Board News and Announcements

JULY 2021 NCBOP/NABP NEWSLETTER

 

 

 

COVID 3 Ws

NC BOARD OF PHARMACY STAFF HAVE CONSOLIDATED AND ORGANIZED BY TOPIC ALL COVID-19 UPDATES AS FOLLOWS:

 


 

THURSDAY, JULY 8, 2021 - BOARD ELECTION FOR WESTERN AND NORTHERN DISTRICTS - CANDIDATE INTEREST SESSION DATES AND LOCATIONS

The next Board of Pharmacy election is scheduled to begin November 1, 2021. Two positions on the Board will be filled, the Western District seat presently held by William Mixon and the Northern District seat presently held by Keith Vance.

Mr. Mixon will complete his second consecutive five-year term on April 30, 2022 and thus is term limited.

Dr. Vance will complete his first five-year term on April 30, 2022 and is eligible to run for a second term.

The Western District comprises Alexander, Alleghany, Ashe, Avery, Buncombe, Burke, Caldwell, Catawba, Cherokee, Clay, Cleveland, Gaston, Graham, Haywood, Henderson, Jackson, Lincoln, Macon, Madison, McDowell, Mitchell, Polk, Rutherford, Swain, Transylvania, Watauga, Wilkes, and Yancey Counties.

The Northern District comprises Alamance, Caswell, Forsyth, Guilford, Orange, Person, Rockingham, Stokes, Surry, and Yadkin Counties.

The winners of this election will begin their terms on May 1, 2022.

To be eligible to run for one of the two seats, the candidate must be a licensed pharmacist residing in one of the counties that comprise the district at the time of the election. Candidates who wish to stand for election will be required to submit a petition signed by 10 pharmacists residing in the relevant district to the Board office by October 1, 2021.

CANDIDATE INTEREST SESSIONS:

Board staff will host two question-and-answer sessions in August. Dates and locations are listed below. Anyone interested in learning more about Board service and the election process should plan to attend one of these two sessions.


 

UPDATE TO ITEM POSTED LATE LAST MONTH:

NC DHHS DRUG CONTROL UNIT ISSUES STATEMENT CONCERNING FULL IMPLEMENTATION OF CONTROLLED SUBSTANCE REPORTING SYSTEM.  NC DHHS’ Drug Control Unit has announced that the Controlled Substance Reporting System (“CSRS”) will be fully implemented on July 7, 2021.  See the statement here. Board staff’s broader FAQ on the STOP Act also covers this topic and a number of others:  http://www.ncbop.org/PDF/GuidanceImplementationSTOPACTJuly2017.pdf.

*JULY 7, 2021 UPDATE*  Some pharmacists have asked whether the DHHS statement describes pharmacists’ CSRS review obligation under the STOP Act differently than the Board’s FAQ on the same topic.  DHHS staff have confirmed that it does “not have an interpretation of the statute that is different to the guidance set out by the Board of Pharmacy.”  Question #12 of the Board’s FAQ (http://www.ncbop.org/PDF/GuidanceImplementationSTOPACTJuly2017.pdf) speaks to the issue:

12.  Does the STOP Act require pharmacists to review CSRS information prior to dispensing a “targeted controlled substance”?

Yes, in some circumstances.

The STOP Act provides that a dispenser “shall review” a CSRS report on a patient “for the preceding 12-month period and document this review” when any of the following circumstances exist:

(1) The dispenser has a reasonable belief that the ultimate user may be seeking a targeted controlled substance for any reason other than the treatment of the ultimate user’s existing medical condition.
(2) The prescriber is located outside of the usual geographic area served by the dispenser.
(3) The ultimate user resides outside of the usual geographic area served by the dispenser.
(4) The ultimate user pays for the prescription with cash when the patient has prescription insurance on file with the dispenser.
(5) The ultimate user demonstrates potential misuse of a controlled substance by any one or more of the following:

(a) Over-utilization of the controlled substance.
(b) Requests for early refills.
(c) Utilization of multiple prescribers.
(d) An appearance of being overly sedated or intoxicated upon presenting a prescription.
(e) A request by an unfamiliar ultimate user for an opioid drug by a specific name, street name, color, or identifying marks.

Each of these circumstances is atypical “red flag” indicating potential misuse or abuse of a controlled substance.  Additional resources are available here:  http://www.ncbop.org/faqs/Pharmacist/faq_RedFlagsCS.html and http://www.ncbop.org/faqs/DrugDiversionPocketcard.pdf.

The STOP Act also provides that if a pharmacist “has reason to believe that a prescription for a targeted controlled substance is fraudulent or duplicative,” then the pharmacist “shall withhold delivery of the prescription until the [pharmacist] is able to contact the prescriber and verify that the prescription is medically appropriate.” 

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JULY 13, 2021.)

 


 

WEDNESDAY, JUNE 30, 2021

The NC Board of Pharmacy has an opening for an Inspector/Investigator. The available position is in Western North Carolina covering the counties of: Alleghany, Alexander, Ashe, Avery, Buncombe, Burke, Caldwell, Cherokee, Clay, Davidson, Davie, Forsyth, Graham, Haywood, Iredell, Jackson, Macon, Madison, McDowell, Mitchell, Rowan, Stokes, Surry, Swain, Watauga, Wilkes, Yadkin, Yancey. It is recommended that applicants live within the area in which they will be working.

The salary range for this position is $45,000 - $55,000 annually.

Follow this link for a detailed job description.

All applicants should submit a cover letter of interest along with a resume to Rhonda Jones, Director of Finance and Human Resources, rjones@ncbop.org.

 


 

TUESDAY, JUNE 15, 2021

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- AUGUST 2, 2021 -- ON THE FOLLOWING PROPOSED ACTION:

ADOPTION OF TEMPORARY RULE 21 NCAC 46 .2514 ADMINISTRATION OF LONG-ACTING INJECTABLES

Reasons for Proposed Action:

Session Law 2021-3, Section 2.9.(a), permits “immunizing pharmacists” (as defined by statute) to administer long-acting injectable medications to adults pursuant to prescription.  The law becomes effective on October 1, 2021, and explicitly permits the Board of Pharmacy to adopt temporary rules to implement the section.  The rule is being proposed as a temporary rule so that – by the effective date of the statute – the appropriate standards are in place for training, recordkeeping and other requirements needed to ensure that the drugs are administered with adequate protection of the public health, safety and welfare.  The requirements in the proposed temporary rule are largely imported from 21 NCAC 46 .2507, which governs immunizing pharmacist administration of vaccines, so that the regulated pharmacists will already be familiar with these requirements.

A public hearing will be held on August 2, 2021 at 10:00am remotely by video/teleconference. The public can participate on Teams at https://tinyurl.com/ypfxujd8 or may call 336-604-5350, conference ID 844 348 468#.

Any person may object to the proposed amendment by attending the remote public hearing on August 2, 2021 and/or by submitting a written objection by 12:00 noon on August 3, 2021 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 ncboprulemaking@ncbop.org.

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 email. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 984-236-1850.

Follow this link for the proposed rule language.

Notice of Public Hearing.

 


 

WEDNESDAY, MAY 19, 2021

UPDATED BUPRENORPHINE PRACTICE GUIDELINES – WHAT DO THEY MEAN FOR PHARMACISTS?  On April 28, 2021, the United States Department of Health and Human Services issued revised Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (https://www.federalregister.gov/documents/2021/04/28/2021-08961/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder)  In brief, these new guidelines create an expedited pathway for certain practitioners to obtain an “X waiver” under DATA 2000 to prescribe buprenorphine for the treatment of opioid use disorder to 30 or few patients.  The guidelines accomplish this by exempting certain practitioners from certification requirements related to training and the provision of psychosocial services. 

What does this mean for dispensing pharmacies?  In practical terms, very little.  Prescriptions for buprenorphine to treat opioid use disorder must still come from a practitioner holding an “X” DEA under DATA 2000.  There is simply a more rapid path available for some practitioners to obtain it.

More information here: https://www.samhsa.gov/medication-assisted-treatment/practitioner-resources/faqs.

 


 

TUESDAY, APRIL 20, 2021

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JULY 20, 2021 -- ON THE FOLLOWING PROPOSED ACTIONS:

 

A public hearing will be held on July 20, 2021 at 10:00am remotely by video/teleconference. The public can participate on Teams at https://tinyurl.com/3wn9x3xc or may call 336-604-5350, conference ID 560 519 380#.

Due to the planned reopening of the office of the North Carolina Board of Pharmacy, the Board is providing notice that it will be providing in-person ability to participate in the public hearings on the proposed amendments to 21 NCAC 46 .1317, 46 .1703, 46 .1706 and 46 .2502, and the proposed adoption of 21 NCAC 46 .1616.   The ability to participate in person is in addition to the previously noticed opportunity to participate remotely.  The public hearing will take place at 10:00 a.m. on July 20, 2021, and in-person participation will be at the offices of the North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC  27517.

Due to the planned reopening of the office of the North Carolina Board of Pharmacy, the Board is providing notice that it will be providing in-person ability to participate in the public hearings on the proposed repeal of 21 NCAC 46 .1417 and the proposed amendments to 21 NCAC .1816.  The ability to participate in person is in addition to the previously noticed opportunity to participate remotely.  The public hearing will take place at 10:00 a.m. on July 20, 2021, and in-person participation will be at the offices of the North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC  27517.

Any person may object to the proposed action by attending the remote public hearing on July 20, 2021 and/or by submitting a written objection by 10:00AM on July 20, 2021 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 ncboprulemaking@ncbop.org.

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 email. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 984-236-1850.

 


 

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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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