The Issue At issue in this proceeding is whether Respondent committed the offenses set forth in the Administrative Complaint1 and, if so, what penalty should be imposed.
Findings Of Fact Respondent's licensure and employment Respondent, Nury D. Soler, is now, and was at all times material hereto, licensed as a pharmacist by the State of Florida, having been issued license number PS 0014628. Pertinent to this case, Respondent was the prescription department manager for Westchester Pharmacy for a two-month period extending from some time in October 1996 and at least through December 13, 1996. Westchester Pharmacy is a community pharmacy licensed by Petitioner, pursuant to Section 465.018, Florida Statutes, and located at 7253 Southwest 24th Street, Miami, Florida. The pharmacy owner or permittee was Noriel Batista. The pharmacy inspection On December 14, 1996, a Saturday, Richard Castillo, an investigator employed by the State of Florida, entered the Westchester Pharmacy to conduct a routine community pharmacy inspection. Upon entry, Mr. Castillo observed only one person in the pharmacy, a man later identified as the permittee (Mr. Batista). At the time, Mr. Batista was observed in the vicinity of the prescription area, at the rear of the store. Mr. Castillo proceeded to the counter at the rear of the store, and was approached by Mr. Batista. Thereupon, Mr. Castillo feigned a toothache, and the following events transpired: . . . I put my hands on my face and I said I have some tooth pain, is there anything you can do about it. At which time, he said you really need to go see a dentist. I said that dentists cost a lot of money and that I believed that it was an infection. At which time he came back with a bottle of twenty Amoxicillin, 500 milligram capsules. He sold me the bottle for $10.00 and I gave him the $10.00. He then gave me some preliminary instructions, and went back into the prescription department area. He returned and said that as a gift I'm going to give you these medications; which was four capsules of Motrin 800 milligrams. Amoxicillin is a prescription drug, which Mr. Batista, who was not licensed as a pharmacist, sold without benefit of a prescription. Following the sale, Mr. Castillo identified himself as an investigator, told Mr. Batista he was present to conduct a routine inspection, and asked to speak with the pharmacist. When told the pharmacist was not available, Mr. Castillo asked Mr. Batista to telephone her and ask her to come to the store. Mr. Batista did so, and about an hour later Respondent arrived. Mr. Castillo inspected the pharmacy and completed a community pharmacy inspection report on which he noted a number of perceived deficiencies. (Petitioner's Exhibit 2). First, with regard to Mr. Batista's sale of amoxicillin, Mr. Castillo noted three deficiencies or violations against the pharmacy business, to-wit: (1) there was no pharmacist on duty when the prescription department was open (a perceived violation of Rule 64B16-28.109, Florida Administrative Code); (2) there was no pharmacist present to provide patient counseling, if requested (a perceived violation of Rule 64B16-27.820, Florida Administrative Code); and, (3) since Mr. Batista did not document the sale, Mr. Castillo considered the pharmacy records of dispensing to be incomplete (a perceived violation of Rule 64B16-28.140(3)(b), Florida Administrative Code). Other deficiencies noted by Mr. Castillo against the pharmacy business were as follows: (1) there was no sign displayed that the pharmacy was closed (a perceived violation of Rule 64B16-28.109(1), Florida Administrative Code); (2) the pharmacist's (Ms. Soler's) license was not displayed (a perceived violation of Rule 64B16-27.100(1), Florida Administrative Code); and, (3) there was no sign displayed which stated the hours the prescription department was open each day (a perceived violation of Rule 64B16-28.404, Florida Administrative Code). No further deficiencies were observed and, apart from those noted deficiencies, the prescription department appeared appropriately maintained and operated. Following Respondent's arrival at the pharmacy, Mr. Castillo discussed with her the various deficiencies he had found and had noted on his report. Then, as the "Pharmacist," Respondent signed the report. By signing the report, she acknowledged that "I have read and have had this inspection report and the laws and regulations concerned herein explained, and do affirm that the information given herein is true and correct to the best of my knowledge." Among the information provided on the inspection report was the name of the prescription department manager, which was stated to be the Respondent. Respondent's employment status with Westchester Pharmacy on the date of the inspection Notwithstanding her appearance at Westchester Pharmacy on Saturday, December 14, 1996, and her signing of the inspection report as the Pharmacist for Westchester Pharmacy, Respondent averred, at hearing, that by December 14, 1996, she was no longer affiliated with the pharmacy or responsible for the deficiencies noted. According to Respondent, by December 12, 1996, she had agreed with another pharmacy, Coral Way Pharmacy, Inc., (Coral Way Pharmacy) to serve as its pharmacist effective December 16, 1996, at its pharmacy located at 6965 Southwest 24th Street, Miami, Florida, and that her last date of employment with Westchester Pharmacy was December 13, 1996. While perhaps not entirely free from doubt (given the facial inconsistency between Respondent's contention at hearing and the conclusion one could reasonably draw regarding her association with Westchester Pharmacy, as evidenced by her activities on the date of inspection), the proof demonstrates, more likely than not, that, as Respondent averred, she was no longer employed by Westchester Pharmacy on the day of inspection, her presence on the day of inspection was a matter of accommodation to Mr. Batista, and her signing of the report was a matter of misunderstanding. In so concluding, it is observed that, while the pharmacy was open Monday through Saturday, the prescription department was not open on Saturday, or, stated differently, under the terms of Respondent's employment with Weschester Pharmacy she did not work week-ends. Given that Respondent and Coral Way Pharmacy, reached an agreement on December 12, 1996, for her to begin work at Coral Way Pharmacy on December 16, 1996, it is reasonable to conclude, given the nature of her work-week at Westchester Pharmacy, that her last day of employment with Westchester Pharmacy was Friday, December 13, 1996. Moreover, consistent with the conclusion that Respondent's association with Weschester Pharmacy terminated on December 13, 1996, is the absence of Respondent's wall certificate and license on the date of inspection. Notably, Respondent had not suffered prior disciplinary action in 19 years of practice, and presumably knew that, if employed, she was required to display her wall certificate and license in or near the prescription department. Conversely, she also knew, presumably, that she could not lawfully display them, if she was no longer employed by Westchester Pharmacy. Rule 64B16-27.100, Florida Administrative Code. Since it is presumed that persons will observe the law, the absence of Respondent's wall certificate and license on the date of inspection is consistent with her assertion that, by that date, she was no longer employed by Westchester Pharmacy. Atlantic Coast Line R. Co. v. Mach, 57 So. 2d 447 (Fla. 1952). Finally, also consistent with the conclusion that Respondent's employment with Westchester Pharmacy terminated before the date of the inspection is a statement Respondent made to the inspector. According to the investigator, when asked about the infractions, Respondent stated the following: . . . She said that things needed to change. She asked if she were to leave the pharmacy whether that would change anything, and I said, no, it doesn't matter because you're the pharmacist of record at this point of time. Such statement, when considered in context with other proof of record, discussed supra, is consistent with Respondent having resolved, previously, to terminate her employment with Weschester Pharmacy and, since she did not specifically tell the investigator of her decision, his response evidenced a misunderstanding that resulted in Respondent's execution of the report.
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. DONE AND ENTERED this 25th day of August, 1998, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK 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 Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 1998.
The Issue Whether Petitioner's renewal application for an assisted living facility (ALF) license should be denied based upon Petitioner's failure of the biennial re-licensure survey conducted on June 10 and 11, 2013, and because Petitioner has a controlling interest in another ALF that has an unpaid fine of $5,000.00 from 2012 after its license was revoked.
Findings Of Fact AHCA is the state agency responsible for regulating home health agencies in Florida. In this capacity, AHCA determines whether to approve applications for renewal of licensure as an ALF, and it has administrative jurisdiction to enforce the laws governing such licensees, including the authority to take disciplinary measures against licensees who violate the applicable statutes and rules. Petitioner is a corporation which operates a 62-bed ALF in the Cannon Point neighborhood of Lauderhill, Florida. The ALF has both a standard ALF license and a specialty limited mental health (LMH) license. Petitioner has been owned and operated for approximately 13 years by Susan and William Spaw. Mrs. Spaw serves as president, administrator, and chief financial officer of Petitioner and owns a 51 percent interest in Petitioner. As such, she is "a controlling interest" of Petitioner as defined by section 408.803(7), Florida Statutes. Mrs. Spaw also was a controlling interest of Serenity Gardens, an ALF which had its license revoked by AHCA by Final Order dated March 30, 2012 (Final Order). By the same Final Order, Serenity Gardens also had a $5,000.00 fine imposed against it by AHCA that remained unpaid as of the date of the final hearing in this proceeding. Florida ALF licenses must be renewed every two years. Petitioner filed an application for license renewal with AHCA which was received on March 20, 2013. When Petitioner's application was received by AHCA, it was referred to Jim Alfred (Alfred), senior management analyst in the ALF licensing unit. Alfred reviewed the application to determine whether any items were missing or anything needed to be added or corrected. On April 12, 2013, AHCA issued an Omissions Letter (Omissions Letter) drafted by Alfred to Mrs. Spaw advising that Petitioner's renewal application was determined to be incomplete and specifying the errors and omissions to be addressed within 21 days to deem the application complete. Among other things, the Omissions Letter states that pursuant to section 408.831, if there are any outstanding fines, liens, or overpayments that have been assessed by final order of AHCA against the licensee or a common controlling interest, they must be paid prior to license/registration issuance. The Omissions Letter indicates that AHCA's records show that, in addition to having a controlling ownership interest in Petitioner, Mrs. Shaw also had a controlling ownership interest in Serenity Gardens which had an outstanding fine in Final Order status for the amount of $5,000.00. The Omissions Letter also notified Petitioner that section 429.14(3), Florida Statutes, gives AHCA the authority to deny the renewal application based upon the revocation of license number 10176, which was issued to Serenity Gardens. As part of the ALF license renewal process, AHCA conducts a biennial "survey." The survey is a comprehensive inspection of an ALF facility and its records to determine compliance with applicable statutes and rules. The survey must be completed before the renewal is issued. During the survey, AHCA surveyors observe staff in their interactions with residents and the dispensing of medications. The surveyors also examine the physical plant and review resident records. When Alfred reviewed Petitioner's application, Petitioner's license was "red flagged" in AHCA's computer system because of the revocation of the license for Serenity Gardens and the outstanding $5,000.00 fine. Alfred brought this to the attention of his supervisor, Shaddrick Haston (Haston), AHCA's unit manager for ALFs. Although either the revocation of the license for Serenity Gardens, a facility in which Mrs. Shaw had a controlling interest, or the outstanding $5,000.00 fine would be a sufficient basis for denial of the renewal application, Haston directed Alfred to wait until receipt of the biennial survey results for Petitioner's ALF before moving forward with a possible denial of the renewal application. The biennial re-licensure survey was conducted at Petitioner's facility on June 10 and 11, 2013, by AHCA surveyors Michael Forrester (Forrester) and Nicolas Frias (Frias). At the time of the survey, both Forrester and Frias were experienced surveyors, each with over approximately 100 inspections, including renewal application biennial surveys. Working together, Forrester and Frias determined there were ten deficiencies, commonly cited as "tags," in reference to applicable regulatory standards. Tag A 010 Tag A 010 cited Petitioner with a violation of Florida Administrative Code Rule 58A-5.0181(4) regarding "Continued Residency." This rule requires that the patient must have a face-to-face medical examination by a licensed health care provider at least every three years after the initial assessment, or after a significant change, whichever comes first. The results of the examination must be recorded on AHCA Form 1823 (Form 1823). A resident observation log revealed that on May 7, 2013, a resident was taken by ambulance to the hospital because she was disoriented, stumbling, drooling, and had slurred speech. Petitioner's staff checked her blood sugar and found it very high. The resident also expressed that she wanted to commit suicide. Although the resident was not diagnosed with diabetes at that time, the resident was determined to have high blood sugar which needed to be monitored by home health services. Neither the change in mental status or physical status was documented on a Form 1823 although each qualifies as a "significant change." Tag A 030 Tag A 030 cited Petitioner with a violation of rule 58A-5.0182(6) and section 429.28 regarding "Resident Care-Rights & Facility Procedures." This deficiency was based upon the observation that the ALF had a pet cat that had no documentation of vaccination since 2009. This was considered to be potentially harmful to the residents. This violation was admitted by Petitioner. Tag A 052 Tag A 052 cited Petitioner with violating rule 58A- 5.0185(3) regarding "Medication-Assistance with Self- Administration." Forrester observed staff assisting residents in the self-administration of medications and saw that the required procedures for unlicensed staff were not followed properly with four residents. A staff member was observed assisting one resident with the application of a medication patch on the resident's abdomen. The staff member did not wear gloves, nor did she wash her hands after providing assistance. Two residents received medication without the staff member first reading the label in the presence of the residents. Staff was also observed leaving a resident before the resident took her medication, in violation of the rule. These violations were admitted by Petitioner, but Petitioner attributed these deficiencies to the staff being nervous due to the presence of the surveyors. Tag A 053 Tag A 053 cited Petitioner with violating rule 58A- 5.0185(4) regarding "Medication-Administration." This deficiency was based upon a review of resident records that reflect an unlicensed staff member performed blood glucose testing on a resident. Upon questioning, the surveyors learned that this was not the only time this occurred because Mrs. Spaw and the staff were unaware that a licensed medical professional is required by the rule to perform this type of procedure. Tag A 054 Tag A 054 cited Petitioner with violating rule 58A- 5.0185(5) regarding "Medication – Records." This deficiency was based on the finding that five out of 28 sampled residents' medication observation records (MORs) were not appropriately maintained. Forrester observed a staff member assist resident 18 with two medications. However that resident's MOR revealed that resident 18 should have been provided with three medications. The staff member noted on the MOR that one of the medications, Risperidone, an antipsychotic medication, was not available. After the surveyor questioned why the resident was not receiving the medication, another staff member found the missing medication. Forrester observed a staff member take a package of medications from a filing cabinet and a pill from one of the packages fell on the floor. None of the same pill type was missing from future doses for resident 13. A review of the MOR for resident 13 showed that one capsule by mouth daily was initialed as being given to the resident from June 1 through June 11, 2013. Because one pill was lying on the floor, it is not possible for the resident to have received all of the prior doses. The MOR for resident 16 showed that this resident was to be given one 800mg tablet of ibuprofen three times a day and had in fact received the ibuprofen as ordered from June 1 through June 10, 2013. However, when staff was questioned by the surveyor regarding why no ibuprofen was available for this resident on June 11, the surveyor was told that the physician had discontinued this order in September 2012. According to staff, the pharmacy erroneously printed the order for ibuprofen on the MOR in June. The deficiency was based upon the fact that staff indicated on the resident's MOR for the first ten days of June that they were assisting the resident with this medication when, in fact, no medication was available. A review of the MORs for residents 21 and 22 indicated that unlicensed staff initialed for providing injections. According to staff, the injections were actually provided by licensed health care providers who came to the facility. At some point later, staff wrote "error." Only the individual who actually provides the injection is to initial the MOR. Tag A 056 Tag A 056 cited Petitioner with violating rule 58A- 5.0185(7) regarding "Medication–Labeling and Orders." This deficiency was based, in part, on the finding that Petitioner failed to ensure that medication orders were followed as directed for 12 out of 28 sampled residents. These 12 residents received their 8:00 a.m. medications after 9:00 a.m. on June 11, 2013. According to the facility's pharmacy, the ideal window for providing medications to a resident would be no more than an hour before and an hour after the required medication dosage time as noted on the MORs. The resident is supposed to take the medications at the time intervals given. The timing issue becomes worse when a resident takes a medication more than once a day. The delay of assistance with self-administered medications for sampled residents by staff is not within the recommended pharmacy time intervals for providing medication assistance at dosage times. The facility's failure to provide physician- ordered medication at prescribed dosage times directly affects the well-being of the sampled residents. On June 11, 2013, Mrs. Spaw acknowledged exceeding the recommended time frame for medication distribution and indicated that it might be due to people coming in late. However, the staff individual who was observed distributing medications late stated that she starts the morning medications at 8:00 a.m. Mrs. Spaw indicated during the survey that she thought the medication distribution was beginning at 7:00 a.m. but she is not at the facility at that time.2/ Tag A 056 was also based upon the observation of a resident who did not receive all doses of medication, despite records indicating that all doses had been dispensed when, in fact, one dose was found on the floor. This deficiency was noted under this tag because it represented a failure to follow the doctor's order of prescribing one dosage per day. Tag A 093 Tag A 093 cited Petitioner with violating rule 58A- 5.020(2) regarding "Food Service-Dietary Standards." This deficiency was based upon Petitioner's failure to follow its own prepared menus. This rule requires that menus are to be dated and planned at least one week in advance for both regular and therapeutic diets. Any substitutions are to be noted before or when the meal is served. A three-day supply of nonperishable food, based on the number of weekly meals the facility has contracted with residents to serve, shall be on hand at all times. The surveyors found that the facility was not providing fruit juice despite fruit juice being on the menu, the menus were not showing a substitution, and the facility did not have a stock of fruit juice available. Petitioner provided no explanation or evidence to rebut this deficiency. Tag A 152 Tag A 152 cited Petitioner with violating rule 58A- 5.023(3) regarding "Physical Plant–Safe Living Environment/Other." In accordance with this rule, residents are supposed to be able to decorate their rooms with their own belongings as space permits. This rule also requires that residents are provided with a safe living environment. This deficiency was based upon the observation that a resident's magazine pictures, which he had taped to the wall of his room, were torn down. This left the walls with missing paint, and they were unsightly. A drain cover for a shower was missing in another resident's bathroom leaving an open hole in the floor which could result in injury to the resident. Petitioner did not dispute this deficiency. Tag A 167 Tag A 167 cited Petitioner with violating rule 58A- 5.025(1) regarding "Resident Contracts." Petitioner is required by this rule to maintain resident contracts that have an accurate monthly rental rate. For two of the 28 residents sampled, the surveyors found that one contract had a rate left blank and another had an incorrect rate. Tag AL 241 Tag AL 241 cited Petitioner with violating rule 58A- 5.029(2) regarding "LMH–Records." This rule requires that a facility with a LMH license maintain an up-to-date admission and discharge log identifying all mental health residents. Review of the facility's records showed that Petitioner had only one admission and discharge log which did not identify mental health residents. This rule also requires that each mental health resident shall have a Community Living Support Plan (CLSP) prepared by the facility administrator and the individual's mental health care provider which identified the specific needs of the resident and a plan for how those needs will be met. The CLSP is to be updated annually. A review of resident 1's records showed that Petitioner only had a CLSP that had been last updated in February 2008. Although the resident had an Interim Mental Health Assessment dated February 18, 2013, it did not reference the CLSP or contain any of its mandatory components. The Exit Interview On June 11, 2013, at the completion of the inspection, Forrester and Frias met briefly for an exit interview with Mrs. Spaw, Assistant Administrator Holli Raven (Raven), and Resident Assistant Marcia Gray (Gray). The purpose of the meeting was to provide a summary of the surveyors' findings and to discuss the Petitioner's responses, if any, to the concerns.3/ Forrestor represented at the meeting that he and Frias believed the deficiencies were all Class III violations but that the determination of classifications was subject to review by their supervisor. Statement of Deficiencies On June 20, 2013, Forrestor hand-delivered to Petitioner a copy of Form 3020, the Statement of Deficiencies, which included a detailed summary of the applicable rules violated and facts supporting the finding of deficiencies. The cover letter indicated that two tags, A 054 and A 056, regarding medication records, labeling and orders, were considered Class II deficiencies. As such, AHCA directed Petitioner to comply with a designated corrective action plan within five days. When delivering the Statement of Deficiencies, Forrestor explained to Mrs. Spaw that the medication-related deficiencies were upgraded by his supervisor from Level III to Level II. Forrestor's supervisor was not physically present at the survey but reviewed the results reported by Forrestor and Frias and upgraded the classifications based upon her training and familiarity as a licensed practical nurse with medication issues. The corrective action plan required Petitioner to provide a medication training course, approved by the Department of Elder Affairs, to staff. It also required Petitioner to ensure all unlicensed staff maintains a minimum of two hours of continuing education training on providing assistance with self- administered medication. The plan also directed Petitioner to obtain the consultation of a pharmacist to ensure all staff providing assistance with self-administered medication is following the guidelines of section 429.256 and that such consultation must be no less than three months in length. Petitioner immediately hired a pharmacy consultant and implemented training for staff. The consultant also reviewed the resident's medical records to make sure they were in compliance with applicable rules. However, Petitioner did not notify AHCA of its compliance efforts nor did AHCA conduct a re-inspection to determine whether the plan was being followed. Mrs. Spaw was very surprised to receive the extensive statement of deficiencies. In particular, she was dismayed that the facility was cited with two Class II violations when the surveyors had indicated at the exit interview that the purported deficiencies were Class III violations. According to Mrs. Spaw, she is not aware of any other facility in her vicinity which has received Class II designations for the types of deficiencies for which her facility is cited.4/ Mrs. Spaw and Forrester had no conversation regarding the findings when he hand-delivered the June 20, 2013, correspondence from AHCA. Mrs. Spaw felt that the survey findings reflected a bias or animus against her facility. However, there was absolutely no evidence of this presented at the final hearing. Both Forrester and Frias testified that they had no prior instruction with regard to how to conduct the survey other than when it was scheduled. They also testified that they conducted the survey at Petitioner's facility in the same fashion that they have conducted numerous other re-licensure surveys. Petitioner did not contest the underlying facts which supported the deficiencies. However, Petitioner suggests that these are relatively minor errors which occurred because a staff member was very nervous due to the surveyors being present and following them while dispensing medications. Notably, the staff person who was involved in the majority of the MOR errors and medication delays did not testify. Petitioner also argues that many of the deficiencies cited are based upon the same facts. For example, there are several deficiencies related to the incident of a pill being found on the floor. However, as explained by Forrester, factual observations may be listed repeatedly because they demonstrate different areas of non-compliance with laws or rules. The same incident may be referenced in support of different tag numbers because there are a variety of laws and rules involved. Notice of Intent to Deny After reviewing the results of Petitioner's re- licensure survey, Alfred met with Haston to discuss Petitioner's re-licensure application. Haston reviewed the results and saw there were two Class II and eight Class III violations. Although Haston wanted Petitioner's facility to remain open because he believes Mrs. Spaw "takes care of patients no one else wants" and there is a need for LMH beds in Petitioner's area, Haston decided to deny re-licensure based upon the failed survey, the outstanding fine from Serenity Gardens, and the fact that the license of Serenity Gardens was revoked. AHCA issued a Notice of Intent to Deny on October 2, 2013, and explained that the denial was based upon the failed biennial re-licensure survey, the outstanding fine imposed by Final Order on March 30, 2012, and that the applicant (Mrs. Spaw on behalf of Petitioner) had a controlling interest in Serenity Gardens, a facility which had its license revoked by Final Order.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order upholding the denial of Petitioner's licensure renewal application. DONE AND ENTERED this 23rd day of May, 2014, in Tallahassee, Leon County, Florida. S MARY LI CREASY 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 23rd day of May, 2014.
Findings Of Fact Respondent Dora Villanueva, is a licensed pharmacist, having been issued license number PS 0014957, and whose last known address is 3017 Southwest 107the Avenue, Miami, Florida 33165. At all times material hereto, Respondent Villanueva was the prescription department manager and part-owner of Century Pharmacy, 3017 Southwest 107th Avenue, Miami, Florida 33165. Respondent Century is permitted to operate a community pharmacy under the laws of the State of Florida, having been issued permit number PH 0006839 and operating at 3017 Southwest 107th Avenue, Miami, Florida 33165. On or about August 5, 1983, a Department of Professional Regulation investigator purchased 20 Librax and 20 Donnatal from Century Pharmacy, without first presenting a prescription. The aforementioned Librax and Donnatal were dispensed by Jose Ceferino Calvera, not a licensed pharmacist in the State of Florida. Librax and Donnatal are medicinal drugs as defined in Subsection 465.003(7), Florida Statutes (1983)(F.S.), and require a prescription to be dispensed. Respondent Dora Villanueva was not present in the pharmacy when the Librax and Donnatal were dispensed on August 5, 1983, and the prescription department of the pharmacy had a sign stating that the prescription department was closed. On or about August 17, 1983, a Department of Professional Regulation investigator purchased ten Dalmane, 20 Librax and 20 Donnatal, from Respondent Villanueva at the Respondent Century Pharmacy, Inc. without first furnishing a prescription. Dalmane, Librax and Donnatal are medicinal drugs as defined in Section 465.003(7), F.S. and require a prescription to be dispensed. On or about August 22, 1983, a Department of Professional Regulation investigator purchased ten Tranxene 7.5 mg and ten Dalmane, 30 mg, from Respondent Villanueva at the Respondent Century Pharmacy, Inc., without a prescription. Tranxene and Dalame are medicinal drugs as defined in Section 465.003(7), F.S., and require a prescription to be dispensed. On or about September 8, 1983, an audit was conducted of the controlled substances at Respondent Century Pharmacy, Inc., for the time period of January 1, 1983 through September 8, 1983. Said audit revealed the following shortages in the drugs which were audited: DRUG SHORTAGE Dalmane 30 mg 1,590 Dalmane 15 mg 799 Ativan 1 mg 151 Ativan 2 mg 4,163 Talwin Injectable 22 Dalmane, Ativan and Talwin are controlled substances as defined in Chapter 893, F.S. and are medicinal drugs as defined in Subsection 465.003(7), F.S. Respondent Villanueva denied making the August 17, 1983 sale. However, she did remember Petitioner's investigator from the August 22, 1983, transaction. Since Petititoner's investigator kept a contemporaneous record of her purchases, Respondent's denial is rejected as not credible. Both Respondent Villanueva and Petitioners investigator are immigrants from Cuba. Respondents claim the investigator was allowed to make the August 22, 1983 purchase without a prescription because she stated she had recently arrived from Cuba and had no doctor or money to pay one. Even if this were an accurate account of the transaction (which Petitioner denies) it would not provide grounds for dispensing controlled drugs without a prescription.
Recommendation Based on the foregoing, it is RECOMMENDED: That Petitioner issue a final order suspending the license of Respondent Dora Villanueva and the permit of Century Pharmacy, Inc. for a period of 90 days. DONE and ENTERED this 31st day of July, 1984 in Tallahassee, Florida. R. T. CARPENTER, 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 31st day of July, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Blas E. Padrino, Esquire 2355 Salzedo Street, Suite 309 Coral Gables, Florida 33134 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
The Issue The matters presented here concern action by an Administrative Complaint filed by the Petitioner against the the named Respondent. By this action, the Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondent. In particular, it is alleged that, in keeping with a controlled substance audit at the Medical Center Pharmacy, certain drug shortages were discovered, namely: (a) Between September 1, 1980, and January 28, 1981, 38,190 unit doses of Talwin 50 mg., a controlled substance; (b) Between September 1, 1980, and January 28, 1981, 16,920 unit doses of Pyribensamine (PBZ), and (c) between the dates of October 4, 1980, and January 29, 1981, 285 unit doses of Percodan. By Count I to the Administrative Complaint, it is alleged that, based upon the facts as set forth above, the Respondent has violated Subsection 465.016(1)(a), Florida Statutes, by violating Subsection 893.07(2), Florida Statutes, dealing with failure to maintain proper records of controlled substances. Count II to the Administrative Complaint states that based upon the alleged facts, the Respondent has violated Subsection 465.016(1)(i), Florida Statutes, by compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of professional practice of pharmacy. Count III alleges a violation of Subsection 465.016(1)(e) Florida Statutes, in view of a violation of Rule 21S-1.114, Florida Administrative Code, for failure to close the pharmacy when a registered pharmacist was not present and on duty related to acts which occurred on January 28, 1981, during the audit. Count IV alleges a violation of Subsection 465.016(1)(e) Florida Statutes, by violating Rule 21S-1.24(4), Florida Administrative Code, for alleged failure to display hours of operation at the pharmacy, based upon observations during the January 28, 1981, audit conducted at the pharmacy. 2/
Findings Of Fact This cause is presented based upon the Administrative Complaint which has been alluded to in the Issues statement to this Recommended Order. That complaint was filed June 4, 1981, and in the face of the Administrative Complaint, the Respondent, by execution of an Election of Rights form on July 10, 1981, indicated that certain material allegations of fact set forth in the Administrative Complaint were in dispute and requested a formal hearing in keeping with Subsection 120.57(1), Florida Statutes. The petitioning agency in this matter is a governmental body in the State of Florida, which has the power to license, regulate and discipline individuals and entities holding licenses or permits to practice pharmacy in the State of Florida. See Chapters 455 and 465, Florida Statutes. Karl L. Smith is registered by the Board of Pharmacy in the State of Florida to be a pharmacist and holds License No. 141337. Edgewood Medical Center Pharmacy, Inc., which did business, at all times pertinent to this Administrative Complaint, as Medical Center Pharmacy, is a community pharmacy licensed by the State of Florida to operate as a pharmacy under the terms of Permit No. 0007060. During the period in question, this pharmacy was located at 3160 West Edgewood Avenue, Jacksonville, Florida. At all times pertinent, Karl L. Smith was the only licensed pharmacist for Medical Center Pharmacy. On January 28, 1981, Petitioner's Investigators C. J. Hokinson and Johnny Danson proceeded to the Medical Center Pharmacy for purposes of conducting an audit of select controlled substances and legend drugs. When the Investigators entered the pharmacy, they spoke with Karl L. Smith who allowed them to examine pharmacy records related to Talwin, a Schedule IV drug and Pyribensamine, a legend drug. The audit process utilized for Talwin started with a zero inventory balance on September 2, 1980, and ended on January 28, 1981, with a total purchase count in the audit period of 39,200 unit doses. There remained on hand at the pharmacy 160 unit doses of the drug and some 850 unit doses were shown to be disposed of by prescription sale. There remained 38,190 unit doses of Talwin unaccounted for by explanation or documentation. An examination on January 28, 1981, of the second drug Pyribensamine, started with the zero inventory dating from September 2, 1980, and the audit period ended January 28, 1981. Within the audit period, there were 17,200 unit doses shown to have been purchased. On hand at the pharmacy on the date of the audit, 100 unit doses were found. An additional 180 unit doses had been dispensed by prescription sale. There remained 16,920 unit doses of Pyribensamine which were unaccounted for by explanation or documentation. While conducting the audit on January 28, 1981, Karl L. Smith, the only registered pharmacist on the premises left the pharmacy without closing it and Kathy Elain Smith, an intern pharmacist not admitted to practice pharmacy, was left in charge. Further the hours of operation for the pharmacy were not posted at the pharmacy on that date. On January 29, 1981, Investigator Danson returned to the pharmacy to conduct an audit for Percodan, a Schedule II drug. The audit period on this occasion started with a zero inventory for October 1, 1980, and the last day of the audit period was January 1, 1981. During this time frame, 1,000 unit doses had been purchased and 560 unit doses were on hand at the pharmacy on the date of the audit. Another 155 unit doses had been dispensed by prescription sale and 285 unit doses were unaccounted for by explanation or documentation. (The exact whereabouts of the missing drug items were not established. Karl L. Smith indicated that those drugs could have been removed by "friends" whom he had allowed to work in the pharmacy with him. No further explanation of the location of the missing drugs was volunteered, notwithstanding the fact that Karl L. Smith had been afforded several opportunities to explain what happened to the missing drugs.)
Findings Of Fact At all times material hereto, Respondent Hotel Pharmacy was a pharmacy permit holder having been issued permit number 0006529. At all times material hereto, Respondent Harry Cartun was a licensed pharmacist. having been issued license number 0011093. At all times material hereto, Respondent Harry Cartun was the owner and manager of Respondent Hotel Pharmacy, located at 1201 Lincoln Road, Miami Beach, Florida. Pursuant to a search of Respondent Hotel Pharmacy's Schedule II files, Petitioner seized the following prescriptions written for a patient named Edward Metzer, which prescriptions were filled by Respondents: DATE PRESCRIBED BY MEDICATION March 17, 1982 Elliot Trevian, M. D. Dilaudid, 4 mgs. No .36 March 25, 1982 Sol Colsky, M. D. Dilaudid, 4 mgs. No .40 March 31, 1982 Gustavo L. Arias, M. D. Dilaudid, 4 mgs. No .40 April 05, 1982 Gustavo L. Arias, M. D. Dilaudid, 4 mgs. No .40 None of the foregoing prescriptions were written by the physicians whose names appear on the prescription. No medical doctor named Elliot Trevian has ever been licensed in the State of Florida. The two prescriptions bearing Dr. Arias' name indicate that he is a psychiatrist--Children and Adolescents. Neither Respondent Harry Cartun nor Respondent Hotel Pharmacy verified the validity of any of the foregoing prescriptions.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondents Hotel Pharmacy and Harry Cartun not guilty of the allegations contained within the Administrative Complaints and dismissing the Administrative Complaints against them. DONE and RECOMMENDED this 9th day of March, 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 9th day of March, 1983. COPIES FURNISHED: W. Douglas Moody, Jr., Esquire 119 North Monroe Street Tallahassee, Florida 32301 Vincent J. Flynn, Esquire 1414 Coral Way 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 Post Office Box 3355 Tallahassee, Florida 32302
Findings Of Fact The Respondent, Howard Newman, is a pharmacist licensed in the State of Florida, holding license number 0014877. The Respondent, Bek-New Chemist, holds community pharmacy permit number 0006282. The Respondent practices pharmacy, and Bek-New Chemist is located, at 3690 Northwest 199th Street, Carol City, Florida 33054. Howard Newman is the owner and operator of Bek-New Chemist. The Petitioner is an agency of the State of Florida charged with administering and enforcing the licensure standards and status of pharmacists and pharmacies in Florida and the regulation and enforcement of their standards of practice. On August 26, 1980, Detective Kenneth Hackett of the Hialeah Police Department, pursuant to information received from a confidential informant, went with that informant to Bek-New Chemist Pharmacy, the Respondent's place of practice. Upon arriving in the parking lot of that establishment, the confidential informant pointed out to Detective Hackett a particular car which he said belonged to a black male by the name of "Howard." The informant told Detective Hackett that Howard would sell controlled drugs without a prescription. Detective Hackett thereupon gave his informant $20 in Hialeah Police Department "investigation funds" and instructed him to go inside and attempt to buy Darvon from the black male previously identified by the informant as "Howard." The informant then proceeded into the pharmacy, followed immediately thereafter by Detective Hackett. The informant identified the black male inside behind the counter as "Howard." Detective Hackett later checked the license number on the car identified as belonging to Howard, the individual in the pharmacy at the time, and identified by the informant, as being registered to the Respondent, Howard Newman. The informant, under the observation of Detective Hackett, engaged the individual identified by that means as the Respondent Howard Newman in a conversation. The Respondent went into the back room area of the pharmacy, returning a few minutes later and again conversing with the police informant. The Respondent then returned to the "back room" and returned with a medication container marked "Valium." The informant thereupon gave the Respondent the subject $20 in cash and the Respondent gave him the container. The container proved, after laboratory tests, the results of which are in evidence, to contain 60 Dextropropoxyphene tablets, commonly known as Darvon. Darvon is a scheduled, controlled drug, the dispensing of which must be accompanied by a prescription. The Respondent thus sold this controlled substance without being furnished a valid prescription or authorized refill therefor while the Respondent was licensed to practice pharmacy in this state.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence in the record and the candor and demeanor of the witnesses, it is RECOMMENDED: That the license of the Respondent, Howard Newman, and the community pharmacy permit of the Respondent Bek-New Chemist be revoked without prejudice to those Respondents reapplying for licensure and permitting upon a proper show of rehabilitation. DONE and ENTERED this 23rd day of June, 1983, in Tallahassee, Florida. P. MICHAEL RUFF 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 23rd day of June, 1983. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Howard Newman 3690 Northwest 199th Street Carol City, Florida 33054 Wanda Willis, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues are those promoted by an administrative complaint brought by the State of Florida, Department of Professional Regulation, against the Respondent, Charles McArthur. In particular, it is alleged that the Respondent practiced pharmacy in the state of Florida with an expired license, in violation of Subsection 465.015(2)(b), Florida Statutes (1981).
Findings Of Fact Respondent, Charles McArthur, is a pharmacist licensed by the State of Florida. His license number is 0012091. On June 20, 1983, Respondent attempted to renew his pharmacy license issued by the state of Florida on a bi-annual basis. He attempted this renewal by appearing in person before officials with the State of Florida, Board of Pharmacy, entitled to grant renewal. That renewal was denied based upon the fact that the Respondent was unable to provide verification of the requisite continuing education credits necessary for relicensure. As a consequence, on June 21, 1983 Respondent's active pharmacy license expired, leaving the Respondent with an inactive pharmacy license. For the period June 21, 1983 through July 20, 1983 Respondent practiced pharmacy with an inactive license. During that time frame, Thomas Hannah, an investigator with the State of Florida, Department of Professional Regulation, visited the Respondent in the pharmacy in which Respondent was practicing in Tallahassee, Florida. He observed the Respondent practice pharmacy and noted the presence of the expired active Florida pharmacy license. On that occasion, Hannah told the Respondent that he was operating without a current license. On the following day, July 20, 1953, Respondent paid the appropriate fees and made proof of the requisite continuing education credits and his active pharmacy license was re-issued. Subsequent to that date Respondent has held an active pharmacy license issued by the State of Florida. In view of the Respondent's practice of pharmacy with an inactive license from the period of June 21, 1983 through July 20, 1983, Respondent was charged with the present offense and requested, and was granted, a formal Subsection 120.57(1), Florida Statutes, hearing. In dealing with other recalcitrant licensees who have not renewed their licenses in the time allotted, the Board of Pharmacy, prior to February, 1980 sent a list to Board inspectors within one or two weeks following the due date of renewal and those inspectors contacted the licensees to ascertain whether the licensees had renewed their pharmacy licenses. If they found that the individual pharmacist did not renew his license that person was given an opportunity to fill out an application, to pay the fee, and to present his continuing education credits to the investigator. Persons who were not entitled to renew due to problems with the continuing education credits were told that they were delinquent, and practicing with a delinquent license was a violation of law. Those persons were given the opportunity to take leave of absence from their active pharmacy practice. Around February, 1980 due to the re- organization of the State of Florida, Department of Professional Regulation, insufficient work force was available to carry out this process of checking on the topic of the delinquent license renewals, and this sequence of inactivity continued until approximately December, 1981. During this period actions were not brought against pharmacists for failure to timely renew a license to practice pharmacy, within the meaning of Section 465.015(2)(b), Florida Statutes, provided they renewed licenses within one year of the appropriate renewal date. In December, 1981 the practice changed and the pharmacists would be prosecuted for failure to timely renew a license to practice pharmacy and continuing to practice with an expired license. This change in policy position which occurred in December, 1981 was not shown in the course of the hearing to be a matter noticed for the benefit of the practicing pharmacists in the State of Florida.
The Issue The issue presented at the final hearing was whether the Respondents' Eddy and Edith Portillo pharmacy permit should be revoked or suspended for the acts of a licensed pharmacist hired by the Respondents who engaged in unprofessional and bad faith dispensing of methaqualone as alleged in the Administrative Complaint filed May 26, 1982. John McDonough, a Department medical investigator, John Statnik, a community pharmacist and licensed pharmacist, and Sidney Simkovitz, a retired pharmacist, testified for the Petitioner. Petitioner's Exhibits 1-3 were offered and admitted into evidence. The Respondent Eddy Portillo testified on his own behalf and Respondents' Exhibit 1 was admitted as a late-filed exhibit. A proposed Recommended Order has been submitted by the Petitioner. To the extent that the proposed findings submitted by Petitioner are not reflected in this Order, they were rejected as being either not supported by the weight of admissible evidence or as being irrelevant to the issues determined here.
Findings Of Fact The Respondents Eddy and Edith Portillo hold pharmacy permit number 7276 for Federgo Discount Center, which is located at 1881 79th Street Causeway, North Bay Village, Miami Beach, Florida. Federgo Discount Center is a discount dry goods facility housed in a building of approximately 3,000 square feet. A small portion of the store is occupied by a pharmacy. The Respondent Eddy Portillo is the manager of the entire facility. Since Portillo was not a licensed pharmacist, he hired Michael Interess, a state licensed pharmacist, to operate the pharmacy portion of the store. Pursuant to a "contract work agreement" executed between the Respondent Eddy Portillo and Interess, net profits from the operation of the pharmacy were divided 40 percent to the pharmacist and 60 percent to the store following the deduction of certain delineated items from gross profits. In effect, the pharmacist's wages were based on his success in operating the pharmacy since he was not paid any guaranteed wage. A drug diversion audit conducted by the Petitioner established that the following amounts of methaqualone were dispensed by the pharmacy: November 1, 1981 through February 15, 1982; 56,386 Methaqualone dispensed. June 1, 1980 through February 15, 1982; 251,230 Methaqualone dispensed. When compared to all other Schedule II drugs dispensed by the pharmacy, the percentage of methaqualone dispensed during the audit period was 76.96 percent. No evidence was presented concerning the amount of methaqualone as a percentage of total prescription sales. Based on a seven-day week, approximately 14 methaqualone prescriptions were filled every day of the audit period by the pharmacy. As manager and cashier of the center, the Respondent Eddy Portillo spent a considerable amount of time within the store. The Respondent Portillo received a daily log of all drug sales which indicated the amount of sales in order to compensate Interess, the pharmacist. Although the Respondent Eddy Portillo knew the pharmacy was filling methaqualone prescriptions, he believed the percentage of methaqualone dispensed to be reasonable in relation to total prescription sales. The pharmacy received a large number of methaqualone prescriptions due to its geographical proximity to physicians who apparently frequently prescribed this drug.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered by the Board of Pharmacy dismissing the Administrative Complaint against the Respondents. DONE and ORDERED this 17th day of June, 1983, in Tallahassee, Florida. SHARYN L. SMITH, 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 17th day of June, 1983.
Findings Of Fact At all times relevant hereto, respondent, Cuca Pharmacy, Inc. (Cuca), held community pharmacy license number PH007348 issued by petitioner, Department of Professional Regulation Board of Pharmacy. When the events herein occurred, Hortensia Lopez-Perez was its president and permittee. Its location is 11048 West Flagler Street, Miami, Florida. After the events herein occurred, the pharmacy was closed by emergency suspension order and it has remained closed since that time. In February, 1984 special agent Alberto Fernandez was performing undercover operations in the Miami area for the Drug Enforcement Agency (DEA) for the purpose of enforcing federal narcotic laws. On February 17, he received information from an informant that ten kilograms of cocaine could be purchased for $21,000.00 per kilogram from two individuals named Zayas and Santos. He was told the cocaine was stored at respondent's pharmacy. Fernandez met the two "dealers" in Hialeah but Zayas and Santos were unable to produce any drugs. Consequently, no sale took place. On February 25, Fernandez again received a telephone call from his informant and was told to go to Cuca and meet an individual named Jesus Avila who was interested in selling some cocaine. Fernandez, Avila and the informant met in the rear of the pharmacy where Avila agreed to sell ten kilograms of cocaine to Fernandez for an undisclosed price. They further agreed to meet in a nearby shopping center where Fernandez would show his money and Avila would show the drugs as a good faith gesture. If both parties were satisfied, they agreed to then make the transfer at Cuca. Fernandez went to the shopping center but when Avila did not appear at the designated time, Fernandez returned to Cuca. Respondent's permittee, Hortensia Perez, advised him the drugs were on the way and not to worry. Later on that day, Fernandez received a telephone call from his informant advising that two kilograms had just arrived at Cuca and to return there for the buy. When he returned he met Avila and Lopez-Perez and went to the back of the store. Avila told Fernandez he couldn't sell cocaine that day but could arrange to do so in a few days. On February 29, Fernandez received another telephone call from his informant who advised him that the cocaine was at Cuca and to be there at 3:00 p.m. At the designated time, Fernandez, the informant and Lopez-Perez went to the rear of the pharmacy where Lopez-Perez pulled a clear plastic bag containing a white powdery substance from a metal cabinet and gave it to Fernandez. The transfer of the substance was made without a prescription. Lopez-Perez was then arrested for allegedly violating federal narcotic laws. The contents of the bag were later subjected to a chemical analysis and found to weigh 2.2 pounds (one kilogram) and to be 95 percent pure cocaine hydrochloride, a controlled substance and legend drug which requires a prescription for dispensing. Records of Miami area drug wholesalers introduced into evidence reflected that Cuca had not ordered any cocaine for prescription purposes between 1982 and June, 1984. This was confirmed by testimony from Cuca's prescription department manager. Lopez was charged with one count of conspiring to possess with intent to distribute a controlled substance (cocaine) in violation of Title 21, U.S.C., Section 846, and with one count of possessing with intent to distribute a controlled substance (cocaine) in violation of Title 21, U.S.C., Section 841(a)(1) and Title 18, U.S.C., Section 2. She was found guilty on both counts, and a certified copy of the judgment and probation/commitment order dated August 16, 1984 was received in evidence. That document reflects she was sentenced to five years confinement and three years of special parole on count two and five years probation on the first count. Lopez is free on bond while she appeals that judgment.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty as charged in the first and second administrative complaints and that its license as a community pharmacy be REVOKED. DONE and ORDERED this 13th day of January 1986, in Tallahassee, Florida. DONALD R. ALEXANDER 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 13th day of January, 1986.
Findings Of Fact Respondent holds community pharmacy permit number 0007857, which is issued for the location of 7121 West Flagler Street, Miami, Florida 33144. Filimon Galo is the president, and Miriam Galo is the secretary of Gamy Discount Pharmacy, Inc. On December 9, 1985 and on December 11, 1985, investigators for the Department of Professional Regulation conducted a routine pharmacy inspection of Gamy Discount Pharmacy, Inc. They re-inspected Respondent on January 22, 1986. During each of those inspections, Respondent's prescription department was unclean, unsanitary, and overcrowded. During those inspections, the investigators located several outdated medications in the prescription department. Those medications seized on January 22, 1986, bore expiration dates more than 4 months prior to the date of that inspection. Those medications which were seized by Petitioner contained medicinal drugs and are also known as pharmaceuticals. During the January inspection Respondent had no sign displayed stating the hours when the prescription department is open. During each of Petitioner's inspections, the pharmacy had no sign posted concerning generically equivalent drugs. There was no negative drug formulary in the pharmacy at the time of the inspections. On January 22, 1986, the investigators found one container of a prescription drug--prolizin, a medicinal drug-- which was located outside of the prescription department. During the January inspection, no pharmacist was employed at Respondent's pharmacy. During the January inspection, one vial was seized which bore a handwritten label stating "Diabinol." This vial actually contained a generic equivalent of Diabinol. The vial was misbranded in that it was false or misleading by being labeled with the "brand name" instead of the generic name and did not contain the name and place of business of the manufacturer. During the January inspection, a second vial was located which bore no label. This vial contained a medicinal drug Tranxene and was misbranded in that it did not contain the name and place of business of the manufacturer. During the inspections, prescriptions for controlled substances were discovered which did not contain the name and address of the person for whom the controlled substance was dispensed, the initials of the pharmacist filing the prescription, or the date on which the prescription was filled. During the inspections, Respondent pharmacy had no current drug compendium.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, therefore, RECOMMENDED that a Final Order be entered revoking Respondent's community pharmacy permit. DONE and RECOMMENDED this 19th day of December, 1986, at Tallahassee, 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 19th day of December, 1986. COPIES FURNISHED: Rod Presnell, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Enrique Miranda, Esquire 2542 SW 6th Street Miami, Florida 33135 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wings S. Benton, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
