STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, through its BUREAU OF PHARMACY SERVICES, Petitioner, Case No: : vs. (DOH: 00-04497 & 02-05056) 2D RX PLUS, INC., a Florida Corporation, MICHAEL S. BULLER, 6} ? -7 5 ‘4 | Individually, JOSE A. CASTILLO, individually, and BRIAN A. HILL, Individually, Respondents. / ADMINISTRATIVE COMPLAINT ALMINSTRATIVE COMPLAINT Notice is hereby provided that Petitioner, Department of Health by and through its Bureau of Pharmacy Services (the "bureau”), intends to revoke the permit of Rx Plus, Inc., (“Rx Plus”), to operate as a prescription drug wholesaler (permit number 22:01117) in Florida and impose against Respondents, Rx Plus, Inc., a Florida corporation, Michael S. Buller, individually, Jose Castillo, individually, and Brian Hill, individually, an administrative fine in the amount of forty-five thousand five hundred dollars ($45,500), pursuant to section 499.066(3), Florida Statutes. In support of the intended final agency action the bureau states: (1) Petitioner, Department of Heaith, through its Bureau of Pharmacy Services, (“Bureau”) 2818-A Mahan Drive, Tallahassee, Florida, 32308, is the Florida state agency responsible for 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. (2) Respondent, Rx Plus, Inc., is a Florida registered corporation whose principal place of business is currently 1562 S.E. Village Green Drive #3, Port St. Lucie, St. Lucie County, Florida 34952 and previously 2737 S.E. Morningside Boulevard, Port St. Lucie, Florida. During a portion of the period covered in this Administrative Complaint Respondent, Rx Plus was permitted to conduct prescription drug wholesale business at a former address of 855 N.E. Jensen Beach Boulevard, Jensen Beach, Florida 34957. Respondent, Rx Plus, is currently permitted at 2737 S.E, Morningside Boulevard, Port St. Lucie, as a prescription drug wholesaler (permit number 22:01117) pursuant to the Act. A change of address application was submitted to the department on December 24, 2001, to change the address of the establishment identified on the prescription drug wholesaler permit to 1562 S.E. Village Green Drive #3, Port St. Lucie. However the bureau has not issued a prescription drug wholesaler permit to that address yet. Permit number 22:01117 represents the authority for Rx Plus to engage in the wholesale distribution of prescription drugs in or from Florida at the address printed on the permit until the permit expires on July 31, 2003, unless sooner suspended or revoked. (3) Respondent, Michael S. Buller, is the president of Rx Plus and was at all times material hereto responsible for and involved in the prescription drug wholesale operations of Rx Plus, and specifically the activities alleged in this complaint. (4) Respondent, Jose Castillo, is the Vice President of Rx Plus and was at all times material hereto responsible for and involved in the prescription drug wholesale operations of Rx Plus, and specifically the activities alleged in this complaint. Jose Castillo is also the President of Jemco Medical International, inc., another company permitted as a Prescription drug wholesaler under permit 22:00961, until the Secretary of the Department of Health issued an emergency suspension order of permit 22:00961 on May 2, 2002. (5) Respondent, Brian Hill, is the Vice President of Rx Plus and was at all times material hereto responsible for and involved in the prescription drug wholesale operations of Rx Plus, and specifically the activities alleged in this complaint. Brian Hill is also the Vice President and Secretary of Jemco Medical International, Inc., another company permitted as a prescription drug wholesaler under permit 22:00961, until the Secretary of the Department of Health issued an emergency suspension order of permit 22:00961 on May 2, 2002. (6) Section 499.01(1)(d), F.S., requires a permit for each establishment that operates as a prescription drug wholesaler. An establishment is defined in s. 499.003(13), F.S., as a place of business at one general physical location. Wholesale distribution is defined in s. 499.012(1), F.S., as the distribution of Prescription drugs to persons other than a consumer or patient, with certain exceptions not germane to this complaint. Distribution, as defined in S. 499.003(11), F.S., means to sell: offer to sell; give away; transfer, whether by passage of title, physical movement, or both; deliver; or offer to deliver; but does not mean to administer or dispense, Finally, s. 499.012(2)(a) and (3), F.S., state that a Person that engages in the wholesale distribution of Prescription drugs in or into this state must have a wholesale distributor’s permit issued by the department prior to engaging in Prescription drug wholesaling activity. (7) Records, marked Exhibits A-1 through A-9, related to the wholesale distribution of Prescription drugs from Global Rx to Rx Plus indicate that Rx Plus purchased prescription drugs from Global Rx during the period October 6, 1999 through December 17, 1999. However Global Rx did not obtain a prescription drug wholesaler permit that would authorize it to engage in the wholesale distribution of prescription drugs until February 11, 2000, (8) Records, marked Exhibits A-10 through A-15, related to the wholesale distribution of Prescription drugs from SHC — Schueler Healthcare at 74 Cherry Valley Avenue, West Hempstead, New York 11552, to Rx Plus indicate that Rx Plus received Prescription drugs from SHC — Schueler Healthcare during the period December 3, 2001 through January 10, 2002. However, SHC — Schueler Healthcare at 74 Cherry Valley Avenue, West Hempstead, New York was not permitted as an Out-of-State Prescription Drug Wholesaler in Florida as required bys. 499.012(2)(b), and (3), F.S., prior to distributing prescription drugs into the state of Florida, and more specifically to Rx Plus. Furthermore, SHC — Schueler Healthcare at 74 Cherry, Valley Avenue, West Hempstead, New York was not permitted in its resident state, New York, to engage in the wholesale distribution of prescription drugs in interstate commerce in the United States. (9) Therefore, based on the allegations in paragraphs (6), (7), and (8) Rx Plus violated Ss. 499,005(14), F.S., by purchasing prescription drugs from a person that is not authorized under Chapter 499, F.S., to engage in the wholesale distribution of Prescription drugs. (10) Jose Castiito, on behalf of Jemco Medical International and Rx Plus, engaged in schemes to create documentation for the acquisition of Prescription drugs that did not accurately reflect wholesale transactions of these prescription drugs. At the request of Jose Castillo, Hector Bermudez of Global Rx, created sales documentation, marked as Exhibits A-1 through A-9, for the sale and distribution of Prescription drugs to Rx Plus. However, Hector Bermudez never bought or sold, nor took Possession of these Prescription drugs. Further, Global Rx did not physically distribute these Prescription drugs to Rx Plus. Nonetheless, Rx Plus’ records reflect the sale and distribution of these same Prescription drugs to Jemco Medical International. (11) Therefore, based on the allegations in Paragraph (10), Rx Plus obtained these Prescription drugs from Global Rx by fraud, deceit, misrepresentation or subterfuge, and engaged in misrepresentation or fraud in the distribution of these drugs to Jemco Medical International and thereby violated s. 499.005(23), F.S., (12) Since Global Rx was not permitted as a Prescription Drug Wholesaler as alleged in paragraph (7), the actual source of the prescription drugs referenced in Paragraph (10) is unknown, and therefore the prescription drugs acquired and sold by Rx Plus as represented by Exhibits A-1 through A-9 were held under conditions where they could have been rendered injurious to health. As a result, Rx Plus violated ss, 499.005(1), (2), and (4), F.S., in that these prescription drugs were adulterated Pursuant to s. 499.006(2) and (3), F.S. (13) Rx Pius moved its prescription drug wholesaling activities from 2737 S.E. Morningside Boulevard, Port St. Lucie to 1562 S.E. Village Green Drive #3, Port St. Lucie. effective December 1, 2001. However, Rx Plus did not submit Notification of this change of address in order to obtain a prescription drug wholesaler permit at the Village Green Drive establishment until December 24, 2001. A permit that authorizes an entity to possess prescription drugs pursuant to s. 499.03, F.S., and to engage in the wholesale distribution of prescription drugs under s. 499.012(2)(a), F.S., is valid only for the establishment to which it is issued pursuant to s, 499.01(4), F.S. Further, s. 499.01(4)(a), F.S. requires that a person permitted under ss. 499.001-499.081 must notify the department before making a change of address. (14) As evidence by Exhibits A-10, A-11, A-12, A-16, and A-17, Rx Plus engaged in the wholesale distribution of prescription drugs and took possession of prescription drugs at 1562 S.E. Village Green Drive #3, Port St. Lucie prior to Notifying the department of the change in address and obtaining a prescription drug wholesaler permit for this new address. (15) As aresult of the allegations in paragraphs (13) and (14), . (a) Rx Plus was not in lawful possession of prescription drugs at 1562 S.E, Village Green Drive #3, Port St. Lucie and thereby violated ss. 499.005(12) and 499.03, F.S, (b) Rx Plus violated s. 499.005(22), F.S., by wholesaling Prescription drugs at and from the Village Green establishment without first obtaining a permit that authorizes a person to engage in the wholesale distribution of prescription drugs from that establishment. (16) Onor about February 6, 2002, Rx Plus was not storing prescription drugs at 1562 S.E. Village Green Drive, #3, Port St. Lucie in accordance with requirements of s. 499.0121(3), F.S., and Rule 64F-12.013(3)(a), Florida Administrative Code, These provisions require prescription drugs to be stored in accordance with requirements, if any, in the labeling of such drugs, with requirements in the Official compendium, or if no storage requiremenis are established for a prescription drug, at “controlled” room temperature. Controlled room temperature is a temperature maintained thermostatically between 20° to 25° C (68° to 77° F). Rx Plus was storing the Prescription drugs listed on Exhibit A-18 in an area at 1562 S.E. Village Green Drive, #3 that was neither air conditioned nor otherwise thermostatically controlled. Rx Plus voluntarily relinquished these Prescription drugs to the department when the storage conditions were brought to the attention of Michael Buller. (17) Storing a Prescription drug outside of required temperature conditions adulterates the drug pursuant to s. 499.006(2) and (3), F.S. As a result of the allegations in Paragraph (16), Rx Plus violated s. 499.005(1), (2), and (12), F.S. , (18) On or about December 17, 1999 Respondent, Michael Buller told the bureau’s Rx Plus had not done any business related to Prescription drugs. As a result, Rx Plus did not Produce any records related to prescription drug wholesaling activities, However, Exhibits A-1 through A-9 indicated Rx Plus had engaged in transactions related to Prescription drugs. Based on the representations of Michael Buller on behalf of Rx Plus (a) Rx Plus violated s. 499.005(19), F.S., since it provided false or fraudulent information to the department regarding the absence of regulated Prescription drug wholesaling activities. (b) Rx Plus violated ss, 499.005(6) and (18), F.S., since it either did not maintain records required by ss. 499.001-499.081 and the rules adopted thereunder or refused to allow inspection of records related to prescription drug wholesaling activities during the inspection. (19) Respondents Jose Castillo and Brian Hill are also owners and officers of Jemco Medical International (“Jemco”). Jemco held & prescription drug wholesaler permit (22:00961) Castillo and Brian Hill were directly responsible. Therefore it is not in the interest of public health and safety for Rx Plus to retain its permit as a Prescription drug wholesaler. (20) The violations of Chapter 499, F.S., by Respondenis as set forth in this complaint constitute sufficient grounds for DOH to impose an administrative fine of forty-five thousand five hundred dollars ($45,500) or impose any other penalty authorized by chapter 499, F.S. and chapter 64F-12, Fla, Admin. Code against the Respondents, (a) The intended fine is within the limits prescribed for such violations by section 499.066(3), F.S. and Rule 64F-12.024, Fla. Admin, Code due to the threat to public health posed by these violations. In some instances the upper level of the range and permit revocation iS warranted due to the egregious activities of Respondents and their disregard for the public health and welfare. In particular, Respondents’ violations jeopardize public health because Respondents have failed to demonstrate that the Prescription drugs acquired and distributed in the numerous transactions set forth in this administrative complaint were obtained from authorized sources. Furthermore, Respondents have failed to demonstrate that the Prescription drugs they acquired, held, and distributed were held under conditions to assure that each drug had the identity and strength, and met the standards of quality and purity which it was represented to possess and that the drug had not been contaminated with filth or rendered injurious to health. (b) Rule 64F-12.024 (4), Fla. Admin. Code sets the range of the penalty for the unlawful possession of Prescription drugs, from a Warning Letter to $1,000 per violation, per day and for operating without a valid permit at the cost of the permit, plus a fine up to $1,000 per violation, per day. The violations alleged in Paragraph (15) of this complaint warrant imposition of a fine of $1,000 since Rx Plus did notify the bureau of the new address prior to our discovery of the change in address. (c) Rule 64F-12.024 (4), Fla. Admin. Code Sets the range of the penalty for acquiring prescription drugs from an unauthorized source from a Warning Letter to $1,000 per violation per day. The source of the Prescription drugs for which the violations in Paragraphs (9) and (12) are alleged came from unknown sources and were outside all regulatory channels and $1,000 for 15 transactions, (d) Rule 64F-12.024 (4), Fla. Admin. Code sets the range of the penalty for activity with an adulterated drug from a Warning Letter to a fine of $5,000 per violation per day and revocation of a permit. Since the Prescription drugs involved in Paragraphs (7), (8), and (10) of Pose the greatest risks to the public health and warrant revocation of Rx Plus’s Prescription drug wholesaler permit, Further, the violations alleged in Paragraphs (7), (8) and (10) warrant an and (4), F.S., to $15,500, (ce) Rule 64F-12.024 (4), Fla. Admin. Code sets the range of the penalty for engaging in fraud, deceit, misrepresentation or subterfuge in the acquisition or distribution of a alleged in Paragraph (18)(a) warrant imposition of an administrative fine in the amount of $5,000 and revocation of the permit. (g) Rule 64F-12,024 (4), Fla. Admin. Code sets the range of the penalty for the failure to maintain records and to make records available trom the least severity (Warning Letter) to the greatest severity ($5,000 per violation per day and revocation of q permit). Therefore the violations alleged in Paragraph (18)(b) warrant imposition of an administrative fine in the amount of $5,000. (21) (a) Section 499.067(1), Florida Statutes (F.S.), authorizes the department to with ss. 499.001-499.084 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 revoke a permit if the permittee has violated any provisions of S88. 499.001-499.081 or rules adopted under those sections. (b) The violations alleged in this complaint evidence a substantial failure by drugs from authorized sources, maintain those drugs under appropriate storage conditions, and Provide a complete and accurate audit trail for the acquisition and disposition of Prescription drugs are substantial violations of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. The alleged violations also demonstrate that it would be a danger and not in the best interest of the public health, safety, and welfare to renew Rx Plus’s Prescription drug wholesaler permit. (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 deny renewal and the revocation of permit 22:01117. 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. A petition for administrative hearing must be in writing and must be received by the 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 # A02, Tallahassee FL 32399. 1703. The Agency Clerk's facsimile number is 850-410-1448, Mediation is not available as an alternative remedy. 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 28-106.114 and this complaint shall become a "final order", 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 certified mail to Michael S. Buller, individually and as President of Rx Plus at 1562 S.E. Village Green Drive #3, Port St. Lucie, Florida, 34952 and to Jose Castillo and Brian Hill at the same address this Zz 4 fet day of May, 2002, “3 > , R.PA., C.Ph. of Pharmacy Services 2818-A Mahan Drive Tallahassee, Florida 32308 Telephone: (850) 922-5199 Copy also furnished to: 10 Counsel for the Department: Robert P. Daniti Senior Attorney 4052 Bald Cypress Way Bin #A02 Tallahassee, Florida 32399 (850) 245-4005 Michael S. Buller, President Rx Plus, Inc. 1562 S.E, Village Green Drive #3 Port St. Lucie, Florida 34952 Jose Castillo Rx Plus, Inc. 1562 S.E. Village Green Drive #3 Port St. Lucie, Florida 34952 Brian Hill Rx Plus, Inc, 1562 S.E. Village Green Drive #3 Port St. Lucie, Florida 34952 11 COMPLETE THIS SECTION ON OELIVERY os of Deli > 2B 0 Agent Cl Addres D. Is delivery address di erent from iten 17 Yes if YES, enter delivery addés below: No ——,, SENDER: COMPLETE THis SECTION © ~ « B Complete items 1, 2, and 3. Also complete j item 4 if Restricted Delivery is desired. | @ Print your name and address on the reverse | so that we can return the card to you. i A. Received by (Please Print Clearly) ™ Attach this card to the back of the mailpiece, or on the front if space Permits. ! 4, Article Addressed to: Alc . Michael S. Buller, President , Rx Plus, ine, 1562 S.E. Village Green Drive #3 Port St. Lucie, Florida 34952 3. Service Type D Certified Mat =) Express Malt , C Registered Return Receipt for Merchan, : OB tnsured Mait 0.0. 4, Restricted Delivery? (Extra Fee) D yes \ao Number (Copy from service label) 4 000 OG ea) C027 sug P 2, . ‘Ea 11, July 1999 Domestic Return Receipt 102595-00-M-0¢ Ne \ . ia SENDER: COMPLETE THIS SECTION | ™ Complete items 1, 2, and 3. Also complete { item 4 if Restricted Delivery is desired, +. Print your name and address on the reverse i so that we can return the card to you. ' ™ Attach this card to the back of the mailpiece, or on the Tront if space permits, 1. Article Addressed to: A | C. | Jose Castillo | Rx Plus, Inc. 1562 S.E. Village Green Drive #3 , Port St. Lucie, Florida 34952 | % Date of Dali. “22? C. Sigmat xX C1 Agent , © Adares: D. Is delivery address different from item 12 Yes If YES, enter delivery address below: OO No 3. Service Type O Certified Mal = Express Mail D Registered Xx Return Receipt for Merchan O insured Mail = O'c.0.0, | 4. Restricted Delivery? (Extra Fee) D Yes ! 2. Article Number (Copy from service fabel) 102) OL 00 002 q By q 5 a) PS Form 3811, July 1999 Domestic Return Receipt 102595-00-M-¢ eee FO a eee SENDER: COMPLETE THIS SECTION COMPLETE THIS SECTION ON DELIVERY ™ Complete items 1, 2, and 3. Also complete A. Received by (Please Print Clearly) | B ite of De! item 4 if Restricted Delivery is desired, 23: ¢ ® Print your name and address on the reverse : So that we can return the card to you. C. Sighat , Mf Attach this card to the back of the mailpiece, x Cl Agent , or on the front if space permits. 0 Adare D. ts delivery address different from item 12 O Yes If YES, enter delivery address below: O No eee 1. Article Addressed to: AIC Brian Hill Rx Plus, inc. 1562 S.E. Village Green Drive #3 Port St. Lucie, Florida 34952 3. Senice Type D Certified Mal =O Express Mail Oo Registered Return Receipt for Merchar O Insured Mail ~ £7 0.0.D, 4. Restricted Delivery? (Extra Fee) D Yes 2. Article Number (Copy from service label) q OCO OLD OO? 9 ISUq S502. PS Form 3811, July 1999 Domestic Return Receipt 102595-00-N-¢

Docket for Case No: 02-002581