(a) Purpose. This section is promulgated to promote
the efficient administration and regulation of the delegation by physicians
to pharmacists of the administration of immunizations or vaccinations
under written protocol pursuant to the §157.001 of the Act (related
to Delegation of Certain Functions).
(b) Delegation. A physician licensed to practice medicine
in Texas may delegate to a properly qualified and trained pharmacist
acting under adequate supervision the administration of immunizations
and vaccinations authorized by the physician through the physician's
order, standing medical order, standing delegation order, or other
order or protocol as provided for in this section.
(c) Delegated Administration of Immunizations and Vaccinations
under Written Protocol. Administration of Immunizations and Vaccinations
does not include the selection of drug products not prescribed by
the physician unless the drug product is named in the physician initiated
(d) Supervision. Physician supervision shall be considered
adequate for purposes of this section if the delegating physician
is in compliance with this section and the physician:
(1) is responsible for the formulation or approval
of the physician's order, standing medical order, standing delegation
order, or other order or written protocol and periodically reviews
the order or protocol and the services provided to the patient under
the order or protocol on a schedule defined in the written protocol;
(2) has established a physician-patient relationship
with each patient under 14 years of age and referred the patient to
(3) is geographically located so as to be easily accessible
to the pharmacist administering the immunization or vaccination;
(4) receives, on a schedule defined in the written
protocol, a periodic status report on the patient, including any problem
or complication encountered; and
(5) is available through direct telecommunication for
consultation, assistance, and direction.
(e) Written protocol. Written protocols for purposes
of this section shall mean a physician's order, standing medical order,
standing delegation order, or other written order.
(1) A written protocol must contain at a minimum the
following listed in subparagraphs (A) - (F) of this paragraph:
(A) a statement identifying the individual physician
authorized to prescribe drugs and responsible for the delegation of
administration of immunizations or vaccinations;
(B) a statement identifying the individual pharmacist
authorized to administer immunizations or vaccinations as delegated
by the physician;
(C) a statement identifying the location(s) at which
the pharmacist may administer immunizations or vaccinations which
may not include where the patient resides, except for a licensed nursing
home or hospital;
(D) a statement identifying the immunizations or vaccinations
that may be administered by the pharmacist;
(E) a statement identifying the activities the pharmacist
shall follow in the course of administering immunizations or vaccinations
including procedures to follow in the case of reactions following
(F) a statement that describes the content of, and
the appropriate mechanisms for the pharmacist to report the administration
of immunizations or vaccinations to the physician issuing the written
protocol within 24 hours of administering the immunization or vaccination.
(2) A standard protocol may be used, or the physician
may develop an immunization or vaccination protocol for the individual
patient. If a standard protocol is used, the physician shall record
what deviations, if any, from the standard protocol are ordered for
(f) Review and revision of protocols.
(1) At least annually, written protocols shall be reviewed
by the physician and, if necessary, revised.
(2) Documentation of the administration of immunizations
or vaccinations to the patient by a pharmacist shall be reviewed by
the physician on the schedule established in the protocol.
(g) Construction and interpretation. This section shall
not be construed or interpreted to restrict the use of a pre-established
health care program or restrict a physician from authorizing the provision
of patient care by use of a pre-established health care program if
the patient is institutionalized and the care is to be delivered in
a licensed hospital with an organized medical staff that has authorized
standing delegation orders, standing medical orders, or protocols.
This section may not be construed to limit, expand, or change any
provision of law concerning or relating to therapeutic drug substitution
or administration of medication, including the Texas Pharmacy Act,
Texas Occupations Code §§554.001 - 554.004.
Source Note: The provisions of this §193.16 adopted to be effective November 7, 2013, 38 TexReg 7711