Findings Of Fact Based upon my observation of the witnesses, their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I make the following findings of fact: The Department of Health and Rehabilitative Services (??"HRS") is the regulatory agency charged with the administration of Chapter 499, Florida Statutes, which includes the issuance of permits to operate a drug wholesale facility. Sometime prior to December, 1986, Petitioner, Vetco International, Inc. d/b/a Pompano Vet Supply ("Vetco") was issued Wholesale Drug Permit Number 03:00375 by the Pharmacy Program of HRS. On December 15, 1986, HRS received an application from Thomas Karpinski, owner of Vetco, to renew Vetco's drug wholesale permit for 1987. On December 17, 1986, HRS denied Vetco's application for renewal of its wholesale drug permit for the year 1987. Vetco requested a formal administrative hearing on the denial and the matter was referred to the Division of Administrative Hearings where it was assigned Case No. 87-0832. A hearing was held in that case on August 18, 1987 by Hearing Officer, James Bradwell of the Division of Administrative Hearings. On March 28, 1988, Hearing Officer Bradwell entered a Recommended Order recommending that Vetco's renewal application for the year 1987 be denied. The basis for that recommendation was that the applicable statutes and rules required that facilities where drugs are held be made available for inspection; that on several occasions Vetco's facility was not made available to authorized agents of HRS for inspection; and that Vetco's denial of inspections to HRS constituted a substantial violation of Chapter 499, Florida Statutes and Rule 10D-45, Florida Administrative Code. Hearing Officer Bradwell's Recommended Order was approved and incorporated in a Final Order by HRS dated April 20, 1988. On May 16, 1988, Vetco filed a Notice of Administrative Appeal to the Fourth District Court of Appeal regarding the Final Order issued by HRS on April 20, 1988. The case number assigned by the District Court of Appeal was Case No. 88-1342. On June 23, 1988, Vetco filed a Motion for Imposition of Automatic Stay with the Fourth District Court of Appeal seeking to stay the effect of HRS' April 20, 1988 Final Order. The Motion to Stay was granted by the Fourth District Court of Appeal on July 15, 1988. On December 28, 1988, the Fourth District Court of Appeal, per curiam, affirmed HRS' April 20, 1988 Final Order. The Mandate from the Fourth District Court of Appeal was issued on January 13, 1989. During the time period between the conclusion of the formal administrative hearing in August, 1987 and the issuance of the Recommended Order by Hearing Officer Bradwell in March, 1988, counsel for Vetco initiated efforts to obtain a renewal of the drug wholesale permit for the year 1988. Vetco contends that it did not receive the standard 1988 renewal application form typically sent by HRS prior to the beginning of the new year. By letter dated January 21, 1988, counsel for Vetco advised HRS that Vetco intended to keep its license in effect. In that letter, counsel for Vetco submitted a check for the amount of the renewal fee and provided certain other information required as part of the renewal process. During the period from January, 1988 through May, 1988, there were several exchanges between counsel for Vetco and the representatives of HRS regarding the renewal for the year 1988. HRS took the position that the January 21, 1988 letter from counsel for Vetco could not serve as a renewal application because it was not signed by the owner of the company and was not submitted on the appropriate HRS form. Vetco contends that the January 21, 1988 letter included all of the information legally required to process the renewal application and should have been treated as a renewal application. After exchanging correspondence and phone calls with counsel for Vetco and obtaining a signed form from Vetco, HRS acknowledged on May 24, 1988, that the renewal application was complete. On June 6, 1988, HRS denied Vetco's application for license renewal for the year 1988 citing the Final Order filed on April 20, 1988 and the Findings of Fact set forth in the Recommended Order entered by Hearing Officer Bradwell on March 28, 1988 in connection with the 1987 renewal application. By petition filed June 30, 1988, Vetco sought a formal hearing on the denial of its 1988 renewal application. The matter was referred to the Division of Administrative Hearings and assigned Case No. 88-3596. It is one of the two cases consolidated in the current proceeding. As noted above, by order dated July 13, 1988, the Fourth District Court of Appeal stayed the effect of the Final Order regarding the 1987 renewal application and, by agreement of the parties, Division of Administrative Hearings Case No. 88-3596 was abated pending the decision of the Fourth District Court of Appeal on the 1987 renewal. Thus, Vetco was able to continue business operations uninterrupted throughout 1987 and 1988. On January 6, 1989, Vetco applied for renewal of its drug wholesale permit for the year 1989. By letter dated January 17, 1989, HRS refused to renew Vetco's permit for 1989 citing the Fourth District Court Of Appeal's decision on the 1987 application. On February 2, 1989, Vetco filed a Petition for Formal Hearing challenging this denial. The Petition for Formal Hearing was transferred to the Division of Administrative Hearings and assigned Case No. 89-717. It is the second case involved in this current proceeding. By order dated April 19, 1989, Division of Administrative Hearings' Case Nos. 88-3596 and 89-717 were consolidated.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is: RECOMMENDED: Petitioner's application for renewal of its wholesale drug permit No. 03:00375 for the year 1988 be dismissed as moot and the application for renewal for the year 1989 be DENIED. DONE and ENTERED in Tallahassee, Leon County, Florida, this 23rd day of August, 1989. J. STEPHEN MENTON 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 23th day of August, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NOs. 88-3596 AND 89-0717 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Petitioner's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number Findings of Fact where accepted or reason for rejection 1 2-7 2-12 Adopted in part in Findings of Fact 13-16, otherwise rejected as irrelevant. 13 Adopted in part in Findings of Fact 17, otherwise rejected as irrelevant. 14 Rejected as irrelevant. 15 Adopted in part in Findings of Fact 18-19, otherwise rejected as irrelevant. 16 Adopted in part in Findings of Fact 9-12 and 20, otherwise rejected as irrelevant. 17-21 Rejected as irrelevant. The Respondent's Proposed Findings of Fact The proposed findings of fact in Respondent's Proposed Recommended Order are not numbered. The individual paragraphs are treated as though separately numbered. Proposed Finding Paragraph Number in Recommended Order of Fact Paragraph Findings of Fact where accepted Number reason for rejection 1 3 2 Adopted in part in Findings of Fact 4, otherwise rejected as irrelevant. 3 Adopted in part in Findings of Fact 5, otherwise rejected as irrelevant. 4 6 5 6-7 6 8-12 COPIES FURNISHED: Karen Coolman Amlong, Esquire Amlong & Amlong, P.A. 101 N.E. 3rd Avenue 2nd Fl. Fort Lauderdale, Florida 33301 John Rodriguez, Esquire Technical Health Services, Department of Health and Rehabilitative Services 1317 Winewood Boulevard Building 1, Room 304 Tallahassee, Florida 32399-070 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue Whether Petitioner has been substantially affected by agency statements made by Respondent, and, if so, whether the statements violate section 120.54(1)(a), Florida Statutes?
Findings Of Fact Petitioner, Harmony Environmental (Harmony), is duly- licensed as a Universal Waste Transporter Facility (UWTF) with the Florida Department of Environmental Protection (FDEP), holding EPA ID No. FLR000202424. Additionally, Harmony is registered as a Hazardous Waste Transporter by FDEP as well as the U.S. Department of Transportation (USDOT); a Used Oil Handler by FDEP; a Biomedical Waste Transporter by the Florida Department of Health; and as a Waste Transporter by Broward and Miami-Dade counties. Respondent is the state department charged with regulating drugs, devices, and cosmetics pursuant to section 20.165 and chapter 499, Florida Statutes. Respondent does not have jurisdiction over the permitting of universal waste transporters or over Florida Administrative Code Chapter 62-730. Respondent has not issued any permits or licenses to Petitioner. On May 20, 2014, Respondent’s Inspector Dr. Tram Vu inspected Petitioner. The Entry Notice and On-Site Inspection Report was included as an exhibit to the Petition filed in this matter. It makes reference to the “inspection” by Dr. Vu as one, “conducted under Ch. 499.051, F.S., and Rule 61N-1.019, F.A.C., to assess firm’s activities and compliance.” Respondent admitted the May 20th inspection was conducted under the authority cited in the report. On July 16 and 17, 2014, Dr. Vu again inspected Petitioner. A number of photographs were taken during the inspection. The photographs depict two large white containers referred to in the Petition and at the hearing as “yard super sacks.” Inspector Vu testified that the yard super sacks were sealed and that none of the “prescription drugs” photographed were found outside of the sealed Universal Pharmaceutical Waste (UPW) containers. Dr. Vu subsequently requested Petitioner to “voluntarily” quarantine the super sacks and a black tote, and a voluntary quarantine form was prepared and executed. The voluntary quarantine form states that it is “an alternative to the Florida Department of Business and Professional Regulation (‘DBPR’) removing some or all of the products for examination and sampling pursuant to Section 499.065(2), Florida Statutes.” Respondent issued a Notice of Intent to Deny (NOID) to Petitioner on August 18, 2014, regarding its application for a restricted drug distributor/destruction permit. The NOID concluded that Petitioner acted as a restricted drug distributor/destruction establishment without a license. The NOID cited rule 61N-1.023(4), which provides that such a permit is required for a person to take possession in Florida of a prescription drug for the purpose of arranging for its destruction. When asked by Petitioner in an interrogatory, “Are there any facts or circumstances that would cause the DDC to consider that a prescription drug has become UPW and no longer subject to its authority? If so, state or identify each and every such fact or circumstance.” Respondent answered, “No. The term ‘UPW’ is a term that is within the jurisdiction of another Florida state agency, the Department of Environmental Protection (DEP). A prescription drug is no longer a prescription drug when the nature of the prescription drug is altered or changed in a way that the active ingredient which causes the prescription drug to be a prescription drug is no longer active.” Reginald Dixon, the Director of the Division of Drugs, Devices, and Cosmetics (DDC), acknowledged that in his two years as Director, Respondent’s chapter 61N-1 has not contained any definition that addresses the difference between viable drugs and non-viable drugs and that it contains no reference to UPW. Mr. Dixon further acknowledged that chapter 61N-1 does not contain the statement that “[a] prescription drug is no longer a prescription drug when the nature of the prescription drug is altered or changed in a way that the active ingredient which causes the prescription drug to be a prescription drug is no longer active.” He further acknowledged that he is not aware of any federal or Florida law, rule, or regulation that provides the same or similar statement; and that chapter 61N-1 does not contain any definition or explanation as to how the change or alteration that may render the active ingredient inactive takes place. Respondent’s policy that a drug continues to be a prescription drug until its nature is altered or changed so that the active ingredient that makes it a prescription drug is no longer active applies not only to Petitioner. Such policy would apply to other entities engaged in a similar business, as well as to pharmacies, drug wholesalers, and hospitals when considering how to legally dispose of prescription drugs. Respondent takes the position that the UPW rule “is not a rule that belongs to DBPR” (Hr’g Tr. 62); that Respondent “does not have any jurisdiction over the DEP rules” (Hr’g Tr. 75); and that Respondent does “not look at the DEP rules to determine or use their determination of whether or not a drug is viable . . . or nonviable” (Hr’g Tr. 75). “To the extent that [the UPW] rule talks about viable and nonviable pharmaceuticals, that’s not something within our jurisdiction and we don’t deal with it” (Hr’g Tr. 78). Respondent admitted that it is important for regulated entities to know when the agency considered that a drug is no longer under its jurisdiction. Respondent also admitted that if other regulations exist that do not call prescription drugs “prescription drugs” anymore, but instead call them “solid waste, universal pharmaceutical waste or hazardous waste,” those statutes and regulations may “possibly” have a bearing on chapter 499 and chapter 61N-1. In response to Petitioner’s Request for Admissions, Respondent claimed to be “without knowledge” of whether the hazardous waste program under the Federal Resource Conservation Recovery Act (RCRA) established a “cradle to grave” system for controlling hazardous waste; and whether pursuant to 40 C.F.R. § 272.501, the Federal EPA approved the hazardous waste management program administered by the FDEP pursuant to chapter 403, Florida Statutes. Moreover, Respondent was “without knowledge” of whether the U.S. Food and Drug Administration (FDA) does not regulate drugs that have been discarded as hazardous or pharmaceutical waste; and that the FDA does not regulate generators or handlers of hazardous or pharmaceutical waste. Respondent also claimed to be “without knowledge” that some UPW is generated by hospitals during surgical procedures when a vial containing a standard dose of medication is not fully used because of the patient’s size or condition, with the unused dose “wasted” by placing it in a sealed, properly labeled UPW container; that hospitals that dispose of non-controlled and non-viable drugs in a properly labeled UPW container pursuant to rule 62-730.186, do not routinely create a list or inventory of the drugs being wasted or placed in the container that includes the name of the manufacturer, the name of the drug, the quantity, lot number, expiration date, or any combination of these elements; and that hospitals wasting non-viable controlled substances maintain a log that identifies the name and quantity of the controlled substance wasted, but not the manufacturer, the lot number, or the expiration date; and that such controlled substance log complies with DEA regulations as well as chapter 893, Florida Statutes. Mr. Dixon testified that the act of disposing of the unused portion of a prescription drug in a UPW container at a hospital that also contains sharps, broken glass, tissue, and bloody gauzes could constitute the adulteration of that prescription drug. Further, Mr. Dixon testified that when hospitals dispose of drugs in UPW containers they are “possibly” adulterating drugs, and when Petitioner picks up the UPW container, Petitioner may likewise “possibly” be holding adulterated drugs. Petitioner’s witness, Michelle Chambers, was accepted as an expert witness on UPW and related regulations, both state and federal. Although unpaid for her work due to being the spouse of Petitioner’s owner, she is the compliance coordinator, bookkeeper, and registered agent for Petitioner. Mrs. Chambers trains drug wholesalers how to manage their UPW by directing them to “utilize a return if they can get credit for the drug, but that once a drug becomes waste it falls under the guidelines of UPW and those drug wholesalers need to create a separate area that can handle UPW containers.” When discussing the process of sending UPW to a reverse distributor regulated by Respondent, Mrs. Chambers referred to the FDEP’s pharmaceutical waste guidelines, which state: Only pharmaceuticals with a reasonable expectation of credit can be sent to a reverse distributor. Drop pills, non- credible items, formulated mixtures, items with patient’s names, and raw chemicals cannot be sent to a reverse distributor for credit; thereafter, a waste determination is required and the decision must be made to manage this waste as hazardous waste or UPW waste. Mrs. Chambers stated she had knowledge of unexpired drugs, still in the original packaging that were declared waste by the wholesaler. She asserted that drug wholesalers abandoned or discarded the unexpired drugs in their original packaging because “they couldn’t send it back to a reverse distributor to get credit. There was just no value to it, whatsoever, so they decided to make that waste determination that this is waste, UPW.” Mrs. Chambers stated that UPW labels are attached to UPW containers in Petitioner’s facility, according to the FDEP rule regarding UPW. These labels represent the characteristics of the hazardous waste and other waste inside those containers. Some of the notations on the label refer to a substance, material, or a chemical product that is a prescription drug. She also testified that several documents may be created in the UPW process, such as a hazardous-waste manifest and a bill of lading. In records that a UPW handler is expected to maintain under FDEP rules, a UPW handler is not required to have those records contain the name of the drugs that are in the UPW containers, the manufacturer’s information, or the expiration date of the drugs in the UPW container. She asserted that Petitioner could not reasonably create inventories of all the drugs inside a UPW container because “some of the labels have been poured on by other elements within the container; some are unidentifiable; some are broken . . . it would be very difficult to create an inventory.” Based upon her audits of more than 200 hospitals, Mrs. Chambers stated that if a hospital has a procedure to put non-viable drugs in a UPW container, it is because they are trained to do so. She testified that no hospital she has ever audited has ever kept records that include drug names, manufacturers, or expiration dates for anything they have placed in the UPW containers. Petitioner picks up these containers and brings them to its facility. A UPW handler can add waste to the container, as well as consolidate those containers. Mrs. Chambers also discussed consumer packaging under rule 62-730.186(4)(a), which states: “Consumer packaging” means the packaging that surrounds and encloses a container, in a form intended or suitable for a healthcare or retail venue, or rejected during the manufacture process as long as it is enclosed in its bottle, jar, tube, ampoule, or package for final distribution to a healthcare or retail venue. Further, UPW handlers can conduct activities, including disassembling packages containing several pharmaceuticals into individual pharmaceuticals from consumer packaging. In her experience in the auditing of hospitals for UPW, as well as with Petitioner, Mrs. Chambers stated that controlled substances are put into UPW containers from time to time, yet Petitioner has never been cited or received a notice of violation from the DEA regarding the possession of a controlled substance. To her knowledge, the DEA has never notified any UPW handler in Florida of any violations for possessing controlled substances. Dr. Vu conducts inspections and investigations pursuant to chapter 499, specifically investigating unlicensed activities as well as inspecting facilities that are attempting to obtain a DDC permit. Dr. Vu was tendered and accepted as an expert in pharmacy and conducting inspections for Respondent pursuant to chapter 499. She testified that during her inspection of Petitioner on July 14, 2014, she pulled drugs from UPW containers to inspect them. She admitted there were no prescription drugs outside the UPW containers on Petitioner’s premises. She stated that Petitioner’s agents or employees volunteered to open the UPW containers for her inspection. The scant evidence Dr. Vu relied upon that Petitioner had any controlled substances on the premises was based upon documents she obtained from a third party as well as from Petitioner. She admitted there was no evidence of controlled substances on Petitioner’s premises. While Dr. Vu stated she is able to recognize prescription drugs when she sees them, she is not able to recognize UPW since she is “not trained in universal pharmaceutical waste.” She also stated she is not able to recognize a non-viable drug when she sees it. Dr. Vu has received no training from Respondent on the opening of UPW containers, and even though she has not been trained in UPW rules and definitions, she strongly asserted that Petitioner “[c]learly was in possession of prescription drugs,” and that Petitioner had no permit or authorization to possess prescription drugs. When asked about her understanding of when a prescription drug ceases to be a prescription drug, she replied that “a prescription drug is always a prescription drug unless it’s inactivated or loses its drug ability –- characteristics.” Dr. Vu noted that this understanding is not stated in chapter 61N-1 or chapter 499. David Laven, another drug inspector for Respondent, was tendered and accepted as an expert in pharmacy and issues related to the inspection for Respondent under chapter 499. He testified that Petitioner is not allowed to possess prescription drugs without a DDC permit. On cross-examination, however, he admitted he had not read the rule on UPW, has no knowledge of EPA rules and requirements, and that he is not trained to recognize a non-viable drug. He testified that he considers a prescription drug that is discarded in a UPW container still to be a prescription drug because “there’s still a possibility, depending on how that drug has been disposed of, the container may be partially full –- it can be a full container sometimes. Drugs are thrown in a container for a number of reasons, doesn’t necessarily mean that the drug is no longer viable or can be used in any way.” Regarding the definition of prescription drugs, Mr. Laven stated that “[a] drug is no longer viable or useable if it’s out of date, it’s been damaged in some way, compromised, mis-branded, [or] adulterated.” On October 6, 2014, Petitioner sent a Notice of Unadopted Rules letter to Respondent, stating that the conduct and statements set forth above constitute unpromulgated rules and that, according to section 120.595(4)(b), Florida Statutes, they have 30 days to begin proposed rulemaking in order to rectify the actions and statements made. Respondent did not begin proposed rulemaking in that 30-day period. Respondent presented no evidence or testimony to establish that rulemaking was not feasible or practicable.
The Issue Whether respondent committed the acts alleged in the Administrative Complaint, and, if so, whether respondent's license should be revoked or suspended, or whether other discipline should be imposed.
Findings Of Fact Respondent is a licensed pharmacist in the State of Florida, having been issued license number 005517, and was so licensed at all times material to the Administrative Complaint. The respondent is engaged in the practice of pharmacy at Interbay Discount Drugs, 4332 South Manhattan, Tampa, Florida, where he is the proprietor and the sole pharmacist. On April 23, 1986, Ms. Beth Christie, investigation specialist for the Department of Professional Regulation, conducted a pharmacy inspection of Interbay Discount Drugs. During the pharmacy inspection, Ms. Christie reviewed certain documents, including the Certified Exempt Narcotic Record of Retail Sales maintained by Interbay Discount Drugs. This record, or log, is required to be maintained by a pharmacist to reflect the pharmacist's dispensing of Schedule V drugs. The log must show to whom the Schedule V drug was dispensed, the date it was dispensed, and identify the dispensing pharmacist. The log is used to ensure that certain amounts of exempt drugs are not dispensed to the same customer within a 48-hour period. Since respondent was the sole pharmacist at Interbay Drugs, all the log entries are followed by his initials. Ms. Christie initially reviewed the log while conducting her inspection at Interbay Discount Drugs. She noticed the same names appearing over and over again throughout the log which covered approximately a two-year period. Subsequently, Ms. Christie reviewed the log more extensively and prepared a patient profile for Cynthia D. Anderson and Vester L. McDaniel based on the information contained in the log. The patient profiles contained the date the drug was dispensed to the patient, the drug dispensed, and the quantity. The patient profile revealed that Vester L. McDaniel received Robitussin AC, 2 oz., on the following dates in the 1 1/2-year period from November 30, 1984, through April 21, 1986: 11-30-84 04-25-85 08-20-85 11-21-85 02-08-86 12-04-84 04-27-85 08-22-85 11-23-85 02-10-86 12-11-84 05-02-85 08-24-85 11-26-85 02-12-86 12-15-84 05-07-85 08-27-85 11-30-85 02-14-86 12-20-84 05-11-85 08-29-85 12-03-85 02-17-86 12-22-84 05-16-85 09-02-85 12-04-85 02-18-86 12-27-84 05-21-85 09-05-85 12-07-85 02-21-86 12-31-84 05-25-85 09-07-85 12-10-85 02-24-86 01-05-85 05-27-85 09-10-85 12-12-85 02-26-86 01-10-85 05-29-85 09-12-85 12-14-85 02-28-86 01-15-85 06-03-85 09-14-85 12-17-85 03-03-86 01-22-85 06-07-85 09-17-85 12-19-85 03-10-86 01-29-85 06-11-85 09-21-85 12-21-85 03-12-86 02-02-85 06-15-85 09-26-85 12-23-85 03-14-86 02-06-85 06-18-85 10-01-85 12-26-85 03-17-86 02-09-85 06-22-85 10-03-85 12-28-85 03-19-86 02-12-85 06-28-85 10-08-85 12-31-85 03-21-86 02-16-85 07-02-85 10-10-85 01-02-86 03-24-86 02-18-85 07-06-85 10-12-85 01-04-86 03-26-86 02-21-85 07-09-85 10-14-85 01-06-86 03-28-86 02-23-85 07-13-85 10-15-85 01-08-86 03-31-86 02-26-85 07-16-85 10-22-85 01-11-86 04-02-86 03-01-85 07-18-85 10-24-85 01-14-86 04-04-86 03-05-85 07-20-85 10-26-85 01-16-86 04-06-86 03-08-85 07-23-85 10-29-85 01-18-86 04-09-86 03-14-85 07-30-85 10-31-85 01-20-86 04-11-86 03-18-85 08-01-85 11-02-85 01-22-86 04-14-86 03-23-85 08-03-85 11-05-85 01-24-86 04-17-86 04-04-85 08-06-85 11-07-85 01-27-86 04-19-86 04-06-85 08-08-85 11-09-85 01-29-86 04-21-86 04-10-85 08-10-85 11-14-85 01-31-86 04-18-85 08-13-85 11-16-85 02-03-86 04-20-85 08-17-85 11-19-85 02-06-86 In addition to the above, Mr. McDaniel received Terpin Hydrate with Codeine on September 19, 1985, and November 12, 1985. The record reveals that Mr. McDaniel received Robitussin AC, 2 oz., on October 14 and 15, 1985, and on December 3 and 4, 1985. The quantity of codeine contained in the Robitussin AC dispensed to Mr. McDaniel by respondent within the 48-hour period from 10-14-85 to 10-15-85 and the 48-hour period from 12-3-85 to 12-4-85 exceeded 120 milligrams. The patient profile of Cynthia D. Anderson revealed that Ms. Anderson received Robitussin AC, 2 oz. on February 24, 1984, and received Novahistine DH, 2 oz., on the following dates in the 2-year period from April 14, 1984, to April 23, 1986: 04-25-85 09-04-85 12-09-85 02-21-86 04-14-84 04-29-85 09-06-85 12-11-85 02-24-86 04-20-84 06-29-85 09-09-85 12-13-85 02-26-86 05-04-84 07-02-85 09-11-85 12-16-85 02-28-86 07-31-84 07-06-85 09-13-85 12-21-85 03-03-86 08-23-84 07-09-85 09-16-85 12-23-85 03-05-86 09-05-84 07-11-85 09-18-85 12-30-85 03-07-86 09-08-84 07-13-85 09-20-85 01-01-86 03-10-86 10-11-84 07-15-85 09-23-85 01-03-86 03-12-86 10-13-84 07-17-85 09-30-85 01-07-86 03-14-86 10-16-84 07-22-85 10-02-85 01-10-86 03-17-86 10-23-84 07-24-85 10-04-85 01-13-86 03-19-86 11-01-84 07-26-85 10-07-85 01-14-86 03-21-86 11-15-84 07-29-85 10-09-85 01-16-86 03-24-86 11-17-84 07-31-85 10-11-85 01-20-86 03-26-86 12-07-84 08-02-85 10-15-85 01-22-86 03-28-86 12-27-84 08-07-85 10-17-85 01-24-86 03-31-86 01-28-85 08-09-85 10-21-85 01-27-86 04-02-86 01-30-85 08-12-85 10-23-85 01-29-86 04-04-86 02-06-85 08-14-85 10-25-85 01-31-86 04-06-86 02-12-85 08-16-85 10-29-85 02-03-86 04-08-86 02-15-85 08-20-85 10-31-85 02-05-86 04-10-86 02-18-85 08-22-85 11-18-85 02-07-86 04-14-86 02-21-85 08-24-85 11-22-85 02-10-86 04-14-86 04-06-85 08-26-85 11-27-85 02-12-86 04-18-86 04-09-85 08-28-85 12-02-85 02-14-86 04-21-86 04-11-85 08-30-85 12-04-85 02-17-86 04-23-86 04-23-85 09-02-85 12-06-85 02-19-86 As the above shows, respondent dispensed Novahistine DH, 2 oz., to Ms. Anderson twice on April 14, 1986. 2/ The quantity of codeine contained in the Novahistine DH dispensed to Ms. Anderson on April 14, 1986, exceeded 120 milligrams. Ms. Christie asked respondent about the repeated dispensing of Robitusin AC and Novahistine DH to Mr. McDaniel and Ms. Anderson, and respondent stated that both complained of a chronic cough. However, Ms. Christie observed Ms. Anderson, who happened to purchase Novahistine DH while Ms. Christie was performing her inspection, and Ms. Anderson did not cough at all while she was in the store. Respondent also told Ms. Christie that he continued to provide the drugs to Ms. Anderson and Mr. McDaniel because "they were regular customers and purchased other items in his store [and] it would be awkward for him to refuse to sell the exempt narcotics to them." [T-30] Codeine is a very potent narcotic, and it can be addictive. Approximately 60 milligrams of codeine are contained in one ounce of Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine. Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine, in two ounce quantities, are Schedule V controlled substances. No more than two ounces of these drugs can be dispensed by a pharmacist to the same person within a 48-hour period without a prescription. Although Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine are cough depressants, there are much better things for people with chronic coughs than cough depressants that contain narcotics. A pharmacist who is presented with a request for Robitusin AC, 2 oz., by the same customer every two or three days should be very concerned and cautious. First, the pharmacist should be concerned about the health of the customer. A chronic coughing problem over a period of time should be treated professionally by a physician, not a pharmacist. A pharmacist should advise the customer to see a physician and refuse to sell the customer any more of the drug. Second, the pharmacist should be cautious because of the potential for abuse of the drug. It would be prudent for a pharmacist to refuse to dispense the drug after about three requests within a short period of time. To dispense Robitusin AC regularly over a two-year period cannot be considered dispensing the drug in good faith as a medicine. Any pharmacist dispensing the drug in good faith as a medicine would cease such regular dispensing of the drug long before two years had elapsed. The dispensing of Robitusin AC, 2 oz., and Terpin Hydrate with Codeine to Mr. McDaniel from November 30, 1984, to April 21, 1986, was not in good faith as a medicine. Novahistine DH is a essentially the same drug as Robitusin AC but made by a different company. The dispensing of Novahistine DH to Ms. Anderson from April 14, 1984, to April 23, 1986, was not in good faith as a medicine. Respondent admitted that he used poor judgement in dispensing the drugs to Mr. McDaniel and Ms. Anderson, but he denied that he dispensed the drugs not in good faith as a medicine. Mr. McDaniel was a heavy smoker and had a chronic cough. Respondent stated that he was just not aware that Mr. McDaniel had been receiving Robitusin AC for the period of time that he had. Respondent stated that Ms. Anderson had a family history of chronic bronchitis and respondent felt the medication was needed. Respondent also stated that he did not sell more than two ounces of either Robitusin AC or Novahistine DH to Ms. Anderson or Mr. McDaniel within a 48-hour period, although he admitted that his log reflected that such had occurred. Respondent contended that the customers had written in the wrong dates.
Recommendation Based upon the foregoing findings of fact and conclusions of law it is RECOMMENDED that the Board of Pharmacy enter a final order finding respondent committed those acts set forth in Counts I, II, III, and IV of the Administrative Complaint, imposing an administrative fine of $200 for each of the four counts, for a total fine of $800, and placing the respondent on probation for a period of one year under such terms and conditions as the Board may deem appropriate. DONE and ORDERED this 17th day of April 1987, in Tallahassee, Florida. DIANE A. GRUBBS 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 April 1987.
Findings Of Fact Based upon the record evidence, the following Findings of Facts are made: Idaliza Roman is employed by Respondent as a Collections Specialist II. She is assigned to Respondent's Plantation, Florida office. As part of her job responsibilities, she issues assessments against persons suspected of having engaged in illicit drug activity made taxable by Section 212.0505, Florida Statutes. On October 13, 1989, Roman issued such an assessment against Petitioner. She also issued and filed a tax warrant based on the assessment. The assessment alleged that, on or about August 16, 1989, Petitioner had engaged in a taxable transaction involving 27 kilograms of cocaine. In making this allegation, Roman relied exclusively upon information she had gleaned from a probable cause affidavit contained in a court file, as well as a laboratory report and a property room receipt. She conducted no further investigation into the matter before issuing the assessment. The probable cause affidavit upon which Roman relied reflected that Petitioner had been arrested on August 16, 1989, for a cocaine-related offense. It did not reveal, however, when the alleged offense had been committed. Roman assumed, erroneously, that it had been committed on or about the date of Petitioner's arrest. The arrest actually had been for an offense, involving substantially less than 27 kilograms of cocaine, that Petitioner had allegedly committed in January, 1989. The authorities had no information that Petitioner had been involved in any illicit, drug-related activity on or about August 16, 1989. On April 3, 1990, Roman discovered that the October 13, 1989, assessment against Petitioner and the tax warrant she had issued based on the assessment were incorrect. She thereupon issued and filed a "corrected" tax warrant.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that a final order be issued sustaining Petitioner's challenge to the October 13, 1989, jeopardy assessment issued against him and rescinding the assessment. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 21st day of May, 1990. 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 21st day of May, 1990.
The Issue Whether Respondent committed the violations described in the Administrative Complaint? If so, what disciplinary action should be taken against him?
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. Respondent is now, and has been since October 4, 1979, a licensed pharmacist in the State of Florida. He holds license number PS 0017661. In October of 1987, based upon Respondent's having the year before "pled guilty [in criminal court] to one count of grand theft and one count of possession of diazepam," the Board of Pharmacy suspended Respondent's license for a period of one year and placed him on probation for a period of three years, commencing upon the conclusion of his suspension. On February 4, 1991, February 11, 1991, February 19, 1991, March 6, 1991, and April 18, 1993, in exchange for cash, Respondent sold to Melvin Owens, who was serving as a confidential informant for the Drug Enforcement Administration, 3/ various quantities of drugs, to wit: quazepam, under the brand name of Doral (February 4, February 19, and March 6), triazolam, under the brand name of Halcion (February 4, February 11, February 19, March 6, and April 18), alprazolam, under the band name of Xanax (February 11, February 19, March 6, and April 18), and diethylpropion hydrochloride, under the brand name of Tenuate Dospan (March 6), without first being presented with a prescription for these drugs. All five transactions took place in Palm Beach County, Florida. Although Respondent was employed as a pharmacist at a Phar-Mor Discount Pharmacy (hereinafter referred to as "Phar-Mor") located in Palm Beach County at the time of these transactions, in selling these controlled substances to Owens, Respondent was not acting in the usual course of his professional practice as a Phar-Mor pharmacist. Respondent did not have a permit authorizing him to act as a drug wholesaler at the time of these transactions. On April 24, 1991, Respondent was indicted in federal court on five counts of unlawful distribution of controlled substances for his role in the above-described transactions. Subsequently, the Department issued a three-count Administrative Complaint charging Respondent with wrongdoing in connection with these transactions. Respondent pled guilty to the federal criminal charges pursuant to a plea agreement. Thereafter, Respondent was adjudicated guilty and sentenced to 60 days confinement, followed by two years of supervised release, on each count of the federal indictment, with the sentences to run concurrently.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board enter a final order finding Respondent guilty of the violations alleged in Counts I, II, and III of the Administrative Complaint and disciplining him for having committed these violations by revoking his license. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 12th day of October, 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 12th day of October, 1993.
