DEPARTMENT OF HEALTH, STATE OF FLORIDA DEPARTMENT OF HEALTH PETITIONER, V. CASE NO. 2017-08509 DARSHANA PATEL, R.P.T., RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Darshana Patel, R.P.T., 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 registered pharmacy technician (R.P.T.) within the state of Florida, having been issued license number RPT32959.
3. Respondent's address of record is 14125 U.S. Highway 1, Juno Beach, Florida 33408. 4. Respondent's additional mailing address is 5980 West Sam Houston Parkway N #300, Houston, Texas 77041. 5. At all times material to this Administrative Complaint, Respondent was employed as a registered pharmacy technician at Tri-Coast Pharmacy, Inc. ("Tri-Coast"), a then-permitted special sterile compounding pharmacy located in Juno Beach, Florida. 6. Respondent assisted in the starting of Tri-Coast, and had a profit-sharing arrangement with K.O., the president and owner of Tri-Coast. 7. At all times material to this Administrative Complaint, Tri-Coast employed the services of Pharnnetric Laboratory ("Pharmetric") located in St. Petersburg, Florida,. to outsource its sterility testing of samples of compounded sterile preparations ("CSPs"). 8. Upon completion of testing for sterility and endotoxins of CSPs, Pharmetric would send a certificate of analysis to Tri-Coast indicating whether the sample showed growth of endotoxins1. 1 "Endotoxins" refers to Gram-negative bacteria. Gram-negative bacteria can cause infections including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis in healthcare settings. DOH v. Darshana Patel, R.Ph. 2
9. Pharmetric sent certificates of analysis to Respondent with results reading "Evidence of Growth" for samples of the following lots of CSPs: a. Lot 10192016B, sermorelin GT2, compounded on or about October 19, 2016; b. Lot 10242016C, sermorelin forte 12 mg, compounded on or about October 24, 2016; c. Lot 11012016F, human chorionic gonadotropin 5,000 IU3, compounded on or about November 1, 2016; d. Lot 12192016C, sermorelin acetate 15mg, compounded on or about December 19, 2016; and/or e. Lot 12192016G, human chorionic gonadotropin 5,000 IU, compounded on or about December 19, 2016. 10. Respondent altered or forged one or more of the certificates of analysis in paragraph nine to read "No Evidence of Growth". 11. One or more of the lots of CSPs in paragraph nine were dispensed to patients, and were subsequently the subject of a voluntary 2 Sermorelin is used for treating growth hormone deficiency stimulating the pituitary gland to release growth hormone. Human chorionic gonadotropin (HCG) is a hormone that supports the normal development of an egg in a woman's ovary, and stimulates the release of the egg during ovulation. HCG is used to cause ovulation and to treat infertility in women, and to increase sperm count in men. DOH v. Darshana Patel, R.Ph. 3
Food and Drug Administration recall by Tri-Coast announced on or about November 18, 2016. 12. Section 456.072(1)(m), Florida Statutes (2016), provides that making deceptive, untrue, or fraudulent representations in or related to the practice of a profession or employing a trick or scheme in or related to the practice of a profession constitutes grounds for disciplinary action. 13. Respondent made deceptive, untrue, or fraudulent representations in or related to the practice of her profession, or employed a trick or scheme in or related to the practice of her profession, by altering or forging one or more certificates of analysis for sterility testing of one or more lots of CSPs compounded by Tri-Coast. 14. Based on the foregoing, Respondent has violated Section 456.072(1)(m), Florida Statutes (2016). DOH v. Darshana Patel, R.Ph. 4
WHEREFORE, the 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 the 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 4 Ncl day of Fel,m94- r 2018. Celeste Philip, M.D., M.P.H. Surgeon General and Secretary CLERK DATE FILED DEPARTMENT OF HEALTH DEPUTY CLERK Angel Sanders FEB 2 2 2018 CHRISTOPHER A. JURI Assistant General Counsel Fla. Bar No. 0099014 Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Telephone: (850) 558-9861 Facsimile: (850) 245-4662 Email: christopher.jurich@flhealth.gov PCP Meeting: February 22, 2018 PCP Members: Debra Glass, David Wright DOH v. Darshana Patel, R.Ph. 5
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. Darshana Patel, R.Ph. 6