STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, ve CASE NO. 2018-13109 PHARMACY DOCTORS ENTERPRISES D/B/A ZION CLINIC PHARMACY, 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, Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy, 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 special sterile compounding pharmacy within the state of Florida, having been issued permit number PH27655. Exhibit A 3. Respondent’s address of record is 205 E. Hallandale Beach Blvd., Hallandale Beach, Florida 33009. 4. Onor about August 21, 2015, the Department issued an Order of Emergency Restriction of Permit (‘Emergency Order”) against Respondent in Department case number 2015-12200, which immediately restricted Respondent's special sterile compounding pharmacy permit from compounding sterile preparations and dispensing any compounded sterile preparations. 5. On or about August 24, 2015, Respondent received personal service of the Emergency Order. 6. From on or about August 24, 2015, to on or about October 1, 2015, Respondent dispensed human chorionic gonadotropin (‘HCG’), a compounded sterile preparation, to one or more patients while its special sterile compounding pharmacy permit was restricted from dispensing any compounded sterile preparations. 7. Onor about May 15, 2018, a Department inspector conducted a sterile compounding inspection of Respondent at its address of record. DOH v. Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy 2 DOH Case No, 2018-13109 8. The Department’s inspection on or about May 15, 2018, revealed that Respondent failed to maintain a written compounding record for buprenorphine hydrochloride 3mg/mL, lot number BUVSRO0514. COUNT ONE 9. Petitioner realleges and incorporates paragraphs one through eight as if fully set forth herein. 10. Section 456.072(1)(q), Florida Statutes (2015), provides, in relevant part, that violating a lawful order of the department or the board constitutes grounds for disciplinary action. 11. Respondent violated the Department’s Emergency Order by dispensing HCG, a compounded sterile preparation, to one or more patients while its special sterile compounding pharmacy permit was restricted from dispensing any compounded sterile preparations. 12. Based on the foregoing, Respondent violated section 456.072(1)(q), Florida Statutes. COUNT TWO 13. Petitioner realleges and incorporates paragraphs one through eight as if fully set forth herein. DOH v. Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy 3 DOH Case No. 2018-13109 14. Section 465.023(1)(c), Florida Statutes (2017), 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 s. 465.022(4), has violated any of the rules of the Board of Pharmacy. 15. Rule 64B16-28.140(4), Florida Administrative Code, provides, in relevant part, that a written record shall be maintained for each batch/sub- batch of a compounded product. 16. Respondent failed to maintain a written compounding record for buprenorphine hydrochloride 3mg/mL, lot number BUVSR0514. 17. Based on the foregoing, Respondent violated section 465.023(1)(c), Florida Statutes, through a violation of rule 64Bi6- 28.140(4), Florida Administrative Code. [ remainder of page intentionally left blank ] DOH v. Pharmacy Doctors piterprises d/b/a Zion Clinic Pharmacy 4 DOH Case No, 2018-1310 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 5th day of March, 2020. Scott A. Rivkees, M.D. State Surgeon General = ‘a E '.) /s/ Hannah Phillips DEPARTMENT OF HEALTH HANNAH PHILLIPS DEPUTY CLERK Assistant General Counsel CLERK: ' Wiprrrd Fla. Bar No. 1003347 DATE: MAR 0 5 2029 Florida Department of Health ll 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: March 5, 2020 PCP Members: Michele Weizer; Mark Mikhael DOH v. Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy 5 DOH Case No. 2018-13109 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. Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy 6 DOH Case No, 2018-13109 et ee ne eee enone pee COMPLETE THIS SECTION ON DELIVERY VOM N00. S590 Yebb TI04 PLEO bebe 30 205 E. Hallandale Beach Blvd Hallandale Beach, FL 33009 Pharmacy Doctors Enterpises; 2018-131 _ Phillips:/AC Pack 2. Certified Mail (Form 3800) Article Number A414 7abb 9904 A160 bebe 37 PS Form 3811, Facsimile, July2015 Domestic Return Receipt Exhibit B Ron DeSantis Mission: : Govemo, To protect, promote & improve the health eet . of all people in Florida through integrated origa state, county & community efforts. ori Scott A. Rivkees, MD a, H EALTH State Surgeon General Vision: To be the Healthiest State in the Nation AFFIDAVIT I, Jessica Sapp , hereby certify in my official capacity as custodian for the Board of Pharmacy’s licensure files that the Board of Pharmacy as of ___ April 14, 2020 F has no evidence of an Election of Rights form or other responsive pleading requesting a hearing prior to any agency action regarding Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy, 2018-13109, which would affect the Subject’s substantial interests or rights. S sasincSoep Custodian of Record Department Clerk's Office STATE OF FLORIDA COUNTY OF LEON Sworn to (or affirmed) and subscribed before me by means of K physical presence or c online notarization, this 5 day of , 2020, by SSUCH_Sé ignature of Notary Public Print, Type or Stamp Commissioned name of Notary Public My Commission Expires: Personally Known X OR Produced Identification, eas : ~~ ROSE NICOLE BENSON Type of Identification Produced uy ISSION #6 299471 EXPIRES: April 30, 2028 Bonded Thru Florida Department of Health Office of the General Counsel — Prosecution Services Unit . 4052 Bald Cypress Way, Bin C-65 + Tallahassee, FL 32399-3265 Accredited Health Department EXPRESS MAIL: 2585 Merchants Row, Suite 105 alee] Public Health Accreditation Board PHONE: 850/245-4640 + FAX: 850/245-4662 FloridaHealth.gov Exh bit C Ron DeSantis Mission: Governor To protect, promote & improve the health of all people in Florida through integrated orl a 7 Scott A. Rivkees, MD state, county & community efforts. State Surgeon General Vision: To be the Healthiest State in the Nation AFFIDAVIT I, j 4 , Deputy Clerk for the Department Clerk’s Office, hereby certify in my official capacity as custodian for the Department Clerk’s records, that the Department Clerk’s Office has not received an Election of Rights form or other responsive pleading, which requests a hearing prior to any Department action regarding Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy; CASE NO. 2018- 13109, which would affect the Respondent's substantial interests or rights. [Bncilygl toct Custodian of Record Department Clerk's Office STATE OF FLORIDA COUNTY OF LEON Sworn to (or affirmed) and subscribed before me by means of X physical presence or o online notarization, this 9th_ day of __ April , 2020, by___ Brag bot 22 } Signature of Notary Public lll Ansan | Print, Type or Stamp Commissioned name of Notary Public My Commission Expires: Personally Known__X OR Produced Identification Type of Identification Produced Florida Department of Health Office of the General Counsel — Prosecution Services Unit " 4052 Bald Cypress Way, Bin C-65 « Tallahassee, FL 32399-3265 Accredited Health Department EXPRESS MAIL: 2585 Merchants Row, Suite 105 lala] Public Health Accreditation Board PHONE: 850/245-4640 + FAX: 850/245-4684 - - FloridaHealth.gov Exh | it D Pietrylo, Andrew From: Pietrylo, Andrew Sent: Monday, June 1, 2020 12:34 PM To: afeldman@feldmanpllc.com Ce: Camacho, Alejandro Subject: RE: SERVICE OF DOCUMENT- DOH v Taran/PDE Case No 18-13109 - ANSWER TO ADMINISTRATIVE COMPLAINT Good afternoon Mr. Feldman, lam Mr. Camacho’s supervisor and am responding to your e-mail below. As set forth in the motion you received, the Department served the Administrative Complaint on your client via certified mail on March 16, 2020. Per rule 28- 106.111, Florida Administrative Code, their response was due within 21 days, by April 6, 2020. Prior to your e-mail to Mr. Camacho, the Department had not received any responsive pleading in this case. Ms. Phillips’ last day with the Department was April 9, 2020, and her e-mail account was deactivated on April 11, 2020. Therefore, your e-mails to Ms. Phillips on April 19 and May 7 would have been returned to you as undeliverable. Even if these e-mails had been received, they were both well past the 21-day deadline of April 6, 2020. The case was not referred to DOAH because no such request was received. | will have Mr. Camacho revise the motion to reflect that your request for a formal hearing was received untimely and have him include it and this e-mail chain in the materials for the Board to consider. If you would like to submit a written dispute of the waiver to be included in the materials as well, please ensure it is received by Mr. Camacho no later than June 15, 2020. Either way, you will have an opportunity to appear before the Board and dispute the waiver, if you wish, or to provide mitigating evidence during a hearing not involving disputed issues of material fact. Sincerely, Andrew J. Pietrylo, Jr. Assistant General Counsel Office of the General Counsel Prosecution Services Unit Florida Department of Health 4052 Bald Cypress Way, Bin #C-65 Tallahassee, FL 32399-3265 (850) 558-9905 Andrew.Pietrylo@flhealth.gov Mission: To protect, promote, and improve the health of all people in Florida through integrated state, county, & community efforts. Vision: To be the Healthiest State in the Nation Values: ICARE | innovation: We search for creative solutions and manage resources wisely. C collaboration: We use teamwork to achieve common goals & solve problems. A accountability: We perform with integrity & respect. R responsiveness: We achieve our mission by serving our customers & engaging our partners. E excellence: We promote quality outcomes through learning & continuous performance improvement. Purpose: To protect the public through health care licensure, enforcement and information. Focus: To be the nation's leader in quality health care regulation. Please note: Exhibit E Florida has a very broad public records law. Most written communications to or from state officials regarding state business are public records available to the public and media upon request. Your e-mail communications may therefore be subject to public disclosure. Please consider the environment before printing this e-mail. From: afeldman@feldmanpllc.com Sent: Monday, May 25, 2020 7:03 PM To: Camacho, Alejandro Subject: FW: SERVICE OF DOCUMENT- DOH v Taran/PDE Case No 18-13109 - ANSWER TO ADMINISTRATIVE COMPLAINT Dear Mr. Camacho: | represent Veronica Taran, Pharm D and Pharmacy Doctors Enterprises. Attached is the answer that was served on Department of Health no later than April 19, 2020 via email on attorney Hannah Phillips who filed the original complaint. | also have not been able to find a copy of the complaint e-filed on E-ALJ. Was it filed and docketed? Please withdraw the motions you filed on May 13, 2020 in this case which were received on Friday May 22, 2020. There is no basis for a final determination or judgment. We requested a hearing and would like to move forward with a hearing. Thank you and feel free to contact me about the above. Andrew S. Feldman Feldman Firm PLLC 200 S. Biscayne Blvd, Suite 2770 | Miami, Florida 33131 Office: 305.714.9474 | Office: 786.233.5359|Mobile: 202.320.7705 Email: afeldman@feldmanpllc.com |Website: www.feldmanpllc.com Licensed in Florida, Washington, DC, and New York CONFIDENTIALITY NOTE: This email message from the law office of Feldman Firm PLLC is for the sole use of the intended recipient or recipients and may contain confidential and privileged information. Any unauthorized review, use, disclosure, distribution, or other dissemination of this e-mail message and/or the information contained therein is strictly prohibited. If you are not the intended recipient of this e-mail message, please contact the sender by reply e-mail and destroy all copies of the original message. From: afeldman@feldmanpllc.com Sent: Thursday, May 7, 2020 7:09 AM To: ‘hannah. phillps@flhealth.gov' Subject: RE: SERVICE OF DOCUMENT- DOH v Taran/PDE Case No 18-13109 - ANSWER TO ADMINISTRATIVE COMPLAINT Hannah Did you file this action via e-ALJ? | still have not been able to find it so that | can e-file something on the docket. Thank you. ASF Andrew S. Feldman Feldman Firm PLLC 200 S. Biscayne Blvd, Suite 2770 | Miami, Florida 33131 Office: 305.714.9474 |Office: 786.233.5359|Mobile: 202.320.7705 Email: afeldman@feldmanpllc.com |Website: www.feldmanpllc.com Licensed in Florida, Washington, DC, and New York CONFIDENTIALITY NOTE: This email message from the law office of Feldman Firm PLLC is for the sole use of the intended recipient or recipients and may contain confidential and privileged information. Any unauthorized review, use, disclosure, distribution, or other dissemination of this e-mail message and/or the information contained therein is strictly prohibited. If you are not the intended recipient of this e-mail message, please contact the sender by reply e-mail and destroy all copies of the original message. From: afeldman@feldmanpllc.com Sent: Sunday, April 19, 2020 2:53 PM To: ‘hannah. phillps@flhealth.gov' Subject: SERVICE OF DOCUMENT- DOH v Taran/PDE Case No 18-13109 - ANSWER TO ADMINISTRATIVE COMPLAINT SERVICE OF DOCUMENT CASE STYLE: DOH v Taran/PDE CASE NO 18-13109 PLEADING- ANSWER TO ADMINISTRATIVE COMPLAINT Dear Hannah Please see attached. Andrew S. Feldman Feldman Firm PLLC 200 S. Biscayne Blvd, Suite 2770 | Miami, Florida 33131 Office: 305.714.9474 |Office: 786.233.5359|Mobile: 202.320.7705 Email: afeldman@feldmanpllc.com |Website: www.feldmanpllc.com Licensed in Florida, Washington, DC, and New York CONFIDENTIALITY NOTE: This email message from the law office of Feldman Firm PLLC is for the sole use of the intended recipient or recipients and may contain confidential and privileged information. Any unauthorized review, use, disclosure, distribution, or other dissemination of this e-mail message and/or the information contained therein is strictly prohibited. If you are not the intended recipient of this e-mail message, please contact the sender by reply e-mail and destroy all copies of the original message.

Docket for Case No: 20-004766

Issue Date	Proceedings
Jan. 22, 2021	Order Closing File. CASE CLOSED.
Jan. 22, 2021	Petitioner's Response in Opposition to Respondent's Motion for a Protective Order concerning Depositions in this Case filed.
Jan. 21, 2021	Respondent's Motion for a Protective Order concerning Depositions in this Case filed.
Jan. 21, 2021	Affidavit of Andrew S. Feldman in Support of Motion for Summary Judgment (to Dismiss Administrative Complaint or for Motion of Determination that there was no Waiver Based on Undisputed Material Facts) filed.
Jan. 21, 2021	Respondent's Motion to Dismiss the Administrative Complaint for Ineffective Service of Process and/or for Determination on the Material Undisputed Facts that there was No Waiver of the 21 Day Period for Requesting a Final Hearing filed.
Jan. 05, 2021	Notice of Taking Deposition (PDE) filed.
Jan. 05, 2021	Notice of Taking Deposition (VT) filed.
Jan. 05, 2021	Notice of Taking Deposition (AF) filed.
Dec. 01, 2020	Notice of Court Reporter filed.
Nov. 25, 2020	Notice of Postponing Deposition (V.T.) filed.
Nov. 25, 2020	Notice of Postponing Deposition (Pharmacy Doctors Enterprises, Inc.) filed.
Nov. 25, 2020	Notice of Postponing Deposition (E.Z.) filed.
Nov. 25, 2020	Notice of Postponing Deposition (A.F.) filed.
Nov. 25, 2020	Order Granting Continuance and Rescheduling Hearing by Zoom Conference (hearing set for February 15, 2021; 9:00 a.m., Eastern Time).
Nov. 24, 2020	Joint Motion for Continuance and Enlarge Deadlines filed.
Nov. 19, 2020	Notice of Taking Deposition (A.F.) filed.
Nov. 19, 2020	Notice of Taking Deposition (Pharmacy Doctors Enterprises, Inc.) filed.
Nov. 19, 2020	Notice of Taking Deposition (V.T.) filed.
Nov. 19, 2020	Notice of Taking Deposition (E.Z.) filed.
Nov. 05, 2020	Notice of Court Reporter filed.
Nov. 04, 2020	Notice of Hearing by Zoom Conference (hearing set for December 14, 2020; 8:00 a.m., Eastern Time).
Nov. 03, 2020	Response to Amended Initial Order filed.
Oct. 28, 2020	Notice of Serving Petitioner's First Request for Admissions, First Set of Interrogatories, and First Request for Production filed.
Oct. 27, 2020	Amended Initial Order.
Oct. 27, 2020	Initial Order.
Oct. 26, 2020	Notice of Appearance (Andrew Pietrylo) filed.
Oct. 26, 2020	Seconded Amended Motion for Determination of Waiver and for Final Order by Hearing Not Involving Disputed Issues of Material Factfiled.
Oct. 26, 2020	Respondents' Amended Response in Opposition to Petitioners Amended Motion for Determination of Waiver and for Final Order by Hearing Not Involving Disputed Issues of Material Fact filed.
Oct. 26, 2020	Administrative Complaint filed.
Oct. 26, 2020	Request for Hearing, Pharmacy Doctors Enterprises Answer to Administrative Complaint filed.
Oct. 26, 2020	Agency referral filed.