NEW JERSEY STATE BOARD OF PHARMACY
MINUTES OF THE OPEN SESSION
SEPTEMBER 10, 2008

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 September 10, 2008 at 9:22 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. (Left at 2:45 pm)
Margherita Lafragola, R.Ph.
Elvy T. Paiva, R.Ph.
Marc Sturgill, R.Ph. (Left at 3:00 pm)
Richard Palombo, R.Ph.

OTHERS IN ATTENDANCE

Joanne Boyer, R.Ph. Executive Director
Megan Cordoma, Esq. Deputy Attorney General

IV. UPDATE BY EXECUTIVE DIRECTOR

The Executive Director announced that $21,637.50 was collected in fines and penalties during August, 2008. There were 155 pharmacists licensed during the month of August, 2008. Twenty three by reciprocity and 132 by examination/score transfer. There were 633 pharmacy technicians registered during the month of August, 2008. There were 4 pharmacy permits issued during the month of August, 2008. These were issued as the result of transfer of ownership or new pharmacies opening. There were 14 out of state pharmacies registered during the month of August, 2008.

V. OLD BUSINESS

1) Jay Stuman, R.Ph., Renal Pharmacy operations Manager, Baxter Healthcare Corp, Deerfield , Il. – Regarding request for a special permit for Baxter’s Renal Dialysis Program This matter was last before the Board on 5/28/08 at which time the Board requested additional information

Pamela Allen moved, seconded by Elvy Paiva to inform Mr. Stuman that he is to appear before the Board to answer questions and concerns the Board has in regards to his response for additional information. Failure to cooperate with Board’s request may result in the Board rescinding permission to continue operations. The motion passed unanimously.

2) Ronald Hyman – Request for reinstatement

This matter was last before the Board on 2/27/08 at which time the Board requested additional information

Pamela Allen moved, seconded by Peter Halecky to consider Mr. Hyman’s request for reinstatement once his license to practice pharmacy in the State of Pennsylvania is active and in good standing. The motion passed unanimously.

3) MaryAnn Sheehan – Update on status of Immunization regulations

This matter is to be rescheduled since Ms. Sheehan was unable to attend this meeting.

VI. NEW BUSINESS

1) Pranav K. Patel – Request for a waiver of TOEFL-IBT

Margherita LaFragola moved, seconded by Thomas Bender to deny Mr. Patel’s request for a waiver for failure to show good cause. The motion passed unanimously.

2) Ravi Kohli – Regarding shipment of medications by mail order pharmacies Richard Palombo was recused due to his affiliation with Medco.

Thomas Bender moved, seconded by Peter Halecky that the Board does not have regulations that address this issue, but recommend that this matter be referred to the Nevada Board of Pharmacy since this is where his prescription was shipped from. In addition, the Board also recommends that Mr. Kohli refer to the United States Pharmacopeia (USP) and the specific manufacturer of the medication shipped for answers to his questions. This matter will also be referred to the Rule & Regs committee of the Board and will be raised at the upcoming NABP District I & II meeting in October during the roundtable discussion of the meeting. The motion passed unanimously.

3) Pamela Mandel, Esq. – Regarding marketing services

Elvy Paiva moved, seconded by Richard Palombo that Ms. Mandel did not provide enough information for the Board to adequately respond to the question regarding "what requirements we should be aware of". If you would provide a copy of the services contract and details as to how this process works, the Board would review and respond appropriately. In regards to the question regarding does your "client have to advise the patients that it is being paid by the specific pharmacies", the Board does not have any statute or regulation that addresses this. The motion passed unanimously.

4) Assembly Bill No. 3029 – Prohibits substitution of prescribed epilepsy drugs by pharmacists without prior notification to and written consent of physician and patient

Thomas Bender moved, seconded by Peter Halecky to oppose this Bill as written for the following reasons:

• the State already has a generic substitution bill in place which provides a mechanism to require the pharmacist to dispense brand name medications
• we should rely on the FDA’s experience in determining bioequivalency (this information is relayed to all interested parties via the Orange Book)
• patient can be stable on drug, by the same manufacturer, for a long period of time and have breakthrough seizures due to other factors
• could cause delay in patient’s obtaining medications in order to obtain the required signed consents
• could cause increased health costs; the Board suggests that a cost analysis be performed, perhaps, thru New Jersey State Medicaid

The motion passed unanimously.

5) Board discussion of NJAC 13:39 – 4.5 – definition of "change of ownership" This matter is placed on the agenda at the request of Board President, Edward McGinley

The Board accepted this as informational and will not be taking any action at this time.

VII. MITIGATION/ HEARING REQUESTS

1) Philip Effai Okai, RPIC, Ohene Pharmacy, Newark, NJ

Richard Palombo moved, seconded by Peter Halecky to deny the request for mitigation and accept Mr. Okai’s request of the payment schedule noted in his correspondence. The motion passed unanimously.

2) Amjad Latif, RPIC, Sheefa Pharmacy & Wellness Center, East Orange, NJ

Elvy Paiva moved, seconded by Pamela Allen to deny the request for mitigation of the $250 fine imposed pursuant to NJAC 13:39 – 4.5(a). The motion passed unanimously.

3) Foram Mehta, R.Ph., Walgreens, Hazlet, NJ

Elvy Paiva and Thomas Bender were recused due to their affiliation with Walgreens.

Richard Palombo moved, seconded by Margherita LaFargola to mitigate the $200 fine and the completion of the 2 CE credits imposed pursuant to NJAC 13:39 – 6.5 since new information was provided and the Board is unable to prove or disprove the allegations. The motion passed unanimously.

4) Bernard Buck, R.Ph., Rite Aid, Camden, NJ

Margherita LaFragola was recused due to her affiliation with Rite Aid.

Thomas Bender moved, seconded by Pamela Allen that this matter be moved into Executive Session for advice of counsel and discussion of settlement. The motion passed unanimously. At 11:37 pm, Elvy Paiva moved, seconded by Marc Sturgill to go back into Open Session.

Elvy Paiva moved, seconded by Marc Sturgill that based on advise of counsel this matter is to be rescheduled. The motion passed unanimously.

At 11:48 am, Elvy Paiva moved, seconded by Marc Sturgill to go back into executive Session. The motion passed unanimously.

VIII. COMMITTEE REPORTS

1) Compounding Committee

Peter Halecky reported that the Compounding Committee continues to meet monthly and is currently in the process of drafting non-sterile compounding regulations.

2) NABP District II Meeting, October 16 – 18, 2008, Seaview Marriott, Galloway Township, NJ Board President, Edward McGinley, reminded everyone to register for the meeting and obtain accommodations as deadlines are quickly approaching. Executive Director, Joanne Boyer, reminded all Board Members that if they are attending the meeting as a Board Member, they must submit all travel forms to the Board office as quickly as possible. Forms were provided to all Board members.

IX. APPROVAL OF MINUTES

1) August 13, 2008

Elvy Paiva moved, seconded by Thomas Bender to approve the minutes as amended. The motion passed unanimously.

X. ADJOURNMENT

At 10:55 am Thomas Bender moved, seconded by Pamela Allen to move into Executive Session for the review of 4 Complaints, 3 Old Business items, 7 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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