Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Pharmacy. Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondents. Respondent BGJM, Inc. (hereinafter "Save-on Drugs") holds Permit No. 7171 located at 4282 North State Road 7, Lauderdale Lakes, Florida. Save on Drugs has held said permit at all times material hereto. Respondent Robert E. Levy holds Pharmacy License No. 0017283 and has held said license at all times material hereto. Respondent Levy operated Save on Drugs as the sole proprietor and is the only pharmacist employed at the aforementioned store. Respondent Levy, while working at Save on Drugs, between the dates October 16, 1981 and April 2, 1982, dispensed approximately 139,000 Methaqualone tablets on 3,136 prescriptions. Respondent Levy ceased dispensing Methaqualone tablets approximately three (3) weeks prior to the institution of Petitioner's investigation of Respondent Levy's dispensing of controlled substances. The Respondent dispensed, over a three-month period, some 57,250 units of Methaqualone on behalf of one practitioner, a Dr. Lena. A specific breakdown of Dr. Lena's prescribing activity for part of the relevant period is as follows: DATE PHARMACY DRUG AMOUNT SCRIPT 12/14/81 Save-On Quaa-300 mg. 630 14 12/15 Save-On 720 16 12/16 Save-On 495 11 12/17 Save-On 765 17 12/18 Save-On 1,440 32 12/21 Save-On 945 21 12/22 Save-On 1 x 30 mg. 675 15 12/23 Save-On incl. 1,080 24 12/24 Save-On 1,215 27 12/28 Save-On 1,035 23 12/29 Save-On 1,305 29 12/30 Save-On 1,575 35 12/31 Save-On 1,305 29 Totals 13,185 293 The numerous prescriptions introduced into evidence by the Petitioner reflect circumstances where Respondent Levy failed to properly initial and date Schedule II prescriptions as they were filed. As example, Petitioner offered the following: prescription Nos. 48854, 48052, 50189, 48068, 48856, 48912 and 48905. Louis Fisher 2/ , an employee of the Department of Justice, Drug Enforcement Administration, since approximately November, 1971, has been involved with the regulation of controlled substances. Mr. Fisher works with doctors as well as pharmacists at the retail level. Mr. Fisher is a registered pharmacist and has been charged with drafting regulations for controlled substances. Without question, Methaqualone is a Schedule II drug and is a sedative and hypnotic agent. The drug has a high abuse potential. During the summer of 1982, Methaqualone was changed from Schedule II to a Schedule I controlled substance. After being provided with a hypothetical situation giving the number of prescriptions that Respondent Levy had filled during the time period involved, Mr. Fisher concluded that a pharmacist filling the number of prescriptions within the time period as is here involved by Respondent Levy was, in Mr. Fisher's opinion, unprofessional, excessive, outside the course of good professional practices, and not conduct amounting to professional practice in the patients' best interest. 3/ Dr. Lena was employed by Northeast Medical Services, a stress clinic. In this regard, the parties stipulated that all the prescriptions involved herein were written by a licensed medical doctor. Daniel O'Connell, an investigator with the Department of Professional Regulation, visited the Respondent's store during approximately October 1981, and performed a routine change of ownership inspection. At that time, Respondent Levy engaged in a conversation with investigator O'Connell at which time Respondent Levy was apprised of the problem with respect to dispensing Methaqualone in the south Florida area. Jim R. Golden, an investigator with the Department of Professional Regulation since approximately September 1981, visited Respondent Levy's store during April 1982, to perform a routine inspection to determine the amount of Schedule II drug prescriptions that Respondent was filling. Investigator Golden reviewed a large number of prescriptions that were filled by Respondent for Dr. Lena and inquired of Respondent the reason for dispensing such a large number of prescriptions for Methaqualone tablets. Respondent Levy replied that it was the "money end of it" and that he (Respondent) could fill six (6) Methaqualone prescriptions and do better with those prescriptions from a profit viewpoint than he could with the remainder of his other prescribing activities in the store for the remainder of any given day. Further, Respondent related that he hand to do extensive repairs to make the store operational. (Testimony of Investigator Golden)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That Respondent BGJM, Inc.'s Permit No.7171 be REVOKED. That Respondent Robert E. Levy's Pharmacy License No. 0017283 be placed on probation for a period of two (2) years. RECOMMENDED this 12th day of May, 1983, in Tallahassee, Florida. JAMES E. BRADWELL, 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 12th day of May, 1983.
The Issue Whether the Respondent committed the violations alleged in paragraphs 5 through 24 and 26 through 37 of the Corrected Second Amended Complaint, as modified, and, if so, the penalties that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency charged with the administration and enforcement of Sections 499.001 through .081. § 499.004, Fla. Stat. Worldwide Medical Supply is a prescription drug wholesaler who has been issued a permit, numbered 22:01390, to operate at 1452 North Krome Avenue, Suite 102F, Florida City, Miami-Dade County, Florida. On December 7, 2005, an inspection of Worldwide Medical Supply was conducted after a complaint against Worldwide Medical Supply was filed with the Department. Additional inspections were conducted in or about March 2006 and on May 15, 2007. During all three inspections, the Department's inspectors did not review all of the documents in Worldwide Medical Supply's files but took a sampling of the documents maintained by Worldwide Medical Supply relating to prescription drug sales and purchases. All of the drugs at issue herein are prescription drugs, also known as legend drugs. Paragraph 5 of the Corrected Second Amended Administrative Complaint, as amended; sale of prescription drugs to an unauthorized person in violation of § 499.005(15), Fla. Stat.; Petitioner's Exhibit 1.3 Petitioner's Exhibit 1 contains, in pertinent part, a Worldwide Medical Supply invoice, a Uniform Complaint Form, and a written report of an investigation conducted by the complainant, who was a drug agent. The Worldwide Medical Supply invoice, which is dated September 20, 2005, shows that five "Caverject Imp 20MCGKIT 2"4 were billed and shipped to "Health Environment" at an address in Hialeah, Florida. The Invoice includes a physician's license number and indicates that the Caverject was sent to the attention of "Amneris & Angel." The charge relating to this transaction arose out of a complaint and investigative report filed by a drug agent regarding the subject transaction, in which he reported that the physician whose number was included on the invoice was not employed by Health Environment at the time of the shipment. The Department did not present the testimony of the complaining drug agent, and the Sharon Roberts, one of the Department's inspectors who testified at the final hearing, stated that she had not conducted an investigation into the matter and had no personal knowledge of the matter beyond that which appeared on the invoice and in the report. The evidence related to the violation charged in paragraph 5 of the Corrected Second Amended Administrative Complaint is hearsay and cannot support a finding that the Caverject was delivered to an unauthorized person. See § 120.57(1)(c), Fla. Stat.( Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department is not, therefore, sufficient to establish that the Caverject was sold or transferred to a person who was not authorized to purchase or possess the prescription drug. Paragraph 6 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree in violation of §§ 499.005(14), (18), and (28) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 2. Petitioner's Exhibit 2 consists of a Picking Ticket, a Sales Order, an Invoice, and a Prescription (Legend) Drug Pedigree Form DH2129 ("Pedigree Paper")5 relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 13, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 15 12GM vials of Carimune and 35 6GM vials of Carimune. The Pedigree Paper was signed by a vice president of CT International, and the signature was dated October 10, 2005. The Pedigree Paper relates to the 35 6GM vials of Carimune sold to Worldwide Medical Supply, it identifies "ZLB" as the manufacturer, and lists "ZLB - CT International" as the "wholesaler's name." The Pedigree Paper does not identify the wholesaler that purchased the prescription drug from the manufacturer or the authorized distributor of record, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer or the authorized distributor of record. A stamp on the Pedigree Paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked much of the information that must be included in a pedigree paper, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted a failure to keep the required records of prescription drug transactions. The Department failed, however, to establish that CT International was not authorized to distribute prescription drugs in Florida. Although the records kept by prescription drug wholesalers of transactions involving prescription drugs must include the license number of the person distributing a prescription drug and the person purchasing the drug, the absence of the Florida license number of CT International constitutes an omission in the records. The omission is not, however, proof that CT International is not licensed in Florida, and the Department did not present any evidence to establish the Florida licensure status of CT International. Rather, Ms. Roberts, the Department's inspector, testified that she had no information regarding CT International's licensure status in Florida at the time of the sale of the Carimune because that "was not the issue."6 Paragraph 7 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree in violation of §§ 499.005(14), (18), and (28) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 3. Petitioner's Exhibit 3 consists of a Picking Ticket, a Sales Order, an Invoice, a Credit Memo, and a Pedigree Paper relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 17, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply seven 10ML units of Baygam intramuscular immune globulin. The Pedigree Paper was signed by a vice president of CT International, and the signature was dated October 18, 2005. The Pedigree Paper relates to the seven 10ML units of Baygam sold to Worldwide Medical Supply; lists "CT International" as the wholesaler; identifies "Bayer/Talecris" as the manufacturer; and identifies "McKesson Drug" as the wholesaler that purchased the prescription drug from the manufacturer. The Pedigree Paper does not identify the wholesaler that purchased the prescription drug from McKesson, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer by McKesson. A stamp on the pedigree paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The Baygam was returned by Worldwide Medical Supply to CT International, and a credit memo was issued to Worldwide Medical Supply refunding the cost of the drugs. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked much of the information that must be included in a pedigree paper, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. Paragraph 8 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 4. Petitioner's Exhibit 4 consists of a Picking Ticket, an Invoice, and two Pedigree Papers relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 7, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 14 6GM vials of Carimune and 15 12GM vials of Carimune. The Pedigree Papers for both the 6GM and the 12GM vials of Carimune were signed by a vice president of CT International, and the signatures were dated October 10, 2005. The Pedigree Papers identify "ZLB" as the manufacturer, and lists "ZLB - CT International" as the "wholesaler's name." The Pedigree Papers do not identify the wholesaler that purchased the prescription drugs from the manufacturer or the authorized distributor of record, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer or the authorized distributor of record. A stamp on the Pedigree Paper for the 12GM vials of Carimune indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply; there is no such stamp on the Pedigree Paper for the 6MG vials. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Papers provided by CT International and to review them for accuracy and completeness. The Pedigree Papers lacked much of the information that must be included in a pedigree paper, and they were, therefore, incomplete and could not be authenticated with the information provided. There was no indication that the Pedigree Paper relating to the 6GM vials of Carimune was reviewed for completeness, and the attestation that the Pedigree Paper relating to the 12GM vials of Carimune had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 6MG and 12MG vials of Carimune purchased by Worldwide Medical Supply from CT International were adulterated drugs in that the pedigree papers for the drugs were incomplete. Paragraph 9 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 33. Petitioner's Exhibit 33 consists of a Picking Ticket, an Invoice, and a Pedigree Paper relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 3, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 100 2ML units of Baygam intramuscular immune globulin. The Pedigree Paper was originated by First Choice Pharmaceutical Wholesalers and signed by its sales manager, with the signature dated July 18, 2005. The Pedigree Paper does not identify the manufacturer of the Baygam and no quantity of Baygam is listed; First Choice Pharmaceutical is identified as the wholesaler that purchased an unspecified quantity of Baygam from the manufacturer; and the Pedigree Paper indicates that the first subsequent wholesale distribution of the Baygam was to CT International. It appears that all of the required information is included in reference to CT International's purchase of Baygam from First Choice Pharmaceuticals, and Drew Arnold signed the Petitioner as the authenticator from CT International. Finally, the Pedigree Paper shows that the second subsequent wholesale distribution was to Worldwide Medical Supply in the amount of "100 vls." A stamp on the Pedigree Paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked the name of the manufacturer and the quantity of Baygam purchased by First Choice. The Pedigree Paper was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 100 2ML units of Baygam purchased by Worldwide Medical Supply from CT International were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 10 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 5. Petitioner's Exhibit 5 consists of a Sales Invoice and a document entitled "Pedigree" relating to a transaction between Medex BioPharm and Worldwide Medical Supply. The Invoice, which is dated August 31, 2005, indicates that Medex BioPharm shipped and billed to Worldwide Medical Supply 11 12gm units of Carimune NF. The pedigree paper is a form apparently generated by Medex BioPharm to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and it was signed by Medex BioPharm's compliance officer, with the signature dated September 6, 2005. The pedigree paper identifies the manufacturer of the Carimune as "ZLB" and indicates that Medex BioPharm purchased the Carimune as an "Authorized Distributor," but there is nothing in the pedigree paper regarding the source from which Medex BioPharm purchased the Carimune. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by Medex BioPharm, and, in addition, the pedigree paper was not issued prior to or at the same time the prescription drug was shipped. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medex BioPharm or of Worldwide Medical Supply. At the times relevant to the purchase of the Carimune by Worldwide Medical Supply, however, Medex BioPharm held two licenses in Florida, one as a pharmacy and one as a prescription drug wholesaler. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medex BioPharm and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was not sufficient to establish that Medex BioPharm was not authorized to distribute the Carimune identified in the Invoice and pedigree paper to Worldwide Medical Supply. Medex BioPharm had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Medex BioPharm's license number in the documentation of the sale constitutes only a recordkeeping error. As further proof that Worldwide Medical Supply purchased the Carimune from an unauthorized source, the Department presented the testimony of Ms. Roberts, one of the Department's inspectors. Ms. Roberts testified that she attempted to authenticate the purchase of the Carimune by Medex BioPharm and learned that Medex BioPharm was "purchasing [the Carimune] using their pharmacy license, and then, selling [the Carimune], using their wholesale license."7 According to Ms. Roberts, this practice is not permitted and renders the Carimune contraband drugs. Ms. Roberts did not, however, provide any more specific information regarding the purchase of the Carimune by Medex BioPharm. Ms. Robert's testimony is hearsay and cannot support a finding of fact that Medex BioPharm was not authorized to distribute prescription drugs to Worldwide Medical Supply. See § 120.57(1)(c), Fla. Stat. ("Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department was sufficient to establish that the 11 12gm units of Carimune NF purchased by Worldwide Medical Supply from Medex BioPharm were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 11 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 6. Petitioner's Exhibit 6 consists of a Packing Slip dated September 6, 2005, a Sales Invoice dated September 7, 2005, and a document entitled "Pedigree" relating to a transaction between Medex BioPharm and Worldwide Medical Supply. The Invoice, which is dated September 7, 2005, indicates that Medex BioPharm shipped and billed to Worldwide Medical Supply 20 2ml units of Baygam. The pedigree paper is a form apparently generated by Medex BioPharm to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and it was signed by Medex BioPharm's compliance officer, with the signature dated September 8, 2005. The pedigree paper identifies the manufacturer of the Baygam as "Talecris" and indicates that Medex BioPharm purchased the Baygam as an "Authorized Distributor," but there is nothing in the pedigree paper regarding the source from which Medex BioPharm purchased the Baygam or the date on which it was purchased. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by Medex BioPharm, and, in addition, the pedigree paper was not issued prior to or at the same time the prescription drug was shipped. A stamp on the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medex BioPharm or of Worldwide Medical Supply. At the times relevant to the purchase of the Baygam by Worldwide Medical Supply, however, Medex BioPharm held two licenses in Florida, one as a pharmacy and one as a prescription drug wholesaler. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medex BioPharm and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 33 above, the evidence presented by the Department failed to establish that Medex BioPharm was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 20 2ml units of Baygam purchased by Worldwide Medical Supply from Medex BioPharm were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 12 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 7. Petitioner's Exhibit 7 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated June 10, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 33 10gm units of Gammunex and 14 5gm units of Gammunex. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper was not signed or dated. The pedigree paper identifies the manufacturer of the Gammunex as "Bayer" and indicates that the distributor of record is "FFF" and that the Gammunex was purchased by FFF on June 8, 2005, but there is nothing in the pedigree paper regarding the source from which Medical Infusion Technologies purchased the Gammunex. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by FFF. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammunex.8 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. 48. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was not sufficient to establish that Medical Infusion Technologies was not authorized to distribute the Gammunex identified in the Invoice and pedigree paper to Worldwide Medical Supply. Medical Infusion Technologies had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Medical Infusion Technologies' license number in the documentation of the sale constitutes a recordkeeping error. The evidence presented by the Department was sufficient to establish that the 33 10gm units of Gammunex and 14 5gm units of Gammunex purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 13 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 8. Petitioner's Exhibit 8 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated June 16, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 25 units of Flebogamma. The exhibit also contains a document from Cardinal Health showing that, on June 14, 2005, it sold 25 units of Flebogamma to Medical Infusion Technologies. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is not signed or dated. It identifies the manufacturer of the Flebogamma as "Grifols" and indicates that the distributor of record is "Cardinal Health." An Invoice attached to the pedigree paper shows that the Flebogamma was sold to Medical Infusion Technologies by Cardinal Health, but the pedigree paper does not indicate the lot number and quantity of Flebogamma that Cardinal Health purchased from Grifols, nor does it or the Invoice indicate the dosage form of the Flebogamma purchased by Cardinal Health from Grifols. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Flebogamma.9 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 47 above, the evidence presented by the Department failed to establish that Medical Infusion Technologies was not authorized to distribute prescription drugs in Florida.10 The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. As further proof that Worldwide Medical Supply purchased the Flebogamma from an unauthorized source, the Department presented the testimony of Ms. Roberts that, when she attempted to authenticate the pedigree of the Flebogamma, she telephoned Cardinal Health and asked if they sold the Flebogamma to Medical Infusion Technologies: "They did confirm that they sold to Medical Infusion Technologies this product, but Cardinal explained to me that they sold to Medical Infusion Technologies as an end-user, like a pharmacy, which is not permitted for resale to a wholesaler."11 According to Ms. Robert's, an end- user may not sell a prescription drug to a wholesaler, and such a sale renders the Flebogamma contraband drugs. Ms. Roberts did not provide any more specific information regarding the purchase of the Flebogamma by Medical Infusion Technologies. Ms. Robert's testimony is hearsay and cannot support a finding of fact that Medical Infusion Technologies was not authorized to distribute prescription drugs to Worldwide Medical Supply. See § 120.57(1)(c), Fla. Stat. ("Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department was sufficient to establish that the 25 units of Flebogamma purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 14 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 9. Petitioner's Exhibit 9 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated November 8, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 100 units of Gammar P. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is not signed or dated. It identifies the manufacturer of the Gammar P as "Aventis" and indicates that the distributor of record is "Cardinal Health." The pedigree paper does not include the lot number and quantity of Gammar P that Cardinal Health purchased from Aventis, nor does it indicate the dosage form of the Gammar P purchased by Cardinal Health from Aventis. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Flebogamma.12 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 47 above, the evidence presented by the Department failed to establish that Medical Infusion Technologies was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 100 units of Gammar P purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 15 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of § 499.005(14); Petitioner's Exhibit 10. Petitioner's Exhibit 10 consists of an Order Acknowledgement, a Packing List, a Statement of Account, and an Invoice relating to a transaction between Lupin Pharmaceuticals, Inc., and Worldwide Medical Supply. The Invoice, which is dated August 16, 2004, indicates that Lupin Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply two units of Octagam 5%. Lupin Pharmaceuticals, Inc., was not required to provide a pedigree paper to Worldwide Medical Supply for the sale of the Octagam because Lupin Pharmaceuticals, Inc., is the manufacturer of the drug. It did not, however, have a manufacturer's license to ship prescription drugs to Florida from the address in Kentucky from which it shipped the Octagam to Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Octagam from an unauthorized person. Paragraph 16 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 11. Petitioner's Exhibit 11 consists of an Invoice, a copy of the same Invoice stamped "Paid," and a document entitled "Pedigree Statement" relating to a transaction between Premium Health Services and Worldwide Medical Supply. The Invoice, which is dated September 23, 2004, indicates that Premium Health Services shipped and billed to Worldwide Medical Supply 16 12gm vials of Carimune. The pedigree paper is a form apparently generated by Premium Health Services to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is signed by a "corporate officer" and dated September 23, 2004. The pedigree paper identifies the manufacturer of the Carimune as "ZLB Bioplasma" and indicates that Premium Health Services is the authorized distributor of the Carimune. The pedigree paper does not include the address, telephone number, or purchase invoice number for the purchase of the Carimune by Premium Health Services from ZLB Bioplasma.13 A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Premium Health Services or of Worldwide Medical Supply. The state database shows that Premium Health Services' Florida prescription drug wholesaler license expired on June 30, 2004. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department also was sufficient to establish that Premium Health Services was not authorized to distribute prescription drugs in Florida at the time it sold the Carimune to Worldwide Medical Supply. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 16 12gm vials of Carimune purchased by Worldwide Medical Supply from Premium Health Services were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 17 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 12. Petitioner's Exhibit 12 consists of a Packing Slip, an Invoice, a copy of the same Invoice stamped "Paid," and a Pedigree Paper relating to a transaction between Priority Pharmaceuticals and Worldwide Medical Supply. The Invoice, which is dated May 25, 2005, indicates that Priority Pharmaceuticals shipped and billed to Worldwide Medical Supply 10 10ml units of Baygam. The Pedigree Paper is signed by an individual who identifies himself as "Buyer"; the date of the signature is incomplete, giving the month but no day or year. The Pedigree Paper identifies the manufacturer of the Baygam as "Bayer" and also indicates that "Bayer" is the "authorized distributor of record" in addition to being the manufacturer. The Pedigree Paper shows a subsequent wholesale distribution to Worldwide Medical Supply, but the same individual that signed the Pedigree Paper also signed the subsequent distribution section as the "authenticator." A stamp on the Invoice marked "Paid" indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the 10 10ml units of Baygam purchased by Worldwide Medical Supply from Priority Pharmaceuticals were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 18 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 13. Petitioner's Exhibit 13 consists of five sets of documents relating to transactions between Prodigy Health Supplier Corporation and Worldwide Medical Supply on or about April 27, 2005, and May 11, 18, and 20, 2005. The Department has charged Worldwide Medical Supply in its Corrected Second Amended Administrative Complaint with four violations of Sections 499.001 through .081, Florida Statutes, each corresponding to a specific date.14 The first set of documents consists of a Picking Slip and Invoice dated April 27, 2005, together with a copy of the Picking Slip showing that it was posted April 28, 2005, and a copy of the Invoice showing that it was paid on May 11, 2005. The Invoice, which is dated May 25, 2005, indicates that Prodigy Health Supplier Corporation 30 10g vials of Gammar. No pedigree paper was included with the Invoices and Picking Slips. The evidence presented by the Department was, therefore, sufficient to establish that the 30 10g vials of Gammar were adulterated because they were not accompanied by a pedigree paper. The second set of documents consists of a Pedigree Paper dated May 17, 2005, and Picking Slip and Invoice dated May 11, 2005. The Invoice indicates that 20 6g vials and 10 3g vials of Carimune NF was sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 11, 2005. The Pedigree Paper indicates that ZLB Bioplasma is the manufacturer of the drugs and includes the NDC number, the lot numbers, and the quantity of the drug, which correspond to the lot numbers and quantity of the Carimune sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Carimune, but the invoice number and date identified on the Pedigree Paper are the invoice number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between ZLB Bioplasma and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution. The Pedigree Paper is signed by an individual who identifies himself as "VP"; the signature is dated May 17, 2005. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 6g vials and 10 3g vials of Carimune NF purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. The third set of documents consists of a Pedigree Paper dated May 17, 2005, and a Picking Slip and Invoice dated May 18, 2005. The Invoice indicates that 20 6g vials of Carimune NF were sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 18, 2005. The Pedigree Paper indicates that ZLB Bioplasma is the manufacturer of the drugs and includes the NDC number, the lot numbers, and the quantity of the drug, which correspond to the lot numbers and quantity of the Carimune sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Carimune, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between ZLB Bioplasma and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution history. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 6g vials of Carimune NF purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. The fourth set of documents consists of two Pedigree Papers dated May 20, 2005, and an Invoice dated May 20, 2005. The Invoice indicates that 20 10g vials of Gammar, five 10g units of Flebogamma, and 10 5g units of Flebogamma were sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 20, 2005. The Pedigree Papers indicate that ZLB Bioplasma is the manufacturer of the Gammar P and that Grifols Biologicals is the manufacturer of the Flebogamma; they include the NDC numbers, the lot numbers, and the quantities of the drugs, which correspond to the lot numbers and quantity of the Gammar P and Flebogamma sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper for the Flebogamma further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Flebogamma, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and the date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between Grifols Biologicals and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution history relating to the Flebogamma. The Pedigree Paper for the Gammar P indicates that Premium Health Services was the authorized distributor of record for the Gammar P and that Prodigy Health Supplier Corporation purchased the Gammar P from Premium Health Services, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between Grifols Biologicals and Premium Health Services. In addition, there is nothing on the Pedigree Paper for the Gammar P to indicate that the pedigree from Premium Health Services was authenticated by Prodigy Health Supplier Corporation. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 10g vials of Gammar, five 10g units of Flebogamma, and 10 5g units of Flebogamma purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 19 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 14. Petitioner's Exhibit 14 consists of an Invoice, a Pedigree Paper, and a facsimile transmittal cover page relating to a transaction between PMP Health Services and Worldwide Medical Supply. The Invoice, which is dated April 26, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply eight 10GM units of Gammagard S/D. The Pedigree Paper was apparently originated by PMP Health Services and was signed by an individual who identified himself as "Sec.," with the signature dated April 26, 2004. The Pedigree Paper identifies the manufacturer of the Gammagard as Baxter and includes the lot number and quantity of the drug.15 The invoice number and date below the information related to the manufacturer correspond to the Invoice and date relating to the transaction between PMP Health Services and Worldwide Medical Supply. Cardinal Health is identified on the Pedigree Paper as the authorized distributor of record of the Gammagard, and the subsequent wholesale distribution history shows that the Gammagard was purchased from Cardinal Health by a prescription drug wholesaler in Maryland whose name is illegible on the Pedigree Paper and that the Gammagard was purchased from this company by PMP Health Services. The Pedigree Paper does not contain the purchase date or invoice number for any of the transactions prior to the sale to Worldwide Medical Supply, nor is there any indication that the pedigree of the Gammagard was authenticated by the Maryland company or by PMP Health Services. A facsimile transmittal cover page includes a handwritten note that "This is the pedigree for the Gammagard" and appears to relate to the April 26, 2005, transaction. A stamp on the facsimile transmittal cover page indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of PMP Health Services or of Worldwide Medical Supply. PMP Health Services was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammagard. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by PMP Health Services and to review it for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was not sufficient to establish that PMP Health Services was not authorized to distribute the Gammagard identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. PMP Health Services had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include PMP Health Services' license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the eight 10GM units of Gammagard S/D purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 20 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 15. Petitioner's Exhibit 15 consists of an Invoice and a "Statement Identifying Pharmaceutical Sale" relating to a transaction between PMP Health Services and Worldwide Medical Supply. The Invoice, which is dated June 3, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply eight 10GM units of Gammagard S/D. The "Statement Identifying Pharmaceutical Sale" is a form apparently generated by PMP Health Services to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and was intended as a pedigree paper for the transaction. The pedigree paper is not signed or dated but includes under a paragraph entitled "Unauthorized Vendor Certification" the typewritten name of an individual who is otherwise unidentified. The pedigree paper identifies the manufacturer of the Gammagard as "Baxter" and also includes the NDC number, expiration date, and lot number of the drug. No quantity or dosage amount is included, however. The pedigree paper shows that PMP Health Services purchased the Gammagard from BioMed Plus, which is identified as an "Authorized Distributor"; there is no information regarding BioMed Plus's purchase of the drug or and no further information regarding PMP Health Services' purchase of the drug from BioMed Plus. A stamp on the Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the eight 10GM units of Gammagard S/D purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 21 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 16. Petitioner's Exhibit 16 consists of an Invoice and a Pedigree Paper dated June 21, 2004, and an Invoice and a Pedigree Paper dated July 19, 2004, relating to two transactions between PMP Health Services and Worldwide Medical Supply. The Invoice dated July 19, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply 32 10GM units of Gammunex 10%.16 The Pedigree Paper related to the July 19, 2004, transaction was apparently originated by PMP Health Services and was signed by an individual who identified himself as "Sec.," with the signature dated July 19, 2004. The Pedigree Paper identifies Bayer as the manufacturer of the Gammunex and includes the lot number and quantity of the drug.17 The invoice number and date below the information related to the manufacturer correspond to the Invoice and date relating to the transaction between PMP Health Services and Worldwide Medical Supply. "PHC" is identified on the Pedigree Paper as the authorized distributor of record of the Gammunex, and the subsequent sales history shows that the Gammunex was purchased from PHC by PMP Health Services. The Pedigree Paper contains the purchase date, but it does not include the invoice number for the purchase by PMP Health Services from PHC, nor is there any indication that the pedigree of the Gammunex was authenticated by PMP Health Services. A stamp on the July 19, 2004, Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of PMP Health Services or of Worldwide Medical Supply. PMP Health Services was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammunex. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by PMP Health Services and to review them for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was not sufficient to establish that PMP Health Services was not authorized to distribute the Gammunex identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. PMP Health Services had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include PMP Health Services' license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 32 10GM units of Gammunex 10% purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 22 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of § 499.005(14); Petitioner's Exhibit 17. Petitioner's Exhibit 17 consists of a Sales Order Pick Suggestion and Invoice dated June 7, 2005, and a Sales Order Pick Suggestion and Invoice dated June 22, 2005, relating to two transactions between Questcor Pharmaceuticals, Inc., and Worldwide Medical Supply. The Invoice dated June 7, 2005, indicates that Questcor Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply five units of Acthar; the Invoice dated June 22, 2004, indicates that Questcor Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply five units of Acthar. Questcor Pharmaceuticals, Inc., was not required to provide a pedigree paper to Worldwide Medical Supply for the sale of the Acthar because it is the manufacturer of the drug, but it did not have a manufacturer's license to distribute prescription drugs in Florida from the address in Kentucky from which it shipped the Acthar to Worldwide Medical Supply. It did, however, have a manufacturer's license to distribute prescription drugs in Florida from an address in California. The evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Acthar from an unauthorized person on June 7 and 22, 1005. Paragraph 23 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 18. Petitioner's Exhibit 18 consists of an Invoice dated March 5, 2004, and an Invoice dated October 16, 2003, relating to two transactions between FPP Distribution, Inc., acting as "Logistic Service Providers for: RxBazaar.com," and Worldwide Medical Supply. The Invoice dated October 16, 2003, indicates that FPP Distribution, Inc. shipped and billed to Worldwide Medical Supply 60 10GM tabs of Zyprexa. A handwritten notation appears on this Invoice indicating that the Zyprexa was "Returned for no (1) Pedigree Papers (2) RxBazaar not license [sic] in State of Florida for wholesale distribution." The Invoice dated March 5, 2004, indicates that FPP Distribution, Inc., shipped and billed to Worldwide Medical Supply 3 5MG units of Aricept.18 No pedigree paper was included with the Invoice, and there is no indication that the Aricept was returned. As noted by Worldwide Medical Supply on the October 16, 2003, Invoice, RxBazaar.com was not licensed to distribute prescription drugs in Florida at the time relevant to the sale of the Zyprexa, and neither it nor FPP Distribution, Inc., was licensed to distribute prescription drugs in Florida at the time relevant to the sale of the Aricept. Because neither FPP Distribution, Inc., nor RxBazaar.com was licensed to distribute prescription drugs in Florida at the time relevant to the March 5, 2004, transaction, the evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Aricept from an unauthorized person. However, even though Worldwide Medical Supply did purchase Zyprexa from FPP Distribution, Inc./RxBazaar.com, the evidence establishes that Worldwide Medical Supply returned the shipment and, therefore, for purposes of a separate violation of Sections 499.001 through .081, Florida Statutes, the evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply completed the purchase of the Zyprexa from an unauthorized person. The evidence presented by the Department was sufficient to establish that the 3 5MG units of Aricept purchased by Worldwide Medical Supply from FPP Distribution, Inc./RxBazaar.com were adulterated drugs in that no pedigree paper was provided for the drugs. Finally, no pedigree papers are included in Petitioner's Exhibit 18, and there is no representation on either the October 16, 2003, or the March 5, 2004, Invoices that anyone at Worldwide Medical Supply authenticated the prescription drug pedigrees. Therefore, the evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply fraudulently authenticated the pedigrees of these drugs. Paragraph 24 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 19.19 Petitioner's Exhibit 19 consists of an Invoice and four documents entitled "Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act," which apparently are intended to be pedigree papers, relating to a transaction between Allscripts Healthcare Solutions and Worldwide Medical Supply. The Invoice, which is dated February 2, 2004, indicates that Allscripts Healthcare Solutions shipped and billed to Worldwide Medical Supply 30 200mg tabs of Diflucan; 60 2mg tablets of Risperdal; 60 10mg tabs of Zyprexa; and 60 20mg tabs of Zyprexa. Allscripts Healthcare Solutions provided a statement identifying prior sales to Worldwide Medical Supply for each of these four prescription drugs; these statements were apparently intended to be pedigree papers for each of the drugs. The statements identify the manufacturer and NDC number for each drug; include the bulk lot numbers and expiration dates for the drugs; indicate that Allscripts Healthcare Solutions sold the drugs to Worldwide Medical Supply; provide Allscripts Healthcare Solutions' Florida Out-Of-State Prescription Drug Wholesaler Permit number; identify Amerisource Bergen as the person from whom Allscripts Healthcare Solutions purchased the drugs; identify Amerisource Bergen as an authorized distributor for the drugs; and state that Amerisource Bergen did not provide pedigree documents to Allscripts Healthcare Solutions for the drugs. The statements did not include any information regarding the purchase of the drugs from the manufacturers. The evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply purchased the four prescription drugs from an unauthorized person. Allscripts Healthcare Solutions was properly licensed to distribute prescription drugs in Florida at the times of the transactions at issue. The evidence presented by the Department was sufficient to establish that the 30 200mg tabs of Diflucan, 60 2mg tablets of Risperdal, 60 10mg tabs of Zyprexa, and 60 20mg tabs of Zyprexa purchased by Worldwide Medical Supply from Allscripts Healthcare Solutions were adulterated drugs in that the statements intended to provide the pedigrees for the drugs were incomplete. Paragraph 26 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 21. Petitioner's Exhibit 21 consists of an Invoice, a Packing Slip, and a "Pedigree" relating to a transaction between ActSys Medical, Inc., and Worldwide Medical Supply. The Invoice dated December 22, 2004, indicates that ActSys Medical, Inc., shipped and billed to Worldwide Medical Supply 10 10ml vials of Baygam. The pedigree paper provided by ActSys Medical, Inc., identified the manufacturer of the Baygam as Bayer, and included the NDC number, the quantity, the lot number, and the expiration date of the drugs. The pedigree paper further identified ActSys Medical, Inc., as the supplier of the drugs and identified ActSys Medical, Inc., as the "authorized distributor." There is no further wholesale distribution history for the drugs in the pedigree paper; there is no information in the pedigree paper regarding the purchase of the drugs by ActSys Medical, Inc.; and the pedigree paper is not signed. A stamp on the December 22, 2004, Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of ActSys Medical, Inc., or of Worldwide Medical Supply. ActSys Medical, Inc., was not authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Baygam. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by ActSys Medical, Inc., and to review it for accuracy and completeness. The pedigree paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that ActSys Medical, Inc., was not authorized to distribute the Baygam identified in the Invoice and "Pedigree" provided to Worldwide Medical Supply. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 10 10ml vials of Baygam purchased by Worldwide Medical Supply from ActSys Medical, Inc., were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 27 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 22. Petitioner's Exhibit 22 consists of an Invoice, a copy of the Invoice marked "Paid," a Work Order, and a Pedigree Paper relating to a transaction between Florida Infusion/Nations Drug and Worldwide Medical Supply. The Invoice dated September 15, 2005, indicates that Florida Infusion shipped and billed to Worldwide Medical Supply 14 2ML units of Baygam Immune Globulin I.M. The Pedigree Paper provided by Florida Infusion identified the manufacturer of the Baygam as "Talecris," and included the NDC number, the quantity, the lot number, and the expiration date of the drugs. The Pedigree Paper further identified Florida Infusion as the "authorized distributor of record." There is no further wholesale distribution history for the drugs in the Pedigree Paper and there is no information in the Pedigree Paper regarding the purchase of the drugs by Florida Infusion.20 The invoice number and date included on the Pedigree Paper corresponds to the invoice number and date of the transaction between Florida Infusion and Worldwide Medical Supply. The Pedigree Paper is signed and dated September 19, 2005. A stamp on the September 15, 2005, Work Order indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Florida Infusion or of Worldwide Medical Supply. Florida Infusion was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Baygam. The evidence presented by the Department was not sufficient to establish that Florida Infusion was not authorized to distribute the Baygam identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. Florida Infusion had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Florida Infusion's license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by Florida Infusion and to review it for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the 14 2ML units of Baygam Immune Globulin I.M. purchased by Worldwide Medical Supply from Florida Infusion were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 28 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (18), and (29); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 23. Petitioner's Exhibit 23 consists of five Invoices and accompanying shipping documents and a sixth Invoice that is not accompanied by a shipping document; these documents relate to six transactions between Bellco Drug Corp and Worldwide Medical Supply. The first Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply eight 10ML units of Chorionic Gonad (N/RTN); the second Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 10 10ML units of Chorionic Gonad (N/RTN); the third Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 5 10ML units of Nubain Inj 10MG/ML N/f; the fourth Invoice, dated October 18, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply four 20ML units of Ceftriaxone DOD Inj 1GM and 4 2ML units of Thiamine HCL Inj 100MG/ML; the fifth Invoice, dated October 20, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 24 10CP units of Tamiflu 75MG; and the sixth Invoice, dated October 31, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply one 2ML unit of Baygam SDV and three 10CP units of Tamiflu 75MG.21 A stamp on the October 31, 2005, Invoice indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. No pedigree papers were, however, provided for any of the six transactions. The evidence presented by the Department was sufficient to establish that the prescription drugs purchased by Worldwide Medical Supply from Bellco Drug Corp on October 17, 18, 20, and 31, 2005, were adulterated drugs in that no pedigree papers were provided for the drugs. In addition, the evidence presented by the Department was sufficient to establish that Worldwide Medical Supply's purported authentication of the pedigrees of the drugs purchased from Bellco Drug Corp on October 31, 2005, was fraudulent. No authentication was possible because no pedigree paper was provided for the drugs. Paragraph 29 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (18), and (29); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 24. Petitioner's Exhibit 24 consists of a Packing List and three statements entitled "Prescription Drug Pedigree" relating to a transaction between BioMed Plus Miami and Worldwide Medical Supply. The Packing List, which is dated December 9, 2004, indicates that BioMed Plus Miami shipped and billed to Worldwide Medical Supply 35 5-gram units of Gammunex 10%; 15 10-gram units of Gammunex 10%; and 5 20- gram units of Gammunex 10%. The "Prescription Drug Pedigree" statements included with the Invoices were apparently created by BioMed Plus Miami. The three "pedigree" statements are not signed or dated. The statements identify the manufacturer of the Gammunex 10% as Bayer, and the only information included on the documents is the name and dosage of the drugs, the NDC numbers, the lot numbers, the expiration dates, and the quantities of the drugs expressed in grams. The statements include no information regarding the purchase of the Gammunex by BioMed Plus Miami or the wholesale distribution history of the drugs. A stamp on the Packing List indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the 35 5-gram units of Gammunex 10%, the 15 10-gram units of Gammunex 10%, and the 5 20-gram units of Gammunex 10% purchased by Worldwide Medical Supply from BioMed Plus Miami were adulterated drugs in that the pedigree papers for the drugs were wholly inadequate and incomplete. Paragraph 30 of the Corrected Second Amended Administrative Complaint, as amended; receipt of a prescription drug by a non- permitted facility in violation of §§ 499.005(14) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 25. Petitioner's Exhibit 25 consists of an Invoice and a Packing Slip relating to a transaction between Mercury Medical and Worldwide Medical Supply. The Invoice, which is dated October 13, 2006, indicates that Mercury Medical shipped 20 5ML units of flu vaccine to Rick Nielson at 7904 West Drive, Unit 1017, North Bay Village, Florida 33141 and billed the vaccine to Worldwide Medical Supply. At the time the vaccine was shipped, Rick Nielson was the certified designated representative of Worldwide Medical Supply, and the address to which it was shipped was Mr. Nielson's home address. Mr. Nielson's home was not a facility licensed to receive prescription drug in Florida. The evidence presented by the Department was sufficient to establish that the drug was adulterated because the drug was held by a person not authorized to do so, but the Department presented no evidence to establish that Worldwide Medical Supply was responsible for the shipment or that it committed a violation with respect to this transaction. Paragraph 31 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 26. Petitioner's Exhibit 26 consists of a Packing Slip, a Pedigree Paper, and copies of the Georgia and Florida licenses of Medical Infusion Technologies relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Packing Slip, which is dated April 25, 2006, indicates that a number of 3 gram vials of Carimune NF were shipped to Medical Infusion Technologies at an address in Bossier City, Louisiana. The Pedigree Paper prepared by Worldwide Medical Supply and dated March 6, 2007, indicates that Worldwide Medical Supply purchased nine of the 3 gram vials of Carimune from Medical Infusion Technologies, whose address was noted on the Pedigree Paper as 1525 Doctors Drive, Bossier City, Louisiana. Medical Infusion Technologies did not have a Florida license to distribute prescription drugs from its Bossier City, Louisiana, address. Medical Infusion Technologies' Florida license was issued to Medical Infusion Technologies at 115 Echols Street, Savannah, Georgia. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 32 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 27. Petitioner's Exhibit 27 consists of a two-page Invoice dated September 25, 2006, and an Order Pick Sheet dated October 10, 2006. These documents relate to transactions involving Broughton Pharmaceuticals, LLC, Worldwide Medical Supply, and an entity referred to as "Kuehne & Nagel - Dallas." The Invoice indicates that, on September 25, 2006, Broughton Pharmaceuticals, LLC, shipped and billed to Worldwide Medical Supply at an address in Dallas, Texas, "c/o Kuehne + Nagel, Inc. (Texas)," 702 6gm units of Carimune. The Order Pick Sheet indicates that, on October 10, 2006, Kuehne + Nagel consigned 46 6gm units of Carimune to Worldwide Medical Supply in Florida City, Florida, and a notation appears on the sheet that a particular Federal Express account was to be used. Kuehne + Nagel is a licensed wholesale distributor of prescription drugs in the State of Texas, as is Worldwide Medical Supply, but it is not licensed as a wholesale distributor of prescription drugs in the State of Florida. The evidence presented by the Department was sufficient to support an inference that the 46 6gm units of Carimune were shipped by Kuehne + Nagel to Worldwide Medical Supply in Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 33 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 28. Petitioner's Exhibit 28 consists of two Invoices and a two-page Pedigree Paper that relate to transactions involving Broughton Pharmaceuticals, LLC, Worldwide Medical Supply, and Kuehne + Nagel." The first Invoice indicates that, on September 25, 2006, Broughton Pharmaceuticals, LLC, shipped and billed to Worldwide Medical Supply at an address in Dallas, Texas, "c/o Kuehne + Nagel, Inc. (Texas)," 416 6gm units of Carimune. The second Invoice, dated September 29, 2006, indicates that Worldwide Medical Supply shipped and billed to Reliance Pharmaceuticals, LLC, 28 6gm units of Carimune from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold 28 6gm vials of Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006.22 As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 34 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 29. Petitioner's Exhibit 29 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Reliance Pharmaceuticals, LLC. The Invoice indicates that, on October 27, 2006, Worldwide Medical Supply shipped and billed to Reliance Pharmaceuticals, LLC, 45 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold 33 6gm vials of Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 35 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 30. Petitioner's Exhibit 30 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Juan F. Lamas, Inc., M.D. The Invoice indicates that, on October 16, 2006, Worldwide Medical Supply shipped and billed to Dr. Lamas 7 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 7 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 36 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 31. Petitioner's Exhibit 31 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Integrated Health Center of America, Inc. The Invoice indicates that, on October 10, 2006, Worldwide Medical Supply shipped and billed to Integrated Health Center of America, Inc., 20 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 20 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 37 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 32. Petitioner's Exhibit 32 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Dr. Wohlfeiler Piperato & Associates. The Invoice indicates that, on September 28, 2006,, Worldwide Medical Supply shipped and billed to Dr. Wohlfeiler Piperato & Associates 12 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 12 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. The violations committed by Worldwide Medical Supply are substantial, are of long duration, and involve a significant number of transactions relating to the sale and purchase of prescription drugs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding that Worldwide Medical Supply and Pharmaceuticals, Inc., has committed 37 violations of Sections 499.001 through .081, Florida Statutes; imposing an administrative of $185,000.00; and revoking the license of Worldwide Medical Supply and Pharmaceuticals, Inc., to operate as a prescription drug wholesale distributor. DONE AND ENTERED this 1st day of May, 2008, in Tallahassee, Leon County, Florida. PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 2008.
Findings Of Fact During an audit conducted in early August, 1975 by an agent for the Board of Pharmacy a substantial shortage of Dilaudid, Quaalude, and Tuinal was noted between the record of the amounts of these controlled drugs received and dispensed. Since no running inventory is required to be maintained the auditor commenced his audit with crediting Halcals with having none of these controlled drugs on hand January 1, 1975 and thereafter checking the prescriptions for drugs dispensed against the invoice of drugs received subsequent to January 1. In looking through the prescriptions numerous prescriptions appeared to the investigator to be forged and a subsequent check with the purported issuer disclosed that many of the prescriptions on file were in fact forged prescriptions. The Respondent stipulated that many of the prescriptions on file at Halcals were forged. No deduction was taken for the forged prescriptions, yet the audit showed more than 1600 tablets of the above based drugs had been received than could be accounted for by the prescriptions on file. Further, the audit revealed that approximately 80 percent of the forged prescriptions had been filled out by Respondent; and, also, that of the prescriptions audited, Steinberg filled 80 percent of the prescriptions for those controlled drugs found short on the inventory. Section 893.07 Florida Statutes requires every person dispensing controlled substances (e.g. pharmacists) to maintain on a current basis a complete and accurate record of each substance received and sold, delivered or otherwise disposed of by him. During the course of the audit Respondent acknowledged that on one occasion he "refilled" a prescription for 50 tablets of Dilaudid without recording same when the purchaser told him the original tablets given him tasted like saccharin. Testifying in his own behalf Respondent told of at least one theft in the pharmacy where drugs were stolen. He had no idea what happened to the missing drugs. Each pharmacist on duty is required to date and file all prescriptions and to keep the records of all invoices of controlled substances received. No running inventory is required; therefore, none is kept. Considerable evidence was presented that Respondent filled numerous prescriptions for the controlled drugs noted in the audit which he knew, or should have known, were forged. For filling many of these prescriptions Respondent received "tips". In his testimony Respondent recounted the situation which frequently occurred viz. that at frequent intervals A would present a prescription to Respondent and as soon as Respondent filled this prescription several other prescription holders immediately followed with similar prescriptions. Respondent further testified that he had no reason to suspect anything was wrong with these prescriptions. No charges were preferred against Respondent respecting the filling of any of those forged prescriptions, so all evidence with respect thereto is irrelevant to these proceedings and is disregarded by the hearing officer.
The Issue The issue is whether the pharmacy permit issued to the Respondent, North Florida Drug Corporation, d/b/a Scottie Discount Drugs, should be revoked or otherwise penalized based on the acts alleged in the Administrative Complaint.
Findings Of Fact North Florida Drug Corporation, d/b/a Scottie Discount Drugs, currently holds permit No. PH 0004096 as a Community Pharmacy. Respondent is located at 1448 Bakers Square, Macclenny, Florida. On December 24, 1987, Gustave Goldstein, who had been the designated prescription department manager for Respondent, resigned as a pharmacist at the Respondent's location. He notified Frankie Rosier, the owner and operator of the Respondent, that he was leaving and he notified the DPR that he would no longer be the designated prescription department manager. Carl Messina is the relief pharmacist for the Respondent. From the time of Goldstein's resignation, Messina has told Ms. Rosier many times that it is illegal to operate without a prescription department manager. DPR inspected the Respondent's pharmacy in December, 1987, and determined that there was no prescription department manager after Goldstein quit. DPR conducted an inspection of the Respondent's premises on February 16, 1988, and discovered that there still was no prescription department manager employed there. Frankie Rosier was made aware of this deficiency. On February 16, 1988, the official records of DPR showed that no new designation of a prescription department manager had been filed by Respondent and Goldstein was still listed as the prescription department manager by Respondent. On May 22, 1988, DPR again inspected the premises and determined that there was still no prescription department manager. It is important that each permittee have a designated prescription department manager to assure that all required records are kept and that the pharmacy complies with all legal requirements. This is especially important regarding control and accountability for controlled substances. Without a prescription department manager, a non-pharmacist owner, like Ms. Rosier, would and does have access to these controlled substances without any accountability. By Final Order entered and filed with the agency clerk on December 17, 1987, this same permittee was fined and placed on probation for operating a community pharmacy with an expired permit and for obtaining a permit by misrepresentation or fraud or through an error of the department or the board.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Professional Regulation, Board of Pharmacy, enter a Final Order finding North Florida Drug Corporation, d/b/a Soottie Discount Drugs, guilty of the violations alleged and revoking the community pharmacy permit No. PH 0004096. DONE and ENTERED this 14th day of October, 1988, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 1988. COPIES FURNISHED: Michael A. Mone' Staff Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 North Florida Drug Corporation Scottie Discount Drugs 1448 Bakers Square Macclenny, Florida 32063 Bruce Lamb General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether Respondent's permit to operate a pharmacy should be suspended or revoked for alleged violations of Sections 465.22(1)(c), 465.18(1)(b), 465.18(2)(b) F.S., and Rule 21S-1.14 F.A.C. At the hearing, Petitioner withdrew Count-I of the Complaint. Respondent's Motion To Dismiss Counts II and III of the Complaint at the conclusion of Petitioner's case in chief was denied.
Findings Of Fact Respondent presently holds and did so hold at the time of the events alleged in the Complaint a permit to operate a pharmacy issued by Petitioner (Stipulation.) Prior to the events alleged in the Complaint, Petitioner's agent, Vernon K. Bell, an inspector, obtained an authentic prescription from another pharmacy that had not been picked up by a customer, for use in investigations of other pharmacies. The prescription was issued by Dr. George A. Fernandez, Miami, Florida, Number 012194, dated December 11, 1975, to Fela Rivias and was for twenty-one tablets of Erythrocin, 250 miligrams. Erythrocin is an antibiotic prescription drug used for various infections (Testimony of Bell, Petitioner's Exhibit 1.) On December 19, 1975, Bell visited Respondent's pharmacy and observed that the door to the prescription area was unlocked. On December 22, 1975, at approximately 3:30 P.M., Reynaldo Santiago, another agent of the Board of Pharmacy, entered Respondent's pharmacy with the prescription referred to in paragraph 2 above that had been given to him by Bell. Santiago gave it to the cashier to be filled. He observed her go to the prescription department, open a door, and place the prescription on a counter. He then observed Hildelisa Hernandez go to the prescription department and start filling the prescription. Thereafter, Ms. Hernandez, accompanied by Mr. Jose E. Valdez, came out of the prescription area and Hernandez gave a pill bottle to the cashier. The cashier in turn gave it to Santiago for the price of $3.95 or $4.00. The bottle contained 21 tablets and a label affixed thereon contained pertinent information as set forth in the prescription that Santiago had given to that cashier, including the name of the drug, doctor, prescription number and name of patient (Testimony of Santiago, Petitioner's Exhibit 2.) Santiago took the bottle of pills outside and then he and Bell re- entered the Pharmacy. Bell identified himself to Mr. Valdez and asked him who was his registered pharmacist and if he had a pharmacist on duty. Mr. Valdez stated that Hal Glass was his pharmacist, but that he had left the store at 2:00 P.M. Bell then asked Valdez if he had filled the prescription which Santiago had taken into the store and, after some hesitation, Bell asked Hernandez if she had filled it. She replied in the affirmative. She stated that she was not a licensed pharmacist in Florida, but had been a pharmacist in Cuba. Bell then wrote a violation and left the store. Neither he nor Santiago recalled seeing a sign indicating that the prescription department was closed on December 22 (Testimony of Bell, Santiago.) Jose E. Valdez testified that although he formerly had two pharmacists at his previous pharmacy, in August or September of 1975 he was forced to cut back to one part-time pharmacist because of the bad economic situation. He conceded that Ms. Hernandez was not a registered Florida pharmacist. He also stated that he was not aware of the rules requiring that the prescription department be locked when no pharmacist was present until this incident occurred and that, in fact, the door to the prescription area had not been locked although a sign indicating that the prescription department was closed had always been used. He further testified that on February 1, 1976, he hired a full-time pharmacist who is present at all times when the pharmacy is open and that the prescription department is now always locked when she is not present.
Recommendation That a civil penalty in the sum of $250.00 be imposed against Respondent in lieu of suspension or revocation of its permit, for violation of Section 465.18(1)(b), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code DONE and ENTERED this 26th day of April, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Stanley Kaplan, Esquire 404 Biscayne Building Miami, Florida Seymour M. Litman, Esquire 10 Northwest 14 Avenue Miami, Florida 33125
Findings Of Fact Respondent immigrated to the United States in 1974. He began practicing medicine in Orlando in 1977, specializing in obstetrics and gynecology. His medical doctor's license issued by the Florida Board of Medical Examiners has been in force at all times relevant. In October, 1977, Respondent began treating Ms. Patricia King for menstrual pain and an infection. In January, 1978, King requested that Respondent prescribe Dilaudid 1/ for pain. He did so, and thereafter through April, 1978, prescribed an approximate total of 333 Dilaudid tablets for King. According to the Physician's Desk Reference, Dilaudid is an opiate which can create psychic and physical dependence. Dilaudid is indicated for the relief of moderate to severe pain such as that due to surgery, cancer, soft tissue and bone trauma, biliary colic, myocardial infarction, burns, or renal colic. None of these conditions was present in regard to King or any other patient discussed herein. During the early months of 1978, Respondent became aware that King was addicted to Dilaudid but continued to prescribe this drug for her on the representation that she would seek therapy for her addiction. She also informed Respondent that she was selling some of the Dilaudid tablets and offered to share the proceeds with him. King usually left 25 or 50 at his office in payment for his cooperation. Respondent denies that he asked for this money, totaling $450 to 500, but admitted that he did not return it. During this period, Mr. Billy Pressley began bringing women to Dr. Agrawal ostensibly for treatment. However, Respondent did little more than write prescriptions for Dilaudid and other controlled substances for these individuals. In some cases Pressley did not even bring the purported patient, but merely came to Respondent's office to pick up prescriptions for controlled substances in the names of third persons. In early 1978, Respondent attempted to discontinue his relationship with Pressley and King. However, he was intimidated by their threats and fear of exposure, and continued to write the prescriptions they demanded. On April 19, 1978, police were summoned to Respondent's home to investigate a broken screen. Subsequently, Pressley and King arrived and were arrested by the police and charged with extortion. As a result of the investigation, Respondent was charged with "Delivery of Dilaudid, A.C.S." and entered a plea of Nolo Contendere in the Circuit Court of Orange County. By order issued on April 13, 1979, Respondent was placed on 12 years probation, adjudication of guilt withheld. He thereafter moved to Okeechobee where he has practiced medicine at the Florida Community Health Center without incident. The investigation of Respondent revealed that during March and early April, 1978, he issued two or more dilaudid prescriptions to a Ms. Lynn Elland or others in the name of Elland. Respondent admitted to police that he gave Billy Pressley a Dilaudid prescription for Lynn Elland on April 2, 1978. According to this statement, Pressley provided Respondent with extra money in order to obtain prescriptions for controlled substances. Between approximately February 3 and 24, 1978, Respondent issued prescriptions to Pressley for Quaalude, 2/ 300 mg., 30 tablets, Dilaudid, 4 mg., 60 tablets and Preludin, 3/ 75 mg., 30 tablets. Further, Respondent provided Pressley with a prescription for Dilaudid in the name of Ms. Kim Taekaberry. Between January and April, 1978, Respondent issued approximately four additional prescriptions for Dilaudid, 4 mg., totaling about 90 tablets, in the name of Kim Taekaberry. Respondent acknowledged to police his awareness that Pressley was using Taekaberry in order to obtain Dilaudid prescriptions. Between late January and mid-February, 1978, Respondent issued two prescriptions for Dilaudid, 4 mg., totaling 45 tablets, in the name of Molly Lynch. Respondent acknowledged to police officers that Pressley was also using Lynch to obtain Dilaudid. Between February and April, 1978, Respondent issued approximately four prescriptions for Dilaudid, 4 mg., totaling about 99 tablets, to Ms. Kimberly Skinner. Respondent could not recall whether Skinner had been a patient or the reason he prescribed this medication for her. Between late January and early February, 1978, Respondent issued approximately two prescriptions for Dilaudid, 4 mg., totaling about 30 tablets to Ms. Linda Cleary. Similarly, the Respondent could not recall why he prescribed this medication for Cleary. Between approximately February 2, 1978, and March 21, 1978, Respondent prescribed Preludin, 75 mg., 60 tablets, and Quaalude, 300 mg., 20 tablets to Mr. Gunter Bachman. The Respondent acknowledged in his initial confession to police that he did not maintain patient records for Bachman. Further, it should be noted that Respondent's practice in obstectrics and gynecology would not have involved the treatment of male patients. Between February 24 and April 11, 1978, Respondent issued five prescriptions for Dilaudid, totaling approximately 70 tablets, to Mr. Robin Connelly. Respondent advised police that Connelly complained of chest pains and informed Respondent that he took Dilaudid. Considering the nature of the Respondent's practice, his claim that he was treating Connelly for chest pains is not credible. Further, Respondent's admission to police that on March 28, 1978, he gave Connelly a prescription in the name of Kathy Hosford without examining Ms. Hosford further discredits his explanation of the Connelly chest pains prescription. Between January 3 and March 3, 1978, Respondent issued approximately twelve prescriptions of Dilaudid, 4 mg., totaling approximately 289 tablets, to Mr. Nick Dearie. Respondent admitted to police that Dearie gave him extra money to provide these prescriptions.
Recommendation From the foregoing, it is RECOMMENDED that Respondent be found guilty of Counts 1, 5, 8, 11, 14, 17, 20, 23, 29, and 32 as charged. It is further RECOMMENDED that all other counts be dismissed. It is further RECOMMENDED that the Board of Medical Examiners issue a reprimand to Respondent based on the findings herein. It is further RECOMMENDED that the Board of Medical Examiners place Respondent on probation, under the supervision of a designated physician, for a period of five years. It is further RECOMMENDED that the Board of Medical Examiners withdraw Respondent's authority to prescribe medication controlled under the provisions of Chapter 893, Florida Statutes, by restriction of his license for a period of five years. It is further RECOMMENDED that Respondent be required to successfully complete a course of study in pharmacology prior to removal of his license restriction. RECOMMENDED this 22nd day of October, 1981, 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 22nd day of October, 1981.
Findings Of Fact Respondent, Ben Cohn (Cohn), was at all times material hereto a licensed pharmacist in the State or Florida, having been issued license number 0009536. At all relevant times, Cohn was employed as a pharmacist at Don's Discount Drugs in South Miami, Florida. 1/ In or about October, 1981, Don's Discount Drugs was targeted by the Department of Professional Regulation and the Drug Enforcement Administration for a drug diversion audit of all Schedule II prescription drugs. The impetus for the audit was the quantity of methaqualone tablets, a Schedule II prescription drug, that were being dispensed at the store. The audit revealed no improprieties in the control or accountability of Schedule II prescription drugs at Don's Discount Drugs, but did reveal that during the period from August 4, 1981, through January 6, 1982, Don's Discount Drugs had dispensed 202,404 methaqualone 300 mg. tablets on 4,695 prescriptions. 2/ Of theses Cohn dispensed 118,130 methaqualone tablets on 2,724 prescriptions. The vast majority of these prescriptions were written for 45 tablets. The physicians who wrote the prescriptions which Cohn filled were largely employed by "stress clinics". These clinics actively advertised and solicited patients suffering from stress, and frequently prescribed methaqualone. There is, however, no competent proof that these clinics operated illegally, or that the physicians who wrote the prescriptions at issue in this case failed to do so in the good faith practice of their profession. During the time in question, it was legal in the State of Florida to prescribe and to dispense methaqualone. However, of the approximately 400 community pharmacies in Dade County only 10 would fill methaqualone prescriptions. Cohn knew he was dispensing a controversial drug with a high potential for abuse. Consequently, in filling each of the methaqualone prescriptions in question, as with all Schedule II drug prescriptions, Cohn followed a rigid procedure. As to each prescription, he verified that the person presenting the prescription was the person to whom the prescription was written by requiring a driver's license or others photo identification. Cohn then contacted the United States Department of Justice Drug Enforcement Administration to verify that the prescriber had a current DEA number. Cohn then verified with the prescriber that the prescription had been written for that patient and verified the number of tablets reflected on the prescription. Lastly, Cohn placed that patient's name and address on an index card together with the name of the doctor and the date of the prescription. These cards were maintained in a special file for reference in filling prescriptions to prevent dispensing any Schedule II drugs to the same person as a result of multiple prescriptions issued in too short a time period. All of the prescriptions in question were written by prescribers who were duly licensed by the Florida Board of Medical Examiners. None of the prescriptions in question was written or filled for an excessive number of methaqualone written tablets. 3/ Further, the parties have stipulated that Cohn complied with each of the conditions prescribed by Subsections (a)-(g), Section 893.04(1), Florida Statutes. Notwithstanding the fact that Petitioner offered no proof that any prescription filled by Cohn was not issued by a physician in the good faith practice of his profession, or was otherwise counterindicated, it suggests that Cohn did not act in good faith and in the course of professional practice when he filled the prescriptions. Factors which Petitioner deems important to such conclusion are: (1) the large number of prescriptions issued for the same quantity of drug, (2) the limited number of prescribers, (3) that most prescribers worked at "stress clinics", (4) the sudden influx of patients 18-30 years of age to fill prescriptions, (5) the precounting and prepackaging of methaqualone at the store, (6) the "general tone" of the community in regard to the abuse factor of methaqualone, (7) Cohn's failure to ascertain whether the drug was "for the benefit and welfare" of the patient, and (8) that many of the prescribing physicians maintained their offices outside the general neighborhood of the store. Petitioner's proof was not, however compelling. While the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, appears facially to be a large quantity, Petitioner offered no proof to demonstrate its significance. No evidence was presented comparing the total number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of methaqualone prescriptions filled in Dade County at the time. No evidence was presented comparing the number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of prescriptions filled at that pharmacy. No evidence was presented concerning the statistical significance, if any, of the quantities of methaqualone tablets dispensed at Don's Discount Drugs. In sum, the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, which represents an average of 35 prescriptions filled each day, was not demonstrated to be disproportionate to the legitimate needs of the population of Dade County. While many of the prescribers did maintain their offices outside the pharmacy's neighborhood, and a large number of methaqualone tablets dispensed at Don's Discount Drugs, it is significant that only 10 of 400 community pharmacies in Dade County would fill such prescriptions. Under such circumstances, it would not be unusual for such physicians' patients to travel to fill their prescriptions. Neither would it be unusual to find a large number of prescriptions being filled at the limited number of pharmacies willing to fill them. While Cohn did not ascertain whether the prescriptions were written "for the benefit and welfare" of the patient, or otherwise seek to second guess the attending physician by inquiring about the circumstances or diagnosis that prompted the prescription, he did confirm that the physician was properly licensed and that the physician had issued the prescription to the patient who presented it. The Department offered no credible proof that any physician misappropriately prescribed any drugs in this case. Accordingly, the presumption is that the physicians who wrote the subject prescriptions acted lawfully, and in the good faith practice of their profession. See: Atlantic Coast Line R. Co. v. Mack, 57 So.2d 447 (Fla. 1952). Under such circumstances, it cannot be concluded that Cohn failed to act in good faith and in the course of professional practice when he filled such prescriptions. The remaining factors cited by Petitioner are equally unpersuasive. The fact that the prescriptions were written by a limited number of physicians, most of whom were employed by "stress clinics", was not compelling because there was no showing that such physicians operated improperly. The fact that the store experienced a sudden influx of patients 18-30 years of age was not shown to be pertinent since there was no proof that the prescribing of methaqualone to such age group was counterindicated 4/ The fact that Don's Discount Drugs precounted and prepackaged methaqualone tablets demonstrated only that they anticipated a demand for the product; not any impropriety. Cohn's knowledge of the abuse potential for methaqualone and the procedures he employed to avert such abuse, was addressed in paragraph 6, supra. In rejecting petitioner's contention that Cohn failed to act in good faith and in the course of professional practice, I do not suggest that the factors advanced by Petitioner are not necessarily pertinent to the inquiry. Rather, I conclude that in this case such proof was not persuasive because there was no competent proof that any physician misprescribed or acted other than in the good faith practice of his profession. Such being the proof, it cannot be concluded that Cohn violated a community standard by filling a lawful and proper prescription. Cohn was first licensed as a practicing pharmacist in the State of New York in 1945, and has been practicing in the State of Florida since 1961. He has never been disciplined and has never had an administrative complaint, other than the instant complaint, filed against him regarding his practice of pharmacy.
Recommendation Based on the foregoing Finding of Fact and Conclusions of Law, it is RECOMMENDED: That a Final Order be entered DISMISSING the Administrative Complaint. DONE AND ORDERED this 9th day of September, 1987, in Tallahassee, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of September, 1987.
The Issue The issue presented in this case is whether the Respondents', Otmara Pina and Ali's Pharmacy, licenses should be revoked, suspended or otherwise disciplined for allegedly violating the Florida Pharmacy Act, Chapter 465, Florida Statutes, when filling a series of unauthorized prescriptions for a controlled drug.
Findings Of Fact Respondent, Otmara Pina, is a pharmacist licensed by the State of Florida and holds license number 14075. Respondent, Ali's Pharmacy, is owned by Cerardo Vigoa and Pedro Diaz, and is registered as a pharmacy by the State of Florida under permit number 750. Ali's Pharmacy is located at 3825 West Flagler Street, Miami, Florida where Otmara Pina is and has been during all pertinent times the managing pharmacist for Ali's. Between March 1, 1978 and January 4, 1980, Otmara Pina, while engaged in her employment as managing pharmacist at Ali's, filled and dispensed fifteen (15) prescriptions for 10 mg. Valium tablets, with varying refills thereof, to Mrs. Lila Tomlinson. The fifteen (15) prescriptions filled by Otmara Pina for Mrs. Tomlinson bore the name of Dr. Claudio R. Villoch as prescribing physician. None of the fifteen (15) prescriptions were authorized or signed by Dr. Villoch. Pursuant to Section 893.03(4)(h), Florida Statutes, Valium or Diazepam is a Schedule IV Controlled Substance. At the hearing, the Department voluntarily dismissed that portion of the Amended Administrative Complaint involving the dispensing of 426 Lomotil tablets. The Respondents did not dispute the factual allegations of the Amended Administrative Complaint but did present testimony in mitigation of their position. The individual to whom the drug was dispensed by Respondent Pina was an elderly widow with extremely limited resources who suffered from terminal cancer. The drug was dispensed by Respondent Pina in order to alleviate Mrs. Tomlinson's terminal condition rather than for monetary gain. Respondent Pina attempted to contact Dr. Villoch's office and spoke to an unidentified person in the office who verbally authorized a prescription. The Respondents enjoy an excellent reputation in the community and provide a valuable service for the largely Hispanic neighborhood in which they are located.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby, RECOMMENDED: That the Respondent Otmara Pina be found to have violated Sections 465.015(2)(c), 465.016(1)(e), and 893.13(2)(a)(1), Florida Statutes, and that pursuant to Section 465.016(2), Florida Statutes, she be placed on probation for one year, be issued a letter of reprimand and be required to take an appropriate continuing education course dealing with procedures to be followed in dispensing controlled drugs. Since no evidence was presented concerning Respondents Vigoa and Diaz, the Amended Administrative Complaint filed against them should be dismissed. DONE and ORDERED this 10th day of July, 1981 in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of July, 1981. COPIES FURNISHED: William M. Furlow, Esquire Assistant General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Otmara Pina c/o Ali's Pharmacy 3825 West Flagler Street Miami, Florida 33134 Gerardo Vigoa and Pedro Diaz Ali's Pharmacy 3825 West Flagler Street Miami, Florida 33134
