Board News and Announcements

 

 

 

 

OCTOBER 2016 NEWSLETTER

 

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

 


 

TUESDAY, NOVEMBER 29, 2016

The NC Board of Pharmacy has an opening for an entry level Inspector/Investigator in Northwestern North Carolina. Follow this link for a description of the position, qualifications needed, and details on how to apply.


 

TUESDAY, NOVEMBER 29, 2016 - RECIPROCITY LICENSING NOTICE

Due to the holidays, Reciprocity candidates will not be licensed on Wednesday, December 28, 2016.  Licensure will resume on Wednesday, January 4, 2017 and will continue weekly.


 

MONDAY, NOVEMBER 28, 2016

Please review This Health Alert for the Seacoast Area

The North Carolina Board of Pharmacy has received the following information dealing with Fentanyl being sold as fake Xanax, Percocet, and other opiate painkillers.   This has caused numerous overdose deaths in the Southeastern area of North Carolina.  The North Carolina Harm Reduction Coalition has sent out information concerning this matter.   Please click on flyer link here.


 

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 17, 2016

BOARD OF PHARMACY HAS PROPOSED AMENDMENTS TO THE RULE GOVERNING CONTINUING EDUCATION.  As pharmacists know, in September the Board published for notice and comment various proposed amendments to Rule .2201, which governs continuing education.  The proposed amendments and detailed instructions on how to submit comments and/or attend the public hearing on the amendments are found here:  http://www.ncbop.org/rulemakings.htm. In response to some general inquiries about the proposed amendments, Board staff offer the following: 

Each year, Board staff receive a number of complaints from pharmacists unhappy that they must enter all of their CE courses into the Board system (even CE obtained through an ACPE-accredited provider and logged in CPE monitor) in order to renew.   One effect of the proposed amendments would be to eliminate the need to do so.  The categories of CE that would satisfy renewal requirements are streamlined in the proposed amendment.  Providers of each category of approved CE in the amendment can (and must) maintain an electronic database of each pharmacist to whom they have granted CE.  This will eliminate the need for pharmacists to maintain any paper CE certificates.  Moreover, it will allow pharmacists to simply attest at renewal that they have obtained the required amount of CE (although pharmacists will have to specify the number of hours they obtained from ACPE-accredited courses, NCAP-accredited courses, or preceptorship from a North Carolina-based pharmacy school).   Board staff would begin sampling a larger number of pharmacists for CE audit and would require the CE providers to review the CE claimed by pharmacists selected for audit and report to Board staff that records do (or do not) show that the pharmacist in fact acquired the claimed number of CE credits.  The present, paper-based CE audit process – necessary due to the large number of categories of CE presently allowed for renewal – is burdensome both for Board staff and for pharmacists selected for audit.  The proposed amendments would allow a more robust audit, but one that is much less labor- and time-intensive for pharmacists and Board staff alike. 

Based on feedback, Board staff believe that this simplified CE reporting and attestation system would be well-received by pharmacists.  But, as in all things in life, achieving a simpler CE reporting and auditing system requires trade-offs.  As already noted, the extremely wide variety of categories of CE previously accepted by the Board must be consolidated to a smaller population that can be readily tracked electronically by the CE provider and readily reviewed and reported upon to the Board during the CE audit process.  For similar reasons, the five-hour carry-over is eliminated in the proposed amendments.  Requiring CE providers to audit two years of CE data and then figure out which, if any, CE hours should “carry over” is not feasible.

Board staff and members welcome constructive feedback on the proposed amendments.  Again, instructions for providing comments are found here:   http://www.ncbop.org/rulemakings.htm.

 


 

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.

 


 

2017 LICENSE/REGISTRATION/PERMIT RENEWAL

THE 2017 RENEWAL PERIOD BEGAN ON NOVEMBER 1. All pharmacists, technicians, dispensing physicians and PA/NPs, DME and pharmacy permit holders may renew now. Please follow this link for log in details and FAQs regarding the renewal process: http://www.ncbop.org/2017renewals.html.

 


 

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

 


 

MONDAY, OCTOBER 17, 2016

PHARMACISTS:  ANOTHER REMINDER OF RULE .1815’s EMERGENCY REFILL AUTHORIZATION IN TIME OF NATURAL DISASTER.  Last Wednesday, Board staff reminded pharmacists of their ability, under Board Rule .1815 to issue emergency refills to patients in times of emergency.  Board staff again emphasizes the following from that alert:  Plainly, in time of natural disaster, a patient may not be able to reach – and you as a pharmacist may not be able to reach – the patient’s “home” pharmacy.  Pharmacists certainly may take information off of the label of the patient’s prescription vial (or other container) to create an emergency order.  As always, Board staff are available at 919-246-1050; and Director of Investigations/Inspections Josh Kohler can also be reached at 919-698-1435.

 


 

WEDNESDAY, OCTOBER 12, 2016

PHARMACIES ESTABLISHING TEMPORARY DISPENSING LOCATIONS TO SERVE PATIENTS IN FLOOD-RAVAGED AREAS.  Several pharmacists have contacted Board staff to inquire about establishing temporary dispensing locations because their pharmacy is inaccessible due to flooding and/or to directly serve patients in emergency shelters.  (The Board has begun compiling a list of these sites, found here.)

Consistent with the message from the Board members and staff sent yesterday, pharmacists and pharmacies should feel confident establishing temporary dispensing locations to serve patients during this natural disaster.  Certainly, no new or different permit is needed.  If possible, please let Board staff know that you have established a temporary dispensing location and provide an address.  That way, if members of the public, emergency responders, or others call the Board to ask about access to pharmacy services, Board staff can help direct them to your temporary location(s). As always, Board staff are available at 919-246-1050; and Director of Inspections/Investigations Josh Kohler is also available by cell phone at 919-698-1435.

Temporary Dispensing Sites Opened to Serve Patients Impacted by Hurricane Matthew Flooding

 


 

WEDNESDAY, OCTOBER 12, 2016

PHARMACISTS:  REMINDER OF RULE .1815’s EMERGENCY REFILL AUTHORIZATION IN TIME OF NATURAL DISASTER.  Board staff remind pharmacists that Board rule 21 NCAC 46.1815 (found here:  http://www.ncbop.org/LawsRules/rules.1800.pdf) authorizes pharmacists to dispense up to a 90-day emergency supply of a prescription drug to a patient where the “pharmacist . . . is unable to obtain refill authorization from the prescriber because of the prescriber’s inability to provide medical services to the patient.”  This rule was passed with natural disasters specifically in mind.  Board staff does not view this authorization as being limited to an emergency refill by the same pharmacy that initially dispensed the prescription drug.  Plainly, in time of natural disaster, a patient may not be able to reach – and you as a pharmacist may not be able to reach – the patient’s “home” pharmacy.  Pharmacists certainly may take information off of the label of the patient’s prescription vial (or other container) to create an emergency order.  Again, Board staff are available at 919-246-1050; and Director of Investigations/Inspections Josh Kohler can also be reached at 919-698-1435.

 


 

TUESDAY, OCTOBER 11, 2016

DEALING WITH THE PUBLIC HEALTH EMERGENCIES CREATED BY HURRICANE MATTHEW.  Board staff are certainly aware of the significant public health issues created by intense flooding in southeastern North Carolina.  And Board staff are aware of the often superhuman efforts that pharmacists and pharmacies are expending to ensure that patient needs are being met as well as possible under these circumstances.  Be assured:  Board members and staff support your efforts to ensure that patient needs are being met.   Deviations from the letter of pharmacy law or rule are almost certainly going to be necessary to meet those needs.  Board members and staff understand – and support – you, and know that you will use your compassion and good judgment to deal with the crisis.  Board staff are available at any time – 919-246-1050.  After hours calls may be directed to Josh Kohler, the Board’s Director of Investigations and Inspections, at 919-698-1435.

 


 

MONDAY, SEPTEMBER 19, 2016

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD (JANUARY 17, 2017) ON PROPOSED AMENDMENTS TO RULE 21 NCAC 46 .2201 -- CONTINUING EDUCATION - HOURS: RECORDS: PROVIDERS: CORRESPONDENCE: RECIPROCITY.  The Board has proposed the rule amendment in order to facilitate easier continuing education recordkeeping requirements for pharmacists, as well as to allow for more efficient reporting of continuing education hours to the Board and more efficient and accurate review and audit of those records by the Board.  In addition, the Board has proposed to decrease the number of “contact” continuing education hours that must be received, as well as to formalize certain exemptions provided by the Board.

A public hearing will be held on January 17, 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 January 17, 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/2201NoticeOfTextCEHours091916.pdf.

PROPOSED RULE/AMENDMENT LANGUAGE:
21 NCAC 46 .2201: http://www.ncbop.org/LawsRules/2201ProposedLanguageCEHours091916.pdf.

 


 

FRIDAY, SEPTEMBER 2, 2016

RECENT AMENDMENT TO FEDERAL CONTROLLED SUBSTANCES ACT ALLOWS PARTIAL FILLS OF A SCHEDULE II CONTROLLED SUBSTANCE PRESCRIPTION.  The recently enacted Comprehensive Addiction and Recovery Act of 2016 (“CARA”) amends the federal Controlled Substances Act to allow a pharmacist to partially fill a Schedule II controlled substance prescription.

As pharmacists know, DEA rules previously allowed a Schedule II partial fill only if the pharmacy could not supply the full quantity of the prescription and the pharmacy provided the remainder within 72 hours (with an exception for terminally ill patient). 

CARA allows partial fills of Schedule II prescriptions if:  (1) state law does not prohibit partial fills of Schedule II prescriptions (North Carolina law does not prohibit partial fills of this sort); (2) the prescription is written and filled in compliance with federal and state law; (3) the partial fill is requested by the patient or the prescriber; and (4) the total quantity dispensed in all partial fills does not exceed the total quantity prescribed.

The total amount of the prescription may be filed no later than 30 days from the date of the prescription.  If, however, the Schedule II partial fill is the product of an emergency oral prescription, the 72-hour complete fill restriction remains.

Board staff have, over the years, received many questions about (and expressions of frustration with) the now-amended federal law on Schedule II partial fills.  CARA’s amendment should provide a means of better serving patients and decreasing the amount of unwanted and unused Schedule II prescription medications in households. 

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED OCTOBER 5, 2016.)

 



WEDNESDAY, AUGUST 3, 2016

FDA Releases Draft Guidance, "Insanitary Conditions at Compounding Facilities." 
The U.S. Food & Drug Administration (FDA) today issued a draft guidance, Insanitary Conditions at Compounding Facilities, that identifies examples of insanitary conditions that can result in patient harm.

"FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.  The draft guidance has a public comment period of 60 days."

Please follow this link to review FDA's guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM514666.pdf

 


 

THURSDAY, JULY 7, 2016

FDA ISSUES TWO DRAFT GUIDANCE DOCUMENTS REGARDING HUMAN DRUG COMPOUNDING. The U.S. Food and Drug Administration announced today that it has issued two draft guidance documents regarding human drug compounding. The draft guidance documents are:

The draft documents are applicable to State-licensed pharmacies, Federal facilities, outsourcing facilities and physicians who compound drugs.  Each draft guidance has a public comment period of 90 days. 



 

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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