Board News and Announcements

JULY 2023 NCBOP/NABP NEWSLETTER

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

GENERAL COVID-19 UPDATES
COVID-19 VACCINATION AND THERAPEUTICS RELATED UPDATES AND RESOURCES (UPDATED SEPTEMBER 27, 2023)

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.

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS - Check our CE page often for upcoming CE programs in your area. (LAST UPDATED SEPTEMBER 12, 2023.)

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.

WEDNESDAY, AUGUST 30, 2023

UPDATE ON DIRECT-TO-PATIENT DISPENSING SYSTEM RULEMAKING. The Board of Pharmacy has completed its rulemaking on the authorization for, and regulation of, the use of direct-to-patient dispensing systems. New rule 21 NCAC 46.1821 provides that authorization and the standards that apply to use of DTP systems. Amended rule 21 NCAC 46.1616 authorizes limited service permits to be issued for operation of a DTP system when the system is not located onsite of the home pharmacy.

What’s next? The new rules are not yet operational. Board staff must complete some system programming to implement a DTP system limited service permit application, as well as make changes to the pharmacy services section of pharmacy permit applications. As well, Board staff is working on a comprehensive guidance document to take pharmacists through the rule’s requirements and procedures. Board staff will provide notice to all pharmacists and pharmacies when these implementation activities have been completed. In the meantime, pharmacies wishing to deploy DTP systems should begin familiarizing themselves with the new rules linked above.

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:

The law extends State Health Director Betsey Tilson’s authority to issue standing orders on COVID vaccination and treatment through December 31, 2024. This aligns Dr. Tilson’s authority with the PREP Act declaration extension. More information about the PREP Act extension is found at the April 14, 2023 website item below and here.
The law adds gabapentin to the list of substances whose dispensing must be reported by pharmacists to the North Carolina Controlled Substances Reporting System. The law exempts reporting of gabapentin that is “a component of a compounded prescription that is dispensed in dosages of 100 milligrams or less.” This new reporting requirement becomes effective on March 1, 2024. As pharmacists know, the NC CSRS is administered by the Drug Control Unit at the Department of Health and Human Services. In the coming months, the Drug Control Unit will issue communications concerning implementation of the gabapentin reporting requirements. Board staff will work closely with Drug Control Unit staff to facilitate those communications.
The law adds “controlled substances included in G.S. 90-93(a)(1)a” to the STOP Act’s list of substances that must be prescribed electronically (unless an exception applies). G.S. 90-93(a)(1)a defines as a Schedule V controlled substance “any compound, mixture or preparation containing an of the following limited quantities of narcotic drugs or salts thereof, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture or preparation valuable medicinal qualities other than those possessed by the narcotic alone . . . Not more than 200 milligrams of codeine or any of its salts per 100 milliliters or per 100 grams.” This includes promethazine with codeine Schedule V products. This new electronic prescribing requirement “does not apply to any product that is sold at retail without a prescription” as allowed by North Carolina law. The electronic prescribing requirement becomes effective on January 1, 2024. The Board’s STOP Act guidance document has been updated to reflect this change and may be found here.

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.

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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.