Board News and Announcements

JANUARY 2023 NCBOP/NABP NEWSLETTER

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, MARCH 30, 2023

ONE-TIME TRAINING REQUIREMENT ON THE TREATMENT AND MANAGEMENT OF PATIENTS WITH OPIOID OR OTHER SUBSTANCE USE DISORDERS FOR PRACTITIONERS HOLDING INDIVIDUAL DEA REGISTRATIONS. The Drug Enforcement Administration (DEA) has outlined the requirements for DEA-registered practitioners to meet the new, one-time Medication Access and Training Expansion Act (MATE Act) training requirement that will be tied to their initial or renewal DEA registration, effective June 27, 2023. This requirement applies to practitioners holding individual DEA registrations. A pharmacist who is not an individual DEA registrant – i.e., practice pharmacy under the DEA registration of the employing pharmacy – is not required to obtain this training. But pharmacists such as Clinical Pharmacist Practitioners who are individual DEA registrants that prescribe controlled substances are subject to the requirement.

In December 2022, Congress passed the Consolidated Appropriations Act of 2023 that included three bills to help manage and support patients with opioid or substance use disorder. The MATE Act, which was part of this legislation, requires new and renewing DEA-registered practitioners to complete a one-time, eight-hour training on opioid or other substance use disorders. Practitioners must affirm that they have completed this new training requirement on the date of their next scheduled DEA registration submission on or after June 27, 2023.

There are three ways that practitioners may meet this requirement, which are outlined in DEA's letter. The letter also defines which accredited groups may provide training to meet the requirement, key points related to the training, and a list of practitioners who have been deemed as already satisfied the training. Recommendations for curricular elements in substance use disorders training is also available on the Substance Abuse and Mental Health Services Administration website.

For more information on the MATE Act training requirements, please visit DEA's diversion control website. If you have any additional questions on this issue, please contact the Diversion Control Division Policy Section at ODLP@dea.gov or 571/362-3260.

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.

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS - Check our CE page often for upcoming CE programs in your area. (LAST UPDATED MARCH 30, 2023.)

New vaccination training programs for pharmacists and technicians through UNC Eshelman School of Pharmacy - Saturday, May 6, 2023. In person or online options available. Follow this link for details and registration.

WEDNESDAY, MARCH 15, 2023

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JUNE 13, 2023 -- ON THE FOLLOWING PROPOSED ACTIONS:

ADOPTION OF 21 NCAC 46 .1821 DIRECT-TO-PATIENT DELIVERY SYSTEMS

AMENDMENT TO 21 NCAC 46 .1616 LIMITED SERVICE PERMITS

MONDAY, MARCH 6, 2023

SCAMMERS CALLING PHARMACISTS CLAIMING TO BE BOARD OF PHARMACY STAFF. (Real) Board of Pharmacy staff have received several messages from pharmacists who have reported receiving calls from persons unknown, who claim to be Board of Pharmacy staff, seeking to “verify” various information about the pharmacist or the pharmacy in service to some “merging of records.” This, friends, is old wine in a new bottle. (Real) Board of Pharmacy staff are not making these calls. This FAQ – http://www.ncbop.org/faqs/Pharmacist/faq_ScamCommunications.html – details previous versions of the scam, and the advice offered there remains applicable:

Board staff reminds pharmacists and pharmacy staff that the names of all the Board’s investigators are listed here, and if they are unsure or suspicious when contacted by someone claiming to be a Board staff member (whether by phone, email, or other communication) that they should contact the Board immediately. To be sure, Board staff frequently contact pharmacists and pharmacy staff on all manner of issues. But, again, if you are suspicious about the true identity of the caller, please reach out to the Board office directly.

MONDAY, MARCH 6, 2023

Centers for Disease Control and Prevention Issues Health Alert Network Advisory Concerning Measles Case. CDC has issued an alert that, on February 24, 2023, the Kentucky Department for Public Health identified a confirmed case of measles in an unvaccinated individual with a history of recent international travel. The individual attended a gathering on February 17-18, 2023 at Asbury University in Wilmore, Kentucky attended by some 20,000 people. An undetermined number of attendees may have been exposed.

Healthcare providers should:

Consider measles as a diagnosis in anyone with a febrile illness and clinically compatible symptoms (e.g., rash, cough, coryza, or conjunctivitis) who:

attended the Kentucky event during the exposure dates of February 17 or 18 or has had contact with an attendee.
has recently traveled abroad, especially to countries with ongoing outbreaks.

Immediately notify local or state health departments about any suspected case of measles to ensure rapid testing and investigation. PCR testing for measles is available through the NC State Laboratory of Public Health. Please call the epidemiologist on call at 919-733-3419 for testing approval and information on specimen collection.
Recommend MMR vaccine to patients who are unvaccinated or not fully vaccinated.

More information here.

FRIDAY, FEBRUARY 24, 2023

UPDATE TO STATEWIDE STANDING ORDER FOR QUALIFIED IMMUNIZING PHARMACISTS TO INITIATE HORMONAL CONTRACEPTIVE THERAPY. State Health Director Tilson issued an amended hormonal contraceptive standing order for qualified immunizing pharmacists. The change to the standing order, at bullet point 3, now clarifies that, while a seated blood pressure must be obtained at the time of the patient’s assessment, that measurement may be performed by qualified personnel or device – and not only by the pharmacist. The updated standing order is here: http://www.ncbop.org/PDF/HormonalContraceptiveStandingOrder022323.pdf. And all current standing orders for pharmacists are found here: https://www.dph.ncdhhs.gov/HDSO-pharmacists.htm.

MONDAY, FEBRUARY 13, 2023

FRAUDULENT PROMETHAZINE WITH CODEINE SYRUP PRESCRIPTIONS. A North Carolina pharmacy has reported recently receiving a handful of fraudulent prescriptions for promethazine with codeine syrup. These were electronic prescriptions that purported to be from a health-care facility in Florida for “patients” who had not previously received services at the pharmacy. Diligent pharmacists contacted the Florida facility, where staff stated that it was aware of the fraudulent prescriptions and investigating how they were generated. As pharmacists know, promethazine with codeine syrup is a regular candidate for diversion. The pharmacy staff correctly identified several red flags and followed up on them. Board staff encourages pharmacists to exercise similar diligence. A good red flags resource is found here: http://www.ncbop.org/faqs/Pharmacist/faq_RedFlagsCS.html.

TUESDAY, FEBRUARY 7, 2023

DEA PUBLISHES PROPOSED RULE TO REMOVE SCHEDULING EXEMPTIONS FOR CERTAIN BUTALBITAL PRODUCTS. Board staff have received calls from a few pharmacists in recent days inquiring whether certain butalbital products presently exempted from scheduling under the federal Controlled Substances Act have been moved to Schedule III. At present, exempted butalbital products remain exempted. The federal Drug Enforcement Administration has, however, published a proposed rule that, if adopted, would revoke the exempted prescription product status for all butalbital products previously granted exemptions. If the rule is adopted, these products will become subject to all schedule III controls under the Controlled Substances Act, and this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule III controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle butalbital products. DEA’s proposed rule is found here:
Proposed DEA Rule Moving All Butalbital Products to Schedule III. The comment period on the proposed rule is closed, but DEA has not yet taken final action. Board staff will publish any action that the DEA chooses to take.

TUESDAY, JANUARY 24, 2023

NORTH CAROLINA MEDICAID REMINDS PHARMACY PROVIDERS WITH EXPIRED NCTRACKS CREDENTIALS OF THE PROCESS FOR RENEWING THEM. Staff at the North Carolina Department of Health and Human Services has requested the Board to notify pharmacy providers of the following:

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, 2022, approximately 251 Pharmacy 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.

Affected pharmacies should use the resources above to resolve any issue. Board of Pharmacy staff have no involvement in the issuance, renewal, or cancellation of NC Medicaid credentials.

FRIDAY, JANUARY 13, 2023

CONGRESS ELIMINATES THE DATA-WAIVER PROGRAM AND THE REQUIREMENT FOR THE DATA-WAIVER “X” REGISTRATION NUMBERS ON PRESCRIPTIONS FOR BUPRENORPHINE FOR OPIOID USE DISORDER

On December 29, 2022, with the signing of the Consolidated Appropriations Act of 2023 (the Act), Congress eliminated the “DATA-Waiver Program.” Section 1262 removes the federal requirement for practitioners to
submit a Notice of Intent (have a waiver) to prescribe medications like buprenorphine, for the treatment of opioid use disorder (OUD). With this provision and effective immediately, SAMSHA will no longer be accepting NOIs (waiver applications).

All practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law. North Carolina rules and laws do not conflict with this new authority for prescribing of buprenorphine for opioid use disorder with a current DEA registration.

DEA put out an informational document that states:
DEA fully supports this significant policy reform. In this moment, when the United States is suffering tens of thousands of opioid-related drug poisoning deaths every year, the DEA’s top priority is doing everything in our power to save lives. Medication for opioid use disorder helps those who are fighting to overcome opioid use disorder by sustaining recovery and preventing overdoses. At DEA, our goal is simple: we want medication for opioid use disorder to be readily and safely available to anyone in the country who needs it. The elimination of the X-Waiver will increase access to buprenorphine for those in need.

All DEA registrants should be aware of the following:

·        A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.

·        Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.

·        There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.

Separately, the Act also introduced new training requirements for all prescribers. These requirements will not go into effect until June 21, 2023. The DEA and SAMHSA are actively working to provide further guidance and DEA will follow up with additional information on these requirements shortly. Importantly, these new requirements do not impact the changes related to elimination of the DATA-Waiver Program described above.

MONDAY, DECEMBER 19, 2022

OXYCODONE “RECALL” FRAUD ALERT. The Pharmaceutical Cargo Security Coalition is warning pharmacies and others of a fraud scam in which pharmacies and other healthcare facilities receive a letter, spoofed to appear that it is from a legitimate pharmaceutical distributor, claiming that a “precautionary” manufacturer recall of oxycodone hydrochloride is being conducted. At least one fraudulent notice assigns an NDC code (0406853001) to the “recalled” product. If a pharmacy or any pharmacy staff member receives any type of communication referring to any type of a recall, please document as much information about the notice as possible. The pharmacy should then reach out to a known contact of your distributor to determine if the request is legitimate. If a request is not legitimate, please contact law enforcement. You may also reach out to Chuck Forsaith at the Healthcare Distributors Alliance, cforsaith@hda.org, (401) 623-1344.

WEDNESDAY, NOVEMBER 23, 2022

FDA ISSUES GUIDANCE ON COMPOUNDING AMOXICILLIN TO MITIGATE SHORTAGE. On November 22, the Food and Drug Administration issued guidance to pharmacies on compounding beta-lactam oral antibiotic suspensions to mitigate the effects of a shortage of amoxicillin oral antibiotic powder for suspension. FDA’s announcement is here. The guidance document is here.

FRIDAY, NOVEMBER 4, 2022

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

FRIDAY, OCTOBER 28, 2022

NC DHHS ISSUES INFORMATION TO CLINICIANS ON INCREASE IN ACTIVITY OF MULTIPLE RESPIRATORY VIRUSES OTHER THAN COVID-19. The North Carolina Department of Health and Human Services has issued an alert to clinicians detailing increased activity of multiple, non-COVID-19 respirator viruses including influenza, RSV, and rhinovirus/enterovirus. This alert provides advice to health-care providers on mitigating spread, identifying patients at particular risk, encouraging vaccinations where appropriate, and reporting suspected clusters of influenza, RSV, or severe respiratory illness: http://www.ncbop.org/PDF/NCDHHSIncreaseRespiratoryIllnessMemo102622.pdf.

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 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.

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:

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 hiea@nc.gov. Note: If the form fill functionality is used, you must save the document before emailing it to hiea@nc.gov.

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 hiea@nc.gov.

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.

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.

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.

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.

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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.