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 February 13, 2008 at 10:22 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.
Margherita Lafragola, R.Ph.
Elvy T. Paiva, R.Ph.
Marc Sturgill, R.Ph.
Richard Palombo, R.Ph.

OTHERS IN ATTENDANCE

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

EXCUSED

Jennifer DeVenio Government Member
Axel Miranda Public Member

IV. UPDATE BY EXECUTIVE DIRECTOR

The Executive Director announced that $44,475.00 was collected in fines and penalties during January, 2008. Approximately $14,000 of the above stated amount was as a result of the fines issued for pharmacists failing to complete the required continuing education credits for the May 1, 2005 thru April 30, 2007 biennial license renewal period. There were 46 pharmacists licensed during the month of January, 2008. Nine by reciprocity and 37 by examination/score transfer. There were 20 pharmacy permits issued during the month of January, 2008. These were issued as the result of transfer of ownership or new pharmacies opening.

Ms. Boyer reported that the Division has not been able to have the online registration of pharmacy technicians functioning as planned. In order not to further delay the registration process, the pharmacy technician registration application, along with instructions has been place on the Board’s website (www.njconsumeraffiars.gov/medical/pharmacy.htm) in the "Forms" section. The regulations, as published on September 4, 2007, stated that the registration of all currently employed technicians was to be completed by March 3, 2008. Margerita LaFragola moved, seconded by Richard Palombo to extend the registration period for an additional 9 months. MaryAnn Sheehan, Regulatory Analyst for the Board, will file the proper paperwork for the extension. This extension will require that all technicians will need to registered with the Board by December 1, 2008. It is highly encouraged that all technicians submit a completed application as soon as possible. Once an application is received and reviewed, paperwork will be sent to the applicant regarding the criminal history background check. Pharmacies in the state will be notified of the availability of the application. Once the application process has been completed, including the criminal history background check, a registration document will be forwarded to the technician. This document will note that the registration is good until August 31, 2010. Registered technicians will need to renew their registration at that time and every 2 years thereafter.

Ms. Boyer noted that there was an error in the Board of Pharmacy newsletter published January, 2008. The newsletter stated that "certified technicians" need to register with the Board. This is incorrect. The Board does not require certification of technicians and all technicians need to register with Board. A correction will be placed in the next newsletter.

V. CONTINUING EDUCATION REPORT

Pamela Allen was recused due to her affiliation with the St. Barnabas Health Care System.

Marc Sturgill moved, seconded by Peter Halecky to accept the continuing education report. The motion passed unanimously.

VI. OLD BUSINESS

1) Timothy Koch, Director, Professional Services/Govt. Relations, Wal-Mart – Use of Automated Delivery Device Agreement This matter was last before the Board on 10/11/06 at which time the Board determined to approve the concept and formalize criteria for utilization of secured will call bin technology Elvy Paiva moved, seconded by Marc Sturgill to approve the terms of the Automated Delivery Device Agreement. The Executive Director will forward the Agreement to Mr. Koch for signature. The motion passed unanimously.

VII. NEW BUSINESS

1) Melissa Morris, Research Analyst, Progressive Medical, Inc., Westerville, Ohio – Regarding need for licensing of Drug Utilization Review (DUR) Department

The Chair directed to have Ms Morris submit additional information:

• Are they or will they be operating out of a New Jersey location
• How do they obtain patients
• Are they tied to a pharmacy that dispenses to each patient that they ship to

2) Hemangkumar Patel – Reciprocity candidate requesting a waiver of NJAC 13:39 – 2.9(a)

Elvy Paiva moved, seconded by Richard Palombo to deny Mr. Patel’s request for a waiver. He is advised to take the TOEFL IBT test. The motion passed unanimously.

3) Edward W. Casey – Reciprocity candidate requesting that his employment at Pfizer as a Clinical Education Consultant be accepted as "practice of pharmacy" as noted in NJAC 13:39 – 3.2(a)3

Richard Palombo moved, seconded by Peter Halecky that the his work experience as a Clinical Education Consultant/Medical Outcomes Specialist for Pfizer qualifies as the "practice of pharmacy" as stated in NJAC 13:39:3.2(a)3. The motion passed unanimously.

4) Sreedhar Vajinepalli, RPIC/Owner, Health Care Pharmacy, Passaic, NJ – Requesting a waiver to maintain same permit number upon transfer of ownership

Thomas Bender moved, seconded by Elvya Paiva to approve the request to maintain the same permit number upon transfer of ownership. The motion passed unanimously.

5) Steven Aragona, R.Ph., director of Pharmacy, Hackensack University Medical Center – Request for a waiver of NJAC 13:39 – 11.19(d)

Pamela Allen moved, seconded by Thomas Bender to deny Mr. Aragona’s request for a waiver. The motion passed unanimously.

VIII. MITIGATION/ HEARING REQUESTS

Elvay Paiva and Thomas Bender were recused from the following mitigation requests due to their affiliation with Walgreens.

1) Christine Walsh, RPIC, Walgreens, Teaneck, NJ

Pamela Allen moved, seconded by Peter Halecky to deny the request for mitigation for the warning issued pursuant to NJAC 13:39 – 7.18 and NJAC 13:39 – 6.2(f)7. A copy of the inspector’s hand written report is to be forwarded to Elisa Choi, Attorney, Walgreens. The motion passed unanimously.

2) Margarita Kotsogiannis, RPIC, Walgreens, Carlstadt, NJ

Pamela Allen moved, seconded by Richard Palombo to mitigate the $50 fine issued pursuant to NJAC 13:39 –7.18 and NJAC 13:39 – 6.2(f)7 to $25. The $1,000 fine imposed pursuant to NJAC 8:65 – 5.7 is to be mitigated if Ms. Kotsogiannis is able to provide the Executive Director a copy of the relevant CDS biennial inventory. The motion passed unanimously.

3) Arti Vaidya, RPIC, Walgreens, Fair Lawn, NJ

Pamela Allen moved, seconded by Richard Palombo to have the Enforcement Bureau provide a detailed inspection report. If this report is not available, then the $400 fine imposed pursuant to NJAC 13:39– 6.2(f)7 is to be mitigated. A copy of the inspector’s hand written report is to be forwarded to Elisa Choi, Attorney, Walgreens The motion passed unanimously.

4) Shelly Agarwal, RPIC, Walgreens, Elmwood Park, NJ

Marc Sturgill moved, seconded by Peter Halecky to mitigate the $300 fine imposed pursuant to NJAC 13:39 – 7.18 and NJAC 13:39 – 6.2(f)7. The motion passed unanimously.

5) Kathryn Pombo, RPIC, Walgreens, Newark, NJ

Marc Sturgill moved, seconded by Richard Palombo to mitigate $100 of the $175 fine imposed pursuant to NJAC 13:39 – 7.18 and NJAC 13:39 – 6.2(f)7. The motion passed unanimously.

6) C. Hui Yoo, RPIC, Walgreens, Teaneck, NJ

Pamela Allen moved, seconded by Richard Palombo to mitigate the $100 fine imposed pursuant to NJAC 13:39 – 7.18 and NJAC 13:39 – 6.2(f)7. The motion passed unanimously.

IX. COMMITTEE REPORTS

1) Compounding Committee

Thomas Bender reported that committee expects to have a final draft of the updated sterile compounding regulations after the March 5, 2008 committee meeting. The final draft will then be placed before the Board for review and approval.

2) CQI Committee

Elvy Paiva reported that Assembly Bill No.1803 was reintroduced on January 24, 2008. This Bill is titled "Pharmacy Quality Improvement and Error Prevention Act". The Committee will monitor the Bill’s progress and meet as appropriate.

3) Enforcement Liaison

Peter Halecky will be meeting with the Enforcement Bureau to discuss format and detail of Inspection Reports provided to the Board. Mr. Halecky requested that Board Members forward to him any additional items they wish to be discussed.

X. APPROVAL OF MINUTES

1) January 23, 2008

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

XI. ADJOURNMENT

At 11:20 am Pamela Allen moved, seconded by Marc Sturgill to move into Executive session for the review of 6 complaints, 1 Old Business item, 6 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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