STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, )
)
Petitioner, )
)
vs. ) Case No. 07-4308
) WORLDWIDE MEDICAL SUPPLIES AND ) PHARMACEUTICALS, INC., )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice, a formal hearing was held in this case on February 11 and 12, 2008, in Miami, Florida, before Patricia
M. Hart, a duly-designated Administrative Law Judge of the Division of Administrative Hearings.
APPEARANCES
For Petitioner: Denis A. Dean, Esquire
Office of the Attorney General The Capitol, Plaza Level PL-01 Tallahassee, Florida 32399-1050
For Respondent: Bernard M. Cassidy, Esquire
Bernard Cassidy, P.A.
One East Broward Boulevard, Suite 1410 Fort Lauderdale, Florida 33301
STATEMENT OF 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.
PRELIMINARY STATEMENT
In a Second Amended Administrative Complaint dated
August 24, 2007, the Department of Health, through its Division of Statewide Pharmaceutical Services ("Department"), charged Worldwide Medical Supply and Pharmaceuticals, Inc. ("Worldwide Medical Supply") with numerous violations of Sections 499.001 through .081, Florida Statutes. The charges were based on documents created during the years 2004, 2005, and 2006 that were obtained by the Department during audits conducted by the Department of the records of Worldwide Medical Supply. The various violations were not set forth in separate counts but, rather, were enumerated in separate paragraphs of the Second Amended Administrative Complaint. Worldwide Medical Supply timely requested an administrative hearing, and the Department transmitted the matter to the Division of Administrative Hearings for assignment of an administrative law judge.
Pursuant to notice, the final hearing was conducted on February 11 and 12, 2008.
On November 7, 2007, the Department filed a Corrected Second Amended Administrative Complaint, served November 13, 2007, which did not include any substantive changes to the Second Amended Administrative Complaint but was limited to
changes in the numbering of the paragraphs. The violations alleged against Worldwide Medical Supply were set forth in paragraphs 5 through 37 of the Corrected Second Amended Administrative Complaint and were based on deficiencies in documentation provided to the Department by Worldwide Medical Supply. The Department charged Worldwide Medical Supply with the sale of legend drugs to unauthorized persons; fraudulent authentication of pedigree papers; the purchase of contraband drugs; the purchase of legend drugs from a source not authorized to sell such drugs in Florida; and the receipt of a legend drug by a non-permitted facility. The Department asserted in the Corrected Second Amended Administrative Complaint that these acts were in violation of Sections 499.005(1)-(4), (14), (15),
(18), (28), and (29); 499.006(10); and 499.0051(1)(b), (4), and
, Florida Statutes (2006).1
On November 19, 2007, the Department filed a Notice of Scrivener's Errors in the Corrected Second Amended Administrative Complaint, which included corrections to paragraphs 30 through 37. During the final hearing, the Department also made several additional corrections to citations and dates and withdrew the allegations of violations set forth in paragraph 25 of the Corrected Second Amended Administrative Complaint. The matter, therefore, proceeded to hearing on the charges set forth in paragraphs 5 through 24 and 26 through 37
of the Corrected Second Amended Administrative Complaint, as corrected pursuant to the Notice of Scrivener's Errors in the Corrected Second Amended Administrative Complaint and the corrections made during the final hearing.2
At the final hearing, the Department presented the testimony of Guelsys Lopez, Sharon Roberts, and Richard Sands; Petitioner's Exhibits 1 through 19 and 21 through 33 were offered and received into evidence. Worldwide Medical Supply presented the testimony of Eugene Odin, and Respondent's Exhibits 2 through 4 were offered and received into evidence.
At the request of the Petitioner, official recognition was taken of Florida Administrative Code Chapter 64F-12 in effect at the time of the alleged violations; at the request of the Respondent, official recognition was taken of Chapter 499, Florida Statutes (2005), and of Section 499.005, Florida Statutes (2006).
The two-volume transcript of the proceedings was filed with the Division of Administrative Hearings on March 5, 2008.
Worldwide Medical Supply did not file proposed findings of fact and conclusions of law. The Department timely filed proposed findings of fact and conclusions of law, which have been considered in the preparation of this Recommended Order.
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.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter of this proceeding and of the parties thereto pursuant to Sections 120.569 and 120.57(1), Florida Statutes (2007).
In its Corrected Second Amended Administrative Complaint, the Department seeks to impose penalties against Worldwide Medical Supply that include suspension or revocation of its license and the imposition of an administrative fine. Therefore, it has the burden of proving by clear and convincing
evidence that Worldwide Medical Supply committed the violations alleged in the Corrected Second Amended Administrative Complaint. Department of Banking and Finance, Division of Securities and Investor Protection v. Osbourne Stern and Co., 670 So. 2d 932 (Fla. 1996); and Ferris v. Turlington, 510 So. 2d
292 (Fla. 1987).
As the Florida Supreme Court recently explained, clear and convincing evidence is the proper standard in license revocation proceedings because they are penal in nature and implicate significant property rights. Osbourne Stern & Co., 670 So. 2d at 935; Walker v. Florida Department of Business and Professional Regulation, 705 So. 2d 652, 655 (Fla. 5th DCA 1998)(Sharp, J., dissenting).
The Department filed a Corrected Second Amended Administrative Complaint that included 32 paragraphs that alleged violations relating to particular transactions involving Worldwide Medical Supply. As set forth above in the findings of fact, one or more violations were alleged in each paragraph, and a number of statutes were referenced to support each violation alleged. The following statutes have either been cited by the Department to support the violations alleged in the Corrected Second Amended Administrative Complaint or are relevant to an understanding of the nature of the violations alleged.
The Department has alleged that Worldwide Medical Supply violated several provisions in Section 499.005, Florida Statutes, as follows:
It is unlawful for a person to perform or cause the performance of any of the following acts in this state:
The manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use.
The adulteration or misbranding of any drug, device, or cosmetic.
The receipt of any drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of such drug, device, or cosmetic, for pay or otherwise.
The sale, distribution, purchase, trade, holding, or offering of any drug, device, or cosmetic in violation of
ss. 499.001-499.081.
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The purchase or receipt of a legend drug from a person that is not authorized under this chapter to distribute legend drugs to that purchaser or recipient.
The sale or transfer of a legend drug to a person that is not authorized under the law of the jurisdiction in which the person receives the drug to purchase or possess legend drugs from the person selling or transferring the legend drug.
* * *
(18) Failure to maintain records as required by ss. 499.001-499.081 and rules adopted under those sections.
* * *
Failure to obtain or pass on a pedigree paper.
The receipt of a prescription drug pursuant to a wholesale distribution without either first receiving a pedigree paper that was attested to as accurate and complete by the wholesale distributor or complying with the provisions of s. 499.0121(6)(f)6.
Whenever it alleged that Worldwide Medical Supply purchased contraband drugs, the Department cited
Section 499.006(10), Florida Statutes, which provides in pertinent part that "[a] drug . . . is adulterated:"
(10) If it is a legend drug for which the required pedigree paper is nonexistent, fraudulent, or incomplete under the requirements of s. 499.001-.081 or applicable rules, or that has been purchased held, sold, or distributed at any time by a person not authorized under federal or state law to do so.
Section 499.003(10), Florida Statutes, defines "contraband legend drug" as
any adulterated drug, as defined in
s. 499.006, any counterfeit drug, as defined in this section, and also means any legend drug for which a pedigree paper does not exist, or for which the pedigree paper in existence has been forged, counterfeited, falsely created, or contains any altered, false, or misrepresented matter.
A "legend drug" is defined in Section 499.003(25), Florida Statutes as follows: "Legend drug," "prescription drug," or "medicinal drug" means any drug, including, but not limited to, finished dosage forms, or active ingredients subject to, defined by, or described by s. 503(b) of the Federal Food,
Drug, and Cosmetic Act or s. 465.003(8), s. 499.007(12), or
s. 499.0122(1)(b) or (c)." There is no dispute that all of the drugs at issue in this case are legend or prescription drugs, and the terms "legend drug" and "prescription drug" are used interchangeably herein.
Whenever the Department included allegations related to authentication of pedigree papers, it cited
Section 499.005(28), Florida Statutes, and, sometimes, Section 499.005(29), Florida Statutes. A "pedigree paper" is defined in Section 499.003(31)(a), Florida Statutes, as "[a] document required pursuant to s. 499.0121(6)(d) or (e)."23
Section 499.0121(6)(d), Florida Statutes, which is the portion of Section 499.0121(6) relevant to this proceeding, describes the information that a pedigree paper must include:
(d)1. Each person who is engaged in the wholesale distribution of a prescription drug, and who is not an authorized distributor of record for the drug manufacturer's products, must provide to each wholesale distributor of such drug, before the sale is made to such wholesale distributor, a written statement under oath identifying each previous sale of the drug
back to the last authorized distributor of record, the lot number of the drug, and the sales invoice number of the invoice evidencing the sale of the drug. The written statement must accompany the drug to the next wholesale distributor. The department shall adopt rules relating to the requirements of this written statement.
This paragraph does not apply to a manufacturer unless the manufacturer is performing the manufacturing operation of repackaging prescription drugs.
Each wholesale distributor of prescription drugs must maintain separate and distinct from other required records all statements that are required under subparagraph 1. and paragraph (e).
Each manufacturer of a prescription drug sold in this state must maintain at its corporate offices a current list of authorized distributors and must make such list available to the department upon request.
Each manufacturer shall file a written list of all of the manufacturer's authorized distributors of record with the department. A manufacturer shall notify the department not later than 10 days after any change to the list. The department shall publish a list of all authorized distributors of record on its website.
For the purposes of this subsection, the term "authorized distributors of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products. Effective March 1, 2004, an ongoing relationship is deemed to exist when a wholesale distributor, including any affiliated group, as defined in s. 1504 of the Internal Revenue Code, of which the wholesale distributor is a member:
Is listed on the manufacturer's current list of authorized distributors of record.
Annually purchases not less than 90 percent of all of its purchases of a manufacturer's prescription drug products, based on dollar volume, directly from that manufacturer and has total annual prescription drug sales of $100 million or more.
Has reported to the department pursuant to s. 499.012(3)(g)2. that the wholesale distributor has total annual prescription drug sales of $100 million or more, and has a verifiable account number issued by the manufacturer authorizing the wholesale distributor to purchase the manufacturer's drug products directly from that manufacturer and that wholesale distributor makes not fewer than 12 purchases of that manufacturer's drug products directly from the manufacturer using said verifiable account number in 12 months. The provisions of this sub-subparagraph apply with respect to a manufacturer that fails to file a copy of the manufacturer's list of authorized distributors of record with the department by July 1, 2003; that files a list of authorized distributors of record which contains fewer than 10 wholesale distributors permitted in this state, excluding the wholesale distributors described in sub-subparagraph b.; or that, as a result of changes to the list of authorized distributors of record filed with the department, has fewer than 10 wholesale distributors permitted in this state as authorized distributors of record, excluding the wholesale distributors described in sub- subparagraph b.
A wholesale distributor that satisfies the requirements of sub-subparagraph b. or sub- subparagraph c. shall submit to the department documentation substantiating its qualification pursuant to sub-subparagraph
b. or sub-subparagraph c. The department shall add those wholesale distributors that the department has determined have met the requirements of sub-subparagraph b. or sub- subparagraph c. to the list of authorized distributors of record on the department's website.
This paragraph expires July 1, 2006.
Pursuant to the legislative mandate in
Section 499.0121(6)(d)1., Florida Statutes, the Department enacted Florida Administrative Code Rule 64F-12.012, which provides, in pertinent part, specific requirements for pedigree papers as follows24:
(3) Pedigree Papers
(a) The pedigree paper required by Sections 499.0121(6)(d) and (e), F.S., must include either the proprietary name or the generic name with the name of the manufacturer or distributor reflected on the label of the produce; dosage form; strength; container size; quantity by lot number; the name and address of each owner of the prescription drug that is required to be identified on the pedigree paper; the name and address of each location from which it was shipped if different from the owner's; and the transaction dates. The pedigree paper must clearly identify the invoice to which it relates. A copy of the pedigree paper must be maintained by each recipient.
* * *
A copy of the pedigree paper must be maintained by each recipient. A copy of the pedigree paper provided to a wholesale distributor must be maintained by the wholesaler providing the pedigree paper.
Effective March 2004, a pedigree paper under Section 499.0121(6)(d), F.S., must trace a prescription drug back
to the last authorized distributor of record. The department will maintain a database of authorized
distributors of record on its website at www.doh.state.fl.us/pharmacy/drugs. A prescription drug wholesaler that receives or prepares a pedigree paper under
Section 499.0121(6)(d), F.S., and this chapter that traces the previous distributions of a prescription drug back to a prescription drug wholesaler that is not listed on the department's website as an authorized distributor of record for the drug's manufacturer for the date in which the transaction occurred must maintain and have available for inspection documentation that supports the fact the prescription drug wholesaler is an authorized distributor of record in accordance with the criteria of Section 499.0121(6)(d)5.a., b., or c., F.S.
Whenever the Department included allegations related to recordkeeping, it cited Section 499.005(18), Florida Statutes, which references all of the requirements in
Sections 499.001 through .081, Florida Statutes, relating to the maintenance of records. Section 499.0121(6)(a), Florida Statutes, sets forth the general recordkeeping provisions relating to transactions involving the receipt, distribution, or sale of prescription drugs and provides:
The department shall adopt rules that require keeping such records of prescription drugs as are necessary for the protection of the public health.
Wholesale drug distributors must establish and maintain inventories and
records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records must provide a complete audit trail from receipt to sale or other disposition, be readily retrievable for inspection, and include, at a minimum, the following information:
The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;
The name, principal address, and state license permit or registration number of the person authorized to purchase prescription drugs;
The name, strength, dosage form, and quantity of the drugs received and distributed or disposed of;
The dates of receipt and distribution or other disposition of the drugs; and
Any financial documentation supporting the transaction.
Pursuant to the directive in the preface to Section 499.0121(6), Florida Statutes, the Department adopted Florida Administrative Code 64F-12.012. The provisions governing general recordkeeping requirements provide in pertinent part:
(1)(a) Records to document the movement of drugs, devices or cosmetics must provide a complete audit trail from a person's receipt or acquisition to sale or other disposition of the product or component. A complete audit trail includes records which document each transaction or step in the receipt, manufacture, shipping, transfer, or other
steps in the channel of trade of that person, whether or not physical possession or handling of the product or component occurs. At a minimum, records shall consist of invoices from the supplier or source which documents acquisition of each product by the person and invoices of sale or other transfer by the person to the recipient.
Retail sales transactions to the consumer of over-the-counter drugs, non-restricted devices, or cosmetics are exempt from the requirements of this rule. Additional recordkeeping is required for persons permitted by the department as further stated in this rule.
A person engaged in the distribution of drugs, devices, or cosmetics is not required to maintain documentation from a common carrier that the designated recipient received the product shipped; however, the person must obtain such documentation from the common carrier and make it available to the department upon specific request of the department.
Any person engaged in the manufacture of prescription drugs, the wholesale distribution of prescription drugs, or otherwise receiving or distributing prescription drugs must maintain records as follows:
For each step in the channel of trade, records containing the information required by Section 499.0121(6)(a), F.S., and the Florida permit or license number which authorizes the source to possess and transfer prescription drugs in or into Florida must appear on one document. If delivery of prescription drugs is made to a person other than the purchaser, the name, address or location where the prescription drugs are delivered, and the state license, permit or registration number for that location must be included also.
The state permit or registration number of the purchaser may be omitted if the prescription drugs are exported; but a validated airway bill, bill of lading or other appropriate documentation must be maintained to evidence the exportation of the product.
Invoices must reflect the amount billed per prescription drug product.
Records to document the distribution of prescription drugs required by
Section 499.0121(6), F.S., and this rule are to be created during the transaction (i.e., at the time of order, receipt, processing, picking or shipping) and not retroactively created. . . .
Finally, with respect to the Department's allegations that Worldwide Medical Supply's "authentication is fraudulent," Section 499.0121(4), Florida Statutes, requires that "a wholesaler must review records required under this section for the acquisition of prescription drugs for accuracy and completeness, considering the total facts and circumstances surrounding the transactions and the wholesale distributors involved. This includes authenticating each transaction listed on a pedigree paper, as defined in s. 499.001(31) [reference should be to s. 499.003(31)]." Section 499.003(4), Florida Statutes, defines "authenticate" as follows: "'Authenticate' means to affirmatively verify before any distribution of a legend drug occurs that each transaction listed on the pedigree paper has occurred."25
Based on the findings of fact above, the Department failed to present evidence to establish that Worldwide Medical Supply violated Section 499.005(1) or (2), Florida Statutes.
Based on the findings of fact above, the Department has proven by clear and convincing evidence that, with respect to some transactions identified in the Corrected Second Amended Administrative Complaint, Worldwide Medical Supply received adulterated drugs in violation of Section 499.005(3), Florida Statutes. An adulterated drug is defined in
Section 499.006(10), Florida Statutes, as a prescription drug for which, among other things, the pedigree paper is incomplete. Consequently, whenever Worldwide Medical Supply received incomplete pedigree papers or no pedigree papers at all with respect to prescription drugs it purchased, it received adulterated drugs.
Based on the findings of fact herein, the Department has proven by clear and convincing evidence that, with respect to some transactions identified in the Corrected Second Amended Administrative Complaint, Worldwide Medical Supply purchased prescription drugs in violation of Section 499.0121(4), Florida Statutes, because it failed to authenticate pedigree papers accompanying prescription drugs it purchased.26
Based on the findings of fact herein, the Department has proven by clear and convincing evidence that, with respect
to some transactions identified in the Corrected Second Amended Administrative Complaint, Worldwide Medical Supply purchased prescription drugs from persons not authorized to sell or transfer prescription drugs into Florida, in violation of Section 499.005(14), Florida Statutes.27
Based on the findings of fact herein, the Department has proven by clear and convincing evidence that, in one transaction identified in the Corrected Second Amended Administrative Complaint, Worldwide Medical Supply sold prescription drugs to a person not authorized to purchase such prescription drugs, in violation of Section 499.005(15), Florida Statutes.
Based on the findings of fact herein, the Department has proven by clear and convincing evidence that, with respect to a number of transactions identified in the Corrected Second Amended Administrative Complaint, Worldwide Medical Supply failed to maintain records as required by Sections 499.001 through .081, Florida Statutes, in violation of
Section 499.005(18), Florida Statutes, because it failed to include in its documentation the number of its Florida license to engage in the wholesale distribution of prescription drugs and the number of the Florida license of persons from whom it purchased prescription drugs, as required by
Section 499.0121(6)(a), Florida Statutes.
Based on the findings of fact herein, the Department has proven by clear and convincing evidence that, with respect to some transactions identified in the Corrected Second Amended Administrative Complaint, Worldwide Medical Supply received prescription drugs without first receiving a pedigree paper, in violation of Section 499.005(29), Florida Statutes.
The Department repeatedly charged Worldwide Medical Supply in the Corrected Second Amended Administrative Complaint of having "purchased contraband prescription drugs" in violation of Section 499.0051(1)(b), Florida Statutes, and, in paragraphs
31 through 37 of the Corrected Second Amended Administrative Complaint, the Department charged Worldwide Medical Supply with violations of Section 499.0051(4) and (5), Florida Statutes. Section 499.0051, Florida Statutes, deals with criminal acts involving contraband or adulterated drugs and provides in pertinent part:
FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--
* * *
(b) A person engaged in the wholesale distribution of legend drugs who fails to acquire complete and accurate pedigree papers concerning a legend drug or contraband legend drug prior to obtaining the legend drug or contraband legend drug from another person commits a felony of the third degree, punishable as provided in
s. 775.082, s. 775.083, or s. 775.084.
* * *
PURCHASE OR RECEIPT OF LEGEND DRUG FROM UNAUTHORIZED PERSON.--A person who knowingly purchases or receives from a person not authorized to distribute legend drugs under this chapter a legend drug in a wholesale distribution transaction commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
SALE OR TRANSFER OF LEGEND DRUG TO UNAUTHORIZED PERSON.--A person who knowingly sells or transfers to a person not authorized to purchase or possess legend drugs, under the law of the jurisdiction in which the person receives the drug, a legend drug in a wholesale distribution transaction commits a felony of the second degree, punishable as provided in s. 775.082,
s. 775.083, or s. 775.084.
As noted above, the Department has proven by clear and convincing evidence that Worldwide Medical Supply purchased adulterated drugs in violation of Section 499.005(3), Florida Statutes. Also as noted above, the Department has proven that Worldwide Medical Supply purchased prescription drugs from persons not authorized to sell or transfer them into Florida, in violation of Section 499.005(14), Florida Statutes. The references to Section 499.0051(1)(b), (4), and (5), Florida Statutes, as additional violations are inappropriate because this is a regulatory action, not a criminal action.
Accordingly, the Department's charges that Worldwide Medical Supply violated Section 499.0051(1)(b), (4), or (5), Florida Statutes, should be dismissed.
Penalties
As set forth in its Proposed Recommended Order, the Department seeks revocation of Worldwide Medical Supply's Florida license as a wholesale distributor of prescription drugs and the imposition of an administrative fine in the amount of
$230.000.00. It is noted, however, that this amount should be reduced to $205,000.00 in accordance with the amount of fines recommended by the Department for each violation identified in the Proposed Recommended Order. It is noted that, at the final hearing, the Department withdrew the violation identified in paragraph 25 of the Corrected Second Amended Administrative Complaint and reduced the amount of the fine claimed in paragraph 19 of the Corrected Second Amended Administrative Complaint from $20,000.00 to $5,000.00; these reductions are not reflected in the penalty the Department recommended in its Proposed Recommended Order.
Section 499.006, Florida Statutes, provides in pertinent part:
3) The department may impose an administrative fine, not to exceed
$5,000 per violation per day, for the violation of any provision of ss. 499.001-
499.081 or rules adopted under those sections. Each day a violation continues constitutes a separate violation, and each separate violation is subject to a separate fine. . . . In determining the amount of the fine to be levied for a violation, the department shall consider:
The severity of the violation;
Any actions taken by the person to correct the violation or to remedy complaints; and
Any previous violations.
With respect to the penalties that should be imposed on Worldwide Medical Supply, the Department calculated the recommended fines for each paragraph of the Corrected Second Amended Administrative Complaint on the basis of the number of transactions involved and not on the number of statutory violations. For instance, in paragraph 6 of the Corrected Second Amended Administrative Complaint, the Department recommended the imposition of an administrative fine in the amount of $5,000.00 even though it alleged that Worldwide Medical Supply had violated four separate statutory provisions because only one transaction was involved. Similarly, in paragraph 27 of the Corrected Second Amended Administrative Complaint, the Department recommended the imposition of an administrative fine in the amount of $5,000.00 even though it alleged that Worldwide Medical Supply had violated 11 statutory provisions because only one transaction was involved. And, in paragraph 28 of the Corrected Second Amended Administrative Complaint, the Department recommended the imposition of an administrative fine of $20,000.00 even though it alleged that
Worldwide Medical Supply had violated eight statutory provisions because four different transactions were involved. Accordingly, the penalty recommendation herein is based on the transactions for which the Department has proven a violation of one or more statutory provisions.
Based on the findings of fact herein that the Department has proven that Worldwide Medical Supply committed violations in 37 transactions involving the sale and purchase of prescription drugs, and in consideration of the number and duration of the violations proven by the Department, the maximum administrative fine of $5,000.00 should be imposed for each transaction in which the Department has proven a violation. Using the method used by the Department in calculating its recommended penalty, and based on the number of violations proven by the Department, the amount of the administrative fine imposed on Worldwide Medical Supply should be $185,000.00.
Section 499.067, Florida Statutes, provides in pertinent part:
1)(a) The department may deny, suspend, or revoke a permit if it finds that there has been a substantial failure to comply with ss. 499.001-499.081 or chapter 465,
chapter 501, or chapter 893, the rules adopted under any of those sections or chapters, any final order of the department, or applicable federal laws or regulations or other state laws or rules governing drugs, devices, or cosmetics.
* * *
The department may deny, suspend, or revoke any registration required by the provisions of ss. 499.001-499.081 for the violation of any provision of ss. 499.001-
499.081 or of any rules adopted under those sections.
The department may revoke or suspend a permit:
* * *
(c) If the permittee has violated any provision of ss. 499.001-499.081 or rules adopted under those sections
Based on the findings of fact herein, the violations of Sections 499-001 through .081, Florida Statutes, committed by Worldwide Medical Supply are substantial and warrant the revocation of its Florida license to operate as a wholesale distributor of prescription drugs.
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.
ENDNOTES
1/ The documents at issue in this proceeding were dated in 2004, 2005, 2006, 2007, and the statutes in effect in those years establish the applicable law. The provisions of Chapter 499, Florida Statutes, relevant to this proceeding were, however, unchanged from 2004 through 2007, except as noted. For ease of reference, therefore, all citations to the Florida Statutes, are to the 2006 edition, unless otherwise indicated.
2/ The further corrections and amendments to the Corrected Second Amended Administrative Complaint are as follows:
All references to Section 499.051(1)(b), Florida Statutes, are changed to Section 499.0051(1)(b), Florida Statutes.
Paragraph 11: Date changed from September 9, 2005, to
September 6, 2005.
Paragraph 18: Date changed from May 18, 2005, to May 20,
2005.
Paragraph 19: References to June 3 and 21, 2004, and to July 19, 2004, deleted and fine requested lowered from
$20,000.00 to $5,000.00.
Paragraph 25: Withdrawn.
Paragraph 27, second sentence: Delete remainder of sentence after "transaction."
Paragraph 30: Reference to Section 499.005(4)(12), Florida Statutes, changed to Section 499.005(14), Florida Statutes.
Paragraphs 30 through 37: References to
Sections 499.005(12) and (13) and 499.051(4) and (5), Florida Statutes, changed to Section 499.005(14) and (15) and 499.0051(4) and (5), Florida Statutes.
3/ As noted in the Preliminary Statement, the charges against Worldwide Medical Supply are set forth in separate paragraphs of the Corrected Second Amended Administrative Complaint. Each charging paragraph includes factual allegations and alleged statutory violations relating to a specific set or sets of documents dealing with one or more prescription drug purchase or sale transactions. The allegations in each paragraph derive from the sets of documents introduced into evidence as the Petitioner's exhibits. The Findings of Fact will, therefore, be organized according to the paragraph numbers in the Corrected Second Amended Administrative Complaint and the exhibit number corresponding to the pertinent documents will be referenced for each paragraph.
4/ Throughout this Recommended Order, abbreviations of metric units are reproduced as they are written in the invoices and other documents and are not necessarily the correct abbreviations of these units.
5/ Throughout this Recommended Order, reference to "Pedigree Paper" is to the Form DH2129; reference to "pedigree paper" is to a written statement that is not on Form DH2129.
6/ Transcript, vol. 1, p. 124-25.
7/ Transcript, vol. 2, p. 163.
8/ See transcript, vol. 2, p. 172-73.
9/ See endnote 6, above.
10/ Ms. Roberts testified that she learned that Medical Infusion Technologies is a homecare infusion company that is not authorized to sell prescription drugs to a wholesaler such as Worldwide Medical Supply. This testimony is inconsistent with her testimony regarding Petitioner's Exhibit 7 and Petitioner's Exhibit 9, with respect to which she testified that Medical Infusion Technologies was authorized to distribute drugs in Florida and is, therefore, rejected.
11/ Transcript, vol. 1, p. 66-67.
12/ See Transcript, vol. 2, p. 183.
13/ Ms. Roberts testified that the pedigree paper was not sent prior to or at the same time the Carimune was shipped to Worldwide Medical Supply. She based her testimony on a printed notation on the bottom of the pedigree paper showing that Premium Health Services sent the document by facsimile transmittal on October 25, 2004. There is, however, no indication that the document was transmitted to Worldwide Medical Supply on this date. The date the pedigree paper was signed was September 23, 2004, and the date of facsimile transmittal is ambiguous at best and fails to establish that the pedigree paper was not transmitted to Worldwide Medical Supply at the same time as the drug shipment.
14/ It is noted that the documents dated May 20, 2005, relate to two separate transactions. In the Corrected Second Amended Administrative Complaint, the Department has apparently treated these two transactions as one for purposes of the recommended penalty. Consequently, the second set of documents dated
May 20, 2005, will not be addressed.
15/ Ms. Roberts also found fault with the Pedigree Paper because it did not contain the "NDC" number, which is the National Drug Code number. It is noted, however, that the Pedigree Paper used by PMP Health Services was the pedigree Form DH2129 adopted in Florida and effective at the time of the transaction. There is no space on this form for an NDC number.
16/ Although the Department included documents in Petitioner's Exhibit 16 related to the June 21, 2004, transaction, the Department did not present any testimony regarding this transaction or any deficiencies in the documentation.
Consequently, the June 21, 2004, transaction will not be addressed herein.
17/ Ms. Roberts again found fault with the Pedigree Paper because it did not contain the "NDC" number, which is the National Drug Code number. As noted in endnote 15, there is no space on this form for an NDC number.
18/ At the final hearing, the Department's counsel stated that, during a deposition on November 27, 2007, the Department had included in Petitioner's Exhibit 18 an Invoice dated October 16, 2003, related to a transaction between FPP Distribution, Inc. and Worldwide Medical Supply. The Department included reference to the October 16, 2003, transaction in its proposed findings of fact and conclusions of law, but that transaction was not mentioned in the Corrected Second Amended Administrative Complaint; paragraph 23 of the Corrected Second Amended Administrative Complaint was not amended to add this transaction by either the Notice of Scrivener's Errors in the Administrative Complaint filed November 19, 2007, nor did the Department request an amendment at the final hearing to include this transaction in paragraph 23 of the Corrected Second Amended Administrative Complaint. Nonetheless, Worldwide Medical Supply's counsel conducted cross-examination on the October 16, 2003, transaction and will, therefore, be considered to have waived any objection to the addition of this transaction and to have consented to an amendment of paragraph 23 to include the October 16, 2003, transaction.
19/ Although several factual allegations are made in paragraph 24 of the Corrected Second Amended Administrative Complaint and several statutory sections are cited that Worldwide Medical Supply allegedly violated, there is no
specific charge included in the paragraph. Having reviewed the paragraphs in the Corrected Second Amended Administrative Complaint that contain citations to the same statutes, it appears that the Department intended to charge Worldwide Medical Supply with having purchased prescription drugs from an unauthorized source and having purchased contraband prescription drugs.
20/ Ms. Roberts testified that she telephoned Talecris in an attempt to authenticate the pedigree of the Baygam and was told that Talecris did not sell the Baygam at issue to Florida Infusion, leading Ms. Roberts to conclude that the pedigree paper was fraudulent. The testimony regarding her conversation
with a representative of Talecris is, however, hearsay and cannot support a finding of fact. 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.")
21/ The Department apparently did not recognize that there were three separate transactions dated October 17, 2005, and they treated these transactions as one for purposes of the recommended penalty.
22/ The Department's inspector, Richard Sands, also testified that he spoke with an employee of Kuehne + Nagel regarding the Pedigree Paper, and he testified regarding the substance of his conversation with this employee. This testimony is, first, irrelevant because his conversation related to the authentication of the Pedigree Paper and no violation relating to authentication is included in paragraph 33 of the Corrected Second Amended Administrative Complaint. The testimony is also hearsay and cannot support a finding of fact. 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.")
23/ Section 499.003(31)(b), Florida Statutes, contains provisions governing pedigree papers that were effective July 1, 2006. Although there are several transactions identified in the Corrected Second Amended Administrative Complaint that took place subsequent to July 1, 2006, none of the violations alleged with respect to these transactions involved pedigree papers.
Therefore, that portion of the definition of pedigree paper is not included herein because it is not relevant to this proceeding.
24/ Florida Administrative Code Rule 64F-12.012(3)(c) includes provisions that were effective July 1, 2006. As noted above in endnote 2, there are several transactions identified in the Corrected Second Amended Administrative Complaint that took place subsequent to July 6, 2006, but none of the violations alleged involved pedigree papers. Consequently, these portions of the definition of pedigree paper are not relevant to this proceeding.
25/ It is noted that the Department did not reference
Section 499.0121(4), Florida Statutes, in the Corrected Second Amended Administrative Complaint, even though it included this allegation in numerous paragraphs.
26/ In most instances, when the Department charged Worldwide Medical Supply with fraudulent authentication of pedigree papers, it referenced Section 499.005(28), Florida Statutes, as one statute violated by this alleged conduct.
Section 499.005(28), Florida Statutes, identifies as a violation the "[f]ailure to obtain or pass on a pedigree paper." This violation has no application to a transaction in which Worldwide Medical Supply received a pedigree paper, and nowhere in the Corrected Second Amended Administrative Complaint is there an allegation that Worldwide Medical Supply failed to "pass on" a pedigree paper.
27/ The Department takes the position that, whenever a pedigree is incomplete, and, as a result, the drug being purchased is an adulterated or contraband drug pursuant to Section 499.006(1), Florida Statutes, the purchase of the adulterated drug is a purchase from an unauthorized person, which is prohibited by Section 499.005(14), Florida Statutes. The Department's reasoning, as stated by Ms. Roberts during her testimony at the final hearing, is that, even if a wholesaler or manufacturer has a license to distribute prescription drugs in Florida at the time of the sale, no one is authorized to sell a contraband or adulterated drug in Florida, and, therefore, the person is not authorized to distribute the adulterated prescription drugs in Florida. The Department did not cite a rule or statute which provides that a properly licensed prescription drug wholesaler or manufacturer loses its authorization to sell prescription drugs in Florida if the drugs are adulterated or contraband because of the lack of a complete pedigree. In the absence of a statute or rule, the Department's position on this point is rejected, first, because the argument is circuitous, and, second, because the receipt of an adulterated drug and the purchase of a prescription drug from an unauthorized person are two separate offenses, the one prohibited in Section 499.005(3), Florida Statutes, and the other prohibited in
Section 499.005(14), Florida Statutes.
COPIES FURNISHED:
Denis A. Dean, Esquire
Office of the Attorney General The Capitol, Plaza Level PL-01 Tallahassee, Florida 32399-1050
Bernard M. Cassidy, Esquire Bernard Cassidy, P.A.
One East Broward Boulevard, Suite 1410 Fort Lauderdale, Florida 33301
R. S. Power, Agency Clerk Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Dr. Ana M. Viamonte Ros, Secretary Department of Health
4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
Josefina M. Tamayo, General Counsel Department of Health
4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this recommended order. Any exceptions to this recommended order should be filed with the agency that will issue the final order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Jun. 12, 2008 | Agency Final Order | |
| May 01, 2008 | Recommended Order | Respondent committed numerous violations of the Florida Drug and Cosmetic Act, including fraudulent authentication of drug pedigrees and purchase of adulterated drugs. Recommended a $185,000 fine and revocation of license as prescription drug wholesaler. |
