COMMONWEALTH OF PENNSYLVANIA...19 Mr. Michalowski will speak with the Bureau of 20 Enforcement and...
Transcript of COMMONWEALTH OF PENNSYLVANIA...19 Mr. Michalowski will speak with the Bureau of 20 Enforcement and...
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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: 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
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19
October 22, 2019 20
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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
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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
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*** 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
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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
CHAIRPERSON TALBOTT: 8
Second? 9
MR. FRANKIL: 10
Second. 11
CHAIRPERSON TALBOTT: 12
All in favor? Any opposed? 13
[The motion carried unanimously.] 14
*** 15
Approval of minutes of the August 27, 2019 meeting 16
CHAIRPERSON TALBOTT: 17
Motion to approve the minutes from August 18
27? 19
DR. COTCHEN: 20
So moved. 21
CHAIRPERSON TALBOTT: 22
Second? 23
MR. FRANKIL: 24
Second. 25
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CHAIRPERSON TALBOTT: 1
Any discussion? All in favor? Any 2
opposed? 3
[The motion carried unanimously.] 4
*** 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
[Patrick M. Greene, Esquire, Office of Attorney 15
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
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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
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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
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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
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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
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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
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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
[Patrick M. Greene, Esquire, Office of Attorney 21
General, signed orders on a Petition for Immediate 22
Suspension and Physical and Mental Examination.] 23
*** 24
Report of Executive Secretary 25
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[Melanie Zimmerman, R.Ph., Executive Secretary, 1
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
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*** 1
CHAIRPERSON TALBOTT: 2
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
CHAIRPERSON TALBOTT: 8
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
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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
CHAIRPERSON TALBOTT: 22
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
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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
CHAIRPERSON TALBOTT: 23
Does anyone want to make a motion that we 24
approve this program? 25
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Hearing none. We will move on. 1
[The motion failed.] 2
*** 3
New Business (Continued) 4
[Melanie Zimmerman, R.Ph., Executive Secretary, 5
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
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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
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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
CHAIRPERSON TALBOTT: 10
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
CHAIRPERSON TALBOTT: 17
Do we have a second? 18
MR. GREENE: 19
Second. 20
CHAIRPERSON TALBOTT: 21
Anymore discussion? All in favor? Any 22
opposed? 23
[The motion carried unanimously.] 24
*** 25
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CHAIRPERSON TALBOTT: 1
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
CHAIRPERSON TALBOTT: 10
Second? 11
MR. GREENE: 12
Second. 13
CHAIRPERSON TALBOTT: 14
Any other discussion? All in favor? Any 15
opposed? 16
[The motion carried unanimously.] 17
*** 18
CHAIRPERSON TALBOTT: 19
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
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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
CHAIRPERSON TALBOTT: 11
Correct. 12
MR. MICHALOWSKI: 13
So it’s flavoring, more specific, that 14
it’s a waiver from the definition of 15
compounding. 16
CHAIRPERSON TALBOTT: 17
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
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CHAIRPERSON TALBOTT: 1
Second? 2
MR. GREENE: 3
Second. 4
CHAIRPERSON TALBOTT: 5
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
[Melanie Zimmerman, R.Ph., Executive Secretary, noted 19
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
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same issue was discussed earlier in the meeting.] 1
*** 2
Old Business – Intern Hours Waiver 3
[Melanie Zimmerman, R.Ph., Executive Secretary, 4
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
CHAIRPERSON TALBOTT: 10
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
CHAIRPERSON TALBOTT: 17
Any discussion? All in favor? Any 18
opposed? 19
[The motion carried unanimously.] 20
*** 21
Old Business – Meeting Date 22
[Melanie Zimmerman, R.Ph., Executive Secretary, noted 23
the request to change the January 28, 2020 meeting 24
date. 25
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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
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[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
CHAIRPERSON TALBOTT: 13
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
CHAIRPERSON TALBOTT: 22
We have a motion. Do we have a second? 23
MR. FRANKIL: 24
Second. 25
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CHAIRPERSON TALBOTT: 1
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
I move that we approve the Consent 11
Agreement for File Nos. 19-54-003233 & 12
19-54-009972. 13
CHAIRPERSON TALBOTT: 14
We have a motion. Do we have a second? 15
ACTING COMMISSIONER JOHNSON: 16
Second. 17
CHAIRPERSON TALBOTT: 18
Any discussion? Call the vote. 19
20
Frankil, aye; Cotchen, aye; Talbott, 21
recuse; Johnson, aye; Greene, aye. 22
[The motion carried. Ms. Talbott recused herself from 23
deliberations and voting on the motion. The 24
pharmacist’s name is Alyssa Leone Lewis, R.Ph.] 25
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*** 1
DR. COTCHEN: 2
I move that we approve the Consent 3
Agreement for File No. 19-54-009499. 4
CHAIRPERSON TALBOTT: 5
We have a motion. Is there a second? 6
ACTING COMMISSIONER JOHNSON: 7
Second. 8
CHAIRPERSON TALBOTT: 9
Any discussion? Call the vote. 10
11
Frankil, aye; Cotchen, aye; Talbott, 12
recuse; Johnson, aye; Greene, aye. 13
[The motion carried. Ms. Talbott recused herself from 14
deliberations and voting on the motion. The 15
pharmacist’s name is Ki Young Kim, R.Ph.] 16
*** 17
DR. COTCHEN: 18
I move that we approve the Consent 19
Agreement for Case No. 18-54-012188. 20
CHAIRPERSON TALBOTT: 21
We have a motion. Is there a second? 22
MR. FRANKIL: 23
Second. 24
CHAIRPERSON TALBOTT: 25
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Any discussion? Call the vote. 1
2
Frankil, aye; Cotchen, aye; Talbott, aye; 3
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
I move that we approve the Consent 9
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
CHAIRPERSON TALBOTT: 13
We have a motion. Do we have a second? 14
ACTING COMMISSIONER JOHNSON: 15
Second. 16
CHAIRPERSON TALBOTT: 17
Any discussion? Call the vote. 18
19
Frankil, aye; Cotchen, aye; Talbott, aye; 20
Johnson, aye; Greene, aye. 21
[The motion carried unanimously.] 22
*** 23
DR. COTCHEN: 24
I move that we adopt the proposed 25
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Adjudication for College Pharmacy, File 1
No. 18-54-008243. 2
CHAIRPERSON TALBOTT: 3
Do we have a second? 4
ACTING COMMISSIONER JOHNSON: 5
Second. 6
CHAIRPERSON TALBOTT: 7
Any discussion? Call the vote. 8
9
Frankil, aye; Cotchen, aye; Talbott, aye; 10
Johnson, aye; Greene, aye. 11
[The motion carried unanimously.] 12
*** 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
CHAIRPERSON TALBOTT: 18
Do we have a second? 19
ACTING COMMISSIONER JOHNSON: 20
Second. 21
CHAIRPERSON TALBOTT: 22
Any discussion? Call the vote. 23
24
Frankil, aye; Cotchen, aye; Talbott, aye; 25
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Johnson, aye; Greene, aye. 1
[The motion carried unanimously.] 2
*** 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
CHAIRPERSON TALBOTT: 8
Do we have a second? 9
ACTING COMMISSIONER JOHNSON: 10
Second. 11
CHAIRPERSON TALBOTT: 12
Any discussion? Call the vote. 13
14
Frankil, aye; Cotchen, aye; Talbott, aye; 15
Johnson, aye; Greene, aye. 16
[The motion carried unanimously.] 17
*** 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
CHAIRPERSON TALBOTT: 24
We have a motion. Do we have a second? 25
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ACTING COMMISSIONER JOHNSON: 1
Second. 2
CHAIRPERSON TALBOTT: 3
Any discussion? Call the vote. 4
5
Frankil, aye; Cotchen, aye; Talbott, aye; 6
Johnson, aye; Greene, aye. 7
[The motion carried unanimously.] 8
*** 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
CHAIRPERSON TALBOTT: 18
Is there a second? 19
ACTING COMMISSIONER JOHNSON: 20
Second. 21
CHAIRPERSON TALBOTT: 22
Any further discussion? Call the vote. 23
24
Frankil, aye; Cotchen, aye; Talbott, aye; 25
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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
CHAIRPERSON TALBOTT: 12
Do we have a second? 13
ACTING COMMISSIONER JOHNSON: 14
Second. 15
CHAIRPERSON TALBOTT: 16
Any further discussion? Call the vote. 17
18
Frankil, aye; Cotchen, aye; Talbott, aye; 19
Johnson, aye; Greene, aye. 20
[The motion carried unanimously.] 21
*** 22
MR. RUIZ: 23
Is there a motion to deny the Petition 24
for Reinstatement of Frank DePietro, 25
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R.Ph., at File No. 19-54-011691? 1
DR. COTCHEN: 2
So moved. 3
CHAIRPERSON TALBOTT: 4
Do we have a second? 5
ACTING COMMISSIONER JOHNSON: 6
Second. 7
CHAIRPERSON TALBOTT: 8
Any further discussion? Call the vote. 9
10
Frankil, aye; Cotchen, aye; Talbott, aye; 11
Johnson, aye; Greene, aye. 12
[The motion carried unanimously.] 13
*** 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
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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
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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
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MR. FRANKIL: 1
Second. 2
[The motion carried unanimously.] 3
*** 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