ph 42 # STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, through its BUREAU OF PHARMACY SERVICES, Petitioner, : Case No: vs. . eo, . ; (DOH: 01-04777) A.D. PHARMACEUTICALS, INC., a Florida Corporation, and CHANTEL BANATTY, individually, Respondents. wt __ ADMINISTRATIVE COMPLAINT Notice is hereby provided ihat Petitioner, Department of Health by and through its Bureau of Pharmacy Services (the "bureau”), intends to impose against Respondents, A.D. Pharmaceuticals, Inc., (“A.D. Pharmaceuticals”), a Florida corporation, and Chantal Banatty an administrative fine in the amount of Two Hundred Sixteen Thousand dollars ($216,000), pursuant to section 499.066(3), Florida Statutes, and revoke the prescription drug wholesaler permit number 22:01 193, that authorizes A.D, Pharmaceuticals to operate as a prescription drug wholesaler in Florida. In support of the intended final agency action the bureau states: (1) Petitioner, Department of Health (hereinafter “the Department’), through the Bureau of Pharmacy Services (“the Bureau”), 2818-A Mahan Drive, Tallahassee, Florida, 32308, is the state agency charged with implementing and enforcing the provisions of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (“the Act’), including the regulation of the acquisition and distribution of prescription drugs in Florida as well as the permitting of entities to engage in this activity. The prescription drug wholesaler permit is established under the Act. 2986S 276 ose! UI1LCAEH "1daq EP sOlstWdtOre !ZO-PZ-1b Aa Me kd dae Sgengrccror Perr emer mr fr a a eed el 4ZE # (2) Respondent, A.D. Pharmaceuticals, Inc., (“A.D.”) is a Florida registered corporation whose principle place of business is 12580 N.E. 9" Avenue, North Miami, Dade County, Florida, 33161. A.D. is permitted as a prescription drug wholesaler (permit number 22:01193) pursuant to the Act. This permit was initially issued by the bureau on July 7, 2000, and will expire on July 31, 2002. (3) A.D.’s president and sole owner is Chantal Banatty. Ms. Banatty is the person responsible for the violations alleged in this Complaint. (4) On or about February 8, 2000 {invoice 2100); February 9, 2000 (invoice 2101); . = January 12, 2001 (invoices 2085 and 2086); January 19, 2001 (invoice 2086); January 23, 2001 (invoice 2090); January 24, 2001 {invoices 2091 and 2092); January 26, 2001 (invoice 2094); January 29, 2001 (invoice 2095) and January 31, 2001 {invoice 2096), Respondents bought prescription drugs under A.D.’s prescription drug wholesaler permit from Wholesale international located at 3663 S.W. 8" Street, Miami, Florida. (6) In addition, pedigree papers produced by Respondents, for which a corresponding invoice was not produced to the department, indicate Respondents acquired prescription drugs from Wholesale International on or about February 16, 2001 (referencing invoice 0100) and February 20, 2001 (referencing invoice 3004). Similarly, another pedigree paper produced by one of A.D.’s customers, AmeRx, indicates that Respondents also purchased prescription drugs on January 24, 2001 (referencing invoice 2092) from Wholesale International. A pedigree paper is a record required by s. 499.0121 (6)(d), F.S., to be provided by a prescription drug wholesaler distributing a prescription drug to another prescription drug wholesaler when the distributing wholesaler is not the authorized distributor of record for the prescription drug which is the subject of the transaction. The pedigree paper is required to be provided in addition to an invoice or other business records documenting the distribution of a prescription drug. LOSS Zz6 OSE: urleeH “Adeg eplsolsaiWwdto:r £zZ0-rZ-1 see oe yh oY 4 (6) Respondents also produced to the department a purchase record dated February 11, 2000. This document does not indicate the seller of the prescription drugs, however, the pedigree papers (dated February 11, 2001) related to the prescription drugs on the invoice, Neupogen 300 mcg lot #P000992; Procrit 10,000 lot #D003783; Epogen 20,000 lot #P001090; Neupogen 480meg Jot #P000996: and Epogen 10,000 lot #P001031 indicate Respondents acquired the presoription drugs from Mackession (handwriting not completely legible) in New York. Mackession, in New York or anywhere else, is not permitted under the Florida Drug and Cosmetic Act to en in the wholesale distribution of prescription drugs in or into the State of “Florida. (7) Records provided by Respondents indicate they acquired prescription drugs from Tradewind Trading Company, Inc., (‘Tradewind”) of 1906 South Bagdad, Leander, Texas. The following chart, referencing an invoice number and date, identify the records that are the subject of this paragraph. #3006 2/20/01 #3008 2/22/01 #3014 2/26/01 #3016 2/27/01 #3020 3/2/01 #3023 3/4/01 #3012 2/24/01 | #3019 3/1/01 #3010 2/23/01 #3018 2/28/01 #3030_3/7/01 #3034 3/9/01 #3047 39/15/01 #3037 3/12/01 #3042 3/15/01 | #8049 3/17/01 [#3051 3/19/01 #3033 3/8/01 #3046 3/16/01 #3054 3/21/01 # #3056 4/10/01 #3057 3/23/01 | #3059 3/26/01 #3061 9/24/01 #3063 3/28/01 #3067 4/2/01 : #3065 3/30/01 #8065 4/16/01 #3070 4/3/01 = #3075 4/4/01___ #3079 4/6/01 #3089 4/25/01 #3090 4/26/01 #4000 5/1/01 | #3082 4/9/01 | Although Tradewind is permitted under the Act as and Out-of-State Prescription Drug Wholesaler, the prescription drugs were actually hand delivered to Respondents by an individual named Eliseo Martinez. Even if Eliseo Martinez were acting as an agent for Tradewind, he would be required under the Act to be permitted as a prescription drug wholesaler in order to take possession of the prescription drugs in Florida. He would also be required to meet all storage and handling requirements of a prescription drug wholesaler, including but not limited to all recordkeeping requirements to document the transfer of 2e9@s z7z6 ose! U1ebH "23deQ SPpl4olatwWdtOiry fZO-ve-t Se Ais a A aes Sere cone torr ere Ss ce ae ee re ¢SS # 29ts zz6e oss! ; prescription drugs to and from his possession. Eliseo Martinez is the president and sole corporate officer of Wholesale International and at all times material to the allegations in this Compiaint, was physically located and operating in Florida. A.D. Pharmaceuticals paid . Wholesale International by check for the prescription drugs referenced in these transactions. (8). Neither Eliseo Martinez or Wholesale International of 3663 S.W. 8" Street, Miami, Florida, 33134 nor Mackession in New York are currently permitted and none of these persons have been permitted under the Act at any time relevant and material to the transactions alleged in paragraphs (4) - (7) to engage in the wholesale distribution of any prescription drug “from, in or into the State of Florida. ‘The wholesale distribution of prescription drugs for which a permit under Chapter 499, F.S., is required involves either the sale or physical distribution ofa prescription drug. (9) When Respondents, A.D. and Chantel Banatty, acquired the prescription drugs through the transactions alleged in paragraphs (4) - (7), they purchased or received a prescription drug from a person that is not authorized under Chapter 499, F.S., to distribute prescription drugs and thereby violated s. 499.005(14), F.S. (10) Furthermore, since Eliseo Martinez, Wholesale International, and Mackession _were not permitted to engage in the wholesale distribution of prescription drugs in Florida, the prescription drugs acquired in paragraphs (4) - (7) were adulterated pursuant to s. 499.006(2) : and (3), F.S. In addition, some of the prescription drugs acquired in paragraph (4) — (7) were counterfeit, based on the lot numbers and expiration dates identified on the pedigree paper in the following transactions: a) Epogen 10,000, lot#P001031 exp. 08/03 (pedigree referencing invoice # blank dated 2/11/01; invoice is dated 2/11/00), b) Epogen 10,000, lot #P001031 exp. 08/03 (pedigree referencing invoice #3010 dated 2/23/01), c) Neupogen 300 mcg, lot #P000905 exp. 08/02 (pedigree referencing invoice #3016 dated UZ1Te8H “2080 eplszoiatwdlory £ZO-ve7-1t Ci a ae FRR er = ene eee oer SCT REIRE RMT Pro re vl £3 , 2/27/01), d) Epogen 10,000, lot #P001031 exp. 08/03 (pedigree referencing invoice #3035 dated 3/10/01), * e@) Neupogen 300 mcg, lot #P000905 exp. 08/02 (pedigree referencing invoice #3036 dated 3/12/01), . , . f) Neupogen 300 mcg, lot #P000890 exp: 12/02 (pedigree referencing invoice #3055 dated 3/22/01; : g) Neupogen 300 meg, lot #P000889 exp. 12/02 (pedigree referencing invoice #3057 dated - 8/23/01; h) Epogen 10,000, lot #P001031 exp. 08/03 (pedigree referencing invoice #3057 dated 3/23/01), . i) Neupogen 300 meg, lot #P000890 exp. 12/02 (pedigree referencing invoice #3063 dated 3/28/01), a f) Epogen 10,000, lot #P001031 exp. 08/03 (pedigree referencing invoice #3065 dated 3/30/01), . k) Neupogen 300 meg, lot #P000819 exp. 10/01 {pedigree referencing invoice #3070 dated 4/03/01), and 1). Epogen 10,000, lot #7001081 exp. 8/03 (pedigree referencing invoice #3075 dated 4/4/01). Therefore Respondents purchased and received adulterated drugs through the transactions alleged in paragraph (4) — (7) above in violation of ss. 499.005 (1), (3), and (4), F.S. (11) Onor about January 25, 2001 (invoice 5588), February 8, 2001 (invoice 5602), February 9, 2001 (invoice 5603), February 12, 2001 (invoice 5605), February 23, 2001 (invoice “sales order’ 5215), March 12, 2001 (invoice “sales order” 5251) and (invoice “sales order 5252), March 28, 2001 (invoice 5708), and April 4, 2001 (invoice 5718) Respondents sold the prescription drugs acquired as alleged in paragraphs (4) — (7) to AmeRx, Inc., a prescription drug wholesaler located in Florida. Respondents provided to AmeRx the pedigree papers # z2ees zz6 oss! YU21ESH tadeg Epl4olsatWdtoir £3o-veZ-b See pe serena ae ee OR ne Sopeee ope serge geen pet or FR Fn mere ne ve 72 % # referenced in paragraphs (4) — (7) as support for the sale of certain prescription drugs included in those paragraphs. (12) Furthermore, Respondenis, sold prescription drugs to AmeRx in the following transactions. Based on these lot numbers and expiration dates, each of these drugs isa counterfeit prescription drug. a) February 23, 2001 (invoice 5215) Epogen 10,000, lot #P001031 exp. 08/03 (pedigree | referencing invoice #3010 dated 2/23/01) b) March 12, 2001 (invoice 5251) Epogen 10,000, lot #P001031 exp. 08/03 (pedigree -referencing invoice #3035 dated 3/10/01) c) March 12, 2001 (invoice 5252) Neupogen 300 mcg, lot #P000905 exp. 08/02 (pedigree referencing invoice #3016 dated 2/27/01) or { pedigree invoice #3036 dated 3/12/01) dq) February 12, 2001 (invoice 5605) Epogen 10,000, lot#P001031 exp. 08/03 (pedigree referencing invoice # blank dated 2/11/01) e) March 28, 2001 (invoice 5708) Neupogen 300 meg, lot #P000890 exp. 12/02 (pedigree referencing invoice #8063 dated 3/28/01) f) April 4, 2001 (invoice 5718) Epogen 10,000, tot #P001031 exp. 8/03 (pedigree referencing invoice #3075 dated 4/4/01) (18) Additionally, Respondents sold to AmeRx the prescription drug, Neupogen 300 meg, lot number (lot # P000948) referenced on invoice 5754 dated April 27, 2001, and invoice 5757 dated Apri! 30, 2001. Based on the lot number, this Neupogen 300 mcg, is a counterfeit prescription drug. : (14) | Respondents’ wholesale distribution of counterfeit prescription drugs as set forth in paragraphs (12) and (13) is a violation of s. 499.005(8), F.S. (15) Furthermore, Respondents sold and distributed adulterated prescription drugs in violation of ss. 499.005(1), (3), and (4), F.S., when they sold and distributed the prescription drugs in the following transactions. 29tS Z76 Ose! UILeeH "Aded Epl4olatWdtOry tzo-v¥7-t Hp i lt RE CRF OORT Opa oe OR RE RRR Free rl 428 - ‘ (a) Those transactions identified in paragraphs (11), (12), and (13) and (b) An additional 80 transactions identified by AD’s sales invoices numbered: [5582 5583 5587 5589 5617 5618 5622 5623 5654 5674 5675 5677. 5679 5691 5714 5734 The prescription drugs sold by Respondents in these 80 transactions are adulterated because Respondents acquired all prescription drugs from Eliseo Martinez, acting individually, as Wholesale International, or Tradewind as alleged in paragraphs (4) - (7) according to the records produced by Respondents to the department. (16) | Respondents were not maintaining records for a complete audit trail as required by s. 499.0121 (6), F.S., and Rule 64F-12.012, Florida Administrative Code. Specifically, (a) Respondents did not produce to the department pedigree papers, or demonstrate . any exemption from the pedigree paper requirements, for one or more of the © Presoription drugs acquired by them that are listed on the following purchase invoices of A.D. 1712/01 #2085 1/12/01 #2086 2/8/00 #2100 2/13/00 no invoice # 1/19/01 #2086 1/23/01 #2090 ‘| 1/24/01 #2091 & 2092 | 1/26/01 #2094 1/29/01 #2095 1/31/01 #2096 2/23/01 #3010 3/2/00 #3020 3/4/01 #3023 3/12/01 #3037 3/15/01 #3042 3/15/01 #3047 | 3/17/01 #3049 3/21/01 #3054 4/10/01 #3056 3/26/01 #3059 | 3/28/01 #3063 4/4/01 #3075 4/6/01 #3079 4/26/01 #3090 (b) Respondents did not provide invoices for the following prescription drugs listed on pedigree papers provided by them in response to the bureau's record requests. These pedigree papers are referenced by the date and a corresponding invoice number recorded on the pedigree paper. z29¢S z2z6 ose! U1SSH “Adeq epl4solatWdtory !ZOo~ve-b oe ee rermrpny orp se Se ide 8 vl £6 2/16/01 #0100 immune globulin 5.0qms / 50 mi_ #32 2/16/01_#0100 immune globulin 10.0qms / 100ml #14 2/16/01 #0100 immune globulin 20.0gms / 200ml #5 2/20/01 #3004 filgrastim (Neupogen) 300mca #18 2/20/01 #3004 filarastinm(Neupogen) 480 meg #5 a 2/20/01 #3004 immune globulin 20.0 ams / 200m! #200qgms 2/20/01 #3004 epoetin alfa (Epogen) 10,000 #3 2/20/01 #3004 epoetin alfa (Epogen) 20,000 #2 2/20/01 #3004 epoetin alfa (Epogen) 10,000/20,000 #1 2/22/01 #3008 filgrastim (Neupogen) 300mcg 1.0ml #18 2/23/01-#3010 lamivudine (Combivir) 150ma/300ma #3 2/28/01 #3018 filarastim (Neupogen) 300mcq #6 — invoice states #5 3/3/01 #3021 epoetin alfa (Procrit) 10,000 #9 3/3/01 #3021 epoetin alfa (Procrit) 10,000/20,000 #1 3/8/01 #3021 epoetin alfa (Epogen) 20,000 #5 8/3/01 #3021 stavud dine (Zer' rit) 40mg #6 3/3/01 #3021 nelfinavir mesylate (Viracept) 250mg /300 #4 3/3/01 #3021 filgrastim (Neupogen) 480 mcg #5 3/3/01 #3021 epoetin alfa (Epoaen)} 40,000 #1 3/10/01 #3035 epotin alfa (Epoden) 10,000 #6 3/10/01 #3035 filgrastim (Neupogen) 480 meg #7 3/10/01 #3035 epoetin alfa (Epogen) 20,000 #4 3/12/01 #3036 epotein alfa (Epogen 3,000 #4 #4 3/12/01 #3036 epotin alfa (Epogen) 10,000 #2 3/12/01 #3036 filgrastim (Neupogen) 300mcg #8 8/12/01 #3036 immune globulin 110 grams #141 | 3/13/01 #3039 immune globulin 10.0 grams #12 3/16/01 #3046 Lamivudine (Epivir) 150mg #2 3/17/01 #3049 immune dlobulin 120 grams #12 (c) Invoices and.pedigree papers were found at one of A.D.’s customers, AmeRx, Inc., which were not provided by A.D. in response to requests for prescription drug wholesale records made by the department. The records not produced include the following: Invoice #5659 dated 3/8/01 Invoice # 5725 dated 4/9/01 pediaree paper dated 1/24/01 referencing invoice #2092 pedigree paper dated 3/15/01 referencing invoice #3045 — no associated purchase invoice #3045 edigree paper dated 4/11/01 referencing invoice #3058 — no associated purchase invoice #3058 i pedigree paper dated 4/5/01 referencing invoice #3077 — no associated purchase invoice #3077 | pedigree paper dated 4/23/01 referencing invoice #3085 — no associated purchase invoice #3085 pedigree paper dated 4/24/01 referencing invoice #3088 ~— no associated purchase invoice #3088 pedigree paper dated 4/24/01 referencing invoice #3092 ~ no associated purchase invoice #3092 (d) A.D.’s sales records did not accurately identify the prescription drug sold. For example, the following inaccuracies were noted on the following invoices of A.D. # “298s @z6 ose! UR1SSH “1deq epl4olsiWdtoir fZO-¥Z-1 2 ae FOR RRREE RETRE RT T ro ORE Ue Re vt SOL # Y Invoice Date | invoice _{ Product Identified | Lot Number/Pedigree | Problem 2/23/01 5215 Pracrit 20,000 Po0o0996 Procrit lot #s begin with D a a Procrit 40,000 P001006 “ « a Procrit 20,000 Po01093 « “ “ Procrit 20,000 P001051__* a ‘ a “ Procrit 20,000 P001083 “ “ ‘ Procrit 40,000 P000976 “ a ‘ Procrit 40,000 Poo0997 a s a Procrit 40,000 Pooi048_* a “ “ Procrit 40,000 P000813 “ 3/13/01 5256 Procrit 20,000 P001095 “ 1/19/01 5582 Procrit 40,000 Po00943 “ “ Procrit 40,000 P000976 “ * “ Procrit 40,000 P000872 “ « “ Procrit 40,000 P000975 « 2/9/61 5603 Procrit 20,000. P001054 — * « 2/23/01 5621 Procrit 20,000 Pooog66 we a a Procrit 40,000 P001006 " « | Procrit 20,000 Po01093 ‘ Procrit 20,000 P001054 Fr C7 Procrit 20,000 P001083 “ « Procrit 40,000 P000976 « “« “ Procrit 40,000 P000977 ‘ « « Procrit 40,000 P001048 “ « “« Procrit 40,000 P000813 « 2/28/01 5629 Procrit 40,000 P001050 « “ “ Procrit 40,000 P001006 “ 3/15/01 5675 Procrit 40,000 P001053__* « “ “ Procrit 20,000 Po01018_* “ “ Procrit 40,000 ; P001048. “ “ Procrit 40,000 Po01050_—* “ 3/27/01 5707 Procrit 40,000 P001084_—* “ 3/28/01 5708 Procrit 20,000 | P001120 “ . ia Procrit 40,000 Po00954 “ a “ Procrit 40,000 P001053 e “ ‘ Procrit 40,000 Po01084. * . “ : 4/4/01 5718 Neupogen 480 P000829 (correct Same lot # for 2 products “ “ Neupogen 300 P000829 (incorrect) Same lot # for 2 products __* " Procrit 20,000 P001120 Procrit lot #s begin with D Procrit 40,000 P001094. ; Procrit 40,000 P001084 ‘ 5725 Procrit 40,000 Po01118 —* “ ao “ I Procrit 40,000 [ P001084 a f s Procrit 40,000 P001055 “ “ “ Procrit 40,000 Poo1094 “ 4/12/01 5734 Procrit 40,000 P001094 " « { Procrit 40,000 P001053 “ | a “ Procrit 40,000 P001084 « “ a Procrit 20,000 P001120 a 4/12/01 5736 Procrit 100001 P001638 $$ 4/16/01 15741 I Procrit 40.000 «| P0O1094_—* “ « “ Procrit 40,000 P001084 ‘ 4/i7l0i_s—sd| 5742 Procrit 20,000 |.Po01i20. * “ 29es 776 oset YURLeSH “IdSG SPAS satWalOty fZO-FT~E pr Ae Ld 4 phe SEL # P001118 4/25/01 5750 Procrit 40,000. 4/27/01 5755 Procrit 20,000 Poot120 ‘ Procrit 40,000 Po01118 : Section 499.0121 (6), F.S., and Rule 64F-12.012 (1) and (2), Fla. Admin. Code, require wholesale drug distributors to provide a complete audit trail from receipt to sale or other disposition of prescription drugs. Records must include at a minimum, but not be limited to, . identifying information about the source of the drugs; identifying information about the purchaser and recipient of the drugs; the name, strength, dosage form, and quantity of prescription drugs _involved in the transaction; and the dates of the transaction. Respondents’ failure to maintain records and accurately record the substance of the transaction related to the wholesale distribution of prescription drugs as alleged in this paragraph is a violation of s. 499.005(18), F.S. (17) Respondent, Chantal Banatty was convicted of a felony in the third degree on November 27, 2000, in case number 00-026539 related to dealing in stolen drugs. (18) The violations of Chapter 499, F.S., by A.D. Pharmaceuticals and Chantal Banatty as set forth in this complaint constitute sufficient grounds for DOH to revoke A.D.’s prescription drug wholesaler permit and impose an administrative fine of Two Hundred Sixteen Thousand dollars ($216,000) or impose any other penalty authorized by Chapter 499, F.S. and Chapter 64F-12, Florida Administrative Code against the Respondents. (19) Rule 64F-12.024 (4), Florida Administrative Code sets the range of the penalty for violations of the Florida Drug and Cosmetic Act, Chapter 499, F.S. Pursuant to that rule the bureau intends to impose the fines and action as noted. (a) The rule authorizes a fine for the purchase or acquisition of a prescription drug from an unauthorized source ranging from $250 to $1,000 per violation per day. A.D. Pharmaceuticals’ sources of the prescription drugs that are the subject of this complaint were not permitted in their resident states to engage in the wholesale distribution of prescription drugs 10 49¢¢s 7276 ose! ud1e@5H "2deqQ ePl4oisatWNdtoiy $Zo-PrZ-t ope spre 7 CC oe ee oe & ve stl # in interstate commerce in the United States. Therefore the purchase of prescription drugs from these sources is a more serious violation than purchasing prescription drugs from a source that is permitted to wholesale prescription drugs in its resident state buthas not yet obtained an Out- of-State Prescription Drug Wholesaler permit from the State of Florida to wholesale prescription drugs. Moreover, the prescription drugs purchased by Respondents from unauthorized sources as alleged in this Complaint are needed by people who are extremely ill, suffering from AIDS, cancer, and other conditions of persons with compromised immune systems. Further, the fact that some of the prescription drugs involved in these transactions were counterfeit, warrants the . department to impose the upper level of the range of penalty for the violations and enhance the penalty with revocation of the permit that authorizes A.D. to wholesale prescription drugs. The bureau intends to fine Respondents $49, 000 (49 transactions in paragraphs (4) — (7) at $1,000 each) and revoke permit 22:01 193 for this violation. (b} The rule authorizes a fine for the sale or delivery of an adulterated or counterfeit prescription drug ranging from $250 - $5,000 per violation per day and suspension or revocation of the permit with a fine. The bureau intends to fine Respondents $123,000 (83 transactions in paragraphs (11) — (13) and (15)(b) at $1,000 each + eight counterfeit transactions in paragraphs (12) and (13) at $5, 000) and revoke permit 22:011983 for this violation. (c) The rule authorizes a fine for the failure to maintain records as 5 required r ranging from $250 - $5,000 per violation per day and suspension or revocation of the permit with a fine. The bureau intends to fine Respondents $44,000 (paragraph (16)(a) - $1,000; (b) — $29,000 based on 29 products at $1,000 each; (c) - $9,000 based on 9 records at $1,000 each); and (d) - $5,000) and revoke permit 22:01 193 for this violation. (20) Section 499.067(1), F.S., authorizes the department to 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 893, or chapter 501, or the rules adopted under any of those sections or chapters. In addition, s. 499.067(3)(c), F.S., authorizes the department to deny, suspend or 11 249tS 2@6 ose! UATeeH “Adeqd epl4uolaiwdlo:vy !go-ve-t CU nm orm enna corer one me ope reer ener ns cee poorer oor Me i [aaah tauaianldaed ALL Accs al r Seta ae vl Sol # 29€¢E 226 osst ulz1e8H , revoke a permit if the permittee has violated any provisions of ss. 499.001-499.081 or rules | adopted under those sections. Furthermore, s. 499.067(5), F.S., authorizes the departinent to “deny, suspend, or revoke a permit issued under the Act which authorizes the permittee to purchase prescription drugs, if any owner, officer, employee, or other person who participates in administering or operating the establishment has been found guilty of any violation of ss. '499.001-499.081 ... any rules adopted under any of those sections or chapters, or any federal ; or state drug law, regardless of whether the person has been pardoned, had her civil rights restored, or had adjudication withheld.” = (21) The violations alleged in this complaint evidence a substantial failure to comply and are substantial violations of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. The unlawful acquisition practices of A.D. Pharmaceuticals facilitated the distribution of adulterated and counterfeit prescription drugs. Additionally, the purchasing and distribution practices of prescription drugs by A.D. Pharmaceuticals present a public health threat and the continued authority to engage in the wholesale distribution of prescription drugs poses a danger and is not in the best interest of the public health, safety and welfare. Finally, the practices of A.D. Pharmaceuticals as alleged in this complaint represent a substantial disregard for the regulatory scheme regarding the wholesaling of prescription drugs and undermines the regulatory structure established by federal and state law for the protection of the public health that warrant revocation of the authority to engage in the wholesale distribution of prescription drugs under permit 22:01193. . (22) You have the right to request an administrative hearing pursuant to sections 120.569 and 120.57, F.S., if you wish to challenge the imposition of the administrative fine and the intended agency action to revoke permit 22:01231. Such proceedings are governed by sections 120.569 and 120.57, F.S., and Rules 28-106 and 28-107, Florida Administrative Code. Request for a hearing, formal or informal, must comply with Rule 28-107.004, Florida Administrative Code. 12 "adeq epl4olaiwWdto:y !ZO-rZ-1t beeen gern peop cen pen Se ee ee rp ernere " bh Soh # (a) A petition for administrative hearing must be in writing and must be received by Mr. Theodore M. Henderson, Agency Clerk for the Department, within twenty-one (21) days from the receipt of this complaint. The address of the Agency Clerk is 4052 Bald Cypress Way, BIN # AO2, Tallahassee FL 32399-1703. The Agency Clerk’s facsimile number is 850-410- 1448, Oo (b) Mediation is not available as an alternative remedy. (c) Your failure to submit a petition for hearing within 21 days from receipt of this complaint will constitute a waiver of your right to an administrative hearing, under Florida ~ ‘Administrative Code Rule 28-106.111 and this complaint shall become a “final order". (d) Should this complaint become a final order, a party who is adversely affected by it is entitled to judicial review pursuant to section 120.68, Fla. Stat. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings may be commenced by filing one copy of a Notice of Appeal with the Agency Clerk of the Department of Health and a second copy, accompanied ‘by the filing fees required by law, with the Court of Appeal in the appropriate District Court. The notice must be filed within 30 days of rendition of the final order. - (23) The undersigned certifies that a true copy of this administrative complaint was sent by U.S. Certified Mail, Return Receipt Requested, to Chantal! Banatty, President of A.D. Pharmaceuticals, Inc., at 12580 N.E. 9" Avenue, North Miami, Florida, 33161, this th day of January, 2002. | b ff (dt Hilf Chief of harmacy Services 2818-A Mahan Drive Tallahassee, Florida 32308 Telephone: (850) 922-5190 Copy also furnished to: Counsel for the Department: Robert P. Daniti, Senior Attorney; 4052 Bald Cypress Way, Bin A02; Tallahassee, Florida 32399- 1703; Telephone (850) 245-4005; Facsimile (850) 413 8749; Florida Bar No. 191599 13 ees eze Ose: U21eBH "10eq ePl4olatWdlo:r !7O-¥Z-3} L ‘ SO ERECT NERNEY TIE ore reset sore mati wee 1-24-02; 4:35PM;Florida Dept. Health 3850 S22 S367 # 27 2 SF EE TTI PR TP TT CRREIE ETERI re E E i f SENDER: COMPLETE THIS SECTION COMPLETE THIS SECTION ON DELIVERY “m Complete items 1, 2, and 3, Also complete ‘A. Received by (Please Print Clearly) |B. Dyte of Delivery Item 4 if Restricted Delivery Is desired. . |. D/O, ‘O- ™ Print your name and address on the reverse oa ~ so that we can return the card to you. 4 g . 2 : m Attach this card to the back of the mailpiece, olay, t i or on the front if space permits. Aen Addressee 1 Yes 1. Article Addressed to: 0 ’ Chantal Banaity;:President ; _ A.D. Pharmaceuticals, Inc. —— : 12580 N.E.. 9" Avenue I[® Serfeeipe ee rE : farni ‘ : Certified Mail Express Mail . North Miami, Florida, 33161 | “Oo Registered Return Recelpt for Merchandise : : * . {DD Insured Mail C.0.D. ; : : i | 4, Restricted Delivery? (Extra Fee) D Yes ‘ 2. Article Number (Copy from service iabed SF 295 ; - k PS Form 3811, July 1999 Domestic Return Receipt : 102596-00-M0552 : . a ‘

Docket for Case No: 02-000463