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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
H0406|||| LEGISLATURE OF THE STATE OF IDAHO |||| Fifty-fifth Legislature Second Regular Session - 2000IN THE HOUSE OF REPRESENTATIVES HOUSE BILL NO. 406 BY MR. SPEAKER Requested by: Board of Pharmacy 1 AN ACT 2 RELATING TO THE BOARD OF PHARMACY; AMENDING SECTION 54-1705, IDAHO CODE, TO 3 PROVIDE THAT A PRESCRIPTION DRUG OR LEGEND DRUG IS LABELED IN COMPLIANCE 4 WITH FEDERAL REQUIREMENTS AND TO MAKE TECHNICAL CORRECTIONS; AND PROVIDING 5 AN EFFECTIVE DATE. 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 2 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 3 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 theregulationsrules 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 4 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 9eitherone 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
RS09345
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
334-2356
H 40