and includes the NDC number, the lot numbers, and the quantity of the drug, which correspond to the lot numbers and quantity of the Carimune sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Carimune, but the invoice number and date identified on the Pedigree Paper are the invoice number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between ZLB Bioplasma and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution. The Pedigree Paper is signed by an individual who identifies himself as "VP"; the signature is dated May 17, 2005. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 6g vials and 10 3g vials of Carimune NF purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. The third set of documents consists of a Pedigree Paper dated May 17, 2005, and a Picking Slip and Invoice dated May 18, 2005. The Invoice indicates that 20 6g vials of Carimune NF were sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 18, 2005. The Pedigree Paper indicates that ZLB Bioplasma is the manufacturer of the drugs and includes the NDC number, the lot numbers, and the quantity of the drug, which correspond to the lot numbers and quantity of the Carimune sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Carimune, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between ZLB Bioplasma and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution history. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 6g vials of Carimune NF purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. The fourth set of documents consists of two Pedigree Papers dated May 20, 2005, and an Invoice dated May 20, 2005. The Invoice indicates that 20 10g vials of Gammar, five 10g units of Flebogamma, and 10 5g units of Flebogamma were sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 20, 2005. The Pedigree Papers indicate that ZLB Bioplasma is the manufacturer of the Gammar P and that Grifols Biologicals is the manufacturer of the Flebogamma; they include the NDC numbers, the lot numbers, and the quantities of the drugs, which correspond to the lot numbers and quantity of the Gammar P and Flebogamma sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper for the Flebogamma further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Flebogamma, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and the date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between Grifols Biologicals and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution history relating to the Flebogamma. The Pedigree Paper for the Gammar P indicates that Premium Health Services was the authorized distributor of record for the Gammar P and that Prodigy Health Supplier Corporation purchased the Gammar P from Premium Health Services, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between Grifols Biologicals and Premium Health Services. In addition, there is nothing on the Pedigree Paper for the Gammar P to indicate that the pedigree from Premium Health Services was authenticated by Prodigy Health Supplier Corporation. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 10g vials of Gammar, five 10g units of Flebogamma, and 10 5g units of Flebogamma purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 19 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 14. Petitioner's Exhibit 14 consists of an Invoice, a Pedigree Paper, and a facsimile transmittal cover page relating to a transaction between PMP Health Services and Worldwide Medical Supply. The Invoice, which is dated April 26, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply eight 10GM units of Gammagard S/D. The Pedigree Paper was apparently originated by PMP Health Services and was signed by an individual who identified himself as "Sec.," with the signature dated April 26, 2004. The Pedigree Paper identifies the manufacturer of the Gammagard as Baxter and includes the lot number and quantity of the drug.15 The invoice number and date below the information related to the manufacturer correspond to the Invoice and date relating to the transaction between PMP Health Services and Worldwide Medical Supply. Cardinal Health is identified on the Pedigree Paper as the authorized distributor of record of the Gammagard, and the subsequent wholesale distribution history shows that the Gammagard was purchased from Cardinal Health by a prescription drug wholesaler in Maryland whose name is illegible on the Pedigree Paper and that the Gammagard was purchased from this company by PMP Health Services. The Pedigree Paper does not contain the purchase date or invoice number for any of the transactions prior to the sale to Worldwide Medical Supply, nor is there any indication that the pedigree of the Gammagard was authenticated by the Maryland company or by PMP Health Services. A facsimile transmittal cover page includes a handwritten note that "This is the pedigree for the Gammagard" and appears to relate to the April 26, 2005, transaction. A stamp on the facsimile transmittal cover page indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of PMP Health Services or of Worldwide Medical Supply. PMP Health Services was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammagard. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by PMP Health Services and to review it for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was not sufficient to establish that PMP Health Services was not authorized to distribute the Gammagard identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. PMP Health Services had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include PMP Health Services' license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the eight 10GM units of Gammagard S/D purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 20 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 15. Petitioner's Exhibit 15 consists of an Invoice and a "Statement Identifying Pharmaceutical Sale" relating to a transaction between PMP Health Services and Worldwide Medical Supply. The Invoice, which is dated June 3, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply eight 10GM units of Gammagard S/D. The "Statement Identifying Pharmaceutical Sale" is a form apparently generated by PMP Health Services to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and was intended as a pedigree paper for the transaction. The pedigree paper is not signed or dated but includes under a paragraph entitled "Unauthorized Vendor Certification" the typewritten name of an individual who is otherwise unidentified. The pedigree paper identifies the manufacturer of the Gammagard as "Baxter" and also includes the NDC number, expiration date, and lot number of the drug. No quantity or dosage amount is included, however. The pedigree paper shows that PMP Health Services purchased the Gammagard from BioMed Plus, which is identified as an "Authorized Distributor"; there is no information regarding BioMed Plus's purchase of the drug or and no further information regarding PMP Health Services' purchase of the drug from BioMed Plus. A stamp on the Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the eight 10GM units of Gammagard S/D purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 21 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 16. Petitioner's Exhibit 16 consists of an Invoice and a Pedigree Paper dated June 21, 2004, and an Invoice and a Pedigree Paper dated July 19, 2004, relating to two transactions between PMP Health Services and Worldwide Medical Supply. The Invoice dated July 19, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply 32 10GM units of Gammunex 10%.16 The Pedigree Paper related to the July 19, 2004, transaction was apparently originated by PMP Health Services and was signed by an individual who identified himself as "Sec.," with the signature dated July 19, 2004. The Pedigree Paper identifies Bayer as the manufacturer of the Gammunex and includes the lot number and quantity of the drug.17 The invoice number and date below the information related to the manufacturer correspond to the Invoice and date relating to the transaction between PMP Health Services and Worldwide Medical Supply. "PHC" is identified on the Pedigree Paper as the authorized distributor of record of the Gammunex, and the subsequent sales history shows that the Gammunex was purchased from PHC by PMP Health Services. The Pedigree Paper contains the purchase date, but it does not include the invoice number for the purchase by PMP Health Services from PHC, nor is there any indication that the pedigree of the Gammunex was authenticated by PMP Health Services. A stamp on the July 19, 2004, Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of PMP Health Services or of Worldwide Medical Supply. PMP Health Services was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammunex. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by PMP Health Services and to review them for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was not sufficient to establish that PMP Health Services was not authorized to distribute the Gammunex identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. PMP Health Services had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include PMP Health Services' license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 32 10GM units of Gammunex 10% purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 22 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of § 499.005(14); Petitioner's Exhibit 17. Petitioner's Exhibit 17 consists of a Sales Order Pick Suggestion and Invoice dated June 7, 2005, and a Sales Order Pick Suggestion and Invoice dated June 22, 2005, relating to two transactions between Questcor Pharmaceuticals, Inc., and Worldwide Medical Supply. The Invoice dated June 7, 2005, indicates that Questcor Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply five units of Acthar; the Invoice dated June 22, 2004, indicates that Questcor Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply five units of Acthar. Questcor Pharmaceuticals, Inc., was not required to provide a pedigree paper to Worldwide Medical Supply for the sale of the Acthar because it is the manufacturer of the drug, but it did not have a manufacturer's license to distribute prescription drugs in Florida from the address in Kentucky from which it shipped the Acthar to Worldwide Medical Supply. It did, however, have a manufacturer's license to distribute prescription drugs in Florida from an address in California. The evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Acthar from an unauthorized person on June 7 and 22, 1005. Paragraph 23 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 18. Petitioner's Exhibit 18 consists of an Invoice dated March 5, 2004, and an Invoice dated October 16, 2003, relating to two transactions between FPP Distribution, Inc., acting as "Logistic Service Providers for: RxBazaar.com," and Worldwide Medical Supply. The Invoice dated October 16, 2003, indicates that FPP Distribution, Inc. shipped and billed to Worldwide Medical Supply 60 10GM tabs of Zyprexa. A handwritten notation appears on this Invoice indicating that the Zyprexa was "Returned for no (1) Pedigree Papers (2) RxBazaar not license [sic] in State of Florida for wholesale distribution." The Invoice dated March 5, 2004, indicates that FPP Distribution, Inc., shipped and billed to Worldwide Medical Supply 3 5MG units of Aricept.18 No pedigree paper was included with the Invoice, and there is no indication that the Aricept was returned. As noted by Worldwide Medical Supply on the October 16, 2003, Invoice, RxBazaar.com was not licensed to distribute prescription drugs in Florida at the time relevant to the sale of the Zyprexa, and neither it nor FPP Distribution, Inc., was licensed to distribute prescription drugs in Florida at the time relevant to the sale of the Aricept. Because neither FPP Distribution, Inc., nor RxBazaar.com was licensed to distribute prescription drugs in Florida at the time relevant to the March 5, 2004, transaction, the evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Aricept from an unauthorized person. However, even though Worldwide Medical Supply did purchase Zyprexa from FPP Distribution, Inc./RxBazaar.com, the evidence establishes that Worldwide Medical Supply returned the shipment and, therefore, for purposes of a separate violation of Sections 499.001 through .081, Florida Statutes, the evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply completed the purchase of the Zyprexa from an unauthorized person. The evidence presented by the Department was sufficient to establish that the 3 5MG units of Aricept purchased by Worldwide Medical Supply from FPP Distribution, Inc./RxBazaar.com were adulterated drugs in that no pedigree paper was provided for the drugs. Finally, no pedigree papers are included in Petitioner's Exhibit 18, and there is no representation on either the October 16, 2003, or the March 5, 2004, Invoices that anyone at Worldwide Medical Supply authenticated the prescription drug pedigrees. Therefore, the evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply fraudulently authenticated the pedigrees of these drugs. Paragraph 24 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 19.19 Petitioner's Exhibit 19 consists of an Invoice and four documents entitled "Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act," which apparently are intended to be pedigree papers, relating to a transaction between Allscripts Healthcare Solutions and Worldwide Medical Supply. The Invoice, which is dated February 2, 2004, indicates that Allscripts Healthcare Solutions shipped and billed to Worldwide Medical Supply 30 200mg tabs of Diflucan; 60 2mg tablets of Risperdal; 60 10mg tabs of Zyprexa; and 60 20mg tabs of Zyprexa. Allscripts Healthcare Solutions provided a statement identifying prior sales to Worldwide Medical Supply for each of these four prescription drugs; these statements were apparently intended to be pedigree papers for each of the drugs. The statements identify the manufacturer and NDC number for each drug; include the bulk lot numbers and expiration dates for the drugs; indicate that Allscripts Healthcare Solutions sold the drugs to Worldwide Medical Supply; provide Allscripts Healthcare Solutions' Florida Out-Of-State Prescription Drug Wholesaler Permit number; identify Amerisource Bergen as the person from whom Allscripts Healthcare Solutions purchased the drugs; identify Amerisource Bergen as an authorized distributor for the drugs; and state that Amerisource Bergen did not provide pedigree documents to Allscripts Healthcare Solutions for the drugs. The statements did not include any information regarding the purchase of the drugs from the manufacturers. The evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply purchased the four prescription drugs from an unauthorized person. Allscripts Healthcare Solutions was properly licensed to distribute prescription drugs in Florida at the times of the transactions at issue. The evidence presented by the Department was sufficient to establish that the 30 200mg tabs of Diflucan, 60 2mg tablets of Risperdal, 60 10mg tabs of Zyprexa, and 60 20mg tabs of Zyprexa purchased by Worldwide Medical Supply from Allscripts Healthcare Solutions were adulterated drugs in that the statements intended to provide the pedigrees for the drugs were incomplete. Paragraph 26 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 21. Petitioner's Exhibit 21 consists of an Invoice, a Packing Slip, and a "Pedigree" relating to a transaction between ActSys Medical, Inc., and Worldwide Medical Supply. The Invoice dated December 22, 2004, indicates that ActSys Medical, Inc., shipped and billed to Worldwide Medical Supply 10 10ml vials of Baygam. The pedigree paper provided by ActSys Medical, Inc., identified the manufacturer of the Baygam as Bayer, and included the NDC number, the quantity, the lot number, and the expiration date of the drugs. The pedigree paper further identified ActSys Medical, Inc., as the supplier of the drugs and identified ActSys Medical, Inc., as the "authorized distributor." There is no further wholesale distribution history for the drugs in the pedigree paper; there is no information in the pedigree paper regarding the purchase of the drugs by ActSys Medical, Inc.; and the pedigree paper is not signed. A stamp on the December 22, 2004, Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of ActSys Medical, Inc., or of Worldwide Medical Supply. ActSys Medical, Inc., was not authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Baygam. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by ActSys Medical, Inc., and to review it for accuracy and completeness. The pedigree paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that ActSys Medical, Inc., was not authorized to distribute the Baygam identified in the Invoice and "Pedigree" provided to Worldwide Medical Supply. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 10 10ml vials of Baygam purchased by Worldwide Medical Supply from ActSys Medical, Inc., were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 27 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 22. Petitioner's Exhibit 22 consists of an Invoice, a copy of the Invoice marked "Paid," a Work Order, and a Pedigree Paper relating to a transaction between Florida Infusion/Nations Drug and Worldwide Medical Supply. The Invoice dated September 15, 2005, indicates that Florida Infusion shipped and billed to Worldwide Medical Supply 14 2ML units of Baygam Immune Globulin I.M. The Pedigree Paper provided by Florida Infusion identified the manufacturer of the Baygam as "Talecris," and included the NDC number, the quantity, the lot number, and the expiration date of the drugs. The Pedigree Paper further identified Florida Infusion as the "authorized distributor of record." There is no further wholesale distribution history for the drugs in the Pedigree Paper and there is no information in the Pedigree Paper regarding the purchase of the drugs by Florida Infusion.20 The invoice number and date included on the Pedigree Paper corresponds to the invoice number and date of the transaction between Florida Infusion and Worldwide Medical Supply. The Pedigree Paper is signed and dated September 19, 2005. A stamp on the September 15, 2005, Work Order indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Florida Infusion or of Worldwide Medical Supply. Florida Infusion was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Baygam. The evidence presented by the Department was not sufficient to establish that Florida Infusion was not authorized to distribute the Baygam identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. Florida Infusion had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Florida Infusion's license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by Florida Infusion and to review it for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the 14 2ML units of Baygam Immune Globulin I.M. purchased by Worldwide Medical Supply from Florida Infusion were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 28 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (18), and (29); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 23. Petitioner's Exhibit 23 consists of five Invoices and accompanying shipping documents and a sixth Invoice that is not accompanied by a shipping document; these documents relate to six transactions between Bellco Drug Corp and Worldwide Medical Supply. The first Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply eight 10ML units of Chorionic Gonad (N/RTN); the second Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 10 10ML units of Chorionic Gonad (N/RTN); the third Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 5 10ML units of Nubain Inj 10MG/ML N/f; the fourth Invoice, dated October 18, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply four 20ML units of Ceftriaxone DOD Inj 1GM and 4 2ML units of Thiamine HCL Inj 100MG/ML; the fifth Invoice, dated October 20, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 24 10CP units of Tamiflu 75MG; and the sixth Invoice, dated October 31, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply one 2ML unit of Baygam SDV and three 10CP units of Tamiflu 75MG.21 A stamp on the October 31, 2005, Invoice indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. No pedigree papers were, however, provided for any of the six transactions. The evidence presented by the Department was sufficient to establish that the prescription drugs purchased by Worldwide Medical Supply from Bellco Drug Corp on October 17, 18, 20, and 31, 2005, were adulterated drugs in that no pedigree papers were provided for the drugs. In addition, the evidence presented by the Department was sufficient to establish that Worldwide Medical Supply's purported authentication of the pedigrees of the drugs purchased from Bellco Drug Corp on October 31, 2005, was fraudulent. No authentication was possible because no pedigree paper was provided for the drugs. Paragraph 29 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (18), and (29); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 24. Petitioner's Exhibit 24 consists of a Packing List and three statements entitled "Prescription Drug Pedigree" relating to a transaction between BioMed Plus Miami and Worldwide Medical Supply. The Packing List, which is dated December 9, 2004, indicates that BioMed Plus Miami shipped and billed to Worldwide Medical Supply 35 5-gram units of Gammunex 10%; 15 10-gram units of Gammunex 10%; and 5 20- gram units of Gammunex 10%. The "Prescription Drug Pedigree" statements included with the Invoices were apparently created by BioMed Plus Miami. The three "pedigree" statements are not signed or dated. The statements identify the manufacturer of the Gammunex 10% as Bayer, and the only information included on the documents is the name and dosage of the drugs, the NDC numbers, the lot numbers, the expiration dates, and the quantities of the drugs expressed in grams. The statements include no information regarding the purchase of the Gammunex by BioMed Plus Miami or the wholesale distribution history of the drugs. A stamp on the Packing List indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the 35 5-gram units of Gammunex 10%, the 15 10-gram units of Gammunex 10%, and the 5 20-gram units of Gammunex 10% purchased by Worldwide Medical Supply from BioMed Plus Miami were adulterated drugs in that the pedigree papers for the drugs were wholly inadequate and incomplete. Paragraph 30 of the Corrected Second Amended Administrative Complaint, as amended; receipt of a prescription drug by a non- permitted facility in violation of §§ 499.005(14) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 25. Petitioner's Exhibit 25 consists of an Invoice and a Packing Slip relating to a transaction between Mercury Medical and Worldwide Medical Supply. The Invoice, which is dated October 13, 2006, indicates that Mercury Medical shipped 20 5ML units of flu vaccine to Rick Nielson at 7904 West Drive, Unit 1017, North Bay Village, Florida 33141 and billed the vaccine to Worldwide Medical Supply. At the time the vaccine was shipped, Rick Nielson was the certified designated representative of Worldwide Medical Supply, and the address to which it was shipped was Mr. Nielson's home address. Mr. Nielson's home was not a facility licensed to receive prescription drug in Florida. The evidence presented by the Department was sufficient to establish that the drug was adulterated because the drug was held by a person not authorized to do so, but the Department presented no evidence to establish that Worldwide Medical Supply was responsible for the shipment or that it committed a violation with respect to this transaction. Paragraph 31 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 26. Petitioner's Exhibit 26 consists of a Packing Slip, a Pedigree Paper, and copies of the Georgia and Florida licenses of Medical Infusion Technologies relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Packing Slip, which is dated April 25, 2006, indicates that a number of 3 gram vials of Carimune NF were shipped to Medical Infusion Technologies at an address in Bossier City, Louisiana. The Pedigree Paper prepared by Worldwide Medical Supply and dated March 6, 2007, indicates that Worldwide Medical Supply purchased nine of the 3 gram vials of Carimune from Medical Infusion Technologies, whose address was noted on the Pedigree Paper as 1525 Doctors Drive, Bossier City, Louisiana. Medical Infusion Technologies did not have a Florida license to distribute prescription drugs from its Bossier City, Louisiana, address. Medical Infusion Technologies' Florida license was issued to Medical Infusion Technologies at 115 Echols Street, Savannah, Georgia. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 32 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 27. Petitioner's Exhibit 27 consists of a two-page Invoice dated September 25, 2006, and an Order Pick Sheet dated October 10, 2006. These documents relate to transactions involving Broughton Pharmaceuticals, LLC, Worldwide Medical Supply, and an entity referred to as "Kuehne & Nagel - Dallas." The Invoice indicates that, on September 25, 2006, Broughton Pharmaceuticals, LLC, shipped and billed to Worldwide Medical Supply at an address in Dallas, Texas, "c/o Kuehne + Nagel, Inc. (Texas)," 702 6gm units of Carimune. The Order Pick Sheet indicates that, on October 10, 2006, Kuehne + Nagel consigned 46 6gm units of Carimune to Worldwide Medical Supply in Florida City, Florida, and a notation appears on the sheet that a particular Federal Express account was to be used. Kuehne + Nagel is a licensed wholesale distributor of prescription drugs in the State of Texas, as is Worldwide Medical Supply, but it is not licensed as a wholesale distributor of prescription drugs in the State of Florida. The evidence presented by the Department was sufficient to support an inference that the 46 6gm units of Carimune were shipped by Kuehne + Nagel to Worldwide Medical Supply in Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 33 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 28. Petitioner's Exhibit 28 consists of two Invoices and a two-page Pedigree Paper that relate to transactions involving Broughton Pharmaceuticals, LLC, Worldwide Medical Supply, and Kuehne + Nagel." The first Invoice indicates that, on September 25, 2006, Broughton Pharmaceuticals, LLC, shipped and billed to Worldwide Medical Supply at an address in Dallas, Texas, "c/o Kuehne + Nagel, Inc. (Texas)," 416 6gm units of Carimune. The second Invoice, dated September 29, 2006, indicates that Worldwide Medical Supply shipped and billed to Reliance Pharmaceuticals, LLC, 28 6gm units of Carimune from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold 28 6gm vials of Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006.22 As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 34 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 29. Petitioner's Exhibit 29 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Reliance Pharmaceuticals, LLC. The Invoice indicates that, on October 27, 2006, Worldwide Medical Supply shipped and billed to Reliance Pharmaceuticals, LLC, 45 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold 33 6gm vials of Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 35 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 30. Petitioner's Exhibit 30 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Juan F. Lamas, Inc., M.D. The Invoice indicates that, on October 16, 2006, Worldwide Medical Supply shipped and billed to Dr. Lamas 7 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 7 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 36 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 31. Petitioner's Exhibit 31 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Integrated Health Center of America, Inc. The Invoice indicates that, on October 10, 2006, Worldwide Medical Supply shipped and billed to Integrated Health Center of America, Inc., 20 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 20 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 37 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 32. Petitioner's Exhibit 32 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Dr. Wohlfeiler Piperato & Associates. The Invoice indicates that, on September 28, 2006,, Worldwide Medical Supply shipped and billed to Dr. Wohlfeiler Piperato & Associates 12 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 12 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. The violations committed by Worldwide Medical Supply are substantial, are of long duration, and involve a significant number of transactions relating to the sale and purchase of prescription drugs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding that Worldwide Medical Supply and Pharmaceuticals, Inc., has committed 37 violations of Sections 499.001 through .081, Florida Statutes; imposing an administrative of $185,000.00; and revoking the license of Worldwide Medical Supply and Pharmaceuticals, Inc., to operate as a prescription drug wholesale distributor. DONE AND ENTERED this 1st day of May, 2008, in Tallahassee, Leon County, Florida. PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 2008.
The Issue Whether the permit held by the Respondents to operate a pharmacy in the State of Florida should be revoked.
Findings Of Fact A Complaint and Notice to Show Cause was filed against the Respondents, Ponce de Leon, Inc., doing business as Capel Drugstore, and Milagros Ferreras, Evina Valera and Julio C. Pascual, on December 27, 1978, alleging that the Respondents failed to maintain on a current basis a complete and accurate record of controlled substances controlled by Chapter 893, Florida Statutes, and that Respondents while holding a permit to operate a pharmacy in the State of Florida permitted the unlawful practice of pharmacy at Ponce de Leon, Inc., doing business as Capel Drugstore, located at 6661 SW 8th Street, Miami, Florida, by permitting a person not licensed or registered as a pharmacist or pharmacy intern in this state, to wit Milagros Ferreras, to fill and dispense a controlled substance with prescriptions and without prescriptions to various people on various dates. A hearing was requested by the Respondents on January 5, 1979. Notice of Hearing was sent to the parties on February 5, 1979. The first witness called on behalf of the Petitioner was V. K. Bell, Agent for the Florida Board of Pharmacy and a licensed pharmacist. Agent Bell testified that while at a local wholesaler in the Miami area he noticed that Ponce de Leon, Inc., doing business as Capel Drugstore, had been buying a large volume of Quaalude tablets, which is a Schedule II controlled substance that has been the subject of high abuse in the Dade County area. Thereupon, he proceeded to Capel Drugstore in order to review their records. He said that he found the prescription records did not account for proper disposition through lawful dispensing of a large volume of the Quaalude tablets that were purchased and documented by the invoices. He testified that he talked with the pharmacist, Francisco DeQueuedo, and Respondent, Milagros Ferreras, one of the owners of Ponce de Leon, Inc., doing business as Capel Drugstore, and the President of the corporation. Mr. Bell advised Ms. Ferreras and Mr. DeQueuedo of their right to remain silent and not answer questions, that anything they said could be used against them, and that they had the right to have an attorney present if they desired. He then questioned the Respondent, Ms. Ferreras, and Mr. DeQueuedo. Ms. Ferreras stated that she had bought a bad business and found that she was having financial difficulties with the business, and she started to sell Quaalude tablets for 50 cents each to some 15 or 20 different people without prescriptions. Mr. Bell testified that Ms. Ferreras then stated that she had made sales of the controlled substance without prescriptions. Agent Bell testified that the pharmacist, Mr. DeQueuedo, admitted to him that he knew that Respondent Ferreras was making these sales, and that she would from time to time bring him prescriptions which he would sign, indicating on the prescriptions that he did in fact fill them, although he had not, and then put them on file at the pharmacy in an attempt to cover up some of the shortages due to the unlawful sales of the Quaalude tablets. After this conversation Mr. Bell testified that he proceeded to do a drug accountability audit. Mr. Bell said that even with giving the pharmacy credit for those prescriptions which were signed by the pharmacist, he could not account for 27,440 Quaalude tablets. The drug accountability report was identified by Mr. Bell and was introduced into evidence as Petitioner's Exhibit number 1. Agent Bell identified a series of documents which constituted various invoices and prescriptions utilized in the drug accountability audit as well as a perpetual inventory, which the pharmacist had run. These documents were marked as Petitioner's Composite Exhibit number 2 and were introduced into evidence. Thereafter, Mr. Bell identified a document which he noted was a copy of a receipt which he gave to the pharmacist noting the various invoices contained in Composite Exhibit number 2, which were removed from the pharmacy. This receipt was marked as Petitioner's Exhibit number 3 and was introduced into evidence. Mr. Bell verified a document which was the receipt that he gave to the pharmacist, Mr. DeQueuedo, when he removed the original prescriptions from the pharmacy file, which prescriptions were also part of the Composite Exhibit number 2. This receipt was marked as Petitioner's Exhibit number 4 and was introduced into evidence. Mr. Bell then identified another document, which was marked for identification as Petitioner's Exhibit number 5, and Agent Bell testified that this was a statement made to him in his conversations with the Respondent, Ms. Ferreras, and the pharmacist, Mr. DeQueuedo, which he reduced to writing and which both the pharmacist and Respondent Ferreras signed. Exhibit number 5 substantiates the testimony which was given by Mr. Bell in respect to the unlawful dispensing of controlled substances by Ms. Ferreras, falsification of the prescription records by Mr. DeQueuedo, and the shortages found in the drug accountability audit. Robert S. Pacitti, a police officer with the Dade County Public Safety Department, was called as a witness for Petitioner. Officer Pacitti stated that he had received a telephone call from Agent Bell with reference to Ms. Ferreras and Mr. DeQueuedo. Officer Pacitti testified that he went to the Capel Drugstore and advised both the Respondent Ferreras and Mr. DeQueuedo, the pharmacist, of their Miranda rights. Officer Pacitti obtained a verbal statement from Mr. DeQueuedo that he was aware of the fact that Ms. Ferreras was dispensing Quaalude tablets. Officer Pacitti then took Respondent Ferreras down to the Dade County Public Safety Department, where she made a statement taken by a stenographer in Officer Pacitti's presence confirming the testimony of Agent Bell and Officer Pacitti. Respondent Ferreras stated that the individuals to whom she had sold Quaalude tablets promised to bring her prescriptions for them at a later date but did not do so. Officer Pacitti identified a document marked as Petitioner's Exhibit number 6 as a copy of the statement of Respondent Milagros Ferreras, and thereafter this statement was introduced into evidence as Petitioner's Exhibit number 6. Officer Pacitti testified that even though the large quantity of Quaalude tablets was being sold for 50 cents each, the street value of these tablets was between $3.00 and $5.00 per tablet. The secretary of Jack R. Blumenfeld, the attorney of record for Respondent Milagros Ferreras, presented photocopies of letters from two physicians indicating that Ms. Ferreras had been in the hospital and then had been advised to restrict her physical activity and avoid emotional strain. These letters were marked and filed by the Hearing Officer. After listening to the testimony of Agent Bell and Officer Pacitti, and after examining the exhibits introduced into evidence, it is the finding of this Hearing Officer that the Respondent, Milagros Ferreras, did permit the improper keeping of records at Ponce de Leon, Inc., doing business as Capel Drugstore, and that complete and accurate records of controlled substances were not maintained on a current basis. It is the further finding of this Hearing Officer that the Respondent, Milagros Ferreras, allowed the pharmacist, Francisco DeQueuedo, to file false information in the files of Ponce de Leon, Inc., doing business as Capel Drugstore, by placing prescriptions in the files which were not actually dispensed by the pharmacist to the individuals named thereon. The Hearing Officer finds that the Respondent, Milagros Ferreras, President of the corporation doing business as Capel Drugstore, improperly dispensed and sold Quaalude tablets to individuals with prescriptions and to individuals without prescriptions.
Recommendation Revoke the permit to operate a pharmacy in the State of Florida issued to Ponce de Leon, Inc., doing business as Capel Drugstore, and Milagros Ferreras, Evina Valera and Julio C. Pascual. DONE and ORDERED this 15th day of March, 1979, in Tallahassee, Leon County, Florida. DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Jack R. Blumenfeld, Esquire 619 NW 12th Avenue Miami, Florida 33136 Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 H. F. Bevis Executive Secretary Florida Board of Pharmacy Post Office Box 3355 Tallahassee, Florida 32302
The Issue The issue is whether Petitioner is entitled to a permit as a prescription drug wholesale distributor.
Findings Of Fact On August 29, 2007, Petitioner filed with Respondent an application for a permit as a prescription drug wholesaler establishment (Application). Pursuant to a change in the law effective July 1, 2008, this permit is now for a prescription drug wholesale distributor. The Application lists Boris Rios as the sole owner of Petitioner and its president and manager. The Application lists Alexander Valdes as the next highest-ranking employee with a title of certified designated representative (CDR). The Application requires Petitioner to list all persons who meet the following descriptions of affiliates: a) "a director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant"; b) "a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant"; c) "a person who has filed or is required to file a personal information statement pursuant to s. 499.012(4), F.S., or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(3), F.S."; d) "the five largest natural shareholders who own at least 5 percent of the permittee or applicant . . ."; and e) "shareholder[s] owning 5% or more of the applicant." In response to this item, the Application states that Mr. Rios meets the criteria set forth in paragraphs a) through e), and Mr. Valdes meets the criteria set forth in paragraph b). Attached to the Application are Personal Information Statements for Mr. Rios and Mr. Valdes. Mr. Rios's Personal Information Statement discloses his employment, from July 2003 to July 2007, as a "sales mgr" with Worldwide Medical Supplies and Pharmaceuticals, Inc. (Worldwide). His statement includes a resume that states he was a "sales executive" for Worldwide from July 2003 to February 2004, a "purchasing/deliver[ies] manager" for Worldwide from February 2004 to May 2005, and a "sales manager" for Worldwide from May 2005 to July 2007. As sales manager, Mr. Rios stated that he "[o]ver looked all sales transactions for all sales reps (7 man sales force). Buy establishing sales strategies and product promotions to help increase our sales and profit margins. And keeping sales force motivated and inspired by creating incentives to reach goals." Mr. Rios's attached resume shows that he had been a sales manager for another pharmaceutical manufacturer from January 2001 to July 2003. Mr. Rios's statement also answers in the negative a question asking whether he, "or a company for which you were an owner, officer, director, or manager, has been fined or disciplined by a regulatory agency in any state (including Florida) for any offense that would constitute a violation of Chapter 499, Florida Statutes?" However, his statement answers in the affirmative a question asking whether he, "or a company for which you were an owner, officer, director, or manager, ever held a permit issued under Chapter 499, Florida Statutes, in a different name than [Petitioner's name]?" However, on a mostly blank page entitled, Additional Information," Mr. Rios handwrote that he was employed by Worldwide from July 2003 to July 2007 as the sales manager of seven salespersons from May 2005 to July 2007, as the purchasing manager from February 2004 to May 2005, and as a sales representative from July 2003 to February 2004. Mr. Valdes's Personal Information Statement discloses his employment with Worldwide from 2003 to present as a "sales mgr" and "D Rep," meaning certified designated representative. Inserted in the Application is a letter dated May 30, 2008, from Mr. Valdes to Rebecca Burnett, an employee of Respondent, stating that he was "hereby submit[ting] my resignation from Worldwide . . . effective May 30, 2008 " Mr. Valdes's Personal Information Statement contains a long typewritten statement that says he was employed at Worldwide since 2003 in "various positions," starting as a sales person, then a sales manager, and finally a CDR, following his preparing for and passing the certification test. At about the same time, a newer Worldwide employee, Rick Nielsen, also took the CDR test, passed, and became a CDR for Worldwide, working a different shift from Mr. Valdes. Mr. Valdes stated that he often ordered Worldwide not to accept or to return a product due to product-safety issues, and he helped state inspectors in their investigations concerning these matters. However, on the Personal Information Statement itself, Mr. Valdes answered in the negative a question whether he or any company for which he had been a manager had been fined or disciplined by a regulatory agency. By letter dated September 8, 2008 (Denial Letter), Respondent advised Petitioner of its intent to deny the application. Among the reasons cited for denial are that Petitioner listed Mr. Valdes as its CDR. The Denial Letter states that, in Final Order Number 08-1216, Respondent found 37 violations of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, and revoked the permit of Worldwide Medical Supplies and Pharmaceuticals, Inc. (Worldwide), to operate as a prescription drug wholesale distributor. According to the Denial Letter, Mr. Valdes was Worldwide's CDR from August 2005 to May 2008 and sales manager from April 2003 to May 2008; he is also the son of the president and owner of Worldwide, Miriam Gonzalez. The Denial Letter states that Mr. Valdes was listed on the Application as a key employee of Worldwide and did not submit to Respondent his resignation as Worldwide's CDR until May 30, 2008. The Denial Letter asserts that, on four occasions from July 18 to November 8, 2005, Mr. Valdes received and authenticated a pedigree that was not authenticated, so that Worldwide failed to keep the required records of prescription drug transactions. The Denial Letter states that, on six occasions between October 17 and 31, 2005, Mr. Valdes or another Worldwide employee falsely represented under Mr. Valdes's signature that a pedigree had been presented to Worldwide and authenticated by Mr. Valdes, but Worldwide had not received the complete and accurate pedigrees and had not maintained them. The Denial Letter states that receipt of the drugs without a complete or accurate pedigree caused the drugs to be deemed adulterated. The Denial Letter states that, on August 16 and September 23, 2004; and September 25, October 16, and October 27, 2006, Worldwide purchased a prescription drug from an unlicensed manufacturer or wholesaler. The letter states that this activity constituted the purchase of contraband in commerce and was detrimental to the public health. The Denial Letter asserts that Mr. Rios was an affiliated party of Worldwide at all material times. The Denial Letter states that Mr. Rios owns Petitioner and provides financial support and assistance to Petitioner, so he is an affiliate of Petitioner. The Denial Letter states that Respondent found that Petitioner was not entitled to licensure under Section 499.012(4)(d)9, Florida Statutes. The Denial Letter states that, pursuant to Section 499.012(10)(b), Florida Statutes, Respondent may deny an application if it finds that the managers, officers, or directors of the applicant or an affiliate of the applicant are incompetent or untrustworthy. Based on the facts set forth above, Respondent finds Mr. Valdes, an affiliate, incompetent or untrustworthy. The Denial Letter states that, pursuant to Section 499.012(10)(g), Florida Statutes, Respondent may deny an application if it finds that the applicant is affiliated, directly or indirectly through ownership, control or other business relations, with any person or persons whose business operations are or have been detrimental to the public health. Based on the facts set forth above, Respondent finds Mr. Valdes is an affiliate whose prior business operations are or have been detrimental to the public health The Denial Letter states that, pursuant to Section 499.012(10)(r), Florida Statutes, Respondent may deny an application if it finds that the applicant or any affiliate has failed to comply with the requirements for manufacturing or distributing prescription drugs under Chapter 499, Florida Statutes. The Denial Letter asserts that Section 499.003(3), Florida Statutes, defines an affiliate to be a person who has filed or is required to file a personal information statement or a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant. The Denial Letter states that Respondent finds that Mr. Valdes, while employed at Worldwide, failed to comply with the laws related to the distribution of prescription drugs while having a duty to be actively involved in and aware of the actual daily operation of the company. The Denial Letter states that Mr. Valdes had a duty to be actively involved in and aware of the actual daily operations of the company. The Denial Letter states that, while Mr. Valdes was CDR for Worldwide, the company purchased prescription drugs from an unauthorized source, in violation of Section 499.005(16), Florida Statutes; failed to maintain records of prescription drug distributions as required by Florida Administrative Code Rule 64F-12.012(6) and (10), in violation of Section 499.005(18), Florida Statutes; accepted or maintained incomplete or nonexistent pedigrees and sold drugs to unlicensed persons, thus violating the adulterated-drug provisions of Section 499.005(1), (2), and (4), Florida Statutes. The Denial Letter states that, pursuant to Section 499.012(10)(m), Florida Statutes, Respondent may deny an application if the applicant or affiliate receives, directly or indirectly, financial support and assistance from a person who was an affiliate of a permittee whose permit was subject to discipline or suspended or revoked. The Denial Letter states that Petitioner receives financial support and assistance from Mr. Rios, who was an affiliate of Worldwide and is an affiliate of Petitioner. The Denial Letter states that, at all material times, Worldwide engaged in business operations that were detrimental to the public health by purchasing adulterated prescription drugs and by adulterating prescription drugs. Worldwide filed a renewal application on May 17, 2007, for a renewal term from July 1, 2007, to June 30, 2008. The renewal application lists Ms. Gonzalez as the company's sole shareholder and manager. The only persons listed among the next four highest-ranking employees are Mr. Valdes, who is listed as the CDR and "Longistic [sic] Manager" and Mr. Rios, who is listed as "Purch/Sales Director." Each man is reported as "a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee " Sometime in 2007, Respondent commenced a disciplinary proceeding against Worldwide. In its Second Amended Administrative Complaint dated August 24, 2007, Respondent alleged that Worldwide violated Sections 499.001 through 499.081, Florida Statutes, based on documents that it had prepared during 2004-06. A formal hearing took place on February 11 and 12, 2008, and Administrative Law Judge Patricia M. Hart entered a Recommended Order on May 1, 2008, which was adopted in its entirety by Final Order entered October 12, 2008 (FO). The Final Order finds Worldwide guilty of 37 violations of Chapter 499, Florida Statutes, imposes administrative fines of $185,000, and revokes Worldwide's permit as a Prescription Drug Wholesaler. The Final Order (FO) was never appealed. The FO finds multiple acts and omissions attributable to Worldwide in the handling of prescription drugs shipped to it or, in some cases, purchased by it. Concerning incomplete and thus fraudulent authentications of pedigree papers, these acts and omissions ranged from February to April, June to September, and December 2004; and April to November 2005. Only seven of these violations occurred in 2004; the rest were in 2005. Concerning purchases from unlawful persons, of which there were a dozen, these acts and omissions took place in August 2004, December 2004, June 2005 (two), April 2006, September 2006 (two purchases from Kuehne & Nagel) October 2006 (four purchases from Kuehne & Nagel), and March 2007. Mr. Valdes is named in connection with six of the unlawful transactions. For October 2005 (except for one transaction in November 2005, as indicated), the FO found a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 35 6GM vials of Carimune was incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of seven 10ML units of Baygam as incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 15 12GM vials of Carimune as incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 100 2ML units of Baygam was incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 100 units of Gammar P as incomplete and thus "false" (November 2005), and one pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of one 2ML unit of Baygam SDV and three 10CP units of Tamiflu 75MG was incomplete and thus "fraudulent." In his responses to requests for admission in this case, Mr. Valdes admits that he received and authenticated the pedigree paper, on October 10, 2005, for Carimune; the pedigree paper, on October 18, 2005, for Baygam; the pedigree paper, on July 18, 2005, for Baygam; and the pedigree paper, on November 8, 2005, for Gammar P. Worldwide never employed many employees, perhaps never more than 8-10. Ms. Gonzalez owned the company, but reduced her interest to 51 percent from February 2004 to December 31, 2006, during which period Mr. Nielsen owned 49 percent. However, Mr. Nielsen terminated his employment with Worldwide on December 31, 2006, and evidently relinquished his interest in the company at that time. Upon initial employment, Mr. Nielsen occupied a position in which he supervised the purchasing manager, Mr. Rios, who, even though called a manager, supervised no one. At that time, Mr. Rios was lower-ranking than Ms. Gonzalez, Mr. Nielsen, Mr. Valdes, and possibly another employee. At some point, Mr. Nielsen was designated a CDR for Worldwide, and he remained a CDR for Worldwide until he left employment with the company. Prior to that, Mr. Gonzalez had served as the CDR for Worldwide. Mr. Valdes also served as a CDR for Worldwide. Based on his responses to requests for admission, Mr. Valdes started as CDR for Worldwide in August 2005, so he and Mr. Nielsen were both CDRs for Worldwide at the same time. Mr. Valdes served until the end of July or early August 2006, when, dissatisfied with his employment situation, he terminated his employment. Mr. Valdes did not return until early January 2007 when his mother needed him to serve as CDR again because Mr. Nielsen had left, and no one remaining with Worldwide could pass the test to become a CDR. Mr. Valdes produced testimonials from various persons, such as a former drug agent supervisor of Respondent and current investigators of Medicaid fraud, who commend him for assisting in combating fraud in the wholesale pharmaceutical industry. However, at the hearing, Mr. Valdes never explained how he was not at fault or responsible for the violations in which the paperwork bore his stamp or other violations taking place, particularly while he was CDR. Mr. Valdes was sales manager during the 2004 violations and a CDR during all of the bad-pedigree transactions from August to December 2005, as well as one bad-purchase transaction in April 2006. He had sizable responsibilities during a timeframe that many violations were taking place at Worldwide, and, despite the three commendations and candid demeanor at the hearing, does not appear to have done a good job discharging these important duties. As confirmed by Ms. Gonzalez, Mr. Rios was the sales manager from May 2005 to July 2007, and he had supervisory authority over a sales staff that, at most, numbered seven persons. Mr. Rios could hire and fire salespersons, but he had no contact with the prescription drugs. From February 2004 to May 2005, Mr. Rios was purchasing manager, but worked under the supervision of Mr. Nielsen and lacked any managerial duties.
Recommendation It is RECOMMENDED that the Department of Health enter a final order denying the application for a permit as a prescription drug wholesale distributor until Mr. Rios substitutes a qualified CDR for Mr. Valdes--a condition that the Department of Health should allow Mr. Valdes a reasonable time to satisfy. If Mr. Rios cannot submit the name of a qualified CDR within such time, the final order should provide for the denial of the application without prejudice to refiling at a later date with a qualified CDR. DONE AND ENTERED this 9th day of March, 2009, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of March, 2009. COPIES FURNISHED: Alexander Valdes, Qualified Representative 14052 Southwest 80th Street Miami, Florida 33183 Gary L. Asbell, Esquire Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Rebecca Poston, R.Ph., Executive Director Drugs, Devices, and Cosmetics Program Department of Health 4052 Bald Cypress Way, BIN C04 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701
The Issue The central issue in this case is whether the jeopardy assessment filed by the Department against Petitioner should be affirmed.
Findings Of Fact Based upon the testimony of the witnesses and the documentary evidence received at the hearing, I make the following findings of fact: The petitioner, Albert Charles Harris, is also known as Bert or Albert Harris. During the month of July, 1986, Petitioner was employed to copilot a flight from Florida to Colombia and to return to an airstrip located near Lakeland, Florida. The private flight was arranged for the purpose of bringing 460 kilograms of cocaine into the State of Florida. The airplane was owned by a drug importation organization that arranged transportation for drugs from Colombia to the United States. Cocaine is a controlled substance enumerated in Section 893.03, Florida Statutes. Richard Bahmann was employed as the pilot for the July flight in which Petitioner participated. Frank Bahmann was also employed to fly a cover plane for the aircraft piloted by Richard Bahmann and Petitioner. The "mission" of the Bahmanns and Petitioner was to assure the safe delivery of cocaine from its owners in Colombia to its owners in Florida. Petitioner did not own the substance transported. Petitioner's employers did not own the substance transported. Petitioner and the others were to be paid based upon the volume of cocaine they were able to transport to Florida. Petitioner participated in the transportation of 460 kilograms of cocaine from Colombia to Florida in July, 1986. The street value of cocaine in the Miami area in July, 1986 was $35,000/kilo. The amounts owed to the Bahmanns and Petitioner for their participation in the transportation was $330,000. There is no evidence as to what amount Petitioner's employers were paid for their part in the transportation.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the tax warrant and jeopardy assessment filed against Albert Charles Harris be affirmed. DONE and RECOMMENDED this 30th day of August, 1988, in Tallahassee, Florida. JOYOUS D. PARRISH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of August, 1988. COPIES FURNISHED: Douglas Stratton 505 Lincoln Road Miami Beach, Florida 33139 William Watson and Jeffrey Dikman Department of Legal Affairs Tax Section, Capitol Building Tallahassee, Florida 32399-1050 Sam D. Alexander Executive Director 102 Carlton Building Tallahassee, Florida 32399-0100 William D. Townsend General Counsel 104 Carlton Building Tallahassee, Florida 32399-0100 =================================================================