North Carolina Board of Pharmacy Meeting Feb. 19, 2013: Agenda --Update on Compounding Working Group

February 19, 2013
870th Meeting of the NORTH CAROLINA BOARD OF PHARMACY
6015 Farrington Road, Suite 201, Chapel Hill, NC 27517
Monday, February 18, 2013
10:00 A.M. Permit Meeting (Room 215)
1:00 P.M. Prehearing Conference – Bill Mixon
Tuesday, February 19, 2013
9:00 A.M. Welcome and Ethics Statement
Consideration of Minutes of January 2013 Meeting
Reciprocity Candidate - RPh. Joseph Larry Custer
Reinstatement Request – R.Ph. Kirk Smith, License # 05586
Reinstatement Request – R.Ph. Karen Bencuya, License #10042
Request for Modification of Reinstatement Order - RPh. Genny Brewer, License #16013
11:30-12:15 P.M. Reports to the Board
Retail Merchants, ACP, NC Mutual
12:15 -1:30 P.M. Catered Lunch
Introduction of NCPRN Executive Director Valanda Nelson
Presentation on Container Integrity - Ned Milenkovich, Rexam
Council of Licensure, Enforcement and Regulation (“CLEAR”) Board Member Training
Program, April 26, 2013, North Carolina Board of Nursing
Revocation of Registration for Non-Payment of Child Support – Tech. Kimberly Jackson,
Reg. #32596
Report on Progress of the Pharmacy Compounding Working Group
General Assembly Bills that could affect the NCBOP – S32, S33, S37

NABP 109th Annual Meeting - May 18-21, 2013, St. Louis, MO
2013 SEI Filing Reminder
Financial Reports
Financial and Performance Audit to be Conducted by Office of the State Auditor
Beginning Monday, February 25.
Lists of Pharmacist Licensed by Examination 2010 - 2012
Investigative Statistics
Consent Agenda
Prehearing Conference
Staff Issues a Letter of Warning
Medco Health Solutions of Columbus West, Permit #08513
CPP Candidates
RPh. Courtney Hines, License #21799
RPh. Caroline Howard, License #20367
RPh. Heidi Mack, License #20656
RPh. Danielle Raymer, License #13565
Increase in Pharmacists to Technician Ratio
1. Walgreens Pharmacy Chapel Hill, Permit # 11223 Eric Montijo RPh, App. 1/29/2013
2. CVS Pharmacy Winston-Salem, Permit # 10805 Ahunna Freeman RPh, App.
1/29/2013
3. Center Pharmacy Fayetteville, Permit # 10290, Rebecca Miller Brady RPh, App.
1/29/2013
4. Walgreens Pharmacy Hickory, Permit # 10360, David Goble RPh, App. 1/29/2013
5. Old Main Pharmacy Pembroke, Permit # 11213, Justin Daniel RPh, App. 2/6/2013
6. Faulkner’s Drugs Monroe, Permit # 28112, David Jamison RPh, App. 2/6/2013
Closed Session
Possible Summary Suspension

Next Meeting for North Carolina's Board of Pharmacy Scheduled for Feb. 19, 2013; No Agenda Posted Yet

North Carolina Board of Pharmacy Met Yesterday, January 15, 2013, Compounding Issues Discussed

AGENDA 
January 15, 2013
869th Meeting of the NORTH CAROLINA BOARD OF PHARMACY
6015 Farrington Road, Suite 201, Chapel Hill, NC  27517
Monday, January 14, 2013
10:00 A.M. Permit Meeting (Room 215)
1:00 P.M.   Prehearing Conference – Carol Yates Day
2:00 P.M. Reciprocity Meeting
Tuesday, January 15, 2013
9:00 A.M. Welcome and Ethics Statement
Consideration of Minutes of November 2012 Meeting
Disciplinary Hearing - RPh. Thomas J. Norkus, License #08600
Reinstatement Request - RPh. Patrick Hale, License #06896
Update on Progress of the Pharmacy Compounding Working Group
Report from the December 19, 2012 FDA Intergovernmental Meeting on Pharmacy
Compounding
11:30-12:15 P.M. Reports to the Board
NCAP, PRN, BOP Committees
12:15 -1:30 P.M. Catered Lunch
Amendment to Hospital/LTC Rules: Report of January 14, 2013 Public Hearing;
Decision on Adoption
2013 MALTAGON Meeting Programming - September 29th - October 2nd, 2013,
Asheville, NC
DEA Publishes Proposed Rules to Govern Controlled Substance Take-Back Programs
Financial Reports

North Carolina's Involvement in National Pharmacy Compounding Efforts

Involvement in National Pharmacy
Compounding Efforts
Board staff is working closely with National Association
of Boards of Pharmacy® (NABP®) staff on the NABP compounding action plan, a broad-gauge national effort aimed at
supporting state boards of pharmacy in providing effective
oversight of compounding pharmacy practices.
In addition, committees in both the US Senate and US House
of Representatives have convened to analyze the causes of the
NECC tragedy and to explore potential federal regulation in the
area of pharmacy compounding. In response to requests from
these committees, Board staff provided substantial information
on North Carolina’s regulation of pharmacy compounding.

Quotation from North Carolina's Board of Pharmacy's January 2013 Newsletter found here

North Carolina Board of Pharmacy Steps Up Inspections of Compounding Pharmacies

Inspections of Compounding Pharmacies
Stepped Up
Board staff has stepped up inspections of North Carolina
pharmacies that specialize in compounding to ensure compliance with relevant law. In addition, Board staff is collecting
information from out-of-state pharmacies permitted in North
Carolina that specialize in compounding for the same purpose.
Already, Board inspectors have noted another uptick in the
compounding of “over-the-counter” drugs for general resale.
This is not a legal practice. This activity was the subject of
a lengthy item in the April 2008 Newsletter: www.ncbop.org/
Newsletters/Apr2008.pdf. Given the clarity of the law and
Board staff’s repeated emphasis on this issue, instances of this
practice will no longer be treated as an “educational” matter.
They will be treated as a disciplinary matter.

Quotation found in Jan. 2013 North Carolina Board of Pharmacy Newsletter found here

North Carolina Pharmacy Compounding Working Group

The Pharmacy Compounding Working Group
The Board has also created, empaneled, and charged a Pharmacy
Compounding Working Group to conduct a comprehensive review of
 all aspects of compounding pharmacy regulation
including (1) whether and to what extent changes are needed in
either or both of the North Carolina Pharmacy Practice Act and
Board of Pharmacy rules governing compounding pharmacy;
(2) whether and to what extent United States Pharmacopeia
Chapter <797> standards should be specifically incorporated
into state law; (3) whether and to what extent North Carolina
law should mandate or recognize any form of “accreditation”
for compounding pharmacies; (4) whether and to what extent
changes are needed in Board investigator training or inspection
methods with respect to compounding pharmacies; and
(5) what particular issues, if any, with respect to out-of-state
compounding pharmacies, require different or additional regulatory
approaches. Each of these broad topics will encompass
numerous subsidiary issues. The working group will provide a
report and recommendation to the full Board on these issues.

Quoted from North Carolina Board of Pharmacy January 2013 Newsletter found here

North Carolina's Immediate Response to the NECC-Caused Fungal Meningitis Outbreak

The Board’s Immediate Response to the
NECC-Caused Fungal Meningitis Outbreak
The Board summarily suspended NECC’s out-of-state
pharmacy permit on October 3, 2012, one hour after receiving
confirmation that NECC products were suspected in the fungal
meningitis outbreak.
Board investigative staff cooperated closely with North Carolina Division of Public Health staff to visit and/or telephone
every clinic in North Carolina identified as having received
potentially contaminated methylprednisolone products from
NECC. The Board staff specifically thanks Amanda Fuller
Moore and her staff at the Division of Public Health for their
superb efforts. During these in-person and telephone contacts,
Board and Division of Public Health staff ensured that the clinics were aware of the recall, had removed NECC products from
inventory, and were notifying potentially affected patients.
When the NECC recall was extended to all sterile products
produced by that pharmacy, Board investigative staff again
cooperated closely with Division of Public Health staff to ensure that all affected clinics had pulled every NECC product
from inventory and were notifying patients as recommended
by Food and Drug Administration (FDA).
Immediately upon learning that FDA had urged Ameridose
to recall all compounded products produced at that facility, the
Board members summarily suspended Ameridose’s out-of-state
pharmacy permits.

Quoted from January 2013 edition of North Carolina Board of Pharmacy Newsletter found here

During November Meeting, North Carolina State Board of Pharmacy Meeting Board Will Appoint Members to Pharmacy Compounding Working Group

 and board will also discuss update on Fungal Meningitis Outbreak/NECC Matters.  To view agenda for November meeting click here

NC Board of Pharmacy summarily Suspended Ameridose Out-of-State Pharmacy Permit

WEDNESDAY, OCTOBER 31, 2012

AMERIDOSE INSTITUTES RECALL OF ALL PRODUCTS: Ameridose, which holds out-of-state pharmacy permits #10410 and #10411, announced today that it is recalling all products. Ameridose is affiliated by ownership with New England Compounding Center, whose permit was summarily suspended by the Board of Pharmacy on October 3, 2012. Ameridose ceased operations in early October pending inspections by the Massachusetts Board of Pharmacy and the Food and Drug Administration. According to press reports, FDA has reported potential problems with sterility control at the Ameridose facility. More information may be found here: http://www.boston.com/whitecoatnotes/2012/10/31/ameridose-recalls-all-drugs-after-fda-finds-problems-with-its-sterility-testing/Yno31L2Aw7LeAjOElo0DnO/story.html Reports state that no Ameridose product has been linked to a patient injury or illness. The recall is being instituted as a precautionary measure. Forms and instructions for any health-care facility who has Ameridose products in its inventory may be found here: http://www.ameridose.com/news/. Ameridose will be notifying each facility to which it has shipped products of the recall by fax. ALL HEALTH CARE FACILITIES IN NORTH CAROLINA ARE URGED TO DETERMINE IF THEY HAVE ANY AMERIDOSE PRODUCTS IN THEIR STOCK AND RETURN THOSE PRODUCTS AS DIRECTED IN THE LINKED INSTRUCTIONS. Board staff will communicate further information to pharmacists and health-care providers as it becomes available.
UPDATE: On November 1, 2012, the Board of Pharmacy summarily suspended out-of-state pharmacy permits 10410 and 10411 held by Ameridose, 201 and 205 Flanders Road, Westborough, Massachusetts. The suspension orders may be found here:

• Order Summarily Suspending Permit #10410, Ameridose, LLC
• Order Summarily Suspending Permit #10411, Ameridose, LLC

Source found here

North Carolina Board of Pharmacy Starting Working Group on Compounding

FRIDAY, OCTOBER 19, 2012

COMPOUNDING PHARMACY WORKING GROUP. The Board decided at its October meeting to put together a small working group to review all aspects of North Carolina regulation of compounding pharmacy and to make a report and recommendation. North Carolina pharmacists with an interest in participating should communicate that interest to Jay Campbell, the Board’s Executive Director, by Friday, November 2. The Board will select the members shortly afterward.

Source found here

NORTH CAROLINA BOARD OF PHARMACY SUMMARILY SUSPENDS NEW ENGLAND COMPOUNDING CENTER’S PHARMACY PERMIT

WEDNESDAY, OCTOBER 3, 2012

NORTH CAROLINA BOARD OF PHARMACY SUMMARILY SUSPENDS NEW ENGLAND COMPOUNDING CENTER’S PHARMACY PERMIT NUMBER 08439.  The Board of Pharmacy today summarily suspended out-of-state pharmacy permit number 08439 held by the New England Compounding Center, 697 Waverly Street, Framingham, Massachusetts 07102.  Board staff strongly advises any pharmacy or other health care facility in North Carolina that has any sterile product compounded by New England Compounding Center to take immediate, appropriate action.  The Board’s summary suspension order may be found here (click here).

North Carolina clinicians are advised to be alert for communications from North Carolina Public Health concerning this matter.

More information concerning the circumstances leading to the Board’s action may be found here: 

http://www.newschannel5.com/story/19710698/meningitis-investigators-eye-link-to-compounding-pharmacy

http://www.nytimes.com/2012/10/03/health/meningitis-cases-are-linked-to-steroid-injections.html?hpw&_r=1&

DOMPERIDONE COMPOUNDING PERMISSIBLE ONLY AS PART OF AN INVESTIGATIONAL NEW DRUG APPLICATION (IND).

Statement from the North Carolina Board of Pharmacy found here:
TUESDAY, AUGUST 14, 2012
DOMPERIDONE COMPOUNDING PERMISSIBLE ONLY AS PART OF AN INVESTIGATIONAL NEW DRUG APPLICATION (IND). Board staff have received calls and questions about the compounding of domperidone. Domperidone is not a drug approved for human use in the United States. Accordingly, any domperidone product dispensed in the United States outside of an IND is unapproved, adulterated and misbranded under both federal and North Carolina law. Notwithstanding misleading Internet information to the contrary, it is not legal in the United States to acquire, compound, dispense, or administer domperidone outside of an IND. The FDA has long provided clear guidance on this point, which may be found here: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm073070.htm

As FDA’s information further states, "FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women." Domperidone may be useful for "some patients with severe gastrointestinal disorders . . . that are refractory to standard therapy." A physician who would like to prescribe domperidone for this indication may contact FDA to open an Investigational New Drug Application (IND). An FDA-authorized IND would "allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S."
Pharmacists are expected to conform their conduct to these legal requirements.

Royal Palm Compounding Pharmacy Disciplined by North Carolina Board of Pharmacy

THE NORTH CAROLINA BOARD OF PHARMACY recently entered a consent order of discipline against
Royal Palm Compounding Pharmacy.  To view the consent order, click here.