Board News and Announcements

 

 

 

 

 

 

APRIL 2015 NEWSLETTER

 

 

FRIDAY, APRIL 17, 2015 - Voting for Board Member Election for Southeastern District Now Open.

Voting began on April 15 for the Southeastern District seat, presently held by Robert (Joey) McLaughlin.

Please follow this link to log in and cast your vote now. It takes less than a minute: https://www.ncbop1.org/online/pharmacistelection/login.asp.

Voting will last through May 15, 2015. Although only the seat from the southeastern district is up for election this year, all North Carolina pharmacists residing in the state and actively licensed by the Board as of March 15, 2015 are eligible to vote.

Once you log in to the voting site you’ll be able to view the six candidates and their biographical information before casting your final vote – or you may view them here: http://www.ncbop.org/election2015SoutheasternDistrictCandidates.html.

**Any pharmacist eligible to vote may instead request a paper ballot by notifying the Board in writing on or before April 20, 2015. Send a fax, letter, or email to the Board and include your name, license number, and home address. Written requests for a paper ballot must actually be received by the Board on or before April 20. Fax your request to 919.246.1056, attention Kristin Moore; mail to NCBOP Election, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517; or email kmoore@ncbop.org.**

Thank you for voting. https://www.ncbop1.org/online/pharmacistelection/login.asp

 


 

WEDNESDAY, APRIL 8, 2015

The NC Board of Pharmacy has openings for an entry level Inspector/Investigator. The primary duties of the position will be to conduct inspections of retail pharmacies, hospital pharmacies, compounding pharmacies, and Durable Medical Equipment (DME) facilities.  Additional duties may also include conducting investigations on pharmacists, pharmacies, pharmacy technicians and durable medical equipment facilities as assigned by the Director or Associate Director of Investigations and Inspections.  The applicant must be able to review and/or audit pharmacy, healthcare and other records for proper documentation; analyze records for problems with prescriptions and other dispensing issues.  The applicant must be able to compile data, compile an investigatory report and testify at Board hearings, court trials, or in other settings.

The inspections and investigations conducted by the employee deal with allegations of violations of applicable state and federal laws, rules, and regulations of the NC Board of Pharmacy.

Requirements for application for the inspector/investigator position require a four-year degree from an accredited college or university and one year of pharmacy and / or investigation experience; OR a two-year degree from an accredited college or university and two (2) years of pharmacy or investigative experience.  Applicants are required to be a resident of North Carolina, have a valid NC driver’s license, and bring a certified copy of a criminal background check from their local county Clerk of Superior Court.

The first of two (2) available positions are in Northeastern NC covering the counties of: Person, Granville, Vance, Warren, Northampton, Hertford, Gates, Pasquotank, Perquimans, Camden, Currituck, Chowan, Bertie, Halifax, Franklin, Nash, Edgecombe, Martin, Washington, Tyrrell, Dare, Hyde, Beaufort, Pitt, Greene, Lenoir, Craven, Johnston, Wayne & Wilson.  The second available position is in Northwestern NC covering the counties of: Ashe, Alleghany, Surry, Stokes, Watauga, Wilkes, Yadkin, Forsyth, Avery, Caldwell, Alexander Iredell, Davie, Davidson, Rowan, Mitchell, Burke, Yancey, McDowell, Madison & Buncombe.  It is recommended that applicants live within the area in which they will be working.

All applicants should submit a cover letter of interest along with a resume no later than Friday, May 1, 2015, by e-mail to Joshua Kohler, Director of Investigations/Inspections, jkohler@ncbop.org.

 


 

WEDNESDAY, APRIL 1, 2015 - North Carolina Board of Pharmacy Announces a Recall of All Lots of Non- Sterile and Sterile Products Compounded, Repackaged, and Distributed by Prescription Center Between September 10, 2014 and March 10, 2015 Due to Lack of Sterility, Potency, and Stability Assurance.

FOR IMMEDIATE RELEASE – April 1, 2015 – Fayetteville, NC.  The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. This recall order is due the pharmacy’s inability to ensure sterility, stability, and potency for these products.  In addition to ordering a recall, the Board of Pharmacy ordered the Prescription Center closed.  The Board has not received a complaint of an injury caused by any recalled product, but use of compounded products lacking assurance of sterility, stability, and potency places patients at risk. MORE INFORMATION HERE.

 


 

DME SUBCOMMITTEE ELECTION BEGINS JUNE 1, 2015

Election for Rehabilitation Technology Supplier Subcommittee Seat.
In June 2015, the NC Board of Pharmacy DME Subcommittee will hold an election for the Rehabilitation Technology Supplier representative seat. This seat is presently held by DME Subcommittee member Edward Dressen, who is eligible to run for a second term.

The Rehabilitation Technology Supplier representative must practice in the particular area for which he or she is nominated, but need not practice exclusively in that area.

The April 1, 2015 petition deadline has passed and Mr. Dressen will be the committee's only candidate for this seat.

All North Carolina DME permit holders residing in the state as of March 15, 2015 are eligible to vote. Voting will be electronic again this year; a DME PIC will log in to his/her individual Board account to cast an electronic ballot. More details, including instructions for requesting a paper ballot if preferred, will follow in the coming weeks and will be posted here.

Questions regarding the DME subcommittee election should be directed to Cindy Parham, NCBOP Investigations and Inspections Coordinator, at cparham@ncbop.org.

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED APRIL 10, 2015.)

 


 

WEDNESDAY, MARCH 25, 2015

NOTICE OF PUBLIC HEARING (JUNE 16, 2015) ON PROPOSED AMENDMENT TO RULE 21 NCAC 46 .1801 - RIGHT TO REFUSE A PRESCRIPTION. The Board proposes amending the rule regarding refusal of a prescription in order to judge the validity of prescriptions by reference to the standards set by the occupational licensing boards of the prescribers, rather than by attempting to enumerate those standards in the rule, in light of changing standards set by other boards for those prescribers.

A public hearing will be held on June 16, 2015 at 9:00am at the NC Board of Pharmacy office, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.

Any person may object to the proposed amendment by attending the public hearing on June 16, 2015 and/or by submitting a written objection by 9:00am on June 16, 2015 to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, fax (919) 246-1056, e-mail jcampbell@ncbop.org. The North Carolina Board of Pharmacy is interested in all comments pertaining to the proposed rule. All persons interested and potentially affected by the proposal are strongly encouraged to read this entire notice and make comments on the proposed rule.

If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-431-3000.

NOTICE OF TEXT/PUBLIC HEARING:
http://www.ncbop.org/LawsRules/1801NoticeOfTextRightToRefuseRxJune2015.pdf


PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .1801: http://www.ncbop.org/LawsRules/1801ProposedAmendmentRightToRefuseRxJune2015.pdf

 


 

THURSDAY, MARCH 12, 2015

ATTENTION HOSPITAL PHARMACISTS AND PHYSICIANS: Sandoz Pharmaceuticals is recalling multiple lots of fomepizole injection apparently due to FDA concerns at one of the manufacturing facilities. For affected lots and Carolinas Poison Center recommendations for action, please see  http://www.ncpoisoncenter.org/body.cfm?id=36&action=detail&ref=93.

 


 

FRIDAY, MARCH 6, 2015

NORTH CAROLINA CONTROLLED SUBSTANCE REPORTING SYSTEM WEB-INTERFACE REDESIGN.  The Drug Control Unit of the Department of Health and Human Services, which administers the NC CSRS, has redesigned the CSRS web interface.  The aim is to provide users with a more intuitive interface, as well as provide convenient features like password reset, profile update, prescribing history, and easy to read reports.  More information about the redesign is found here: http://www.ncbop.org/PDF/NCControlledSubstanceReportingSystemRedesignMar2015.pdf.

The Drug Control Unit has also produced a short training video, which may be accessed here:  https://ncdmh-dhhs.webex.com/ncdmh-dhhs/ldr.php?RCID=8d0d101b90c441d3ad300d7fcfd01eee.

Pharmacists are reminded of the Board’s expectations with respect to CSRS accessibility and use:  http://www.ncbop.org/faqs/Pharmacist/faq_NCCSRS.htm.

 


 

FRIDAY, MARCH 6, 2015

PROPER IDENTIFICATION OF COMPOUNDING RISK LEVELS AND NOTIFICATION TO THE BOARD OF PHARMACY.  Pharmacies that hold a permit from the North Carolina Board of Pharmacy and that engage in any type of compounding are required to notify the Board.  Such pharmacies must report (both on an initial permit application and as part of each annual renewal):  (1) whether they compound; (2) a good-faith estimate of the percentage of the pharmacy’s dispensing that involves compounded products; (3) whether the pharmacy engages in non-sterile compounding; (4) whether the pharmacy engages in sterile compounding; and (5) what risk level of sterile compounding, as defined by USP <797>, the pharmacy performs.  Accurate reporting of this information is crucial for at least two reasons:  First, failure to provide accurate information in connection with seeking or renewing a permit is grounds to revoke or void a pharmacy permit.  N.C.G.S. § 90-85.38.  Second, the Board’s risk-based inspection intervals are driven by the scope and type of service provided at a pharmacy, particularly compounding services.  Board staff has developed a guidance document intended to reduce any confusion about this reporting requirement: http://www.ncbop.org/PDF/CompoundingRiskLevelsandCategoriesMar2015.pdf

 


 

TUESDAY, FEBRUARY 3, 2015

NOTICE OF PUBLIC HEARING (MAY 12, 2015) ON PROPOSED AMENDMENT TO RULE 21 NCAC 46 .3301 - TECHNICIAN REGISTRATION. The Board proposes amending the technician registration statute to improve conformity to the statutory requirements of G.S. 90-85.15A, including those adopted in Session Law 2013-379.

A public hearing will be held on May 12, 2015 at 9:00am at the NC Board of Pharmacy office, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.

Any person may object to the proposed amendment by attending the public hearing on May 12, 2015 and/or by submitting a written objection by 9:00am on May 12, 2015 to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, fax (919) 246-1056, e-mail jcampbell@ncbop.org. The North Carolina Board of Pharmacy is interested in all comments pertaining to the proposed rule. All persons interested and potentially affected by the proposal are strongly encouraged to read this entire notice and make comments on the proposed rule.

If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-431-3000.

NOTICE OF TEXT/PUBLIC HEARING:
http://www.ncbop.org/LawsRules/3301ProposedAmendTechnicianRegNoticeofTextJuly2015.pdf


PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .3301: http://www.ncbop.org/LawsRules/3301ProposedAmendmentTechnicianRegistrationJuly2015.pdf

 


 

TUESDAY, DECEMBER 9, 2014

VOLUNTEER PHARMACY TECHNICIANS PRACTICING AT FREE CLINIC SITES DO NOT NEED TO COMPLETE A TECHNICIAN REGISTRATION.  In October 2014, Board staff notified pharmacists of a situation in which a non-registered pharmacy technician practicing at a free clinic was found to have diverted controlled substances.  That technician had previously surrendered her registration for engaging in similar diversion at an employing pharmacy.  As a result, Board staff noted that, going forward, volunteer technicians at free clinics would be required to register as technicians and would need to complete that registration by February 28, 2015.  This action was premature, and Executive Director Jay Campbell takes full responsibility, and apologizes, for the prematurity.  Board Rule .3301(d) provides:  “Volunteer pharmacy technicians providing services at a facility which has a pharmacy permit designated as a free clinic shall complete the training program described in G.S. 90-85.15A(b) but need not register with the Board.”

Accordingly, any change in registration requirement for volunteer pharmacy technicians would have to be accomplished by rule amendment. Technicians presently practicing solely in a volunteer capacity at a free clinic are not required to register with the Board. And any technician who has done so as a result of the October 2014 memo may contact the Board for a refund of the registration fee.

The incident that led to the October communication does show that appropriate tracking and vetting of volunteer pharmacy technicians needs to occur. And Board staff looks forward to engaging appropriate stakeholders on an appropriate solution.

 


 

Health Advisories (last updated March 12, 2015) - Check here regularly for the latest alerts and recall notices.

 


 

Medicare/Medicaid (last updated December 2013) - Check here regularly for the latest updates regarding Medicare/Medicaid.


 

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The North Carolina Board of Pharmacy's mission is to protect the public health, safety and welfare in pharmaceutical matters. The Board sets standards for academic and practical experience programs prior to licensure, issues permits to operate pharmacies and DME facilities, and annually renews licenses, permits and registrations.

For more information, please see About the NCBOP.



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