§328-16 Drugs limited to dispensing on prescription. (a) A prescription drug shall be dispensed only if its label bears the following:
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:
(c) A prescription may be communicated in writing, orally, or by electronic transmission, and shall include the following information:
(d) Any prescription may be refilled by the pharmacy and a prescription for medical oxygen may be refilled by the medical oxygen distributor if that refilling is authorized by the practitioner either:
or the refilling is conducted pursuant to section 461-11.9.
(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:
(f) For the purposes of this section, a "prescription drug" is a drug intended for use by a person that:
(g) Any drug other than medical oxygen dispensed pursuant to a prescription shall be exempt from the requirements of section 328-15 (except paragraphs (1), (9), (11), and (12), and the packaging requirements of paragraphs (7) and (8)), if the drug bears a label containing:
This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of subsection (a), (b), (c), or (d).
(h) The director of health, by rule, may remove drugs subject to sections 328-15(4) and 328-17 from the requirements of subsection (a), (b), (c), or (d) when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the Federal Act by regulations issued thereunder may also, by rules issued by the director, be removed from the requirements of subsection (a), (b), (c), or (d).
(i) A drug that is subject to subsections (a), (b), (c), and (d) shall be deemed to be misbranded if, at any time prior to dispensing, its label fails to bear the statement "Caution: Federal law prohibits dispensing without prescription", "Caution: State law prohibits dispensing without prescription", or "Rx only". A drug to which subsections (a), (b), (c), and (d) do not apply shall be deemed to be misbranded if, at any time prior to dispensing, its label bears a caution statement quoted in the preceding sentence.
(j) Nothing in this section shall be construed to relieve any person from any requirement, prescribed by or under authority of law with respect to drugs now included or that may hereafter be included within the classifications of controlled substances as defined in the applicable federal and state laws relating to controlled substances.
(k) [Subsection effective until December 31, 2023. For subsection effective January 1, 2024, see below.] Oral code numbers or designations shall be issued by the department of public safety, pursuant to applicable laws and rules.
(k) [Subsection effective January 1, 2024. For subsection effective until December 31, 2023, see above.] Oral code numbers or designations shall be issued by the department of law enforcement, pursuant to applicable laws and rules.
(l) Any person who transmits, maintains, or receives any prescription or prescription refill orally, in writing, or electronically shall ensure the security, integrity, and confidentiality of the prescription and any information contained therein. [L 1967, c 152, §10; HRS §328-16; am L 1972, c 151, §9; am L 1979, c 96, §1; am L 1982, c 87, §1; am L 1984, c 25, §1; am L 1994, c 172, §2; am L 1996, c 208, §2; am L 1997, c 214, §4 and c 215, §1; am L 2000, c 83, §2; am L 2001, c 124, §3; am L 2002, c 256, §4; am L 2003, c 56, §2; am L 2013, c 250, §4; am L 2016, c 242, §2; am L 2018, c 154, §4; am L 2022, c 278, §17; am L 2024, c 100, §3]