Board News and Announcements

 

JANUARY 2024 NCBOP/NABP NEWSLETTER

Practitioners wishing to subscribe to the North Carolina Board of Pharmacy Newsletter may complete the form found at the bottom of this page.

 

 

 


 

WEDNESDAY, MARCH 13, 2024

NOTICE OF PUBLIC HEARING (MAY 21, 2024) AND COMMENT PERIOD ON THE FOLLOWING PROPOSED ACTION:

AMENDMENT TO 21 NCAC 46 .2504 PATIENT COUNSELING

A public hearing will be held on Tuesday, May 21, 2024 at 9:30AM at the NC Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.

Follow this link for details, including proposed amended language and instructions/deadline for submitting comments.

 


 

TUESDAY, MARCH 12, 2024

BOARD OF PHARMACY TO FILL A VACANCY FOR THE SOUTHEASTERN DISTRICT BOARD MEMBER POSITION. Board President Andy Bowman announced today (March 12, 2024) that he will be leaving Board service to a accept a professional and personal opportunity in Virginia.  Board members and staff are grateful for Dr. Bowman’s eight years’ of superlative service to the Board and the citizens of North Carolina.  He will be deeply missed.

The Board of Pharmacy welcomes applicants for the soon-to-be vacant Southeastern District Board Member position.  The Board will consider candidates to fill the remainder of that term, which expires on April 30, 2026.  The following procedure will be used to fill the vacancy:

1.  Eligible Pharmacists.  A pharmacist who holds an active North Carolina license to practice pharmacy and who resides (residential address, not work/practice address) in one of the counties comprising the Southeastern District:  Beaufort, Bladen, Brunswick, Carteret, Columbus, Craven, Cumberland, Duplin, Greene, Harnett, Hoke, Johnston, Jones, Lenoir, New Hanover, Onslow, Pamlico, Pender, Pitt, Robeson, Sampson, Scotland and Wayne Counties.

2.  Nomination Process.  Interested pharmacists shall submit the following materials to the Board’s Executive Director, Jay Campbell, by 5 p.m. Friday, April 26, 2024:  (1) a letter of interest and any written materials the pharmacist wishes the Board to consider; and (2) the signatures, legibly printed/typed names, and North Carolina pharmacist license numbers of ten (10) other pharmacists residing in the Southeastern District supporting the pharmacist’s candidacy.

These materials may be submitted by U.S. Mail (to arrive at the Board by close of business April 26, 2024), electronic mail (jcampbell@ncbop.org), or facsimile transmission (919-246-1056).  To avoid any candidate materials being overlooked, the interested pharmacist should also contact Executive Director Jay Campbell by telephone (919-246-1050) and advise that candidate materials have been mailed, e-mailed, or faxed.

Note:  The current members of the Board of Pharmacy may nominate candidates, but will do so only if no or only one candidate self-nominates.

Board staff will review all materials received by close of business Friday, April 26, 2024, to confirm the candidate’s eligibility and that the nomination is supported by ten (10) pharmacists residing in the Southeastern District.

The Board will consider the candidates at its meeting on Tuesday, May 21, 2024. 

Any pharmacist with questions about Board Member service or the nomination/selection process should contact Executive Director Jay Campbell by phone (919-246-1050) or email (jcampbell@ncbop.org).

 


 

MONDAY, MARCH 11, 2024

NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES ISSUES UPDATED COVID TREATMENT MEMO.  Today (March 11, 2024), NC DHHS issued an updated COVID-19 treatment provider memo.  Included in this memo is a reminder that EUA-labeled Paxlovid is no longer authorized for use, information about PAXCESS – a program that can help patients with financial barriers obtain Paxlovid, an update on clinical data on the efficacy of antiviral treatments, and a note on the large portion of the North Carolina population considered high risk based on age or health conditions.  The memo is found here:  https://covid19.ncdhhs.gov/covid-treatments-provider-memo-march-2024/download?attachment.

 


 

WEDNESDAY, MARCH 6, 2024

NORTH CAROLINA ASSOCIATION OF PHARMACISTS MEDICAID PROVIDER ENROLLMENT TOOLKIT.   On January 8, 2024, North Carolina Medicaid began allowing pharmacists, who provide care and prescribe medications via statewide protocols put in place by SL 2021-110, to enroll as healthcare providers. (For general information about those SL 2021-110 authorities, see this guidance document).  Prior to this date, and since 2018, clinical pharmacist practitioners, working under a collaborative agreement, have been allowed to enroll as NC Medicaid providers.   

The Board of Pharmacy plays no part in the enrollment process.  But the North Carolina Association of Pharmacists (NCAP) provides an online resource to assist pharmacists in navigating the provider enrollment process.  The resource includes an informational webinar, access to SL 2021-110 authorized state-wide protocols, enrollment requirements, screen shots and information to avoid hard stops and ensure successful submission; as well as information regarding Medicaid post-submission communications and requirements prior to being granted your provider approval.  The NCAP resource also provides medical claim submission instructions for Medicaid Direct and the Medicaid Managed Care Organizations.  The resource is available at https://www.ncpharmacists.org/medicaid-enrollment-and-billing.

 


 

TUESDAY, MARCH 5, 2024

NORTH CAROLINA MEDICAID ISSUES STATEMENT ABOUT COVERAGE OF IMPORTED BENZATHINE BENZYLPENICILLIN. NC Medicaid will now cover imported benzathine benzylpenicillin (Extencilline) for use in outpatient medical drug claims. This new coverage is being added to address the ongoing national shortages of Bicillin® L-A (penicillin G benzathine injectable suspension).

While we have not heard of major shortages in North Carolina, we wanted to ensure that providers had access to every tool that may be available.

The statement on the policy change is available at https://www.ncdhhs.gov/news/press-releases/2024/03/04/ncdhhs-releases-statement-state-health-director-dr-elizabeth-cuervo-tilson-increasing-access

Provider guidance on extencilline is available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a026d0c-6f91-4ee3-b193-b2186a37e7ca

More detailed information on Medicaid billing is available at NC Medicaid to Cover Imported Benzathine Benzylpenicillin (Extencilline): Billing Guidelines | NC Medicaid (ncdhhs.gov)

 


 

MONDAY, MARCH 4, 2024

*UPDATE* CHANGE HEALTHCARE CYBER ATTACK AND TRANSMISSION OF ELECTRONIC PRESCRIPTIONS.  Board staff is aware of the Change Healthcare cyber attack.  Among the many disruptions created, some pharmacies are unable to receive electronic prescriptions.  Board staff understands that workarounds have enabled non-controlled substance prescriptions to continue to flow to affected pharmacies by conversion to facsimile.
With respect to controlled substance prescriptions, Board staff offers the following reminders:

  1. Prescriptions for “targeted controlled substances” under the North Carolina STOP Act must be prescribed electronically UNLESS an exception applies.  One exception is a “practitioner experiencing a technical failure or other circumstance preventing electronic transmission.”  That exception has direct, and obvious, applicability to this situation.  For more information on the NC STOP Act, see Pharmacist's Guide to the STOP Act
  2. Other means of transmitting controlled substance prescriptions in a way compliant with federal law remain available.  The include:
    1. Facsimile transmission of Schedule 3, 4, and 5 prescriptions.  Note, however, that federal law requires that a fax prescription for a controlled substance be hand-signed by the prescriber. 
    2. Verbal transmission of Schedule 3, 4, and 5 prescriptions.
    3. Written transmission of Schedule 2, 3, 4, and 5 prescriptions.  It is permissible under federal law for the prescriber to send a copy of the Schedule 2 prescription ahead to a pharmacy by fax transmission so that the pharmacy can begin preparing it while the patient is in transit.  But the patient must present the original written prescription in the pharmacy prior to dispensing.
    4. The DEA Pharmacist’s Manual --  https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist's_Manual_DEA.pdf  -- is an excellent source for refreshing your knowledge on permissible means of transmitting controlled substances.  Pages 38-50 of the Manual cover this topic.

Representatives from Change Healthcare and SureScripts relayed the following during a call with state regulators on Friday, March 1:

  1. Change Healthcare intends to reactivate the ability of its system to transmit non-controlled electronic prescriptions at 2pm EST/1 pm CST Friday, March 1, 2024.
  2. If that reactivation proves successful and stable, it will move to reactivate controlled substance electronic prescription transmission “soon afterward.”  Change Healthcare could not offer a more specific timeline.

*UPDATE*  On Saturday, March 2,  2024, Surescripts determined that it was safe to turn electronic prescribing for controlled services (ECPS) back on for pharmacies connecting to Surescripts through Change Healthcare.

Reconnection was activated at 1 pm ET/Noon CST on Saturday, March 2, though Surescripts cautioned that it could take up to 24 hours for all affected pharmacies to begin receiving ECPS scripts. Change Healthcare has published a website concerning the cyber attack and is updating regularly -- https://www.unitedhealthgroup.com/ns/changehealthcare.html

 


 

SATURDAY, MARCH 2, 2024

ATTENTION ALL LICENSEES, REGISTRANTS, AND PERMIT HOLDERS - THE REGULAR RENEWAL PERIOD HAS ENDED. DME AND PHARMACY PERMIT HOLDERS MAY STILL RENEW WITH PENALTY. March 1, 2024 was the deadline to renew your pharmacist license, CPP license, PA/NP or dispensing physician registration, or technician registration for the current year. Any license or registration that was not renewed will be moved to inactive status.

Pharmacy and DME permit holders who did not renew by the March 1 deadline may renew with a late penalty from March 2 through March 31. Any permit not renewed by March 31, 2024 will be closed. Log in and renew now via the Board’s Licensure Gateway. Click on the FACILITY MANAGEMENT tab to log in to your pharmacy or DME permit.

 


NCBOP YouTube Channel

 

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

 


 

TUESDAY, FEBRUARY 27, 2024

DISPENSING OPTOMETRIST REGISTRATION SYSTEM OPEN EFFECTIVE MARCH 1, 2024.  Effective Friday, March 1, 2024, optometrists may register with the Board of Pharmacy to dispense certain prescription drugs.  G.S. § 90-127.4.  Dispensing optometrists may dispense prescription drugs to their own patients only for the diagnosis and treatment of abnormal conditions of the eye and its adnexa.  G.S. § 90-127.4(a) & (c).   Dispensing optometrists may not compound medications, nor may they dispense controlled substances.  G.S. § 90-127.4(a). 

Dispensing optometrists must register with the Board of Pharmacy prior to beginning dispensing activities and must renew that registration annually.  G.S. § 90-85.26B.  The initial registration fee is $75, as is the annual renewal fee.  G.S. § 90-85.24(a)(20). 

A dispensing optometrist must comply in all respects with relevant laws and regulations that apply to pharmacists governing the distribution of drugs, including packaging, labeling, and record keeping.  G.S. § 90-85.26B.  The Board of Pharmacy may discipline a dispensing optometrist’s registration for violation of these laws and regulations.  The Board of Optometry may discipline an optometrist’s license to practice optometry.  G.S. § 90-85.25B.

Step-by-step instructions for completing a dispensing optometrist registration are found here.

 


 

THURSDAY, FEBRUARY 22, 2024

NORTH CAROLINA DIVISION OF PUBLIC HEALTH ISSUES CLINICIAN ALERT ON CIPROFLOXACIN- AND PENICILLIN-RESISTANT STRAINS OF MENINGOCOCCAL DISEASE IN THE CHARLOTTE METROPOLITAN REGION.  The North Carolina Division of Public Health (NC DPH) is alerting clinicians in North Carolina to an increase in ciprofloxacin- and penicillin-resistant strains of invasive meningococcal disease caused by Neisseria meningitidis serogroup Y (NmY) in the Charlotte Metropolitan region.

Since February 2023, two cases of invasive meningococcal disease have been found to be resistant to ciprofloxacin and penicillin in residents of Mecklenburg County and one case in a resident of neighboring York County, South Carolina. These cases meet the threshold to recommend discontinuing the use of ciprofloxacin for prophylaxis of close contacts per CDC’s updated guidance.

Providers in the Charlotte Metropolitan region including Cabarrus, Gaston, Iredell, Lincoln, Mecklenburg, Rowan, and Union Counties should discontinue the use of ciprofloxacin for prophylaxis of close contacts of invasive meningococcal disease cases and prescribe rifampin, ceftriaxone, or azithromycin instead. Providers treating residents from Chester, Lancaster, or York counties in South Carolina should also follow this guidance for patients being treated in North Carolina medical facilities.

Clinicians should contact their local health departments or the Communicable Disease Branch epidemiologist on-call 24/7 number (919-733-3419) for questions.

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS - Check our CE page often for upcoming CE programs in your area. (LAST UPDATED FEBRUARY 27, 2024.)

 


 

WEDNESDAY, FEBRUARY 21, 2024

NORTH CAROLINA DHHS REMINDS PHARMACIES THAT EUA-LABELED PAXLOVID PRODUCT IS NOT AUTHORIZED AFTER MARCH 8, 2024.  NC DHHS has communicated the following to providers who have EUA-labeled Paxlovid product in inventory.  Questions should be directed to NC DHHS’s COVID-19 Testing and Treatment Team at covid19testingandtreatments@dhhs.nc.gov:

Dear Providers,  

As a reminder, all EUA-labeled Paxlovid will no longer be authorized after March 8, 2024. To ensure continued access to Paxlovid and to avoid potential supply chain issues, we strongly encourage you to begin purchasing commercial product now, if not done already.  
For EUA-labeled product in your current inventory, please follow the guidance below:  

  1. Check the true expiration date online at paxlovidlotexpiry.com and dispose of any expired product. 
  2. Return any non-expired EUA-labeled product as soon as possible. Returning product will ensure a credit to the USG inventory as NDA-labeled supply. In other words, all non-expired product will be replaced with NDA-labeled product for use in the USG Patient Assistance Program, so no product will be wasted. The deadline to return EUA-labeled product is February 29th. For specific information on Paxlovid returns, including to request pre-paid shipping visit PaxlovidEUAreturns.com, email PaxlovidEUAreturns@inmar.com, or call 877-740-6148. 

Take action now to understand the Paxlovid Patient Support Program: 
ALL patients should continue to have access to Paxlovid at little to no cost via the PAXCESS Patient Support Program. 

For more information and to enroll patients, visit Paxlovid.pfizerpro.com or call 1-877-C19-PACK. 
As a reminder, pharmacies must enroll with Assist Rx to participate in the USG Patient Assistance portion of PAXCESS. USG PAP dispensing sites will be reimbursed for any Paxlovid dispensed, along with a dispensing fee. To enroll, visit https://pharmacy.iassist.com/, or email PharmacyNetworkContract102101@assistrx.com.

We encourage all providers to periodically visit the COVID-19 Therapeutics Provider Hub for the most up-to-date information and guidelines related to COVID-19 therapeutic distribution in NC. As always, feel free to contact us at covid19testingandtreatments@dhhs.nc.gov with any questions.  

We appreciate your continued support,
North Carolina Department of Health and Human Services
COVID-19 Testing & Treatment Team

 


 

TUESDAY, FEBRUARY 20, 2024

*UPDATE* TRANSFER OF ON-FILE, UNFILLED CONTROLLED SUBSTANCE PRESCRIPTIONS.   On July 27, 2023, the DEA issued a final rule governing the transfer of electronic controlled substance prescriptions prior to initial fill.  The rule is here.

Among other things, the DEA rule provides that for a valid transfer to occur:  “The prescription must be transferred from one retail pharmacy to another retail pharmacy in its electronic form. At no time may an intermediary convert an electronic prescription to another form (e.g., facsimile) for transmission.”  Furthermore, the rule states:  “The contents of the prescription required by this part must not be altered during transfer between retail pharmacies. Any change to the content during transfer, including truncation or removal of data, will render the electronic prescription invalid.”  21 CFR § 1306.08(f)(1)&(2).

DEA commentary accompanying the rule asserted that SCRIPT Standard Version 2017071 enables the transfer of controlled substance prescriptions between pharmacies in a way that satisfies these rule requirements.  Board staff received a number of comments that DEA’s assertion was fanciful, and that SCRIPT Standard Version 2017071 does no such thing.  In a February 14, 2024 letter to stakeholders, Surescripts has confirmed that SCRIPT Standard Version 2017071 does not do what DEA thinks that it does – and never has.   Surescripts states that SCRIPT Standard Version 2022011 is capable of transferring controlled substance prescriptions in a way that complies with the DEA rule, but the Centers for Medicare and Medicaid Services must adopt a rule allowing the industry to adopt this updated SCRIPT standard.  Surescripts hopes that will happen soon (full Surecripts letter found here)  Until then, friends . . .

Questions regarding implementation of the DEA transfer  rule should be directed to DEA's Greensboro office at (336) 632-4297.

 


 

TUESDAY, FEBRUARY 20, 2024

*UPDATE*  NORTH CAROLINA DRUG CONTROL UNIT ISSUES FAQ GUIDANCE ON REPORTING GABAPENTIN TO THE CSRS. Last fall, the General Assembly passed, and the Governor signed into law, a statute making gabapentin a drug whose dispensing must be reported to the Controlled Substance Reporting System (CSRS).  Gabapentin becomes reportable on March 1, 2024.  The Drug Control Unit, which administers the CSRS, has created and updated a FAQ document (found here) providing instructions, including instructions on how a pharmacy that does not hold a DEA registration may register for access to the CSRS to report gabapentin dispensing. Pharmacists with additional questions should contact the Drug Control Unit.

 


 

TUESDAY, JANUARY 23, 2024

STATE AND FEDERAL PHARMACY LAW APPLICABLE TO WALK-IN IV THERAPY CLINICS. Board staff have fielded several inquiries from licensed medical professionals concerning clinics that offer walk-in intravenous therapy services. This guidance document sets forth North Carolina law governing the need for pharmacy permits and the preparation of sterile drug products.

 


 

THURSDAY, JANUARY 18, 2024

FDA WARNS CONSUMERS NOT TO PURCHASE OR USE NEPTUNE’S FIX OR ANY TIANEPTINE PRODUCT. The FDA has issued a warning that consumers not purchase or use tianeptine containing products. Tianeptine is not an FDA-approved substance, but is often sold at convenience stores, gas stations, and the like with claims that it will improve mental function and treat anxiety, depression, pain, opioid use disorder, and other conditions.  FDA continues to receive severe adverse event reports associated with use of tianeptine products.  Pharmacists should be aware of this danger and prepared to advise patients who indicate they are using tianeptine products or ask about them. 

 


 

WEDNESDAY, JANUARY 10, 2024

NORTH CAROLINA MEDICAID REMINDS PHARMACY PROVIDERS OF THE NEED TO RENEW PROVIDER ENROLLMENT CREDENTIALS.  On January 10, North Carolina Medicaid released the following concerning pharmacy eligibility to serve as Medicaid providers.  All questions should be directed to North Carolina Medicaid.

Beginning in May 2021, NC Medicaid started taking additional steps, as outlined in the NCTracks Changes to Provider Verification Process bulletin, to ensure providers meet their contractual obligation to maintain their credentials on their NCTracks provider enrollment record.  Multiple bulletin articles were published to notify providers of the change, and providers receive four targeted reminders prior to their suspension notification.  Regardless of these efforts to inform and assist providers with this responsibility, we continue to see a fairly large number suspended, and subsequently terminated, from the NC Medicaid program due to their expired credential.  
  
For this reason, and as part of an additional outreach effort, we are notifying NC associations when the number of provider taxonomy suspensions exceed a defined threshold of unique providers on the report received at the end of each month.  
 
On December 31, 2023, approximately 115 Pharmacist providers were suspended due to an expired credential.  These providers have sixty days from the date of suspension to ensure that their license is renewed, and their NCTracks provider enrollment record is updated to avoid termination.  Providers may update their NCTracks provider record through the Manage Change Request process.  NCTracks User Guides and Fact Sheets offer basic instructions for making the necessary update and any additional questions may be referred to the NCTracks Call Center at 800-668-6696. 

 


 

TUESDAY, DECEMBER 19, 2023

DEA RULEMAKING IN 2023.  In 2023, the federal Drug Enforcement Administration (“DEA”) completed three rulemakings that significantly impact pharmacy practice.  Each have been discussed individually on the BOP website, but this article in the National Association of Boards of Pharmacy’s Innovations magazine summarizes all three well:  DEA Updates:  Three New Rules Every Pharmacist Should Know.

 


 

MONDAY, DECEMBER 4, 2023

*REMINDER*  FDA EXTENDED EXPIRATION DATES FOR SOME COVID-19 THERAPEUTICS. Pharmacists are reminded that the federal Food and Drug Administration (FDA) has exercised authority from time to time to extend expiration dates of certain lots of COVID-19 therapeutics. More information on these extended expiration dates is found here.  This FDA resource includes links to a searchable and downloadable table listing original and, if applicable, extended expiration dates for bamlanivimab, bebtelovimab, etesevimab, Evusheld, Lagevrio (molnupiravir), REGEN-COV, and sotrovimab.  Also included is a link to Paxlovid expiry data from Pfizer.

When dispensing a COVID-19 therapeutic to a patient or caregiver, it is crucial that the pharmacist specifically point out, if applicable, that an expiration date printed on the packaging has been extended.  Failure to do so could either or both confuse the patient/caregiver and cause the patient to not take/receive the therapy.  A handful of patients have filed complaints against pharmacists and pharmacies because they believed their COVID-19 therapeutic was expired when dispensed.  In each case, the product’s expiration date had been extended by FDA, but the pharmacist had not pointed this out and counseled the patient at the time of dispensing. 

 


 


WEDNESDAY, NOVEMBER 15, 2023

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JANUARY 8, 2024 -- ON THE FOLLOWING PROPOSED ACTIONS:

AMENDMENT TO 21 NCAC 46 .1613 EXTENSION PERIOD FOR CERTAIN MEMBERS OF THE ARMED FORCES

Reason for Proposed Action:

S.L. 2023-129 gave optometrists the authority to dispense certain drugs to their patients, and required any dispensing optometrists to register with the Board of Pharmacy. In order to satisfy NCGS 93B-15, the Board has proposed adding dispensing optometrists to the list of registrants who are entitled to an extension of time to renew their registrations in the event of military deployment.

A public hearing will be held on January 8, 2024 at 10:00am at the NC Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.

Any person may object to the proposed rule changes by attending the public hearing on January 8, 2024 and/or by submitting a written objection by February 13, 2024 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.

 


 

TUESDAY, OCTOBER 31, 2023

BOARD IMPLEMENTS DIRECT-TO-PATIENT DISPENSING SYSTEM RULES.  The Board of Pharmacy has completed its rulemaking on the authorization for, and regulation of, the use of direct-to-patient (DTP) dispensing systems.  Board Rule .1821 provides that authorization and the standards that apply to use of DTP systems. Board Rule .1616 authorizes limited-service permits to be issued for operation of a DTP system when the system is not located on-site at the home pharmacy.

Board staff has completed programming to implement a limited-service permit application for an off-site DTP system, as well to allow an existing pharmacy to notify the Board that it will deploy an on-site DTP system.    

Detailed guidance on the rules and standards governing DTP systems, as well as step-by-step instructions to add an on-site DTP system to an existing pharmacy’s services or to apply for an off-site DTP system limited-service permit are found here.

The general limited-service permit guidance document has also been updated to include information on DTP system permits.

 


WEDNESDAY, OCTOBER 11, 2023

IMMUNIZING PHARMACISTS’ AUTHORITY TO ADMINISTER COVID-19 AND FLU VACCINES TO PEDIATRIC PATIENTS.  With flu and COVID vaccine season upon us, a number of pharmacists have reached out to Board staff about immunizing pharmacist authority to administer flu and COVID vaccine to pediatric patients.  With all the recent changes to North Carolina law and PREP Act declarations, it can be confusing.  Here is the skinny on flu and COVID vaccine authority:

  1. PREP Act declarations authorizing pharmacists to administer flu and COVID vaccine to patients age 3 and older are still in effect, and will be until December 31, 2024.
  2. State law now allows immunizing pharmacists to administer flu and COVID vaccine to patients age 7 and older pursuant to protocol and parental permission.  State law allows immunizing pharmacists to administer any ACIP-recommended vaccine to patients 6 and older pursuant to prescription and parental permission.
  3. So, for flu and COVID – immunizing pharmacists can administer to patients 3 and older and can do that under their own authority under the PREP Act.   Immunizing pharmacists can also use Dr. Tilson’s statewide standing order (https://www.dph.ncdhhs.gov/HDSO-pharmacists.htm) to do this for COVID vaccine (which typically makes billing and recordkeeping easier).  These paths are available until December 31, 2024.
  4. After December 31, 2024, immunizing pharmacists can administer flu and COVID vaccine pursuant to protocol, but only to patients age 7 or older, or pursuant to prescription for patients age 6 or older.

For a comprehensive overview of immunizing pharmacist authority, see the FAQ guidance here:  http://www.ncbop.org/faqs/Pharmacist/faq_Pharmacist.html#ImmunizingAuth.



 

THURSDAY, SEPTEMBER 14, 2023

PHARMACIST ADMINISTRATION OF RSV VACCINE TO ADULT PATIENTS BY PROTOCOL.  Under state law, a qualified immunizing pharmacist may administer any vaccine recommended by the Advisory Committee on Immunization Practices (“ACIP”) to patients 18 years or older pursuant to protocols developed in compliance with Board Rule .2507(b)(12).  ACIP has recommended RSV vaccine for adults 60 or older:  https://www.cdc.gov/vaccines/acip/recommendations.html. Accordingly, qualified immunizing pharmacists may administer RSV vaccine to this patient population pursuant to protocol.  Immunizing pharmacists must, however, update their protocols with their supervising physician as required by Rule .2507(b)(12) prior to doing so.  Additional information about immunizing pharmacist authority to administer vaccines is found here:  http://www.ncbop.org/faqs/ExpandedVaccineAuthorityFAQ.pdf.

 


 

THURSDAY, SEPTEMBER 7, 2023

NC DHHS ISSUES UPDATED COVID-19 TREATMENT GUIDANCE.  COVID-19 cases are rising in North Carolina.  NC DHHS has issued updated treatment guidance to health care providers, found here.

 


 

FRIDAY, SEPTEMBER 1, 2023

FROM THE NC DEPARTMENT OF HEALTH AND HUMAN SERVICES: IMPORTANT IMMUNIZATION UPDATES - COVID-19 VACCINE COMMERCIALIZATION PLAN AND RSV MONOCLONAL ANTIBODY.

COVID-19 Vaccine Commercialization
FDA authorization and/or approval and the Advisory Committee on Immunization Practices (ACIP)/Centers for Disease Control and Prevention (CDC) recommendation of the updated, monovalent (XBB 1.5) 2023-2024 COVID-19 vaccine is expected the week of September 11, 2023.  ACIP is scheduled to vote on the 2023-2024 COVID-19 vaccine on September 12, 2023.

Once ACIP recommends the updated COVID-19 vaccines and CDC’s director approves, the current bivalent COVID-19 vaccines will no longer be authorized for use. At that time, you will be required to stop administering the bivalent doses and waste any remaining doses on hand following your agency’s disposal policies as well as appropriately waste inventory in NCIR.  Administration of non-authorized products is considered a vaccine administration error and must be reported to the Vaccine Adverse Events Reporting System (VAERS).
 
Follow this link for more detailed information.

 


 

THURSDAY, AUGUST 10, 2023

FDA AND DEA ISSUE PUBLIC LETTER CONCERNING PERSISTENT SHORTAGES OF STIMULANT MEDICATIONS.  On August 1, FDA and DEA released a joint letter to the public discussing the persistent shortages of stimulant medications, factors contributing to those shortages, and FDA/DEA plans to mitigate them.  Read more here:  FDA/DEA Joint Letter to the Public.

 


 

MONDAY, JULY 10, 2023

USP COMPOUNDING CHAPTER REVISION IMPLEMENTATION
United States Pharmacopeia (USP) has published the chapter revisions for USP <795> and <797> for non-sterile and sterile compounding. USP has also published the newly developed chapter <825>, which sets standards for compounding radiopharmaceuticals. These chapters, along with USP Chapter <800> Handling of Hazardous Drugs, will become enforceable for compounding operations on November 1, 2023.  Over the next few months, Board Staff will be posting guidance documents about these revisions and our updated inspection forms that reflect these revisions.

In the meantime, you can find additional resources on these USP Chapters. 

USP<795>: https://www.usp.org/compounding/general-chapter-795
USP<797>: https://www.usp.org/compounding/general-chapter-797
USP <800>:  https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare
USP <825>:  https://www.usp.org/small-molecules/general-chapter-825

With respect to USP Chapter <800> and non-compounding activities involving hazardous medications, pharmacists are reminded:

The NC Board of Pharmacy views compliance with USP <800> for non-compounding activities involving hazardous medications as a best practice. As pharmacists know, USP Chapter <800> standards are designed to protect pharmacists, pharmacy staff, patients, and the public from the harmful effects of exposure to hazardous medications.

As USP Chapter <800> standards for non-compounding activities become commonly followed, North Carolina law is likely to reflect that doing so is considered standard of practice. In that case, failure to comply may be evidence of negligence. Therefore, you are encouraged to evaluate (and to continue to re-evaluate) to what extent compliance reflects the appropriate standard of care. Board staff will continue to make observations during inspections to help identify potential risk for handling Hazardous Medications, and will provide education on how to comply with USP Chapter <800> standards to minimize risk to pharmacy staff, patients, and the public. These observations regarding USP Chapter <800> compliance in non-compounding activities involving Hazardous Medications will not, by themselves, serve as a basis for disciplinary action by the Board. The Board's full position statement may be found here.

Board Staff have created helpful educational information that addresses the identification of Hazardous Drugs, instructions on conducting an Assessment of Risk, and templates for non-compounding pharmacies to develop Standard Operating Procedures (SOPs) addressed in USP<800>. This informational material is for pharmacies that DO NOT compound with hazardous medications and may be found here.

 


 

FRIDAY, JUNE 30, 2023

SL 2023-65 ENACTS SEVERAL PROVISIONS THAT AFFECT PHARMACY PRACTICE.  On June 29, 2023, the Governor signed into law SL 2023-65, which impacts pharmacy practice in several respects:

 


 

THURSDAY, JUNE 29, 2023

FDA ISSUES DRAFT GUIDANCE ON THE DRUG QUALITY AND SECURITY ACT’S WHOLESALING PROHIBITION FOR 503B OURSOURCING FACILITIES.  On June 27, 2023 the federal Food and Drug Administration (“FDA”) issued a draft guidance document titled “Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act.”  Section 503B states that an outsourcing facility is not eligible for the statutory exemptions for its compounded product if the product is sold or transferred by an “entity other than the outsourcing facility that compounded such drug.”   Board staff have received calls from time to time inquiring whether this provision prohibits pharmacies from purchasing a compounded prescription product from a 503B outsourcing facility and then dispensing it to a patient pursuant to an individual patient prescription.  FDA’s draft guidance states, among other things, that the following situations would not be subject to Section 503B’s wholesaling prohibition:

* An outsourcing facility distributes a drug it compounded (without obtaining a patient-specific prescription) to a health care professional who administers it in a health care setting (e.g., in a hospital or the physician’s office)

* An outsourcing facility distributes a drug it compounded (without obtaining a patient-specific prescription) to a hospital or health system, health clinic, or physician’s office, and it is administered within that hospital or health system, health clinic, or physician’s office.

* An outsourcing facility distributes a drug it compounded (without obtaining a patient-specific prescription) to a hospital or health system, health clinic, or physician’s office where it is used as office stock to dispense to patients pursuant to prescriptions.

* An outsourcing facility distributes a drug it compounded to a state-licensed pharmacy, federal facility, or licensing physician, which subsequently dispenses the drug pursuant to a prescription.

The draft guidance is found here:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act. The title page of the draft guidance contains instructions to submit comments and suggestions within 60 days.

 


 

THURSDAY, MARCH 23, 2023

DEA PUBLISHES PROPOSED RULES FOR PERMANENT TELEMEDICINE FLEXIBILITIES INVOLVING CONTROLLED SUBSTANCES.  The DEA has published proposed rules concerning the practice of telemedicine involving controlled substances. On February 24, the DEA announced “Proposed Rules for Permanent Telemedicine Flexibilities.”   Among other things, these proposed rules would allow telemedicine prescribing of a 30-day supply of Schedule III-V non-narcotic controlled substances, or a 30-day supply of buprenorphine for the treatment of opioid use disorder.  DEA’s proposed rule for Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation is found here: https://www.govinfo.gov/content/pkg/FR-2023-03-01/pdf/2023-04248.pdf.

DEA’s proposed rule for Expansion of Induction of Buprenorphine via Telemedicine Encounter is found here:  https://www.govinfo.gov/content/pkg/FR-2023-03-01/pdf/2023-04217.pdf. Each notice includes timelines and instructions for public comment.

 


 

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

 


 

Medicare/Medicaid (last updated January 24, 2023) - Check here regularly for the latest updates regarding Medicare/Medicaid.


 

Looking for a news item that is no longer here? Try our search page or send an email to Kristin Moore.

 


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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