Bob Daniti ;850 922 53267 3-27-02; 1:21PM;Florida “ant. Health STATE OF FLORIDA 02 DEPARTMENT OF HEALTH “APR 19 PM 2, DEPARTMENT OF HEALTH, ADMIN: SiR Rai through its BUREAU OF HEAR RINGS IVE PHARMACY SERVICES, Petitioner, Case No: vs. (DOH: 01-04794) OSPREY CAPITAL GROUP, INC., a Florida Corporation, and Donald B, Andersen, Individually, Respondents. / a ADMINISTRATIVE COMPLAINT Notice is hereby provided that Petitioner, Department of Health by and through its Bureau of Pharmacy Services (the "bureau”), intends to impose against Respondent, Osprey Capital Group, Inc., d/b/a Osprey Group (“Osprey Group”), a Florida corporation and Respondent, Donald B. Andersen, an administrative fine in the amount of Fifteen Thousand Dollars ($15,000), pursuant to section 499.066(3), Florida Statutes, and revoke the prescription _ drug wholesaler permit number 22:01231, that authorizes Osprey Group 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 (“F.S.”), 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 Florida Drug and Cosmetic Act, Chapter 499, F.S. 3-27-02; 1:21PM;Florida Mapt. Health Eob Daniti 7850 922 5267 (2) Respondent, Osprey Capital Group, Inc., is a Florida registered corporation whose principle place of business is 9553 Harding Avenue, Suite 201, Surfside, Dade County, Florida, 33154. Respondent is permitted as a prescription drug wholesaler (permit number 22:01231) under the name, Osprey Group pursuant to the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. This permit was initially issued on January 26, 2001 and will expire by operation of law on January 31, 2003, (3) Respondent, Donald B. Andersen is the President and 100% owner of Osprey Group and at all times material to the allegations in this complaint was responsible for the prescription drug wholesaling activities alleged herein. (4) On or about June 4, 2001, by invoice #53101, Osprey Group sold prescription drugs under its prescription drug wholesaler permit to Sentry Drugs, a licensed pharmacy at 9783 S.W. 72" Street, Miami, Florida 33173. (5) Respondents could not produce records of purchase for the prescription drugs sold on invoice #53101 in response to a request for such purchase records by the bureau on June 6, 2001. This failure to produce records required by s. 499.0121(6), F.S., and Rule 64F- 12.012, Florida Administrative Code, (“F.A.C.”) to be maintained and made available to the bureau for the purchase of prescription drugs is a violation of ss. 499.005(6), and (18), F.S. , (6) On June 6, 2001, Respondent, Donald Andersen, explained to the bureau’s agent that the prescription drugs solid on invoice #53101 were purchased from a Rob Tescher (spelled phonetically). Andersen further explained to the bureau’s agent that Rob Tescher did not provide records documenting Tescher’s sale of prescription drugs to Osprey and Andersen and that Tescher did not have a permit to wholesale prescription drugs. (7) Any person distributing prescription drugs in or into the State of Florida is required to hold a valid permit as provided by s. 499.012, F.S., to engage in the wholesale distribution of prescription drugs prior to selling or physically distributing any prescription drug to Osprey Group. Rob Tescher is not currently and has not been permitted under Chapter 499, SY B-27-O2; 1:21PM;Florida Dept. Health Bob Daniti 3850 822 5367 F.S., at any time relevant and material to the transaction alleged in paragraphs (5) and (6), to engage in the wholesale distribution of any prescription drug from, in or into the State of Florida. (8) When Respondents acquired the prescription drugs from Rob Tescher, 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. (9) Furthermore, when Respondents purchased prescription drugs from Tescher, they purchased and received adulterated drugs as defined in 3 499.006(2) and (3), F.S., in violation of ss. 499.005(3) and (4), F.S., in that Rob Tescher was not permitted to engage in the wholesale distribution of prescription drugs in or into Florida. (10) Furthermore, the prescription drugs allegedly sold in paragraph (4) appeared worn and had glue residue on the containers. In addition, none of the prescription drugs had a manufacturer's package insert or outsert attached. The manufacturer’s insert or outsert includes additional labeling required by the United States Food and Drug Administration for a prescription drug and the absence of this additional labeling renders a prescription drug misbranded pursuant to s. 499.007, F.S., and Rule 64F-12.006(1), F.A.C, Therefore Respondents violated Rule 64F-12.013(5), F.A.C., because they failed to examine the product to prevent acceptance of prescription drugs that are unfit for distribution. (11) When Respondents sold and distributed the prescription drugs pursuant to the transactions identified in paragraph (4), they sold and distributed adulterated prescription drugs in violation of ss. 499.005(1), (3), and (4), F.S. (12) The violations of Chapter 499, F.S., by Respondents as set forth in this complaint constitute sufficient grounds for DOH to impose an administrative fine of Fifteen Thousand Dollars ($15,000) or impose any other penaity authorized by chapter 499, F.S. and chapter 64F- 12, F.A.C. against the Respondents. w 6/ 3-27-02; 1:21PM;Florida Mapt. Healtn Bob Daniti 7850 922 S387 (18) Rule 64F-12.024 (4), F.A.C. sets the range of the penalty for violations of the Florida Drug and Cosmetic Act, Chapter 499, F.S. as follows and the bureau intends to impose the fines and action as noted. (a) For the failure to maintain and make records available the rule provides for a fine of $500 to $5,000 per violation per day and suspension or revocation of the permit with a fine. The intended fine and agency action is $5,000 (one occurrence) and revocation of the permit. (b) For the sale or delivery of an adulterated or misbranded prescription drug the rule provides for a fine of $250 - $5,000 per violation per day and suspension or revocation of the permit with a fine. The intended fine and agency action is $5,000 (one transaction) and revocation of the permit. (c) For the purchase of a prescription drug from an unauthorized source the rule provides for a fine of $250 to $1,000 per violation per day. However the department intends to treat this matter with enhanced penalties as provided for in the rule and the intended fine is $5,000 and revocation of the permit. Respondents’ source of the prescription drugs that are the subject of this complaint was not permitted to engage in the wholesale distribution of prescription drugs in interstate commerce anywhere in the United States. Therefore the purchase of prescription drugs from this source is a more serious violation than purchasing prescription drugs from a source that is permitted to wholesale prescription drugs in another state but has not yet obtained an Out-of-State Prescription Drug Wholesaler permit under the Act. Each intended fine is within the limits prescribed for such violations by section 499.066(3), F.S. and Rule 64F-12.024, F.A.C., and the upper level of the range is warranted due to the threat to public health posed by these violations. In particular, Respondent’s violations jeopardize public health because they purchased or otherwise acquired and distributed adulterated and misbranded prescription drugs. Ts 3-27-02; 1:21PM;Florida Mept. Health (14) Section 499.067(1), Florida Statutes (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 revoke a permit if the permittee has violated any provisions of ss. 499.001- 499.081 or rules adopted under those sections. (15) 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 Respondents facilitated the distribution of adulterated and misbranded prescription drugs. Additionally, the purchasing and distribution practices of prescription drugs by Respondents 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 Osprey Group 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 22:01231. (16) 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. (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 Bob Daniti 7650 922 S367 # ar 3-27-02; 1:71PM;Florida Meet. Health Bop Daniti 3650 922 5367 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. (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. (17) The undersigned certifies that a true copy of this administrative complaint was sent by U.S. Certified Mail, Return Receipt Requested, to Donald B. Andersen, President, for Osprey Capital Group, inc., at 9553 Harding Avenue, Suite 201, Surfside, Florida, 33154, this ta day of January, 2002. «Ph., C.Ph. armacy 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 (850) 245-4005; (850) 413 8743-Fax Florida Bar No. 191599 sv 3-27-02; 1:21PM;Florida mept. Health Ben Daniti 5850 922 5367 # 17° 9 ATTENTION: “HLED 02 APR 12 PM >: 13 OWiISiey 7 Pp ADMINIS Tig iVe BUREAU OF PHARMACY SERVICES HEARINGS e 9818-A MAHAN DRIVE TALLAHASSEE, FLORIDA 32308 (850) 487-1257 Ball, Bal, a FACSIMILETRANSMISSON FROM: Sandra Stovall nh ' : . her Clerks OSfice Compliance Officer TELEPHONE NUMBER: (850) 487-1257x210 FAX NUMBER: SunCom 277-1257 (850) 922-5367 SunCom 292-5367 DATE: 3ler{o2 TOTAL PAGES: COMMENTS: % G (including cover) Adm. Corp. Fr Osprey Group The certified mail letter was returned unclaimed 50 the Conplaint wes hand delivered on Harch 11,2002. This transmission may contain material that is CONFIDENTIAL under federal and Florida statutes and is intended to be delivered to only the named addressee. Unauthorized use of this information may be a violation of criminal statutes. If this information is received by anyone other than the named addressee, the recipient shall immediately notify the sender at the address or telephone number above and obtain instruction as to the disposal thereof. Under no circumst addressee. ances shall this material be shared, retained or copied by anyone other than the named

Docket for Case No: 02-001448