§328-16 Drugs limited to dispensing on prescription. (a) A prescription drug shall be dispensed only if its label bears the following:

(1) 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) 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 of the prescription or of its filling;

(5) The name of the practitioner if the seller is not the practitioner;

(6) The name, strength, and quantity of the drug;

(7) The date the potency of the drug expires if the date is available from the manufacturer or principal labeler;

(8) The number of refills available, if any; and

(9) 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 the drug does not indicate the number of times it may be refilled, if any, the pharmacist shall not refill that prescription unless the pharmacist is subsequently authorized to do so by the practitioner. The act of dispensing a drug other than a professional sample 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 or a pharmacy intern upon a written prescription from a practitioner or an out-of-state practitioner as provided in section 328-17.6; provided that all valid written prescriptions shall include the following information:

(A) The date of issuance;

(B) The original signature of the practitioner;

(D) The name, strength, and quantity of the drug, and specific directions for the drug's use;

(E) 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 filling the prescription has the address on file;

(F) The room number and route of administration, if the patient is in an institutional facility; and

(G) 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:

(i) The prescription is refilled only once during the three-month period;

(ii) The refill does not exceed a thirty-day supply of the drug;

(iii) The refill does not provide any amount of the drug fifteen months beyond the date the original prescription was written; and

(iv) The provisions listed in this subparagraph shall apply only to pharmacies practicing in the State.

(2) Upon an oral prescription from the practitioner; provided that:

(A) The pharmacist or pharmacy intern shall promptly reduce to writing:

(i) The oral prescription in full;

(ii) The name, strength, and quantity of the drug, and specific directions for the drug's use;

(iii) The date the oral prescription was received;

(iv) The name and oral code designation of the practitioner; and

(v) 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, unless the pharmacy filling the prescription has the address on file;

(B) The prescriptions and records described in subparagraph (A) shall be subject to the inspection of the department or its agents at all times; and

(3) By a practitioner, other than a pharmacist, to an ultimate user; provided that:

(A) 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; and

(iv) 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

(B) The records described in subparagraph (A) shall be subject to the inspection of the department or its agents at all times; and

(4) By refilling any written or oral prescription if that refilling is authorized by the practitioner either:

(A) In the original prescription; or

(B) By oral order, which shall be reduced promptly to writing and filed by the pharmacist or pharmacy intern.

(1) Is a habit forming drug to which section 328-15(4) applies;

(2) Because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner; or

(3) Is limited by an approved application under section 505 of the Federal Act or section 328-17 to use under the professional supervision of a practitioner.

(d) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner 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:

(1) The name and address of the pharmacy;

(2) The serial number and date of the prescription or of its filling;

(3) The name of the practitioner; and

(4) If stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in the prescription.

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 subsections (a) and (b) of this section.

(e) The director of health, may, by regulation, remove drugs subject to sections 328-15(4) and 328-17 from the requirements of subsections (a) and (b) of this section 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 regulations issued by the director, be removed from the requirements of subsections (a) and (b) of this section.

(f) A drug which is subject to subsections (a) and (b) of this section 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," or "Caution: State law prohibits dispensing without prescription." A drug to which subsections (a) and (b) of this section do not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.

(g) 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 which may hereafter be included within the classifications of narcotic drugs or marijuana as defined in the applicable federal and state laws relating to narcotic drugs and marijuana. [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]