REPORT TITLE:
Prescription Drugs


DESCRIPTION:
Liberalizes regulatory controls and restrictions on the
distribution of medical oxygen and the dispensing of prescription
drug (non-controlled substances drugs).  (HB2525 HD1)



 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                        2525
HOUSE OF REPRESENTATIVES                H.B. NO.           H.D. 1
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
 
10 equipment, 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 which may be lawfully sold without a
 
19 practitioner's order."
 

 
Page 2                                                     2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

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

 
Page 3                                                     2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1 upon a prescription, including finished dosage forms and active
 
 2 ingredients subject to section 328-16, or section 503(b) of the
 
 3 Federal Act[.], or any drug product compounded or prepared
 
 4 pursuant to a practitioner's order."
 
 5      SECTION 2.  Section 328-16, Hawaii Revised Statutes, is
 
 6 amended to read as follows:
 
 7      "328-16  Drugs limited to dispensing on prescription.(a)
 
 8 A prescription drug shall be dispensed only if its label bears
 
 9 the following:
 
10      (1)  The name, business address, and telephone number of the
 
11           seller.  The business address shall be the physical
 
12           location of the pharmacy or the dispensing
 
13           practitioner's office;
 
14      (2)  The name of the person for whom the drug was prescribed
 
15           or the name of the owner of the animal for which the
 
16           drug was prescribed;
 
17      (3)  The serial number of the prescription;
 
18      (4)  The date of the prescription or of its filling;
 
19      (5)  The name of the practitioner if the seller is not the
 
20           practitioner;
 
21      (6)  The name, strength, and quantity of the drug;
 
22      (7)  The date the potency of the drug expires if the date is
 
23           available from the manufacturer or principal labeler;
 

 
Page 4                                                     2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1      (8)  The number of refills available, if any; and
 
 2      (9)  Specific directions for the drug's use; provided that
 
 3           if the specific directions for use are too lengthy for
 
 4           inclusion on the label, the notation "take according to
 
 5           written instructions" may be used if separate written
 
 6           instructions for use are actually issued with the drug
 
 7           by the practitioner or the pharmacist, but in no event
 
 8           shall the notation "take as directed," referring to
 
 9           oral instructions, be considered acceptable.
 
10 If any prescription for [the] a drug does not indicate the number
 
11 of times it may be refilled, if any, the pharmacist shall not
 
12 refill that prescription unless [the pharmacist is] subsequently
 
13 authorized to do so by the practitioner.  The act of dispensing a
 
14 drug other than a professional sample or medical oxygen contrary
 
15 to this subsection shall be deemed to be an act that results in a
 
16 drug being misbranded while held for sale.
 
17      (b)  In addition to the requirements enumerated in
 
18 subsection (a), a prescription drug shall be dispensed only:
 
19      (1)  By a pharmacist or pharmacy intern [upon a written
 
20           prescription from a practitioner or an out-of-state
 
21           practitioner as provided in section 328-17.6; provided
 
22           that all valid written prescriptions shall include the
 
23           following information:
 

 
Page 5                                                     2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

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

 
 
 
Page 6                                                     2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

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

 
Page 7                                                     2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

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

 
Page 8                                                     2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

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

 
Page 9                                                     2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1      (6)  The room number and route of administration, if the
 
 2           patient is in an institutional facility; and
 
 3      (7)  The number of allowable refills, if the prescription is
 
 4           refillable.  If the number of refills authorized by the
 
 5           practitioner is indicated using the terms "as needed"
 
 6           or "prn," the prescription may be refilled up to twelve
 
 7           months from the date the original prescription was
 
 8           written.  After the twelve-month period, the "as
 
 9           needed" or "prn" prescription may be refilled for a
 
10           subsequent three-month period; provided:
 
11           (A)  The prescription is refilled only once during the
 
12                three-month period;
 
13           (B)  The refill does not exceed a thirty-day supply of
 
14                the drug;
 
15           (C)  The refill does not provide any amount of the drug
 
16                fifteen months beyond the date the original
 
17                prescription was written;
 
18           (D)  In the case of medical oxygen, the duration of
 
19                therapy indicated on a valid certificate of
 
20                medical necessity shall supercede any limitations
 
21                or restrictions on refilling; and
 
22           (E)  The provisions listed in this subparagraph shall
 
23                apply only to pharmacies and medical oxygen
 
24                distributors practicing in the State.
 

 
Page 10                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1      [(4) (d)  By refilling any] (d) Any written or oral
 
 2 prescription may be refilled by the pharmacy and a written or
 
 3 oral prescription for medical oxygen may be refilled by the
 
 4 medical oxygen distributor if that refilling is authorized by the
 
 5 practitioner either:
 
 6      [(A)](1)  In the original prescription; or
 
 7      [(B)](2)  By oral order, which shall be reduced promptly to
 
 8      writing and filed by the receiving pharmacist [or], pharmacy
 
 9      intern[.], or medical oxygen distributor.
 
10      [(c)](e)  For the purposes of this section, a "prescription
 
11 drug" is a drug intended for use by a person which:
 
12      (1)  Is a habit forming drug to which section 328-15(4)
 
13           applies;
 
14      (2)  Because of its toxicity or other potentiality for
 
15           harmful effect, or the method of its use, or the
 
16           collateral measures necessary to its use, is not safe
 
17           for use except under the supervision of a practitioner;
 
18           or
 
19      (3)  Is limited by an approved application under section 505
 
20           of the Federal Act or section 328-17 to use under the
 
21           professional supervision of a practitioner.
 
22      [(d)](f)  Any drug other than medical oxygen dispensed by
 
23 filling or refilling a [written or oral] prescription of a
 

 
Page 11                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1 practitioner shall be exempt from the requirements of section
 
 2 328-15 (except paragraphs (1), (9), (11), and (12), and the
 
 3 packaging requirements of paragraphs (7) and (8)), if the drug
 
 4 bears a label containing:
 
 5      (1)  The name and address of the pharmacy;
 
 6      (2)  The serial number and the date of the prescription or
 
 7           of its filling;
 
 8      (3)  The name of the practitioner; and
 
 9      (4)  If stated in the prescription, the name of the patient,
 
10           and the directions for use and cautionary statements,
 
11           if any, contained in the prescription.
 
12 This exemption shall not apply to any drug dispensed in the
 
13 course of the conduct of a business of dispensing drugs pursuant
 
14 to diagnosis by mail, or to a drug dispensed in violation of
 
15 [subsections] subsection (a) [and], (b), (c), or (d) of this
 
16 section.
 
17      [(e)](g)  The director of health, may, by regulation, remove
 
18 drugs subject to sections 328-15(4) and 328-17 from the
 
19 requirements of [subsections] subsection (a)[and], (b), (c), or
 
20 (d) of this section when such requirements are not necessary for
 
21 the protection of the public health.  Drugs removed from the
 
22 prescription requirements of the Federal Act by regulations
 
23 issued thereunder may also, by regulations issued by the
 

 
Page 12                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1 director, be removed from the requirements of [subsections]
 
 2 subsection (a)[and], (b), (c), or (d) of this section.
 
 3      [(f)](h)  A drug which is subject to [subsections]
 
 4 subsection (a)[and], (b), (c), or (d) of this section shall be
 
 5 deemed to be misbranded if at any time prior to dispensing its
 
 6 label fails to bear the statement "Caution: Federal law prohibits
 
 7 dispensing without prescription," or "Caution: State law
 
 8 prohibits dispensing without prescription."  A drug to which
 
 9 [subsections] subsection (a) [and], (b), (c), or (d) of this
 
10 section [do] does not apply shall be deemed to be misbranded if
 
11 at any time prior to dispensing its label bears the caution
 
12 statement quoted in the preceding sentence.
 
13      [(g)](i)  Nothing in this section shall be construed to
 
14 relieve any person from any requirement, prescribed by or under
 
15 authority of law with respect to drugs now included or which may
 
16 hereafter be included within the classifications of [narcotic
 
17 drugs or marijuana] controlled substances as defined in the
 
18 applicable federal and state laws relating to [narcotic drugs and
 
19 marijuana] controlled substances.
 
20      (j)  Oral code numbers or designations shall be issued by
 
21 the department of public safety, pursuant to applicable statutes
 
22 and rules."
 

 
 
 
Page 13                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1      SECTION 3.  Section 328-17.5, Hawaii Revised Statutes, is
 
 2 amended to read as follows:
 
 3      "[[]328-17.5[]]  Principal labeler responsibility under
 
 4 recall of drug.  Whenever the manufacturer of a drug voluntarily
 
 5 recalls the drug or the Federal Food and Drug Administration or a
 
 6 court orders the recall of a drug, the principal labeler of the
 
 7 drug shall remove the drug from all pharmacies, prescriber
 
 8 offices, medical oxygen distributors, distributors of non-
 
 9 prescription drugs, and health care facilities."
 
10      SECTION 4.  Section 328-17.6, Hawaii Revised Statutes, is
 
11 amended to read as follows:
 
12      "328-17.6  Out-of-state prescriptions.(a)  An out-of-
 
13 state practitioner may [make] issue a written or [orally-
 
14 ordered] oral prescription within the confines of the
 
15 practitioner's license and in accordance with Hawaii laws and
 
16 rules.  [The prescription may either be filled one time or
 
17 refilled one time, but not both; provided that:
 
18      (1)  The prescription filled or refilled pursuant to this
 
19           section shall be limited to not more than a thirty-day
 
20           supply of any drug; and
 
21      (2)  If orally-ordered, the] An oral prescription shall be
 
22           personally [ordered] communicated by [an] the out-of-
 
23           state practitioner and received only by a
 

 
Page 14                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1           pharmacist[.], except that a medical oxygen order may
 
 2           be received by a medical oxygen distributor.
 
 3      (b)  An out-of-state pharmacy may transfer prescription
 
 4 information for refilling purposes and an out-of-state medical
 
 5 oxygen distributor may transfer prescription information for the
 
 6 purpose of refilling a medical oxygen order.
 
 7      [(b)](c)  Any pharmacist or medical oxygen distributor who
 
 8 fills or refills a prescription from an out-of-state
 
 9 [prescription] practitioner shall:
 
10      (1)  Note the following on the [pharmacist's] prescription
 
11           record:  the out-of-state practitioner's full name,
 
12           address, and telephone number[, and Drug Enforcement
 
13           Administration registration number; provided that the
 
14           Drug Enforcement Administration registration number
 
15           shall be required only for original fills communicated
 
16           via telephone or facsimile];
 
17      (2)  Be responsible for validating [the authenticity of the
 
18           out-of-state practitioner's Drug Enforcement
 
19           Administration registration number;] and verifying the
 
20           practitioner's prescriptive authority by virtue of a
 
21           valid out-of-state license, a Drug Enforcement
 
22           Administration registration number, or other measures
 
23           as appropriate; and
 

 
Page 15                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1      (3)  Demand proper identification from the person whose name
 
 2           appears on the prescription prior to filling the
 
 3           prescription, in addition to complying with any
 
 4           identification procedures established by the department
 
 5           for filling and refilling an out-of-state prescription.
 
 6      [(c)](d)  Before refilling [an] a transferred out-of-state
 
 7 prescription, a pharmacist or medical oxygen distributor
 
 8 [receiving transferred prescription information] shall:
 
 9      (1)  Advise the person whose name appears on the
 
10           prescription that the prescription on file at the
 
11           originating out-of-state pharmacy or medical oxygen
 
12           distributor may be canceled [before the pharmacist can
 
13           refill the prescription]; and
 
14      (2)  Record all information required to be on a
 
15           prescription, including, but not limited to:
 
16           (A)  The date of issuance of the original prescription;
 
17           (B)  The number of refills authorized on the original
 
18                prescription;
 
19           (C)  The date the original prescription was dispensed;
 
20           (D)  The number of valid refills remaining and the date
 
21                of the last refill;
 
22           (E)  The out-of-state pharmacy's or out-of-state
 
23                medical oxygen distributor's name[,] and
 

 
Page 16                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1                address,[and Drug Enforcement Administration
 
 2                registration number,] and the original
 
 3                prescription number or control number from which
 
 4                the prescription information was transferred; and
 
 5           (F)  The name of the transferor pharmacist[.] or
 
 6                medical oxygen distributor agent.
 
 7      [(d)](e)  A pharmacist or medical oxygen distributor who
 
 8 fills or refills an out-of-state prescription shall be
 
 9 responsible if the prescription is not written in the form
 
10 prescribed by Hawaii laws and rules.
 
11      [(e)](f)  [The pharmacist shall follow all labeling
 
12 procedures established by the department for filling and
 
13 refilling an out-of-state prescription.  The]  An out-of-state
 
14 prescription shall be appropriately identified as "Out-of-State
 
15 Filled" or "Out-of-State Refilled", and shall state the date of
 
16 filling or refilling and the local address of the person whose
 
17 name appears on the prescription.
 
18      [(f)](g)  All transferred prescriptions shall be maintained
 
19 for a period of five years from the date of filling or refilling.
 
20 Filled out-of-state prescriptions shall be kept in a special file
 
21 for five years.  The department may establish additional
 
22 recordkeeping and reporting procedures for filled and refilled
 
23 out-of-state prescriptions.
 

 
Page 17                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1      [(g)](h)  This section shall not apply to prescriptions for
 
 2 controlled substances and habit forming drugs."
 
 3      SECTION 5.  Section 328-17.7, Hawaii Revised Statutes, is
 
 4 amended to read as follows:
 
 5      "328-17.7  Record of prescriptions.  Every practitioner
 
 6 [or], pharmacist, or medical oxygen distributor who compounds,
 
 7 sells, or delivers any [prescription containing any poisonous
 
 8 drug, or substance deleterious to human life, to be used as
 
 9 medicine, shall enter upon the practitioner's or pharmacist's
 
10 books the prescription written out in full, with the date
 
11 thereof, with the practitioner's or pharmacist's own name
 
12 appended thereto, or the name of the practitioner who prescribed
 
13 the same, and the person to whom the same was delivered.]
 
14 prescribed drug to a patient or a patient's agent shall maintain
 
15 records that identify the specific drug product, the prescribing
 
16 practitioner, the patient, the date of prescribing or filling,
 
17 and the name of the practitioner, pharmacist, or medical oxygen
 
18 distributor dispensing the drug.  No prescription shall be
 
19 compounded, sold, or delivered unless the name of the person
 
20 compounding, selling, or delivering the same, or the name of the
 
21 practitioner prescribing the same, is appended to the
 
22 prescription in full, and every prescription shall be preserved
 
23 for a period of not less than five years.  The [books and
 

 
Page 18                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1 prescriptions] prescription records shall be subject at all times
 
 2 to the inspection of the director of health or the director's
 
 3 agent."
 
 4      SECTION 6.  Section 461-1, Hawaii Revised Statutes, is
 
 5 amended as follows:
 
 6      1.  By adding three new definitions to be appropriately
 
 7 inserted and to read:
 
 8      ""Medical oxygen" means the prescription drug oxygen.
 
 9      "Medical oxygen distributor" means any person, including a
 
10 prescription drug wholesale distributor, who distributes or
 
11 dispenses medical oxygen, pursuant to a prescription.
 
12      "Prescription drug" means any drug dispensed, distributed,
 
13 or sold pursuant to a practitioner's order."
 
14      2.  By amending the definitions of "cosmetics," "drug" and
 
15 "pharmacy" to read:
 
16      ""Cosmetics," which includes "soap", "dentifrice", and
 
17 "toilet article", means:
 
18      (1)  [articles] Articles intended to be rubbed, poured, or
 
19           sprinkled on, introduced into, or otherwise applied to
 
20           the human body, or any part thereof, for cleansing,
 
21           beautifying, or promoting attractiveness; and
 
22      (2)  [articles] Articles intended for use as a component of
 
23           any such articles.
 

 
Page 19                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1      "Drug" means:
 
 2      (1)  [articles] Articles recognized in the official United
 
 3           States pharmacopoeia, official homeopathic
 
 4           pharmacopoeia of the United States, or official
 
 5           national formulary, or any supplement to any of
 
 6           them[,];
 
 7      (2)  Articles intended for use in the diagnosis, cure,
 
 8           mitigation, treatment, or prevention of disease in
 
 9           human beings or animals; [and (2) articles]
 
10      (3)  Articles (other than food or clothing) intended to
 
11           affect the structure or any function of the body of
 
12           human beings or animals; and [(3) articles]
 
13      (4)  Articles intended for use as a component of any
 
14           articles specified in [clause] paragraph (1), [or] (2),
 
15           or (3), above; provided that the term "drug" shall not
 
16           include [patent medicines, electrical or mechanical
 
17           devices] devices or their components, parts or
 
18           accessories, cosmetics, [and] or liquor as defined in
 
19           section 281-1.
 
20      "Pharmacy" means every store, shop, or place [where]:
 
21      (1)  Where prescription drugs are dispensed or sold at
 
22           retail, or displayed for sale at retail; or
 

 
 
 
Page 20                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1      (2)  [where physicians] Where practitioners' prescriptions
 
 2           or drug preparations are compounded; or
 
 3      (3)  [which] Which has upon it or displayed within it, or
 
 4           affixed to or used in connection with it, a sign
 
 5           bearing the word or words "pharmacist", "pharmacy",
 
 6           "apothecary", "drug store", "druggist", "drugs",
 
 7           "medicines", "medicine store", "drug sundries",
 
 8           "remedies", or any word or words of similar or like
 
 9           import; or
 
10      (4)  [any store or shop or other place with respect to
 
11           which] Where any of the above words or combination of
 
12           words are used in any advertisement.
 
13 The meaning of "pharmacy" shall not include any medical oxygen
 
14 distributor."
 
15      3.  By repealing the definition of "patent medicine."
 
16      [""Patent medicine" means any packaged, bottled, or nonbulk
 
17 chemical, drug, or medicine, when identified by and sold under a
 
18 trademark, trade name, or other trade symbol privately owned or
 
19 registered in the United States Patent Office, or registered as
 
20 provided by the laws of the State, and which is labeled with
 
21 directions for use, and bears the name and address of the
 
22 manufacturer or distributor; provided that the chemical, drug, or
 
23 medicine meets the requirements of the pure food and drug laws of
 

 
Page 21                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1 the United States and the State.  "Patent medicine" shall not
 
 2 include therapeutic vitamins when used either alone, or in
 
 3 combination with other drugs."]
 
 4      SECTION 7.  Section 461-15, Hawaii Revised Statutes, is
 
 5 amended by amending subsection (a) to read as follows:
 
 6      "(a) It shall be unlawful:
 
 7      (1)  For any person to sell or offer for sale at public
 
 8           auction, or to sell or offer for sale at private sale
 
 9           in a place where public auctions are conducted, any
 
10           prescription drugs without first obtaining a permit
 
11           from the board of pharmacy to do so;
 
12      (2)  For any person to [in any manner] distribute or
 
13           dispense samples of any prescription drugs [or medical
 
14           supplies] without first obtaining a permit from the
 
15           board to do so; provided that nothing in this paragraph
 
16           shall interfere with the furnishing of samples or drugs
 
17           directly to physicians, druggists, dentists,
 
18           veterinarians, and optometrists for use in their
 
19           professional practice;
 
20      (3)  For wholesalers to sell, distribute, or dispense any
 
21           prescription drug, except to a pharmacist, physician,
 
22           dentist, veterinarian, or optometrist who is allowed to
 
23           use pharmaceutical agents under chapter 459 or to a
 

 
Page 22                                                    2525
                                     H.B. NO.           H.D. 1        
                                                        
                                                        

 
 1           generally recognized industrial, agricultural,
 
 2           manufacturing, or scientific user of drugs for
 
 3           professional or business purposes; provided that it
 
 4           shall be unlawful for wholesalers to sell, distribute,
 
 5           or dispense any prescription pharmaceutical agent which
 
 6           is not listed under section 459-15 to any optometrist;
 
 7      (4)  For any wholesale prescription drug distributor to sell
 
 8           or distribute medical oxygen except to a licensed
 
 9           practitioner with prescriptive authority, a pharmacist,
 
10           a medical oxygen distributor, to a patient or a
 
11           patient's agent, pursuant to a prescription, or to
 
12           emergency medical services for administration by
 
13           trained personnel for oxygen deficiency and
 
14           resuscitation;"
 
15      (5)  For any medical oxygen distributor to supply medical
 
16           oxygen pursuant to a prescription order to a patient or
 
17           a patient's agent without first obtaining a permit from
 
18           the board to do so; and
 
19      [(4)](6)  For any person, as principal or agent, to conduct
 
20           or engage in the business of preparing, manufacturing,
 
21           compounding, packing, or repacking any drug without
 
22           first obtaining a permit from the board to do so; and
 

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

 
 
 
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 1      "(a)  The board shall collect application, license, and
 
 2 permit fees for each permit to operate a pharmacy or for each
 
 3 license to operate as a wholesale prescription drug distributor
 
 4 and a fee for the issuance of a permit in accordance with section
 
 5 461-15(a)(1), [(4), and] (5)[.], (6) and (7)."
 
 6      SECTION 9.  Statutory material to be repealed is bracketed.
 
 7 New statutory material is underscored.
 
 8      SECTION 10.  This Act shall take effect upon its approval.