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

(1)  The name, business address, and telephone numberof the seller.  The business address shall be the physical location of thepharmacy or the dispensing practitioner's office;

(2)  The name of the personfor whom the drug was prescribed or the name of the owner of the animal forwhich the drug was prescribed;

(3)  The serial number ofthe prescription;

(4)  The date theprescription was prepared;

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

(6)  The name, strength, andquantity 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 isdispensed, whichever is earlier;

(8)  The number of refillsavailable, if any;

(9)  In the case of the dispensing of an equivalentgeneric drug product, the statement "same as (brand name of the drug productprescribed or the referenced listed drug name)", or words of similarmeaning; and

(10)  Specific directions for the drug's use; providedthat if the specific directions for use are too lengthy for inclusion on thelabel, the notation "take according to written instructions" may beused if separate written instructions for use are actually issued with the drugby the practitioner or the pharmacist, but in no event shall the notation"take as directed", referring to oral instructions, be consideredacceptable.

If any prescription for a drug does not indicate thenumber of times it may be refilled, if any, the pharmacist shall not refillthat prescription unless subsequently authorized to do so by the practitioner. The act of dispensing a prescription drug other than a professional sample ormedical oxygen contrary to this subsection shall be deemed to be an act thatresults in a drug being misbranded while held for sale.

(b)  In addition to the requirements enumeratedin subsection (a), a prescription drug shall be dispensed only:

(1)  By a pharmacist pursuant to a valid prescriptionor section 461-1;

(2)  By a medical oxygen distributor pursuant to aprescription or certificate of medical necessity; provided that the drug to bedispensed is medical oxygen; or

(3)  By a practitioner to an ultimate user; providedthat:

(A)  The practitioner shall inform the patient,prior to dispensing any drug other than a professional sample, that the patientmay have a written, orally ordered, or electronically transmitted or conveyedprescription directed to a pharmacy or a medical oxygen distributor of thepatient's own choice;

(B)  The practitioner shall promptly record inthe practitioner's records:

(i)  The prescription in full;

(ii)  The name, strength, and quantity of thedrug, 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 whomthe drug was prescribed or the name of the owner of the animal for which thedrug was prescribed;

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

(D)  No undisclosed rebate, refund, commission,preference, discount, or other consideration, whether in the form of money orotherwise, has been offered to the practitioner as compensation or inducementto dispense or prescribe any specific drug in preference to other drugs thatmight be used for the identical therapeutic indication.

(c)  A prescription may be communicated inwriting, orally, or by electronic transmission,and shall include the following information:

(1)  The authorization of the practitioner noted asfollows:

(A)  Written prescriptions shall include theoriginal signature of the practitioner;

(B)  Oralprescriptions shall be promptly recorded by the pharmacist or medical oxygendistributor and shall include the practitioner's oral code designation; and

(C)  Electronicprescriptions shall be irrefutably traceable to the prescribing practitioner bya recognizable and unique practitioner identifier such as:

(i)  A bitmap or graphic image of theprescriber's handwritten signature and the prescriber's oral code designation(or license number or other identifier if the prescriber is an out-of-statepractitioner);

(ii)  An electronicsignature;

(iii)  A digitalsignature; or

(iv)  By other means asapproved by the director;

(2)  The date of issuance;

(3)  The practitioner'sname, business telephone number, and business address, unless the practitioneris otherwise uniquely identified and the pharmacy or medical oxygen distributordispensing the prescription has the prescriber's contact information on fileaccessible within the dispensing area;

(4)  The name, strength, andquantity of the drug to be dispensed, and specific directions for the drug'suse;

(5)  The name and address ofthe person for whom the prescription was written or the name of the owner ofthe animal for which the drug was prescribed, unless the pharmacy or medicaloxygen distributor dispensing the prescription has the address on fileaccessible within the dispensing area;

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

(7)  The number of allowablerefills, if the prescription is refillable.  If the number of refillsauthorized by the practitioner is indicated using the terms "asneeded" or "prn", the prescription may be refilled up to twelvemonths from the date the original prescription was written.  After the twelve-monthperiod, the "as needed" or "prn" prescription may berefilled for a subsequent three-month period; provided:

(A)  The prescription is refilled only onceduring the three-month period;

(B)  The refill doesnot exceed a thirty-day supply of the drug;

(C)  The refill doesnot provide any amount of the drug fifteen months beyond the date the originalprescription was written;

(D)  In the case ofmedical oxygen, the duration of therapy indicated on a certificate of medicalnecessity shall supersede any limitations or restrictions on refilling; and

(E)  Subparagraphs(A) to (D) shall apply only to pharmacies and medical oxygen distributorspracticing in the State.

(d)  Any prescription may be refilled by thepharmacy and a prescription for medical oxygen may be refilled by the medicaloxygen distributor if that refilling is authorized by the practitioner either:

(1)  In the original prescription; or

(2)  By oral or electronic order, which shall bepromptly recorded and filed by the receiving pharmacist or medical oxygendistributor.

(e)  Prescription information may betransferred between pharmacies, between a pharmacy and a medical oxygendistributor, and between medical oxygen distributors for dispensing purposes;provided that:

(1)  Medical oxygen distributors may communicate orreceive prescription information related only to the dispensing of medicaloxygen;

(2)  The prescription information includes allelements of subsection (c)(2) to (7) and the following:

(A)  Authentication of the transmittingpharmacy or medical oxygen distributor who is providing the prescriptioninformation including the following:

(i)  The name of the pharmacist or medicaloxygen distributor providing the information;

(ii)  The name, telephone number, and address orlocation of the pharmacy or medical oxygen distributor firm providing theinformation; and

(iii)  The serial number, prescription number,control number, or other unique identifier of the prescription record fromwhich the information was transferred;

(B)  The date the original prescription wasissued;

(C)  The date of the last refill; and

(D)  The number of refills remaining.

(f)  For the purposes of this section, a"prescription drug" is a drug intended for use by a person that:

(1)  Is a habit forming drug to which section328-15(4) applies;

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

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

(g)  Any drug other than medical oxygendispensed pursuant to a prescription shall be exempt from the requirements ofsection 328-15 (except paragraphs (1), (9), (11), and (12), and the packagingrequirements 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 the date of the prescriptionor of its filling;

(3)  The name of the practitioner;

(4)  The name of the patient;

(5)  The directions for use; and

(6)  Any cautionary statements contained in theprescription.

This exemption shall not apply to any drug dispensedin the course of the conduct of a business of dispensing drugs pursuant todiagnosis by mail, or to a drug dispensed in violation of subsection (a), (b),(c), or (d).

(h)  The director of health, by rule, mayremove drugs subject to sections 328-15(4) and 328-17 from the requirements ofsubsection (a), (b), (c), or (d) when such requirements are not necessary forthe protection of the public health.  Drugs removed from the prescriptionrequirements of the Federal Act by regulations issued thereunder may also, byrules 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 todispensing, its label fails to bear the statement "Caution:  Federal lawprohibits dispensing without prescription", "Caution:  State lawprohibits dispensing without prescription", or "Rx only".  Adrug to which subsections (a), (b), (c), and (d) do not apply shall be deemedto be misbranded if, at any time prior to dispensing, its label bears a cautionstatement quoted in the preceding sentence.

(j)  Nothing in this section shall be construedto relieve any person from any requirement, prescribed by or under authority oflaw with respect to drugs now included or that may hereafter be included withinthe classifications of controlled substances as defined in the applicablefederal and state laws relating to controlled substances.

(k)  Oral code numbers or designations shall beissued by the department of public safety, pursuant to applicable laws andrules.

(l)  Any person who transmits, maintains, orreceives any prescription or prescription refill orally, in writing, orelectronically shall ensure the security, integrity, and confidentiality of theprescription 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 L1984, 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]

 

Law Journals and Reviews

 

  Pharmaceutical Soundings in Hawaii.  VII HBJ No.13, at pg. 33.