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H0483................................by JUDICIARY, RULES AND ADMINISTRATION
DRUGS - ADULTERATION - Amends existing law to provide penalties for persons
who intentionally adulterate a drug that is held for sale or distribution;
to provide penalties for health care providers who, with knowledge that a
drug has been adulterated, permit that drug to be administered or dispensed
to a person; to define terms; to provide a determination whether a drug has
been adulterated; and to provide an exception for prescribing a change in
strength, quality or purity of a drug if the change is made pursuant to the
orders of a practitioner prescribing a drug for the purpose of
administering the drug to a patient.
01/24 House intro - 1st rdg - to printing
01/25 Rpt prt - to Jud
02/01 Rpt out - rec d/p - to 2nd rdg
02/04 2nd rdg - to 3rd rdg
02/08 3rd rdg - PASSED - 63-0-7
AYES -- Aikele, Barraclough, Barrett, Bedke, Black, Block, Boe, Bolz,
Bradford, Bruneel, Callister, Campbell, Clark, Collins, Crow, Cuddy,
Deal, Denney, Ellis, Ellsworth, Eskridge, Field(13), Field(20),
Gagner, Gould, Hadley, Hammond, Harwood, Henbest, Higgins, Hornbeck,
Kellogg, Kendell, Kunz, Lake, Langford, Loertscher, Mader, Martinez,
McKague, Meyer, Montgomery, Mortensen, Moyle, Pearce, Pischner,
Pomeroy, Raybould, Ridinger, Roberts, Robison, Sali, Schaefer,
Sellman, Shepherd, Smith(33), Smylie, Stevenson, Tilman, Trail,
Wheeler, Wood, Young
NAYS -- None
Absent and excused -- Bell, Bieter, Jaquet, Jones, Smith(23), Stone,
Mr. Speaker
Floor Sponsors - Gould & Henbest
Title apvd - to Senate
02/11 Senate intro - 1st rdg - to Jud
03/04 Rpt out - rec d/p - to 2nd rdg
03/05 2nd rdg - to 3rd rdg
03/12 3rd rdg - PASSED - 35-0-0
AYES -- Andreason, Boatright, Branch(Bartlett), Brandt, Bunderson,
Burtenshaw, Cameron, Darrington, Davis, Deide, Dunklin, Frasure,
Geddes, Goedde, Hawkins, Hill, Ingram, Ipsen, Keough, King-Barrutia,
Little, Lodge, Marley, Noh, Richardson, Risch, Sandy, Schroeder,
Sims, Sorensen, Stegner, Stennett, Thorne, Wheeler, Williams
NAYS -- None
Absent and excused -- None
Floor Sponsors - Sorensen & King-Barrutia
Title apvd - to House
03/12 To enrol
03/13 Rpt enrol - Sp signed
Pres signed
03/14 To Governor
03/22 Governor signed
Session Law Chapter 231
Effective: 07/01/02
|||| LEGISLATURE OF THE STATE OF IDAHO ||||
Fifty-sixth Legislature Second Regular Session - 2002
IN THE HOUSE OF REPRESENTATIVES
HOUSE BILL NO. 483
BY JUDICIARY, RULES AND ADMINISTRATION COMMITTEE
1 AN ACT
2 RELATING TO ADULTERATED DRUGS; AMENDING SECTION 37-117, IDAHO CODE, TO PROVIDE
3 PENALTIES FOR A PERSON WHO INTENTIONALLY ADULTERATES A DRUG THAT IS HELD
4 FOR SALE OR DISTRIBUTION, TO PROVIDE PENALTIES FOR HEALTH CARE PROVIDERS
5 WHO, WITH KNOWLEDGE THAT A DRUG HAS BEEN ADULTERATED, PERMIT THAT DRUG TO
6 BE ADMINISTERED OR DISPENSED TO A PERSON, TO DEFINE TERMS AND TO PROVIDE A
7 DETERMINATION WHETHER A DRUG HAS BEEN ADULTERATED, TO PROVIDE A CORRECT
8 CITATION AND TO MAKE TECHNICAL CORRECTIONS; AMENDING SECTION 37-126, IDAHO
9 CODE, TO PROVIDE THAT NOTHING IN THE STATUTE PROHIBITING DISPENSING ADUL-
10 TERATED DRUGS OR DEVICES SHALL BE DEEMED TO PROHIBIT A CHANGE IN THE
11 STRENGTH, QUALITY OR PURITY OF A DRUG, IF THE CHANGE IS MADE BY OR PURSU-
12 ANT TO THE ORDERS OF A PRACTITIONER PRESCRIBING THE DRUG FOR THE PURPOSE
13 OF ADMINISTERING THE DRUG TO A PATIENT AND TO MAKE TECHNICAL CORRECTIONS.
14 Be It Enacted by the Legislature of the State of Idaho:
15 SECTION 1. That Section 37-117, Idaho Code, be, and the same is hereby
16 amended to read as follows:
17 37-117. VIOLATIONS A MISDEMEANOR -- PENALTY -- EXCEPTIONS.
18 (1) (a) Any person who intentionally adulterates a drug that is held for
19 sale or distribution, or that is to be administered or dispensed, shall be
20 guilty of a felony and shall, upon conviction thereof, be subject to
21 imprisonment for not more than fifteen (15) years or a fine of not more
22 than fifty thousand dollars ($50,000), or both.
23 (b) Any health care provider who, with knowledge that a drug has been
24 adulterated, permits that drug to be administered or dispensed to a person
25 shall be guilty of a felony and shall, upon conviction thereof, be subject
26 to imprisonment for not more than fifteen (15) years, or a fine of not
27 more than fifty thousand dollars ($50,000), or both. For the purposes of
28 this subsection, the term "health care provider" shall be defined as any
29 person licensed in this state to prescribe, dispense, conduct research
30 with respect to, or administer drugs in the course of professional prac-
31 tice and any unlicensed person, who, as part of such person's employment
32 or profession, provides health care services.
33 (c) The determination of whether or not a drug has been adulterated shall
34 be made in accordance with the provisions of section 37-126, Idaho Code.
35 (2) Any person who violates any of the provisions of this act or of rules
36 and regulations promulgated by the board of health and welfare thereunder or
37 who interferes with the director of the department of health and welfare or
38 the personnel of the department in the administration of this act shall be
39 guilty of a misdemeanor and shall on conviction thereof be subject to impris-
40 onment for not more than six (6) months or a fine of not more than five hun-
41 dred dollars ($500), or both such imprisonment and fine, but if the violation
42 is committed after a conviction of such person under this section has become
43 final, such person shall be subject to imprisonment for not more than one (1)
2
1 year, or a fine of not more than one thousand dollars ($1000), or both such
2 imprisonment and fine.
3 (b3) No person shall be subject to the penalties of subsection (a2) of
4 this section, for having violated section 37-115 (a) or (c), Idaho Code, if he
5 establishes a guaranty or undertaking signed by, and containing the name and
6 address of, the person residing in the state of Idaho from whom he received in
7 good faith the article, to the effect that such article is not adulterated or
8 misbranded within the meaning of this act, designating this act.
9 (c4) No publisher, radio broadcast licensee, or agency or medium for the
10 dissemination of an advertisement, except the manufacturer, packer, distribu-
11 tor, or seller of the article to which a false advertisement relates, shall be
12 liable under this section by reason of the dissemination by him of such false
13 advertisement, unless he has refused, on the request of the director to fur-
14 nish him the name and post-office address of the manufacturer, packer, dis-
15 tributor, seller, or advertising agency, residing in the state of Idaho who
16 causes him to disseminate such advertisement.
17 SECTION 2. That Section 37-126, Idaho Code, be, and the same is hereby
18 amended to read as follows:
19 37-126. DRUGS OR DEVICES DEEMED ADULTERATED. A drug or device shall be
20 deemed to be adulterated:--(a) (1) If it consists in whole or in part of any
21 filthy, putrid, or decomposed substance; or (2) if it has been produced, pre-
22 pared, packed, or held under insanitary conditions whereby it may have been
23 contaminated with filth, or whereby it may have been rendered injurious to
24 health; or (3) if it is a drug and its container is composed, in whole or in
25 part, of any poisonous or deleterious substance which may render the contents
26 injurious to health; or (4) if it is a drug and it bears or contains, for pur-
27 poses of coloring only, a coal-tar color other than one from a batch certified
28 under the authority of the federal act.
29 (b) If it purports to be or is represented as a drug the name of which is
30 recognized in an official compendium, and its strength differs from, or its
31 quality or purity falls below, the standard set forth in such compendium. Such
32 determination as to strength, quality or purity shall be made in accordance
33 with the tests or methods of assay set forth in such compendium or in the
34 absence of or inadequacy of such tests or methods of assay, these prescribed
35 under authority of the federal act. No drug defined in an official compendium
36 shall be deemed to be adulterated under this paragraph because it differs from
37 the standard of strength, quality, or purity therefor set forth in such com-
38 pendium, if its difference in strength, quality, or purity from such standard
39 is plainly stated on its label. Whenever a drug is recognized in both the
40 United States Pharmacopoeia and the Homoeopathic Homeopathic Pharmacopoeia of
41 the United States it shall be subject to the requirements of the United States
42 Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug,
43 in which case it shall be subject to the provisions of the Homeopathic Pharma-
44 copoeia of the United States and not to those of the United States Pharmaco-
45 poeia. Nothing in this subsection shall be deemed to prohibit a change in the
46 strength, quality or purity of a drug, if the change is made by or pursuant to
47 the orders of a practitioner prescribing the drug for the purpose of adminis-
48 tering the drug to a patient.
49 (c) If it is not subject to the provisions of paragraph subsection (b) of
50 this section and its strength differs from, or its purity or quality falls
51 below, that which it purports or is represented to possess. Nothing in this
52 subsection shall be deemed to prohibit a change in the strength, quality or
53 purity of a drug, if the change is made by or pursuant to the orders of the
3
1 practitioner prescribing the drug for the purpose of administering the drug to
2 a patient.
3 (d) If it is a drug and any substance has been: (1) mixed or packed
4 therewith so as to reduce its quality or strength; or (2) substituted wholly
5 or in part therefor. Nothing in this subsection shall be deemed to prohibit a
6 change in the strength, quality or purity of a drug, if the change is made by
7 or pursuant to the orders of the practitioner prescribing the drug for the
8 purpose of administering the drug to a patient.
STATEMENT OF PURPOSE
RS 11571C1
This proposal amends, Idaho Code, Sections 37-117 and 37-126 of the
Idaho Food, Drug and Cosmetic Act. Amendments to section 37-117
provide for increased penalties for a person who intentionally
alters a drug that is held for sale or distribution. It also
provides for consequences for health care providers who, with
knowledge that a drug has been tampered with, allow it to be
administered or dispensed to a patient. It will provide guidelines
to determine if a drug has been illegally adulterated.
Amendments to Section 37-126 will provide protection for licensed
health care practitioners who make alterations to pharmaceutical
drugs in the course of treatment.
FISCAL IMPACT
There is no fiscal impact from this proposal.
Contact
Name: Bill von Tagen, Office of the Attorney General
Phone: 334—4140
STATEMENT OF PURPOSE/FISCAL NOTE H 483