agenda department of business and professional regulation ...concerning the wholesale distribution...

AGENDA Department of Business and Professional Regulation

Drug Wholesale Distributor Advisory Council

Conference Call Number: 1-888-585-9008 Conference Code: 170778661

July 9, 2020

9:30 a.m.

Council Members: Steve Mays, Prescription Drug Wholesalers Jeenu Philip, Chair, Board of Pharmacy Joseph Lavino, CVS Health, Retail Pharmacy Michael Mone, Vice-Chair, Primary Prescription Drug Wholesalers Scott Brock, Pharmaceutical Manufacturers Arlene Elliott, Agency for Health Care Administration Dean Ellis, Secondary Prescription Drug Wholesalers Jeffrey Tuller, Primary Prescription Drug Wholesalers Patrick Barnes, Hospital Pharmacist Peter Hart, Medical Gas Jennifer Goldman, MD, Physician

DBPR Staff: Walter Copeland, Division Director Halsey Beshears, Secretary Tim Page, Deputy Secretary Renee Alsobrook, Compliance Manager Stephanie Prine, Government Operations Consultant Rebecca Burnett, Regulatory Supervisor

Call to Order: Jeenu Philip, Chair TAB 1: Chair’s Report – Jeenu Philip, Chair

a. March 26, 2020 Meeting Transcript (information only) b. 499.01211, F. S. – Drug Wholesale Distributor Advisory Council

TAB 2: Division Director’s Report – Walter Copeland a. COVID-19 division update b. HB-19 update c. Summary of active permits currently issued through Division d. Rules update

TAB 3: Other Business

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATIONDRUG WHOLESALE DISTRIBUTOR ADVISORY COUNCIL

MEETING

DATE: July 9, 2020

TIME: 9:30 a.m. to 10:05 a.m.

LOCATION: Telephonic

This meeting came on to be heard at the time and place

aforesaid, when and where the following proceedings were

reported by:

Peggy L. Ward, Court Reporter For The Record Reporting, Inc. 1500 Mahan Drive, Suite 140 Tallahassee, Florida 32308

FOR THE RECORD REPORTING TALLAHASSEE, FLORIDA 850.222.5491

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P R O C E E D I N G S

- - -

MS. PRINE: Okay. We're going to go ahead and

get started, and I'll call the roll.

THE CHAIR: Call the meeting to order.

Stephanie, if you can proceed with the roll call,

please.

MS. PRINE: Okay. Steve Mays?

MR. MAYS: Present.

MS. PRINE: Jeenu Philip?

MR. PHILIP: Present.

MS. PRINE: Joseph Lavino?

MR. LAVINO: Present.

MS. PRINE: I don't think that Michael Mone is

on the call. But just in case, Michael, are you on

the call?

(No response.)

MS. PRINE: Scott Brock?

MR. BROCK: Here.

MS. PRINE: Arlene Elliott?

MS. ELLIOTT: Present.

MS. PRINE: Dean Ellis?

MR. ElLIS: Present.

MS. PRINE: Jeffrey Tuller?

MR. TULLER: Present.


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MS. PRINE: Patrick Barnes?

(No response.)

MS. PRINE: Peter Hart?

MR. HART: Present.

MS. PRINE: Dr. Goldman? Jennifer Goldman?

(No response.)

MS. PRINE: Okay. I think we have a quorum.

And here in Tallahassee, we have Director Walter

Copeland, myself, Stephanie Prine, and Chief Renee

Alsobrook.

THE CHAIR: All right. Thank you very much,

Stephanie.

So we'll start with, under Tab 1, the Chair's

Report. I have nothing new to report on my end. I

guess the meeting transcript is in the agenda --

provided in the agenda for informational purposes

only.

And then I guess proceeding on, Stephanie or

Mr. Copeland, regarding 499.01211, is there

anything specific you wanted me to do with the

statute?

MR. COPELAND: Nothing specific. Just to kind

of remind everybody and myself what the purpose of

the Advisory Council is, and that's to

periodically, you know, review Chapter 499, the


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related rules and provide recommendations regarding

improving the section of prescription drugs and

public health, improving coordination with other

state's regulatory agencies and federal government

concerning the wholesale distribution of drugs and

minimizing the impact of regulation of the

wholesale distribution industry on (inaudible).

So that's the summary.

THE CHAIR: Okay. Yeah. So it's really just

reminding everybody of the charge of this council.

And from a reference standpoint, it's under

499.01211 of the Florida Statutes.

I guess with that being said, are there any

questions from the group around any of this, the

meeting transcript or the advisory council?

(No response.)

THE CHAIR: Hearing none, we'll move on to

Tab 2, Division Director's Report. Mr. Copeland,

please proceed.

MR. COPELAND: I'm going to go through the tabs

here. And Chief Alsobrook, you pipe up. You've

led a lot of the charge on some of these areas.

So I'm going to give a broad-brush overview.

Renee can provide some additional detail, and then

we'll provide any answers to questions that we can.


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But the first item we had was our COVID-19

division update. You know, obviously our

division's been impacted significantly, as many

other businesses have.

And we've managed well since March. We're

under a telework mandate for our division. We

have -- just to remind you-all, we have 32

positions within the division, 16 of those are in

the field already.

It hasn't impacted their -- it's impacted them,

but we have about 16 also here in the Tallahassee

office, and everyone is teleworking. Chief

Alsobrook, myself and our office manager are here

most every day.

But just real quick, since March, as you can

imagine, new applications coming into the division

have decreased somewhat. Through December we were

averaging about 300 new applications for the month

of May. I think we had right at 200.

Our compliance team, led by Chief Alsobrook,

inspections and investigations, our turn-around

time on those have slowed a little.

But we are well behind our benchmark on our

days to complete. And I'll let Renee kind of give

you a little more input in that area.


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But our team in the field has been impacted,

obviously, with having trouble with site visits and

getting access and things like that.

But they've done a great job of realigning and

doing a lot of the inspections and investigative

work electronically. And it's -- they've done a

great job out there zigging and zagging.

We've also spent a lot of time, in our

application processing group, assisting clients,

our stakeholder's applicants, both new applicants

and renewal applicants.

We've just had a myriad of issues that have

popped up with difficulties due to the COVID. And,

for example, people have had difficulties getting

stuff notarized. People have had difficulties

getting the required information for the personal

information statements.

We've had difficulty with our certified

designated representative exam due to exam

locations being closed.

And without getting into too much detail, we

have really taken a subjective approach to

utilizing discretion in certain areas where we're

allowed under statute to help people get the

permit -- or stakeholders get the permits renewed


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or their new permits.

And I appreciate the team working and really

assisting people. They're acting like owners. And

we're continuing to do what we can under statute

and within our discretion to assist.

We had a big -- one area we -- earlier in the

pandemic, there was a very rough shortage of hand

sanitizers, as all of you-all know.

We did use our discretion with our

over-the-counter permitting for hand sanitizer

manufacturers that qualified under the FDA updated

mandates they put out regarding the sanitizers.

So we were able to get -- I think the last time

I looked, 10 or 12 new hand sanitizer manufacturing

groups up and running, and we got them up and

running immediately.

Just a -- a lot of the other areas the

division and the teams within our division have

been pulled off to help with, we've worked a lot on

procurement of PPE through our channels, through

our business partners to help the state and the

agency, and Mr. Tuller has helped us with that.

I've dealt with him quite a bit, so I do appreciate

that.

Chief Alsobrook and her team have led a drug


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shortage work group for a couple of months now, and

I'll let her fill you in a little more on that.

But it's involved other agencies, other

municipalities and it's involved industry

representatives.

And they've really identified some areas that

maybe we can look at going forward massaging or

updating our rules to have a better reaction to any

future problems that may pop up. And so that's

been a good help.

Just -- again, we're no different than everyone

else having to realign their operations every day

due to this pandemic. And it's unfortunate that

we're all facing it.

But it's not an excuse for not getting our work

done and we're getting our work done. And I

appreciate the team pulling together, and we'll get

through this and -- and we'll learn a lot of good

efficiencies through going through this exercise.

Does anybody -- that's the COVID. That's my

broad-brush summary update. Do you-all have any

questions? Or Renee, do you want to pipe in?

You've led the charge on a lot of this so, please.

MS. ALSOBROOK: Yes, Director. A couple of

things. When we can possibly get together in a


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face-to-face meeting, we'll put together some of

the information we obtained through the drug

shortage work group.

As the Director indicated, we did have a couple

of conference calls with some industry members and

interested parties, particularly down in South

Florida that did come up with some ideas I wanted

to present to the Drug Wholesale Distributor

Advisory Council.

Some may require statutory change, some may be

rules, but, you know, some information that I

wanted to present to you for your information. I

don't know that there's anything necessarily we can

do with it.

But I do think that there might be some

emergency rules -- some rules that we could

implement for emergency situations. But I clearly

wanted your input in that.

We also, in addition to the other things the

Director talked to you about, have been working

with various other agencies, including DEA, the

Office of Criminal Investigation, the Attorney

General's Office, on investigations pertaining to

products that are being offered for sale. Secure

COVID. You probably saw just today the miracle


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minerals' arrest in Bradenton for the bleach that

cured for COVID.

We were involved with the initiation of that

investigation. We're involved currently with some

device fraud. That some people are selling some

N95 masks, or claim to be N95 masks and they are

not.

So we're assisting to the extent that we are

able to do so with the Attorney General's

investigation and prosecution of that.

Generally our assistance is, you know,

connecting the dots for people, because we're not

law enforcement. We can't conduct arrests and we

can't put people in jail, nor do we want to.

But we can utilize our contacts with the DEA,

and the chief investigator for the DEA with medical

devices, and our contacts with local law

enforcement and the Office of Criminal

Investigation to make sure that people get -- cut

through the bureaucracy to get to the people that

they need to get to.

In the case of the bleach prosecution, we were

able to reach out to the Department of Health, and

I knew that the Department of Health has a Poison

Control Center.


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So we were able to connect them to the Poison

Control Center and get information from Poison

Control of anybody that had reported to that center

people who had been poisoned from taking that

particular cure for COVID.

So they were able to get some patient names or

people's names that had actually consumed the cure

and had not gotten cured. So little things like

that we're able to do when we work together on it.

Also, with our drug shortage work group, we

worked with the Department of Health, statewide

pharmacists who obviously was running across

shortages of drugs.

So we were able to assist her in providing

addresses and contact information for you guys,

because we had that available through our system,

so that she would have contact information to reach

out to people, if she needed it, to assist her in

dissemination or distribution of drugs, and answer

questions for our licensees as to whether they

could assist in the matter if the Department of

Health was asking them to do so.

So we're all trying to work as a big team

resolving this. And any other questions you guys

might have for me, I will be glad to answer.


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MR. COPELAND: All right. Thank you.

Let's move on to b., the HB-19 update. And

just to remind everyone, House Bill 19 is Florida's

International Prescription Drug Importation bill

that was entered into law in June of 2019.

Division of Drugs, Devices and Cosmetics, we're

responsible for the development and implementation

of the international program within the bill.

And the Agency for Health Care Administration,

they're in charge of establishment and maintenance

of the Canadian importation program under the bill.

Just to give you an update, we're kind of in a

holding pattern right now. The Federal Government,

HHS, has issued a safe importation plan and they're

in the process of developing rules related to such

at the federal level.

We don't have a time frame, obviously, on what

we're looking at, as far as getting the final

rules, but we're moving ahead with establishing the

new permit types required under the bill.

And we also worked in conjunction with the

Agency for Health Care Administration and provided

comments that were submitted to HHS, giving them

our input and suggestions and responses to their

proposed rulemaking.


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And in saying all of that, we are moving

forward in developing the two applications that are

required within the House Bill 19. And we're doing

that not knowing when the federal rules may be

promulgated and come down. And it could have

impact on our side of things. But we've got to go

ahead and keep moving forward.

And we're developing the permit type in

conjunction with the Department of Health, Board of

Pharmacy. And so that's -- Chief Alsobrook, her

team have kind of led the HB-19 from our division.

Is there any more detail we need to get into?

I mean, we'll answer any questions we can on that.

It's another area that -- it's interesting, but

it does -- it takes a lot of your staff's time and

there's a lot of infrastructure, IT issues and

things we're dealing with as far as following the

requirements of the law.

I hope I didn't confuse everybody on that. But

if there is anything, Renee, you want to offer,

please interject.

MS. ELLIOTT: Walter, this is Arlene, and I'm

sorry to interrupt. I just want to give the update

from the agency that we're in the blackout period,

so we cannot make any comments about the Canadian


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importation.

MR. COPELAND: Understood. And thank you,

Miss Elliott.

Are you-all ready to move forward? Under c.,

I've got -- just to give you a brief update on what

the division is looking at as far as work flow and

give you an idea of the permits we've issued and

where we stand, right now, through May, we had

46,600 active permits compared to 42,377 at the end

of last fiscal year, June 30th, '19.

11,848 of those permits are what I -- what we

consider substantive; your wholesale distributors,

your manufacturers, your virtual permits.

The other 30-something thousand are certified

designated representative permits and things like

that that are essentially -- they're reported as

permits, but they're not the meat and potatoes of

what we do.

So we're about 2,635 licenses active over where

we were last year. And of the 2,635, the majority

of those are the health care clinic establishment

licenses.

So we're -- licensing here in the state, it's

creeping up a little bit, but not a whole lot. We

are still seeing and will continue to see a big


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number of the HCC permits as everybody is coming on

board with that.

So that's just kind of a broad-brush summary of

licensing here through our division. Anyone have

any input or questions we could try to answer on

that?

MR. ELLIS: Walter, this is Dean Ellis.

Earlier, you had mentioned that you're getting

300 new permit applications per moth. Is that -- I

assume that also includes the CDRs and that sort of

thing, the numbers you just mentioned? It's not

actually prescription drug wholesale --

MR. COPELAND: No. No, you're exactly right.

And that's an average based on the six month end of

December. So you're right. It's not -- it's the

whole pool.

MR. ELLIS: Yeah. I asked that because I was

like, how can you possibly handle that.

MR. COPELAND: And noted on that, we're all

working -- the agency -- our agency has some new

options they're putting into play on the

information technology side that's going to allow

us to better -- better utilize where are your

metrics and things like that.

So we're working with what we have right now.


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But we're going to have some better tools as we

move forward.

MR. ELLIS: It's been getting better every

year. So that's a good thing.

MR. COPELAND: Absolutely. Absolutely.

Rules update, we went through the state had a

mandated -- Renee, I think it's every five years

we're doing it. The rule review that required each

responsible division to go through their applicable

rules and make sure they're all still needed and

such. And we've gone through that exercise and

we've just finished here in DDC.

But back to what Chief Alsobrook referred to

earlier is, especially during this pandemic we've

gone through and -- addressing some of the issues

that have come up, we've got a lot of notes and a

lot of things we do want to discuss with the

advisory council related to possible rule

revisions, if available, and updates.

Just to make -- you know, make business more

seamless, not take away from safety one bit, but

maybe see around corners and things we could

possibly put into play before we have more

emergencies in the future.

So what we're going to do is, Chief Alsobrook


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had referred to is get a presentation for you-all

where we can point out some of the substantive

areas we want your input on. And we want to review

for possible -- for rule updates, revisions, if we

can make it happen.

And so we will put those together and

communicate such so we can move on the analysis of

maybe what can be done, what can't be done, and the

input from the industry side.

Renee, do you have anything specific to that?

I mean, as far as...

MS. ALSOBROOK: No, sir, not specific as to the

rule -- for the rules update, other than what

you've indicated, that's the plan for us to do once

we choke down a couple of these other big, big

chores.

Right now -- it wasn't on the agenda, but one

of the things that we may end up having to do,

Director, is some rules on the CSR.

As you-all know, we've been telling you that

we've been working on an upgrade to the CSR, the

Controlled Substance Reporting to stop -- Tran

Bui -- I don't know if any of you-all know her, but

she's one of our inspectors in Orlando.

Dr. Bui and I have been working with an IP,


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Dave Cantrell is the employee and Michelle

Markoski, weekly we're in the process of writing

the user manual at this time for the system.

We're hoping it's going to be a good product.

I know that there's been a couple of folks out

there from the industry that have assisted in

testing. I think AmerisoureBergen loaned us

somebody to test.

And basically what that means is you submit

data into a beta system and we see if it works.

So at this point in time we're trying to figure

out all of the angles of the system and see if the

user manual is going to have to require a rule be

published that the user manual -- under

Chapter 120, Florida Statutes, can just be a user

manual or is it going to require a rule.

So that's a possible rule update that we may

have to do. But other than that, we're hoping to

launch this new CSR by October to get it out there

for folks to use it.

But it has been a big chore. There's been a

lot of turnover. It started back when (inaudible)

couple of directors and (inaudible) in the

division.

So you know how it works. Every time somebody


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leaves (inaudible) takes a couple of steps back to

get it moving forward (inaudibe) we're going to

have to get it completed before we can move on to

the next thing.

And of course with House Bill 19, that's the

same thing. That probably is going to require some

rule also before we can move on to a clean-up rules

project that we can present to you.

But I think we'll have a pretty busy fall and

(inaudible) and I look forward to working with you

on these big efforts, all of which will be rules.

THE CHAIR: Miss Alsobrook, this is Jeenu

Philip. Just a quick question. I'm not sure if I

caught that correctly.

So the current user manual, is it in rules or

are we just updating it?

MS. ALSOBROOK: The current user manual is not

in rules, but you are using it. Yes, sir.

THE CHAIR: Okay. So -- but you're not sure

if, as you update the user manual, if that has to

be -- if new rules have to be created that would

cover that update.

MS. ALSOBROOK: That's correct.

THE CHAIR: Okay.

MS. ALSOBROOK: That's what happens when you


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have a lawyer writing something, Mr. Chair. That's

what the Director tells me all the time. Gosh, I

wish you weren't a lawyer.

MR. COPELAND: I use her as a lawyer, then I

make her take her lawyer hat off. She does well.

THE CHAIR: Do you want to move on? Anything

else before we move on to the other business?

MR. COPELAND: Nothing from our side, Chair.

THE CHAIR: Okay. All right. So Mr. Copeland

is finished with Tab 2, the Division Director's

Report.

Moving on to the Other Business, the only other

item that is under the Other Business tab is we are

going to open up nominations for vice chair.

At the beginning of the call, we found out that

Vice Chair Michael Mone was no longer going to be

on this committee.

So that would open this up for -- or provide us

an opening for vice chair. So at this time I will,

I guess, vote to take nominations for vice chair.

MR. ELLIS: Mr. Chair, this is Dean Ellis. I

would like to nominate Jeffrey Tuller for vice

chair.

THE CHAIR: Okay. So Mr. Ellis nominates

Mr. Tuller for vice chair. Do we have a second?


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MR. MAYS: Second.

THE CHAIR: Okay. I'm sorry, who was the

second?

MR. MAYS: Steve Mays.

THE CHAIR: Steve Mays. Okay. So we have a

nomination for Mr. Tuller and a second from

Mr. Mays. Mr. Tuller, do you accept the

nomination?

MR. TULLER: Yes. Thank you. I do.

THE CHAIR: All right. Very good. Any other

nominations?

(No response.)

THE CHAIR: All right. Hearing none, we'll

take a vote. So all in favor of Mr. Tuller being

vice chair, please signify by saying aye.

(Ayes.)

THE CHAIR: All right. Do we have any opposed?

(No response.)

THE CHAIR: Hearing none, the motion passes.

And so congratulations, Mr. Tuller, on being vice

chair.

MR. TULLER: Thank you, Mr. Chair.

THE CHAIR: All right. Any other items that

need to be discussed for today?

MS. ALSOBROOK: Mr. Chair, you have a vacancy


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for your prescription drug wholesaler position that

Mr. Mone vacated.

So if you guys will get the word out, if the

Director will get the word out, send to Stephanie

any information you may have relative to someone

who may be interested and we can give them an

application.

THE CHAIR: Okay.

MR. ELLIS: Renee, this is Dean Ellis again.

The folks who resubmitted for appointment, has that

been completed or will we be notified of that?

MR. COPELAND: Stephanie will follow-up.

MS. ALSOBROOK: We'll follow-up, Mr. Ellis, and

let you know.

MR. ELLIS: Okay. Thank you.

THE CHAIR: All right. If there is no other

business left to discuss, I will make a motion to

adjourn.

MR. MAYS: Steve Mays. Second.

THE CHAIR: All right. I have a second. All

in favor signify by saying aye.

(Ayes.)

THE CHAIR: All right. Thank you.

(Proceedings concluded at 10:05 a.m.)

* * *


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CERTIFICATE OF REPORTER

STATE OF FLORIDA )

COUNTY OF LEON )

I, Peggy L. Ward, Court Reporter, do hereby certify

that I was authorized to and did report the foregoing

proceedings, and that the transcript is a true and complete

record of my stenographic notes.

DATED this 16th day of September, 2020, at

Tallahassee, Leon County, Florida.

______________________________Peggy L. Ward, Court ReporterCommission No.: GG957644Expiration: February 12, 2024


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agenda department of business and professional regulation ...concerning the wholesale distribution...

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