Board News and Announcements

 

 

 

 

 

 

JANUARY 2017 NEWSLETTER

 

 

THURSDAY, MARCH 30, 2017

BOARD ISSUES EDUCATIONAL GUIDANCE ON CANNABIDIOL (“CBD”) OIL PRODUCTS IN PHARMACIES.  In response to questions from pharmacies and pharmacists concerning North Carolina law governing the possession and use of cannabidiol (CBD) oil products.  This FAQ document explains North Carolina law in this area, and notes particularly that North Carolina law does not authorize pharmacies to possess, sell, or otherwise dispense cannabidiol oil products. READ THE GUIDANCE HERE.

 


 

THURSDAY, MARCH 30, 2017

CE RULE CHANGES TO BECOME EFFECTIVE JANUARY 1, 2018.  The Board has completed a rulemaking making changes to the continuing education requirements for licensure renewal.  Board staff have received a number of good questions about the transition process.  This FAQ guidance answers them. 

 



THURSDAY, MARCH 2 - THE 2017 REGULAR RENEWAL PERIOD HAS ENDED

THE 2017 RENEWAL PERIOD (GRACE PERIOD) ENDED ON MARCH 1, 2017. Any pharmacist, technician, dispensing physician, or PA/NP who did not renew his/her license or registration by the March 1 deadline is now inactive.

DME and pharmacy permit holders may still renew with a late penalty between now and March 31, 2017. Select the appropriate link below to log in and apply for late renewal:

PHARMACY PERMIT HOLDERS: https://www.ncbop2.org/Licensee/Account/LoginPharmacy

DME PERMIT HOLDERS: https://www.ncbop2.org/Licensee/Account/LoginDME

If your pharmacy or DME facility has closed, you must complete the appropriate form and submit it to the Board office if you have not already done so:

Pharmacy Close Form

DME Close Form

ANY PHARMACY OR DME PERMIT NOT REINSTATED BY MARCH 31, 2017 WILL BE CLOSED.

 


 

TUESDAY, FEBRUARY 21, 2017

AMENDMENTS TO CONTINUING EDUCATION RULE .2201 TO GO INTO EFFECT JANUARY 1, 2018.

Board rule .2201, CONTINUING EDUCATION -- HOURS: RECORDS: PROVIDERS: CORRESPONDENCE: RECIPROCITY has been amended and will go into effect on January 1, 2018. The current version of the rule remains in effect until December 31, 2017. Please follow this link for rule language, both current and as amended January 1, 2018.

Please note that pharmacists will receive information from the Board in the coming weeks on implementation of the new rules for 2018.

 


 

TUESDAY, FEBRUARY 21, 2017

NC BOARD OF PHARMACY MANDATORY PERIODIC RULE REVIEW.
In accordance with N.C. Gen. Stat. § 150B-21.3A and 26 NCAC 05 .0206, the North Carolina Board of Pharmacy has adopted initial determinations of its rules for purposes of completing the mandatory periodic rule review.  The report of its initial determinations is at the link below.

The Board will be accepting public comment on the initial rule designations until the close of business on Monday, May 1, 2017.  If you wish to submit public comment about any of the proposed rule classifications, you may do so by either mailing a public comment to the attention of the Board’s Executive Director, Jay Campbell, by US Postal Service or other delivery service to 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, or by e-mail to rulereview@ncbop.org.

”Public comment” is defined by N.C. Gen. Stat. § 150B-21.3A(a)(5) as a written objection to all or part of a rule.  Additionally, pursuant to N.C. Gen. Stat. § 150B-21.3A(c)(2), in order for the North Carolina Rules Review Commission to determine whether the public comment has merit, the public comment must address the specific substance of the rule and address any of the standards of Commission review, as set forth in N.C. Gen. Stat. § 150B‑21.9(a).

http://www.ncbop.org/LawsRules/NCBOP_RULEMAKING_Report_on_Periodic_Rule_Review150B_21.3AFeb2017.pdf

 


 

FRIDAY, FEBRUARY 3, 2017

NORTH CAROLINA STATEWIDE NALOXONE STANDING ORDER UPDATED.  Pharmacies that participate in the statewide naloxone standing order are advised that the order has been reissued by Kelly Kimple, MD, to ensure continuity between the departure of Randall Williams, MD – the previous State Health Director – and his eventual successor.  There has been no change in the content of the standing order.  The updated order may be found here:  https://www.naloxonesaves.org/files/2017/01/2017-Naloxone-Standing-Order.pdf

 


 

THURSDAY, JANUARY 26, 2017

FDA ISSUES FINAL GUIDANCE DOCUMENTS ON THE USE OF BULK DRUG PRODUCT FOR COMPOUNDING BY PHARMACIES AND OUTSOURCING FACILITIES.  The Food and Drug Administration has issued final guidance on the use of bulk drug product for compounding by pharmacies (under Section 503A of the Food, Drug, and Cosmetic Act) and outsourcing facilities (under Section 503B of the Food, Drug, and Cosmetic Act).  All compounders should give these documents their immediate attention:

 


 

THURSDAY, JANUARY 26, 2017

PHARMACY TECHNICIAN CERTIFICATION BOARD SUSPENDS IMPLEMENTATION OF PLANNED 2020 ACCREDITED EDUCATION REQUIREMENT FOR PHARMACY TECHNICIANS.   The Pharmacy Technician Certification Board (PTCB) is suspending the implementation of the accredited education requirement for pharmacy technicians. In 2013, PTCB announced that the requirement would take effect in 2020, but PTCB has “determined that additional deliberation and research are needed to address stakeholder input, develop supporting policy, and conduct further study of technician roles,” said Larry Wagenknecht, chair of the PTCB Board of Governors, and chief executive officer of the Michigan Pharmacists Association, in a news release. The role of pharmacy technicians is evolving, and PTCB is taking steps to support the pharmacy community.

 


 

MONDAY, JANUARY 23, 2017

PET MEDICATION SAFETY ALERT: FDA WARNS OF ILLNESSES AND DEATHS IN PETS EXPOSED TO PRESCRIPTION TOPICAL TREATMENTS

On January 18, 2017, the FDA published an alert for pet owners, veterinarians, health care providers, and pharmacists regarding the exposure of pets to the topical medication Fluorouracil 5% (5-FU).
The original alert can be found here at: http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm537434.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

This recommendation comes in light of the FDA receiving reports of five dogs having become ill and died after accidentally ingesting the topical medication. In one of the reported incidents, the dog experienced vomiting, seizures, and died within 12 hours of consuming the medication. Although there have not been any reports involving cats, they are expected to be extremely sensitive to the topical medication as well.

The FDA has recommended that people who use Fluorouracil use caution when applying in the medications and take the following protective measures to prevent their pets from ingesting the medication:

Additional information regarding the care and safety of pets can be found here: http://www.fda.gov/AnimalVeterinary/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

As a reminder, people using any topical medication should use caution when applying and storing the medication when there are household pets present, as very small amounts of exposure could be dangerous to these animals. In particular, owners should take caution when touching their pets or allowing them to be licked after the application of any topical substance.

 


 

Temporary Dispensing Sites Opened to Serve Patients Impacted by Hurricane Matthew Flooding - List updated January 20, 2017

 


 

The North Carolina Board of Pharmacy's monthly meetings are live-streamed via YouTube. Follow the link below to subscribe to the Board's YouTube channel. (Meeting dates found here.)

https://www.youtube.com/channel/UC8Kgn3mOzRT8s0FJwsu8U0g

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED MARCH 13, 2017.)

 


 

FRIDAY, NOVEMBER 18, 2016

BOARD PROPOSES RULE AMENDMENT TO ALIGN BOARD OF PHARMACY MEMBER ELECTIONS WITH THE ANNUAL PHARMACIST LICENSE RENEWAL PERIOD.  Today, the Board of Pharmacy published proposed amendments to its rules governing Board member elections.  The proposal would shift the member election period to coincide with the pharmacist license renewal period.  Pharmacist participation in Board member elections is poor.  When the Board amended election rules in 2009 to allow for electronic voting, the number of pharmacist voters began to rise.  Even so, the increase was not dramatic and peaked in the spring 2011 election when 3,347 pharmacists cast ballots (out of 10,321 eligible to vote, or 32.4%).  The spring 2016 primary election saw just 1,941 ballots cast (out of 11,570 eligible to vote, or 16.8%), the lowest total since at least 1987 and perhaps the lowest percentage of eligible voters in the history of Board elections. 

Multiple factors likely contribute to poor pharmacist voter turnout in Board elections.  That said, the Board believes (and is hopeful) that linking the voting period to the annual license renewal period will improve pharmacist voter participation.  Every pharmacist in the state must log on to the Board’s website to complete annual renewal of license.  Providing pharmacists with a specific reminder of an ongoing Board member election – and a pop-up link to the electronic voting tool – as part of the electronic renewal would remove any possible convenience barrier to exercising the franchise.

The proposed amendments do not change the composition of the Board, the terms of Board members, eligibility for Board membership, or any other aspect of Board elections other than timing.

 


 

FRIDAY, NOVEMBER 18, 2016

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD (FEBRUARY 21, 2017) ON PROPOSED AMENDMENTS TO RULE 21 NCAC 46 .1505 – EXAMINATION.  The Board has proposed the amendment of its licensing examination rule in order to adopt the examination administrator’s maximum recommended number of attempts to pass the examination.  In addition, the Board has proposed clarifications of the existing rule provisions.

A public hearing will be held on February 21, 2017 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 February 21, 2017 and/or by submitting a written objection by 9:00am on February 21, 2017 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: Click Here

• PROPOSED RULE/AMENDMENT LANGUAGE:  Click Here


 

FRIDAY, NOVEMBER 18, 2016

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD (FEBRUARY 21, 2017) ON PROPOSED AMENDMENTS TO RULES 21 NCAC 46 .2102, .2104, .2105, .2107, and .2108  – ELIGIBILITY TO VOTE, COMMITTEE ON NOMINATIONS,  NOMINATION BY PETITION, BALLOTS:  CASTING AND COUNTING, DETERMINATION OF ELECTION RESULTS.  The Board has proposed the amendment of several of its Board member election rules in order to shift the voting period to coincide with the pharmacist licensing renewal period.  The Board proposed to provide an opportunity for pharmacists to vote by electronic ballot at the same time that they perform their on-line license renewal.  The Board believes that aligning voting with license renewal is likely to increase pharmacist participation in voting.  The Board further proposed to eliminate the option for voting by paper ballots, as no pharmacist has voted by paper ballot since 2011, and elimination of this option will conserve Board resources by allowing it to cease production of paper ballots.  The Board further proposes to amend the rules to codify run-off procedures, as run-offs have often become necessary.

A public hearing will be held on February 21, 2017 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 February 21, 2017 and/or by submitting a written objection by 9:00am on February 21, 2017 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:  Click Here

• PROPOSED RULE/AMENDMENT LANGUAGE: 1) 21 NCAC 46 .2102 2) 21 NCAC 46 .2104

3) 21 NCAC 46 .2105 4) 21 NCAC 46 .2107 5) 21 NCAC 46 .2108

 


 

THURSDAY, NOVEMBER 3, 2016

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.

Please note:  The estimate of the percentage of the pharmacy’s dispensing that involves compounded products does not  affect a pharmacy’s inspection interval.  That interval is determined by the type of compounding services provided, not the volume of compounding services provided. Board staff published a guidance document intended to reduce any confusion about this reporting requirement: http://www.ncbop.org/PDF/CompoundingRiskLevelsandCategoriesMar2015.pdf.

Pharmacists are also reminded that the Board Rule. 2801 requires any pharmacy that provides compounding services to maintain a reference library that includes current USP Standards for compounding and that the Pharmacist-Manager or Pharmacist-Manager’s designee pharmacist be knowledgeable in all compounding functions, including USP categories of compounding.

 


 

THURSDAY, OCTOBER 27, 2016

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD (FEBRUARY 21, 2017) ON PROPOSED ADOPTION OF RULE 21 NCAC 46 .1615 -- e-PROFILE NUMBER REQUIRED FOR LICENSE, PERMIT, OR REGISTRATION.  The Board has proposed the adoption of this rule in order to more efficiently and accurately fulfill its statutory function of reviewing applications for issuance and renewal of licenses, permits and registrations.

A public hearing will be held on February 21, 2017 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 January 17, 2017 and/or by submitting a written objection by 9:00am on February 21, 2017 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/1615NoticeOfTexteProfileFeb2017Hearing.pdf

PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .1615: http://www.ncbop.org/LawsRules/1615ProposedRuleeProfileFeb2017.pdf

 


 

Health Advisories (last updated March 7, 2016) - Check here regularly for the latest alerts and recall notices.

 


 

Medicare/Medicaid (last updated May 12, 2015) - 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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