STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Vv. CASE NO.: 2011-08095 TREASURE COAST SPECIALTY PHARMACY, INC., RESPONDENT. ee T PLA: COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Treasure Coast Specialty Pharmacy, Inc., and in support thereof alleges: 1. Petitioner Is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2. At all times material to this Complaint, Respondent was a permitted community pharmacy within the State of Florida, having been issued permit number PH 22113. 3. Respondent's address of record Is 1114 Jensen Beach Boulevard, Jensen Beach, Florida 34957, 4. Respondent Is owned and operated by P.D., who is a licensed pharmacist in the State of Florida. From November 1, 2010, to April 30, 2011, Respondent also employed the following pharmacists: A.T.D., J.L.L., AG.L., and M.K.M. Although P.D. Filed September 30, 2011 11:40 AM Division of Administrative Hearings dispensed approximately 84.56% of the total medications dispensed by Respondent during that tlme period, A.T.D. dispended approximately 13.75%, J.L.L. dispensed approximately 0.58%, M.K.M. dispensed 0.26%, and A.G.L. dispensed 0.86%. 5. Throughout the above time perlod, Respondent dispensed of anabolic- androgenic steroids and human growth hormone (hGH) to patients located throughout the United States and other countries. 6. Anabolic-androgenic steroids are steroid compounds, _ including testosterone and Its synthetic relatives, that possess anabolic and androgenic effects. Anabolics have the effect of building lean muscle mass, and androgens express male secondary sexual characteristics. Steroid users consume anabolic-androgenic steroids for thelr anabolic effects, but the androgenic effects are generally responsible for adverse reactions. Common adverse reactions Include profound effects on the cardiovascular system, the liver, the musculoskeletal system, the hematological system, and the male and female reproductive systems. Several studles have also reported an association between anabolic-androgenic steroids and serious psychological problems, including psychosis, mania, hyperaggressiveness, and dependency. 7. According to Section 893.03(3), Florida Statutes, anabolic steroids are Schedule III controlled substances that have a potential for abuse less than the substances contained in Schedules I and II. However, abuse of Schedule III substances may lead to moderate or low physical dependence or high psychological dependence, or, In the case of anabolic steroids, may lead to physical damage. 8. HGH Is often consumed in conjunction with anabolic-androgenic steroids. Adverse effects from the use of hGH include fluid retention and muscle edema, in the short-term, and myopathy (a disease In which muscle fibers do not function), carpal tunnel syndrome, and acromegaly (a disorder Involving excess production of growth hormone by the pitultary gland), in the long-term. 9. United States Food and Drug Administration (FDA) regulations, Including 21 U.S.C. 333(e), currently govern the prescribing of hGH. Under these regulations, hGH may only be prescribed for a valld medical condition recognized by the FDA. FDA recognized conditions do not include performance enhancement or body building. 10. During March 2010, a federal Drug Enforcement Administration (DEA) ‘ Diversion Investigator conducted an Inspection of Respondent and observed that Respondent received excessive numbers of anabolic-androgenic steroid prescriptions and the prescriptions received clearly indicated that the prescribing physiclans were located In states other than the states where the patients resided. The DEA investigator obtained approximately 992 pages of prescription fulfillment records for Schedule III, IV, and V controlled substances dispensed by Respondent. The majority of the medications dispensed were anabolic-androgenic sterotds and hGH, 11. According to the DEA’s investigation of Respondent, the majority of Respondent’s dispensing was done as a result of orders for medications placed on the Internet. Physicians who have never examined patients signed prescriptions that were presented to them for signature based on orders that patients placed over the internet. Physicians signed the prescriptions without examining the patients and without determining whether the quantities and dosages of the anabolic-androgenic steroids and hGH were medically appropriate. Most often the prescribing physician and the patient were located in different states. 12. The signed prescriptions were delivered to Respondent, which filled them, despite the apparent lack of physiclan-patient relationships, and shipped the filled prescriptions to the patients. 13. Respondent knew or should have known that the prescriptions for anabolic-androgenic sterolds and hGH that were supplied to Respondent for fulfillment were. signed by physicians who were often not located in the same states as the patients seeking the medications and that the physicians did not establish a physician- patient relationship with the patients. 14. In 2007, A.F., an individual Involved in the distribution of anabolic- androgenic sterolds and hGH throughout the United States, began using Respondent to fill orders for steroids and hGH that he received via the Internet. A.F, is currently serving a twenty-month sentence in federal prison for unlawfully conspiring to distribute, and distributing, anabolic-androgenic steroids. 15. A.F. established a business selling anabolic-ancrogenic steroids and hGH via the internet and recruited physicians who were willing to sign prescriptions for the orders that patlents placed over the Internet without examining the patients or establishing any type of physiclan-patient relationship. A.F. paid these physicians a fee for each prescription for steroids and hGH that they signed. A.F. then forwarded the signed prescriptions to Respondent for fulfillment. Respondent filled the prescriptions and shipped the medications to A.F.'s customers, who were located throughout the United States. 16. _A.F, introduced P.D. to S.L., another Internet anabolic-androgenic steroid and hGH supplier located In Kansas, who had access to physicians willing to sign prescriptions for orders for steroids and hGH that patients placed over the Internet. Respondent also filled prescriptions for patients who placed internet anabolic- androgenic steroid and hGH orders with S.L. 17. Between October 2008 and April 2010, Respondent also fulfilled and dispensed all of the anabolic-androgenic steroid and hGH orders for patients of a Tennessee-based clinic owned by E.W. 18. From October 1, 2010, through March 31, 2011, Respondent dispensed 10,774 prescriptions for anabolic-androngenic steroids and hGH. Of these, Respondent shipped 7,671 filled prescriptions to purchasers In states other than Florida or countries other than the United States. _ 19. — Fifty-seven different physicians wrote the 10,774 prescriptions mentioned above. Of these physicians, 30 practice In the state of Florida. One physician, J.P., who practices in Florida, wrote 4,430 of the 10,774 prescriptions. Of the 4,430 prescriptions, J.P. wrote 3,160 for patients who llved In locations outside Florida, and included Guam, the Virgin Islands, Finland, and Canada. 20. | Respondent’s dispensing records for November 1, 2010 through April 30, 2011, also documented at least two Instances of physicians prescribing anabolic- androgenic sterolds to themselves, This Is prohibited by Section 458.331(1)(r), Florida Statutes (2010), which forbids a physician from prescribing, dispensing, or administering any medicinal drug appearing on any schedule set forth in chapter 893 to himself. | Respondent's pharmacists knew or should have known that It was Inappropriate and illegal for physicians to prescribe anabollc-androgenic steroids to themselves. 21, From November 1, 2010 through April 30, 2011, Respondent dispensed 3,703 Schedule II controlled substance prescriptions. A large majority of the prescriptions dispensed were prescriptions for oxycodone, Furthermore, of the 3,703 Schedule II controlled substance prescriptions dispensed for thls time period, Respondent dispensed at least 1,451 of them to patients who resided 75 or more miles away from the physicians that wrote the prescriptions. ’ 22. Oxycodone is an opioid class drug prescribed to treat pain. According to Section 893.03(2), Florida Statutes, oxycodone Is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use In treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence. Opioid, or opiate, drugs have similar actions as the drug opium and are typically prescribed to treat pain. Oplold drugs are synthetically manufactured, while opiate drugs are naturally occurring, but the terms opioid and oplate are often used interchangeably. Oploid drugs are addictive and subject to abuse. 23. On March 30, 2011, the Department performed an annual inspection of Respondent, during which an investigator noticed faxes for prescriptions for oxcycodone from IMR, a medical clinic jocated approximately 70 miles from Respondent, In West Palm Beach, Florida. The Investigator questioned pharmacist A.T.D. about the faxes, and he stated that it is general practice for IMR to fax prescriptions for oxycodone to Respondent. Respondent fills the prescriptions and someone from IMR retrieves the filled prescriptions from Respondent and returns them to IMR for distribution to the patients. 24. On June 15, 2011, DEA agents conducted surveillance of IMR and stopped an Individual after he left the clinic with a prescription for Roxicodone. The individuat advised DEA agents that he had been unsuccessful at filling the Roxicodone prescription at several local pharmacies. He further advised DEA agents that he later returned to IMR, where the office manager advised him that for an additional fee he could travel to Respondent, some 70 miles away, to obtain his Roxicodone, The individual pald the fee to the office manager and she crossed his address off the prescription and placed the letters “TCSP” In place of the address, The individual agreed to cooperate with the DEA, and an undercover agent accompanied him to Respondent to obtain the medication. Respondent pharmacist, A.T.D., filled the Roxicodone prescription without payment of any money to Respondent. COUNT ONE 25. Petitioner realleges and Incorporates paragraphs 1 through 24 as if fully set forth herein. 26. Section 465.023(41)(h), Florida Statutes (2010), provides that the Department or the Board of Pharmacy (Board) may revoke or suspend the permit of any pharmacy permitted, and may fine, place on probation, or otherwise discipline any any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, dispenses any medicinal drug based on upon a communication that purports to be a prescription as defined by Sections 465.003(14) or 893.02, Florida Statutes (2010), when the pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitloner-patlent relationship that includes a documented patient evaluation, including a history and a physical examination adequate to establish the diagnosis for which any drug Is prescribed and any other requirement established by board rule under Chaptesr 458, 459, 461, 463, 464, or 466, Florida Statutes, 27. Respondent dispensed large quantities of controlled drugs when Its pharmacists knew or had reason to believe that the purported prescriptions were not based upon valld practitloner-patient relationships In one or more of the following manners: a. By dispensing 10,774 prescriptions for Scheduled III controlled substances, including anabolic-androgenic steroids and hGH, over the course of six months, to patients who live outside Florida, in states or countries different from those of the prescribing physiclans’; and/or b. By dispensing 3,703 prescriptions for Schedule II controlled substances, including oxycodone, to patients who resides long distances from the prescribing physicians. 28. Based on the foregoing, Respondent has violated Section 465.023(1)(h), Florida Statutes (2010), by dispensing medicinal drugs based on upon communications that purported to be prescriptions as defined by Sections 465.003(14) or 893.02, Florida Statutes (2010), when the pharmacists knew or had reason to believe that the purported prescriptions were not based upon valid practitioner-patient relationships. COUNT TWO 29. Petitioner realleges and incorporates paragraphs 1 through 24 as If fully set forth herein. 30. Section 465.016(1)(I), Florida Statutes (2010), provides that compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of the professional practice of pharmacy constitutes grounds for disciplinary action. For the purposes of this section, It shall be legally presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interests of the patient and Is not In the course of the professional practice of pharmacy. 31. Respondent compounded, dispensed, or distributed legend drugs, Including controlled substances, other than in the course of the professional practice of pharmacy, in the one or more of the following manners: a. By dispensing excessive and/or inappropriate quantities of anabolic- androgenic steroids; b. By dispensing excessive and/or inappropriate quantities of hGH; and/or (om By dispensing excessive and/or inappropriate quantities of oxycodone. 32. Based on the foregoing, Respondent has violated Section 465.016(1)(i), Florida Statutes (2010), by compounding, dispensing, or distributing legend drugs, including controlled substances, other than In the course of the professional practice of pharmacy. WHEREFORE, Petitioner respectfully requests that the Board of Pharmacy enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's permit, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other rellef that the Board deems appropriate. SIGNED this {3 day of Qua , 2011. H. Frank Farmer, Jr, MD, PhD, FACP State Surgeon FILED Assistant General Counsel DEPARTMENT OF HEALTH DOH Prosecution Services Unit DEPUTY CLERK 4052 Bald Cypress Way, Bin C-65 CLERKBNG LO SoduL, Tallahassee, FL 32399-3265 Florida Bar # 21640 pave. 1-13 +) (850) 245-4640 (850) 245-4681 FAX JLF PCP: July 13, 2011 PCP Members: Melvin, Pharm.D, and Risch, R.Ph. DOH V.TREASURE COAST SPECIALTY PHARMACY, INC. Case No. 2011-08095 DOH V, TREASURE COAST SPECIALTY PHARMACY, INC. Case No. 2011-08095 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120. 57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum Issued on his or her behalf If a hearing is requested. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitloner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition any other discipline imposed.

Docket for Case No: 11-005075