Board News and Announcements

JULY 2022 NCBOP/NABP NEWSLETTER

 

 

NCBOP YouTube Channel

 

The NC Board of Pharmacy has a YouTube channel. Board meetings are live-streamed and past meetings are archived here.

 

 


 

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



 

THURSDAY, SEPTEMBER 22, 2022

DISCONTINUATION OF CDC's DISTRIBUTION OF INTRAVENOUS ARTESUNATE AS COMMERCIAL DRUG IS WIDELY AVAILABLE IN THE UNITED STATES. The CDC will discontinue its distribution of intravenous artesunate for treatment of severe malaria in the U.S. on September 30, 2022. Commercial intravenous artesunate, Artesunate for InjectionTM, is available in adequate supply from major drug distributors.

Because severe malaria can progress to death quickly, it is recommend that hospitals and pharmacists have a plan for rapid diagnosis and treatment of malaria within 24 hours to ensure that patients with malaria have the best chance of recovery. Further details can be found here.



 

TUESDAY, SEPTEMBER 13, 2022

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JANUARY 4, 2023 -- ON THE FOLLOWING PROPOSED ACTIONS:

REPEAL OF 21 NCAC 46 .1819 COVID-19 DRUG PRESERVATION RULE

Read more at http://www.ncbop.org/rulemakings.htm.

 


 

FRIDAY, SEPTEMBER 9, 2022

NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES INFORMATION FOR PHARMACISTS REGARDING ACCESS TO TPOXX FOR TREATMENT OF MONKEYPOX.  In response to inquiries from practitioners in North Carolina, NCDHHS has issued the following information for pharmacists concerning TPOXX access.

At this time, there are no FDA-approved treatments for monkeypox infection.  TPOXX (tecovirimat), an oral antiviral FDA-approved for the treatment of human smallpox disease, can be considered for treatment of monkeypox.  CDC currently holds a non-research expanded access Investigational New Drug (EA-IND) protocol that allows for the use of TPOXX for primary or early empiric treatment of non-variola orthopoxvirus infections, including monkeypox, in adults and children of all ages.  Treatment Information for Healthcare Professionals | Monkeypox | Poxvirus | CDC.

Prescribing physicians are responsible for completing the necessary paperwork associated with the EA-IND protocol.  This includes obtaining signed, informed consent from the patient prior to initiating treatment.  Detailed information about the EA-IND protocol can be found here.

Pharmacies dispensing TPOXX should ensure that signed, informed consent has been obtained by the prescriber prior to dispensing.

Physicians, Advanced Practice Registered Nurses and Physicians Assistants with active licensure in good standing with their respective governing bodies can prescribe and dispense TPOXX for treatment of monkeypox in accordance with the EA-IND, from their office, if the following conditions are met:

  1. There is absolutely no charge to the patient for the drug or act of dispensing, including seeking reimbursement of dispensing fees through 3rd party payors.
  2. Products are labeled in accordance with State and Federal dispensing laws.

TPOXX is only available through the Strategic National Stockpile.  While distribution directly from the Strategic National Stockpile is currently limited, there are more than 900 courses of TPOXX pre-positioned at provider locations across the state.  Providers in need of TPOXX, can place a request using this NC DHHS Monkeypox Medical Countermeasures Request Form. Requests are evaluated based on need and approved requests are currently being filled via transfer of pre-positioned product until direct distribution improves.

For questions regarding TPOXX, please contact PHPR.SNS@DHHS.NC.GOV.

 


 

TUESDAY, SEPTEMBER 6, 2022

STATE HEALTH DIRECTOR TILSON PUBLISHED STATEWIDE STANDING ORDERS FOR PFIZER AND MODERNA BIVALENT COVID-19 BOOSTER VACCINES.  On August 31, 2022, the Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize single booster dose bivalent formulations.  More information is available here:  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use?utm_medium=email&utm_source=govdelivery

State Health Director Betsey Tilson has issued statewide standing orders for the bivalent boosters, along with provider updates:

Provider Communication

The Statewide Standing Order FDA EUA Moderna Bivalent Booster (18+) and Pfizer Bivalent Booster (12+) are now published online and available.

All current SWSOs are 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.

Please read and review the Fact Sheet for Healthcare Providers:

 


 

WEDNESDAY, AUGUST 31, 2022

*REMINDER*  NORTH CAROLINA BOARD OF PHARMACY INTERN REGISTRATION SYSTEM IS ACTIVE – PHARMACY STUDENTS, FGPEC-HOLDERS ACQUIRING PRACTICAL EXPERIENCE, AND OTHER QUALIFYING INTERNS MUST REGISTER BY SEPTEMBER 1, 2022. Revised Board of Pharmacy Rule .1503 requires that any person who wishes to serve as a pharmacy intern and obtain practical experience in North Carolina must register with the Board.  A person may not, and will not, receive credit for any practical experience required for licensure and obtained in North Carolina unless and until registered as a pharmacy intern.

The registration period opened August 1, 2022, and persons who wish to obtain practical experience in North Carolina must be registered by September 1, 2022.  There is no fee for intern registration.

Effective September 1, 2022, North Carolina pharmacists and pharmacies who host pharmacy interns as part of an academic experiential program or who host/employ pharmacy interns outside of an academic experiential program must verify that the would-be intern is, in fact, registered.  Interns may print a Board-issued certificate after completing registration.  Pharmacists and pharmacies should also use the Board’s License/Permit Verification tool to confirm intern status --  https://portal.ncbop.org/verification/search.aspx.

Pharmacy students.  The substantial majority of pharmacy interns will be students who are currently enrolled in an ACPE-accredited school of pharmacy.  Detailed registration instructions for incoming and currently-enrolled students are found here. Please consult those instructions before beginning the registration process.  Note that you will need to have three documents for upload to complete a registration:  (1) a photograph of yourself (passport type); (2) proof of enrollment from your school of pharmacy (please consult with the appropriate person(s) at your school to obtain the proof of enrollment); and (3) a signed (manual, not electronic) copy of a FERPA Waiver (found here) that will authorize the Board of Pharmacy to obtain certain enrollment and academic status information from your school of pharmacy.  Note:  While the majority of pharmacy students who are acquiring practical experience in North Carolina will be enrolled in a North Carolina-based school of pharmacy, not all will.  The intern registration requirement applies to all enrolled pharmacy students acquiring practical experience in North Carolina, whether the school is located in North Carolina or in another state.

FGPEC-Holding Graduates of a Foreign School of Pharmacy.  A graduate of a foreign school of pharmacy who has successfully completed the Foreign Pharmacy Graduate Equivalency Examination and the Test of English as a Foreign Language is eligible for pharmacy intern status and must register to acquire required practical experience.  Detailed registration instructions for FGPEC-holding graduates of a foreign school of pharmacy are found here. Please consult those instructions before beginning the registration process.  Note that you will need to have two documents for upload to complete a registration:  (1) a photograph of yourself (passport type); and (2) your NABP-issued FPGEC certificate. 

Other Categories of Pharmacy InternThree more categories of persons are required to register as a pharmacy intern, though these are likely to be a small percentage of interns:

  1. Graduates of an ACPE-Accredited School of Pharmacy Who Are Not Licensed in Any State, Have an Active Application for North Carolina Licensure, But Have Not Yet Passed the Licensure Exams.  Any pharmacy school graduate who, come September 1, 2022, is practicing in a North Carolina pharmacy, has applied for licensure in North Carolina, but has not yet passed the NAPLEX and MPJE, will need to register as an intern.  The registration application is accessed through your profile on the Board’s Licensure Gateway (https://portal.ncbop.org/).  If you have any questions about the process, please contact Board licensing staff.
  2. Pharmacist Licensed in Another State Who Is Gaining Practical Experience Required to Reciprocate to North Carolina.  Occasionally, a pharmacist seeking to reciprocate licensure from another state has been out of practice for a sufficiently long period of time that some refresher practical experience is required.  A reciprocity applicant who falls into this category will be contacted by Board licensing staff when the application is reviewed.  Such candidates must register as an intern prior to obtaining refresher practical experience.  The registration application is accessed through your profile on the Board’s Licensure Gateway (https://portal.ncbop.org/).  If you have questions about the process, please contact Board licensing staff.
  3. Pharmacist With An Inactive North Carolina License Who Is Gaining Practical Experience Required to Reinstate.  Occasionally, a pharmacist seeking to reinstate a North Carolina license has been out of practice for a sufficiently long period of time that some refresher practical experience is required. A reinstatement applicant who falls into this category will be contacted by Board licensing staff when the application is reviewed.  Such candidates must register as an intern prior to obtaining refresher practical experience.  The registration application is accessed through your profile on the Board’s Licensure Gateway (https://portal.ncbop.org/).  If you have questions about the process, please contact Board licensing staff.


 

THURSDAY, AUGUST 18, 2022

IT’S (COMING) BACK!  EFFECTIVE OCTOBER 1, 2022, GENERAL ASSEMBLY REVIVES REQUIREMENT TO NOTIFY PRESCRIBERS WHEN DISPENSING AN INTERCHANGEABLE BIOSIMILAR. In 2015, the General Assembly amended the Pharmacy Practice Act to clarify that, when authorized by the prescriber, an interchangeable biosimilar product may be substituted by a pharmacist.  That statute also directed a pharmacist who acted on the prescriber’s authorization “within a reasonable time” to notify the prescriber of that substitution, including the name and manufacturer of the specific biological product dispensed to the patient.  More detail is found at Item 2312 of the October 2015 Newsletter. The notification requirement, however, sunsetted on October 1, 2020.

A provision of the General Assembly’s most recent appropriations act has resurrected the notification requirement.  Effective October 1, 2022, a pharmacist who, as authorized by the prescriber, dispenses an interchangeable biosimilar to a patient must, within five business days, “communicate to the prescriber the product name and manufacturer of the specific biological product dispensed to the patient.”  The statute lists five means of making this communication electronically.  An entry into any of the following “that is electronically accessible to the prescriber” by “the pharmacist or a designee is presumed to provide the required communication and notice to the prescriber”:  “(1) An interoperable electronic medical records system.  (2) Electronic prescribing technology.  (3) A pharmacy benefit management system.  (4) The North Carolina Health Information Exchange Network.  (5) A pharmacy record.”  Absent one of these methods, the statutes says that “the pharmacist or a designee shall provide the required communication to the prescriber by facsimile, telephone, electronic transmission, or other prevailing means.”  The statute specifies that there is no required communication to the prescriber if there is no FDA-approved interchangeable biosimilar for the product prescribed or if a refill prescription is not changed from the product dispensed on the prior filling of the prescription.” 

The FDA’s Purple Book, which lists approved biological products, including licensed biosimilar and interchangeable products, is found here:  https://purplebooksearch.fda.gov/.

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED SEPTEMBER 6, 2022.)

 


 

WEDNESDAY, AUGUST 3, 2022

NORTH CAROLINA COVID-19 STATE OF EMERGENCY ENDS AUGUST 15, 2022 – HOW DOES THIS AFFECT PHARMACISTS?  As has been widely reported, the North Carolina COVID-19 state of emergency sunsets on August 15, 2022.  Overall, the end of the North Carolina state of emergency will have relatively little effect on pharmacy practice.  Here are details:

  1. Board of Pharmacy Waivers.  The Board of Pharmacy’s waiver authority is keyed by a state of emergency.  So, on August 15, the Board’s waiver authority will expire.  This will, however, have a negligible effect on pharmacy practice:
      1. Inter- and Intra-Pharmacy Remote Operations.  The Board withdrew the March 17, 2020 expanded emergency services waiver authorizing remote operations effective July 1, 2022, when it began enforcing amended Rule .1816 and new Rule .2515 which authorize and govern inter- and intra-pharmacy remote operations, respectively.  See http://www.ncbop.org/PDF/GuideToInterPharmacyRMOP.pdf and http://www.ncbop.org/PDF/GuidanceForIntraPharmacyRMOPServices.pdf.
      2. Cross-Jurisdictional Practice.  Effective December 31, 2020, the Board withdrew the March 10, 2020 emergency services waiver allowing pharmacists and certified technicians in good standing in another state to practice in North Carolina under certain conditions. 
      3. Temporary Relocation.  The portion of the March 10, 2020 emergency services waiver allowing temporary pharmacy relocations without re-permitting will expire on August 15, 2022 when the state of emergency sunsets.
      4. Waiver and Clarification Concerning Pharmacy Intern Status.  The Board’s June 16, 2020 waiver and clarification that 2020 pharmacy school graduates retained internship status through December 31, 2020 expired on its own terms on that date.  And, in all events, intern status (including that of pharmacy school graduates) is now governed by amended Rule. 1503:  http://www.ncbop.org/NewsItems/PharmacyInternRegistration.html.
      5. CPR Certification for Immunizers.  The Executive Director’s exercise of authority under the March 10, 2020 emergency services waiver to waive enforcement of the requirement that an immunizing pharmacist hold a current provider level cardiopulmonary resuscitation certification will end on August 15, 2022 when the state of emergency sunsets.
      6. Supervision of Immunizing Pharmacy Technicians.  The Executive Director’s December 8, 2020 exercise of authority under the March 10, 2020 emergency services waiver to broaden the definition of “supervision” for immunizing pharmacy technicians was superseded by amended Rule .2507, which incorporated that same supervision standard:  The technician “[e]ither (i) has an Immunizing Pharmacist on site and readily available to assist as needed, or (ii) has another licensed health care provider authorized to administer vaccines on site and readily available to assist asneeded and has a supervising pharmacist readily available by phone or other telecommunications method for consultation as needed.”  21 NCAC 46.2507(c)(5) (effective July 1, 2022)
  2. State Health Director’s Standing Orders.  Throughout the COVID-19 state of emergency, State Health Director Tilson has issued a number of COVID-19 related standing orders:  https://www.dph.ncdhhs.gov/HDSO-pharmacists.htm. Those standing orders remain in effect after the August 15 sunset.  In S.L. 2022-74, the General Assembly continued Dr. Tilson’s authority to issue statewide standing orders to facilitate the administration of COVID-19 vaccinations, diagnostic tests, or other treatments until rescinded.
  3. PREP Act Declarations.   Federal Department of Health and Human Services’ PREP Act declarations granting pharmacists and pharmacy technicians various authorities remain in effect after the August 15 sunset.  The PREP Act declarations are keyed to the federal declaration of public health emergency, which does not sunset on August 15. 


 

FRIDAY, JULY 29, 2022

CHANGES TO SCHEDULE 2 CONTROLLED SUBSTANCE PRESCRIPTIONS.  Board staff have received many calls and emails inquiring about the continued ability for pharmacists to make certain changes to Schedule II prescriptions in consultation with the prescriber: http://www.ncbop.org/faqs/Pharmacist/faq_ChangestoSchIICS.htm. The source of the angst appears to be as follows:  A 2019 presidential executive order required all federal agencies to review and consolidate various informal guidance documents.  As a result of this review, the federal Drug Enforcement Administration removed informal guidance on its website that concerned changes to Schedule II prescriptions.  The National Association of Chain Drug Stores issued a letter describing a private phone call with unnamed DEA officials, during which NACDS interpreted their statements as an “implication” that a Schedule II prescriptions may not be altered or changed in any way by a pharmacist.

Whatever was said on this phone call, Board of Pharmacy staff disagrees that a pharmacist may not make certain changes to a Schedule II prescription in consultation with the prescriber.  The mere fact that informal guidance was withdrawn does not mean that the conduct the informal guidance described is now “illegal.”  Nor do statements by individual DEA officials on a private phone all establish a “policy” of any sort.  Accordingly, Board staff view the longstanding statement linked above concerning changes to Schedule II prescriptions as appropriate.  If DEA issues any formal guidance or proposed rulemaking change on this matter, Board staff will update. 

 


 

WEDNESDAY, JULY 27, 2022

*UPDATE* WORKING CONDITIONS COMPLAINT FORM. The Board of Pharmacy has created 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.  Previously, this form had to be completed and emailed to Board staff.  The complaint form is now available as a tile selection when pharmacists log on to their profile in the Board’s Licensure Gateway.  Once a pharmacist has completed the form, it will be submitted automatically to enforcement staff.

 


 

FRIDAY, JULY 22, 2022

SUPERVISING PHYSICIAN INFORMATION IS NOT REQUIRED ON PRESCRIPTIONS WRITTEN BY NURSE PRACTITIONERS AND PHYSICIAN ASSISTANTS

This week, Board staff became aware that a chain pharmacy has implemented a policy whereby its prescription processing system will not allow an NP- or PA-issued prescription to be processed without the supervising physician’s name and other information.  This policy has provoked a number of calls to Board staff from pharmacists and prescribers.

A supervising physician’s information is not required on NP- or PA-issued prescriptions.  On February 1, 2021, the NC Medical Board amended the prescribing authority rule for physicians’ assistants by removing the supervising physician information requirement for prescriptions written by physicians’ assistants. 21_NCAC_32S_.0212-Final_approval_.pdf (ncmedboard.org). On August 1, 2021, the NC Medical Board amended the prescribing authority rule for nurse practitioners by removing the supervising physician information requirement for prescriptions written by nurse practitioners http://reports.oah.state.nc.us/ncac/title%2021%20-%20occupational%20licensing%20boards%20and%20commissions/chapter%2032%20-%20north%20carolina%20medical%20board/subchapter%20m/21%20ncac%2032m%20.0109.pdf.

Even before the Medical Board’s 2021 rule amendments (as detailed in long-standing Board guidance, see Item 2403 here: http://www.ncbop.org/Newsletters/Apr2020.pdf), the absence of a supervising physician’s name and telephone number did not render a PA- or NP-issued prescription "invalid," “illegal,” or otherwise ineligible for dispensing under the North Carolina Food Drug and Cosmetic Act or the North Carolina Pharmacy Practice Act. 

Board staff trust that this clarifies this issue.   

 


 

MONDAY, JULY 11, 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.

Board staff have updated the guidance to inter-pharmacy remote medication order processing under Rule .1816.  The updates are two-fold:  (1) noting that Board staff began enforcing the rule on July 1, 2022; and (2) providing detailed instructions on how a pharmacy must notify the Board prior to beginning an RMOP arrangement through the Board’s Licensure Gateway. 

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 must file an application and obtain a permit prior to engaging in RMOP services. 

The updated inter-pharmacy RMOP guidance is found here. It 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.

This document – 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.

 


 

WEDNESDAY, JULY 6, 2022

IMPORTANT INFORMATION/REMINDERS FROM THE NC HEALTH INFORMATION EXCHANGE AUTHORITY CONCERNING JANUARY 1, 2023 DEADLINE FOR PHARMACIES.   In 2015, the North Carolina General Assembly enacted legislation requiring health care providers to connect and remit health care data for recipients of Medicaid, the State Employees Health Plan and CHIP to the North Carolina Health Information Exchange (“NC HealthConnex”) in order to continue to participate in state funded health care plans such as Medicaid, the State Employees Health Plan and CHIP. The deadline for pharmacies to connect and start sending claims data to NC HealthConnex is January 1, 2023.

The NC Health Information Exchange Authority (“NCHIEA”) recommends that providers begin the process of connecting as soon as possible. Below is information on the two forms of participation agreements for pharmacies, instructions on how to complete a participation agreement, and a link to NCHIEA’s How to Connect webpage.  For further information and assistance, please do not hesitate to contact the NC HIEA via phone at (919) 754-6912 or email at hiea@nc.gov.

Links to the two types of participation agreements for pharmacies along with a short description of each:

Instructions and contact information to use when completing a participation agreement:

NCHIEA hosts a monthly How to Connect webinar that is a valuable resource in educating providers on the participation agreement and the overall process of getting connected to NC HealthConnex. Our next How to Connect webinar is on 7/25 from Noon to 1pm ET.

Please don’t hesitate to reach out with questions via email or phone at (919) 754-6912.  NCHIEA appreciates your time and attention to help fulfill its mission and vision.

 


 

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:

 


 

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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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/.

 


 

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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