2000 Legislation
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HOUSE BILL NO. 406 – Drugs, prescription/legend, label


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Daily Data Tracking History

H0406........................................................by MR. SPEAKER
                     Requested by:  Board of Pharmacy
DRUGS - PRESCRIPTION/LEGEND - Amends existing law to provide for labeling
requirements for prescription drugs or legend drugs.
01/17    House intro - 1st rdg - to printing
    Rpt prt - to Health/Wel
02/15    Rpt out - rec d/p - to 2nd rdg
02/16    2nd rdg - to 3rd rdg
02/21    3rd rdg - PASSED - 67-0-3
      AYES -- Alltus, Barrett, Bell, Bieter, Black, Boe, Bruneel,
      Callister, Campbell, Chase, Cheirrett, Clark, Crow, Cuddy, Deal,
      Denney, Ellsworth, Field(13), Field(20), Gagner, Geddes, Gould,
      Hadley, Hammond, Hansen(23), Hansen(29), Henbest, Hornbeck, Jaquet,
      Jones, Judd, Kellogg, Kempton, Kendell, Kunz, Lake, Linford,
      Loertscher, Mader, Marley, McKague, Meyer, Montgomery, Moss, Moyle,
      Pearce, Pischner, Pomeroy, Reynolds, Ridinger, Ringo, Robison, Sali,
      Schaefer, Sellman, Shepherd, Smith, Smylie, Stevenson, Stoicheff,
      Stone, Taylor, Tilman, Trail(Miller), Wheeler, Wood, Zimmermann
      NAYS -- None
      Absent and excused -- Barraclough, Mortensen, Mr Speaker
    Floor Sponsor - Moss
    Title apvd - to Senate
02/22    Senate intro - 1st rdg - to Health/Wel
02/25    Rpt out - rec d/p - to 2nd rdg
02/28    2nd rdg - to 3rd rdg
03/24    3rd rdg - PASSED - 35-0-0
      AYES -- Andreason, Boatright, Branch, Bunderson, Burtenshaw, Cameron,
      Crow, Danielson, Darrington, Davis, Deide, Dunklin, Frasure, Geddes,
      Hawkins, Ingram, Ipsen, Keough, King-Barrutia, Lee, McLaughlin, Noh,
      Parry, Richardson, Riggs, Risch, Sandy, Schroeder, Sorensen, Stegner,
      Stennett, Thorne, Wheeler, Whitworth, Williams
      NAYS -- None
      Absent and excused -- None
    Floor Sponsor - Wheeler
    Title apvd - to House
03/27    To enrol
03/28    Rpt enrol - Sp signed
03/29    Pres signed
03/30    To Governor
    Governor signed
         Session Law Chapter 103
         Effective: 07/01/00

Bill Text

  ||||              LEGISLATURE OF THE STATE OF IDAHO             ||||
 Fifty-fifth Legislature                  Second Regular Session - 2000
                              IN THE HOUSE OF REPRESENTATIVES
                                     HOUSE BILL NO. 406
                                       BY MR. SPEAKER
                              Requested by: Board of Pharmacy
  1                                        AN ACT
  6    Be It Enacted by the Legislature of the State of Idaho:
  7        SECTION 1.  That Section 54-1705, Idaho Code, be, and the same  is  hereby
  8    amended to read as follows:
  9        54-1705.  DEFINITIONS.  (1) "Board of pharmacy" or "board" means the Idaho
 10    state board of pharmacy.
 11        (2)  "Counseling or counsel" means  the  effective  communication  by  the
 12    pharmacist  of  information  as  set  out  in  this chapter, to the patient or
 13    caregiver, in order to improve therapeutic outcomes by maximizing  proper  use
 14    of  prescription  medications  and devices. Specific areas of counseling shall
 15    include, but are not limited to:
 16        (a)  Name and strength and description of the medication;
 17        (b)  Route of administration, dosage, dosage form, continuity  of  therapy
 18        and refill information;
 19        (c)  Special  directions  and precautions for preparation, administration,
 20        storage and use by the patient as deemed necessary by the pharmacist;
 21        (d)  Side effects or adverse  effects  and  interactions  and  therapeutic
 22        contraindications  that  may  be  encountered,  including their avoidance,
 23        which may interfere with the proper use of the medication or device as was
 24        intended by the prescriber, and the action required if they occur;
 25        (e)  Techniques for self-monitoring drug therapy; and
 26        (f)  Action to be taken in the event of a missed dose.
 27        (3)  "Deliver" or "delivery" means the actual, constructive  or  attempted
 28    transfer  of  a  drug or device from one (1) person to another, whether or not
 29    for a consideration.
 30        (4)  "Device" means an instrument, apparatus, implement, machine, contriv-
 31    ance, implant, invitro reagent or other similar related article including  any
 32    component part or accessory which is:
 33        (a)  Recognized  in  the  official United States Pharmacopoeia or official
 34        National Formulary, other drug compendia or any supplement to them;
 35        (b)  Intended for use in the diagnosis of disease or other conditions,  or
 36        the  cure,  mitigation, treatment or prevention of disease in man or other
 37        animal;
 38        (c)  Intended to effect the structure or any function of the body  of  man
 39        or  other animal, and which does not achieve any of its principal intended
 40        purposes through chemical action within or on the body  of  man  or  other
 41        animal, and which is not dependent upon being metabolized for the achieve-
 42        ment of any of its principal intended purposes.
 43        (5)  "Dispense"  or  "dispensing"  means the preparation and delivery of a
  1    prescription drug pursuant to a lawful order of a practitioner in  a  suitable
  2    container  appropriately  labeled for subsequent administration to or use by a
  3    patient or other individual entitled to receive the prescription drug.
  4        (6)  "Distribute" means the delivery of a drug other than by administering
  5    or dispensing.
  6        (7)  "Drug" means:
  7        (a)  Articles recognized as drugs in the official United States  Pharmaco-
  8        poeia,  official  National  Formulary, official Homeopathic Pharmacopoeia,
  9        other drug compendia or any supplement to any of them;
 10        (b)  Articles intended for use in the diagnosis, cure, mitigation,  treat-
 11        ment or prevention of disease in man or other animal;
 12        (c)  Articles,  other  than  food, intended to affect the structure or any
 13        function of the body of man or other animals; and
 14        (d)  Articles intended for use as a component of any articles specified in
 15        paragraph (a), (b) or (c) of this subsection.
 16        (8)  "Drug order" means a written order, in a  hospital  or  other  health
 17    care institution, for an ultimate user of any drug or device issued and signed
 18    by  a  practitioner,  or  an order transmitted by other means of communication
 19    from a practitioner, which is immediately reduced to writing by a  pharmacist,
 20    registered  nurse or other licensed health care practitioner authorized by the
 21    hospital or institution. The order shall contain the name and  bed  number  of
 22    the patient, the name and strength or size of the drug or device, unless spec-
 23    ified  by  individual  institution  policy or guideline, the amount to be dis-
 24    pensed, either in quantity or days, adequate directions for the proper use  of
 25    the drug or device when it is administered to the patient, and the name of the
 26    prescriber.
 27        (9)  "Drug  outlet"  means all pharmacies, nursing homes, residential care
 28    homes, convalescent homes, extended care facilities, drug abuse treatment cen-
 29    ters, penal institutions, hospitals, family planning clinics,  retail  stores,
 30    wholesalers,  manufacturers  and mail order vendors with facilities located in
 31    this state which are engaged in dispensing, delivery or distribution of  drugs
 32    and  drug  manufacturers  and  wholesalers with facilities located outside the
 33    state, but doing business within this state.
 34        (10)  "Prospective drug review" includes, but is not limited to, the  fol-
 35    lowing activities:
 36        (a)  Evaluation of the prescription or medication order for:
 37             1.  Known allergies;
 38             2.  Rational therapy contraindications;
 39             3.  Reasonable dose and route of administration; and
 40             4.  Reasonable directions for use.
 41        (b)  Evaluation of the prescription or medication order for duplication of
 42        therapy.
 43        (c)  Evaluation of the prescription or medication order for interactions:
 44             1.  Drug-drug;
 45             2.  Drug-food; and
 46             3.  Drug-disease.
 47        (d)  Evaluation  of the prescription or medication order for proper utili-
 48        zation:
 49             1.  Over or under utilization; and
 50             2.  Abuse/misuse.
 51        (11)  "Extern" means a bona fide student enrolled in an  approved  college
 52    of pharmacy who has not received his first professional degree in pharmacy.
 53        (12)  "Externship"  means  a  structured  practical  experience program in
 54    pharmacy, approved by the board and administered by a college of pharmacy.
 55        (13)  "Intern" means any person who has completed a course of study at  an
  1    approved  college of pharmacy, received the first professional degree in phar-
  2    macy and is registered with the board as an intern. Interns must register with
  3    the board prior to commencement of an internship program.
  4        (14)  "Internship" means a postgraduate practical experience program under
  5    the supervision of a licensed pharmacist registered as a preceptor.
  6        (15)  "Investigational or new drug" means any drug  which  is  limited  by
  7    state  or  federal law to use under professional supervision of a practitioner
  8    authorized by law to prescribe or administer such drug.
  9        (16)  "Labeling" means the process of preparing and affixing of a label to
 10    any drug container, exclusive however, of  the  labeling  by  a  manufacturer,
 11    packer  or distributor of a nonprescription drug or commercially packaged leg-
 12    end drug or device. Any such label shall include all information  required  by
 13    federal and state law or regulation.
 14        (17)  "Manufacture"  means  the production, preparation, propagation, com-
 15    pounding, conversion or processing of a device or a drug, either  directly  or
 16    indirectly by extraction from substances of natural origin or independently by
 17    means  of  chemical  synthesis  or by a combination of extraction and chemical
 18    synthesis and includes any packaging or repackaging of the substance or label-
 19    ing or relabeling of its container, except that this term does not include the
 20    preparation or compounding of a drug by an individual for his own use  or  the
 21    preparation, compounding, packaging or labeling of a drug:
 22        (a)  By  a  pharmacist or practitioner as an incident to his administering
 23        or dispensing of a drug in the course of his professional practice; or
 24        (b)  By a practitioner or by his authorization under his  supervision  for
 25        the  purpose of or as an incident to research, teaching or chemical analy-
 26        sis and not for sale.
 27        (18)  "Manufacturer" means a person who by compounding, cultivating,  har-
 28    vesting,  mixing  or  other  process,  produces  or prepares legend drugs, and
 29    includes persons who prepare such drugs in dosage forms by  mixing,  compound-
 30    ing,  encapsulating,  entableting,  or  other  process,  or  who  packages  or
 31    repackages  such  drugs,  but does not include pharmacists or practitioners in
 32    the practice of their profession.
 33        (19)  "Precursor" means a substance, other than a legend drug which is  an
 34    immediate  chemical  intermediate  that can be processed or synthesized into a
 35    legend drug, and is used or produced primarily for use in the manufacture of a
 36    legend drug by persons other than persons licensed to manufacture such  legend
 37    drugs  by the Idaho board of pharmacy, registered by the state board of health
 38    and welfare, or licensed to practice pharmacy by the Idaho board of pharmacy.
 39        (20)  "Person" means an individual, corporation, partnership,  association
 40    or any other legal entity.
 41        (21)  "Pharmaceutical  care"  means  drug therapy and other pharmaceutical
 42    patient care services intended to achieve outcomes related to the cure or pre-
 43    vention of a disease, elimination or reduction of  a  patient's  symptoms,  or
 44    arresting  or slowing of a disease process as defined in the regulations rules
 45    of the board.
 46        (22)  "Pharmacist" means an individual licensed by this state to engage in
 47    the practice of pharmacy.
 48        (23)  "Pharmacy" means any facility, department or other place where  pre-
 49    scriptions  are  filled or compounded and are sold, dispensed, offered or dis-
 50    played for sale, which has, as its principal purpose, the dispensing  of  drug
 51    and health supplies intended for the general health, welfare and safety of the
 52    public.
 53        (24)  "Practitioner" shall mean a physician, dentist, veterinarian, scien-
 54    tific  investigator or other person (other than a pharmacist) licensed in this
 55    state and permitted by such license to dispense, conduct research with respect
  1    to or administer drugs in the course of professional practice or  research  in
  2    this state.
  3        (25)  "Preceptor"  means  a  pharmacist  licensed in the state and in good
  4    standing, who supervises the internship training of a registered  intern.  The
  5    preceptor must be registered as a preceptor and shall be actively engaged on a
  6    full-time employment basis in the approved training area.
  7        (26)  "Prescription drug or legend drug" means a drug which, under federal
  8    law  is  required,  prior  to being dispensed or delivered, to be labeled with
  9    either one of the following statements:
 10        (a)  "Caution: Federal law prohibits dispensing without a  prescription;";
 11        or
 12        (b)  "Rx Only"; or
 13        (c)  "Caution:  Federal  law restricts this drug to use by or on the order
 14        of a licensed veterinarian;";
 15    or a drug which is required by any applicable federal or state law or  regula-
 16    tion  to  be dispensed on prescription only or is restricted to use by practi-
 17    tioners only.
 18        (27)  "Prescription drug order" means a lawful written or verbal order  of
 19    a practitioner for a drug.
 20        (28)  "Nonprescription  drugs"  means medicines or drugs which may be sold
 21    without a prescription and which are prepackaged for use by the  consumer  and
 22    labeled in accordance with the requirements of the statutes and regulations of
 23    this state and the federal government.
 24        (29)  "Record" means all papers, letters, memoranda, notes, prescriptions,
 25    drug orders, invoices, statements, patient medication charts or files, comput-
 26    erized  records  or other written indicia, documents or objects which are used
 27    in any way in connection with the purchase, sale or handling of  any  drug  or
 28    device.
 29        (30)  "Sale" means every sale and includes:
 30        (a)  Manufacturing,  processing,  transporting, handling, packaging or any
 31        other production, preparation or repackaging;
 32        (b)  Exposure, offer, or any other proffer;
 33        (c)  Holding, storing or any other possession;
 34        (d)  Dispensing, giving, delivering or any other supplying; and
 35        (e)  Applying, administering or any other usage.
 36        (31)  "Warehouseman" means a person who stores legend drugs for others and
 37    who has no control over the disposition of such drugs except for  the  purpose
 38    of such storage.
 39        (32)  "Wholesaler"  means a person engaged in the business of distributing
 40    legend drugs that he himself has not produced or prepared, to persons included
 41    in any of the classes named in subsection  (2)  (a)  through  (f)  of  section
 42    54-1734, Idaho Code.
 43        SECTION  2.  This  act shall be in full force and effect on and after July
 44    1, 2000.

Statement of Purpose / Fiscal Impact

                       STATEMENT OF PURPOSE

The purpose of this proposed legislation is to revise the
definition of prescription drug or legend drug to comply with new
federal labeling requirements.

                         FISCAL IMPACT
There will be no impact on the General Fund, no cost to the general
public or practitioners, and implementation of legislation will be
from the Board of Pharmacy dedicated funds.

CONTACT:  Richard K. "Mick" Markuson, Director                                               
          Idaho State Board of Pharmacy

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