Board News and Announcements

 

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JANUARY 2015 NEWSLETTER

 


 

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

 


 

WEDNESDAY, MARCH 25, 2015

The 2015 regular renewal period has ended and the late penalty renewal phase for pharmacies and DME facilities will end on March 31, 2015.

Pharmacies and DME facilities that have not renewed their permits may do so ONLY UNTIL March 31 with a late penalty. The fee for a late renewal during this phase is $400.00. Any pharmacy or DME permit not renewed by March 31 will be CLOSED.

Access the pharmacy log in page here to renew with a late penalty.

Access the DME log in page here to renew with a late penalty.

 


THURSDAY, MARCH 19, 2015 - UPCOMING BOARD ELECTION


The next Board election will take place in April and May. One position on the Board will be filled: The Southeastern District seat presently held by Robert (Joey) McLaughlin. Mr. McLaughlin will complete his second consecutive five-year term on April 30, 2016 and thus is term limited.

The nomination deadline was March 15, 2015 and the following pharmacists have submitted the required petitions to be placed on the ballot:

Ashley Abode
Lisa Ashworth
Andy Bowman
Jennifer Buxton
Henry Herring
Mark Lyons

Online voting is scheduled to begin on April 15 and will last through May 15. All pharmacists who live in North Carolina and who are actively licensed as of March 15, 2015 are eligible to vote.

Candidate photos and biographical sketches will be posted here in a couple of weeks, so please check back soon or follow us on Twitter @NCBOPNews.

 


 

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

 


 

THURSDAY, MARCH 5, 2015 - DME SUBCOMMITTEE ELECTION

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.

If interested in becoming a candidate for this position, a person-in-charge (“PIC”) of a DME facility (who is the permit holder for purposes of North Carolina law) who also meets the practice area qualification stated above may submit a petition to appear on the June ballot. Any petitioner must be a registered NC DME permit holder as of March 15, 2015. The petition must be filed in the Board office or postmarked by April 1, 2015. Anyone wishing to learn more about the duties of a DME subcommittee member may contact Cindy Parham, NCBOP Investigations and Inspections Coordinator, at cparham@ncbop.org.

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. Access the Device and Medical Equipment Committee Nominating Form here.

 


 

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

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED MARCH 3, 2015.)

 


 

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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