Petitioner: DEPARTMENT OF HEALTH
Respondent: OSPREY CAPITAL GROUP, INC., AND DONALD B. ANDERSEN
Judges: STUART M. LERNER
Agency: Department of Health
Locations: Miami, Florida
Filed: Apr. 12, 2002
Status: Closed
Settled and/or Dismissed prior to entry of RO/FO on Friday, July 19, 2002.
Latest Update: Oct. 31, 2024
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
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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.
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Under no circumst
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ances shall this material be shared, retained or copied by anyone other than the named
Docket for Case No: 02-001448
Issue Date |
Proceedings |
Aug. 27, 2002 |
Final Order filed.
|
Jul. 19, 2002 |
Order Closing File issued. CASE CLOSED.
|
Jul. 18, 2002 |
Letter to Judge Lerner from R. Daniti advising that parties have settled (filed via facsimile).
|
Jul. 17, 2002 |
Petitioner`s Response to Respondents` Motion to Compel Better Answers to Interrogatories (filed via facsimile).
|
Jul. 16, 2002 |
Motion to Compel Better Answers to Interrogatories (filed by Respondent via facsimile)
|
Jun. 20, 2002 |
Petitioner`s Response Opposing Respondent`s Request for Hearing on Objection to Paragraph Two of Request to Produce (filed via facsimile).
|
Jun. 20, 2002 |
Petitioner`s Response to Respondent`s Motion to Compel Answers to Interrogatories (filed via facsimile).
|
Jun. 19, 2002 |
Respondent`s Request for Hearing as to Petitioner`s Objection to Paragraph Two of Request to Produce and Memorandum of Law in Support Thereof filed.
|
Jun. 19, 2002 |
Motion to Compel Answers to Interrogatories filed by Respondents. |
Jun. 17, 2002 |
Petitioner`s Notice of Serving Answers to Respondent`s First Set of Interrogatories (filed via facsimile).
|
May 22, 2002 |
Order Granting Continuance and Re-scheduling Video Teleconference issued (video hearing set for August 22, 2002; 9:00 a.m.; Miami and Tallahassee, FL).
|
May 20, 2002 |
Respondent`s Dates of Unavailability (filed via facsimile).
|
May 15, 2002 |
Petitioner`s Response to Motion to Reschedule Final Hearing (filed via facsimile).
|
May 09, 2002 |
Motion to Reschedule Hearing filed by Respondents.
|
May 01, 2002 |
Order of Pre-hearing Instructions issued.
|
May 01, 2002 |
Notice of Hearing by Video Teleconference issued (video hearing set for June 20, 2002; 9:00 a.m.; Miami and Tallahassee, FL).
|
Apr. 23, 2002 |
Petitioner`s Response to Initial Order (filed via facsimile).
|
Apr. 22, 2002 |
Respondent`s response to initial order (filed via facsimile).
|
Apr. 22, 2002 |
Notice of Propounding Interrogatories (filed by Respondent via facsimile). |
Apr. 22, 2002 |
Respondent`s First Request for Production of Documents (filed via facsimile).
|
Apr. 15, 2002 |
Initial Order issued.
|
Apr. 12, 2002 |
Entry Notice and On-Site Inspection Report filed.
|
Apr. 12, 2002 |
Administrative Complaint filed.
|
Apr. 12, 2002 |
Answer to Administrative Complaint and Petition for Administrative Hearing filed.
|
Apr. 12, 2002 |
Notice (of Agency referral) filed.
|