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

AMENDMENT TO 21 NCAC 46 .1401 HOSPITALS: OTHER HEALTH FACILITIES - REGISTRATION AND PERMITS

AMENDMENT TO 21 NCAC 46 .1415 HOSPITALS: OTHER HEALTH FACILITIES - MEDICATION IN HEALTH CARE FACILITY EMERGENCY DEPARTMENTS

Time and Date of Hearing:  9:30AM, July 9, 2024

Reasons for Proposed Actions:
Amendment to 21 NCAC 46 .1401: 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). Follow this link for proposed rule language.

Amendment to 21 NCAC 46 .1415: 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). Follow this link for proposed rule language.

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 May 21, 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.

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.