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 The Home is licensed as an assisted living facility. It is also licensed to provide extended congregate care, limited nursing services, and limited mental health services. The Home accepted Respondent as a resident. In July 1998, Petitioner had to transport Respondent to the hospital due to an overdose of medication. Upon his return from the hospital, Respondent told Petitioner's staff that he had taken the overdose intentionally. Thereafter, the Home required Respondent to sign a mental health contract dated September 9, 1998. This contract states as follows in relevant part: Qualifications for the Home requires [sic] that a member or applicant must not be mentally ill, habitually inebriated, or addicted to the use of a controlled substance. With these requirements, I understand that to be eligible and maintain my membership in the Home, I must agree to the terms of this contract. * * * If I use alcohol or any non-prescribed drugs I understand I may be dismissed from the Home. I understand that I will allow the Veterans' Domiciliary Home of Florida to supervise the self-administering of my medications. I will take my medication as it is prescribed by the primary physician. I will only be given my full prescription at the time of my discharge. I understand upon reasonable suspicion of being under the influence of alcohol or illegal drugs, I consent to testing. The Domiciliary Home staff may take a blood, saliva, or supervised urine sample to test for illegal drugs or alcohol. I authorize members of the Domiciliary staff to perform random searches of my person, vehicle, living quarters, or belongings to determine if I am using drugs or alcohol. If I refuse to allow a blood, saliva, or urine test, or search, or if I interfere in any way with the staff's performance of these duties, I may be dismissed. The Home also required Respondent to sign a Dual Diagnosis/Substance Abuse/Psychiatric (dual diagnosis) contract dated September 14, 1998. In addition to terms and conditions similar to the ones set forth above, the dual diagnosis contract provides as follows in relevant part: 10. In order to assist me in gaining freedom from alcohol and drugs, I will not use alcohol, tranquilizers, sleeping medication, over the counter medications, or any other chemical escapes which have not been prescribed by a physician. If I use alcohol or non-prescribed drugs, I understand I will be dismissed from the Home. In November 1998, one of Respondent's doctors wrote him a prescription for Ritalin. Respondent became very upset when a nurse would not administer the Ritalin to him without first checking with Petitioner's staff physician. Eventually, Respondent's primary care physician approved the administration of Ritalin together with Respondent's other medications. In January 1999, Respondent worked for Petitioner as a receptionist. After working overtime on one occasion, Respondent's speech was slurred, his eyes were dull, and his voice was horse. Petitioner's staff became suspicious that Respondent was taking medication in violation of his contracts. Respondent subsequently tested negatively for all substances except his prescribed medicines. In March 1999, Respondent violated his contracts by having a prescription for methadone filled at a drugstore and removing twenty-four of the pills from the bottle before turning the medicine over to Petitioner's staff as required by his contract. Petitioner's staff advised Respondent that he would be dismissed from the Home by letter dated March 23, 1999. Respondent subsequently requested Petitioner's Executive Director to review the decision to discharge him from the Home. By letter dated August 16, 1999, Petitioner rescinded its decision to dismiss Respondent from the Home but warned him that any further infraction would result in his immediate expulsion. On April 14, 2000, Petitioner conducted a routine facility-wide room inspection at the Home. During the course of the inspection, Petitioner found a bottle of Ephedra 250 in Respondent's room. According to the label on the bottle, Ephedra 250 is a dietary supplement that General Nutrition Corporation (GNC) markets. During the hearing, Respondent admitted that he heard about Ephedra 250 on a television show that discussed its benefits as a diet aid as well as its dangerous side effects. The label states as follows in pertinent part: WARNING: Seek advice from a health care practitioner prior to use if you are pregnant or nursing, or if you have high blood pressure, heart or thyroid disease, diabetes, difficulty in urination due to prostate enlargement, or if taking MAO inhibitor or any other prescription drug. Reduce or discontinue use if nervousness, tremor, sleeplessness, loss of appetite or nausea occur. Not intended for use by person under the age of 18. The maximum recommended dosage of Ephedrine for a healthy adult is no more than 100 mg in a 24 hour period for not more than 12 weeks. Improper use of this product may be hazardous to a person's health. Each capsule of Ephedra 250 contains 250 mg of MA Huang Extract (Ephedra sinica) or ( 15 mg of 6 percent Ephedrine). The greater weight of the evidence indicates that Ephedra 250 is an over-the-counter medication despite being labeled as a diet supplement. Ephedrine is a prescription drug in Florida unless an individual dose is less than a specified quantity. Petitioner's staff properly became concerned about Respondent's possession of Ephedra 250 because he takes numerous prescribed medications, which can have serious side effects, if taken with certain other medications. Ephedrine is one of those drugs. For instance, Respondent takes Cozaar for high blood pressure, Methadose to reduce his dependency on Percoset, and Ritalin. Persuasive evidence indicates that large doses of Ephedra can be used as a recreational drug. Respondent knew or should have known that Ephedra 250 was prohibited by his contracts with the Home.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing Respondent as a resident of the Robert H. Jenkins Veterans' Domiciliary Home of Florida. DONE AND ENTERED this 6th day of October, 2000, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD 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 6th day of October, 2000. COPIES FURNISHED: James W. Sloan, Esquire Department of Veterans' Affairs Post Office Box 21003 St. Petersburg, Florida 33731-8903 William T. Fisher 1300 Sycamore Lane, Suite 148 Lake City, Florida 32025 Lt. Col. Robin L. Higgins, Executive Director Department of Veterans' Affairs Post Office Box 31003 St. Petersburg, Florida 33731-8903
The Issue This is a license discipline case, in which the Petitioner seeks to take disciplinary action against a pharmacy licensee on the basis of alleged violations of Sections 465.014, 465.023(1)(c), and 465.025(3)(b), Florida Statutes.
Findings Of Fact The Respondent in this case, Nan-Dan, Inc., is, and has been at all times material to the Second Amended Administrative Complaint, a licensed community pharmacy, holding license number PH 0002807. The Respondent does business as "Buy-Rite Drugs." The Respondent's address is 103 South 3rd Street, Lantana, Florida 33462-2853. The Respondent Nan-Dan, Inc., does not do business as "Professional Rx Systems." There is another business entity known as "Professional Rx Systems," which was licensed in November of 1987, and which does business as "Nan-Dan Corp., Inc." Professional Rx Systems is a licensed community pharmacy, having been issued license number PH 0010094. Professional Rx Systems is a separate and distinct licensee and is a separate and distinct business entity from Nan- Dan, Inc., the Respondent in this case. On or about May 30, 1991, a pharmacy (probably Professional Rx Systems) prepared a billing statement regarding prescriptions for patient O.I. The entries on the billing statement include an entry for prescription number 6171144, described as "60 ROBAXIN-750 TABS," with a corresponding charge of $33.42. The second page of the May 30, 1991, billing statement includes an entry for prescription number 4173954, described as "30 DARVOCET N 100," with a corresponding charge of $20.02. Robaxin 750 and Darvocet N-100 are both brand name drugs. Dr. Faustino Gonzalez was and is the Medical Director of Gold Star Medical Management, a company which subcontracts with Humana Medical Plans to provide medical services to a group of patients. The facilities at which Gold Star Medical Management provides medical services probably includes Eason Nursing Home. In any event, in approximately May of 1991, Gold Star Medical Management did a quality review for Eason Nursing Home, in which it looked at the prescriptions for numerous patients. Of the cases that were reviewed, Dr. Gonzalez did not recall seeing anything but generic drugs which had been actually dispensed to the patients. However, Dr. Gonzalez does not recall whether the Robaxin 750 listed on the billing statement described above was one of the drugs he reviewed. Similarly, there is no evidence that the Darvocet N- 100 listed on the billing statement described above was one of the drugs reviewed by Gold Star Medical Management. Dr. Gonzalez did not recall whether he had ever actually seen patient O.I. and he did not know whether the drugs actually furnished to patient O.I. were brand name drugs or generic drugs. There is no evidence in the record of this case of the identity of the pharmacist or pharmacists who may have dispensed any drugs to patient O.I. There is no evidence in the record of this case as to the amount of the cost savings, if any, that accrued or might have accrued to the pharmacy if generic drugs had been dispensed in lieu of brand name drugs. There is no evidence in the record of this case as to how much was paid by or on behalf of the patient O.I. for the drugs itemized on the billing statement described above. For a brief period during July of 1987, the Respondent employed Harold B. Steinberg as a pharmacist. Mr. Steinberg presently has a hostile attitude towards the owner of the Respondent corporation. From approximately February of 1991 through May of 1991, Joyce Trapp was employed by the Respondent as a pharmacy technician.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Pharmacy enter a Final Order in this case dismissing all of the violations alleged in the Second Amended Administrative Complaint. DONE AND ENTERED this 25th day of August, 1993, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO.92-4270 The following are my specific rulings on all proposed findings of fact submitted by all parties. Findings submitted by Petitioner: Paragraph 1: Rejected as contrary to the greater weight of the evidence. (See Petitioner's Exhibit 2.) Paragraph 2: Rejected as not supported by clear and convincing evidence. The only witness to testify on this matter only referred to Eason as one of the nuring homes "being taken care of by Mr. Erb's operation." Mr. Erb has two operations, only one of which is a respondent here. Further, the witness' lack of reliable information on the matter is revealed by his testimony that he ". . . never got to see the papers." As a final matter, the Hearing Officer has given very little credit to Mr. Steinberg's testimony. Mr. Steinberg's testimony was vague and imprecise and Mr. Steinberg appeared to have very hostile feelings towards the owner of the Respondent entity. Paragraph 3: Accepted. Paragraph 4: Rejected as not supported by persuasive clear and convincing evidence. Mr. Steinberg's testimony on this subject was vague and imprecise. It also has some unexplained conflicting details, among them the assertion at one point that Steinberg was the only pharmacist on the premises and the later assertion that Mr. Erb was present and that Mr. Erb was also a pharmacist. Further, the only evidence of the absence of supervision consists of hearsay evidence that would not be admissible over objection in a civil action, largely because the hearsay speakers are unidentified. And as a final matter, the activities vaguely described by Mr. Steinberg do not constitute "dispensing" within the statutory definition of the word "dispense" at Section 465.003(5), Florida Statutes (1986 Supp.). Paragraph 5: Rejected as irrelevant or as subordinate and unnecessary details. Paragraph 6: Accepted. Paragraph 7: Rejected as irrelevant because not charged in the Second Amended Administrative Complaint. Also rejected as not supported by persuasive clear and convincing evidence. Ms. Trapp appeared to have a very poor memory and her testimony tended to be vague and incomplete. Paragraph 8: Rejected for several reasons, including the fact that without a reference to the time and place of these proposed facts, there is no way to determine whether these proposed facts are relevant to the allegations of the Second Amended Administrative Complaint. Also rejected because there is no persuasive clear and convincing evidence of these proposed facts. Paragraphs 9, 10, 11 and 12: Accepted in substance. Paragraph 13: Rejected as either not supported by persuasive clear and convincing evidence or as being contrary to the greater weight of the evidence. In this regard it is noted that, although Petitioner's Ex. 3 is incomplete at the top, the visible portion of the business name at the top of the statement is "X SYSTEMS" and printed across the bottom of the statement is the business name "PROFESSIONAL RX SYSTEMS." Accordingly, it is more likely that the drugs billed to patient O.I. were billed by Professional Rx Systems (which is not a Respondent in this case) than that they were billed by the Respondent, Nan-Dan, Inc., d/b/a Buy Rite Drugs. Further, Dr. Gonzalez' testimony was to the effect that he was not sure whether his review included the drugs allegedly furnished to patient O.I. Paragraphs 14 and 15: Rejected as not supported by persuasive competent substantial evidence. As noted above, any dispensing involving the patient O.I. was probably done by someone other than the Respondent and, in any event, there is no persuasive competent substantial evidence as to what was actually dispensed. Paragraph 16: Accepted. Paragraph 17: Rejected as not supported by persuasive competent substantial evidence or as contrary to the greater weight of the evidence. (See discussion of Paragraphs 13, 14, and 15, above.) Paragraph 18: Accepted that the mentioned drug is a brand name "medicinal drug." The remainder of this paragraph is rejected as irrelevant, as well as not supported by persuasive competent substantial evidence. Paragraph 19: Rejected as not supported by persuasive competent substantial evidence. Findings submitted by Respondent: Paragraphs 1 and 2: Accepted. Paragraphs 3, 4, 5, and 6: Accepted in substance. Paragraph 7: Accepted. Paragraphs 8, 9, 10, 11, 12, and 13: Accepted in substance. Paragraphs 14 and 14: The last two paragraphs (both of which are numbered as 14) of the Respondent's proposed findings are, for the most part, rejected as constituting arguments as to why findings should not be made, rather than proposed findings of fact. (It is noted that the arguments are, essentially, correct and have been considered in deciding what findings should be made.) COPIES FURNISHED: Wayne H. Mitchell, Esquire Department of Business and Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 William M. Furlow, Esquire Katz, Kutter, Haigler, Alderman, Davis & Marks, P.A. Post Office Box 1877 Tallahassee, Florida 32302-1877 Jack McRay, General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, Florida 32399-0775
The Issue The matters presented here concern action by an Administrative Complaint filed by the Petitioner against the the named Respondent. By this action, the Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondent. In particular, it is alleged that, in keeping with a controlled substance audit at the Medical Center Pharmacy, certain drug shortages were discovered, namely: (a) Between September 1, 1980, and January 28, 1981, 38,190 unit doses of Talwin 50 mg., a controlled substance; (b) Between September 1, 1980, and January 28, 1981, 16,920 unit doses of Pyribensamine (PBZ), and (c) between the dates of October 4, 1980, and January 29, 1981, 285 unit doses of Percodan. By Count I to the Administrative Complaint, it is alleged that, based upon the facts as set forth above, the Respondent has violated Subsection 465.016(1)(a), Florida Statutes, by violating Subsection 893.07(2), Florida Statutes, dealing with failure to maintain proper records of controlled substances. Count II to the Administrative Complaint states that based upon the alleged facts, the Respondent has violated Subsection 465.016(1)(i), Florida Statutes, by compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of professional practice of pharmacy. Count III alleges a violation of Subsection 465.016(1)(e) Florida Statutes, in view of a violation of Rule 21S-1.114, Florida Administrative Code, for failure to close the pharmacy when a registered pharmacist was not present and on duty related to acts which occurred on January 28, 1981, during the audit. Count IV alleges a violation of Subsection 465.016(1)(e) Florida Statutes, by violating Rule 21S-1.24(4), Florida Administrative Code, for alleged failure to display hours of operation at the pharmacy, based upon observations during the January 28, 1981, audit conducted at the pharmacy. 2/
Findings Of Fact This cause is presented based upon the Administrative Complaint which has been alluded to in the Issues statement to this Recommended Order. That complaint was filed June 4, 1981, and in the face of the Administrative Complaint, the Respondent, by execution of an Election of Rights form on July 10, 1981, indicated that certain material allegations of fact set forth in the Administrative Complaint were in dispute and requested a formal hearing in keeping with Subsection 120.57(1), Florida Statutes. The petitioning agency in this matter is a governmental body in the State of Florida, which has the power to license, regulate and discipline individuals and entities holding licenses or permits to practice pharmacy in the State of Florida. See Chapters 455 and 465, Florida Statutes. Karl L. Smith is registered by the Board of Pharmacy in the State of Florida to be a pharmacist and holds License No. 141337. Edgewood Medical Center Pharmacy, Inc., which did business, at all times pertinent to this Administrative Complaint, as Medical Center Pharmacy, is a community pharmacy licensed by the State of Florida to operate as a pharmacy under the terms of Permit No. 0007060. During the period in question, this pharmacy was located at 3160 West Edgewood Avenue, Jacksonville, Florida. At all times pertinent, Karl L. Smith was the only licensed pharmacist for Medical Center Pharmacy. On January 28, 1981, Petitioner's Investigators C. J. Hokinson and Johnny Danson proceeded to the Medical Center Pharmacy for purposes of conducting an audit of select controlled substances and legend drugs. When the Investigators entered the pharmacy, they spoke with Karl L. Smith who allowed them to examine pharmacy records related to Talwin, a Schedule IV drug and Pyribensamine, a legend drug. The audit process utilized for Talwin started with a zero inventory balance on September 2, 1980, and ended on January 28, 1981, with a total purchase count in the audit period of 39,200 unit doses. There remained on hand at the pharmacy 160 unit doses of the drug and some 850 unit doses were shown to be disposed of by prescription sale. There remained 38,190 unit doses of Talwin unaccounted for by explanation or documentation. An examination on January 28, 1981, of the second drug Pyribensamine, started with the zero inventory dating from September 2, 1980, and the audit period ended January 28, 1981. Within the audit period, there were 17,200 unit doses shown to have been purchased. On hand at the pharmacy on the date of the audit, 100 unit doses were found. An additional 180 unit doses had been dispensed by prescription sale. There remained 16,920 unit doses of Pyribensamine which were unaccounted for by explanation or documentation. While conducting the audit on January 28, 1981, Karl L. Smith, the only registered pharmacist on the premises left the pharmacy without closing it and Kathy Elain Smith, an intern pharmacist not admitted to practice pharmacy, was left in charge. Further the hours of operation for the pharmacy were not posted at the pharmacy on that date. On January 29, 1981, Investigator Danson returned to the pharmacy to conduct an audit for Percodan, a Schedule II drug. The audit period on this occasion started with a zero inventory for October 1, 1980, and the last day of the audit period was January 1, 1981. During this time frame, 1,000 unit doses had been purchased and 560 unit doses were on hand at the pharmacy on the date of the audit. Another 155 unit doses had been dispensed by prescription sale and 285 unit doses were unaccounted for by explanation or documentation. (The exact whereabouts of the missing drug items were not established. Karl L. Smith indicated that those drugs could have been removed by "friends" whom he had allowed to work in the pharmacy with him. No further explanation of the location of the missing drugs was volunteered, notwithstanding the fact that Karl L. Smith had been afforded several opportunities to explain what happened to the missing drugs.)
