STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Vv. CASE NO. 2015-00235 SUNTREE PHARMACY INC, RESPONDENT. / ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health (“Department”), by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Suntree Pharmacy Inc, and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of pharmacy pursuant to section 20.43, Florida Statutes; chapter 456, Florida Statutes; and chapter 465, Florida Statutes. 2. At all times material to this Administrative Complaint, Respondent was a permitted community pharmacy within the state of Florida, having been issued permit number PH18030. 3. Respondent's address of record is 7640 North Wickham Road, Unit 117, Melbourne, Florida 32940. Facts Related to May 1, 2015, Inspection 4. On or about May 1, 2015, Department inspector(s) presented to Respondent’s address of record to conduct a community pharmacy inspection. 5. | The Department's inspection on or about May 1, 2015, revealed that Respondent compounded and/or dispensed the following controlled substances in capsule dosage form instead of the prescribed tablet dosage form: a. Hydromorphone 4mg capsules dispensed on or about April 23, 2015, to Patient A.S. instead of the prescribed Dilaudid 4mg tablets; b. Hydromorphone 4mg capsules dispensed on or about April 23, 2015, to Patient J.S. instead of the prescribed Dilaudid 4mg tabiets; c. Hydromorphone 8mg capsules dispensed on or about April 23, 2015, to Patient M.J. instead of the prescribed Dilaudid 8mg tablets; DOH v. Suntree Pharmacy Inc 2 DOH Case No. 2015-00235 . d. Hydromorphone 4mg capsules dispensed on or about April 23, 2015, to Patient A.B. instead of the prescribed Dilaudid 4mg tablets; e. Methadone 10mg capsules dispensed on or about April 23, 2015, to Patient A.B. instead of the prescribed methadone 10mg tablets; f. Oxycodone 30mg capsules dispensed on or about April 23, 2015, to Patient M.M. instead of the prescribed Roxicodone 30mg tablets; g. Oxycodone 30mg capsules dispensed on or about April 23, 2015, to Patient J.- instead of the prescribed oxycodone 30mg tablets; h. Methadone 10mg capsules dispensed on or about April 23, 2015, to Patient J.R instead of the prescribed methadone 10mg tablets; i. Oxycodone 30mg capsules dispensed on or about April 23, 2015, to Patient J.S. instead of the prescribed Roxicodone 30mg tablets; DOH v., Suntree Pharmacy Inc 3 DOH Case No, 2015-00235 j. Hydromorphone 8mg capsules dispensed on or about April 23, 2015, to Patient M.C. instead of the prescribed Dilaudid 8mg tablets; k. Hydromorphone 8mg capsules dispensed on or about April 23, 2015, to Patient D.P. instead of the prescribed Dilaudid 8mg tablets; |. Hydromorphone 8mg capsules dispensed on or about April 24, 2015, to Patient B.C. instead of the prescribed Dilaudid 8mg tablets; m.Hydromorphone 8mg capsules dispensed on or about April 24, 2015, to Patient B.B. instead of the prescribed hydromorphone 8mg tablets; n. Hydromorphone 8mg capsules dispensed on or about April 24, 2015, to Patient T.B. instead of the prescribed Dilaudid 8mg tablets; o. Oxycodone 30mg capsules dispensed on or about April 24, 2015, to Patient D.H. instead of the prescribed oxycodone 30mg tablets; DOH v. Suntree Pharmacy Inc 4 DOH Case No. 2015-00235 p. Oxycodone 30mg capsules dispensed on or about April 30, 2015, to Patient S.D. instead of the prescribed Roxicodone 30mg tablets; q. Hydromorphone 4mg capsules dispensed on or about April 30, 2015, to Patient V.T. instead of the prescribed hydromorphone 4mg tablets; r. Hydromorphone 8mg capsules dispensed on or about April 30, 2015, to Patient P.W. instead of the prescribed Dilaudid 8mg tablets; s. Hydromorphone 8mg capsules dispensed on or about April 30, 2015, to Patient D.P. instead of the prescribed Dilaudid 8mg tablets; and/or t. Oxycodone 30mg capsules dispensed on or about May 1, 2015, to Patient J.L. instead of the prescribed oxycodone 30mg tablets. 6. | The Department's inspection on or about May 1, 2015, revealed that Respondent failed to properly maintain one or more written compounding records with the name of the patient(s) who received the particular compounded product for the following lots: DOH v. Suntree Pharmacy Inc 5 DOH Case No. 2015-00235 a. Lot number 02022015@25 for 300 oxycodone i5mg capsules compounded on or about February 2, 2015; b. Lot number 03092015@27 for 300 methadone 10mg capsules compounded on or about March 9, 2015; c. Lot number 03272015@13 for 300 methadone 10mg capsules compounded on or about March 27, 2015; d. Lot number 03272015@14 for 300 hydromorphone 4mg capsules compounded on or about March 27, 2015; e. Lot number 04012015@27 for 300 oxycodone 30mg capsules compounded on or about April 1, 2015; and/or f. Lot number 04032015@9 for 300 hydromorphone 8mg capsules compounded on or about April 3, 2015. Facts Related to May 30, 2019, Inspection 7. On or about May 30, 2019, Department inspector(s) presented to Respondent’s address of record to conduct a community pharmacy inspection. 8. The Department's inspection on or about May 30, 2019, revealed that Respondent compounded and/or dispensed the following DOH v. Suntree Pharmacy Inc 6 DOH Case No. 2015-00235 controlled substances in capsule dosage form instead of the prescribed tablet dosage form: a. Methadone 10mg capsules dispensed on or about May 14, 2019, to Patient B.P. instead of the prescribed methadone 10mg tablets; and/or b. Hydromorphone 8mg capsules dispensed on or about May 15, 2019, to Patient H.N. instead of the prescribed Dilaudid 8mg tablets. COUNT ONE 9. Petitioner realleges and incorporates paragraphs one through eight as if fully set forth herein. 10. Section 465.023(1)(c), Florida Statutes (2014-2018), provides, in relevant part, that the department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under section 465.022(3), Florida Statutes, has violated any of the requirements of this chapter. DOH v, Suntree Pharmacy Inc 7 DOH Case No. 2015-00235 11. Section 465.016(1)(g), Florida Statutes (2014-2018), provides that using in the compounding of a prescription, or furnishing upon prescription, an ingredient or article different in any manner from the ingredient or article prescribed, except as authorized in section 465.019(6), Florida Statutes, or section 465.025, Florida Statutes, constitutes grounds for disciplinary action. 12. From on or about April 23, 2015, to on or about May 1, 2015, Respondent compounded and/or dispensed the following controlled substances in capsule dosage form instead of the prescribed tablet dosage form to one or more patients: a. Oxycodone 15mg; b. Methadone 10mg; c. Hydromorphone 4mg; d. Oxycodone 30mg; and/or e. Hydromorphone 8mg. 13. From on or about May 14, 2019, to on or about May 15, 2019, Respondent compounded and/or dispensed the following controlled substances in capsule dosage form instead of the prescribed tablet dosage form to one or more patients: DOH v. Suntree Pharmacy Inc 8 DOH Case No. 2015-00235 a. Methadone 10mg; and/or b. Hydromorphone 8mg. 14. Based on the foregoing, Respondent violated section 465.023(1)(c), Florida Statutes, through a violation of section 465.016(1)(g), Florida Statutes. COUNT TWO 15. Petitioner realleges and incorporates paragraphs one through eight as if fully set forth herein. 16. Section 465.023(1)(c), Florida Statutes (2014), provides, in relevant part, that the department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under section 465.022(3), Florida Statutes, has violated any of the rules of the Board of Pharmacy. 17. Rule 64B16-28.140(4)(i), Florida Administrative Code, provides that a written record shall be maintained for each batch/sub-batch of a compounded product and shall include the name of the patient who received the particular compounded product. DOH v. Suntree Pharmacy Inc 9 DOH Case No. 2015-00235 18. From on or about February 2, 2015, to on or about April 3, 2015, Respondent failed to properly maintain one or more written compounding records with the name of the patient(s) who received the particular compounded product for the following lots: a. Lot number 02022015@25 for 300 oxycodone 15mg capsules; b. Lot number 03092015@27 for 300 methadone 10mg capsules; c. Lot number 03272015@13 for 300 methadone 10mg capsules; d. Lot number 03272015@14 for 300 hydromorphone 4mg capsules; e, Lot number 04012015@27 for 300 oxycodone 30mg capsules; and/or f. Lot number 04032015@9 for 300 hydromorphone 8mg capsules. 19. Based on the foregoing, Respondent violated section 465.023(1)(c), Florida Statutes, through a violation of rule 64B16- 28.140(4)(i), Florida Administrative Code. DOH v. Suntree Pharmacy Inc 10 DOH Case No, 2015-00235 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 license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this 20th day of February, 2020. Scott A. Rivkees, M.D. State Surgeon General FILED DEPARTMENT OF HEALTH DEPUTY CLERK s/ Hannah Phillips ; AMS HANNAH PHILLIPS CLERK: Chaar, 1 2020 Assistant General Counsel DATE: Fla. Bar No. 1003347 Florida Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin #C-65 Tallahassee, Florida 32399-3265 Telephone: (850) 558-9824 Facsimile: (850) 245-4662 Email: hannah. phillips@flhealth.gov PCP Meeting: February 20, 2020 PCP Members: Michele Weizer; Blanca Rivera DOH v, Suntree Pharmacy Inc 11 DOH Case No. 2015-00235 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. A request or petition for an administrative hearing must be in writing and must be received by the Department within 21 days from the day Respondent received the Administrative Complaint, pursuant to rule 28-106.111(2), Florida Administrative Code. If Respondent fails to request a hearing within 21 days of receipt of this Administrative Complaint, Respondent waives the right to request a hearing on the facts alleged in_ this Administrative Complaint pursuant to rule 28-106.111(4), Florida Administrative Code. Any request for an administrative proceeding to challenge or contest the material facts or charges contained in the Administrative Complaint must conform to rule 28-106.2015(5), Florida Administrative Code. Please note that mediation under section 120.573, Florida Statutes, is not available to resolve this Administrative Complaint. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner 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 to any other discipline imposed. DOH v. Suntree Pharmacy Inc 12 DOH Case No. 2015-00235

Docket for Case No: 20-002764