Drug product and biological product selection
HRS §328-92
in effect328-92. Drug product and biological product selection
(a) When filling a prescription order for a drug prescribed by its brand name, a pharmacist or the pharmacist's authorized agent shall:
(1) Offer to the consumer an equivalent generic drug
product or an interchangeable biological product from the Hawaii list of
equivalent generic drug products and interchangeable biological products adopted
pursuant to section 328-96;
(2) Upon the request of the consumer, inform the consumer of
the savings; and
(3) Inform the consumer of the consumer's right to refuse
substitution.
The pharmacist shall substitute an equivalent
generic drug product or an interchangeable biological product if the
practitioner does not prohibit substitution under subsection (b), and the
substitute equivalent generic drug product or interchangeable biological
product results in a savings. The pharmacist shall not substitute if the
consumer refuses.
(b) The pharmacist shall
not substitute an equivalent generic drug product or an interchangeable
biological product if the practitioner indicates "brand medically
necessary" or words of similar meaning on the prescription. The
designation "brand medically necessary" or other similar words or
phrases must be handwritten by the practitioner and shall not be preprinted or
stamped on the written prescription. The pharmacist shall not substitute an
equivalent generic drug product or an interchangeable biological product
if a prescription is orally or electronically ordered
and the practitioner or authorized employee of the practitioner indicates
"brand medically necessary" or other similar words or phrases.
The pharmacist shall note the practitioner's instructions
on the prescription record required to be maintained under section 328-17.7.
This subsection shall not apply when it does not comply
with any federal requirement for services reimbursable by medicaid or medicare.
(c) The pharmacist shall not substitute an
equivalent generic drug product or an interchangeable biological product for
any prescription for an anti-epileptic drug, except upon the consent of the
practitioner and the patient or the patient's parent or guardian. This narrow
exception for epileptic patients shall not be construed as a policy decision to
make exceptions for any other conditions.
(d) Within two business days following the
dispensing of a biological product, the dispensing pharmacist or the
pharmacist's designee shall communicate to the practitioner the specific
product provided to the patient, including the name of the product and the
manufacturer. The communication shall be conveyed by making an entry that is
electronically accessible to the practitioner through:
(1) An interoperable electronic medical records
system;
(2) An electronic prescribing technology;
(3) A pharmacy benefit management system; or
(4) A pharmacy record.
(e) Entry into an electronic records system as
described in subsection (d) is presumed to provide notice to the prescriber. Otherwise,
the pharmacist shall communicate the biological product dispensed to the
prescriber 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 United States Food and Drug Administration for the product prescribed; or
(2) A refill prescription is not changed from the
product dispensed on the prior filling of the prescription.
(f) The county
prosecutors and the attorney general may bring action upon complaint by an
aggrieved person or upon their own motion in the name of the State against any
person to enjoin any violation of this part.
[L 1980, c 187, pt of §1;
am L 1982, c 122, §1(4); gen ch 1985; am L 1992, c 193, §§1, 5; am L 1996, c
209, §3; am L 1997, c 214, §6; am L 2003, c 56, §6; am L 2016, c 242, §4]
Source: Hawaii State Legislature (capitol.hawaii.gov), via Internet Archive capturesURL: http://www.capitol.hawaii.gov/hrscurrent/Vol06_Ch0321-0344/HRS0328/HRS_0328-0092.htmFetched: 11/10/2026