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SB2038
THE SENATE
S.B. NO.
2038
THIRTY-THIRD LEGISLATURE, 2026
STATE OF HAWAII
A BILL FOR AN ACT
relating
to medication labeling
.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
����
SECTION
1
.
�
Section 328-16, Hawaii Revised Statutes, is
amended as follows:
����
1.
�
By amending subsections (a) to (c) to read:
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"(a)
�
A prescription drug shall be dispensed only
if its label bears the following:
����
(1)
�
[
The
]
Except as otherwise authorized for medication abortion care in section
453-16 or 457-8.7
, the
name, business address, and telephone number
of the seller.
�
The business address
shall be the physical location of the pharmacy or the dispensing practitioner's
office;
����
(2)
�
Except as otherwise authorized for [
expedited
]
:
���������
(A)
�
Expedited
partner
therapy in section 453-52 [
or
an
]
;
���������
(B)
�
An
opioid antagonist in section 461-11.8[
,
]
;
or
���������
(C)
�
Medication abortion care in section 453-16 or 457-8.7
,
���������
the name of the person for whom the drug was
prescribed or the name of the owner of the animal for which the drug was
prescribed;
����
(3)
�
The serial number of the prescription;
����
(4)
�
The date the prescription was prepared;
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(5)
�
[
The
]
Except as otherwise authorized for medication
abortion care in section 453-16 or 457-8.7
, the
name of the practitioner if the seller is not the
practitioner;
����
(6)
�
The name, strength, and quantity of the drug;
����
(7)
�
The "use by" date for the drug, which shall be:
���������
(A)
�
The expiration date on the
manufacturer's container; or
���������
(B)
�
One year from the date the drug is
dispensed,
���������
whichever
is earlier;
����
(8)
�
The number of refills available, if any;
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(9)
�
In the case of the dispensing of an
equivalent generic drug product, the statement "same as (brand name of the
drug product prescribed or the referenced listed drug name)", or words of
similar meaning;
���
(10)
�
In the case of the dispensing of an
interchangeable biological product, the statement "interchangeable with
(brand name of the biological product prescribed or the referenced biological
drug name)", or words of similar meaning; and
���
(11)
�
Specific directions for the drug's use;
provided that if the specific directions for use are too lengthy for inclusion
on the label, the notation "take according to written instructions"
may be used if separate written instructions for use are actually issued with
the drug by the practitioner or the pharmacist, but in no event shall the
notation "take as directed", referring to oral instructions, be
considered acceptable.
If any
prescription for a drug does not indicate the number of times it may be
refilled, if any, the pharmacist shall not refill that prescription unless
subsequently authorized to do so by the practitioner or pursuant to section
461-11.9.
�
The act of dispensing a
prescription drug other than a professional sample or medical oxygen contrary
to this subsection shall be deemed to be an act that results in a drug being
misbranded while held for sale.
����
(b)
�
In addition to the requirements enumerated in
subsection (a), a prescription drug shall be dispensed only:
����
(1)
�
By a pharmacist pursuant to a valid
prescription or section 453-52, 461-1, 461-11.8, or 461-11.9;
����
(2)
�
By a medical oxygen distributor
pursuant to a prescription or certificate of medical necessity; provided that
the drug to be dispensed is medical oxygen; or
����
(3)
�
By a practitioner to an ultimate user;
provided that:
���������
(A)
�
Except as otherwise authorized for
expedited partner therapy in section 453-52, the practitioner shall inform the
patient, before dispensing any drug other than a professional sample, that the
patient may have a written, orally ordered, or electronically transmitted or
conveyed prescription directed to a pharmacy or a medical oxygen distributor of
the patient's own choice;
���������
(B)
�
The practitioner shall promptly record
in the practitioner's records:
��������������
(i)
�
The prescription in full;
�������������
(ii)
�
The name, strength, and quantity of the
drug, and specific directions for the drug's use;
������������
(iii)
�
The date the drug was dispensed;
�������������
(iv)
�
Except as otherwise authorized for
expedited partner therapy in section 453-52 or for an opioid antagonist in
section 461-11.8, the name and address of the person for whom the drug was
prescribed or the name of the owner of the animal for which the drug was
prescribed; and
��������������
(v)
�
Prescription drugs dispensed or
prescribed for expedited partner therapy as authorized under section 453-52 or
for an opioid antagonist in section 461-11.8;
���������
(C)
�
The records described in subparagraph
(B) shall be subject to the inspection of the department or its agents at all
times;
provided that the inspection of records for
medication
abortion care shall require a subpoena issued by a court of competent
jurisdiction;
and
���������
(D)
�
No undisclosed rebate, refund,
commission, preference, discount, or other consideration, whether in the form
of money or otherwise, has been offered to the practitioner as compensation or
inducement to dispense or prescribe any specific drug in preference to other
drugs that might be used for the identical therapeutic indication.
����
(c)
�
A prescription may be communicated in
writing, orally, or by electronic
transmission
,
and shall include the following information:
����
(1)
�
The authorization of the practitioner
noted as follows:
���������
(A)
�
Written prescriptions shall include the
original signature of the practitioner;
���������
(B)
�
Oral prescriptions shall be promptly recorded by the
pharmacist or medical oxygen distributor and shall include the practitioner's
oral code designation; and
���������
(C)
�
Electronic prescriptions shall be irrefutably traceable to
the prescribing practitioner by a recognizable and unique practitioner
identifier such as:
��������������
(i)
�
A bitmap or graphic image of the
prescriber's handwritten signature and the prescriber's oral code designation
(or license number or other identifier if the prescriber is an out-of-state
practitioner);
�������������
(ii)
�
An
electronic
signature;
������������
(iii)
�
A digital signature; or
�������������
(iv)
�
By other means as approved by the director;
����
(2)
�
The date of issuance;
����
(3)
�
The practitioner's name, business telephone number, and
business address, unless the practitioner is otherwise uniquely identified and
the pharmacy or medical oxygen distributor dispensing the prescription has the
prescriber's contact information on file accessible within the dispensing area;
����
(4)
�
The name, strength, and quantity of the drug to be
dispensed, and specific directions for the drug's use;
����
(5)
�
Except as otherwise authorized for expedited partner
therapy in section 453-52 or for an opioid antagonist in section 461-11.8, the
name and address of the person for whom the prescription was written or the
name of the owner of the animal for which the drug was prescribed, unless the
pharmacy or medical oxygen distributor dispensing the prescription has the
address on file accessible within the dispensing area;
����
(6)
�
The room number and route of administration, if the patient
is in an institutional facility; [
and
]
����
(7)
�
The number of allowable refills, if the prescription is
refillable.
�
If the number of refills
authorized by the practitioner is indicated using the terms "as
needed" or "prn", the prescription may be refilled up to twelve
months from the date the original prescription was written.
�
After the twelve-month period, the "as
needed" or "prn" prescription may be refilled for a subsequent
three-month period; provided:
���������
(A)
�
The prescription is refilled only once
during the three-month period;
���������
(B)
�
The
refill
does not exceed a thirty-day supply of the drug;
���������
(C)
�
T
he refill
does not provide any amount of the drug fifteen months beyond the date the
original prescription was written;
���������
(D)
�
In the case of medical oxygen, the duration of therapy
indicated on a certificate of medical necessity shall supersede any limitations
or restrictions on refilling; and
���������
(E)
�
Subparagraphs (A) to (D) shall apply
only to pharmacies and medical oxygen distributors practicing in the State[
.
]
;
and
����
(8)
�
In the case of
medication
abortion care, if the pregnant person has elected to have an anonymous
prescription label under section 453-16(c) or 457‑8.7(c).
"
����
2.
�
By amending subsection (e) to read:
����
"(e)
�
Prescription information may be transferred
between pharmacies, between a pharmacy and a medical oxygen distributor, and
between medical oxygen distributors for dispensing purposes; provided that:
����
(1)
�
Medical oxygen distributors may
communicate or receive prescription information related only to the dispensing
of medical oxygen;
����
(2)
�
The prescription information includes
all elements of subsection (c)(2) to [
(7)
]
(8)
and the following:
���������
(A)
�
Authentication of the transmitting
pharmacy or medical oxygen distributor who is providing the prescription
information including the following:
��������������
(i)
�
The name of the pharmacist or medical
oxygen distributor providing the information;
�������������
(ii)
�
The name, telephone number, and address
or location of the pharmacy or medical oxygen distributor firm providing the
information; and
������������
(iii)
�
The serial number, prescription number,
control number, or other unique identifier of the prescription record from
which the information was transferred;
���������
(B)
�
The date the original prescription was
issued;
���������
(C)
�
The date of the last refill; and
���������
(D)
�
The number of refills remaining."
����
SECTION
2
.
�
Section 453-16,
Hawaii Revised Statutes, is amended to read as follows:
����
"
�
453-16
�
Intentional termination of pregnancy; refusal to perform.
�
(a)
�
A licensed physician or surgeon or licensed osteopathic physician and
surgeon may provide abortion care.
�
A
licensed physician assistant may provide medication or aspiration abortion care
in the first trimester of pregnancy.
����
(b)
�
The State shall not deny or interfere with a
pregnant person's right to choose to:
����
(1)
�
Obtain an abortion; or
����
(2)
�
Terminate a pregnancy if the
termination is necessary to protect the life or health of the pregnant person.
����
(c)
�
If the pregnant person elects to have an anonymous
prescription label, any medication abortion care prescribed under this section
shall be dispensed with a label under section
328-16
bearing:
����
(1)
�
"Medication Abortion Care"
instead of the name of the person for whom the drug was prescribed;
����
(2)
�
"Seller Name" instead of
the name of the seller;
����
(3)
�
"Business Address" instead
of the business address of the seller;
����
(4)
�
"000-000-0000" or a comparable
indication instead of the telephone number of the seller; and
����
(5)
�
"Practitioner Name"
if the seller is not the practitioner.
����
[
(c)
]
(d)
�
Nothing in this section shall
require any hospital or any person to participate in an abortion nor shall any
hospital or any person be liable for a refusal.
����
[
(d)
]
(e)
�
For purposes of this section:
����
"Abortion"
means an intentional termination of the pregnancy of a nonviable fetus.
����
"Nonviable
fetus" means a fetus that does not have a reasonable likelihood of
sustained survival outside of the uterus.
"
����
SECTION
3
.
�
Section
457-8.7, Hawaii Revised Statutes, is amended to read as follows:
����
"
�457-8.7
�
Advanced practice registered nurses; abortions by medication or
aspiration; refusal to perform.
�
(a)
�
Notwithstanding section 453-16 or any other law to the
contrary
, an advanced practice registered nurse may
provide medication or aspiration abortion care in the first trimester of
pregnancy, so long as the advanced practice registered nurse:
����
(1)
�
Has prescriptive authority;
����
(2)
�
Practices within the advanced practice
registered nurse's practice specialty; and
����
(3)
�
Has a valid, unencumbered license
obtained in accordance with this chapter.
����
(b)
�
The State shall not deny or interfere with a
pregnant person's right to choose to:
����
(1)
�
Obtain an abortion; or
����
(2)
�
Terminate a pregnancy if the
termination is necessary to protect the life or health of the pregnant person.
����
(c)
�
If the pregnant person elects to have an anonymous
prescription label, any medication abortion care prescribed under this section
shall be dispensed with a label under section
328-16
bearing:
����
(1)
�
"Medication Abortion Care"
instead of the name of the person for whom the drug was prescribed;
����
(2)
�
"Seller Name" instead of
the name of the seller;
����
(3)
�
"Business Address" instead
of the business address of the seller;
����
(4)
�
"000-000-0000" or a comparable
indication instead of the telephone number of the seller; and
����
(5)
�
"Practitioner Name"
if the seller is not the practitioner.
����
[
(c)
]
�
(d)
�
Nothing in this section shall require any hospital or any person to
participate in an abortion, nor shall any hospital or any person be liable for
a refusal.
����
[
(d)
]
�
(e)
�
For purposes of this section,
"abortion" and "nonviable fetus" shall have the same
meaning as defined in section 453-16."
����
SECTION 4.
�
Statutory material to be repealed is bracketed and stricken.
�
New statutory material is underscored.
����
SECTION
5.
�
This Act shall take effect on January
1, 2027.
INTRODUCED BY:
_____________________________
Report Title:
Abortion;
Mifepristone; Medication; Pharmacy; Prescription; Health
Description:
Authorizes
certain pregnant persons to receive abortion medication with a label that does
not bear their name and other identifying information.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.