Vermont Board of Pharmacy Unapproved Minutes for July 24, 2013 Board Meeting--Including a Discussion of Who Regulates Physician Who Dispensing

VERMONT BOARD OF PHARMACY – Unapproved Minutes
Secretary of State, Office of Professional Regulation
89 Main Street, 3
rd
 Floor, Montpelier, VT  05620-3402
July 24, 2013 at 9:00 A.M.
1. The meeting was called to order at 9:05 a.m.
 Members Present: Mr. Jeffrey Firlik, RPh, Chair; Ms. Julie A. Eaton, RPh, Vice-Chair; Ms. Judith
Wernecke, Public Member, Secretary; Mr. Steven M. Vincent, RPh; Mr. James Arisman, Esq.,
Public Member; and Mr. Larry Labor, RPh
 Members Absent: King Milne, RPh
OPR Personnel Present:  Mr. Larry S. Novins, Board Counsel; Mr. Ronald Klein RPh, Executive
Officer; and Ms. Aprille Morrison, Licensing Board Specialist.
Others Present:  Quincy Campbell, Mike Fish, Analesa Muir, Heather Shouldice, Sal Morana,
Rita Bagolini (by phone) and Dick Wilcox (by phone)
2. The Chair called for approval of the Minutes of the June 26, 2013 meeting as presented.  Mr.
Vincent made a motion to approve the minutes.  The motion was seconded by Ms. Eaton.
Motion passed.
3.  Hearings/Stipulations et al:
9:15 AM – Hearing – John Walters, Docket # 2013-213 – Motion for Continuance granted just
prior to meeting.
 
Mr. Klein presented an order for removal of conditions for Enosburg Pharmacy. Mr. Vincent
made a motion to accept the order.  The motion was seconded by Mr. Labor.  Motion passed.
Mr. Klein presented an order for removal of conditions for Corner Drug Co., Inc. and William
Aimi, RPh.  Ms. Eaton made a motion to table the request as the Board requires further
information regarding inspections.  The motion was seconded by Mr. Labor.  Motion passed.
5.  Guests:
 
 10:30 am – Heather Shouldice, VT Association of Chain Drug Stores – Clarification on Act 75.
Ms. Shouldice and Mike Fish from Hannaford’s Drug Stores addressed the Board regarding the
legislative requirements imposed on the Board regarding Act 75.  Mr. Novins stated the Board
should not be trying to interpret the intent of legislature as regards the additional prescription
requirements mandated by the legislation.  Ms. Shouldice will contact the chairman of the
Senate Judiciary Committee to request a meeting to discuss the intent of the legislature.     Ms.
Shouldice will also file a petition with the Board of Pharmacy seeking a declaratory judgment on
certain applicable parts of the legislation.    It is anticipated the Board will take up the petition at
its August meeting.
 11:00 AM – Sal Morana – Discussion with the Board regarding a proposal to consolidate the
drug purchasing for three hospitals.  Mr. Morana informed the Board the three hospitals are Board of Pharmacy   Page 2
looking to consolidate their drug purchasing in order to reduce costs and waste.  The Board
recommended that they register a separate entity as a distributor.
6.  Case Manager’s Report:
 Ms. Preston reported to the Board on the number of cases they currently have.  There are 33
cases, nine (9) ready for Investigative Team meeting, one (1) ready for closing, seven (7) are in
intake, seven (7) have had charges filed, four (4) are pending hearing, four (4) are under
investigation and one (1) is awaiting response.
7. Legislation/Rulemaking:
Legislative Updates:
A) Proposals for Statute Amendments:
• The Board discussed amending the statutes to give the Board the ability to require
certification of technicians.  The Board would like to require any individual who assists in
the preparation of a prescription to be nationally certified.  The Board discussed the
different categories they would like to have for technicians and their transition from noncertified to certified.  The Board has agreed they would like to request authority from
Legislature to require certification of technicians.
• Mr. Klein addressed the Board regarding the National Precursor Log Exchange (NPLEx)
called for in Act 75 passed by the 2013 Vermont General Assembly.  This online system
monitors the purchase of precursor chemicals and over the counter drugs used in the
illegal production of methamphetamine, a Schedule I controlled substance.    The system
acts to prevent the purchase of excessive quantities of these chemicals and drugs. In
small quantities, these over the counter drugs do have legitimate medical uses.   It
appears that neither the Vermont Prescription Monitoring System (VPMS) nor the
Vermont Board of Pharmacy have statutory authority to manage/monitor the
implementation and operation of the system.  The statutes requiring the implementation
and use of the NPLEx are in Department of Health Statutes.  Mr. Klein will contact the VT
Department of Health to try to get this straightened out and see if the Board of Pharmacy
needs to amend their regulations so as to manage the system.   Mr. Klein stated it may
be appropriate for the Board to request amendments to the statute at the next session of
the legislature.
• Definition for collaborative practice: a licensed pharmacist providing certain patient care
pursuant to rules adopted by the Board of Pharmacy under a written agreement with a
collaborating physician.
• Mr. Novins informed the Board of the additional licensure statuses that he would like to
see added to the statutes for all professions.  His proposal would allow there to be at
least three license statuses, active, inactive (per request) and lapsed/expired.  The Board
agreed that there should be additional licensure statuses added to statute.
• Ms. Eaton would like Mr. Klein to notify all prescribing Boards (Medical, Naturopathic
Physicians & Surgeons, Osteopathic Physicians, Dental Board, Midwives, Optometry and
Board of Veterinary Medicine) that according to Act 75 all written or type written
prescriptions for Schedule II, III and IV controlled substances must contain the quantity in
numeric and written out format. Board of Pharmacy   Page 3
 B) Rules Amendments and Revisions:
• The Board discussed return of unused drugs from nursing homes to a pharmacy for
resale and reimbursement.  The Board was under the understanding that this was
already allowable under federal regulations as long as the packaging was not tampered
with and they were not controlled substances.  They were also under the understanding
that as long as the medication was under the direction of a licensed professional (nurse,
physician, physician assistant or medical assistant) that it could be returned to a
pharmacy.  Mr. Klein does not know of any federal regulations that allow this.  Mr. Klein
asked the Board their thoughts regarding a cancer drug repository.  The Board felt this
was not a discussion they wanted to take up at this time, that there were too many
liabilities with retail pharmacies holding these.
• Mr. Vincent brought up the issue of physician dispensing.  The Board would like Mr. Klein

Vermont Board of Pharmacy March 27, 2013 Agenda for Meeting

BOARD OF PHARMACY
Secretary of State, Office of Professional Regulation
32 College Street, Schulmaier Hall, Montpelier, VT
Agenda
March 27, 2013 at 9:00 A.M.
1. Call to order (review agenda).
2. Approval of the Minutes of the December 5, 2012 and January 23, 2013 meetings.
3. Hearings/Stipulations et al:
9:15 am – Stipulation and Consent order in the matter of Karen Rouse, Docket # 2012-384
1:00 pm – Motion for Supervision Re. Glenn Myer, Docket # 2009-487, Follow-Up Case # M2011-54
4. Discussion Items:
10:00 am – Pharmacist Workload Issues Discussion
Josh Bolin from NABP attending
To participate by conference call please call the toll free number: 866-642-1665 and enter participant pass
code 463516.
5. Case Manager’s Report:
Carla Preston, Case Manager, to report on current and follow-up cases.
6. COMPLAINTS, review of Reports of Concluded Investigation:
Report of Concluded Investigation Re.: 2011-850 (Larry Labor is the Investigative Team member)
Report of Concluded Investigation Re.: 2011-851 (Larry Labor is the Investigative Team member)
Report of Concluded Investigation Re.: 2012-100 and 2012-101 (Julie Eaton is the Investigative Team
member)
Report of Concluded Investigation Re.: 2012-96 and 2012-97 (Julie Eaton is the Investigative Team
member)
Report of Concluded Investigation Re.: 2012-94 and 2012-95 (Julie Eaton is the Investigative Team
member)
Report of Concluded Investigation Re.: 2012-88 and 2012-89 (Julie Eaton is the Investigative Team
member)
Report of Concluded Investigation Re.: 2012-143 (Jeffrey Firlik is the Investigative Team member)
7. Reports: None
8. Legislation/Rulemaking:
Legislation in other states – Ronald Klein discussion
9. Review Applications:
Drug Depot, Inc. d/b/a APS Pharmacy – Palm Harbor, FL (Non-Resident Drug Outlet)
Abraxis Bioscience, LLC – Melrose Park, IL (Wholesale Distributor Application)
Diabetic Care Rx, LLC d/b/a DCRX Infusion – Sunrise, FL (Non-Resident Drug Outlet)
Porter Hospital – request for waiver of Administrative Rule 6.2c
Hotbar, LLC d/b/a Monroe Clinic Drugs – Monroe, LA
Board of Pharmacy Page 2
Advantage Pharmacy, LLC – Hattiesburg, MS
Vicksburg Special Care Pharmacy & Compounding, LLC – Vicksburg, MS
10. Executive Officer Report
11. Correspondence:
David Herlihy E-mail re.: Physician Dispensing
All-American Allergy Alternatives – letter regarding prescription pick-up and delivery
Express Scripts – Tour of Technology & Innovation Center during NABP meeting in St. Louis (attendance)
12. Pharmacy Technicians: Total number of Active Registered Technicians is 1, 574 (1,458 Resident, 116
Non-Resident).
13. Newsletter Topics!
14. National Association of Boards of Pharmacy (NABP)
NABP Annual Meeting
15. Public Comment
16. Other Business
MPJE Item Writing
OPR credential list – review/consolidate
17. The next meeting is scheduled for Wednesday, March 27, 2013, at 9:00 A.M.
18. Adjourn
2013 MEETING DATES
April 24th, May 15th, June 26th, July 24th, August 28th, September 25th, October 23rd and December 4th
Executive Office Report
February 27, 2013 at 9:00 A.M.
1. Applications approved for licensure as a Pharmacist (including Interns and Preceptors):
Robyn Wahl – Endorsement Derek Mixon – Endorsement
Danielle Swanson – Endorsement Sean Carpenter – Endorsement
Alexis Cayoca – Endorsement John Nahas – Endorsement
Thomas Henry III – Endorsement Thomas Cooney – Endorsement
Ronald Klein – Endorsement Lea Sporzynski – Endorsement
Kristin DeBellis – Reinstatement Kelly Conn – Endorsement
James Bartingale - Endorsement
2. Applications for licensure as an Out of State Registered Pharmacist (Telepharmacy):
Bhumi Patel
Board of Pharmacy Page 3
3. In-State Drug Outlets (pharmacies, wholesalers, manufacturers, etc.):
River Street Pharmacy – Springfield, VT licensed 1/28/13
PharmaLogic, Ltd. – Williston, VT licensed 2/19/13
Porter Medical Center Long Term Care Pharmacy – Middlebury, VT licensed 3/7/13
Shaw’s Osco Pharmacy #7515-411 – Colchester, VT (Change in Ownership) licensed 3/7/13
Shaw’s Osco Pharmacy #7516-412 – Berlin, VT (Change in Ownership) licensed 3/7/13
Shaw’s Osco Pharmacy #7517-413 – Burlington, VT (Change in Ownership) licensed 3/7/13
Shaw’s Osco Pharmacy #7518-414 – Williston, VT (Change in Ownership) licensed 3/7/13
Shaw’s Osco Pharmacy #7649/430 – Waterbury, VT (Change in Ownership) licensed 3/7/13
4.. Change in Pharmacist Manager:
Porter Hospital Pharmacy – change of Pharmacy Manager to Renee Mosier – processed 2/1/13
Kinney Drugs, Inc. #29 – change of Pharmacy Manager to Laura Racicot – processed 2/5/13
Rite Aid Pharmacy #10329 – change of Pharmacy Manager to Carrie Chew – processed 2/5/13
Hannaford Food & Drug #8129 – change of Pharmacy Manager to Heidi Yialiades – processed 2/21/13
Price Chopper Pharmacy #127 – change of Pharmacy Manager to Cynthia Holley – processed 2/26/13
Shaw’s Osco Pharmacy #7517/413 – change of Pharmacy Manager to Karen Wyman – processed 3/7/13
5. Non-Resident Pharmacies:
Leiter’s Cambrian Park Drugs, Inc. d/b/a Leiter’s Pharmacy(Change of Ownership)– San Jose, CA
licensed 1/25/13
Nuro Pharma, Inc. d/b/a Nuro Pharma – Las Vegas, NV licensed 1/25/13
Bella Brands, LLC – Sandy, UT licensed 1/28/13
Post Oak Pharmacy, LP d/b/a Lifecheck Drug #19 – Houston, TX licensed 2/1/13
Myhan Enterprises, Inc. d/b/a Colbert Pharmacy – Sheffield, AL licensed 2/5/13
Thrift Pharmacy, Inc. – Pompano Beach, FL licensed 2/5/13
Advantage Pharmacy LLC – Memphis, TN licensed 2/7/13
Goot Nursing Home Pharmacy, Inc. d/b/a PharMerica – Phoenix, AZ licensed 2/13/13
PharmaLabs, LLc – St. Petersburg, FL licensed 2/19/13
Malanda, Inc. d/b/a Mandell’s Clinical Pharmacy – Somerset, NJ licensed 2/19/13
Wegmans Food Markets, Inc. – Cheektowqaga, NY licensed 2/22/13
Medcart LTC, Inc. d/b/a Medcart Specialty Pharmacy – Livonia, MI licensed 2/26/13
Pet Rescue Rx, Inc. d/b/a Pet Rescue Rx – Akron, NY licensed 3/6/13
Hopkinton Drug, Inc. - Hopkinton, MA licensed 3/6/13
OncoMed The Oncology Pharmacy of Philadelphia PA LLC – Crum Lynne, PA licensed 3/12/13
Crescent Drug Corp. d/b/a Echo Drugs – Long Island City, NY licensed 3/13/13
RxCare Providers Corp. d/b/a Echo Pharmacy – Long Island City, NY licensed 3/13/13
National Compounding Company, Inc. d/b/a Soothe Compounding Pharmacy – Bradenton, FL licensed
3/15/13
Cardinal Health 414, LLC – Denver, CO licensed 3/15/13
Serquinox LLC d/b/a Equinox Healthcare – Ellicott City, MD - change in ownership processed
3/19/13
6. Non-Resident Wholesaler/Manufacturer Drug Outlets:
Foundation Care LLC – Earth City, MO licensed 1/30/13
Cooper Surgical, Inc. – Trumbull, CT licensed 2/1/13
Paratus Health Systems, LLC – Alpharetta, GA licensed 2/13/13
Albertsons LLC d/b/a Albertsons LLC Distribution Center #8720 – Ponjca City, OK licensed
2/22/13
Med-Pro Distributors, LLC – Charlotte, NC licensed 2/26/13
OPO, Inc. d/b/a Obagi Pharmacy Operations – Sandy,. UT licensed 2/28/13
Board of Pharmacy Page 4
Nutrishare, Inc. – Louisville, KY licensed 3/7/13
Nutrishare, Inc. – Elk Grove, CA licensed 3/7/13
Penn Veterinary Supply, Inc. – Lancaster, PA licensed 3/8/13
RGH Enterprises, Inc. d/b/a Edgepark Medical Supplies; Independence Medical – Grand Prairie,
TX licensed 3/13/13
JHP Pharmaceuticals, LLC – Rochester, MI licensed 3/15/13
Biogen Idec US Corporation d/b/a Biogen Idec Inc. – Research Triangle Park, NC licensed
3/19/13
Zoetis LLC – Lewisberry, PA – Change in Ownership and Name – processed 3/19/13
7. Continuing Education:
“AHEC Vermont Geriatrics Conference” – Submitted by Sandy Gauthier from the University
of Vermont CME program. This was approved by R. Klein for 7.5 hours of live (didactic)
continuing pharmacy education credits. The conference will be held on April 9, 2013. Approval
number CPE001(L)-0124.
“A Bridge to Healing: Insights into the Management of Pain and Suffering” – Submitted by
Robert Swartz from Northeastern Vermont Area Health Education Center. This was approved by
R. Klein for 5.5 hours of live (didactic) continuing pharmacy education credits. The conference
will be held April 3, 2013. Approval number CPE002 (L)-0227.
“Pharmacy and Therapeutics Committee Meeting” – Submitted by Erica Counter, CPhT of
Fletcher Allen Health Care. This was approved by R. Klein for one(1) hour of live (didactic)
continuing pharmacy education credits. The conference will be held March 8, 2013. Approval
number CPE003 (L)-0327.

No Office Use Allowed in Vermont

The November Newsletter of the Vermont Board of Pharmacy provides the following discussion:

‘Office Use’ Prescriptions
A recent question to the Board office asked whether
an “office use” prescription is valid. The answer is no.
Medications prescribed must be dispensed to a patient.
When medication is sent from a pharmacy to a practitioner
for administration, the transfer is actually a distribution.

The transfer of prescription medication is permitted
from one registrant (pharmacy) to another registrant
(pharmacy) or licensee (practitioner). Such transfer
must be documented by use of an invoice record. The
invoice record should have the name, strength, form of
the medication, the name and address of both the seller
and purchaser, and the date of sale. This invoice record
should be kept with other invoice records.
If the medication being transferred is a controlled substance
 (CS), there are additional invoice requirements.
The invoice record must also include the Drug Enforcement Administration
 (DEA) numbers of both the seller
and the purchaser.
If the medication is a Schedule II CS, the purchaser
must provide a DEA Form 222 to the seller before the
transfer is completed.
Sales of both non-CS and CS to other registrants and
practitioners should not exceed 5% of total sales during
any consecutive 12-month period.

Source found here

Vermont Office Use Compounding

During the August 22, 2012, Vermont State Board of Pharmacy Meeting, the board discussed an email question regarding office use compounding.  Although the specific question was not provided in the minutes, here is the answer given:

h.  Istvan Nadas E-mail – Questions about Vermont office use compounding:

Question 1.  See rule  8.19, the cap cannot exceed 5% of total annual sales.  The alternative
would be for the veterinarian to write a script that can be filled at a pharmacy.  Also, see the
FDA’s good manufacturing rules.  Aprille will respond.

Question 2.  They have to be licensed in Vermont as an out of state pharmacy and abide by
Vermont Statutes and rules.  Aprille will respond.

Question 3.  See answer to number one.  Aprille will respond.

To see the entire board minutes click here.

Vermont State Board of Pharmacy Tables Whether to Grant Wells Pharmacy Network (previously Francks Labs) a Non-Residence Pharmacy Licence

The Vermont State Board of Pharmacy August 22, 2012, board meeting minutes reflect the following:

The following applications were tabled until next month until we get more info. 

Wells Pharmacy Network, LLC – Ocala, FL.  It is unclear what the business actually is.  It appears the FDA shut down their compounding.  The Board would like more information about this.  DEA certificate was Francks Labs, not the applicant, Wells Pharmacy Network.   

The entire August 2012 board minutes can be found here.

Vermont Board of Pharmacy Responds to Question About Compounding

During its May 2012, the Vermont Board of Pharmacy minutes reflect the following response regarding compounding: 

Emily Rourk E-Mail – Compounding Pharmacies and Central Fill.  Ms. Rourk questioned if compounding pharmacies were allowed to participate in central fill practices.  The Board stated there is no restriction to prevent compounding pharmacies to participate in central fill practices.  However she should reference the FDA rules regarding compounding pharmacies.  For example the medicines should be for specific patients not warehoused.  Aprille will respond.

Entire minutes from May 2012 can be viewed here.