COMMONWEALTH OF PENNSYLVANIA...19 Mr. Michalowski will speak with the Bureau of 20 Enforcement and...

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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: 9:00 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

October 22, 2019 20

21

22

23

24

25


2

State Board of Pharmacy 1 October 22, 2019 2

3 BOARD MEMBERS: 4 5 Terry M. Talbott, R.Ph., Chairperson 6 K. Kalonji Johnson, Acting Commissioner, Bureau of 7 Professional and Occupational Affairs 8 Robert B. Frankil, R.Ph., Vice Chairman 9 Janet Getzey Hart, R.Ph., Secretary - Absent 10 Gayle A. Cotchen, Pharm.D./MBA, R.Ph. 11 Patrick M. Greene, Esquire, Office of Attorney 12

General 13 14

15 BUREAU PERSONNEL: 16 17 Juan A. Ruiz, Esquire, Board Counsel 18 Jaime Black, Esquire, BPOA Board Counsel 19 Ray Michalowski, Esquire, Prosecution Liaison 20 Angela B. Lucci, Esquire, Board Prosecutor 21 Caroline A. Bailey, Esquire, Board Prosecutor 22 Melanie Zimmerman, R.Ph., Executive Secretary 23 Anthony Fanucci, Pharm.D., Legal Intern, Office of 24 Attorney General 25 26

27 ALSO PRESENT: 28 29 Andrew LaFratte, MPA, Department of State Policy 30 Office 31 Christine Roussel, Pharm.D., BCOP, Pennsylvania 32 Society of Health-System Pharmacists, Doylestown 33 Hospital 34 Larry Jones, Executive Director, Pennsylvania 35 Society of Health-System Pharmacists 36 Patricia A. Epple, CAE, Pennsylvania Pharmacists 37 Association 38 Lisa Scannapieco, Director of Pharmacy Education and 39 Clinical Integration, Pentec Health 40

Barbara Knightly, Executive Vice President of 41 Pharmacy, Pentec Health & International Academy of 42 Compounding Pharmacists 43 Jenna L. McCarthy, Malady & Wooten 44 Robert Grobinski, Cardinal Health 45 Lauren Paul, CVS Health 46 Frank Trollo, Central Admixture Pharmacy Services 47 Heather Coy, AllianceRx Walgreens Prime 48 Teresa Moore, Secundum Artem Reaching Pharmacists with 49 Help Nurse Peer Assistance Program 50


3

State Board of Pharmacy 1 October 22, 2019 2

3 4 ALSO PRESENT: (Continued) 5 6 Kerry E. Maloney, Esquire, Post & Schell 7 Jim Reed, Area Healthcare Supervisor, Walgreens 8 Ursula Chizhik, Vice President of Quality & Regulatory 9 Affairs at FLAVORx 10 Sara Simon, Investigative Data Reporter, Spotlight PA 11 Andrew C. Harvan, Esquire, Pennsylvania Medical 12

Society 13 14 15 16 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


4

*** 1

State Board of Pharmacy 2

October 22, 2019 3

*** 4

The regularly scheduled meeting of the State 5

Board of Pharmacy was held on Tuesday, October 22, 6

2019. Terry M. Talbott, R.Ph., Chairperson, called 7

the meeting to order at 9 a.m. K. Kalonji Johnson, 8

Acting Commissioner, Bureau of Professional and 9

Occupational Affairs, was not present at the 10

commencement of the meeting. 11

The Pledge of Allegiance was recited. 12

*** 13

Evacuation Announcement 14

[Melanie Zimmerman, R.Ph., Executive Secretary, 15

reviewed the emergency evacuation procedures for One 16

Penn Center.] 17

*** 18

[Chairperson Talbott requested the introduction of 19

Board members, Board staff, and audience members.] 20

*** 21

[Chairperson Talbott requested that all electronic 22

devices be turned off or silenced.] 23

*** 24

Approval of Agenda 25


5

CHAIRPERSON TALBOTT: 1

I will entertain a motion to approve the 2

agenda for today. Are there any 3

additions? 4

Motion to approve the agenda. 5

DR. COTCHEN: 6

So moved. 7


Second? 9

MR. FRANKIL: 10

Second. 11


All in favor? Any opposed? 13

[The motion carried unanimously.] 14

*** 15

Approval of minutes of the August 27, 2019 meeting 16


Motion to approve the minutes from August 18

27? 19

DR. COTCHEN: 20

So moved. 21


Second? 23

MR. FRANKIL: 24

Second. 25


6


Any discussion? All in favor? Any 2

opposed? 3


*** 5

[Patrick M. Greene, Esquire, Office of Attorney 6

General, exited the meeting at 9:04 a.m. for recusal 7

purposes.] 8

*** 9

Report of Prosecutorial Division 10

[Caroline A. Bailey, Esquire, Board Prosecutor, 11

presented the Consent Agreement for File No. 19-54-12

003453.] 13

*** 14


General, reentered the meeting at 9:06 a.m.] 16

*** 17

[Terry M. Talbott, R.Ph., Chairperson, exited the 18

meeting at 9:06 a.m. for recusal purposes.] 19

*** 20

[Caroline A. Bailey, Esquire, Board Prosecutor, 21

presented the Consent Agreements for File Nos. 19-54-22

003233 & 19-54-009972 and File No. 19-54-009499.] 23

*** 24

[Terry M. Talbott, R.Ph., Chairperson, reentered the 25


7

meeting 9:09 a.m.] 1

*** 2

[Angela B. Lucci, Esquire, Board Prosecutor, presented 3

the Consent Agreement for File No. 18-54-012188.] 4

*** 5

[Ray Michalowski, Esquire, Prosecution Liaison, 6

presented the VRP Consent Agreements for File No. 19-7

54-009933, File No. 19-54-009625, File No. 19-54-8

010375, and File No. 19-54-010959. 9

Mr. Michalowski referred to Act 96 of 2018 10

regarding the Controlled Substance, Drug, Device, and 11

Cosmetic Act and the new e-prescribing law soon going 12

into effect. He mentioned receiving calls from staff 13

at the Drug Enforcement Administration (DEA) wondering 14

why the act does not require pharmacists to check on 15

the exceptions or exemptions. He explained to the DEA 16

that most pharmacists probably will, and it is just 17

the way the act was written. 18

Mr. Michalowski informed the Board that the 19

Department of Health has a 14-page FAQ on their main 20

website. The Department of Health is the enforcement 21

authority. He mentioned guidelines on that website 22

which refer back to the statute until the new 23

regulations are promulgated. He noted electronic 24

prescribing systems are tied into electronic medical 25


8

records (EMRs) and electronic health record (EHR) 1

systems. He discussed the ability of prescribers to 2

obtain an exemption for one year. 3

Chairperson Talbott explained that pharmacists do 4

not know who is exempt from Act 96 of 2018 and 5

prescriptions will be assumed to be valid when 6

written. She stated physicians have proof through the 7

Department of Health of an exemption. 8

Chairperson Talbott suggested placing a link on 9

the Board's website to the Department of Health’s 10

FAQs. 11

Patricia A. Epple, CEO, Pennsylvania Pharmacists 12

Association, commented that the Prescription Drug 13

Monitoring Program (PDMP) was going to send out a 14

letter clarifying the pharmacists' obligations. 15

Chairperson Talbott addressed other states that 16

have gone to mandated electronic prescribing. She 17

stated it has not become an audit issue, because the 18

burden is on the doctor, not the pharmacist. She 19

noted that across the country roughly 68 percent of 20

physicians are already electronically prescribing and 21

Medicare is requiring controlled substances to be 22

electronically prescribed by January 1, 2021. 23

Chairperson Talbott emphasized the importance of 24

making pharmacists aware to fill prescriptions that 25


9

are not electronic as long as they believe the 1

prescription is otherwise valid. 2

Mr. Frankil mentioned the importance of the 3

Department of Health notifying other practitioners 4

about Act 96 of 2018 and not just notifying the 5

medical societies. He recommended doctors and 6

prescribers noting exemptions from e-prescribing on 7

the prescription, which would avoid phone calls from 8

pharmacists. 9

Mr. Michalowski stated Mr. Ruiz can share the 10

information with counsels on other boards to confirm 11

their awareness, even though it tends to be more of an 12

association-related issue to provide information to 13

members. 14

Chairperson Talbott noted the importance of 15

educating inspectors and suggested providing 16

inspectors with the actual link to the Department of 17

Health’s FAQs. 18

Mr. Michalowski will speak with the Bureau of 19

Enforcement and Investigation (BEI) about this issue 20

but does not think the inspectors will be a problem 21

because it is not really an auditable issue for 22

pharmacies. He also questioned PDMP to see whether it 23

will become a reportable item, noting that they also 24

did not think it was going to become a reportable 25


10

item; they are just trying to complete the 1

regulations. 2

Mr. Frankil discussed insurance company audits 3

and pharmacy benefit manager (PBM) business, where he 4

sees PBM’s auditing this matter. 5

Mr. Michalowski will share the information with 6

inspectors and investigators. He anticipates more 7

consumer complaints early on from pharmacists who may 8

refuse to fill written prescriptions and then 9

complaints from audit areas two years down the road 10

when 80-90 percent of medications are prescribed 11

electronically. He also does not anticipate hospitals 12

or institutional pharmacies having a problem with this 13

because they will have quick access to their own 14

doctors without getting something from 300 miles away. 15

Chairperson Talbott addressed a newsletter 16

article to be published in January 2020. Mr. Frankil 17

will write an article on filling controlled substance 18

prescriptions and showing compassion. It will include 19

the fact that it is not the pharmacist’s 20

responsibility to check on whether a prescriber has an 21

exemption to the electronic prescribing requirements. 22

23

Chairperson Talbott questioned whether anything 24

was new concerning medical marijuana. Mr. Michalowski 25


11

noted an increase in the number patients, 1

prescriptions, and products since anxiety was added as 2

one of the eligible conditions. 3

Christine Roussel, Pharm.D., BCOP, Pennsylvania 4

Society of Health-System Pharmacists, informed the 5

Board that a group of pharmacists are going to the 6

Medical Marijuana Advisory Board Meeting next month to 7

support recommendations for safe labeling of cannabis. 8

She noted that current labeling is not patient-9

friendly and there are safety issues that could be 10

addressed with improved labeling.] 11

*** 12

Report of Board Counsel 13

[Juan A. Ruiz, Esquire, Board Counsel, noted four 14

proposed Adjudications and Orders for discussion 15

during Executive Session. He also noted a 16

reinstatement hearing scheduled for 10:00 a.m.] 17

*** 18

Report of Board Chairperson 19

[Terry M. Talbott, R.Ph., Chairperson, addressed her 20

attendance at the NABP/AACP District 1 & 2 Meeting in 21

Burlington, Vermont. She mentioned that Nicole 22

Chopski, Executive Director of the Idaho Board of 23

Pharmacy, discussed innovative transitions to patient 24

care where pharmacists can basically delegate anything 25


12

to anybody who has the ability to perform the work 1

safely; this has been working well in Idaho and moving 2

slowly into other states. 3

Chairperson Talbott noted discussion regarding 4

compounding and flavoring and the delay of the 5

revised United States Pharmacopeia (USP) 795 and 797. 6

She mentioned a discussion concerning whether or not 7

flavoring was compounding. She stated a 8

representative from USP who was present at the meeting 9

indicated that flavoring has always been listed in one 10

of the chapters, but with the revision to the USP 11

chapters, flavoring as a compounding activity is more 12

evident. 13

Chairperson Talbott noted the next NABP Annual 14

Meeting is in Baltimore in May 2020. 15

Chairperson Talbott noted Ms. Hart is currently 16

attending the National Association of State Controlled 17

Substances Authorities Conference.] 18

*** 19

Report of Probable Cause Screening Committee 20


General, signed orders on a Petition for Immediate 22

Suspension and Physical and Mental Examination.] 23

*** 24

Report of Executive Secretary 25


13


mentioned the need for sufficient articles in order 2

for the Bureau to publish the newsletter in January 3

2020. She noted Mr. Frankil’s article on the filling 4

of controlled substance prescriptions and showing 5

compassion to patients and Mr. Michalowski’s article 6

on the Department of Health’s new e-prescribing 7

requirements. The newsletter article deadline is 8

November 15, 2019. 9

Chairperson Talbott suggested an article 10

concerning postponement of USP 795 and 797. 11

Mr. Ruiz suggested also writing an article 12

regarding the Boards’ stance on enforcing 800 or 13

delaying it as other states have. 14

No decision was made on who might write the 15

articles. 16

Ms. Zimmerman noted applications for discussion 17

during executive session.] 18

*** 19

New Business 20

[Melanie Zimmerman, R.Ph., Executive Secretary, noted 21

the request from Main Line Health who is seeking Board 22

approval of a continuing medical education (CME) 23

program entitled “Physician Wellness: Putting an End 24

to Burnout.”] 25


14

*** 1


Anybody want to make a motion to approve 3

it? 4

MR. FRANKIL: 5

I will make the motion to approve this 6

CME. 7


Do we want to approve it? 9

MR. RUIZ: 10

It seems it is a program they offer for 11

doctors for CME credit. Pharmacists 12

there were wondering if they could 13

utilize this as well because the issue is 14

burnout and wondered if they could get 15

pharmacy CE credit for it. Since it is 16

not Accreditation Council for Pharmacy 17

Education (ACPE) approved, it has to come 18

to the Board for approval. 19

MS. ZIMMERMAN: 20

The one thing is if you are going to 21

recognize their accrediting agency as 22

being equivalent to ACPE. Maybe the 23

Board needs to start thinking about 24

developing a formal process associated 25


15

with CEs for this type of thing. Other 1

Boards, what they do is there is an 2

application, there is an associated fee 3

because they are a fee-for-service agency 4

and then each continuing education has 5

its own license record, an expiration 6

date, and that kind of thing. If this is 7

something the Board would like to 8

consider as being equivalent to ACPE 9

standards and approve the program, we 10

need to start thinking about a more 11

formal process. 12

MR. RUIZ: 13

At this time, I think you can just do it 14

on a case-by-case basis. I think Melanie 15

is right. If you start getting more of 16

these, you are going to have to start 17

looking at it from a different 18

perspective. 19

Right now, what is in front of you is 20

a single request from Main Line Health. 21


My concern is we have been hesitant to do 23

things like this in the past because it 24

opens the floodgates and we do have to 25


16

have another formal process, which means 1

Melanie will send it all to us and we 2

will have to have another committee to 3

look at it all, which is not a big deal. 4

I know there is an awful lot out there. 5

My gut was no. We have ACPE and I know 6

we have the waiver, but they can still 7

go. They just do not get the CE. 8

DR. COTCHEN: 9

The ones we have seen in the past that we 10

have approved have submitted significant 11

documentation to show the equivalence to 12

ACPE accreditation. Just to have this 13

request come in and approve it, I do not 14

know that it is equivalent. I am sure it 15

is a good program. I do not mean to diss 16

the program. We have programs at the 17

institution. I do not know that the 18

Board would be able to handle individual 19

ones with the amount of documentation we 20

would need to see to see that it has ACPE 21

equivalence. 22


Does anyone want to make a motion that we 24

approve this program? 25


17

Hearing none. We will move on. 1

[The motion failed.] 2

*** 3

New Business (Continued) 4


questioned whether the Board had any nominations for 6

the National Association of Boards of Pharmacy’s 7

annual awards. The Board had none. 8

Ms. Zimmerman noted receiving questions in the 9

Board office about USP and the new compounding 10

standards related to flavoring as well as questions on 11

waivers of the new USP 800 chapter. 12

Chairperson Talbott questioned what would happen, 13

if the Board decided to exempt flavoring, to the 14

regulations that were just passed. Mr. Ruiz stated 15

that it would need a waiver to be implemented right 16

away until the regulation can be amended again to 17

allow for the flavoring to be done. 18

Chairperson Talbott referred to correspondence 19

from Neal Watson at NABP, where approximately five to 20

seven states are still looking to implement USP 800, 21

but everybody else is looking to delay enforcement to 22

everything because the revisions to USP 797 reference 23

USP 800. 24

Mr. Michalowski noted enforcing and inspecting at 25


18

the level of USP 795 and 797 as they have existed in 1

their original version, which would work best for 2

inspectors. He stated something outside of USP 800 3

could be mentioned to the individuals who they are 4

dealing with, but it would not be enforceable. 5

Mr. Ruiz reviewed the Board’s discussion with 6

delaying enforcement of 800 but still keeping it in 7

compliance with the current USP 795 and 797. He 8

suggested a waiver of that section with flavoring and 9

starting a regulation package to add that exemption. 10

Chairperson Talbott emphasized the need for very 11

specific language that allows for flavoring of 12

conventionally manufactured medication and that the 13

flavors had been tested and do not alter the 14

concentration of the medication. She stated most 15

pharmacists buy flavoring from companies where the 16

formula has been tested. 17

Chairperson Talbott provided language obtained 18

from other states that allow for unencumbered 19

flavoring of conventionally manufactured medications 20

in pharmacies provided that the flavors used are 21

inert, tested and do not alter medication 22

concentration beyond USP’s accepted level of variance, 23

and the pharmacist must be able to provide proof of 24

that upon request. 25


19

Larry Jones, Executive Director, Pennsylvania 1

Society of Health-System Pharmacists, mentioned the 2

definition within USP called standard deviation that 3

is allowable in any compounding situation, which does 4

not change the intended active ingredient and is well 5

within that standard. He noted, until further clarity 6

is provided at the USP level, that is the standard for 7

now.] 8

*** 9


The first piece is we are going to 11

enforce 795 and 797 as currently written. 12

MR. RUIZ: 13

Correct. Is there a motion? 14

MR. FRANKIL: 15

I will make that motion. 16


Do we have a second? 18

MR. GREENE: 19

Second. 20


Anymore discussion? All in favor? Any 22

opposed? 23


*** 25


20


The second piece is we are going to delay 2

enforcement of USP 800 until such time as 3

the revisions to 795 and 797 are 4

completed by USP and adopted by USP. 5

MR. RUIZ: 6

Correct. 7

MR. FRANKIL: 8

So moved. 9


Second? 11

MR. GREENE: 12

Second. 13


Any other discussion? All in favor? Any 15

opposed? 16


*** 18


The third is we are going to establish a 20

waiver, which will say that pharmacists 21

may flavor conventionally manufactured 22

medications provided the flavors used are 23

inert, tested and do not alter a 24

medication’s concentration beyond USP’s 25


21

accepted level of variance pending 1

revisions of current regulations. 2

MR. FRANKIL: 3

So moved. 4

MR. MICHALOWSKI: 5

You are saying they are allowed to do it. 6

You are not saying it is not compounding 7

and that is kind of the point. 8

MR. RUIZ: 9

Correct. 10


Correct. 12

MR. MICHALOWSKI: 13

So it’s flavoring, more specific, that 14

it’s a waiver from the definition of 15

compounding. 16


We are going to amend it to say what Juan 18

and Ray said. 19

MR. RUIZ: 20

For the purposes of the regulations as 21

written, the Board does not consider 22

flavoring at this point compounding if it 23

meets the definitions that we have just 24

stated. 25


22


Second? 2

MR. GREENE: 3

Second. 4


Any other discussion? All in favor? Any 6

opposed? 7

[The motion carried. Dr. Cotchen abstained from 8

voting on the motion.] 9

*** 10

[Terry Talbott, R.Ph., Chairperson, requested Mr. Ruiz 11

post on the Board’s web site and send to Ms. Pat Epple 12

and the Pennsylvania Society of Health-System 13

Pharmacists (PSHP) information on the Board’s 14

decisions regarding USP; PPA and PSHP may provide 15

this information to their members.] 16

*** 17

New Business (Continued) 18


information provided by NABP regarding how USP 20

postponement will impact their program, particularly 21

their Verified Pharmacy Program (VPP) inspections. 22

Ms. Zimmerman also noted for the Board’s review 23

the Controlled Substance, Drug, Device, and Cosmetic 24

Act and new electronic prescribing requirements. This 25


23

same issue was discussed earlier in the meeting.] 1

*** 2

Old Business – Intern Hours Waiver 3


addressed the intern hours waiver that ends on January 5

1, 2020. She stated that the applicable Board 6

regulations are not going to be amended by that date 7

and asked if the Board would extend that waiver.] 8

*** 9


Motion to extend the waiver to 2022. 11

DR. COTCHEN: 12

I move that we extend the waiver until 13

January 1, 2022. 14

MR. FRANKIL: 15

Second. 16


Any discussion? All in favor? Any 18

opposed? 19


*** 21

Old Business – Meeting Date 22


the request to change the January 28, 2020 meeting 24

date. 25


24

Mr. Ruiz informed the Board he no longer has a 1

conflict with that date. The meeting date will remain 2

as scheduled.] 3

*** 4

[Terry M. Talbott, R.Ph., Chairperson, announced 5

Dr. Cotchen’s retirement and thanked her for her 6

services on behalf of pharmacists and citizens of the 7

Commonwealth.] 8

*** 9

[The Board recessed from 10:11 a.m. until 10:26 a.m.] 10

*** 11

[Mr. Ruiz noted the time and place for the hearing 12

scheduled in the matter of the Petition for 13

Reinstatement of Frank DePietro, R.Ph., Case No. 19-14

54-011691. 15

Mr. Ruiz stated the order scheduling the hearing 16

had gone out to Mr. DePietro’s address of record on 17

October 1, 2019. Mr. Ruiz checked with the front desk 18

and noted that Mr. DePietro had not signed in or 19

checked in and Mr. Ruiz has received no communication 20

from Mr. DePietro. 21

Mr. Ruiz concluded the hearing since Mr. DePietro 22

has the burden of proof in this matter and is not 23

present.] 24

*** 25


25

[Pursuant to Section 708(a)(5) of the Sunshine Act, at 1

10:28 a.m., the Board entered into Executive Session 2

with Juan A. Ruiz, Esquire, Board Counsel, to receive 3

legal advice and engage in quasi-judicial 4

deliberations. The Board returned to open session at 5

11:10 a.m.] 6

*** 7

[K. Kalonji Johnson, Acting Commissioner, Bureau of 8

Professional and Occupational, entered the meeting 9

during Executive Session.] 10

*** 11

MOTIONS 12


The Board of Pharmacy met in executive 14

session to discuss and review consent 15

orders and other legal documents. 16

Are there any motions regarding these 17

discussions? 18

DR. COTCHEN: 19

I move that we approve the Consent 20

Agreement for File No. 19-54-003453. 21


We have a motion. Do we have a second? 23

MR. FRANKIL: 24

Second. 25


26


Any discussion? Call the vote. 2

3

Frankil, aye; Cotchen, aye; Talbott, aye; 4

Johnson, aye; Greene, recuse. 5

[The motion carried. Mr. Greene recused himself from 6

deliberations and voting on the motion. The 7

pharmacist’s name is Timothy William Forester, R.Ph.] 8

*** 9

DR. COTCHEN: 10


Agreement for File Nos. 19-54-003233 & 12

19-54-009972. 13



ACTING COMMISSIONER JOHNSON: 16

Second. 17



20

Frankil, aye; Cotchen, aye; Talbott, 21

recuse; Johnson, aye; Greene, aye. 22

[The motion carried. Ms. Talbott recused herself from 23


pharmacist’s name is Alyssa Leone Lewis, R.Ph.] 25


27

*** 1

DR. COTCHEN: 2


Agreement for File No. 19-54-009499. 4


We have a motion. Is there a second? 6


Second. 8



11

Frankil, aye; Cotchen, aye; Talbott, 12

recuse; Johnson, aye; Greene, aye. 13

[The motion carried. Ms. Talbott recused herself from 14


pharmacist’s name is Ki Young Kim, R.Ph.] 16

*** 17

DR. COTCHEN: 18


Agreement for Case No. 18-54-012188. 20


We have a motion. Is there a second? 22

MR. FRANKIL: 23

Second. 24



28


2


Johnson, aye; Greene, aye. 4

[The motion carried unanimously. The pharmacist’s 5

name is Tram M. Cao, R.Ph.] 6

*** 7

DR. COTCHEN: 8


Agreements for File No. 19-54-009933, 10

File No. 19-54-009625, File No. 19-54-11

010375, and File No. 19-54-010959. 12




Second. 16



19




*** 23

DR. COTCHEN: 24

I move that we adopt the proposed 25


29

Adjudication for College Pharmacy, File 1

No. 18-54-008243. 2




Second. 6



9




*** 13

DR. COTCHEN: 14

I move that we adopt the proposed 15

Adjudication for Daniel Jacob Reinherz, 16

R.Ph., File No. 19-54-000620. 17




Second. 21



24



30



*** 3

DR. COTCHEN: 4

I move that we approve the request for 5

reduced intern hours to 1000 hours that 6

was submitted by April Kaye Binoya. 7




Second. 11



14




*** 18

DR. COTCHEN: 19

I move that we approve the Application 20

for Extension of Authorization to Test 21

that was submitted by Bonita Ramotar as 22

discussed during executive session. 23




31


Second. 2



5




*** 9

MR. RUIZ: 10

Is there a motion to adopt the proposed 11

Adjudication and Order and address 12

exceptions in the case of Gino S. 13

Cordisco, R.Ph., at File Nos. 15-54-01804 14

& 17-54-11497? 15

DR. COTCHEN: 16

So moved. 17


Is there a second? 19


Second. 21


Any further discussion? Call the vote. 23

24



32

Johnson, aye; Greene, recuse. 1

[The motion carried. Mr. Greene recused himself from 2

deliberations and voting on the motion.] 3

*** 4

MR. RUIZ: 5

Is there a motion to adopt the proposed 6

Adjudication and substitute for the 7

Board’s final order in the case of 8

ZooPharm, Inc., at File No. 19-54-008168? 9

DR. COTCHEN: 10

So moved. 11




Second. 15



18




*** 22

MR. RUIZ: 23

Is there a motion to deny the Petition 24

for Reinstatement of Frank DePietro, 25


33

R.Ph., at File No. 19-54-011691? 1

DR. COTCHEN: 2

So moved. 3




Second. 7



10




*** 14

Report of Acting Commissioner 15

[K. Kalonji Johnson, Acting Commissioner, Bureau of 16

Professional and Occupational Affairs, addressed the 17

Board to confirm everyone’s emails at pa.gov were 18

working correctly. He noted more resources for 19

information technology (IT) staff who have been 20

reaching out to Board Members to get them back online. 21

Acting Commissioner Johnson informed the Board of 22

changes at One Penn Center, where security will be 23

provided by Capitol Police starting November 1, 2019. 24

He also informed the Board that lobby doors will open 25


34

at 8:30 a.m. and be closed to the public at 4:00 p.m., 1

and nobody will be able to enter the building unless 2

they have an entry badge. He stated that anyone 3

entering the building on state Board business will 4

need to have identification visible and show it to 5

Capitol Police or will have to get a visitor’s badge. 6

Acting Commissioner Johnson stated that all of 7

the professional organizations will be provided with 8

information regarding the changes. He mentioned that 9

all renewal notices will also have notification about 10

the new customer service hours. 11

Acting Commissioner Johnson discussed 12

modernization of facilities by upgrading technology 13

within the Board room and possibly connecting webcams 14

to stream Board meetings, hearings, and interviews. 15

He mentioned connecting regional offices and satellite 16

offices for individuals who cannot be in Harrisburg. 17

Acting Commissioner Johnson addressed a Right-to-18

Know Request received by the Department of State from 19

a journalist from the New York Times regarding 20

pharmacists’ workloads and working conditions, noting 21

it to be a topic of discussion at some of the Board 22

meetings. He stated the Board does not have authority 23

to regulate working conditions, noting that to be the 24

formal response. 25


35

Acting Commissioner Johnson referred to the 1

pharmacy tech bill, noting that the Legislative 2

Affairs Office and the Policy Office is working with 3

Representative DeLuca on the technical aspects. He 4

noted the bill to be sparse in terms of scope of 5

practice for pharmacy technicians. 6

Acting Commissioner Johnson addressed Boards that 7

travel for their various Board meetings. He mentioned 8

the Board of Pharmacy may be able to do this after 9

looking at the budget, finding individual members 10

willing to travel, and then finding host sites. 11

Chairperson Talbott requested placing Pharmacy 12

Board travel on the agenda for next month. 13

Acting Commissioner Johnson supported the 14

opportunity to provide outreach and education and 15

information for students and individuals who may not 16

be able to attend meetings in Harrisburg. 17

Acting Commissioner Johnson updated the Board 18

regarding Board member vacancies. He mentioned 19

speaking with Mr. Steve Latanishen, noting that 20

nominations should be reaching the Senate.] 21

*** 22

Adjournment 23

DR. COTCHEN: 24

I move that we adjourn the meeting. 25


36

MR. FRANKIL: 1

Second. 2


*** 4

[There being no further business, the State Board of 5

Pharmacy Meeting adjourned at 11:45 a.m.] 6

*** 7

8

CERTIFICATE 9

10

I hereby certify that the foregoing summary 11

minutes of the State Board of Pharmacy meeting, was 12

reduced to writing by me or under my supervision, and 13

that the minutes accurately summarize the substance of 14

the State Board of Pharmacy meeting. 15

16

17

18

Alicia R. Gascoigne, 19

Minute Clerk 20

Sargent’s Court Reporting 21

Service, Inc. 22

23

24

25

26


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STATE BOARD OF PHARMACY 1 REFERENCE INDEX 2

3 October 22, 2019 4

5 6 TIME AGENDA 7 8 9:00 Official Call to Order 9 10 9:00 Pledge of Allegiance and Emergency 11 Announcement 12

13 9:01 Introduction of Board Members, Board 14 Staff, and Audience Members 15 16 9:04 Approval of Agenda and Minutes 17 18 9:04 Report of Prosecutorial Division 19 20 9:32 Report of Board Counsel 21 22 9:32 Report of Board Chairperson 23 24 9:36 Report of Committees 25 26

9:37 Report of Executive Secretary 27 28 9:40 New Business 29 30 10:09 Old Business 31 32 10:11 Recess 33 34 10:26 Return to Open Session 35 36 10:26 Hearing – No Show 37 38 10:28 Executive Session 39 40

11:10 Return to Open Session 41 42 11:10 Motions 43 44 11:14 Applications 45 46 11:16 Report of Acting Commissioner 47 48 11:45 Adjournment 49 50

COMMONWEALTH OF PENNSYLVANIA...19 Mr. Michalowski will speak with the Bureau of 20 Enforcement and...

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Transcript of COMMONWEALTH OF PENNSYLVANIA...19 Mr. Michalowski will speak with the Bureau of 20 Enforcement and...