Board News and Announcements
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:
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:
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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)
- 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.
- 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.
MONDAY, AUGUST 1, 2022
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.
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 Intern. Three more categories of persons are required to register as a pharmacy intern, though these are likely to be a small percentage of interns:
- 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.
- 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.
- 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.
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.
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.
FRIDAY, JULY 22, 2022
NOVAVAX COVID-19 VACCINE AUTHORIZED AND RECOMMENDED FOR ADULTS 18 AND OLDER. The Food and Drug Administration and the Centers for Disease Control and Prevention have announced that the Novavax COVID-19 vaccine can be used as an additional vaccine option for adults ages 18 years and older.
The Novavax COVID-19 vaccine is the latest authorized and recommended vaccine to prevent severe illness, hospitalization and death caused by the virus. The Novavax COVID-19 vaccine provides a more familiar type of protein-based vaccine technology that has been used for more than 30 years in shots that help prevent diseases like shingles, hepatitis B, the flu and other illnesses.
The Novavax vaccine will be made available in the coming weeks to North Carolinians over the age of 18 who are not yet vaccinated. It is given in a two-dose primary series, with a second dose administered between three-to-eight weeks after the first.
For more information about COVID-19 vaccines, testing and treatments, visit MySpot.nc.gov or contact the North Carolina COVID-19 Vaccine Help Center by phone at 1-888-675-4567.
MONDAY, JULY 18, 2022
All applicants should submit a cover letter of interest along with a resume to Rhonda Jones, Director of Finance and Human Resources, firstname.lastname@example.org.
THURSDAY, JULY 14, 2022
NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES MONKEYPOX GUIDANCE TO CLINICIANS. NC DHHS has issued monkeypox guidance to clinicians and clinical labs: http://www.ncbop.org/PDF/NCDHHSMonkeypoxProviderMemoUpdate_071222.pdf. Pharmacists and pharmacies may find this an especially useful resource when interacting with patients or other health care providers on the subject of monkeypox.
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.
THURSDAY, JULY 7, 2022
BOARD OF PHARMACY MOURNS THE PASSING OF LAZELLE MARKS. The members and staff of the Board of Pharmacy grieve the loss of Lazelle Marks, who passed away today, July 7, 2022. Lazelle served on the Board from 2010 to 2015. He brought to the board a lifetime of service to pharmacy, to his patients, and to his community. Lazelle was a pillar of the Rockingham community, and the patients at Medical Center Pharmacy had in him a compassionate caregiver and stalwart advocate. Lazelle was an inspiration and mentor to hundreds of independent community pharmacists in North Carolina through his long service as a board member at Mutual Drug Company.
The phrase “still waters run deep” aptly described Lazelle’s time with the Board. Never one to draw attention to himself, Lazelle brought a deeply contemplative approach to every issue that came before the Board. He would quietly absorb the various viewpoints and policy positions on a given issue and, unerringly, reach a conclusion that placed patient well-being and safety first. Board members and staff also remember Lazelle as a warm, welcoming friend who was graced with a sublime sense of humor.
Coach Dean Smith once said, “You should never be proud of doing the right thing. You should just do it.” We think Lazelle, a Tar Heel to his core, would be proud that Coach Smith’s observation applies perfectly to his life. Lazelle was a man who constantly did the right things, because they were the right things to do. We will miss him. And we extend our deepest sympathies to Lazelle’s sons, Greg and Jon, both pharmacists and both lucky beyond measure to have had their father’s example in pharmacy and in life.
UPDATED THURSDAY, JULY 7, 2022 TO INCLUDE NOTICE FROM NC MEDICAID - SEE BELOW
JULY 6, 2022 *UPDATE* PHARMACIST ROLE IN PAXLOVID THERAPY FOR COVID-19. As pharmacists know, the FDA has issued emergency authorization (“EUA”) for Pfizer’s Paxlovid, an oral antiviral, for the treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients.
On July 6, 2022, the FDA amended the Paxlovid EUA to state:
PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:
O Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function; and
O Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.
FDA’s July 6, 2022 announcement is found here: 6 July 2022 FDA Statement. The full, revised Paxlovid EUA is found here: Paxlovid Emergency Use Authorization.
The Ninth Amendment to the US DHHS PREP Act declaration (found here: PREP Act Declaration Ninth Amendment) authorizes pharmacists to “order and administer” oral COVID-19 therapies. The Ninth Amendment specifies that such ordering must comply with the terms of any FDA EUA or approval. See also Board of Pharmacy Guidance to PREP Act Declaration Ninth Amendment.
Accordingly, under the terms of the PREP Act Declaration Ninth Amendment and the newly revised Paxlovid EUA, pharmacists may “order and administer” Paxlovid therapy for COVID-19. Pharmacists ordering and administering Paxlovid therapy must follow the conditions described in the revised EUA, which are summarized in the FDA’s 6 July 2022 FDA Statement. The Paxlovid Emergency Use Authorization, at pages 9 to 11, provides more detail on requirements for health care providers administering Paxlovid – including directives on provider and patient education, tracking and reporting of adverse events and medication errors, drug storage, and dispensing record creation and maintenance.
Pharmacists are reminded that Paxlovid contains 100 mg ritonavir in each dose. Ritonavir is a CYP3A4 inhibitor and may affect the hepatic metabolism of various drugs. Therefore, it is important to understand that coadministration of Paxlovid with several classes of drugs could result in potentially serious drug-drug interaction mediated adverse reactions. The Paxlovid FDA EUA Fact Sheet for Health Care Providers contains a list of established and potentially significant drug interactions (see Section 7.3). It is critical when dispensing Paxlovid to inquire about a patient’s medication therapy. Standard drug interaction software is not a substitute for patient-specific screening. And pharmacists should specifically inquire if the patient has received an organ transplant, as Paxlovid interactions with anti-rejection drugs have been documented. All potential drug-drug interactions should, of course, be evaluated and, where appropriate, discussed with the patient’s transplant care or primary care providers.
Paxlovid FDA EUA Fact Sheet for Health Care Providers
Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treament of COVID-19
FDA Updates on Paxlovid for Health Care Providers
NIH COVID-19 Treatment Guidelines Panel’s Statement on Potential DDI’s between Paxlovid and Concomitant Medications
University of Liverpool COVID-19 Drug Interaction Checker
IDSA Statement on Considerations for Use of Paxlovid in Treatment of COVID-19 for Patient’s with HIV and Hep C
JULY 7, 2022 UPDATE FROM NC MEDICAID: NC Medicaid Pharmacy POS Billing for Pharmacist Prescribed Paxlovid:
The July 6, 2022 FDA Statement authorizes state licensed pharmacists to prescribe Paxlovid. It is the responsibility of the pharmacist to prescribe Paxlovid in accordance with conditions of the FDA’s July 6th guidance.
Only CPP credentialed pharmacists are enrolled as NC Medicaid providers. This means non-CPP pharmacists prescribing Paxlovid must use the pharmacy NPI as the prescriber on POS pharmacy claims submitted to NC Medicaid. Using the pharmacy NPI will avoid denials for non-enrolled provider. A State standing order will not be issued for Paxlovid.
In addition to the above, the following is applicable to Paxlovid POS claims.
- Reimbursement is the ingredient cost (currently free) plus the professional dispensing fee.
- No copay applies because Paxlovid is for treatment of COVID19.
- Pharmacist must enter the COVID19 diagnosis on the claim.
This pharmacy POS billing guidance is effective July 6, 2022. NCTracks system readiness for claims processing is anticipated by July 18, 2022. After claims processing is active, retro billing back to the July 6, 2022, start date can be done.
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 email@example.com.
Links to the two types of participation agreements for pharmacies along with a short description of each:
- Full Participation Agreement for Pharmacies for NC HealthConnex Access and Data Use
- The full participation agreement for pharmacies allows pharmacy providers full use of NC HealthConnex, including electronic exchange of vaccine information.
- It also enables compliance with claims data connection and data submission provisions in the Statewide Health Information Exchange Act.
- Submission-Only Agreement for NC HealthConnex for Pharmacies
- The submission-only participation agreement for pharmacies enables a pharmacy to submit the claims data required by law in a one-way technical connection for compliance with the Statewide Health Information Exchange Act.
- This agreement prohibits all other data exchange services, including HIE query/data exchange and clinical registries.
- Submission-only participants must work with their EHR vendor to filter data to state-funded populations.
Instructions and contact information to use when completing a participation agreement:
- The participation agreement is an editable .PDF document with fillable fields for your organization-specific information. NCHIEA prefers this agreement to be completed and submitted electronically to firstname.lastname@example.org. Note: If the form fill functionality is used, you must save the document before emailing it to email@example.com.
- A participant may also send a completed and signed participation agreement in a hard copy to the address below. However, email is preferred. NC HIEA does not require two copies. The physical mailing address is:
N.C. Health Information Exchange Authority
Re: N.C. HIEA Participation Agreement
Mail Service Center 4101
Raleigh, NC 27699-4101
- For FAQs About NC HealthConnex Participation click here.
- For questions, please feel free to call NCHIEA at 919-754-6912 or email at firstname.lastname@example.org.
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.
- Click here to visit NCHIEA’s How to Connect webpage and register for the next webinar.
WEDNESDAY, JULY 6, 2022
GUIDANCE FROM NC DHHS ON HOW PHARMACIES IN NORTH CAROLINA CAN GAIN ACCESS TO FREE COVID-19 THERAPIES. To ensure efficient and equitable distribution, COVID-19 therapeutics such as Paxlovid, Lagevrio and Evusheld are currently purchased by the federal government from their manufacturers and are not available on the commercial market.
If your pharmacy is not currently receiving allocations of COVID-19 therapeutics, you may submit a request to the North Carolina Department of Health and Human Services (NC DHHS) to receive COVID-19 oral antivirals and/or Evusheld by following the steps outlined in this guidance.
MONDAY, JUNE 27, 2022
ADMINISTRATION OF COVID-19 VACCINE TO PATIENTS UNDER THREE YEARS OF AGE. The Food and Drug Administration has approved Pfizer and Moderna COVID-19 vaccines for patients as young as six months. Pharmacists have inquired of Board staff about their authority to administer COVID-19 vaccines to these pediatric patients. Still-in-effect PREP Act declarations issued by the United States Department of Health and Human Services authorize qualified pharmacists to administer COVID-19 vaccines to patients age three or older. North Carolina law authorizes qualified immunizing pharmacists to administer COVID-19 vaccines to patients age 10 or older pursuant to protocol, and 6 or older pursuant to a patient-specific prescription. While the PREP Act declaration remains in place, pharmacists may exercise the broader authority to administer COVID-19 vaccine to patients age 3 or older. There is no authority under PREP Act declaration or North Carolina law for pharmacists to administer COVID-19 to a patient younger than 3 years of age.
Updated statewide standing orders and fact sheets are found here:
- Statewide Standing Order for Pfizer-BioNTech mRNA COVID-19 Vaccine Administration in Patients 6 Months to 4 Years (June 20, 2022)
- Statewide Standing Order for Moderna COVID-19 Vaccine Administration in Patients 6 Months to 5 Years (June 20, 2022)
Fact sheets for Healthcare Providers:
- Moderna: Moderna Recipients FS 6m-5y 06172022 (fda.gov)
- Pfizer: Pfizer Recipient FS 6m-4y Maroon 06172022 (fda.gov)
All current statewide standing orders 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
FRIDAY, JUNE 24, 2022
CDC BROADENS RECOMMENDATION OF COVID-19 VACCINES FOR INDIVIDUALS 6 THROUGH 17 YEARS OF AGE TO INCLUDE THE MODERNA COVID-19 VACCINE PRODUCT.
Following the FDA authorization, the Centers for Disease Control and Prevention (CDC) broadened their recommendation of COVID-19 vaccines for individuals 6 through 17 years to include the Moderna COVID-19 vaccine product.
PROVIDER COMMUNICATION FROM THE NC DEPARTMENT OF HEALTH AND HUMAN SERVICES IS FOUND HERE.
The Statewide Standing Order FDA EUA Moderna 6y-11y and Moderna 12+ are now published online and available:
- Statewide Standing Order for Moderna mRNA COVID-19 Vaccine Administration in Patients 6 Years through 11 Years (June 23, 2022)
- Statewide Standing Order for FDA Authorized Moderna COVID-19 Vaccine Administration in Patients 12 Years and Older (June 23, 2022)
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:
MONDAY, JUNE 13, 2022
NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES UPDATES GUIDANCE TO PROVIDERS FOR OUTPATIENT TREATMENT AND PREVENTION OF COVID-19. State Health Director Tilson has issued updated guidance to providers concerning outpatient COVID-19 treatment. Key updates include: (1) Statement on limited bebtelovimab availability and expected NC supply to be depleted in August 2022; (2) Information regarding COVID-19 rebound; and (3) Updated overview of Veklury (remdesivir) since gaining full FDA approval. The full update is linked here. Broader guidance for providers is found here: Therapeutics Information for Providers Page.
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:
- Share information, resources and tips with customers and health care providers at www.ncdhhs.gov/formula. Please find a family-facing fact sheet and provider guidance document on this page.
- Please contact NCDHHS at 1-800-662-7030 if you are having difficulty with on-shelf supply, ordering of standard or specialty formulas, or have other insights on the shortage.
- Consider exploring additional infant formula products that may be available for order. The provider guidance includes a formula equivalency table for your reference.
Actions NCDHHS is taking:
- Sharing information, resources and tips with families and health care providers at www.ncdhhs.gov/formula
- Through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), NCDHHS is helping to connect families participating in WIC directly to needed formula and placing bulk orders with manufacturers on behalf of local WIC agencies and the families they serve.
- Using flexibility from the federal government to make it easier for WIC participants to access available formula. North Carolina is already using available USDA rule waivers to help retailers continue to serve WIC-enrolled families during the shortage and help families return or exchange formulas included in the recall.
- Working with the federal government to waive additional rules for the WIC program to make it easier for WIC participants to access available formula. North Carolina has requested waivers that would give WIC-enrolled families more flexibility to purchase other types of formula and in a wider variety of sizes based on availability and health care provider recommendations.
- Providing guidance to local WIC agencies and health care providers to make it easier for health care providers to give WIC-enrolled families several options of formula types and sizes on a single prescription to meet their children’s specialized formula needs.
- Monitoring the formula supply across the state and keeping our partner organizations updated.
- Working with retailers across the state to assess their supply and to post materials to help educate consumers about formula options.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS, Remember to check our CE page often for upcoming CE programs in your area. (LAST UPDATED JULY 12, 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:
- Nicotine replacement therapy that is approved by the United States Food and Drug Administration
- Self-administered oral or transdermal contraceptives* (see note below regarding training requirements)
- Prenatal vitamins
- Post-exposure prophylaxis medications for the prevention of human immunodeficiency virus (HIV)
- Glucagon for the treatment of severe hypoglycemia
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:
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/.
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.
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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