SB2038

SECTION 1. Section 328-16, Hawaii Revised Statutes, is amended as follows:

1. By amending subsections (a) to (c) to read:

"(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

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;

(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;

(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) The 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;

(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:	_____________________________

THE SENATE	S.B. NO.	2038
THIRTY-THIRD LEGISLATURE, 2026
STATE OF HAWAII