Board News and Announcements

 

APRIL 2024 NCBOP/NABP NEWSLETTER

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THURSDAY, MAY 23, 2024

NOTICE OF PUBLIC HEARING (JULY 9, 2024) AND COMMENT PERIOD ON THE FOLLOWING PROPOSED ACTIONS:

Reasons for Proposed Action:

The Board proposes to amend its Rule .1401, which deals with the process of health care facilities registering with, and being issued permits by, the Board. The existing rule requires separate permits when drugs are dispensed from "separate locations" owned by a health care facility. This has caused confusion for entities -- such as larger hospitals -- that have multiple dispensing areas in the same hospital building or in attached or contiguous campus buildings. The proposed amendment would make clear that separate dispensing areas for inpatient populations may operate under one permit, so long as they are in the same building or in a building on property contiguous to the principal permitted location. The amendment would further remove unnecessary provisions covered by other statutes or rules. The rule amendment was recommended by a committee made up of Board members, pharmacists from hospitals of differing sizes, and pharmacists from other health care facility settings (such as long term care).

Reasons for Proposed Action:

The Board proposes to amend its Rule .1415, which deals with dispensing medications in health care facility (i.e., hospital) emergency departments. The existing rule permits an emergency department to dispense a 24-hour supply of drugs to patients being discharged from the emergency department. Regulated entities have approached the Board with concerns that limitation to a 24-hour supply poses problems with respect to (a) patients who may have difficulty getting additional prescriptions filled before the 24-hour supply expires (such as patients being discharged on weekends in rural areas) and (b) continuity of care for drugs that require longer courses of treatment and may create adverse effects in the case that they are interrupted. The proposed amendment would increase that limit to seven days. In addition, the proposed rule would clarify unclear language about whether a hospital emergency department may dispense drugs to discharged patients at a time when the hospital has an outpatient pharmacy open and available to dispense those drugs. The rule amendment was recommended by a committee made up of Board members, pharmacists from hospitals of differing sizes, and pharmacists from other health care facility settings (such as long term care).

A public hearing will be held on July 9, 2024 at 9:30AM 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 July 9, 2024 and/or by submitting a written objection by August 16, 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.

Procedure for Subjecting a Proposed Rule to Legislative Review: If an objection is not resolved prior to the adoption of the rule, a person may also submit a written objection to the Rules Review Commission. If the Rules Review Commission receives written and signed objections after the adoption of the Rule 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 letters via U.S. Mail, private courier service, or hand delivery to 1711 New Hope Church Road, Raleigh, North Carolina, or via email to oah.rules@oah.nc.gov. If you have any further questions concerning the submission of objections to the Commission, please review 26 NCAC 05 .0110 or call a Commission staff attorney at 984-236-1850.

 


 

NEW CE OPPORTUNITIES: PHARMACISTS & TECHNICIANS - Check our CE page often for upcoming CE programs in your area. (LAST UPDATED APRIL 19, 2024.)

 


 

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.

 


 

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.


 

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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.

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