North Carolina Board of Pharmacy

Rulemakings In Progress

 

WEDNESDAY, MARCH 9, 2022

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- JUNE 20, 2022 -- ON THE FOLLOWING PROPOSED ACTIONS:

AMENDMENT TO 21 NCAC 46 .1317 DEFINITIONS (ACPE)

Reason for Proposed Action:

The Board of Pharmacy proposes to amend its definition section to reflect a change in terminology announced by the Accreditation Council for Pharmacy Education (“ACPE”). The Board has different processes for graduates of pharmacy schools who are regulated by the U.S. Department of Education (which have previously been referred to as “accredited” by ACPE) and for graduates of foreign pharmacy schools (which have previously been referred to as “certified” by ACPE). ACPE has announced that, beginning January 1, 2023, it will refer to foreign pharmacy schools as “international-accredited.” There is no pertinent change in either the ACPE process or the Board’s process for either type of school -- merely a terminology change. The current rule defines an “approved school or college of pharmacy” as one “accredited by the American Council on Pharmaceutical Education.” The Board proposes to amend the rule to avoid any potential confusion that might be caused by ACPE’s change in terminology. In addition, the rule is proposed for amendment to reflect a change in ACPE’s name from “American Council on Pharmaceutical Education” to “Accreditation Council for Pharmacy Education.” The actual organization has not changed.


REPEAL OF 21 NCAC 46 .2403 DRUGS AND DEVICES TO BE DISPENSED

Reason for Proposed Action:

The Department of Health and Human Services, through State Health Director Betsy Tilson and Assistant Secretary for Public Health Mark Benton, has requested that the Board of Pharmacy repeal this rule as unnecessary. The rule publishes a formulary of certain drugs that registered nurses in local health departments may dispense. The formulary is a means by which the Department of Health and Human Services (subject to agreement by the Board of Pharmacy) can communicate to registered nurses in local health departments (which DHHS essentially oversees) which drugs they may dispense. DHHS has more effective ways than this rule to provide notice to those health department employees.

A public hearing will be held on June 20, 2022 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 adoption by attending the public hearing on June 20, 2022 and/or by submitting a written objection by June 20, 2022 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.

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.

 


 

TUESDAY, FEBRUARY 1, 2022

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- APRIL 28, 2022 -- ON THE FOLLOWING PROPOSED ACTION:

ADOPTION OF 21 NCAC 46 .2514 ADMINISTRATION OF LONG-ACTING INJECTABLES

Reason for Proposed Action:

Session Law 2021-3, Section 2.9.(a), permits “immunizing pharmacists” (as defined by statute) to administer long-acting injectable medications to adults pursuant to prescription. The law became effective on October 1, 2021, and the Board of Pharmacy adopted a temporary rule (21 NCAC 46 .2514) to implement the section, as permitted by the statute. Because of the placement of the longacting injectable authority in the “immunizing pharmacist” statute (90-85.15B), a permanent rule governing the administration of these drugs must be approved by both the Board of Pharmacy and the Medical Board. The Board of Pharmacy has proposed adoption of a permanent version of Rule .2514. The proposed rule would put appropriate standards in place for training, recordkeeping and other requirements needed to ensure that the drugs are administered with adequate protection of the public health,
safety, and welfare. The requirements in the proposed rule are largely imported from 21 NCAC 46 .2507, which governs immunizing pharmacist administration of vaccines, so that the regulated pharmacists will already be familiar with these requirements. Moreover, the proposed permanent rule does not vary in any substantial way from the temporary rule that has been operating without any known incident since October 1, 2021. The Medical Board has proposed a new rule (21 NCAC 32U .0102) that would adopt proposed permanent Rule .2514 by reference.

A public hearing will be held on April 28, 2022 at 10:00am remotely by video/teleconference. The public can participate on Teams at https://tinyurl.com/2p8czkmb or may call 336-604-5350, conference ID 232 964 29#.

Any person may object to the proposed adoption by attending the remote public hearing on April 28, 2022 and/or by submitting a written objection by May 2, 2022 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.

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.

Follow this link for the proposed rule language.

 


 

TUESDAY, FEBRUARY 1, 2022

NOTICE OF PUBLIC HEARING AND COMMENT PERIOD -- APRIL 28, 2022 -- ON THE FOLLOWING PROPOSED ACTIONS:

ADOPTION OF 21 NCAC 46 .1820 CODE OF ETHICS
AMENDMENT TO 21 NCAC 46 .2507 ADMINISTRATION OF VACCINES BY PHARMACISTS

Reason for Proposed Actions:

Session Law 2021-110 made a number of changes governing the administration of vaccines by pharmacy personnel. Two of those changes require rule changes. First, Session Law 2021-110 permits pharmacy technicians to administer certain vaccinations under pharmacist supervision. Session Law 2021-110, Section 4.(b) requires the Board of Pharmacy and the Medical Board to adopt rules governing pharmacy technician administration of vaccinations. The Board of Pharmacy has proposed amendments to 21 NCAC 46. 2507 to put appropriate standards in place for training, supervision, and other requirements to ensure adequate protection of the public health, safety, and welfare. Note that, by virtue of a Declaration under the Public Readiness and Emergency Preparedness (PREP) Act, since October 20, 2020, the United States Department of Health and Human Services has authorized pharmacy technicians to administer certain vaccines, preempting state law. The requirements in the amendments to Rule .2507 are based on the guidance that the Board of Pharmacy has previously provided for safe technician administration under the PREP Act, without any known incident for over a year.

Second, Session Law 2021-110 required the Board of Pharmacy and the Medical Board to adopt “a statement of ethics for immunizing pharmacists.” Moreover, Session Law 2021-110 adopted “unprofessional conduct” as a new ground of discipline for pharmacists (and, by extension, pharmacies) in G.S. 90-85.38. The Boards have jointly proposed adoption of the American Pharmacists Association Code of Ethics to define professional conduct, including but not limited to that conduct by immunizing pharmacists. This reflects an approach taken by numerous licensing boards in adopting an established industry set of conduct standards as reflecting appropriate professional practice. Proposed new rule 21 NCAC 46 .1820 would adopt that code of ethics by reference, and the amendments to Rule .2507 would refer to that rule as specifically governing pharmacists’ immunization activities. The Medical Board has proposed amending 21 NCAC 32U .0101 to effectively adopt the amendments to Rule .2507 by reference (and also thereby the application of new Rule .1820 to immunization).

A public hearing will be held on April 28, 2022 at 10:00am remotely by video/teleconference. The public can participate on Teams at https://tinyurl.com/2p8czkmb or may call 336-604-5350, conference ID 232 964 29#.

Any person may object to the proposed adoption and amendment by attending the remote public hearing on April 28, 2022 and/or by submitting a written objection by May 2, 2022 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.

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.

Follow this link for the proposed rule language.