The Issue These two consolidated cases are both license discipline cases in which the Petitioner seeks to take disciplinary action against an individual pharmacist and a community pharmacy for various statutory violations which are alleged in separate Administrative Complaints. At the hearing the Respondents admitted some of the allegations of the Administrative Complaints. Thereafter both the Petitioner and the Respondents presented testimony and exhibits. At the conclusion of the hearing, the parties decided not to order a transcript of the hearing. The parties were allowed until November 25, 1987, within which to file their proposed recommended orders. Both parties filed timely proposed recommended orders containing proposed findings of fact and conclusions of law. Specific rulings on all proposed findings of fact submitted by the parties are contained in the Appendix which is attached to and incorpor- ated into this recommended order.
Findings Of Fact Based on the stipulations and admissions of the parties, on the exhibits received in evidence, and on the testimony of the witnesses at hearing, I make the following findings of fact. Findings based on stipulations and admissions Respondent Gus Goldstein is, and has been at all times material hereto, a pharmacist in the State of Florida, having been issued license number PS 0005354. Respondent's last known address is 110 East Adams Street, Jacksonville, Florida 32202. Respondent Gus Goldstein is and has been at all times material hereto, designated as the prescription department manager of Center Pharmacy, a community pharmacy in the State of Florida, having been issued permit number PH 0002430 and located at 110 East Adams Street, Jacksonville, Florida 32202. On or about December 23, 1986, a pharmacy medication audit was conducted at Center Pharmacy for the period between approximately June 1, 1986, and December 23, 1986. That audit revealed that the Respondents' records for the period of June 1, 1986, through December 23, 1986, failed to account for the following: Description Bought Dispensed Unaccounted For Tylenol #3 w/codeine 4200 2102 2098 Tylenol #4 w/codeine 5000 2600 2400 Fiorinal #3 1900 1810 90 Valium 5mg. 900 380 520 (Diazepam 5mg.) Valium 10mg. 2200 1600 600 (Diazepam 10mg.) Tylenol #3 with Codeine and APAP with Codeine 30mg are "medicinal drugs" as defined in Section 465.003(7), Florida Statutes, which contain codeine, a controlled substance, in such quantity that they are included in Schedule III of Chapter 893, Florida Statutes. Tylenol #4 with Codeine and APAP with Codeine 60mg are "medicinal drugs" as defined in Section 465.003(7), Florida Statutes, which contain codeine, a controlled substance, in such quantity that they are included in Schedule III of Chapter 893, Florida Statutes. Fiorinal #3 with Codeine is a "medicinal drug" as defined in Section 465.003(7), Florida Statutes, which contains codeine, a controlled substance, in such quantity as to be included in Schedule III of Chapter 893, Florida Statutes. Valium is a brand name of a "medicinal drug" as defined in Section 465.003(7), Florida Statutes, which contains diazepam, a controlled substance, which is listed in Schedule IV of Chapter 893, Florida Statutes. Tylenol #3 with Codeine is a brand name of a "medicinal drug" as defined in Section 465.003(7), Florida Statutes, which contains a sufficient quantity of codeine, a controlled substance, to be listed in Schedule III of Chapter 893, Florida Statutes. Respondent Center Pharmacy is, and has been at all times material hereto, the permittee of Center Pharmacy, a community pharmacy, located in the State of Florida at 110 East Adams Street, Jacksonville, Florida 32202, having been issued permit number PH 0002430. Respondent Center Pharmacy has, and had at all times material hereto, Gus Goldstein, a pharmacist in the State of Florida having been issued license number PS 0005354, designated as its prescription department manager. Respondent Center Pharmacy is, and has been at all times material hereto, registered with the United States Drug Enforcement Administration. Respondent has been issued certificate of Registration Number AC 5050719. Findings based on the evidence adduced at the hearing On or about October 27, 1986, Respondent Gus Goldstein created a record which purported to be a telephone prescription (#116-450) for F.W. for Tylenol #3 with Codeine, purportedly prescribed by Dr. Samuel J. Alford, M.D. The prescription (#116-450) for F.W. for Tylenol #3 with Codeine was not authorized by Dr. Samuel J. Alford, M.D. Respondent Gus Goldstein dispensed Tylenol #3 with Codeine to F.W. without first being furnished with a prescription. Respondent Gus Goldstein knew that the purported telephone prescription (#116-450) for F.W. was a false record. During the process of dispensing drugs, normally there will be small errors in the counting of the drugs. These small errors will result in shortages in the drug inventory which cannot be accounted for. If proper record-keeping and dispensing practices are followed, the shortages resulting from these small errors normally will be in the range of from 1 percent to 2 percent of drugs dispensed; certainly no more than 3 percent of drugs dispensed. Shortages greater than 3 percent of drugs dispensed are indicative of a failure to follow proper record- keeping and dispensing practices.
Recommendation Based on all of the foregoing, I recommend that the Board of Pharmacy enter a final order in these consolidated cases to the following effect: Finding the Respondent Gus Goldstein guilty of the violations charged in Counts One, Two, and Three of the Administrative Complaint in Case Number 87-3151; Dismissing the violation charged against Gus Goldstein in Count Four of the Administrative Complaint in Case Number 87- 3151; Imposing an administrative fine against Gus Goldstein in the amount of five hundred dollars ($500.00) for each of the violations of which he is found guilty; i.e., administrative fines totaling fifteen hundred dollars ($1,500.00); Revoking Gus Goldstein's license to practice pharmacy; Finding the Respondent Center Pharmacy guilty of the violation charged in the Administrative Complaint in Case Number 87-3913; Imposing an administrative fine against Respondent Center Pharmacy in the amount of five hundred dollars ($500.00); and Revoking the permit of Center Pharmacy. DONE AND ENTERED this 9th day of December, 1987, at Tallahassee, Florida. MICHAEL M. PARRISH, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of December, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NOS. 87-3151 AND 87-3913 The following are my specific rulings on all of the findings of fact proposed by the parties. In the rulings which follow I have rejected much of what both parties offered as proposed findings of fact due to the form of the proposals. The most frequent defect in the form is the commencement of a statement with the words "So-and-so testified," followed by a summary of the testimony. Testimony is, of course, one of the raw materials from which findings of fact are made, but (with the exception of perjury trials) summarization or quotation of testimony is hardly ever an appropriate finding of fact. Rather than summarize or quote the testimony, the parties should refine from the testimony the essential material and relevant facts and submit that refined product as their proposed findings. Findings proposed by Petitioner: Paragraph 1: Accepted. Paragraph 2: Rejected for the following reasons: First, it is a summary of testimony, rather than proposed findings of fact; second, parts of it are inconsistent with the greater weight of the evidence; and, third, most of it consists of subordinate, irrelevant, or unnecessary details. First unnumbered paragraph following Par. 2: Rejected for the first and third reasons noted immediately above. Second unnumbered paragraph following Par. 2: Rejected as a commentary on the evidence rather than a proposed finding of fact. Further, the portion following the comma is inconsistent with the greater weight of the evidence. Paragraph 3: Rejected for the same reasons as rejection of Paragraph 2. Unnumbered paragraph following Par. 3: Rejected for the following reasons: First it is a summary of the testimony, rather than proposed findings of fact, and, second, most of it consists of subordinate, irrelevant, or unnecessary details. Paragraph 4: Rejected as constituting a summary of testimony rather than proposed findings of fact. Last unnumbered paragraph: Rejected as constituting argument or conclusions of law rather than proposed findings of fact. Findings proposed by Respondents: Paragraph 1: Accepted. Paragraph 2: Covered in part by stipulated facts. Most of the remainder rejected as subordinate or unnecessary details or as not supported by competent substantial evidence. First unnumbered paragraph following Par. 2: First three sentences rejected as summary of testimony rather than proposed findings of fact. Second and third sentences also rejected as not being supported by persuasive competent substantial evidence. The remainder of this paragraph is rejected as consisting of subordinate, irrelevant, or unnecessary details. Second unnumbered paragraph following Par 2: Rejected as constituting a summary of testimony rather than proposed findings of fact and because it constitutes subordinate, irrelevant, or unnecessary details. Paragraph 3: Rejected as irrelevant and as not supported by competent substantial evidence. First unnumbered paragraph following Par. 3: Rejected as constituting argument or legal conclusions rather than proposed findings of fact. Second unnumbered paragraph following Par. 3: Rejected as constituting argument or legal conclusions rather than proposed findings of fact. Further, portions of the arguments and conclusions are based on inferences which are not warranted by the evidence. Paragraph 4: Rejected as summary of testimony rather than proposed findings of fact and as constituting subordinate and unnecessary details. First unnumbered paragraph following Par. 4: Rejected for the same reasons as rejection of Paragraph 4. Second unnumbered paragraph following Par. 4: First sentence rejected as constituting argument rather than proposed findings of fact. Second sentence accepted in substance. Last sentence accepted. COPIES FURNISHED: Mr. Rod Presnell Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Dept. of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Michael A. Atter, Esquire 333-1 East Monroe Street Jacksonville, Florida 32202
The Issue Whether Respondents committed the offenses described in the Amended Administrative Complaints? If so, what disciplinary action should be taken against them?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Department is a state government licensing and regulatory agency. Haro is now, and has been since April of 1980, a licensed pharmacist in the State of Florida. He holds license number PS 0017949. Rome is now, and has been since February of 1978, the holder of permit number PH 0007008, which authorizes it to operate La Generosa Pharmacy (hereinafter referred to as "La Generosa" or the "Pharmacy") as a community pharmacy in Dade County, Florida. At no time in the past has Rome, as the holder of permit number PH 0007008, been disciplined by the Board of Pharmacy. For the past eighteen years, Roger Diaz has been Rome's sole corporate shareholder and the owner of the Pharmacy. Haro was employed as the prescription department manager of La Generosa and its only pharmacist from approximately October 16, 1990, until some time after the dates of the alleged violations in these consolidated cases. He worked full-time (40 hours a week). Harold Gluck is an investigator with the Department. On December 4, 1990, at approximately 2:00 p.m., Gluck attempted to conduct a routine annual inspection of the Pharmacy, which had last been inspected 13 months previous. Upon entering the Pharmacy, Gluck found that there was no pharmacist on duty. Diaz was there, however. The lights in the prescription department were off and a "closed" sign was posted. A door to the prescription department, although closed, was unlocked. Gluck opened the door, walked in and turned on the lights. He saw Haro's license hanging on the wall. On the counter, he observed prescription vials containing pharmaceuticals. It appeared to Gluck that someone had been in the process of filling these vials and had been interrupted before completing the task. Gluck inquired of Diaz as to the whereabouts of the pharmacist. Diaz, in response to Gluck's inquiry, indicated that Haro had taken the day off to tend to some personal business. Gluck then asked Diaz who was filling the prescription vials "if the pharmacist isn't here." Diaz responded, "I don't know." Gluck continued his inspection. On the shelves in the prescription department he discovered a large number of expired drugs, some of which had expiration dates that predated the last inspection of the Pharmacy that had been conducted 13 months previous. None of the drugs that had been outdated for more than 13 months had been on the shelves during the last inspection. Gluck's inspection on December 4, 1990, also revealed prescription drugs in the Pharmacy outside of the prescription department. After cursorily examining the premises, Gluck left the Pharmacy. He told Diaz that he would be paying a return visit the following day to speak with Haro and to conduct a more thorough inspection. He warned Diaz not to enter the prescription department and asked him to lock the doors leading into that area of the Pharmacy. Diaz indicated that he would comply. Later that day at around 5:00 p.m., following Glucks's departure, Haro went to the Pharmacy "to observe how [it] was functioning." As he had promised, Gluck returned to the Pharmacy on December 5, 1990. He was accompanied by another of the Department's investigators, as well as three HRS drug inspectors. The prescription department was closed and Haro was nowhere to be seen. Diaz was present and Gluck asked him whether Haro had reported to work that day. Diaz told Gluck that Haro had again taken the day off to take care of a personal matter. Gluck tried to open the door he had used the day before to enter the prescription department, but it was locked and Diaz claimed not to know where to find a key to unlock the door. With Diaz's permission, Gluck and one of the HRS drug inspectors, Cesar Arias, walked into a back storage room that was adjacent the prescription department (hereinafter referred to as the "storage room") to ascertain if there was another entrance to the prescription department. There they spotted an unlocked door that led to the prescription department. After obtaining Diaz's authorization, they pushed the door open. In so doing, they moved an appliance, that had been behind the door, out of the way. They then walked into the prescription department. While in the prescription department, Gluck and Arias noticed a doorway that was covered, but not completely, by a piece of paneling. They removed the piece of paneling and then walked into the room (hereinafter referred to as the "hidden room"). The December 5, 1990, inspection of the Pharmacy revealed the following: Of the approximately 2,000 containers on the shelves in the prescription department, approximately 200 contained expired pharmaceuticals. Expired pharmaceuticals that Haro had removed from the shelves were in boxes in the storage room. There were containers of pharmaceuticals on the shelves in the prescription department that had labels which understated the quantity of pharmaceuticals in the container. There were containers of pharmaceuticals on the shelves in the prescription department that had labels which inaccurately described the strength of the pharmaceuticals in the container. On the shelves in the prescription department were containers of pharmaceuticals to which samples, that had been removed from their original packaging, had been added. According to records in the prescription department, prescriptions had been filled on December 4, 1990. Prescriptions for controlled substances that had been filled by Haro within the past month were lacking the date the prescription had been filled, the patient's name and address, the dispensing pharmacist's initials and/or the prescribing physician's DEA registration number. A bottle of Uropol, which Haro had for his own personal use, was in the prescription department. Uropol is a foreign drug that has not been approved for use in the United States. Vials containing prescription drugs that had been dispensed by Jorge's Pharmacy, another local pharmacy, were in the hidden room, as well as in bags, ready for customer pick-up, in the storage area. These vials had labels prepared by Jorge's Pharmacy. References to Jorge's Pharmacy's appear- ing on the labels, however, had been "whited out" so as to make it appear that Jorge's Pharmacy's was not the dispensing pharmacy. Furthermore, some of these vials contained lesser quantities of drugs than indicated on their labels. As Diaz candidly admitted to the inspection team during the inspection, Jorge's Pharmacy had filled these prescriptions pursuant to an arrangement that it had with Diaz. These were Medicaid prescriptions. Jorge's Pharmacy was a participant in the Medicaid program. La Generosa had been suspended from the program and therefore, unlike Jorge's Pharmacy, was not able to fill Medicaid prescriptions. Wanting to keep his Medicaid customers, Diaz had devised and implemented a scheme that allowed him to continue to do business with these customers. He had his Medicaid customers present their prescriptions to him or Blanca Uzman, one of his subordinates, at a counter outside of the store's prescription department (hereinafter referred to as the "outside counter"). The prescriptions were thereafter taken to Jorge's Pharmacy, where they were filled. The labeled vials containing the dispensed drugs were then delivered to La Generosa, where they were ultimately picked up, at the outside counter, but not before an effort had been made to obliterate, by using white-out, all references to Jorge's Pharmacy appearing on the vials' labels. Although Haro knew of this scheme, he was in no way involved in it. A prescription balance and prescription weights were in the hidden room. Neither a copy of the laws and rules governing the practice of pharmacy, a negative formulary, nor a biennial inventory record of controlled substances were located by the inspection team, although these items were on the premises. Following the December 5, 1990, inspection of La Generosa, administrative charges were brought against both Haro and Rome. Subsequent inspections of the Pharmacy established that "everything was in proper order."
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board, with respect to Case No. 91-6297, enter a final order finding Haro guilty of the violations alleged in Counts I, III, VIII, VIV, and XV of the Amended Complaint/Haro and disciplining him for having committed these violations by suspending his license for a period of 60 days, placing him on probation for a period of one year following the end of his suspension subject to such terms as the Board may specify, and requiring him to pay an administrative fine in the amount of $1,500.00, and, with respect to Case No. 92-0227, enter a final order finding Rome guilty of the violations alleged in Counts I, V, VII, IX, and XI of the Amended Complaint/Rome and disciplining it for having committed these violations by suspending its permit to operate La Generosa as a community pharmacy for a period of two years, placing it on probation for a period of one year following the end of its suspension subject to such terms as the Board may specify, and requiring it to pay an administrative fine in the amount of $2,500.00. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 27th day of September, 1993. STUART M. LERNER 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 27th day of September, 1993.
Findings Of Fact Based upon the entire record, the following findings of fact are determined: Background At all times relevant hereto, respondent, Obi E. Enemchukwu, was licensed as a pharmacist having been issued license number PS 0023082 by petitioner, Department of Professional Regulation, Board of Pharmacy (Board). He has been licensed as a pharmacist since 1981. There is no evidence that respondent has been the subject of disciplinary action prior to this occasion. When the events herein occurred, respondent was the designated prescription department manager and pharmacy permittee for Oviedo Drug World (ODW), a community pharmacy located at 83 Geneva Drive, Oviedo, Florida. A community pharmacy is not defined by statute or rule. However, a Board witness described such a pharmacy as being a drug store that serves customers in an outpatient or ambulatory setting. As the prescription manager for the pharmacy, respondent was responsible for maintaining all drug records, providing for the security of the prescription department, and following all other rules governing the practice of pharmacy. Count I This count alleges that respondent violated a Board rule by virtue of the ODW prescription department being "opened at 9:00 a.m. with a pharmacy technician only on duty with no pharmacist present until approximately 9:15 a.m.". In this regard, the evidence shows that on February 28, 1991, a DPR senior pharmacist, Charles C. Lewis, made a routine inspection of ODW. He entered the premises at approximately 9:00 a.m. and found the drug store open, the lights on in the pharmacy section, and only a pharmacist technician on duty. Respondent was not on the premises. Respondent eventually entered the premises around 9:10 a.m. Because the law requires that a registered pharmacist be on duty whenever a community pharmacy is open, respondent, as the designated manager, was in contravention of that requirement. Count II The second count alleges that "on one occasion in approximately August 1990, pharmacist technicians on duty were required to dispense medicinal drugs despite no pharmacist having been present". As to this charge, respondent admitted without further proof that the allegations were true. Thus, the charge in Count II has been sustained. Count III The third count alleges that "on at least two occasions refills for medicinal drugs were dispensed without authorization from the prescribing physician." As to this count, during the course of his inspection of ODW's prescription file, Lewis found copies of two original prescriptions dispensed by respondent on Saturday, February 9, 1991, and Saturday, February 16, 1991, respectively. Original prescriptions are those either handwritten by a doctor and brought in for filling by the patient or those that are telephoned in to the pharmacy by the doctor's office. If a prescription is telephoned in, it must be immediately reduced to writing by the pharmacist. Original prescriptions do not include refills. In this case, the two prescriptions were the type telephoned in by the doctor directly to the pharmacy. Because doctors are rarely in their offices on Saturday, Lewis turned the prescription records over to DPR for further investigation. The records of the prescriptions have been received in evidence as a part of petitioner's exhibits 1 and 2. The prescriptions indicate that Dr. James E. Quinn prescribed thirty Nalfon tablets (600 mg.) to patient L. C. on February 9, 1991, and Dr. Michael E. Meyer prescribed ten Tagamet tablets (300 mg.) to patient J. K. on February 16, 1991. The record does not disclose whether the drugs are scheduled legend drugs or non-scheduled legend drugs. Deposition testimony given by Drs. Quinn and Meyer established that neither doctor authorized by telephone or in writing that the two prescriptions in question be filled. Respondent concedes that he dispensed the drugs, and by doing so, he violated the law. Count IV The final count alleges that respondent, as a pharmacy permittee, violated former rule 21S-1.023 (now renumbered as rule 21S-28.112) by dispensing a medicinal drug in violation of state law. Because this charge is founded on the same set of facts set forth in findings of fact 4, 5 and 6, it is found that this charge has been sustained. Mitigation and Penalty At hearing, respondent generally offered mitigating testimony. As to Count I, he indicated he planned to arrive at the store at 9:00 a.m. but an automobile accident tied up traffic and caused him to be ten minutes late. He suspects that the store owner, who had the only other set of keys, opened up the store and pharmacy area and improperly let the technician into the pharmacy area even though respondent had not yet arrived. As to Count II, respondent acknowledged that two prescriptions were dispensed by pharmacy technicians without a pharmacist on duty but believes the store owner authorized the technician to dispense two prescriptions that he had filled the previous evening. He says appropriate instructions have been given to insure that this will not occur again. Finally, respondent gave the following explanation for dispensing the two prescriptions without authorization from a doctor. During the time period in question, respondent had a practice of partially filling prescriptions. In other words, even though a prescription might authorize a total of 100 tablets, respondent would dispense them piecemeal (e.g., 10 at a time) over the life of the prescription. Thus, at the end of the prescription period, if only 80 of 100 tablets had been previously dispensed, he would fill the remaining 20 tablets even though the prescription from a particular doctor had expired. In the case of the two prescriptions in issue, respondent believes that the customers either had a valid prescription from another doctor but he inadvertently refilled the prescription using the former doctor's name because the prescription had not been used up, or he noted that the patient had not been given the total number of tablets authorized under the original prescription. However, no documentation was submitted by respondent to support the claim that he was presented with a new valid prescription by one of the customers. Respondent apparently no longer engages in this practice. Finally, throughout the course of this proceeding, respondent has fully cooperated with the Board. Although the Board did not submit a proposed order containing a recommended penalty, at hearing counsel for the Board suggested that respondent's conduct warrants the imposition of a fine, probation and a reprimand.
Recommendation Based upon the foregoing findings of facts and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Sections 465.014, 465.015(2)(c), 465.016(1)(e)and (n), and 465.023(1)(c), Florida Statutes (1989), and that he be given a reprimand, fined $500 and his license placed on probation for one year. DONE and ENTERED this 12th day of March, 1992, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1992. COPIES FURNISHED: Tracey S. Hartman, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Obi E. Enemchukwu P. O. Box 32 Tavares, FL 32778-0032 Jack L. McRay, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue Whether Petitioner should be granted a Retail Pharmacy Drug Wholesale Distribution Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (2009).1
Findings Of Fact Background Petitioner holds Florida Community Pharmacy License No. PH23699 (the “pharmacy license”), pursuant to Chapter 499, Florida Statutes. The establishment is located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835 (“establishment”), where Petitioner’s records are stored. On or about July 29, 2009, Petitioner submitted the first portions an application to Respondent for a Retail Pharmacy Wholesaler Distributor Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (“application”). On September 16, 2009, Respondent's drug agents conducted an onsite inspection of the establishment (“inspection”) for purposes of assisting in Respondent’s determination of whether to issue the permit to Petitioner. On or about November 13, 2009, Respondent notified Petitioner that Respondent intended to deny the application (“notice”), and Petitioner filed a petition for administrative review, raising disputes of material fact (“petition”). Prescription Drug Inventory and Petition as a “Retail Pharmacy” To qualify as a retail pharmacy, Petitioner must have adequate inventory on hand that would be required by the general public for a variety of medical conditions. On the date of inspection, there was inadequate inventory on hand. There were only 18 commercially-available prescription drugs. Many of the drugs were injectables, which would only fill the needs of a very specific and limited patient population. At the time of inspection, Petitioner’s on-hand inventory of prescription drugs lacked any opiate painkillers and any drugs indicated for treatment or maintenance of (i) high blood cholesterol levels, (ii) systemic bacterial infections (oral antibiotics), (iii) osteoporosis, (iv) cough (syrups), (v) viral infections, (vi) depression, and (vii) asthma. These are some of the most commonly-required drugs in the pharmacological arsenal. Petitioner’s specialization in the area of compounded prescription drugs is evidenced by Petitioner’s prescription drug inventory and the nature of the prescriptions Petitioner filled in the months leading up to inspection. Most of Petitioner’s on-hand prescription drug inventory was composed of compounded prescription drugs or ingredients to be used in compounding prescription drugs. Less than eight percent of Petitioner's prescription drugs, or about 18 items, consisted of commercially-available prescription drugs in finished dosage forms. In the two-month period before September 29, 2009, Petitioner did not dispense a single dose of commercially- available, finished-form prescription drugs. All were specially-prepared or “compounded” products tailored to the specific needs of individual patients. Petitioner, as a result of an inability to meet the most basic and commonplace prescription drug needs of the general public, lacked adequate inventory required by the general public. Petitioner served a specific and limited patient population: i.e., those patients requiring specially-compounded prescription drugs and those rare patients whose needs could not be met by commercially-available products. Petitioner's explanation as to the reason for having only 18 commercially-available prescription drugs available at the time of inspection is not persuasive; Petitioner, therefore, was not a retail pharmacy. Life Specialty Pharmacy Medical Equipment and Supplies, Inc.: Petitioner’s Unauthorized Source for Prescription Drugs Life Specialty Pharmacy Medical Equipment and Supplies, Inc. (“Life Specialty”), a separate entity from Petitioner, is under common control with Petitioner. It has the same owners, principals, and pharmacy department manager. Life Specialty holds Community and Special Parenteral/Enteral Pharmacy License No. PH22346 for an establishment located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835. It is not authorized under Florida law to purchase, receive, own, or distribute prescription drugs. Petitioner’s prescription drug inventory at the time of inspection included certain quantities of Sarapin, a prescription drug. Life Specialty acquired and received Sarapin from a Kmart pharmacy that is no longer in business. At the time Life Specialty acquired and received the Sarapin from Kmart pharmacy, that drug was readily available from Life Specialty’s prescription drug wholesale suppliers. Life Specialty later transferred the Sarapin to Petitioner. Life Specialty lacks any permit or authorization under Part I of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (Act), to engage in the wholesale distribution of prescription drugs. Petitioner, nevertheless, received prescription drugs from Life Specialty, and many of these drugs were in Petitioner’s prescription drug inventory at the time of inspection, including prescription drugs compounded by Life Specialty. Those drugs included: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Chloral Hydrate (CIV), Crystal USP 100% 125gm Testosterone Propionate Micro USP Ketamine Hydrochloride USP 100% Powder 25mg Amphotericin B USP 100% Powder 1gm Cyclobenzaprine HCl USP Recordkeeping and Pedigree Papers During the course of the inspection, Respondent requested the opportunity to review pedigree papers and other source-related records for the prescription drugs Petitioner received from Life Specialty. Specifically, Petitioner could not produce any pedigree papers for prescription drugs received from Life Specialty. Petitioner received from Life Specialty, without a valid pedigree paper, the following: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Testosterone Propionate Micro USP Cyclobenzaprine HCl USP Recordkeeping Petitioner did not acquire all of its pedigree papers contemporaneously with the underlying transactions. Petitioner acquired many of the pedigree papers for the prescription drugs in its inventory after the Respondent's inspection. Petitioner's explanation for these failures was not credible.
Recommendation Based on the Findings of Facts and the Conclusion of Law cited above, it is RECOMMENDED that the Department of Health enter a final order, denying Petitioner's application for a permit to act as a retail pharmacy drug wholesale distributor. DONE AND ENTERED this 1st day of September, 2010, in Tallahassee, Leon County, Florida. S DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of September, 2010.
Findings Of Fact At all times material hereto, Respondent Alberto Calil was the owner of Farmacia La Familia, the holder of a permit to operate a pharmacy under the laws of the State of Florida, having been issued permit number 0007056. At all times material hereto, Respondent Hildelisa M. Hernandez has been licensed as a pharmacist under the laws of the State of Florida, having been issued license number 0016352. At all times material hereto, Hernandez has been the managing pharmacist at Farmacia La Familia and, specifically, has been the only pharmacist employed there. Prior to the events alleged in the Administrative Complaints filed herein, Respondent Nelson Torres had an ownership interest in Farmacia La Familia. In February 1982, he transferred his interest in the business, and his shares of stock in the corporation owning the business, to Respondent Calil. At the time of the formal hearing in this cause, Torres did not own or operate a pharmacy. The Miami office of the Department of Professional Regulation received an anonymous letter advising, essentially, that a number of pharmacies were being operated other than in compliance with the law. Georgina Auspitz, an investigator with the Department of Professional Regulation, was instructed by her supervisor to visit each of the pharmacies named in that letter to investigate the allegation. On Friday, March 26, 1982, Auspitz entered the Farmacia La Familia. After a brief conversation with Respondent Hernandez and a customer of the pharmacy, Auspitz asked Hernandez for three dollars' worth of Tranxene 3.75 mg. Hernandez went into the dispensary part of the pharmacy and returned with a manila envelope containing 15 capsules. At no time during this transaction did Auspitz present Hernandez with a prescription. On Monday, March 29, 1982, Auspitz took the envelope and its contents to the Dade County Public Safety Department. A subsequent chemical analysis of the capsules revealed the presence of the controlled substance known as clorazepate, the active ingredient in Tranxene. On April 6, 1982, Auspitz returned to the Farmacia La Familia. She asked Manuel J. Diaz Garcia1 an employee of the pharmacy, for three dollars' worth of Tranxene 7.5 mg. Diaz went into the dispensary part of the pharmacy, had a discussion with an unidentified female, and returned to the main part of the pharmacy to wait on customers. After being advised that the order was ready, Diaz gave Auspitz a manila envelope containing 11 capsules. Auspitz paid Diaz, Diaz placed the money in the cash register, and Auspitz left the pharmacy. At no time during this transaction did Auspitz present to Diaz a prescription. Auspitz took the manila envelope and its contents to the Dade County Public Safety Department. A subsequent chemical analysis of the capsules revealed the presence of the controlled substance known as clorazepate, the active ingredient in Tranxene. After she had made her second "buy" at Farmacia La Familia, Auspitz contacted the City of Miami Police Department to ascertain if one of its narcotics detectives would accompany her on subsequent "buys." As a result of her request, Detective Noel Rojas was assigned to accompany her. On April 8, 1982, Auspitz and Rojas went to the Farmacia La Familia. Crus Caballero, an employee of the pharmacy, approached them. Auspitz told Caballero she wanted three dollars' worth of Ativan, and Rojas told Caballero he wanted five dollars' worth of Valium 5 mg. Caballero wrote something on a scrap piece of paper and went into the dispensary portion of the pharmacy, left the piece of paper, and returned to wait on other customers. Respondent Hernandez came to the door of the dispensary area, "looked over" Auspitz and Rojas, and returned to the dispensary. A few moments later, Caballero brought two manila envelopes to where Auspitz and Rojas were waiting. Although Auspitz had ordered three dollars' worth of Ativan, Caballero only brought her two dollars' worth. After Auspitz agreed to take the smaller quantity, Caballero placed both manila envelopes into one bag, and Auspitz and Rojas paid for their purchases and left the pharmacy. At no time during this transaction did Auspitz or Rojas present Caballero with a prescription. Upon leaving the pharmacy, Auspitz and Rojas separated their purchases. Auspitz took hers to the Dade County Public Safety Department, and Rojas took his to the City of Miami Police Department. The chemical analysis performed on the six tablets purchased by Auspitz revealed the presence of the controlled substance lorazepam, the active ingredient in Ativan. The chemical analysis performed on the 23 tablets purchased by Rojas revealed the presence of the controlled substance diazepam, the active ingredient in Valium. Neither Manuel J. Diaz Garcia nor Crus Caballero is licensed as a pharmacist or registered as a pharmacy intern in the State of Florida.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing the Administrative Complaint filed against Respondent Nelson Torres with prejudice; finding Respondents Farmacia La Familia, Alberto Calil and Hildelisa M. Hernandez guilty of each and every count in the Administrative Complaints filed against them; and revoking pharmacy permit number 0007056 issued to Respondents Farmacia La Familia and Alberto Calil, and further revoking pharmacist license number 0016352 issued to Respondent Hildelisa M. Hernandez DONE and RECOMMENDED this 5th day of April, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, 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 5th day of April, 1983. COPIES FURNISHED: W. Douglas Moody, Esquire 119 North Monroe Street Tallahassee, Florida 32301 Raul A. Cossio, Esquire 1900 Coral Way, Suite 404 Miami, Florida 33145 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Hinton F. Bevis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 3230123
Findings Of Fact Respondent holds community pharmacy license No. PH0007711, renewed January 13, 1983. On May 21, 1981, Lester J. Henderson signed a new establishment permit application as owner, officer, manager and registered pharmacist. On June 9, 1981, petitioner conducted a new establishment inspection of Tampa Park Plaza Pharmacy. On June 19, 1981, Mr. Henderson wrote that "Andrew Mobley is no longer the Pharmacy Manager of Tampa Park Plaza Pharmacy, but I am . . . ." Petitioner's Exhibit No. 1. Petitioner received this notification on June 24, 1981, and, on the following day, wrote Mr. Henderson "to advise that effective as of June 19, 1981, our records were amended to reflect that you are the pharmacist manager." MBHS Corp., Inc. (MBHS), owns Tampa Park Plaza Pharmacy, (the pharmacy) and MBHS is owned in turn by its three officers. MBHS' president, Andrew Mobley, and Lester Henderson, an MBHS vice-president, are registered pharmacists. Samuel Snowden, also an MBHS vice-president and the third stockholder, is not a pharmacist. After the pharmacy opened for business, Andrew Mobley left Florida, and left the every day operation of the pharmacy to Lester Henderson, whom he knew to have had no retail experience as a pharmacist. In December of 1981, Mr. Mobley returned from Oklahoma to find a complete dearth of pharmaceutical records. Mr. Henderson explained that he did not like paperwork. Mr. Mobley returned to Oklahoma, again leaving the every day operation of the pharmacy to Mr. Henderson, but returned to Tampa when a bank that had made the pharmacy a loan threatened to call it in. He found scheduled drugs mixed in together, with unscheduled drugs, and a continued lack of records. Mr. Mobley then set up an inventory control book, something that had been neglected to that point. It developed that some Dilaudid was missing, which seemed to be news to Mr. Henderson. Mr. Mobley told Mr. Henderson the fact that the drugs were missing would have to be reported to the Department of Professional Regulation and Mr. Mobley got forms from the Department of Professional Regulation's office on Henderson Boulevard, which he gave to Mr. Henderson to fill out. Mr. Henderson never did fill them out and reportedly said "Andrew . . . must be crazy if he thinks I'm going to fill out those papers and send them in to those people." (T. 35) Mr. Mobley worked with Mr. Henderson in an effort to straighten out record keeping at the pharmacy, but also took a job at Walgreen's beginning in February of 1983. He left this job in June to take over from Mr. Henderson as pharmacy manager at the pharmacy. Mr. Henderson has not been employed at the pharmacy since. Edward G. Bludworth and Merry L. Paige, investigators in petitioner's employ, visited the pharmacy about ten o'clock on February 16, 1983. The prescription department was open; it was unlocked and there was no "closed" sign, but there was no pharmacist on duty. When the investigators asked to speak to the pharmacist, the store clerk made several telephone calls. She was only able to locate Mr. Henderson at about two o'clock, after the investigators had left. Mr. Bludworth and Ms. Paige conducted an audit of scheduled drugs at the pharmacy on February 16, 1983. Because of the lack of an inventory report as of the spring of 1981, they assumed no drugs on hand as of June 9, 1981. On this assumption they concluded that 296 tablets of Dilaudid 2 mg. were missing and unaccounted for. Dilaudid contains dihy dromorphinone [sic]. On the same assumption, they found a shortage of 41 Percodan tablets, which contain oxycodone, and an overage of 97 Demerol tablets 50 mg. Petitioner's Exhibit No. During the audit period, the pharmacy purchased 400 tablets of Dilaudid 2 mg. and 500 Percodan tablets. Id. The discrepancies uncovered by the audit exceeded significantly the five percent error rate that the investigators commonly see. Mr. Bludworth and Ms. Paige returned for a second visit on April 19, 1983, at about ten o'clock in the morning. Once again, the prescription department was unlocked and open. There was no "closed" sign and no pharmacist to be seen. This time Mr. Henderson's presence was procured by noon. On one of their visits, Mr. Henderson told the investigators that there had been a break-in at the pharmacy more than a year earlier. He said he had reported the incident at the time to the authorities but was unable to produce documentation of any such report. The investigators requested such documentation at the time of the visit, and Ms. Paige later telephoned him to ask again for documentation.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for one (1) year. DONE and ENTERED this 20th day of October, 1983, in Tallahassee, Florida. ROBERT T. BENTON II 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 20th day of October, 1983. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Andrew Mobley Tampa Park Plaza Pharmacy 1497 Nebraska Avenue Tampa, Florida 33602 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wanda Willis, Executive Director Department of Professional Regulation Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
