SUBCHAPTER 32u - Pharmacists vaccinations
SECTION .0100 - pharmacists vaccinations
21 NCAC 32U .0101 ADMINISTRATION OF VACCINES BY
(a) An Immunizing Pharmacist shall administer only those
vaccines or immunizations permitted by G.S. 90-85.15B and shall do so subject
to all requirements of that statute and this Rule.
(b) The following words and terms, when used in this Rule,
have the following meanings:
(1) "Administer" means the direct
application of a drug to the body of a patient by injection, inhalation,
ingestion, or other means by:
(A) an Immunizing Pharmacist or a Pharmacy Intern who is
under the direct, in-person supervision of an Immunizing Pharmacist; or
(B) the patient at the direction of either an Immunizing
Pharmacist or a health care provider authorized by North Carolina law to
prescribe the vaccine.
(2) "Immunizing Pharmacist" shall
have the meaning provided in G.S. 90-85.3(i1).
(3) "Pharmacy Intern" shall have the
meaning provided in 21 NCAC 46 .1317(28).
(4) "Physician" means an M.D. or D.O.
currently licensed with the North Carolina Medical Board who is responsible for
the supervision of the Immunizing Pharmacist pursuant to the Written Protocol
between the Immunizing Pharmacist and the Physician.
(12) "Written Protocol" is a document
prepared, signed, and dated by the Physician and Immunizing Pharmacist that
shall contain the following:
(A) the name of the Physician responsible for
authorizing the Written Protocol;
(B) the name of the Immunizing Pharmacist authorized to
(C) the immunizations or vaccinations that may be
administered by the Immunizing Pharmacist;
(D) the screening questionnaires and safety procedures
that shall at least include the then-current minimum standard screening
questionnaire and safety procedures adopted by the Medical Board, the Board of
Nursing, and the Board of Pharmacy pursuant to S.L. 2013-246, s. 6, and
available at the North Carolina Medical Board's office and on its website
(E) the procedures to follow, including any drugs
required by the Immunizing Pharmacist for treatment of the patient, in the
event of an emergency or adverse event following vaccine administration;
(F) the reporting requirements by the Immunizing
Pharmacist to the Physician, including content and time frame; and
(G) the locations at which the Immunizing Pharmacist may
administer immunizations or vaccinations.
The Physician and the
Immunizing Pharmacist shall review the Written Protocol at least annually and
revise it if necessary.
(c) An Immunizing Pharmacist who, because of physical
disability, is unable to obtain a current provider level CPR certification pursuant
to G.S. 90-85.3(i1)(1), may administer vaccines in the presence of a pharmacy
technician or pharmacist who holds a current provider level CPR certification.
(d) With each dose of vaccine, either the Immunizing
Pharmacist or a Pharmacy Intern shall give the most current vaccine information
regarding the purpose, risks, benefits, and contraindications of the vaccine to
the patient or legal representative. The Immunizing Pharmacist or Pharmacy
Intern must ensure that the patient or legal representative has the opportunity
to read, or to have read to him or her, the information provided and to have
any questions answered prior to administration of the vaccine.
(e) In agreeing to serve as a supervising Physician, the
Physician shall agree to meet the following requirements:
(1) be responsible for the formulation or
approval of the Written Protocol and review the Written Protocol and the
services provided to patients under the Written Protocol, as set out in Subparagraph
(b)(12) of this Rule;
(2) be accessible to the Immunizing Pharmacist
or be available through direct telecommunication for consultation, assistance,
direction, and provide back-up coverage; and
(3) receive a periodic status reports from the
Immunizing Pharmacist, including any problems or complications encountered.
(f) The following requirements pertain to drugs
administered by an Immunizing Pharmacist:
(1) Drugs administered by an Immunizing
Pharmacist under the provisions of this Rule shall be in the legal possession
(A) a pharmacy, which shall be the pharmacy responsible
for drug accountability, including the maintenance of records of administration
of the immunization or vaccination; or
(B) the Physician, who shall be responsible for drug
accountability, including the maintenance of records of administration of the
immunization or vaccination;
(2) Drugs shall be transported and stored at
the proper temperatures indicated for each drug;
(3) Immunizing Pharmacists, while engaged in
the administration of vaccines under the Written Protocol, shall have in their
custody and control the vaccines identified in the Written Protocol and any
other drugs listed in the Written Protocol to treat adverse events; and
(4) After administering vaccines at a location
other than a pharmacy, the Immunizing Pharmacist shall return all unused
prescription medications to the pharmacy or Physician responsible for the
(g) Record Keeping and Reporting.
(1) An Immunizing Pharmacist shall maintain the
following information, readily retrievable, in the pharmacy records in
accordance with the applicable rules and statute regarding each administration:
(A) the name, address, and date of birth of the patient;
(B) the date of the administration;
(C) the administration site of injection (e.g., right
arm, left leg, right upper arm);
(D) route of administration of the vaccine;
(E) the name, manufacturer, lot number, and expiration
date of the vaccine;
(F) dose administered;
(G) the name and address of the patient's primary health
care provider, as identified by the patient; and
(H) the name or identifiable initials of the Immunizing
(2) An Immunizing Pharmacist shall document the
annual review with the Physician of the Written Protocol as required in this
(3) An Immunizing Pharmacist shall report
adverse events associated with administration of a vaccine to either the
prescriber, when administering a vaccine pursuant to G.S. 90-85.15B(a), or the
patient's primary care provider, if the patient identifies one, when
administering a vaccine pursuant to G.S. 90-85.15B(b).
(h) The Immunizing Pharmacist shall maintain written
policies and procedures for handling and disposal of used or contaminated
equipment and supplies.
History Note: Authority G.S. 90-85.3(r); 90-85.15B;
Emergency Adoption Eff. September 10, 2004;
Temporary Adoption Eff. December 29, 2004;
Eff. November 1, 2005;
Amended Eff. February 1, 2008;
Emergency Amendment Eff. October 9, 2009;
Temporary Amendment Eff. December 29, 2009;
Temporary Amendment Expired on October 12, 2010;
Amended Eff. September 1, 2014; March 1, 2012.