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GEORGIA BOARD OF PHARMACY

Conference Call

2 Peachtree Street, NW, 6

th

Floor

Mike Faulk, Vice-President Dennis Troughton, Director, GDNA

Carrie Ashbee Michael Karnbach, Deputy Director, GDNA

Michael Azzolin Max Changus, Assistant Attorney General

Michael Brinson Kimberly Emm, Attorney

Hal Henderson Brandi Howell, Business Support Analyst I

Bill Prather

Dean Stone Visitors:

Stephen Georgeson, GRA Pharmacy Council

Greg Reybold

Travis Clark

President Harris established that a quorum was present and called the meeting to order at 9:02 a.m.

Mr. Lacefield asked the visitors on the call to send an email via the “Contact Us” portal on the website if

he/she would like his/her name reflected as being in attendance in the minutes.

Approval of Minutes

Mr. Prather made a motion to approve the Public and Executive Session minutes from the June 17, 2020

Report of Licenses Issued

Mr. Brinson made a motion to ratify the list of licenses issued. Mr. Stone seconded and the Board voted

unanimously in favor of the motion.

Petitions for Rule Waiver or Variance

The Board discussed the rule variance petitions submitted by Nathan P. Hoxsie and Erica Wilkins, along

with the rule waiver petition submitted by Torrea S. Harris. President Harris commented that all three

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individuals failed the practical at one point. She further stated that Ms. Wilkins and Ms. Harris were

meant to be an accommodation of current times. He added that he thinks the concern was addressed in part

by putting in a caveat stating if the individual has failed an exam previously, he/she would not qualify.

Mr. Changus stated that every applicant that has previously failed an exam would be in the same situation.

He further stated that there is deliberation and consideration as to why the rule was written that way. Mr.

Stone commented that he would be interested in reviewing each applicant’s scores to get a bigger context

for all three. Mr. Lacefield responded by stating that the Board could discuss each applicant’s exam scores

in Executive Session. Mr. Henderson commented that his concern is regarding consistency and asked if

the Board were to waive this rule for these three applicants, how many others are in the same position who

did not through the trouble of submitting a petition? President Harris responded by stating that each

candidate has an opportunity to petition the Board. She continued by stating when the Board created the

Executive Session.

Mr. Brinson made a motion to grant the rule waiver petition from Georgia State Prison, PHH05792. Mr.

Henderson seconded and the Board voted unanimously in favor of the motion.

Mr. Brinson made a motion to grant the rule waiver petitions submitted by AU Medical Center Cancer

Center Pharmacy, PHCL0000012, AU Medical Center Employee Pharmacy, PHRE010837, AU Medical

Center Georgia Cancer Center – Downtown, PHCL000043, AU Medical Center Inpatient Pharmacy,

PHH003623, AU Medical Center Outpatient Pharmacy, PHRE002638, and AU Medical Center Retail

Pharmacy, PHRE010130. Mr. Stone seconded and the Board voted unanimously in favor of the motion.

wholesalers and third party logistics. Mr. Daly’s letter states that they have received dozens of inquiries

about the ability to ship drug samples directly to patients due to a recently released FDA guidance and the

FDA is allowing direct shipment for the duration of the emergency, however it is ultimately up to the

states. His letter asks if Georgia would allow direct shipment in rare circumstances to designated patients.

The Board directed staff to respond to Mr. Daly by referring him to O.C.G.A. § 16-13-72, which gives

guidelines on how to provide samples.

Correspondence from Lisa Recht, GE Healthcare Pharmacy

The Board considered this correspondence regarding pharmacy intern hours. Ms. Recht’s inquiry asks if

virtual internship hours will be counted the same as physical intern hours. After discussion, the Board

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Correspondence from Kaitlyn George

compounding pharmacies. He stated that under the Food & Drug Cosmetic Act, Congress required the

FDA to present a MOU to the states for signature that would address the interstate distribution of

inordinate amounts of compounded medications and also provide for the appropriate investigation by states

of complaints related to compounded drugs shipped out of state. Mr. Snow stated they provided a number

of different versions of the MOU over the years. He stated that in May, the FDA issued a final MOU,

which is currently being reviewed by the Office of Management and Budget (OMB) to make sure the

MOU follows the Paper Reduction Act and would not present undue financial hardship on state boards.

Mr. Snow stated that this is a final MOU that once it does go live, states will have a year to evaluate and

decide if they want to sign under that MOU. He stated that this will be a challenge and many states have

apprehension about signing it, but on the flip side, the ramifications of not signing it are pretty severe. Mr.

Georgia. He stated that compounding has become very specialized and this could have a major impact on

the availability of those drugs in Georgia. He further stated that his purpose is to put this on the Board’s

radar so it can know what the issues are that have been raised by the states so a thorough investigation can

begin.

President Harris commented that this has been dragging out for years and it is a travesty that it has gotten

to this point. The Board discussed the ramifications of signing and not signing the MOU. Mr. Snow

commented that one of the concerns is in the drafting of this MOU, the FDA significantly changed the

historical definition of distribution and dispensing. He stated Georgia law patterns the historical

understanding of the terms and states that "dispense" or "dispensing" means the preparation and delivery of

patient, even patient-specific delivery to a patient, is under the definition of “distribution”. Mr. Snow

stated that what this is doing is vastly increasing the jurisdictional reach of the FDA to oversee and regulate

what had traditionally been state regulated dispensing activities. President Harris thanked Mr. Snow for

keeping the Board informed and providing the information.

Correspondence from Scott Brunner, Alliance for Pharmacy Compounding

The Board viewed this correspondence for informational purposes only.

Correspondence from Neal Watson, NABP

The Board considered this correspondence asking the following questions:

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the facility. If NABP wishes to inspect a pharmacy or facility in the State of Georgia, the Board has asked

that they notify GDNA prior to doing so, which they appear to have been complying with.

Georgia Drugs and Narcotics Agency – Dennis Troughton

Director Troughton reported that GDNA has conducted 2472 inspections and received 421 complaints for

FY2020. He added that for FY2021 GDNA has conducted 81 inspections and received 13 complaints.

Attorney General’s Report – Max Changus

No report.

Information on Practical Exam: Mr. Lacefield reported that at the Board’s previous meeting there was a

request for data regarding the practical examination. He stated that he emailed the information to the

Board earlier that morning. He further stated that it is information related to the number of times the

Board’s candidates took exams and whether the candidate was licensed or not. Mr. Azzolin commented

that the data presented was really good and that he has converted it to a graphical format. He shared the

information with the Board.

thinks the Board definitely needs to look at the practical and if it were to continue it, it needs to review and

revamp it. Mr. Prather stated that he believes it would be good to have members from the retail and

hospital sides, along with Ms. Gardner, since she is a former board member and has assisted with the exam.

He further stated that Ms. Gardner would be an asset to any committee.

Mr. Stone asked if all of the committee meetings need to be public. Ms. Emm responded that the actual

examination and any discussion on its questions would be confidential and done in Executive Session. Mr.

Changus commented that he agreed with Ms. Emm and stated the meeting would need to be posted.

President Harris asked if there were any volunteers to serve on the committee. Mr. Azzolin asked if it was

appropriate to have someone who is no longer on the Board participate on the committee. He added that he

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participate in the reviewing that confidential information. Mr. Changus responded that the exam questions

practical. Vice-President Faulk commented that in regards to the concern about the information being

shared with someone outside of the Board, the Board has former members assist with proctoring the

examination, so he does not think it is an issue. President Harris commented that Ms. Gardner is viewed as

a consultant. Mr. Azzolin responded that if that is the case, he agrees with it, but just wanted to inquire as

to the appropriateness of it.

Mr. Azzolin and Mr. Stone volunteered to be on the committee. President Harris stated she would assist as

well. Mr. Changus stated that it was previously mentioned that exam discussions would be in Executive

Session and another item mentioned was the Board has former board members assist with conducting the

practical exams. He stated that this would be a meeting that needs to be noted where the committee is just

Changus responded by stating that the question is how does the Board best move forward with the practical

examination in whatever form it might take. He further stated that the Board could have input in Open

Session on the matter; however, once it starts discussion on the examination questions themselves, which

would need to be reserved to the Board and allowed to be discussed in Executive Session so everyone does

not have access to that information. With no further discussion, Mr. Prather made a motion to appoint Mr.

Stone and Mr. Azzolin to the committee. Mr. Henderson seconded and the Board voted unanimously in

favor of the motion.

Legal Services – Kimberly Emm

Ms. Emm discussed the legislative change made to federal student loans. Mr. Azzolin made a motion to

Voting in favor of the motion were those present who included Carrie Ashbee, Michael Azzolin, Michael

Brinson, Mike Faulk, Lisa Harris, Hal Henderson, Bill Prather and Dean Stone.

Georgia Drugs and Narcotics Agency – Dennis Troughton

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Cognizant’s Report – Mike Faulk

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Correspondences/Requests

license without an exam. He stated that in terms of the delay due to COVID-19, there is nothing unique

about each of their situations as far as the rule goes. He added that if the Board waives the requirement for

one, it would have to do so for everybody. Mr. Azzolin stated that as a follow up to what he stated earlier,

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should be allowed to rely on the standards of the MPJE, NAPLEX and the accredited colleges of

it is safe, bring it back. Mr. Lacefield responded that the Board has waived it already. He added that for

just this particular group of people, it has not. He continued by stating that at this point, we can assume the

pandemic will end at some time, but the Board is talking about a finite amount of time this exam

requirement is waived. Mr. Lacefield stated the exam is already waived for most candidates. He further

stated there is a small population that it is not waived for and the Board is talking about that small

population. Mr. Brinson commented he previously had been in favor of maintaining the practical

examination; however, this situation has changed his opinion on the subject. Mr. Azzolin commented that

the Board has denied the three rule petitions, which gets the Board to the point of discussing philosophy of

the practical in general. He stated that he understands there is a sentimental aspect of this practical, and as

he read in the minutes, a member stated that it is a rite of passage. He continued by stating that he

stated that now the budget factors into it. He stated that he if were asked about the practical today, he

would probably lean towards doing away with it because of COVID-19. Mr. Lacefield commented that

today the Board is discussing if it wants to amend the emergency rule, not changing the rule in its totality.

Mr. Henderson stated that he felt the two were tied together. He added that he thinks if the Board amends

the rule and allow applicants to get licensed, the future decision of the Board has an impact on this. Ms.

Ashbee agreed with Mr. Henderson. Mr. Changus commented that this topic was brought up from the

three rule petitions and suggested the Board add to this matter to its August agenda for discussion, rather

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than trying to decide something now. Ms. Ashbee responded that as the consumer member of the Board,

Mr. Brinson made a motion for the Board to take the following actions:

Georgia Drugs and Narcotics Agency – Dennis Troughton

Cognizant’s Report – Mike Faulk

Attorney General’s Report – Max Changus

Mr. Changus discussed the following cases:

Mr. Changus discussed pending litigation.

Executive Director’s Report – Eric Lacefield

No report.