Current through Rules and Regulations filed through March 20, 2024
(1) If a practitioner of the healing arts
prescribes a biological product by its nonproprietary name, the pharmacist may
substitute the biological product with an interchangeable biological product,
but shall dispense the lowest retail-priced interchangeable biological product,
which is in stock.
(2)
Substitutions as provided in this rule are authorized for the express purpose
of making available to the consumer the lowest retail priced interchangeable
biological product which is in stock.
(3) Whenever a substitution is made:
(a) The pharmacist shall record on the
original prescription the fact that there has been a substitution and the
identity of the dispensed interchangeable biological product and its
manufacturer. Such prescription shall be maintained for two years and shall be
available for inspection by the board or its representative.
(b) The pharmacist shall affix to the
prescription label or container or an auxiliary label, the name of the
interchangeable biological product, with an explanation of "interchangeable
biological product for (insert name of prescribed biological product)" or
similar language to indicate substitution has occurred, unless the prescribing
practitioner indicated that the name of the biological product may not appear
upon the prescription label.
1. This labeling
requirement does not apply to biological products dispensed for in-patient
hospital services, to hospital-administered biological products for
outpatients, or to biological products in specialty packaging for dosing
purposes. This labeling requirement does apply to hospital retail pharmacies
and to any biological products dispensed by a hospital for a patient's use or
administration at home.
(4) The substitution of any biological
product by a registered pharmacist pursuant to this rule section does not
constitute the practice of medicine.
(5) A patient for whom a prescription
biological product order is intended may instruct a pharmacist not to
substitute an interchangeable biological product in lieu of a prescribed
biological product.
(6) A
practitioner of the healing arts may instruct the pharmacist not to substitute
an interchangeable biological product in lieu of a prescribed biological
product by including the words "brand necessary" in the body of the
prescription.
(a) When a prescription is a
hard copy biological product order, such indication of brand necessary must be
in the practitioner's own handwriting and shall not be printed, applied by
rubber stamp, or any such similar means.
(b) When the prescription is an electronic
prescription drug or biological product order, the words "brand necessary" are
not required to be in the practitioner's own handwriting and may be included on
the prescription in any manner or by any method.
(c) When a practitioner has designated "brand
necessary" on an electronic biological product order, an interchangeable
biological product shall not be substituted without the practitioner's express
consent, which shall be documented by the pharmacist on the prescription and by
the practitioner in the patient's medical record.
(7) Within forty-eight (48) hours, excluding
weekends and holidays, following the dispensing of a biological product, the
dispensing pharmacist or the pharmacist's designee shall communicate to the
prescriber the specific product provided to the patient, including the name of
the biological product and the manufacturer.
(a) The communication shall be conveyed by
making an entry into an interoperable electronic medical records system or
through electronic prescribing technology or a pharmacy record that is
electronically accessible by the prescriber. Otherwise, the pharmacist shall
communicate the biological product dispensed to the prescriber by using
facsimile, telephone, electronic transmission, or other prevailing means,
provided that communication shall not be required where:
1. There is no interchangeable biological
product approved by the federal Food and Drug Administration for the prescribed
product; or
2. A refill
prescription is not changed from the product dispensed on the prior filling of
the prescription.
(8) A link for the current list of all
biological products determined by the federal Food and Drug Administration to
be interchangeable with a specific biological products is available on the
Board's website.
O.C.G.A.
§§
26-4-5, 26-4-27, 26-4-28, 26-4-81.
