Board News and Announcements

APRIL 2022 NCBOP/NABP NEWSLETTER

 

 

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



 

WEDNESDAY, MAY 25, 2022

*UPDATE* GUIDANCE TO REVISED BOARD RULE GOVERNING INTER-PHARMACY REMOTE MEDICATION ORDER PROCESSING.  The Board of Pharmacy has completed a rulemaking to amend Rule .1816, now titled “Centralized Pharmacy Services.”  The amended rule broadens the availability of remote medication order processing (“RMOP”) arrangements among pharmacies to all pharmacy practice types.  The full rule is found here:  21 NCAC 46.1816.

The new RMOP provisions became effective March 1, 2022.  However, the Board’s Expanded Emergency Services Waiver, issued on March 17, 2020 as a result of the COVID-19 public health emergency, authorized expanded RMOP arrangements:  Expanded Emergency Services Waiver

*UPDATE* Previously, Board staff announced that pharmacies may continue to operate RMOP arrangements pursuant to the waiver until June 1, 2022, after which the Board would enforce the Rule .1816-based RMOP requirements.  Uptake of the NABP Verify option has exceeded Board staff’s initial estimates.  Accordingly, and to give sufficient time for those pharmacists who need to obtain an NABP Verify credential and for Board staff to review and approve those registrations, pharmacies may continue to operate RMOP arrangements pursuant to the waiver until July 1, 2022.  The Board will enforce the Rule .1816-based requirements effective that date.

A related reminder:  As discussed in the guidance document linked below, all pharmacies participating in an RMOP arrangement must hold a North Carolina pharmacy permit.  A pharmacy that wishes to engage in an RMOP arrangement that does not hold a North Carolina pharmacy permit should file an application immediately to maximize the likelihood that the permit application has been reviewed and allowed prior to July 1, 2022. 

To assist pharmacies transitioning to the rule-based RMOP requirements, Board staff have prepared two guidance documents.

The first – found here: http://www.ncbop.org/PDF/GuideToInterPharmacyRMOP.pdf - provides a detailed overview of the revised rule governing inter-pharmacy RMOP arrangements.  Please note:  This guidance document only concerns RMOP serves arranged among two pharmacies.  A different rule -- 21 NCAC 46.2515  -- authorizes and governs intra-pharmacy remote services (i.e., a pharmacy uses its own personnel to provide off-site services).  A guide to Rule .2515’s operation is found here:  Intra-Pharmacy RMOP Guidance

The second – found here: http://www.ncbop.org/PDF/HowToRegisterAsNABPVerifyHolder.pdf - provides detailed instructions on how out-of-state pharmacists who are performing RMOP services and who are not individually licensed to practice pharmacy in North Carolina may obtain an NABP Verify credential and register with the Board of Pharmacy, as required by revised Rule .1816.

 


 

FRIDAY, MAY 20, 2022

FROM THE NC DEPARTMENT OF HEALTH AND HUMAN RESOURCES DIVISION OF CHILD AND FAMILY WELL-BEING - INFANT FORMULA SHORTAGE INFORMATION. Leaders from across North Carolina, including the Governor’s Office, NCDHHS, retailers, health care providers, community organizations and others are working to support North Carolina families and ensure that there is access to safe, healthy nutrition for babies. In general, supply in North Carolina is currently adequate to meet the need for standard formulas.  However, certain brands of formula and certain specialized formulas may not be available in all areas, and families may struggle to find the specific formula that they usually buy. State and federal partners are acting to further increase supply. At NCDHHS, we have prioritized actions to educate families and health care providers about alternative formula options and to work with manufacturers to ensure availability of supply for most products.

Actions Pharmacists Can Take:

Actions NCDHHS is taking:

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED MAY 25, 2022.)

 


 

FRIDAY, MAY 20, 2022

STATEWIDE STANDING ORDER FOR FDA AUTHORIZED PFIZER/COMIRNATY COVID-19 VACCINE ADMINISTRATION IN PATIENTS AGES 5-11 YEARS. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 5 years of age and older.

The Statewide Standing Order for Pfizer 5-11 has been revised due to updated FDA authorization and CDC recommendations.  

Please read the Pfizer 5-11 Fact Sheet for Healthcare Providers.

This (and all current SWSO) revised Statewide Standing Order for FDA authorized Pfizer/COMIRNATY COVID-19 Vaccine Administration in Patients Ages 5-11 Years is available on the NCDHHS site on the following pages: https://publichealth.nc.gov/HDSO-pharmacists.htm and https://covid19.ncdhhs.gov/guidance#vaccination-info-for-providers.

 


 

THURSDAY, MAY 5, 2022

NOTICE TO OUT-OF-STATE PHARMACIES HOLDING A NORTH CAROLINA PHARMACY PERMIT CONCERNING PHARMACIST-MANAGER DESIGNATION.  The Board of Pharmacy recently amended 21 NCAC 46.1607, Out-Of-State Pharmacies (“Rule .1607”). Under amended rule, effective May 1, 2022, the “pharmacist-manager for the out-of-state permit issued by this Board must be the same person as the pharmacist-manager (whether called a pharmacist-manager, a person-in-charge or otherwise) of the pharmacy on the permit issued by the pharmacy’s home state.” 

All out-of-state permit holders must log into the Board’s Licensure Gateway, review the designated pharmacist-manager and, if necessary, complete a Pharmacist-Manager (PM) Change Request.  Detailed instructions available here: http://www.ncbop.org/PDF/PMChangeforOutofStatePharmacies.pdf.

 


 

TUESDAY, APRIL 26, 2022

BOARD PROMULGATES NEW RULE GOVERNING INTRA-PHARMACY REMOTE OPERATIONS.  The Board has completed a rulemaking to create new Rule .2515, “Remote Work By Pharmacy Personnel.”  The rule authorizes, and governs, a pharmacy’s use of its own pharmacy personnel employees to perform certain remote operations.  The rule is effective May 1, 2022.  The Board’s March 17, 2020 Expanded Emergency Services Waiver, issued as a result of the COVID-19 public health emergency, previously authorized intra-pharmacy remote operations.  New Rule .2515 does not differ materially from the waiver provisions concerning intra-pharmacy remote operations.  Accordingly, Rule .2515 (and not the waiver) will govern this practice come May 1.  Detailed guidance to Rule .2515 is found here. Please note:  A different rule, Rule. 1816, governs inter-pharmacy remote medication order processing arrangements.  Detailed guidance to that rule is found here:  Inter-Pharmacy RMOP Guidance.

 


 

THURSDAY, APRIL 21, 2022

FDA SEEKS PUBLIC COMMENT ON PROPOSAL TO REQUIRE THAT OPIOID ANALGESICS USED IN OUTPATIENT SETTINGS BE DISPENSED WITH PRE-PAID MAIL-BACK ENVELOPES AND THAT PHARMACISTS PROVIDE EDUCATION ON OPIOID DISPOSAL.  FDA is seeking comment on proposed changes to its Opioid Analgesic Risk Evaluation and Mitigation Strategy to require opioids be dispensed with pre-paid envelopes to return unused medication to DEA-registered disposal facilities and that pharmacists educate patients on opioid disposal.  FDA is exploring these proposals as a means of increasing disposal of unused opioids, which are a diversion risk, in a manner that mitigates environmental risks.   FDA is accepting comments through June 21, 2022.  More detail on FDA’s proposal is found here:  https://www.fda.gov/news-events/press-announcements/fda-considers-new-approach-improve-safe-disposal-prescription-opioid-analgesics-decrease-unnecessary.

 


 

MONDAY, APRIL 11, 2022

STATE HEALTH DIRECTOR ISSUES STANDING ORDERS TO IMPLEMENT QUALIFIED PHARMACISTS’ AUTHORITY TO PROVIDE CERTAIN THERAPEUTICS.  As pharmacists know, the General Assembly passed and Governor Cooper signed into law S.L. 2021-110, which confers on qualified pharmacists the ability to dispense, deliver, or administer certain therapeutics.  (For a complete overview of S.L. 2021-110, see:  http://www.ncbop.org/PDF/SL2021110GuidanceAug2021.pdf)

State Health Director Betsey Tilson has issued five standing orders under this new authority:

Futher details and links to each of the standing orders and their accompanying documents may be found here: https://ncpublichealth.info/HDSO-pharmacists.htm.

*As the Oral and Transdermal Hormonal Contraceptives standing order notes, immunizing pharmacists “who provide contraception products in accordance with this standing order must also complete North Carolina Hormonal Contraception Training Program.”  The North Carolina Association of Pharmacists has produced this training program, which is now available here:  https://ncap.memberclicks.net/2022-hormonal-contraception-training-and-toolkit.  The Board of Pharmacy has agreed to fund the training program for up to 6,000 North Carolina resident pharmacists over the next 12 months.  NCAP will maintain records of pharmacists who have completed this training.

Once an immunizing pharmacist has completed the North Carolina Hormonal Contraception Training Program, the pharmacist must report that to the Board by logging on to their profile at the Board’s Licensure Gateway, selecting the “Pharmacist” tile under “Licenses & Registrations”, and clicking on the “Contraceptive Trained” option:

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THURSDAY, MARCH 31, 2022

STATE HEALTH DIRECTOR UPDATES MODERNA AND PFIZER COVID-19 VACCINE STANDING ORDERS.  State Health Director Betsey Tilson has updated the state standing orders to reflect FDA’s authorization of a second booster for certain patient populations.  The updated standing orders are found here:

They are also found here (along with all other state standing orders for pharmacists):  https://ncpublichealth.info/HDSO-pharmacists.htm.

 


 

MONDAY, MARCH 28, 2022

STATE HEALTH DIRECTOR UPDATES NALOXONE STANDING ORDER.  State Health Director Betsey Tilson has updated the naloxone standing order for pharmacists.  The chief update is that the standing order now authorizes pharmacists to dispense “FDA-approved naloxone products used in accordance with approved directions” and references a list of such products and directions.  The standing order directs pharmacists that “product selection should be made based on patient preference, availability, insurance coverage, and other pertinent factors.”  The revised standing order is found here:  https://publichealth.nc.gov/docs/NCNaloxoneStandingOrderforPharmacistsMarch2022.pdf.  The list of FDA-approved naloxone products is available here:  https://publichealth.nc.gov/docs/NaloxoneProductsforPharmacistDispensing.pdf (the product list is also linked through the standing order itself).  Additional resources for safe and proper dispensing of naloxone are found here:  https://naloxonesaves.org/.

 


 

MONDAY, MARCH 28, 2022

WORKING CONDITIONS COMPLAINT FORM. The Board of Pharmacy has put together a complaint form for pharmacists to report working conditions in their pharmacy that they believe are creating a threat to public health and safety.  This complaint form asks several questions regarding the practices in the pharmacy.  It is important for the complainants to answer as many questions as they can as thoroughly as they can, so that Board staff can thoroughly investigate these complaints, and the Board can take meaningful action.  If a pharmacist has concerns about their pharmacy’s working conditions creating a threat to public safety, please fill out this form and email to complaints@ncbop.org.

 


 

WEDNESDAY, MARCH 9, 2022

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JUNE 20, 2022 -- ON THE FOLLOWING PROPOSED ACTIONS:

AMENDMENT TO 21 NCAC 46 .1317 DEFINITIONS (ACPE)

REPEAL OF 21 NCAC 46 .2403 DRUGS AND DEVICES TO BE DISPENSED

All public hearing details may be found here.

 


 

Health Advisories (last updated September 15, 2021) - Check here regularly for the latest alerts and recall notices.

 


 

Medicare/Medicaid (last updated March 2, 2022) - 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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