meeting minutes department of health board...

MEETING MINUTES

DEPARTMENT OF HEALTH BOARD OF PHARMACY FULL BOARD MEETING

August 11-12, 2015 Double Tree by Hilton

100 Fairway Dr. Deerfield Beach, FL 33441

(954) 427-7700

PLEASE TURN OFF ALL CELL PHONES, PAGERS AND BEEPERS DURING THE MEETING. THANK YOU.

Board Staff

Board Members

Michele Weizer, PharmD, BCPS, Chair, Boca

Raton

Debra B. Glass, BPharm, Vice-Chair, Tallahassee

Goar Alvarez, PharmD, Cooper City

Leo “Lee” Fallon, BPharm, PhD, The Villages

Gavin Meshad, Consumer Member, Sarasota

Jeenu Philip, BPharm, Jacksonville

Mark Mikhael, PharmD, Orlando

Jeffrey J. Mesaros, PharmD, JD, Orlando

Allison Dudley, Executive Director

Emily Roach, Program Operations Administrator

Amber Greene, Regulatory Specialist III

Board Counsel

David Flynn, Assistant Attorney General

Lynette Norr, Assistant Attorney General

Department of Health Staff

Matthew Witters, Assistant General Counsel

Christopher Jurich, Assistant General Counsel

Participants in this public meeting should be aware that these proceedings are being recorded and that

an audio file of the meeting will be posted to the board’s website.

Tuesday, August 11, 2015 – 9:00 a.m.

Meeting called to order by Dr. Weizer at 9:00 am. Dr. Weizer stated the board has a new member, David Bisaillon. Dr. Weizer excused him from this meeting. All other members were present.

TAB 1: REPORTS – Michele Weizer, PharmD, BCPS, Chair

A. Chair’s Report – Michele Weizer, PharmD, BCPS

Dr. Weizer stated she recently attended American Society of Health-System Pharmacists

where they discussed House of Delegates and provider status. Dr. Weizer stated the NABP District lll meeting will begin on Saturday, August 15, 2015 and the Chair and Vice Chair meeting will be held in Tallahassee in September 2015. 1. Tripartite Committee appointments A. Megan Murphy-Menezes B. Humberto “Bert” Martinez, BPharm, R.Ph., C.Ph., M.D. Motion: by Dr. Fallon, to appoint Megan Murphy-Menezes and Humberto “Bert” Martinez to tripartite committee. Motion carried.

B. Executive Director's Report – Allison Dudley, Executive Director

1. Strategic Planning discussion Ms. Dudley asked the board members to identify the strengths, weaknesses, opportunities and challenges the board faces. Mr. Philip explained one of the strengths is the boards working relationship with the department and the legislators. Dr. Fallon stated a weakness is the need for better education for the pharmacists. Dr. Mesaros stated an opportunity would be to collaborate practice and education. Dr. Mikhael suggested to utilize more technology. Mr. Philip stated one of the challenges being faced is the restriction by legislation; we need to focus on how to put the laws in legislation to give the board more authority.

2. Meeting Times

Ms. Dudley requested the board meeting go back to an 8 am start time. Motion: by, Dr. Fallon, to approve 8 am start times for the board meetings. Motion carried.

3. Discussion- Clarification regarding storage of dispensed drugs at assisted living facilities and drug treatment centers

Ms. Dudley explained the board office in Tallahassee has been receiving a lot of calls regarding whether or not at assisted living facilities and drug treatment centers need a pharmacy permit. Ms. Dudley stated assisted living facilities and drug treatment centers will not require a pharmacy permit.

4. Discussion- User guide for web based iviewer Ms. Dudley explained to the board that there is still an issue with the new web iviewer program. Ms. Dudley then stated the board office is excited to start using the new program and all the features it offers.

5. Change of Ownership Discussion Ms. Dudley stated the way Rule 64B16-28.2021 reads right now a 100% stock transfer is not a change of ownership. Ms. Dudley requested the board open this rule up for discussion. Motion: by Mr. Philip, to move Rule 28.2021 to Rules committee for discussion. Motion carried. 6. 797 Workshop discussion Ms. Dudley explained there will be a 797 workshop following the October board meeting. The workshop will be held on October 8, 2015 in Tampa. Ms. Dudley stated 5 live ce hours will be offered to attendees.

C. Attorney General's Report - David Flynn, Assistant Attorney General

1. Monthly Rules Report None at this time.

2. Declaratory Statement

A. Prescription Health Network ( continued to October)

B. Florida Health Care Plans Pharmacy Florida Health Care Plans Pharmacy was looking for clarification on whether a pharmacy cashier is permitted under §465.014, F.S. and 64B16-27.420 to operate a computer software program under specified conditions in order to improve delivery of the right medication to the right patient.

After discussion the board determined a cashier’s duty is to ring up the sale. Dr. Fallon stated its public safety. Motion: by Dr. Fallon, to deny request for declaratory statement. Motion carried. C. Centra Care Cynthia Mikos represented Centra Care.

Centra Care was looking for clarification of the word “give” as stated in 465.0276(2)(c). Ms. Mikos explained the patients do have the option elect what form of prescription was offered to them. She then stated the patients are offered to accept or decline via ipad in the office. Motion: by Dr. Fallon, to accept request for declaratory statement. Motion carried. 3. Petition for Variance or Waiver A. Center for Living Well Family Healthcare - Request to Withdraw Motion by: Dr. Mesaros, to accept request to withdraw. Motion carried. B. The Medimix, LLC Edwin Bayo served as counsel for The Medimix, LLC. The Medimix, LLC requested a permanent waiver of Rule 64B16-28.202(4)(a) so that the Medimix would not be required to deliver the prescription files to another pharmacy. Ms. Dudley stated the board office has been receiving calls regarding the need to close the pharmacy but unable to find a pharmacy to take the patient records. Mr. Bayo explained the majority of patients have already made other arrangements for their files. He then stated Medimix will provide the Board office the telephone number and location of files in case needed the information. Motion: by Dr. Alvarez, to accept request for variance and include a 30 day time frame. Motion carried.

D. Investigative Services Report – Michelle Miller, Bureau of Enforcement Ms. Miller stated out of 5,468 pharmacies, 737 have been inspected (13.48 %.). Ms. Miller stated out of 7,381 Dispensing Practitioners, 597 have been inspected (8.09 %). Please note DOH is only 6 weeks into the new fiscal year.

TAB 2: BUSINESS – Michele Weizer, PharmD, BCPS, Chair

A. Ratification of Issued Licenses/Certificates & Staffing Ratios 1. Pharmacist (Licensure)(Client 2201) – 205 2. Pharmacist (Exam Eligibility)(Client 2201) – 802 3. Pharmacist Interns (Client 2202) – 163 4. Registered Pharmacy Technicians (Client 2208) – 1269 5. Consultant Pharmacist (Client 2203) – 43

6. Nuclear Pharmacist (Client 2204) – 3 7. Pharmacy/Facilities (Client 2205) – 132 8. Nonresident Sterile Compounding (Client 2210) –32 9. CE Providers – 10. CE Courses – 11. CE Individual Request (Approved) – 4 12. CE Individual Request (Denied) –0

Motion: by Ms. Glass, to approve ratification of issued licenses. Motion carried.

B. Review and Approval of Minutes 1. June 9-10, 2015 Meeting Minutes

Motion: by Mr. Philip, to approve meeting minutes. Motion carried.

2. June 9, 2015 Controlled Substance Standards Committee Meeting Minutes

Motion: by Mr. Philip, to approve meeting minutes. Motion carried. 3. June 9, 2015 Compounding Committee Meeting Minutes

Motion: by Dr. Mikhael, to approve meeting minutes. Motion carried.

C. MedAvail Technologies Withdrawn

D. Request for reduction of hours 1. Brian McDonald- Factor Pharmacy Mr. McDonald was not present. The board suggested continuing until next meeting due to unanswered questions regarding the operation hours. Motion: by Dr. Alvarez, to continue until next meeting. Motion carried. 2. Robert Palumbo – Wellness Rx. Bob Parrado was there on behalf of Wellness Rx. This case was continued until Wednesday, August 12, 2015. The board requested clarification on the business plan. The board was looking for the specific hours and days business would be open; types of drugs that would be compounded and anticipate any maintenance medications.

Mr. Palumbo was in attendance on Wednesday and was available for questions from the board. Mr. Palumbo provided the board with the current business plan as requested the day before. The plan provided to the board included daily operating hours and days open. Mr. Palumbo advised the board that Wellness RX will be cash based only for now and there will not be any controlled substances. Motion: by Mr. Meshad, to accept request for reduction of hours. Motion carried.

E. One Point Care- Pete Speranza- Automated Pharmacy Systems in Long-Term Care, Hospice and Prisons

Mr. Sperenza, General Counsel for One Point Care was seeking clarification with respect to the application of the automated pharmacy systems statute and regulation. One requirement in connection with maintaining the ModifiedClass II Institutional Pharmacy, Type B license (“Class IIB”).

The Board felt Mr. Sperenza was interpreting the law correctly and no vote was needed. Ms. Dudley stated the board office will work with Mr. Sperenza to get the permits needed in. F. Wal-Mart, Tim Koch Dr. Fallon recused himself due to his employment with Wal-Mart. Mr. Koch explained Wal-Mart was looking for clarification for issue that recently came up on inspections. The issue was the term “Central Fill” being visible on the prescription label. Mr. Flynn stated the term Central Fill needed to be on the original prescription. Mr. Flynn stated Rule 28.450 (6)(a)(1) needed to be on the rules committee. Mr. Flynn then stated the language needed to be cleaned up. Mr. Whitten, with Bureau of Enforcement suggested opening the rule for development. Bureau of Enforcement will give guidance to the inspectors that the rule has been opened to address “central fill” being written on the face of prescription. Motion: by Dr. Mesaros to open Rule 64B16-28.450 for development so it adheres to central fill being on face of prescription. Motion carried. G. Pharmacy Creations / Mark Boesen- Request for clarification and/or amendment of Final Order

Joe Bitterman, Senior Operations Director was present on behalf of Pharmacy Creations. Mr. Bitterman explained to the board that Pharmacy Creations was looking for an amendment of the Final order issued in April 2015. Dr. Weizer stated there was no mistake with the final order. The final order indicated a requirement that all sterile compounded products shipped into Florida shall have independently certified sterility and endotoxin testing and the product will be accompanied by the certificate results of the sterility and endotoxin testing. Dr. Weizer stated that was the intent of the Board, no mistake was made. Dr. Mikhael stated when he made the original motion and it was his intent that they needed to exceed 797 because of prior discipline. Motion: by Dr. Mesaros to ADJOURN at 11:52 am. Motion carried.

Wednesday, August 12, 2015 - 9:00 a.m.

Meeting called to order by Dr. Weizer at 9:00 am.

Dr. Weizer stated the board has a new member, David Bisaillon. Dr. Weizer excused him from this meeting. All other members were present.

TAB 3: COMMITTEE REPORTS & ACTIONS (FROM 8/10 & 8/11) - Michele Weizer, PharmD, BCPS, Chair; Jeff Mesaros, PharmD, Gavin Meshad & David Flynn, Assistant Attorney General

1. Controlled Substance Standards Committee, Gavin Meshad, Chair Mr. Meshad explained this is the second meeting of the Controlled Substance Standards committee. Mr. Meshad stated during the meeting held on Monday, August 10, 2015 a work group was formed and will meet in Tallahassee prior to the next board meeting. Mr. Meshad explained the intention of the work group is to compile ideas and create an educational program. Mr. Meshad stated Florida can lead by example with the ongoing issues surrounding controlled substances.

2. Rules Committee Dr. Mesaros and Lynette Norr provided the board and audience a recap of all items discussed during the Tuesday, August 11, 2015 meeting. The proposed rule amendments and form amendments were: Rule 64B16-26.1031 Vaccine Certification Program (1) will now reflect the correct name and date of form DH-MQA 1234; (2)(c) there is a period after "immunization registry" and the remainder is deleted because that form does not need to be incorporated into the rule; (2)(m) adds: The immunization and vaccine guidelines in the February 1, 2015, Adult Immunization Schedule by the United States Centers for Disease Control and Prevention, entitled "Recommended Adult Immunization Schedule -- United States -- 2015." and the remainder is deleted. (2)(n) adds: The immunizations or vaccines recommended by the United States Centers for Disease Control and Prevention for international travel as of July 1, 2015. (2)(q) adds: State of emergency administration of immunizations or vaccines. Motion: by Dr. Alvarez, to accept proposed amendments to Rule 26.1031. Motion carried. Motion: by Dr. Alvarez, that there is not an adverse economic impact on small business. Motion carried. Motion : by Dr. Alvarez, that the changes will not directly or indirectly increase regulatory costs to any entity including government in excess of $200,000.00 in aggregate in Florida within one year after the implementation of the rule. Motion carried.

FORM DH-MQA 1234: Page 1, box at top: corrected the rule name to Vaccine Certification Program; Page 1, shaded box: adds "OR PHARMACY COURSEWORK" Section II, Paragraph 6.: Delete "CE" from check boxes Section IV: Delete paragraphs 2 and 3. Section VI: Delete last sentence of paragraphs 1 and 2; Section VI: Add paragraph 4 "Please attach a sample attendee evaluation instrument." Approval date is 08/12/2015 Motion: by Dr. Fallon, to accept proposed amendments to DH Form 1234. Motion carried. Motion: by Dr. Fallon, that there is not an adverse economic impact on small business. Motion carried. Motion : by Dr. Fallon, that the changes will not directly or indirectly increase regulatory costs to any entity including government in excess of $200,000.00 in aggregate in Florida within one year after the implementation of the rule. Motion carried.

Rule 64B16-26.1032 Immunization Administration Certification Application and Information The first sentence will now reflect the correct date of Form DH-MQA 1125; The last sentence will now read: The application must be accompanied with a non-refundable application fee, if applicable, as set forth in Rule 64B16-26.1001, F.A.C. Motion: by Mr. Philip, to add the term non-refundable application fee, if applicable, as set forth in Rule 64B16-26.1001, F.A.C.. Motion carried

Motion: by Dr. Fallon, there is not an adverse economic impact on small business and that the changes will not directly or indirectly increase regulatory costs to any entity including government in excess of $200,000.00 in aggregate in Florida within one year after the implementation of the rule. Motion carried. Motion: by Dr. Mesaros, to state nonrefundable application fee for Immunization Administration Certification Application shall be $55 for pharmacists and no fee for registered pharmacy interns. Motion carried. Motion: by Dr. Fallon, there is not an adverse economic impact on small business and that the changes will not directly or indirectly increase regulatory costs to any entity including government in excess of $200,000.00 in aggregate in Florida within one year after the implementation of the rule. Motion carried.

FORM DH-MQA 1125 will now reflect no application fee for registered pharmacy interns in all appropriate locations, and a new date of 08/12/2015. Motion: by Dr. Fallon, to accept proposed edits to form DH 1125 and ,there is not an adverse economic impact on small business and that the changes will not directly or indirectly increase regulatory costs to any entity including government in excess of $200,000.00 in aggregate in Florida within one year after the implementation of the rule. Motion carried. Rule 64B16-26.1001 Voted to open for development (4) was modified to correct the application name and to specify the $55 fee is for pharmacists and no fee for registered pharmacy interns. Motion by: Dr. Mesaros, to open Rule 64B16-26.1001 for development. Motion carried. Rules 64B16-27.1003, 27.101, 27.105, 27.200, 27.430, 27.510 and 27.440 are no longer needed due to language stated in the statutes. Motion: by Dr. Fallon, to repeal Rules 64B16-27.1003,27.101,27.105,27.200,27.430, 27.510

and 27.440 and there is not an adverse economic impact on small business and that the changes will not directly or indirectly increase regulatory costs to any entity including government in excess of $200,000.00 in aggregate in Florida within one year after the implementation of the rule. Motion carried.

3. Sterile Compounding Committee Dr. Weizer and David Flynn provided the Board a recap of Tuesday’s, August 11, 2015 committee meeting. Dr. Weizer explained the committee is working on vetting additional types of vendors. The committee reviewed current process of vetting. Mr. Flynn suggested Rule 64B1627.700 be limited to animal products. Motion: by Dr. Mikhael, to accept recommendations of the committee regarding rule 28.905 and will not have to go through SERC analysis. Motion carried.

TAB 4: DISCIPLINARY CASES – Matthew Witters, Esq. & Michelle Weizer, PharmD, BCPS, Chair

1. Prosecution Services Report – Matt Witters, Assistant General Counsel Mr. Witters stated the inventory was 335 cases last time and is now up to 377 cases. Mr. Witters stated we currently have 184 cases that are 1 year or older and asked the Board to consider allowing to continue to prosecute those cases. Motion: by Dr. Mikhael, to allow PSU to continue prosecuting cases one year and older. Motion carried.

SETTLEMENT AGREEMENTS - APPEARANCE REQUIRED

SA-1 Leo Eugene Wojcechowskyj, R. Ph. Case No. 2014-17979

Respondent was present and sworn in. Respondent was represented by counsel Brian Kahan. Dr. Mikhael and Ms. Glass were recused due to participation on the probable cause panel. Mr. Jurich represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: Count one: violation of Florida Statute 456.072(1)(k), FS

(2014), by and through a violation of section 465.022(11)(b), FS (2014).

The terms of the Settlement Agreement are: Appearance; Fine $2000.00 to be paid within 30 days of the filing of Final Order; Cost $2,608.96 to be paid within 90 days of filing of Final Order; One year Probation- respondent shall not serve as PDM , shall not work for more than two pharmacies during each quarter of probation period, shall submit written quarterly reports to compliance officer, shall ensure employers submits written report to compliance officer, shall make mandatory appearance before the board during last three months of probation; Continuing education- must complete a 12 hour board approved Laws and Rules course within 1 year of the filing of Final Order. Motion by: Dr. Fallon, to accept Settlement Agreement. Motion carried.

SA-2 Sejal Parbhoo, R. Ph. Case No. 2014-07825

Respondent was present and sworn in. Respondent was represented by counsel, Edwin Bayo. Dr. Alvarez and Dr. Fallon were recused due to participation on the probable cause panel. Mr. Jurich represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of Florida Statute 465.016(1)(t)(3), FS (2013).

The terms of the Orally Amended Settlement Agreement are: Appearance; Fine $500.00 to be paid within 30 days of the filing of Final Order; Cost $1,942.73 to be paid within 12 months of filing of Final Order; Continuing education- must complete a 8 hour board approved Medical Errors course within 1 year of the filing of Final Order. Motion by: Dr. Mikhael, to accept Orally Amended Settlement Agreement. Motion carried.

SA-3 Scott Alan Jacques, R. Ph. Case No. 2014-09636

Respondent was not present and sworn in. Respondent was not represented by counsel. Dr. Weizer and Mrs. Glass were recused due to participation on the probable cause panel. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of Florida Statute section 456.072(1)(hh), FS 2013, by being terminated from a treatment program for impaired practitioners, which is overseen by impaired practitioner consultant as described in Section 456.076, Florida

Statutes, for the failure to comply without good cause, with terms of the monitoring or treatment contract entered into by the licensee, or for not successfully completing and drug treatment or alcohol treatment program, constitutes grounds for disciplinary action.

The terms of the Settlement Agreement are: Appearance; Cost $1,130.28 to be paid within 90 days of filing of Final Order; Evaluation by Department/PRN approved evaluator and follows all requirements and recommendations; Suspension until respondent undergoes an evaluation by Department/PRN approved evaluator and is deemed safe to practice pharmacy with reasonable skill and safety; Probation upon conclusion of the suspension for two years or a period concurrent with PRN contract if any; Probation shall be tolled until such time where respondent gains employment within the practice of pharmacy. Motion by: Mr. Philip to waive appearance due to the respondent being in a work camp. Motion carried. Motion by: Dr. Fallon, to accept Settlement Agreement. Motion carried.

SA-4 William Walker, R. Ph. Case No. 2014-06540

Respondent was present and sworn in. Respondent was not represented by counsel. Dr. Weizer and Mr. Philip were recused due to participation on the probable cause panel. Debra Glass chaired the case due to the Board chair being recused. Mr. Jurich represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of Florida Statute 456.072(1)(k), FS (2013), through a violation of section 465.022(11)(a), FS (2013), by failing to ensure permittee’s compliance with Rule 64B16-28.1081, Florida Administrative Code, and Rule 61N-1.012(7), Florida Administrative Code.

The terms of the Settlement Agreement are: Appearance; Fine $2000.00 to be paid within 30 days of the filing of Final Order; Cost $1,018.60 to be paid within 12 months of filing of Final Order; Continuing education- must complete a 12 hour board approved Laws and Rules course within 1 year of the filing of Final Order. Motion by: Dr. Alvarez, to reject Settlement Agreement and offer-counter agreement that includes all terms of the settlement agreement and places a two year restriction on serving as a Prescription Department Manager. Motion carried.

SA-5 Jermaine Omara Bowen, R. Ph. Case No. 2013-00120

SA-6 New Era Pharmaceuticals, LLC. Case No. 2013-00117

Settlement agreements 5 & 6 were continued to the October board meeting due to lack of quorum.

SA-7 Ismail Mohamed Mohamed, R. Ph. Case No. 2010-12514

This case will be continued until the October board meeting due to lack of quorum. The required appearance will be waived.

Respondent was present and sworn in. Respondent was represented by counsel, Alvin Peters. Dr. Mikhael and Mr. Meshad were recused due to participation on the probable cause panel. Dr. Fallon and Debra Glass were also recused due their working relationship with CVS. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of Section 456.072(1)(k), FS (2009), through a violation of Section 465.016(1)(s), FS (2009), by dispensing any medicinal drug based upon a communication that purports to be a prescription as defined by s. 465.003(14) or s. 893.02(20) when the pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitioner-patient relationship.

The terms of the Settlement Agreement are: Appearance; Fine $5000.00 to be paid within 90 days of the filing of Final Order; Cost $8,401.45 to be paid within 3 years of filing of Final Order; Continuing Education- must complete board approved 12 hours Laws and Rules and 20 hour board approved Controlled Substances courses within 1 year of filing of Final Order; Probation- respondent not to function as PDM in any Florida permitted pharmacy, in the event the respondent returns to Florida respondent must submit monthly reports identifying the PDM of record at the pharmacy in which the respondent is employed and make mandatory appearance before the board during last three months of probation.

SA-8 Manuel Villaverde, R. Ph. Case No. 2015-00145

Respondent was present and sworn in. Respondent was not represented by counsel. Dr. Mikhael and Mr. Philip were recused due to participation on the probable cause panel. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of Section 456.072(1)(k), FS (2014), through a violation of Section 465.022(11)(a), FS (2014), by failing to ensure the permittee’s compliance with Rule 64B16-28.110, FAC, by having expired medications within the active stock.

The terms of the Settlement Agreement are: Appearance; Fine $500.00 to be paid within 30 days of the filing of Final Order; Cost $774.86 to be paid within 90 days of filing of Final Order; Continuing Education- must complete board approved 12 hours Laws and Rules within 1 year of filing of Final Order. Motion by: Dr. Alvarez, to accept Settlement Agreement. Motion carried.

SA-9 Michael Paul Fulghum, R. Ph. Case No. 2014-17625

Respondent was present and sworn in. Respondent was represented by counsel, Edwin Bayo. Dr. Mesaros and Mrs. Glass were recused due to participation on the probable cause panel. Dr. Martha Brown with Professional Resource Network was there on the respondent’s behalf. Dr. Brown stated that the respondent was in full compliance with PRN and felt as though he can practice with reasonable skill and safety. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: Count 1: violation of Section 465.016(1)(i), FS (2014), by compounding, dispensing or distributing hydrocodone/APAP, Tussionex and/or carisprodol, other than in the course of the professional practice of pharmacy. Count two: violation of Section 465.016(1)(e), FS (2014), by violating section 893.13(7)(a)(9), FS (2014), by acquiring or obtaining, or attempting to acquire or obtain, possession of hydrocodone/APAP, Tussinex and/or carisprodol by misrepresentation, fraud , forgery, deception or subterfuge.

The terms of the Settlement Agreement are: Appearance; Fine $2,500.00 to be paid within 180 days of the filing of Final Order; Cost $2,493.53 to be paid within 180 days of filing of Final Order; Respondent shall undergo PRN evaluation within 60 days of filing of Final Order; Suspension until respondents appears before the Board and demonstrates is safe to practice with reasonable skill and safety; Probation – 2 years’ probation to begin following the reinstatement of respondent’s license and will run concurrent with any PRN monitoring period. During period of probation respondent shall not function as PDM in any Florida permitted pharmacy; shall make mandatory appearance before the Board during last 3 months of probation and shall not work in more than two pharmacies. Motion by: Dr. Mikhael to accept the Settlement Agreement. Motion carried.

Break 11:17-11:30

DETERMINATION OF WAIVERS

DOW-1 Speed ll Pharmacy, Inc. Case No. 2014-02099

Respondent was not present. Respondent was not represented by counsel Dr. Weizer and Ms. Glass were recused due to participation on the probable cause panel. Dr. Mikhael chaired the case due to the board chair being recused. Mr. Jurich represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of Section 456.072(1)(q), FS (2013), by violating a lawful order of the department or the board, or by failing to comply with a lawfully issued subpoena of the department. Motion by: Mr. Philip, to find that respondent was properly served and waived the right to a formal hearing. Motion carried. Motion by: Mr. Philip, to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion: by Mr. Philip, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Mr. Philip, to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Recommended Penalty: Revocation. Motion: by Mr. Philip, to accept the recommendations of the Department. Motion carried.

PSU will withdraw motion for cost.

DOW-2 David Richard Fish, R. Ph. Case No. 2015-01733

Respondent was not present. Respondent was not represented by counsel Dr. Mikhael and Ms. Glass were recused due to participation on the probable cause panel. Mr. Jurich represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of section 456.072(1)(hh), FS (2014).

Motion by: Dr. Fallon, to find that respondent was properly served and waived the right to a formal hearing. Motion carried. Motion by: Dr. Fallon, to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion: by Dr. Fallon, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Dr. Fallon, to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Recommended Penalty: Revocation. PSU will withdraw motion for cost. Motion: by Dr. Fallon, to accept the recommendations of the Department. Motion carried.

DOW-3 Ace Pharmacy, Inc. Case No. 2014-10541

Respondent was not present. Respondent was not represented by counsel Dr. Fallon and Dr. Alvarez were recused due to participation on the probable cause panel. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of Section 456.072(1)(k), FS (2014), by violating section 465.023 (1)(c), FS (2014), by violating Rule 64B16-28.202(3), FAC, by failing to notify the Board in writing as to the effective date of closure and return the pharmacy permit to the Board of Pharmacy office or arrange with the local Bureau of Investigative Services of the Department to have the pharmacy permit returned to the Board of Pharmacy, and notify the Board of Pharmacy which permittee is to receive the prescription files. Motion by: Ms. Glass, to find that respondent was properly served and waived the right to a formal hearing. Motion carried. Motion by: Ms. Glass, to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion: by Ms. Glass, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Ms. Glass, to adopt the conclusions of law set forth in the Administrative

Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Recommended Penalty: Revocation PSU will withdraw motion for cost. Motion: by Ms. Glass, to accept the recommendations of the Department. Motion carried.

DOW-4 Ace Pharmacy, LLC Case No. 2014-10543

Respondent was not present. Respondent was not represented by counsel Dr. Fallon and Dr. Alvarez were recused due to participation on the probable cause panel. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of Section 456.072(1)(k), FS (2014) by violating section 465.023(1)(c), FS (2014), by violating Rule 64B16-28.202(3), FAC, by failing to notify the Board in writing as to the effective date of closure and return the pharmacy permit to the Board of Pharmacy office or arrange with the local Bureau of Investigative services of the department to have the pharmacy permit returned to the Board of Pharmacy, and notify the Board which permittee is to receive the prescription files, and Rule 64B16-28.1081, FAC, by failing to keep prescription department of the establishment open for a minimum of forty (40) hours per week. Motion by: Ms. Glass, to find that respondent was properly served and to find that respondent was properly served and waived the right to a formal hearing. Motion carried. Motion by: Ms. Glass, to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion: by Ms. Glass, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Ms. Glass, to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Recommended Penalty: Revocation. PSU will withdraw motion for cost.

Motion: by Ms. Glass, to accept the recommendations of the Department. Motion carried.

DOW-5 Tasha Nyomi Johnson, RPT Case No. 2014-08970

Respondent was not present. Respondent was not represented by counsel. Dr. Weizer and Mr. Philip were recused due to participation on the probable cause panel. Debra Glass chaired this case due to Board chair being recused. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: Count one: violation of section 456.072(1)(x), FS (2013), by failing to report to the board or department if there is no board, in writing within 30 days after the licensee has been convicted or found guilty of, or entered into a plea of nolo contendere to, regardless of adjudication, which is a crime in any jurisdiction.; Count two: violation of section 456.072(1)(c), FS (2013), by being convicted or found guilty of, or entering a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, a licensee’s profession. Motion by: Dr. Alvarez, to find that respondent was properly served and waived the right to a formal hearing. Motion carried. Motion by: Dr. Alvarez, to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion: by Dr. Alvarez, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Dr. Alvarez, to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Recommended Penalty: Suspension until evaluated by PRN and deemed safe to practice with reasonable skill and safety. Motion: by Mr. Meshad, to accept the recommendations of the Department. Motion carried.

DOW-6 Cortney Dionna Boger, RPT Case No. 2014-13605

Respondent was not present. Respondent was not represented by counsel.

Dr. Mikhael chaired this case due to board chair and vice chair being recused. Dr. Weizer and Mrs. Glass were recused due to participation on the probable cause panel. Jeenu Philip was also recused due to his working relationship with Walgreens. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: violation of section 465.016(1)(e), FS (2013-2014), by violating Chapter 893, FS. Motion by: Dr. Fallon, to find that respondent was properly served and waived the right to a formal hearing. Motion carried. Motion by: Dr. Fallon, to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion: by Dr. Fallon, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Dr. Fallon, to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Recommended Penalty: Revocation PSU withdrew motion for costs. Motion: by Dr. Fallon, to accept the recommendations of the Department. Motion carried.

VOLUNTARY RELINQUISHMENTS

VR-1 Ashley Rae Fortune, RPT, Case No. 2014-11338

The Department suggests that the Board entertain a Motion Accepting the Voluntary Relinquishment executed by Respondent in resolution of this case. Motion: by Mr. Meshad, to accept Voluntary Relinquishments. Motion carried.

VR-2 James Tommy Carter, Jr., RPT, Case No. 2014-00975

The Department suggests that the Board entertain a Motion Accepting the Voluntary Relinquishment executed by Respondent in resolution of this case. Motion: by Dr. Mesaros, to accept Voluntary Relinquishments. Motion carried.

VR-3 Aqua Pharmacy, Inc. Case No. 2015-09911


VR-4 Legacy Drugstore Corp. Case No. 2015-09136


VR-5 Rapid Pharmacy Corp., Case No. 2015-06992


VR-6 Michael David Anderson, RPT. Case No. 2014-17959

The Department suggests that the Board entertain a Motion Accepting the Voluntary Relinquishment executed by Respondent in resolution of this case. Motion: by Mr. Meshad, to accept Voluntary Relinquishments. Motion carried.

VR-7 J-M Ward Enterprises, LLC. Case No. 2014-03015


INFORMALS I-1 Richard Weiner, R.Ph. Case No. 2014-16248

Respondent was present and sworn in. Respondent was not represented by counsel. Dr. Mikhael and Mr. Meshad were recused due to participation on the probable cause panel. Mr. Jurich represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: Count one: violation of Section 465.022(11)(a), FS (2014), by and through a violation of Rule 64B16-28.110, FAC. Motion: Dr. Alvarez, by to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion by Dr. Alvarez, to find that respondent was properly served and has requested a formal

hearing. Motion carried. Motion: by Dr. Alvarez, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Mrs. Glass to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Department Recommendations: Board approved 12 hours Laws and Rules course and $142.21 in cost to be paid in 90 days of filing of final order. Motion: by Mr. Philip to accept the recommendations of the Department. Motion carried.

I-2 Pine Island Drugs, Inc. Case No. 2014-16249

Respondent was present. Respondent was not represented by counsel.

Representative present was Richard Weiner, owner of Pine Island Drugs. Dr. Mikhael and Mr. Meshad were recused due to participation on the probable cause panel. Mr. Jurich, represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: Count one: violation of Section 465.023(1)(c), FS (2014), by and through a violation of Rule 64B16-28.110, FAC. Count two: violation of section 465.023(1)(c), FS (2014), by and through a violation of section 499.005(2), FS (2014). Motion: by Dr. Alvarez, to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion by Mrs. Glass, to find that respondent was properly served and has requested a formal

hearing Motion carried. Motion: by Dr. Alvarez, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Dr. Alvarez, to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Department Recommendations $2000 fine payable within 30 days of filing of final order; costs of $403.93 payable in 90 days of filing of final order; semi-annual inspections at the respondent’s cost; 1 year probation; mandatory appearance during last 3 months of probation and corrective action plan submitted to board chair within 90 days. Motion: by Dr. Fallon, to accept the recommendations of the Department. Motion carried.

I-3 Mary Elizabeth Little, R.Ph. Case Nos. 2014-15264, 2014-15262 & 2014-15303

Continued to next meeting due to not having a complete case file.

Motion: by Dr. Mesaros, to grant continuance. Motion carried.

I-4 Treshena L. Dixon, R.Ph., C.Ph., Case No. 2011-17089 and

2011-17091-

Respondent was not present. Respondent was not represented by counsel. Dr. Mikhael and Mr. Meshad were recused due to participation on the probable cause panel. Mr. Witters represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: Count one: violation of Section 456.072(1)(c), FS (2014), by being convicted or found guilty of, or entering a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, a licensee’s profession. Count two: violation of section 456.072 (1)(x), FS (2014), by failing to report to the board, or the department if there is no board, in writing within 30 days after the licensee has been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication , which is a crime in any jurisdiction. Motion: Dr. Fallon, by to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion by Dr. Fallon, to find that respondent was properly served and has requested a formal

hearing. Motion carried. Motion: by Dr. Fallon, to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Dr. Fallon, to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Department Recommendations: Revocation. Motion: by Dr. Fallon, to accept the recommendations of the Department. Motion carried. PSU withdrew motion for costs.

I-5 Amanda Marie Laurenzo, R.Ph. Case No. 2014-21034

Respondent was not present. Respondent was represented by counsel, John McAvoy. Dr. Fallon and Mrs. Glass were recused due to participation on the probable cause panel.

Mr. Jurich represented the Department and presented the case to the Board. Allegations of the Administrative Complaint: Count one: violation of Section 456.072(1)(c), FS. (2014); Count two: violation of section 456.07291)(hh), FS (2014); Count three: violation of section 456.072(1)(x), FS (2011-2014). Motion: Dr. Mikhael by to accept the investigative report into evidence for the purposes of imposing a penalty. Motion carried. Motion by Dr. Mikhael to find that respondent was properly served and has requested a formal

hearing. Motion carried. Motion: by Dr. Mikhael to adopt the findings and facts as set forth in the Administrative Complaint. Motion carried. Motion: by Dr. Mikhael to adopt the conclusions of law set forth in the Administrative Complaint and find that this constitutes a violation of the Pharmacy Practice Act. Motion carried. Department Recommendations: Revocation Motion: by Dr. Mikhael to accept the recommendations of the Department. Motion carried. PSU withdrew motion for costs.

Lunch break 12:56-2:05 pm

TAB 5: APPLICATIONS REQUIRING BOARD REVIEW- Debra Glass, BPharm, Vice-Chair

A. Pharmacist Applications

1. Michael Saavedra, File:46519 – Request to withdraw Motion by: Dr. Mesaros to accept request to withdraw application. Motion carried. 2. Joseph Putnam, File: 46141 Applicant was present and sworn in. Applicant was not represented by counsel.

Dr. Martha brown with PRN was there on applicants behalf. Dr. Brown stated applicant is in compliance and can practice with reasonable skill and safety. Motion: by Mr. Philip to approve the application. Motion carried. 3. Neha Patel, File: 46158 Applicant was not present and sworn in. Applicant was not represented by counsel. Motion: by Dr. Fallon to reject the application based on prior discipline. Motion carried. 4. Michael Lee Roehm, File: 46288 Applicant was present and sworn in. Applicant was not represented by counsel. Motion: by Mr. Philip to approve the application. Motion carried.

B. Registered Pharmacy Technician

1. Ava Taylor Antone, File:

Applicant was not present and sworn in. Applicant was not represented by counsel. The board will require an appearance at one of the next two board meetings and require a PRN evaluation within 60 days. The applicant will also have the option to withdraw the current application.

2. Devraj Singh, File: 55624

Applicant was present and sworn in. Applicant was not represented by counsel. Motion: by Dr. Mikhael to approve the application. Motion carried.

3. Verdresa Lanea Mitchell, File: 61790

Applicant was present and sworn in. Applicant was represented by counsel. The board suggested to applicant to request a continuance until the next board meeting in order to obtain the required documentation needed. The applicant requested a continuance.

Motion: by Dr. Alvarez to approve request for continuance. Motion carried.

C. Pharmacy Permit Applications 1. Civic Center Pharmacy, File: 103

Applicant was present and sworn in. Applicant was not represented by counsel. Tenille Davis, Pharmacist in Charge was there on behalf of applicant. Motion: by Dr. Mikhael to approve the application. Motion carried.

2. American Outcomes Management, File: 108

Applicant was present and sworn in. Applicant was not represented by counsel. Michael Fadeyi, Pharmacist in Charge was there on behalf of applicant. Dr. Mikhael moved to deny the application based on non-compliance with 797 and incorrect answers on application questionnaire, however the applicant was given the option to withdraw the application. Mr. Fadeyi requested to withdraw the application. Motion: by Dr. Mikhael to approve request to withdraw. Motion carried.

3. DV Properties, Inc. File: 22740

Applicant was present and sworn in. Applicant was not represented by counsel. Motion: by Dr. Mesaros to approve the application. Motion carried.

4. Hybrid Pharma, File: 21375

Applicant was present and sworn in. Applicant was represented by counsel, Edwin Bayo. Mr. Bayo requested another inspection be done and for the Board chair to approve. Motion: by Dr. Mesaros to continue to the next meeting. The applicant waived the 90 day review. The applicant will be re-inspected by the department. If applicant passes inspection the Chair can approve the application and the applicant will not be required to appear at the next meeting. Motion carried.

D. Reconsideration Application 1. MedQuest, File: 189

Applicant was present and sworn in. Applicant was represented by counsel, Martin Dix. Motion: by Dr. Mikhael to reconsider and accept the application. Motion carried.

E. Pharmacy Intern Applications 1.Jocelyn Ariana Zuessman

Applicant was present and sworn in. Applicant was not represented by counsel. Dr. Martha Brown with PRN was there on applicant’s behalf. Motion: by Ms. Glass, to approve the application. Motion carried.

TAB 6: LICENSURE ISSUES

A. Petition for Termination of Probation

1. Mitchell Ginsburg, Case No. 2011-18659

Respondent was present and sworn in. Respondent was not represented by counsel. Motion: by Dr. Mikhael, to accept termination of probation. Motion carried.

2. Jerome Golden Center, Case No. 2011-08766

Respondent was present and sworn in. Respondent was not represented by counsel. Than Le , Prescription Department Manager for Respondent was present. Motion: by Mr. Meshad to accept termination of probation. Motion carried.

3. Brashear’s Vital Care, Case No. 2012-11041

Respondent was present and sworn in. Respondent was represented by counsel, Brian Kahan. Motion: by Dr. Fallon, to accept termination of probation based on final inspection. Motion carried.

4. Jeffrey Goldrich, Case No. 2011-03164 & 2011-03256

Respondent was present and sworn in. Respondent was represented by counsel, Edwin Bayo. Dr. Martha Brown with PRN was there on respondents behalf.

Motion: by Dr. Mikhael to accept termination of probation. Motion carried. Public comments: Dr. Mikhael stated rules for PDM need to be reviewed to determine if can require some minimum amount of time that PDMs must be in the pharmacy, because the Board is seeing disciplinary cases come through where the PDM has never spent any time in the pharmacy. He is concerned young people in the business do not understand the importance of PDM responsibilities, and that some people are “selling” their license to be listed as PDM without understanding what it can mean if the pharmacy is inspected and found lacking. Bob Parrado recapped a letter submitted by FPA Executive Director Michael Jackson, addressing issues pharmacists are having with changes made by HB 1049 (2014) and how the Board will enforce Section 465.1862(2)(a), Florida Statutes, regarding pharmacy benefit managers, who are not currently licensed by the Board. Executive Director Allison Dudley stated that the Board had been inundated with requests by people on the agenda to move their item for an early appearance before the Board, and that anyone who is notified that they must appear before the Board needs to plan for a full-day meeting. She said the Board will start stating that in the notification letter and bold the sentence. The board delegated to the Board Chair the authority to develop the annual regulatory plan with the Board’s counsel.

Motion: by Ms. Glass, for ADJOURMENT at 4:30 pm. Motion carried.

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