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COMMONWEALTH OF MASSACHUSETTS

Board of Registration in Pharmacy

NOTICE OF THE REGULARLY SCHEDULED MEETING OF THE

BOARD OF REGISTRATION IN PHARMACY

April 5, 2016

239 Causeway Street ~ Room 417 A&B

Boston, Massachusetts 02114

Agenda

Time #

Item

Exhibits Contact 8:30 I

CALL TO ORDER

E.

Taglieri

8:35 II

APPROVAL OF AGENDA

Introduction of Pharmacy Intern(s)

8:40 III

APPROVAL OF BOARD MINUTES

Draft of March 1, 2016 Regular Session Minutes

8:45 IV

PRESCRIPTION MONITORING PROGRAM UPDATE

E.

Sheehan

9:15 V

APPLICATIONS

IVG Veterinary Compounding Pharmacy - Transfer of

Ownership

Coram/CVS Specialty Infusion- Renovation/Expansion.

10:00 VI

REPORTS

Applications approved pursuant to Licensure Policy 13-01

Monthly Report from Probation

Reports

R. Harris

K. Fishman

10:05 VII

FLEX SESSION

NABP Annual meeting

D.

Sencabaugh

10:20 VIII

POLICIES

Outsourcing Facility Registration Transition Plan

Outsourcing Facility Staff Action Policy

Division Policy 16-01 Routine Responses

V. Berg

10 :45 IX

REGULATIONS

Proposed new regulations 247 CMR 19:00 - Hazardous Drugs

W. Frisch

M. Chan

1

11:30 X

FILE REVIEW

1. SA-INV-7899, CVS #2500, DS3606

2. PHA-2015-0126, CVS #1886, DS3334

3. SA-INV-7520, Coram CVS Specialty Infusion, DS3601

4. PHA-2016-0008, CVS #610, DS24018

5. SA-INV-8816, CVS #2200, DS2767

6. PHA-2015-0027, CVS #220, DS17722

7. PHA-2015-0095. Katie Ruth Blais, PH233923

8. SA-INV-7900, Rite Aid #10172, DS2405

9. SA-INV-7213, PharmaHealth Pharmacy, DS3056

10. SA-INV-8123, Winchendon Family Pharmacy, DS89843

11. SA-INV-7376, Preferred Pharmacy, DS3542

12. SA-INV-8938, Janet Troche, PT17388

13. PHA-2015-0073, Sullivan's Pharmacy, DS3335

14. SA-INV-9058, Pepperell Family, DS3541

15. SA-INV-8237, Ashburnham Family Pharmacy, DS3314

12:30

LUNCH BREAK

1:30 XI

EXECUTIVE SESSION

The Board will meet in Executive Session as authorized pursuant to M.G.L. c. 30A, § 21(a)(1) for the purpose of discussing the reputation, character, physical condition or mental health, rather than professional competence, of an individual, or to discuss the discipline or dismissal of, or complaints or charges brought against, a public officer, employee, staff member or individual. Specifically, the Board will discuss and evaluate the Good Moral Character as required for registration for pending applicants.

CLOSED SESSION

2:30 XII

ADJUDICATORY SESSION (M.G.L. c. 30A, § 18)

CLOSED SESSION

3:15 XIII

M.G.L. c. 112, § 65C SESSION

CLOSED SESSION

5:00 XIV

ADJOURNMENT

2

COMMONWEALTH OF MASSACHUSETTS

BOARD OF REGISTRATION IN PHARMACY

MINUTES OF THE REGULARLY SCHEDULED MEETING

239 Causeway Street, Fourth Floor Room 417A

Boston Massachusetts, 02114

April 5, 2016

Board Members Present Board Members Not Present Edmund Taglieri Jr., R.Ph, MSM, NHA Patrick Gannon, RPh, MS President Richard Tinsley, MBA, M.Ed. Timothy Fensky, R.Ph,

FACA Karen Conley, RN, DNP

President

elect Ali Raja, MD, M.B.A., M.P.H.

Garrett Cavanaugh, RPh

Michael Godek, R.Ph, Secretary

Phillippe Bouvier, R.Ph.

Catherine Basile, Pharm D, R.Ph.

Susan Cornacchio, JD

William Cox CPhT (arrived at 8:40)

Andrew Stein, Pharm D, R.Ph.

Richard Tinsley, MBA, M.Ed.,

Board Staff

Present

David Sencabaugh, RPh, Executive Director

William Frisch, Director of Pharmacy Compliance

Kelly Barnes, Director of Pharmacy Quality Assurance

Heather Engman, JD, MPH Board Counsel

Sam Leadholm, JD, Board Counsel

Richard Harris, Program Analyst

Monica Vasquez, Compliance Officer

Julienne Tran, PharmD, RPh. Pharmacy Investigator

Christina Mogni, R. Ph., Pharmacy Investigator

Cheryl Lathum, Pharm D., R.Ph., Senior Investigator

Greg Melton, JD, R.Ph., Pharmacy Investigator

Vita Palazzolo Berg, JD, Chief Board Counsel

Karen Fishman, Probation Monitor

TOPIC: I

CALL TO ORDER

8:30 AM

DISCUSSION

: A quorum of the Board was present, established by roll call. President E. TAGLIERI chaired

the meeting and asked if anyone was recording. Hearing “no", he explained that the Board of Pharmacy was

recording the meeting. D. SENCABAUGH introduced APPE students Brian Ho from Northeastern University and Mei Zou , from MCPHS University.

TOPIC II.

APPROVAL OF AGENDA

DISCUSSION

The open file review on Sullivans Pharmacy, Winchendon Family Pharmacy, and Ashburnham

Family Pharmacy

will be deferred.

ACTION:

1. Motion by M. GODEK, seconded by, C. BASILE, and voted unanimously to approve the agenda (W. COX had not yet arrived). 3

TOPIC III.

APPROVAL OF BOARD MINUTES

1. Draft

March 1, 2016, Regular Session Minutes

DISCUSSION

Need to correct minutes by removing M

Godek from the “affirmative" section of applications, specifically on the Nimble Pharmacy vote.

ACTION:

2. Motion by M. GODEK, seconded by, P. BOUVIER, and voted unanimously to approve the minutes of the

General Session from

March 1, 2016, with the noted change

(W. COX had not yet arrived).

TOPIC IV:

PMP Program Update

Eric Sheehan, Interim Bureau Director HCSQ, presented an overview of the new PMP program, scheduled to be

released this spring. Sheehan was jo ined by Director of OPMDC and Tom Innis of the Ripples Group.

Sheehan explained that the new program will have the capability to connect with up to 42 states when it comes

to the "go live" date of 5/31/16.

TOPIC V:

APPLICATIONS TIME: 9:10AM-10:14AM

1. IVG Veterinary Compounding Pharmacy Transfer of Ownership

DISCUSSION

: IVG was represented by Veterinarian Dr. Patrick Welch and Attorney Sean Ryan of Donoghue

Barrett & Singal.

Ethos Veterinary Health LLC is the new owner of IVG. Since ownership of Ethos consists of

eighteen out-of-state veterinarians, they are simultaneously seeking the expansion of a waiver to 247 CMR

6.01(3), allowing such ownership. After making the case that there is a compelling reason to grant the waiver,

and answering the Board Member"s questions about the owner veterinarians writing prescriptions that will be

filled at IVG, the Board members were satisfied. 3. ACTION: Motion by T. FENSKY, seconded by, C. BASILE, and voted unanimously, to approve the application for the transfer of ownership and the waiver. 2.

Coram/CVS Specialty Pharmacy Renovation/Expansion

RECUSAL: Susan Cornacchio recused and was not present during discussion or voting on this topic.

DISCUSSION

Coram/CVS was represented by MOR Shamir Patel and Attorney Joe Lavino. The discussion

centered around the ratification by the Board of the Board Staff"s approval of “Phase I" (limited compounding

performed with an isolator) of a 4-phased plan to renovate and expand the sterile compounding facility, and the

request by Coram to expand the Phase I approach to include refills. Director of Quality Assurance, K. Barnes

and Director of Compliance, W. Frisch, expressed concerns about such expansion, based on the history of

abnormal results at the facility, and other issues of concern.

Board Members asked for clarification of what

Coram was looking for them to vote on. MOR Patel stated that they wanted permission to compound the first

dose, 1 st refills, and subsequent refills on low risk CSPs, as well as some limited ability to do the same for medium risk CSPs.

There was action on

that request. 4. ACTION: Motion by T. FENSKY, seconded by W. COX, to approve the request by Coram, and voted unanimously to OPPOSE said request. 5. 6.

ACTION: Motion by T. FENSKY, seconded by C. BASILE, to approve the first fill on low risk and limited

medium (what was approved by Staff already) and voted unanimously, to approve the

Phase I as initially approved

by Board Staff, for a maximum of 90 days. 7. 4

TOPIC VI.

REPORTS

Applications Approved Pursuant to Licensure Policy 13-01

DISCUSSION

: R. HARRIS noted that during the past month there have been thirty-eight (38) change of managers, and four (4) renovation/expansions since the last Board meeting.

ACTION

: So noted

Report of activities Probation Monitor

DISCUSSION

K. FISHMAN

provided the February 23, 2016 - March 25, 2016, Board of Pharmacy Statistics Report for the Probation monitor, which noted that: there are (5 9 ) licensees on probation, thirteen (13) satisfactorily completed probation, two (2) licensee did not cure within 30 days, and four (4) given the opportunity to cure.

ACTION

: So noted

TOPIC VII.

Flex Session

1.

NABP Annual Meeting

DISCUSSION:

D. SENCABAUGH

updated the Board on the NABP

Annual Meeting being held in San Diego,

CA May 14

17. T. FENSKY will be attending as the voting delegate, and he is also running for the District I

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