RULEMAKINGS IN PROGRESS

Notice of Public Hearing and Comment Period on the Following Proposed Actions:

AMENDMENT TO 21 NCAC 46 .1418 HEALTH CARE FACILITY PHARMACY TECHNICIANS

Time and Date of Hearing:  10:00AM, January 6, 2026

Reasons for Proposed Action(s):
The Board of Pharmacy proposes amending this rule to expand health care facilities’ discretion in employing their pharmacy technicians in several ways. These proposed amendments are the culmination of a two-year process of a Board working group that included representatives of a wide variety of health care facility pharmacies, including hospitals, long-term care facilities, hospice and others.

The rule currently sets out certain functions that can be performed in hospitals by “validating technicians,” which was the defined term that the Board used to describe technicians that the Board determined had the knowledge to perform those specific tasks.

First, the industry experts recommended expansion of the tasks that validating technicians may perform under the oversight of a health care facility pharmacist. The amendment proposes to increase the ability of those technicians to confirm that automated devices have functioned as intended in dispensing or preparing drugs, given that the technology has an extremely high accuracy rate, and that the drugs still must be reviewed by a pharmacist as safe and effective for the patient. The amendment further proposes to allow technicians to validate the preparation and packaging of large-batch, low-risk, non-patient-specific products.

Second, the proposed amendment would increase the number of technicians who can serve as validating technicians. At the time of the initial rule, an associate’s degree in pharmacy technology was the only available credential with adequate assurances that technicians could perform the tasks set out in the rule. However, the Pharmacy Technician Certification Board has since created certification programs for a variety of technician competencies and tasks. The working group carefully considered the components of those programs and whether (and which of) those programs are adequate preparation for certain tasks. The proposed amendment reflects that judgment. Furthermore, the Pharmacy Technician Certification Board programs are accessible to any technician, rather than only those technicians who have the ability to attend an associate’s degree program. North Carolina already leads the country in the number of technicians holding these certifications, and the proposed amendment would recognize their qualifications to perform these tasks.

Third, the current rule is limited to hospital pharmacies and technicians. The proposed amendment would expand to include all health care facilities that are addressed in the relevant section and defined in 21 NCAC 46 .1317. The original rule was limited, as it arose out of a pilot program involving three hospitals. With over fourteen years of experience under the rule, the working group recommended that there were no relevant differences among any of the types of health care facilities.

Follow
this link for proposed rule language.

A public hearing will be held on January 6, 2026 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 6, 2026 and/or by submitting a written objection by January 6, 2026 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 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.

Notice of Public Hearing and Comment Period on the Following Proposed Action:

PERIODIC REVIEW AND EXPIRATION OF EXISTING RULES REPORT FOR PUBLICATION ON THE OAH WEBSITE [G.S. 150B-21.3A(c)(1)]

Scheduled month and year for RRC review: May 2026

Comment period begins July 8, 2025 and ends September 11, 2025.

Reasons for Proposed Action:
Every decade, the Administrative Procedure Act requires each state board or agency to review its rules to determine if they remain necessary or are unnecessary. As to the necessary rules, the boards are to determine whether those rules are required to implement or conform to federal law. The Board has proposed determinations as to its existing rules. Those determinations are listed in columns F through H on the document linked below. (All subsequent columns are for future use.) The Board invites comments on its designations as to whether rules are necessary or unnecessary, and whether necessary rules are required to implement or conform to federal law.

 FOLLOW THIS LINK FOR A LISTING OF RULES

Any person wishing to submit public comments must do so by September 11, 2025. Submit written comments by mail to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517; by fax (919) 246-1056; or by e-mail ncboprulemaking@ncbop.org.

“Public comment” is defined by G.S. 150B-21.3A(a)(5) as a written objection to all or part of a rule. Additionally, pursuant to G.S. 150B-21.3A(c)(2), in order for the Rules Review Commission to determine whether the public comment has merit, the public comment must address the specific substance of the rule and address any of the standards of Commission review, as set forth in G.S. 150B-21.9(a).

Notice of Public Hearing and Comment Period on the Following Proposed Actions:

AMENDMENT TO 21 NCAC 46 .2504 PATIENT COUNSELING

Time and Date of Hearing:  9:30AM, May 21, 2024

Reasons for Proposed Action(s):
The principal purpose of the amendment is to clarify the rule. The existing rule addresses patient history information requirements, drug utilization reviews, offers to counsel and counseling in a non-chronological and circuitous fashion. The amended rule would address these topics in a sequential work-flow order. It further would clarify how the rule operates, and may differ, in different practice settings. Substantively, the amendment would provide for initial general counseling to take place through recorded technological means, in cases where that is appropriate.

Follow this link for proposed rule language.

A public hearing will be held on May 21, 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 May 21, 2024 and/or by submitting a written objection by June 14, 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.