Board News and Announcements
APRIL 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.
NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS - Check our CE page often for upcoming CE programs in your area. (LAST UPDATED APRIL 19, 2024.)
The NC Board of Pharmacy has a YouTube channel. Board meetings are live-streamed and past meetings are archived here.
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.
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, 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, 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.
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.
**
Copyright © 2006 North Carolina Board of Pharmacy
site design IV Design