REPORT TITLE:
Prescription Drugs


DESCRIPTION:
Liberalizes regulatory controls and restrictions on the
distribution of medical oxygen and the dispensing of prescription
drugs (non-controlled substances drugs).  (HB2525 HD2)



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                        2525
HOUSE OF REPRESENTATIVES                H.B. NO.           H.D. 2
TWENTIETH LEGISLATURE, 2000                                
STATE OF HAWAII                                            
                                                             
________________________________________________________________
________________________________________________________________


                   A  BILL  FOR  AN  ACT

RELATING TO PRESCRIPTION DRUGS.



BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 1      SECTION 1.  Section 328-1, Hawaii Revised Statutes, is
 
 2 amended as follows:
 
 3      1.  By adding four new definitions to be appropriately
 
 4 inserted and to read:
 
 5      ""Certificate of medical necessity" means the United States
 
 6 Department of Health and Human Services, Health Care Financing
 
 7 Administration's FORM HCFA 484, which identifies the patient-
 
 8 recipient, the supplier, and the prescriber of medical services
 
 9 and establishes an estimated length of time of need for equipment
 
10 or therapy, or both, to treat the ailment indicated by the
 
11 diagnosis codes listed thereon.
 
12      "Medical oxygen" means the prescription drug oxygen.
 
13      "Medical oxygen distributor" means any person, including a
 
14 prescription drug wholesale distributor, who distributes or
 
15 dispenses medical oxygen pursuant to a prescription.
 
16      "Nonprescription drug", "over-the-counter drug", or
 
17 "nonlegend drug", means any packaged, bottled, or nonbulk
 
18 chemical, drug, or medicine that may be lawfully sold without a
 
19 practitioner's order."
 

 
Page 2                                                     2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      2.   By amending the definition of "drug" to read:
 
 2      ""Drug" means:
 
 3      (1)  Articles recognized in the official United States
 
 4           Pharmacopoeia, official United States Pharmacopoeia
 
 5           Dispensing Information, official Homeopathic
 
 6           Pharmacopoeia of the United States, or official
 
 7           National Formulary, or any supplement to any of them;
 
 8      (2)  Articles intended for use in the diagnosis, cure,
 
 9           mitigation, treatment, or prevention of disease in
 
10           humans or animals;
 
11      (3)  Articles (other than food[)] or clothing) intended to
 
12           affect the structure or any function of the body of
 
13           humans or animals; or
 
14      (4)  Articles intended for use as a component of any article
 
15           specified in [this definition above but not including
 
16           devices or their components, parts, or accessories.]
 
17           paragraph (1), (2), or (3); provided that the term
 
18           "drug" shall not include devices or their components,
 
19           parts or accessories, cosmetics, or liquor as defined
 
20           in section 281-1."
 
21      3.  By amending the definition of "prescription drug" to
 
22 read:
 

 
 
 
Page 3                                                     2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      ""Prescription drug" means [any]:
 
 2      (1)  Any drug required by federal or state statutes,
 
 3           regulations, or rules to be dispensed only [by] upon a
 
 4           prescription, including finished dosage forms and
 
 5           active ingredients subject to section 328-16 or section
 
 6           503(b) of the Federal Act[.]; or
 
 7      (2)  Any drug product compounded or prepared pursuant to a
 
 8           practitioner's order."
 
 9      SECTION 2.  Section 328-16, Hawaii Revised Statutes, is
 
10 amended to read as follows:
 
11      "328-16  Drugs limited to dispensing on prescription.(a)
 
12 A prescription drug shall be dispensed only if its label bears
 
13 the following:
 
14      (1)  The name, business address, and telephone number of the
 
15           seller.  The business address shall be the physical
 
16           location of the pharmacy or the dispensing
 
17           practitioner's office;
 
18      (2)  The name of the person for whom the drug was prescribed
 
19           or the name of the owner of the animal for which the
 
20           drug was prescribed;
 
21      (3)  The serial number of the prescription;
 
22      (4)  The date of the prescription or of its filling;
 

 
 
 
Page 4                                                     2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      (5)  The name of the practitioner if the seller is not the
 
 2           practitioner;
 
 3      (6)  The name, strength, and quantity of the drug;
 
 4      (7)  The date the potency of the drug expires if the date is
 
 5           available from the manufacturer or principal labeler;
 
 6      (8)  The number of refills available, if any; and
 
 7      (9)  Specific directions for the drug's use; provided that
 
 8           if the specific directions for use are too lengthy for
 
 9           inclusion on the label, the notation "take according to
 
10           written instructions" may be used if separate written
 
11           instructions for use are actually issued with the drug
 
12           by the practitioner or the pharmacist, but in no event
 
13           shall the notation "take as directed[,]", referring to
 
14           oral instructions, be considered acceptable.
 
15 If any prescription for [the] a drug does not indicate the number
 
16 of times it may be refilled, if any, the pharmacist shall not
 
17 refill that prescription unless [the pharmacist is] subsequently
 
18 authorized to do so by the practitioner.  The act of dispensing a
 
19 drug other than a professional sample or medical oxygen contrary
 
20 to this subsection shall be deemed to be an act that results in a
 
21 drug being misbranded while held for sale.
 
22      (b)  In addition to the requirements enumerated in
 
23 subsection (a), a prescription drug shall be dispensed only:
 

 
Page 5                                                     2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      (1)  By a pharmacist or a pharmacy intern [upon a written
 
 2           prescription from a practitioner or an out-of-state
 
 3           practitioner as provided in section 328-17.6; provided
 
 4           that all valid written prescriptions shall include the
 
 5           following information:
 
 6           (A)  The date of issuance;
 
 7           (B)  The original signature of the practitioner;
 
 8           (C)  The practitioner's printed name and business
 
 9                address;
 
10           (D)  The name, strength, and quantity of the drug, and
 
11                specific directions for the drug's use;
 
12           (E)  The name and address of the person for whom the
 
13                prescription was written or the name of the owner
 
14                of the animal for which the drug was prescribed,
 
15                unless the pharmacy filling the prescription has
 
16                the address on file;
 
17           (F)  The room number and route of administration, if
 
18                the patient is in an institutional facility; and
 
19           (G)  The number of allowable refills, if the
 
20                prescription is refillable.  If the number of
 
21                refills authorized by the practitioner is
 
22                indicated using the terms "as needed" or "prn",
 
23                the prescription may be refilled up to twelve
 

 
Page 6                                                     2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1                months from the date the original prescription was
 
 2                written.  After the twelve-month period, the "as
 
 3                needed" or "prn" prescription may be refilled for
 
 4                a subsequent three-month period; provided:
 
 5                (i)  The prescription is refilled only once
 
 6                     during the three-month period;
 
 7               (ii)  The refill does not exceed a thirty-day
 
 8                     supply of the drug;
 
 9              (iii)  The refill does not provide any amount of the
 
10                     drug fifteen months beyond the date the
 
11                     original prescription was written; and
 
12               (iv)  The provisions listed in this subparagraph
 
13                     shall apply only to pharmacies practicing in
 
14                     the State.] pursuant to a valid
 
15                     prescription;
 
16      (2)  [Upon an oral prescription from the practitioner;
 
17           provided that:
 
18           (A)  The pharmacist or pharmacy intern shall promptly
 
19                reduce to writing:
 
20                (i)  The oral prescription in full;
 
21               (ii)  The name, strength, and quantity of the drug,
 
22                     and specific directions for the drug's use;
 
23              (iii)  The date the oral prescription was received;
 

 
Page 7                                                     2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1               (iv)  The name and oral code designation of the
 
 2                     practitioner; and
 
 3                (v)  The name and address of the person for whom
 
 4                     the drug was prescribed or the name of the
 
 5                     owner of the animal for which the drug was
 
 6                     prescribed, unless the pharmacy filling the
 
 7                     prescription has the address on file;
 
 8           (B)  The prescriptions and records described in
 
 9                subparagraph (A) shall be subject to the
 
10                inspection of the department or its agents at all
 
11                times; and
 
12           (C)  The department of health assigns the oral code
 
13                designation to the practitioner;] By a medical
 
14           oxygen distributor pursuant to a valid prescription or
 
15           valid certificate of medical necessity; provided that
 
16           the drug to be dispensed is medical oxygen; or
 
17      (3)  By a practitioner[, other than a pharmacist,] to an
 
18           ultimate user; provided that:
 
19           (A)  The practitioner shall promptly record in the
 
20                practitioner's records:
 
21                (i)  The prescription in full;
 
22               (ii)  The name, strength, and quantity of the drug,
 
23                     and specific directions for the drug's use;
 

 
Page 8                                                     2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1              (iii)  The date the drug was dispensed; and
 
 2               (iv)  The name and address of the person for whom
 
 3                     the drug was prescribed or the name of the
 
 4                     owner of the animal for which the drug was
 
 5                     prescribed;
 
 6                and
 
 7           (B)  The records described in subparagraph (A) shall be
 
 8                subject to the inspection of the department or its
 
 9                agents at all times[; and].
 
10      (c)  A valid prescription may be communicated in writing,
 
11 orally, by facsimile, or by electronic transmission, and shall
 
12 include the following information:
 
13      (1)  The date of issuance;
 
14      (2)  The authorization of the practitioner noted as follows:
 
15           (A)  Written prescriptions shall include the original
 
16                signature of the practitioner;
 
17           (B)  Oral prescriptions shall be promptly reduced to
 
18                writing by the pharmacist, pharmacist intern, or
 
19                medical oxygen distributor, and shall include the
 
20                practitioner's oral code designation; and
 
21           (C)  Facsimile or electronic prescriptions shall be
 
22                traceable to the prescribing practitioner;
 
23      (3)  The practitioner's name and business address;
 

 
Page 9                                                     2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      (4)  The name, strength, and quantity of the drug to be
 
 2           dispensed, and specific directions for the drug's use;
 
 3      (5)  The name and address of the person for whom the
 
 4           prescription was written or the name of the owner of
 
 5           the animal for which the drug was prescribed, unless
 
 6           the pharmacy or medical oxygen distributor filling the
 
 7           prescription has the address on file;
 
 8      (6)  The room number and route of administration, if the
 
 9           patient is in an institutional facility; and
 
10      (7)  The number of allowable refills, if the prescription is
 
11           refillable.  If the number of refills authorized by the
 
12           practitioner is indicated using the terms "as needed"
 
13           or "prn", the prescription may be refilled up to twelve
 
14           months from the date the original prescription was
 
15           written.  After the twelve-month period, the "as
 
16           needed" or "prn" prescription may be refilled for a
 
17           subsequent three-month period; provided:
 
18           (A)  The prescription is refilled only once during the
 
19                three-month period;
 
20           (B)  The refill does not exceed a thirty-day supply of
 
21                the drug;
 

 
 
 
 
 
Page 10                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1           (C)  The refill does not provide any amount of the drug
 
 2                fifteen months beyond the date the original
 
 3                prescription was written;
 
 4           (D)  In the case of medical oxygen, the duration of
 
 5                therapy indicated on a valid certificate of
 
 6                medical necessity shall supercede any limitations
 
 7                or restrictions on refilling; and
 
 8           (E)  The provisions of subparagraphs (A) to (D) shall
 
 9                apply only to pharmacies and medical oxygen
 
10                distributors practicing in the State.
 
11      [(4) By refilling any] (d)  Any written or oral prescription
 
12 may be refilled by the pharmacy and a written or oral
 
13 prescription for medical oxygen may be refilled by the medical
 
14 oxygen distributor if that refilling is authorized by the
 
15 practitioner either:
 
16      [(A)] (1) In the original prescription; or
 
17      [(B)] (2) By oral order, which shall be reduced promptly to
 
18                writing and filed by the receiving pharmacist
 
19                [or], pharmacy intern[.], or medical oxygen
 
20                distributor.
 
21      [(c)] (e)  For the purposes of this section, a "prescription
 
22 drug" is a drug intended for use by a person [which] that:
 
23      (1)   Is a habit forming drug to which section 328-15(4)
 
24            applies;
 

 
Page 11                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      (2)   Because of its toxicity or other potentiality for
 
 2            harmful effect, or the method of its use, or the
 
 3            collateral measures necessary to its use, is not safe
 
 4            for use except under the supervision of a
 
 5            practitioner; or
 
 6      (3)   Is limited by an approved application under section
 
 7            505 of the Federal Act, or section 328-17, to use
 
 8            under the professional supervision of a practitioner.
 
 9      [(d)] (f)  Any drug other than medical oxygen dispensed by
 
10 filling or refilling a [written or oral] prescription of a
 
11 practitioner shall be exempt from the requirements of section
 
12 328-15 (except paragraphs (1), (9), (11), and (12), and the
 
13 packaging requirements of paragraphs (7) and (8)), if the drug
 
14 bears a label containing:
 
15      (1)   The name and address of the pharmacy;
 
16      (2)   The serial number and the date of the prescription or
 
17            of its filling;
 
18      (3)   The name of the practitioner; and
 
19      (4)   If stated in the prescription, the name of the
 
20            patient, and the directions for use and cautionary
 
21            statements, if any, contained in the prescription.
 
22 This exemption shall not apply to any drug dispensed in the
 
23 course of the conduct of a business of dispensing drugs pursuant
 

 
Page 12                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1 to diagnosis by mail, or to a drug dispensed in violation of
 
 2 [subsections] subsection (a) [and], (b) [of this section.], (c),
 
 3 or (d).
 
 4      [(e)] (g)  The director of health, [may,] by [regulation,]
 
 5 rule, may remove drugs subject to sections 328-15(4) and 328-17
 
 6 from the requirements of [subsections] subsection (a)[and], (b)
 
 7 [of this section], (c), or (d) when such requirements are not
 
 8 necessary for the protection of the public health.  Drugs removed
 
 9 from the prescription requirements of the Federal Act by
 
10 regulations issued thereunder may also, by [regulations] rules
 
11 issued by the director, be removed from the requirements of
 
12 [subsections] subsection (a)[and], (b) [of this section.], (c),
 
13 or (d).
 
14      [(f)] (h)  A drug [which] that is subject to [subsections]
 
15 subsection (a)[and], (b) [of this section], (c), or (d) shall be
 
16 deemed to be misbranded if at any time prior to dispensing its
 
17 label fails to bear the statement "Caution: Federal law prohibits
 
18 dispensing without prescription[,]", or "Caution: State law
 
19 prohibits dispensing without prescription[.]".  A drug to which
 
20 [subsections] subsection (a) [and], (b) [of this section do],
 
21 (c), or (d) does not apply, shall be deemed to be misbranded if
 
22 at any time prior to dispensing its label bears the caution
 
23 statement quoted in the preceding sentence.
 

 
Page 13                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      [(g)] (i)  Nothing in this section shall be construed to
 
 2 relieve any person from any requirement, prescribed by or under
 
 3 authority of law with respect to drugs now included or [which]
 
 4 that may hereafter be included within the classifications of
 
 5 [narcotic drugs or marijuana] controlled substances as defined in
 
 6 the applicable federal and state laws relating to [narcotic drugs
 
 7 and marijuana.] controlled substances.
 
 8      (j)  Oral code numbers or designations shall be issued by
 
 9 the department of public safety, pursuant to applicable laws and
 
10 rules."
 
11      SECTION 3.  Section 328-17.5, Hawaii Revised Statutes, is
 
12 amended to read as follows:
 
13      "[[]328-17.5[]]  Principal labeler responsibility under
 
14 recall of drug.  Whenever the manufacturer of a drug voluntarily
 
15 recalls the drug or the Federal Food and Drug Administration or a
 
16 court orders the recall of a drug, the principal labeler of the
 
17 drug shall remove the drug from all pharmacies, prescriber
 
18 offices, medical oxygen distributors, distributors of non-
 
19 prescription drugs, and health care facilities."
 
20      SECTION 4.  Section 328-17.6, Hawaii Revised Statutes, is
 
21 amended to read as follows:
 
22      "328-17.6  Out-of-state prescriptions.(a)  An out-of-
 
23 state practitioner may [make] issue a written or [orally-
 

 
Page 14                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1 ordered] oral prescription within the confines of the
 
 2 practitioner's license and in accordance with Hawaii laws and
 
 3 rules.  [The prescription may either be filled one time or
 
 4 refilled one time, but not both; provided that:
 
 5      (1)   The prescription filled or refilled pursuant to this
 
 6            section shall be limited to not more than a thirty-day
 
 7            supply of any drug; and
 
 8      (2)   If orally-ordered, the] An oral prescription shall be
 
 9            personally [ordered] communicated by [an] the out-of-
 
10            state practitioner and received only by a
 
11            pharmacist[.]; provided that a medical oxygen order
 
12            may be received by a medical oxygen distributor.
 
13      (b)  An out-of-state pharmacy may transfer prescription
 
14 information for refilling purposes and an out-of-state medical
 
15 oxygen distributor may transfer prescription information for the
 
16 purpose of refilling a medical oxygen order.
 
17      [(b)] (c)  Any pharmacist or medical oxygen distributor who
 
18 fills or refills a prescription from an out-of-state
 
19 [prescription] practitioner shall:
 
20      (1)   Note the following on the [pharmacist's] prescription
 
21            record:  the out-of-state practitioner's full name,
 
22            address, and telephone number[, and Drug Enforcement
 
23            Administration registration number; provided that the
 

 
Page 15                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1            Drug Enforcement Administration registration number
 
 2            shall be required only for original fills communicated
 
 3            via telephone or facsimile];
 
 4      (2)   Be responsible for validating [the authenticity of the
 
 5            out-of-state practitioner's Drug Enforcement
 
 6            Administration registration number;] and verifying the
 
 7            practitioner's prescriptive authority by virtue of a
 
 8            valid out-of-state license, a Drug Enforcement
 
 9            Administration registration number, or other measures
 
10            as appropriate; and
 
11      (3)   Demand proper identification from the person whose
 
12            name appears on the prescription prior to filling the
 
13            prescription, in addition to complying with any
 
14            identification procedures established by the
 
15            department for filling and refilling an out-of-state
 
16            prescription.
 
17      [(c)] (d)  Before refilling [an] a transferred out-of-state
 
18 prescription, a pharmacist or medical oxygen distributor
 
19 [receiving transferred prescription information] shall:
 
20      (1)   Advise the person whose name appears on the
 
21            prescription that the prescription on file at the
 
22            originating out-of-state pharmacy or medical oxygen
 

 
 
 
Page 16                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1            distributor may be canceled [before the pharmacist can
 
 2            refill the prescription]; and
 
 3      (2)   Record all information required to be on a
 
 4            prescription, including[, but not limited to]:
 
 5            (A) The date of issuance of the original prescription;
 
 6            (B) The number of refills authorized on the original
 
 7                prescription;
 
 8            (C) The date the original prescription was dispensed;
 
 9            (D) The number of valid refills remaining and the date
 
10                of the last refill;
 
11            (E) The out-of-state pharmacy's or out-of-state
 
12                medical oxygen distributor's name[,] and
 
13                address,[and Drug Enforcement Administration
 
14                registration number,] and the original
 
15                prescription number or control number from which
 
16                the prescription information was transferred; and
 
17            (F) The name of the transferor pharmacist[.] or the
 
18                medical oxygen distributor's agent.
 
19      [(d)] (e)  A pharmacist or medical oxygen distributor who
 
20 fills or refills an out-of-state prescription shall be
 
21 responsible if the prescription is not written in the form
 
22 prescribed by Hawaii laws and rules.
 

 
 
 
Page 17                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      [(e)] (f)  [The pharmacist shall follow all labeling
 
 2 procedures established by the department for filling and
 
 3 refilling an out-of-state prescription.  The]  An out-of-state
 
 4 prescription shall be appropriately identified as "Out-of-State
 
 5 Filled" or "Out-of-State Refilled[,]", and shall state the date
 
 6 of filling or refilling and the local address of the person whose
 
 7 name appears on the prescription.
 
 8      [(f)] (g)  All transferred prescriptions shall be maintained
 
 9 for a period of five years from the date of filling or refilling.
 
10 Filled out-of-state prescriptions shall be kept in a special file
 
11 for five years.  The department may establish additional
 
12 recordkeeping and reporting procedures for filled and refilled
 
13 out-of-state prescriptions.
 
14      [(g)] (h)  This section shall not apply to prescriptions for
 
15 controlled substances and habit forming drugs."
 
16      SECTION 5.  Section 328-17.7, Hawaii Revised Statutes, is
 
17 amended to read as follows:
 
18      "328-17.7  Record of prescriptions.  Every practitioner
 
19 [or], pharmacist, or medical oxygen distributor, who compounds,
 
20 sells, or delivers any [prescription containing any poisonous
 
21 drug, or substance deleterious to human life, to be used as
 
22 medicine, shall enter upon the practitioner's or pharmacist's
 
23 books the prescription written out in full, with the date
 

 
Page 18                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1 thereof, with the practitioner's or pharmacist's own name
 
 2 appended thereto, or the name of the practitioner who prescribed
 
 3 the same, and the person to whom the same was delivered.]
 
 4 prescribed drug to a patient or a patient's agent shall maintain
 
 5 records that identify:
 
 6      (1)   The specific drug product;
 
 7      (2)   The prescribing practitioner;
 
 8      (3)   The patient;
 
 9      (4)   The date of prescribing or filling; and
 
10      (5)   The name of the practitioner, pharmacist, or medical
 
11            oxygen distributor dispensing the drug.
 
12 No prescription shall be compounded, sold, or delivered unless
 
13 the name of the person compounding, selling, or delivering the
 
14 same, or the name of the practitioner prescribing the same, is
 
15 appended to the prescription in full, and every prescription
 
16 shall be preserved for a period of not less than five years.  The
 
17 [books and prescriptions] prescription records shall be subject
 
18 at all times to the inspection of the director of health or the
 
19 director's agent."
 
20      SECTION 6.  Section 461-1, Hawaii Revised Statutes, is
 
21 amended as follows:
 
22      1.  By adding three new definitions to be appropriately
 
23 inserted and to read:
 

 
Page 19                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      ""Medical oxygen" means the prescription drug oxygen.
 
 2      "Medical oxygen distributor" means any person, including a
 
 3 prescription drug wholesale distributor, who distributes or
 
 4 dispenses medical oxygen pursuant to a prescription.
 
 5      "Prescription drug" means any drug dispensed, distributed,
 
 6 or sold pursuant to a practitioner's order."
 
 7      2.  By amending the definition of "cosmetics" to read:
 
 8      ""Cosmetics", which includes "soap", "dentifrice", and
 
 9 "toilet article", means:
 
10      (1)  [articles] Articles intended to be rubbed, poured, or
 
11           sprinkled on, introduced into, or otherwise applied to
 
12           the human body, or any part thereof, for cleansing,
 
13           beautifying, or promoting attractiveness; and
 
14      (2)  [articles] Articles intended for use as a component of
 
15           any such articles."
 
16      3.  By amending the definition of "drug" to read:
 
17      ""Drug" means:
 
18      (1)  [articles] Articles recognized in the official United
 
19           States pharmacopoeia, official homeopathic
 
20           pharmacopoeia of the United States, or official
 
21           national formulary, or any supplement to any of
 
22           them[,];
 

 
 
 
Page 20                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      (2)  Articles intended for use in the diagnosis, cure,
 
 2           mitigation, treatment, or prevention of disease in
 
 3           human beings or animals; [and (2) articles]
 
 4      (3)  Articles (other than food or clothing) intended to
 
 5           affect the structure or any function of the body of
 
 6           human beings or animals; and [(3) articles]
 
 7      (4)  Articles intended for use as a component of any
 
 8           articles specified in [clause] paragraph (1), [or] (2),
 
 9           or (3), above; provided that the term "drug" shall not
 
10           include [patent medicines, electrical or mechanical
 
11           devices,] devices or their components, parts, or
 
12           accessories, cosmetics, [and] or liquor as defined in
 
13           section 281-1."
 
14      4.  By amending the definition of "pharmacy" to read:
 
15      ""Pharmacy" means every store, shop, or place [where]:
 
16      (1)  Where prescription drugs are dispensed or sold at
 
17           retail, or displayed for sale at retail; [or]
 
18      (2)  [where physicians] Where practitioners' prescriptions
 
19           or drug preparations are compounded; [or]
 
20      (3)  [which] That has upon it [or], displayed within it, or
 
21           affixed to or used in connection with it, a sign
 
22           bearing the [word or] words "pharmacist", "pharmacy",
 
23           "apothecary", "drug store", "druggist", "drugs",
 

 
Page 21                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1           "medicines", "medicine store", "drug sundries",
 
 2           "remedies", or any [word or] words of similar or like
 
 3           import; or
 
 4      (4)  [any store or shop or other place with respect to
 
 5           which] Where any of the above words or combination of
 
 6           words are used in any advertisement.
 
 7 The term "pharmacy" shall not include any medical oxygen
 
 8 distributor."
 
 9      5.  By repealing the definition of "patent medicine".
 
10      [""Patent medicine" means any packaged, bottled, or nonbulk
 
11 chemical, drug, or medicine, when identified by and sold under a
 
12 trademark, trade name, or other trade symbol privately owned or
 
13 registered in the United States Patent Office, or registered as
 
14 provided by the laws of the State, and [which] that is labeled
 
15 with directions for use, and bears the name and address of the
 
16 manufacturer or distributor; provided that the chemical, drug, or
 
17 medicine meets the requirements of the pure food and drug laws of
 
18 the United States and the State.  "Patent medicine" shall not
 
19 include therapeutic vitamins when used either alone, or in
 
20 combination with other drugs."]
 
21      SECTION 7.  Section 461-15, Hawaii Revised Statutes, is
 
22 amended by amending subsection (a) to read as follows:
 
23      "(a) It shall be unlawful:
 

 
Page 22                                                    2525
                                     H.B. NO.           H.D. 2
                                                        
                                                        

 
 1      (1)  For any person to sell or offer for sale at public
 
 2           auction, or to sell or offer for sale at private sale
 
 3           in a place where public auctions are conducted, any
 
 4           prescription drugs without first obtaining a permit
 
 5           from the board of pharmacy to do so;
 
 6      (2)  For any person to [in any manner] distribute or
 
 7           dispense samples of any prescription drugs [or medical
 
 8           supplies] without first obtaining a permit from the
 
 9           board to do so; provided that nothing in this paragraph
 
10           shall interfere with the furnishing of samples or drugs
 
11           directly to physicians, druggists, dentists,
 
12           veterinarians, and optometrists for use in their
 
13           professional practice;
 
14      (3)  For wholesalers to sell, distribute, or dispense any
 
15           prescription drug, except to a pharmacist, physician,
 
16           dentist, veterinarian, or optometrist who is allowed to
 
17           use pharmaceutical agents under chapter 459 or to a
 
18           generally recognized industrial, agricultural,
 
19           manufacturing, or scientific user of drugs for
 
20           professional or business purposes; provided that it
 
21           shall be unlawful for wholesalers to sell, distribute,
 
22           or dispense any prescription pharmaceutical agent
 

 
 
 
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 1           [which] that is not listed under section [459-15] 459-
 
 2           7.4(c) to any optometrist;
 
 3      (4)  For any wholesale prescription drug distributor to sell
 
 4           or distribute medical oxygen except to a:
 
 5             (i) Licensed practitioner with prescriptive
 
 6                 authority;
 
 7            (ii) Pharmacist;
 
 8            (ii) Medical oxygen distributor;
 
 9           (iii) Patient or a patient's agent pursuant to a
 
10                 prescription; or
 
11            (iv) Emergency medical services for administration by
 
12                 trained personnel for oxygen deficiency and
 
13                 resuscitation;
 
14      (5) For any medical oxygen distributor to supply medical
 
15          oxygen pursuant to a prescription order, to a patient or
 
16          a patient's agent, without first obtaining a permit from
 
17          the board to do so; and
 
18     [(4)] (6)  For any person, as principal or agent, to conduct
 
19           or engage in the business of preparing, manufacturing,
 
20           compounding, packing, or repacking any drug without
 
21           first obtaining a permit from the board to do so; and
 
22     [(5)] (7)  For any out-of-state pharmacy or entity engaging
 
23           in the practice of pharmacy, in any manner to
 

 
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 1           distribute, ship, mail, or deliver prescription drugs
 
 2           or devices into the State without first obtaining a
 
 3           permit from the board; provided that the applicant
 
 4           shall:
 
 5           (A)  Provide the location, names, and titles of all
 
 6                principal corporate officers;
 
 7           (B)  Attest that the applicant or any personnel of the
 
 8                applicant has not been found in violation of any
 
 9                state or federal drug laws, including the illegal
 
10                use of drugs or improper distribution of drugs;
 
11           (C)  Submit verification of a valid unexpired license,
 
12                permit, or registration in good standing to
 
13                conduct the pharmacy in compliance with the laws
 
14                of the home state and agree to maintain in good
 
15                standing [such] the license, permit, or
 
16                registration; and
 
17           (D)  Have in its employ a registered pharmacist whose
 
18                registration is current and in good standing."
 
19      SECTION 8.  Section 461-16, Hawaii Revised Statutes, is
 
20 amended by amending subsection (a) to read as follows:
 
21      "(a)  The board shall collect application, license, and
 
22 permit fees for each permit to operate a pharmacy or for each
 
23 license to operate as a wholesale prescription drug distributor
 

 
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 1 and a fee for the issuance of a permit in accordance with section
 
 2 461-15(a)(1), [(4), and] (5)[.], (6) and (7)."
 
 3      SECTION 9.  Statutory material to be repealed is bracketed.
 
 4 New statutory material is underscored.
 
 5      SECTION 10.  This Act shall take effect upon its approval.