North Carolina Board of Pharmacy
Rulemakings In Progress
NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JUNE 13, 2023 -- ON THE FOLLOWING PROPOSED ACTIONS:
ADOPTION OF 21 NCAC 46 .1821 DIRECT-TO-PATIENT DELIVERY SYSTEMS
AMENDMENT TO 21 NCAC 46 .1616 LIMITED SERVICE PERMITS
Reason for Proposed Action:
The Board of Pharmacy proposes to adopt a rule permitting pharmacies to employ certain direct to patient systems, which are technologies that dispense drugs directly to patients. The proposed rule contains provisions to allow pharmacies to comply with the laws governing dispensing drugs, devices, or medical equipment while using these systems. The proposed rule further contains provisions that would ensure that the systems can be used safely and securely, that required records are maintained, that the home pharmacy can adequately supervise and service these systems, and that patients may use these systems while also receiving information, safeguards and counseling that they need to use their drugs, devices, and medical equipment safely. There is an accompanying proposed change to the Board of Pharmacy's limited service permit rules to provide for permitting of systems that a pharmacy may place in a location other than the home pharmacy's facility.
A public hearing will be held on June 13, 2023 at 9:00am 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 June 13, 2023 and/or by submitting a written objection by June 16, 2023 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 firstname.lastname@example.org.
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.