I. CALL TO ORDER

The Open Meeting of the New Jersey Board of Pharmacy was called to order by Board President Edward McGinley in the Somerset Room, 6th Floor at 124 Halsey Street, Newark, New Jersey on June 25, 2008 at 9:24 a.m. All members were duly notified of the time and place and all pertinent materials were provided to the members.

II. SUNSHINE LAW ANNOUNCEMENT

Mr. Edward McGinley, President read a statement to the effect that the newspapers and appropriate elected officials had been notified of the meeting according to the requirement of the Open Meetings Act N.J.S.A., Chapter 231, PL 1975,/C. 10:4-8.

III. ROLL CALL

Edward G. McGinley, R.Ph. President
Thomas Bender, R.Ph. Vice President
Pamela Allen, R.Ph.
Peter Halecky, R.Ph.
Margherita Lafragola, R.Ph.
Elvy T. Paiva, R.Ph. (Arrived at 9:40 am)
Richard Palombo, R.Ph. (Arrived at 9:36 am)
Marc Sturgill, R.Ph.

OTHERS IN ATTENDANCE

Joanne Boyer, R.Ph. Executive Director
Marianne Greenwald, Esq. Deputy Attorney General

IV. UPDATE BY EXECUTIVE DIRECTOR N/A

V. CONTINUING EDUCATION REPORT

N/A

VI. OLD BUSINESS

1) Perry Bernocchi, Executive Vice President, Byram Healthcare, White Plains, NY – Regarding request for a specialized permit for their New Jersey distribution center This matter was previously before the Board on 11/14/07 and 2/27/08. Byram was to submit a proposal which will include the activities of a pharmacist for all those products/items that require a prescription. Elvy Paiva and Thomas Bender were recused due to their affiliation with Byram Healthcare

At 9:48 am Pamela Allen moved, seconded by Margherita LaFragola to go into Executive Session for deliberation on this matter. At 10:24 am Peter Halecky moved, seconded by Margherita LaFragola to go back into Open Session

Peter Halecky moved, seconded by Pamela Allen to approve Byram Healthcare’s request for a specialized permit pending an inspection of the proposed pharmacy and receipt of the Policy and Procedure that details the pharmacist final check process. The Board approves the following waiver requests:

• NJAC 13:39 – 4.10 (a) & (c)
• NJAC 13:39 – 4.14(b)4, 5 & 8
• NJAC 13:39 – 5.2
• NJAC 13:39 – 5.3
• NJAC 13:39 – 5.5
• NJAC 13:39 – 5.6
• NJAC 13:39 – 5.8(a)1, 2, 4 –13 and 15 – 18
• NJAC 13:39 – 5.11
• NJAC 13:39 – 6.2(f) (only the 35 hour requirement)
• NJAC 13:39 – 6.6
• NJAC 13:39 – 7.12

In addition the Board has determined to grant a waiver of NJAC 13:39 – 4.14(b) 1, 2, & 3. The Board determined not to grant a waiver to perform a minimum of 5% of all the final product review until it fully understands Byram’s policy and procedure regarding this process. Byram Healthcare will be required to submit a Central Fill application as stated in NJAC 13:39 – 4.18. Byram Healthcare may continue to service patients as they do today until final approval by the Board. The motion passed unanimously.

2) Thomas Clancy, R.Ph. – Requesting end date to Consent Order Filed 3/9/06

Pamela Allen moved, seconded by Marc Sturgill that Mr. Clancy has submitted proof of his compliance with the terms of his Consent Order, Filed March 9, 2006 and the Board has decided that the conditions of the Consent Order are now terminated. The motion passed unanimously.

VII. NEW BUSINESS

1) Charles H. Rubinstein – Request for reinstatement

Pamela Allen moved, seconded by Marc Sturgill to schedule Mr. Rubinstein for an Investigative inquiry. The motion passed unanimously.

2) Edward McGinley, VP of Pharmacy Operations, Drug Fair Group, Somerset, NJ – Requesting that the ScriptPro, as utilized by Drug Fair pharmacies, be considered a sophisticated counting device, and not an automated medication system as defined in NJAC 13:39 – 10.2 Edward McGinley was recused due to his affiliation with Drug Fair

Elvy Paiva moved, seconded by Peter Halecky to approve Mr. McGinley’s request that ScriptPro, as utilized by Drug Fair pharmacies, be considered a counting device and not an automated medication system. The motion passed unanimously.

3) Pamela Allen, Corporate Vice President and Chief Pharmacy Officer, St. Barnabas Health Care System, West Orange, NJ – Regarding the use of Intellifill IV Robot Pamela Allen was recused due to her affiliation with the Saint Barnabas Health Care System

At 11:27 am, Elvy Paiva moved, seconded by Peter Halecky to go into Executive Session for deliberation on this matter. At 12:08 pm, Peter Halecky moved, seconded by Elvy Paiva to go back into Open Session.

The Chair directs that the Board understands the potential for this technology, but there is insufficient information presented to render a decision at this time. Ms. Allen is to submit the proposed Policy and Procedure detailing how Livingston Infusion Center would utilize the robot, security access, supervision of staffing, where the robot would be set-up, maintenance intervals and procedures, what products will be utilized, how the finished product will be stored and shipped, a listing of projected hospitals that could utilize this service, the IntelliFil procedure manual as supplied by ForHealth Technologies, Inc., and a copy of the evaluation by Eric Kastango. ForHealth Technologies, Inc is to provide a list of states where this technology is being utilized, the type of license obtained and any conditions mandated by the State. Once this information is received, the matter will be placed before the Board for consideration. The motion passed unanimously.

4) Pamela Mandel, legal counsel for Ashraf Latif, part-owner, Sheefa Pharmacy & Wellness Center, East Orange, NJ – Requesting approval to maintain same permit number upon transfer of ownership

Elvy Paiva moved, seconded by Richard Palombo to approve Mr. Latifs request to have Sheefa Pharmacy & Wellness Center maintain the same permit number upon transfer of ownership. Mr. Latif is to comply with all other requirements in NJAC 13:39 – 4.5. The motion passed unanimously.

5) Catherine Ann Fee – Request for reinstatement

Elvy Paiva moved, seconded by Peter Halecky to schedule Ms. Fee for an Investigative Inquiry. Ms. Fee is to provide the Board with an employment history prior to the Inquiry. The motion passed unanimously.

6) Leonard Stefanelli, R.Ph., West Orange Pharmacy, West Orange, NJ – Request to maintain same ownership upon transfer of ownership

Richard Palombo moved, seconded by Thomas Bender to approve Mr. Stefanelli’s request to have West Orange Pharmacy maintain the same permit number upon transfer of ownership. Mr. Stefanelli is to comply with all other requirements in NJAC 13:39 – 4.5. The motion passed unanimously.

7) John E. Stanovich, Assistant Dean, The University of Findlay School of Pharmacy, Findlay, Ohio – Requesting consideration of their ACPE approved program, Administration of Injectable Medications, Biologicals and Immunizations (Pharmacy Based Immunization Program) to meet the requirement for "appropriate education or certification" as stated in NJSA 45:14 – 63

Richard Palombo moved, seconded by Marc Sturgill to refer this matter to the Immunization Committee for review and recommendation. The Committee will be compiling a list of programs which will be considered acceptable as training for a pharmacist to administer immunizations. The motion passed unanimously.

VIII. MITIGATION/ HEARING REQUESTS

1) Thomas Caruso, RPIC, Pathmark Pharmacy, Deptford, NJ
Edward McGinley was recused since he was employed by Pathmark at the time of the inspection.

Margherita LaFragola moved, seconded by Pamela Allen to deny the request for mitigation for the $200 fine imposed pursuant to NJAC 13:39 – 5.8(a)1 and the $250 fine imposed pursuant to NJAC 8:65 – 2.5(b). The motion passed unanimously.

2) Behzad Aalampour, RPIC, Jefferson Pharmacy, Lake Hopatcong, NJ

Thomas Bender moved, seconded by Pamlea Allen to deny the request for mitigation of the $100 fine imposed pursuant to NJAC 13:39 – 7.18 & 6.2(f)7, the $250 fine imposed pursunat to NJAC 13:39 – 7.12(a)13I and the $1,000 fine imposed pursuant to NJAC 8:65 – 5.7. The motion passed unanimously.

3) Gopi Padmanabhan, RPIC, Target Pharmacy, Cherry Hill, NJ

Peter Halecky moved, seconded by Marc Sturgill to mitigate the $1,000 fine imposed pursuant to NJAC 13:39 – 4.14(b)1. The motion passed unanimously.

IX. COMMITTEE REPORTS

X. APPROVAL OF MINUTES

1) June 11, 2008 Pamela Allen moved, seconded by Marc Sturgill to approve the minutes as amended. The motion passed unanimously.

XI. ADJOURNMENT

At 1:10 pm Margherita LaFragola moved, seconded by Richard Palombo to move into Executive Session for the review of 5 Complaints, 1 Old Business item, 4 New Business items, Secretary’s Report and Recommendation on Retail and Institutional Permits, Secretary’s Report and Recommendation on Inspection Reports, conduct 2 Investigative Inquiries and approval of minutes. The motion passed unanimously

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