§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 the
prescription was prepared;



(5)  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; and



(10)  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. 
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 461-1;



(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)  The practitioner shall inform the patient,
prior to 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; 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;



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



(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:



(1)  In the original prescription; or



(2)  By oral or electronic order, which shall be
promptly recorded and filed by the receiving pharmacist or medical oxygen
distributor.



(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) 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.



(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 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.



(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:



(1)  The name and address of the pharmacy;



(2)  The serial number and the date of the prescription
or 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 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 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)  Oral code numbers or designations shall be
issued by the department of public safety, 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]



 



Law Journals and Reviews



 



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