COMMONWEALTH OF PENNSYLVANIA...2018/11/27  · 3 Sargent's Court Reporting Service, Inc. (814)...

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Sargent's Court Reporting Service, Inc. (814) 536-8908 1 COMMONWEALTH OF PENNSYLVANIA 1 DEPARTMENT OF STATE 2 BUREAU OF PROFESSIONAL AND OCCUPATIONAL AFFAIRS 3 4 F I N A L M I N U T E S 5 6 MEETING OF: 7 8 STATE BOARD OF PHARMACY 9 10 TIME: 8:56 A.M. 11 12 PENNSYLVANIA DEPARTMENT OF STATE 13 Board Room B 14 One Penn Center 15 2601 North Third Street 16 Harrisburg, Pennsylvania 17110 17 18 19 November 27, 2018 20 21 22 23 24 25

Transcript of COMMONWEALTH OF PENNSYLVANIA...2018/11/27  · 3 Sargent's Court Reporting Service, Inc. (814)...

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COMMONWEALTH OF PENNSYLVANIA 1

DEPARTMENT OF STATE 2

BUREAU OF PROFESSIONAL AND OCCUPATIONAL AFFAIRS 3

4

F I N A L M I N U T E S 5

6

MEETING OF: 7

8

STATE BOARD OF PHARMACY 9

10

TIME: 8:56 A.M. 11

12

PENNSYLVANIA DEPARTMENT OF STATE 13

Board Room B 14

One Penn Center 15

2601 North Third Street 16

Harrisburg, Pennsylvania 17110 17

18

19

November 27, 2018 20

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State Board of Pharmacy 1 2

November 27, 2018 3 4

5 BOARD MEMBERS: 6 7 Janet Getzey Hart, R.Ph., Chairperson 8 Katelin Lambert, Deputy Commissioner, Bureau of 9 Professional and Occupational Affairs 10 Robert B. Frankil, R.Ph., Vice Chairman 11 Theresa M. Talbott, R.Ph., Secretary 12

Gayle A. Cotchen, Pharm.D./MBA, R.Ph. 13 Patrick M. Greene, Esquire, Office of Attorney 14 General 15 16 17 BUREAU PERSONNEL: 18 19 Kerry E. Maloney, Esquire, Board Counsel 20 Heather J. McCarthy, Esquire, Board Prosecution 21 Liaison 22 Keith E. Bashore, Esquire, Board Prosecutor 23 J. Karl Geschwindt, Esquire, Board Prosecutor 24 Alissa Harrison, Esquire, Board Prosecutor 25 Tara J. Smith, Esquire, Board Prosecutor 26

Melanie Zimmerman, R.Ph., Executive Secretary 27 28 29 30

ALSO PRESENT: 31 32 Patricia A. Epple, CEO, Pennsylvania Pharmacists 33 Association 34 Lisa Scannapieco, Director of Pharmacy Education and 35 Clinical Integration, Pentec Health 36 Barbara Knightly, Executive Vice President of 37 Pharmacy, Pentec Health 38 Rebecca S. Finley, Pharm.D., MA, FASHP, Dean, 39 Jefferson College of Pharmacy 40

James Reed, Area Healthcare Supervisor, Walgreens 41 Edward Foote, Pharm.D., FCCP, BCPS, Dean, Philadelphia 42 College of Pharmacy at the University of Sciences 43 Gregory Smith, Director of Pharmacy, Central Admixture 44 Pharmacy Services 45 Andrew C. Harvan, Esquire, Pennsylvania Medical 46 Society 47 John Sisto, Express Scripts, Incorporated 48 Erin R. Kawa, Esquire, Post & Schell, P.C. 49

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State Board of Pharmacy 1 2

November 27, 2018 3 4 5 ALSO PRESENT: (Continued) 6 7 Lawrence P. Carey, B.S. Pharm, Pharm.D., Pennsylvania 8 Society of Health-System Pharmacists/Temple School 9 of Pharmacy 10 Steve L. Sheaffer, Pharm.D., FASHP, Pennsylvania 11 Society of Health-System Pharmacists 12

Jenna L. McCarthy, Malady & Wooten 13 Christine Roussel, Pharm.D., BCOP, Pennsylvania 14 Society of Health-System Pharmacists, Doylestown 15 Hospital 16 Charles Hartwell, Esq. 17 18 19 20 21 22 23 24 25 26

27 28 29 30 31 32 33 34 35 36 37 38 39 40

41 42 43 44 45 46 47 48 49 50

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*** 1

State Board of Pharmacy 2

November 27, 2018 3

*** 4

The regularly scheduled meeting of the State 5

Board of Pharmacy was held on Tuesday, November 27, 6

2018. Janet Getzey Hart, R.Ph., Chairperson, called 7

the meeting to order at 8:56 a.m. Katelin Lambert, 8

Deputy Commissioner of Professional and Occupational 9

Affairs, was not present at the commencement of the 10

meeting. 11

The Pledge of Allegiance was recited. 12

*** 13

Introduction of Board Members, Board Staff, and 14

Audience 15

[Chairperson Hart requested the introduction of Board 16

members, Board staff, and audience members in 17

attendance. She also requested that all cell phones 18

and mobile devices be silenced. A quorum was noted to 19

be present.] 20

*** 21

Evacuation Announcement 22

[Melanie Zimmerman, R.Ph., Executive Secretary, 23

reviewed the emergency evacuation procedures for One 24

Penn Center.] 25

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*** 1

Amendments to the Agenda 2

MR. MALONEY: 3

I’m looking for a motion to amend the 4

agenda to include the following: Case 5

No. 18-54-01079, Robert M. Shutty, R.Ph., 6

a review of a final A&O; Case No. 18-54-7

004429, Blake Kelley Armstrong, Motion 8

for Entry of Final Order; and Case No. 9

18-54-007549, Lori Lynn Rings, a Motion 10

to Deem Facts Admitted. 11

Although the Board announced at its 12

last meeting in public session that we 13

would be doing a regulatory work session 14

today on compounding, I wanted formally 15

to put that on the agenda also. 16

MS. TALBOTT: 17

Madam Chair, I will make that motion as 18

requested by Counsel. 19

DR. COTCHEN: 20

Second. 21

CHAIRPERSON HART: 22

Any discussion? All in favor? 23

[The motion carried unanimously.] 24

*** 25

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Approval of Minutes of the August 28, 2018 meeting 1

CHAIRPERSON HART: 2

We need to approve the minutes from the 3

previous meeting. 4

MS. TALBOTT: 5

Madam Chair, I will make the motion to 6

approve the minutes, including where it 7

says Robert Brian Frankil. 8

DR. COTCHEN: 9

Second. 10

CHAIRPERSON HART: 11

Any discussion? All in favor, aye? Any 12

opposed? 13

[The motion carried unanimously.] 14

*** 15

Report of Prosecutorial Division 16

[Heather J. McCarthy, Esquire, Board Prosecution 17

Liaison, on behalf of Julia Feld-Caralle, Esquire, 18

Board Prosecutor, presented the Consent Agreements for 19

File No. 18-54-03901 and File No. 15-54-12860. 20

Patrick M. Greene, Esquire, recused himself from 21

the discussion on both consent agreements.] 22

*** 23

[Heather J. McCarthy, Esquire, Board Prosecution 24

Liaison, presented the Consent Agreement for File No. 25

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18-54-007710.] 1

*** 2

[Keith E. Bashore, Esquire, Board Prosecutor, 3

presented the Consent Agreement for File No. 17-54-4

013664.] 5

*** 6

[J. Karl Geschwindt, Esquire, Board Prosecutor, on 7

behalf of Ray Michalowski, Esquire, Board Prosecutor, 8

presented the Consent Agreement for File No. 18-54-9

006184.] 10

*** 11

[J. Karl Geschwindt, Esquire, Board Prosecutor, 12

presented the Consent Agreement for File No. 18-54-13

010769. 14

Terry Talbott and Chairperson Janet Getzey Hart 15

recused themselves from discussion on the matter.] 16

*** 17

[Tara J. Smith, Esquire, Board Prosecutor, on behalf 18

of Erin Fure, Esquire, Board Prosecutor, presented the 19

Consent Agreement for File No. 18-54-005967. 20

Patrick M. Greene, Esquire, recused himself from 21

the discussion on the matter.] 22

*** 23

[Tara J. Smith, Esquire, Board Prosecutor, presented 24

the Consent Agreement for File No. 18-54-02558.] 25

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*** 1

[Alissa Harrison, Esquire, Board Prosecutor, presented 2

the Consent Agreement for File No. 18-54-007777.] 3

*** 4

Report of Board Counsel 5

[Kerry E. Maloney, Esquire, Board Counsel, discussed 6

completing revisions to the compounding regulations, 7

as well as noting the naloxone exception. He reviewed 8

the naloxone exception where a prescription filled for 9

naloxone can now be left with someone other than the 10

identified patient coming out of prison. 11

Mr. Maloney noted that an exception was also made 12

for naloxone in the same circumstances for the 13

prospective drug review (PDR) requirement. The 14

exception passed as a final omitted because of the 15

opioid crisis as well as being an identified 16

initiative of the Governor in his emergency 17

declaration. 18

Mr. Maloney reported that the Independent 19

Regulatory Review Commission (IRRC) had concerns 20

regarding where the PDR exception was placed in the 21

draft. He informed IRRC of the General Revisions 22

still being considered by the Board, and IRRC voted 23

unanimously to approve the naloxone exception. 24

Mr. Maloney informed the Board that Mr. Mizner, 25

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Vice Chairman of IRRC, thanked the Board for its 1

forward thinking and not neglecting this part of the 2

population. Mr. Maloney also stated that these 3

changes all stemmed from Melanie Zimmerman’s comments 4

and input. He noted that the naloxone exception will 5

be published on December 1, 2018 in the Pennsylvania 6

Bulletin and become final. 7

Mr. Maloney requested the Board hold a General 8

Revisions and Immunization Regulation work session 9

after the next Board Meeting.] 10

*** 11

Change in the Intern Hours Requirement 12

[Chairperson Hart referred to the Change in the Intern 13

Hours Requirement and the letter of support from the 14

PA Pharmacy School Deans. She requested a discussion 15

from the deans who are present in the audience 16

regarding their letter and moving forward with this 17

initiative. 18

Edward Foote, Pharm.D., FCCP, BCPS, Dean of the 19

Philadelphia College of Pharmacy at the University of 20

the Sciences; and Rebecca S. Finley, Pharm.D., MS, 21

FASHP, Dean of the Jefferson College of Pharmacy, 22

Thomas Jefferson University, introduced themselves and 23

offered their support of the initiative. Dr. Foote 24

and Dr. Finley outlined their experiences and the 25

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circumstances that support the change in the intern 1

hours requirement, as well as answered questions from 2

the Board. Mr. Maloney requested a separate verbatim 3

transcript of the discussion be prepared. 4

Kerry E. Maloney, Esquire, Board Counsel, 5

requested a motion for a draft annex for the change to 6

the intern hours requirement which will be separate 7

from other regulation packages.] 8

MS. TALBOTT: 9

I would make a motion that we run this as 10

a separate package from the General 11

Revisions and do it expeditiously, and we 12

include the Board stakeholders, et 13

cetera. 14

DR. COTCHEN: 15

Second. 16

CHAIRPERSON HART: 17

I have a second. Anymore discussion? 18

Call for a vote. All in favor? Opposed? 19

[The motion carried unanimously.] 20

*** 21

Report of Board Counsel – Act 96 of 2018 22

[Kerry E. Maloney, Esquire, Board Counsel, had nothing 23

to add regarding Act 96 of 2018. 24

Chairperson Hart addressed e-Prescribing 25

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applications and confusion regarding the application 1

process, noting states require eCertification to be 2

sent every two years. She stated many of the e-3

Prescribing certifications by companies are 4

proprietary. 5

Mr. Maloney advised the Board there was no 6

requirement for it to take immediate action on any 7

regulations. He discussed making revisions to the 8

regulations to reflect how the Department of Health 9

chooses to handle the e-Prescribing applications. 10

Mr. Maloney and Ms. Heather McCarthy met with 11

Prescription Drug Monitoring Program (PDMP) staff at 12

the Department of Health who requested that a penalty 13

be added for pharmacies that do not report to the PDMP 14

under the Schedule of Civil Penalties under Act 48, 15

which is under the purview of the Commissioner. He 16

stated the penalty for each violation under Act 48 can 17

be up to $1,000 for each day not reported. 18

Mr. Maloney asked the Board for input regarding 19

whether to request the Commissioner to include failure 20

to provide zero reports on the Schedule of Civil 21

Penalties. 22

Ms. Talbott commented that the violation would be 23

only if controlled drugs were dispensed and not 24

reported. Mr. Maloney also commented that some 25

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pharmacies can get a waiver from submitting zero 1

reports. He noted that, after reviewing the Achieving 2

Better Care by Monitoring All Prescriptions Program 3

(ABC-MAP) Act, the Pharmacy Act, and Act 48, there may 4

not be a legal basis for a citation for zero reports. 5

Chairperson Hart noted the importance of giving 6

pharmacies a notice for not reporting, because it 7

could be due to failed transmissions, which should not 8

count as a violation. 9

Mr. Maloney explained that the PDMP system will 10

contact pharmacies with issues. He stated another 11

safeguard was that the Prosecution Division can use 12

some discretion in looking at those issues, and 13

ultimately, the pharmacy can appeal the citation. 14

Mr. Maloney informed PDMP that the Board would 15

consider the matter, and the Commissioner’s Office 16

would have to initiate the inclusion of such a 17

violation as one of the Act 48 Regulations. He also 18

noted that, under Act 48, the Commissioner would seek 19

approval of the Board. 20

Chairperson Hart noted instances where data was 21

actually sent, but there was not a valid match with 22

the patient and the PDMP. She discussed occurrences 23

with interoperability and with the National 24

Association of Boards of Pharmacy (NABP), where there 25

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are greater issues from state to state. 1

Mr. Maloney referred to the Michael Kenney case 2

where a Petition for Review was filed because the 3

respondent wanted out of the Disciplinary Monitoring 4

Unit (DMU) early, and the Board decided not to grant 5

the request. He noted that the terms of the DMU ended 6

in December anyway and that the respondent signed the 7

Consent Agreement knowing its content. A written 8

opinion is anticipated in another month or so, 9

probably after the DMU ends. 10

Mr. Maloney discussed the Lena Lasher case which 11

is in Federal Court, where the judge issued a deadline 12

for discovery to end in March 2019. Mr. Maloney is in 13

contact with the Deputy Attorney General, who is 14

representing the Board and the members who were named, 15

and does not expect another update until March or 16

April 2019. 17

Mr. Maloney noted his attendance at the American 18

Society for Pharmacy Law (ASPL) Conference. 19

Interesting sessions included pharmacists having a 20

corresponding responsibility with diversion. He noted 21

discussion regarding buprenorphine for opiate 22

addiction treatment, ethics in pharmacy, telepharmacy, 23

and substance abuse in the workplace. 24

Mr. Maloney commented that the telemedicine bill 25

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and pharmacy technician bill were not going anywhere 1

in this legislative session.] 2

*** 3

[Janet Getzey Hart, R.Ph., Chairperson, exited the 4

meeting at 9:45 a.m. and reentered the meeting at 5

9:47 a.m.] 6

*** 7

Report of Board Chairperson – Election of Officers and 8

Selection of Committee Members 9

CHAIRPERSON HART: 10

One of our things to do this particular 11

session is to elect a new Chairperson, 12

Vice Chair, and Secretary. 13

Do I have any motions? 14

MR. FRANKIL: 15

I nominate Terry Talbott for Chair. 16

MR. GREENE: 17

Second. 18

CHAIRPERSON HART: 19

Any discussion? All in favor? So noted. 20

So moved. 21

[The motion carried unanimously.] 22

*** 23

CHAIRPERSON HART: 24

Do I have any nominations for Vice Chair? 25

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MS. TALBOTT: 1

Madam Chair, I’ll nominate Robert Brian 2

Frankil to be the Vice Chair. 3

CHAIRPERSON HART: 4

I second. Any discussion? All in favor? 5

[The motion carried unanimously.] 6

*** 7

MS. TALBOTT: 8

I nominate Janet Hart to be Secretary. 9

CHAIRPERSON HART: 10

Do I have a second? 11

MR. GREENE: 12

Second. 13

CHAIRPERSON HART: 14

Any discussion? All in favor? Opposed? 15

[The motion carried unanimously.] 16

*** 17

[Mr. Maloney will inquire as to the re-nomination of 18

Mark Zilner and nomination of the public members. 19

The Board discussed committee assignments and 20

the following changes were noted: Terry Talbott will 21

serve as the ADA Committee with Janet Getzey Hart 22

serving as the alternate and Gayle Cotchen will serve 23

as the chair of the Pharmacy Application Review 24

Committee with Janet Getzey Hart replacing Mark Zilner 25

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as a member of this committee. The Probable Cause 1

Screening Committee and the CPR/Injectable Training 2

Approval Committee will remain the same except for the 3

Board Member whose term has expired.] 4

*** 5

CHAIRPERSON HART: 6

Do we have a motion for all of that? 7

MS. TALBOTT: 8

Yes. 9

DR. COTCHEN: 10

Second. 11

CHAIRPERSON HART: 12

Any discussion? All in favor? Opposed. 13

[The motion carried unanimously.] 14

*** 15

Report of Probable Cause Screening Committee 16

[Patrick M. Greene, Esquire, Office of Attorney 17

General, noted the Probable Cause Screening Committee 18

signed orders for mental and physical examinations and 19

for an immediate temporary suspension.] 20

*** 21

Report of Commissioner - No Report 22

*** 23

Report of Executive Secretary 24

[Melanie Zimmerman, R.Ph., Executive Secretary, 25

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informed the Board that newsletter articles must be 1

provided soon if the Board desires to publish a 2

newsletter in January. 3

Dr. Cotchen questioned whether PDMP should be 4

addressed regarding fines and compliance. 5

Mr. Maloney noted that he is hesitant to draft an 6

article concerning PDMP since it is a Department of 7

Health program rather than a Board of Pharmacy 8

program. If the PDMP would be willing to provide an 9

article, it could be published. 10

Mr. Frankil suggested an update on the status of 11

regulations which could be prepared by Board Counsel 12

Maloney. 13

Steve Sheaffer, Pharm.D., Pennsylvania Society of 14

Health-System Pharmacists, noted that the Department 15

of Health developed a Memorandum of Understanding 16

(MOU) for community pharmacy access to a pandemic flu 17

vaccine. He stated the Pennsylvania Pharmacists 18

Association (PPA) facilitated this opportunity and 19

that he and Pat were working with the Department of 20

Health to obtain updates for submission. 21

Mr. Maloney mentioned the recent CVS waiver that 22

the Board granted in part and denied in part regarding 23

prescription labels which could be distributed after 24

an internal review is completed. Information could be 25

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included on the naloxone exception and the intern 1

hours requirements waiver. 2

Ms. Talbott suggested a statement regarding the 3

number of licensed pharmacists, pharmacies, 4

nonresidents, and the percentage that renewed on time 5

in Pennsylvania. 6

Chairperson Hart suggested an article from the 7

Department of Health concerning medical marijuana. 8

This prompted a discussion where it was determined 9

that Janet Getzey Hart will continue to serve as the 10

Board’s designee on the Medical Marijuana Advisory 11

Board.] 12

*** 13

New Business 14

[Kerry E. Maloney, Esquire, Board Counsel, addressed 15

the Food and Drug Administration’s (FDA’s) Draft 16

Memorandum of Understanding. Mr. Maloney noted 17

Pennsylvania-specific issues, including the 18

requirement of the Prosecutorial Division to report to 19

the FDA the notice of a complaint against a pharmacy 20

within three days. 21

Mr. Maloney also noted an issue on the legal side 22

related to Act 25 that deals with confidentiality of 23

investigative files. He explained that the agency is 24

not permitted to provide investigative files to any 25

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entity other than law enforcement, specifically noting 1

that the Food and Drug Administration was not law 2

enforcement. He noted two letters on the agenda 3

regarding this issue and invited discussion. 4

Barbara Knightly, Executive Vice President of 5

Pharmacy, Pentec Health, explained this was a draft 6

guidance from the FDA asking for comments. She 7

encouraged the Board of Pharmacy to have their legal 8

concerns on file by December 10, 2018. She noted a 9

meeting between NABP and the FDA, where approximately 10

45 states would agree to sign it. 11

Ms. Knightly stated the FDA was working closely 12

with NABP to understand the difference between the 13

traditional compounder 503A as opposed to the 503B. 14

For those acting like a manufacturer, they are trying 15

to make it easier and trying to ask for states to 16

identify those pharmacies that are dispensing more 17

than 50 percent so that the FDA could put them on a 18

risk base section schedule with regard to sterile 19

compounding. 20

Mr. Maloney commented that the Department of 21

Health handles 503B, and the Board does not track the 22

dispensing or distinguish between a retail pharmacy 23

and a compounding pharmacy. He also stated, even with 24

503A, the system and statute does not allow the Board 25

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to distinguish or track the dispensing. 1

Dr. Cotchen commented that the Board of Pharmacy 2

has been very active in attending the FDA meetings. 3

She stated Pennsylvania has been very well represented 4

concerning MOU and believes that the Governor and 5

Commissioner do not want any businesses leaving 6

because the MOU has not been signed. 7

John Sisto, Express Scripts, Incorporated, 8

commented that the FDA clarified at a recent meeting 9

that they are going to interpret it as 50 percent of 10

the compounding scripts, not the total scripts. 11

Mr. Maloney will present recommendations to the 12

Commissioner on this matter since an MOU would be 13

signed by the Commissioner or at a higher level.] 14

*** 15

[Chairperson Hart stated the Board will pass on 16

nominations for National Association of Boards of 17

Pharmacy Awards. 18

*** 19

[Chairperson Hart noted correspondence from Sharon 20

Abraczinskas concerning the scope of practice of 21

pharmacists. Board Members commented that Ms. 22

Abraczinskas needed to be more assertive and suggested 23

responding to Ms. Abraczinskas as a Board, reminding 24

her that it is not within the Board’s purview to pass 25

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legislation allowing individuals to administer flu 1

shots. It was also noted that pharmacists have the 2

ability to refuse a request based on having a valid 3

reason and professional discretion. 4

Mr. Maloney offered to write a response letter 5

conveying references to the regulations and statutes 6

to address Ms. Abraczinskas’ concerns given that the 7

Board cannot provide advisory opinions or interpret 8

the Pharmacy Act or the Board Regulations.] 9

*** 10

[Pursuant to Section 708(a)(5) of the Sunshine Act, at 11

10:15 a.m., the Board entered into Executive Session 12

with Kerry E. Maloney, Esquire, Board Counsel, to 13

receive legal advice and to engage in quasi-judicial 14

deliberations. The Board returned to open session at 15

11:15 a.m.] 16

*** 17

[Katelin Lambert, Deputy Commissioner of Professional 18

and Occupational Affairs, entered the meeting at 19

11:06 a.m., during Executive Session] 20

*** 21

MOTIONS 22

CHAIRPERSON HART: 23

The Board of Pharmacy met in Executive 24

Session to discuss and review consent 25

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orders and other legal documents. Are 1

there any motions regarding these 2

discussions? 3

DR. COTCHEN: 4

Madam Chairperson, I move that we approve 5

the Consent Agreement for File No. 18-54-6

03901. 7

MS. TALBOTT: 8

Second. 9

CHAIRPERSON HART: 10

Call for discussion. Call for a vote. 11

12

Frankil, aye; Greene, recuse; Hart, aye; 13

Cotchen, aye; and Talbott, aye. 14

[The motion carried. Patrick Greene recused himself 15

from deliberations and voting on the motion. 16

The pharmacist’s name is Mary Uhl Huminski, 17

R.Ph.] 18

*** 19

DR. COTCHEN: 20

I move that we approve the Consent 21

Agreement for File No. 18-54-010769. 22

MR. FRANKIL: 23

Second. 24

CHAIRPERSON HART: 25

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Any discussion? Call for a vote. 1

2

Frankil, aye; Greene, aye; Hart, recuse; 3

Cotchen, aye; Talbott, recuse; and 4

Lambert, aye. 5

[The motion carried. Janet Getzey Hart and Terry 6

Talbott recused themselves from deliberations and 7

voting on the motion. 8

The pharmacist’s name is Ha Thi Huynh, R.Ph.] 9

*** 10

DR. COTCHEN: 11

I move that we table the request 12

submitted by Magdy Hassan pending more 13

information about her request for reduced 14

intern hours. 15

MR. FRANKIL: 16

Second. 17

CHAIRPERSON HART: 18

Call for discussion. Call for a vote. 19

20

Frankil, aye; Greene, aye; Lambert, aye; 21

Hart, recuse; Cotchen, aye; and Talbott, 22

recuse. 23

[The motion carried. Janet Getzey Hart and Terry 24

Talbott recused themselves from deliberations and 25

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voting on the motion.] 1

*** 2

[Katelin Lambert, Deputy Commissioner of Professional 3

and Occupational Affairs, exited the meeting at 11:17 4

a.m.] 5

*** 6

DR. COTCHEN: 7

I move that we approve the Consent 8

Agreement for File No. 15-54-12860. 9

MS. TALBOTT: 10

Second. 11

CHAIRPERSON HART: 12

Call for discussion. Call for a vote. 13

14

Frankil, aye; Greene, recuse; Hart, aye; 15

Cotchen, aye; and Talbott, aye. 16

[The motion carried. Patrick Greene recused himself 17

from deliberations and voting on the motion. 18

The pharmacist’s name is Maryann P. Shawaluk, 19

R.Ph.] 20

*** 21

DR. COTCHEN: 22

I move that we approve the Consent 23

Agreement for File No. 17-54-013664. 24

MS. TALBOTT: 25

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Second. 1

CHAIRPERSON HART: 2

Any discussion? Call for a vote. 3

4

Frankil, aye; Greene, aye; Hart, aye; 5

Cotchen, aye; and Talbott, aye. 6

[The motion carried unanimously. The pharmacy’s name 7

is Wells Pharmacy Network, LLC.] 8

*** 9

DR. COTCHEN: 10

I move that we approve the Consent 11

Agreement for File No. 18-54-006184. 12

MS. TALBOTT: 13

Second. 14

CHAIRPERSON HART: 15

Any discussion? Call for a vote. 16

17

Frankil, aye; Greene, aye; Hart, aye; 18

Cotchen, aye; and Talbott, aye. 19

[The motion carried unanimously. The pharmacist’s 20

name is Edward W. Sweeney, R.Ph.] 21

*** 22

DR. COTCHEN: 23

I move that we approve the Consent 24

Agreement for File No. 18-54-005967. 25

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MS. TALBOTT: 1

Second. 2

CHAIRPERSON HART: 3

Any discussion? Call for a vote. 4

5

Frankil, aye; Greene, recuse; Hart, aye; 6

Cotchen, aye; and Talbott, aye. 7

[The motion carried. Patrick Greene recused himself 8

from deliberations and voting on the motion. 9

The pharmacist’s name is Christopher Lee Nowak, 10

R.Ph.] 11

*** 12

DR. COTCHEN: 13

I move that we approve the Consent 14

Agreement for File No. 18-54-007777. 15

MS. TALBOTT: 16

Second. 17

CHAIRPERSON HART: 18

Any discussion? Call for a vote. 19

20

Frankil, aye; Greene, aye; Hart, aye; 21

Cotchen, aye; and Talbott, aye. 22

[The motion carried unanimously. The pharmacist’s 23

name is Donald Alfred Hannon, R.Ph.] 24

*** 25

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DR. COTCHEN: 1

I move that we approve the Consent 2

Agreement for File No. 18-54-007710. 3

MS. TALBOTT: 4

Second. 5

CHAIRPERSON HART: 6

Any discussion? Call for a vote. 7

8

Frankil, aye; Greene, aye; Hart, aye; 9

Cotchen, aye; and Talbott, aye. 10

[The motion carried unanimously.] 11

*** 12

DR. COTCHEN: 13

I move that we approve the Consent 14

Agreement for File No. 18-54-02558. 15

MS. TALBOTT: 16

Second. 17

CHAIRPERSON HART: 18

Any discussion? Call for a vote. 19

20

Frankil, aye; Greene, aye; Hart, aye; 21

Cotchen, aye; and Talbott, aye. 22

[The motion carried unanimously. The pharmacist’s 23

name is Gennady Krupnikas, R.Ph.] 24

*** 25

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DR. COTCHEN: 1

I move that we approve the final 2

Adjudication and Order for Peter M. 3

Campanella, File No. 17-54-00398. 4

MS. TALBOTT: 5

Second. 6

CHAIRPERSON HART: 7

Any discussion? Call for a vote. 8

9

Frankil, aye; Greene, aye; Hart, aye; 10

Cotchen, aye; and Talbott, aye. 11

[The motion carried unanimously.] 12

*** 13

DR. COTCHEN: 14

I move that we approve the final 15

Adjudication and Order for Harold 16

Gillung, R.Ph., File No. 18-54-001780. 17

MR. FRANKIL: 18

Second. 19

CHAIRPERSON HART: 20

Any discussion? Call for a vote. 21

22

Frankil, aye; Greene, aye; Hart, aye; 23

Cotchen, aye; and Talbott, recuse. 24

[The motion carried. Terry Talbott recused herself 25

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from deliberations and voting on the motion.] 1

*** 2

DR. COTCHEN: 3

I move that we adopt the proposed 4

Adjudication and Order for Stacey Orr 5

d/b/a Mod Apothecary, File No. 15-54-6

08420. 7

MS. TALBOTT: 8

Second. 9

CHAIRPERSON HART: 10

Any discussion? Call for a vote. 11

12

Frankil, aye; Greene, aye; Hart, aye; 13

Cotchen, aye; and Talbott, aye. 14

[The motion carried unanimously.] 15

*** 16

DR. COTCHEN: 17

I move that we adopt the proposed 18

Adjudication and Order for Drug Depot, 19

Inc., d/b/a APS Pharmacy, File No. 18-54-20

03878. 21

MS. TALBOTT: 22

Second. 23

CHAIRPERSON HART: 24

Any discussion? Call for a vote. 25

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1

Frankil, aye; Greene, aye; Hart, aye; 2

Cotchen, aye; and Talbott, aye. 3

[The motion carried unanimously.] 4

*** 5

DR. COTCHEN: 6

I move that we adopt the proposed 7

Adjudication and Order for PharmScript, 8

LLC, File No. 18-54-006932. 9

MS. TALBOTT: 10

Second. 11

CHAIRPERSON HART: 12

Any discussion? Call for a vote. 13

14

Frankil, aye; Greene, aye; Hart, aye; 15

Cotchen, aye; and Talbott, nay. 16

[The motion carried. Terry Talbott opposed the 17

motion.] 18

*** 19

DR. COTCHEN: 20

I move that we approve the Pharmacist 21

Application Review submitted by Thomas 22

Andrew Fortier. 23

MS. TALBOTT: 24

Second. 25

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CHAIRPERSON HART: 1

Any discussion? Call for a vote. 2

3

Frankil, aye; Greene, aye; Hart, aye; 4

Cotchen, aye; and Talbott, aye. 5

[The motion carried unanimously.] 6

*** 7

DR. COTCHEN: 8

I move that we table the Intern Hours 9

Evaluation Request from Ravindra Malavia 10

pending receipt of more information. 11

MS. TALBOTT: 12

Second. 13

CHAIRPERSON HART: 14

Any discussion? Call for a vote. 15

16

Frankil, aye; Greene, aye; Hart, aye; 17

Cotchen, aye; and Talbott, aye. 18

[The motion carried unanimously.] 19

*** 20

DR. COTCHEN: 21

I move that we approve the Motion to Deem 22

Facts Admitted and direct Board Counsel 23

to draft an Adjudication and Order with 24

terms consistent with those discussed 25

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during Executive Session for Lori Lynn 1

Rings, File No. 18-54-007549. 2

MS. TALBOTT: 3

Second. 4

CHAIRPERSON HART: 5

Any discussion? Call for a vote. 6

7

Frankil, aye; Greene, aye; Hart, aye; 8

Cotchen, aye; and Talbott, aye. 9

[The motion carried unanimously.] 10

*** 11

DR. COTCHEN: 12

I move that we grant the Motion for Entry 13

of Final Order for Blake Kelley 14

Armstrong, File No. 18-54-004429. 15

MS. TALBOTT: 16

Second. 17

CHAIRPERSON HART: 18

Any discussion? Call for a vote. 19

20

Frankil, aye; Greene, recuse; Hart, aye; 21

Cotchen, aye; and Talbott, aye. 22

[The motion carried. Patrick Greene recused himself 23

from deliberations and voting on the motion.] 24

*** 25

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DR. COTCHEN: 1

I move that we approve the Adjudication 2

and Order for Robert M. Shutty, Case No. 3

18-54-01079, subject to approval of 4

Counsel Division. 5

MS. TALBOTT: 6

Second. 7

CHAIRPERSON HART: 8

Any discussion? Call for a vote. 9

10

Frankil, aye; Greene, aye; Hart, aye; 11

Cotchen, aye; and Talbott, aye. 12

[The motion carried unanimously.] 13

*** 14

MS. TALBOTT: 15

I motion that we submit a nominee for the 16

John F. Atkinson Service Award to NABP 17

and that the nominee be Mr. Maloney. 18

DR. COTCHEN: 19

Second. 20

CHAIRPERSON HART: 21

All in favor? Opposed? 22

[The motion carried unanimously.] 23

*** 24

Adjournment 25

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MS. TALBOTT: 1

Motion to adjourn. 2

MR. FRANKIL: 3

Second. 4

CHAIRPERSON HART: 5

All in favor? 6

[The motion carried unanimously.] 7

*** 8

[There being no further business, the State Board of 9

Pharmacy Meeting adjourned at 11:25 a.m. A regulation 10

work session was held after the Board Meeting.] 11

*** 12

13

14

15

16

17

18

19

20

21

22

23

24

25

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CERTIFICATE 1

2

I hereby certify that the foregoing summary 3

minutes of the State Board of Pharmacy meeting, was 4

reduced to writing by me or under my supervision, and 5

that the minutes accurately summarize the substance of 6

the State Board of Pharmacy meeting. 7

8

9

10

Adam Beck, 11

Minute Clerk 12

Sargent’s Court Reporting 13

Service, Inc. 14

15

16

17

18

19

20

21

22

23

24

25

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STATE BOARD OF PHARMACY 1 REFERENCE INDEX 2

3 November 27, 2018 4

5 6 TIME AGENDA 7 8 8:56 Official Call to Order 9 10 8:56 Pledge of Allegiance 11 12

8:57 Introduction of Board Members, Board 13 Staff, and Audience Members and 14 Evacuation Announcement 15

16 8:58 Amendment to the Agenda 17 18 9:00 Approval of Minutes 19 20 9:00 Report of Prosecutorial Division 21 22 9:09 Report of Board Counsel 23 24 9:13 Discussion - Change in the Intern Hours 25

Requirement 26

27 9:49 Report of Board Chairperson 28 29 9:52 Report of Committees 30 31 9:52 Report of Executive Secretary 32 33 10:00 New Business 34 35 10:15 Executive Session 36 11:15 Return to Open Session 37 38 11:15 Motions 39 40

11:25 Adjournment 41 42 43 44 45 46 47 48 49 50