93RD GENERAL ASSEMBLY
State of Illinois
2003 and 2004
HB4624

 

Introduced 02/04/04, by Kathleen A. Ryg, Jack D. Franks

 

SYNOPSIS AS INTRODUCED:
 
New Act
225 ILCS 85/4   from Ch. 111, par. 4124
225 ILCS 120/15   from Ch. 111, par. 8301-15
320 ILCS 50/10
410 ILCS 620/16   from Ch. 56 1/2, par. 516
720 ILCS 570/102   from Ch. 56 1/2, par. 1102
740 ILCS 20/3   from Ch. 70, par. 903

    Creates the Drug Repository Program Act. Requires the Department of Public Health to establish a drug repository program to accept and dispense prescription drugs donated for the purpose of being dispensed to Illinois residents who meet eligibility standards adopted by the Department. Provides for donations of drugs by drug manufacturers and health care facilities. Prohibits the acceptance of drugs with an expiration date less than 6 months from the date the drug is donated. Provides immunity from civil and criminal liability for persons who donate, accept, or dispense drugs in accordance with the program. Amends the Pharmacy Practice Act of 1987, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic Act, the Illinois Controlled Substances Act, and the Cannabis and Controlled Substances Tort Claims Act to provide that persons engaged in donating or accepting, or packaging, repackaging, or labeling, prescription drugs to the extent permitted or required under the Drug Repository Program Act are exempt from provisions of those other Acts that might prohibit or otherwise regulate such activity.


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FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB4624 LRB093 16557 DRJ 42203 b

1     AN ACT concerning health.
 
2     Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
 
4     Section 1. Short title. This Act may be cited as the Drug
5 Repository Program Act.
 
6     Section 5. Definitions. In this Act:
7     "Department" means the Department of Public Health.
8     "Health care facility" means a hospital, nursing home,
9 physician's office, or other location at which medical or
10 health care services are provided.
11     "Health care professional" means any of the following who
12 provide medical, dental, or other health-related diagnosis,
13 care, or treatment:
14         (1) A physician licensed to practice medicine in all of
15     its branches.
16         (2) A person licensed under the Podiatric Medical
17     Practice Act of 1987.
18         (3) A registered nurse or licensed practical nurse
19     licensed under the Nursing and Advanced Practice Nursing
20     Act.
21         (4) A physician assistant licensed under the Physician
22     Assistant Practice Act of 1987.
23         (5) A dentist or dental hygienist licensed under the
24     Illinois Dental Practice Act.
25         (6) An optometrist licensed under the Illinois
26     Optometric Practice Act of 1987.
27         (7) A pharmacist licensed under the Pharmacy Practice
28     Act of 1987.
29     "Hospital" means a hospital licensed under the Hospital
30     Licensing Act or subject to the University of Illinois Hospital
31     Act.
32     "Nonprofit clinic" means any charitable organization not

 

 

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1     organized and not operated for profit that provides health care
2     services to indigent and uninsured persons. "Nonprofit clinic"
3     does not include a hospital or a facility that is operated for
4     profit.
5     "Nursing home" means a facility licensed under the Nursing
6     Home Care Act.
7     "Pharmacy" has the meaning ascribed to that term in the
8     Pharmacy Practice Act of 1987.
9     "Prescription drug" means any drug to which the following
10     applies:
11         (1) Under the "Food, Drug, and Cosmetic Act," 52 Stat.
12     1040 (1938), 21 U.S.C.A. 301, the drug is required to bear
13     a label containing the legend, "Caution: Federal law
14     prohibits dispensing without prescription" or "Caution:
15     Federal law restricts this drug to use by or on the order
16     of a licensed veterinarian" or any similar restrictive
17     statement, or the drug may be dispensed only upon a
18     prescription.
19         (2) The drug may be dispensed only upon a prescription.
20     "Program" means the drug repository program established
21     under this Act.
22     
 
23     Section 10. Drug repository program. The Department shall
24 establish a drug repository program to accept and dispense
25 prescription drugs donated for the purpose of being dispensed
26 to individuals who are residents of this State and meet
27 eligibility standards established in rules adopted by the
28 Department under Section 30. Only drugs in their original
29 sealed and tamper-evident unit dose packaging may be accepted
30 and dispensed. The packaging must be unopened, except that
31 drugs packaged in single unit doses may be accepted and
32 dispensed when the outside packaging is opened if the single
33 unit dose packaging is undisturbed. Drugs donated by
34 individuals bearing an expiration date that is less than 6
35 months from the date the drug is donated shall not be accepted

 

 

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1 or dispensed. A drug shall not be accepted or dispensed if
2 there is reason to believe that it is adulterated as described
3 in the Illinois Food, Drug and Cosmetic Act. Subject to the
4 limitation specified in this Act, unused drugs dispensed for
5 purposes of the medical assistance program under Article V of
6 the Illinois Public Aid Code may be accepted and dispensed
7 under the drug repository program.
 
8     Section 15. Donations of prescription drugs.
9     (a) Any person, including a drug manufacturer or health
10 care facility, may donate prescription drugs to the program.
11 The drugs must be donated at a pharmacy, hospital, or nonprofit
12 clinic that elects to participate in the program and meets
13 criteria for participation in the program established in rules
14 adopted by the Department under Section 30.
15     (b) Participation in the program by pharmacies, hospitals,
16 and nonprofit clinics is voluntary. Nothing in this Act
17 requires a pharmacy, hospital, or nonprofit clinic to
18 participate in the program.
 
19     Section 20. Dispensing of donated drugs.
20     (a) A pharmacy, hospital, or nonprofit clinic eligible to
21 participate in the program shall dispense drugs donated under
22 this Act to individuals who are residents of this State and
23 meet the eligibility standards established in rules adopted by
24 the Department under Section 30 or to other government entities
25 and nonprofit private entities to be dispensed to individuals
26 who meet the eligibility standards. A drug may be dispensed
27 only pursuant to a prescription issued by a licensed health
28 care professional authorized to prescribe drugs.
29     (b) A pharmacy, hospital, or nonprofit clinic that accepts
30 donated drugs shall comply with all applicable federal laws and
31 laws of this State dealing with storage and distribution of
32 dangerous drugs and shall inspect all drugs prior to dispensing
33 them to determine that they are not adulterated as described in
34 the Illinois Food, Drug and Cosmetic Act.

 

 

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1     (c) The pharmacy, hospital, or nonprofit clinic may charge
2 individuals receiving donated drugs a handling fee established
3 in accordance with rules adopted by the Department under
4 Section 30.
5     (d) Drugs donated to the repository may not be resold.
 
6     Section 25. Immunity.
7     (a) The following are immune from civil or criminal
8 liability and from professional disciplinary action or other
9 administrative liability in connection with their good faith
10 conduct related to the donation, acceptance, or dispensing of
11 drugs under the program:
12         (1) The Department of Public Health and its officers,
13     employees, and agents.
14         (2) Any person, including a drug manufacturer, or
15     government entity that donates drugs to the program.
16         (3) Any pharmacy, hospital, nonprofit clinic, or
17     health care professional that accepts or dispenses drugs
18     under the program.
19         (4) Any pharmacy, hospital, or nonprofit clinic that
20     employs a health care professional who accepts or dispenses
21     drugs under the program.
22     (b) A drug manufacturer is immune from civil or criminal
23     liability for its good faith conduct related to the donation,
24     acceptance, or dispensing of a drug manufactured by the drug
25     manufacturer that is donated by any person under the program,
26     including but not limited to liability for failure to transfer
27     or communicate product or consumer information or the
28     expiration date of the donated drug.
 
29     Section 30. Rules. The Department of Public Health shall
30 adopt rules governing the program. The rules shall include, but
31 need not be limited to, the following:
32         (1) Eligibility criteria for pharmacies, hospitals,
33     and nonprofit clinics to receive and dispense donated drugs
34     under the program.

 

 

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1         (2) Standards and procedures for accepting, safely
2     storing, and dispensing donated drugs.
3         (3) Standards and procedures for inspecting donated
4     drugs to determine that the original unit dose packaging is
5     sealed and tamper-evident and that the drugs are
6     unadulterated, safe, and suitable for dispensing.
7         (4) Eligibility standards based on economic need for
8     individuals to receive drugs.
9         (5) A means, such as an identification card, by which
10     an individual who is eligible to receive donated drugs may
11     demonstrate eligibility to the pharmacy, hospital, or
12     nonprofit clinic dispensing the drugs.
13         (6) A form that an individual receiving a drug from the
14     repository must sign before receiving the drug to confirm
15     that the individual understands the immunity provisions of
16     the program.
17         (7) A formula to determine the amount of a handling fee
18     that pharmacies, hospitals, and nonprofit clinics may
19     charge to drug recipients to cover restocking and
20     dispensing costs.
21         (8) For drugs donated to the repository by individuals:
22             (A) A list of drugs, arranged either by category or
23         by individual drug, that the repository will accept
24         from individuals.
25             (B) A list of drugs, arranged either by category or
26         by individual drug, that the repository will not accept
27         from individuals. The list must include a statement as
28         to why the drug is ineligible for donation.
29             (C) A form each donor must sign stating that the
30         donor is the owner of the drugs and intends to
31         voluntarily donate them to the repository.
32         (9) For drugs donated to the repository by health care
33     facilities:
34             (A) A list of drugs, arranged either by category or
35         by individual drug, that the repository will accept
36         from health care facilities.

 

 

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1             (B) A list of drugs, arranged either by category or
2         by individual drug, that the repository will not accept
3         from health care facilities. The list must include a
4         statement as to why the drug is ineligible for
5         donation.
6         (10) Any other standards and procedures the Department
7     considers appropriate.
 
8     Section 90. The Pharmacy Practice Act of 1987 is amended by
9 changing Section 4 as follows:
 
10     (225 ILCS 85/4)  (from Ch. 111, par. 4124)
11     (Section scheduled to be repealed on January 1, 2008)
12     Sec. 4. Exemptions. Nothing contained in any Section of
13 this Act shall apply to, or in any manner interfere with:
14     (a) the lawful practice of any physician licensed to
15 practice medicine in all of its branches, dentist, podiatrist,
16 veterinarian, or therapeutically or diagnostically certified
17 optometrist within the limits of his or her license, or prevent
18 him or her from supplying to his or her bona fide patients such
19 drugs, medicines, or poisons as may seem to him appropriate;
20     (b) the sale of compressed gases;
21     (c) the sale of patent or proprietary medicines and
22 household remedies when sold in original and unbroken packages
23 only, if such patent or proprietary medicines and household
24 remedies be properly and adequately labeled as to content and
25 usage and generally considered and accepted as harmless and
26 nonpoisonous when used according to the directions on the
27 label, and also do not contain opium or coca leaves, or any
28 compound, salt or derivative thereof, or any drug which,
29 according to the latest editions of the following authoritative
30 pharmaceutical treatises and standards, namely, The United
31 States Pharmacopoeia/National Formulary (USP/NF), the United
32 States Dispensatory, and the Accepted Dental Remedies of the
33 Council of Dental Therapeutics of the American Dental
34 Association or any or either of them, in use on the effective

 

 

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1 date of this Act, or according to the existing provisions of
2 the Federal Food, Drug, and Cosmetic Act and Regulations of the
3 Department of Health and Human Services, Food and Drug
4 Administration, promulgated thereunder now in effect, is
5 designated, described or considered as a narcotic, hypnotic,
6 habit forming, dangerous, or poisonous drug;
7     (d) the sale of poultry and livestock remedies in original
8 and unbroken packages only, labeled for poultry and livestock
9 medication;
10     (e) the sale of poisonous substances or mixture of
11 poisonous substances, in unbroken packages, for nonmedicinal
12 use in the arts or industries or for insecticide purposes;
13 provided, they are properly and adequately labeled as to
14 content and such nonmedicinal usage, in conformity with the
15 provisions of all applicable federal, state and local laws and
16 regulations promulgated thereunder now in effect relating
17 thereto and governing the same, and those which are required
18 under such applicable laws and regulations to be labeled with
19 the word "Poison", are also labeled with the word "Poison"
20 printed thereon in prominent type and the name of a readily
21 obtainable antidote with directions for its administration;
22     (f) the delegation of limited prescriptive authority by a
23 physician licensed to practice medicine in all its branches to
24 a physician assistant under Section 7.5 of the Physician
25 Assistant Practice Act of 1987. This delegated authority may
26 but is not required to include prescription of Schedule III,
27 IV, or V controlled substances, as defined in Article II of the
28 Illinois Controlled Substances Act, in accordance with written
29 guidelines under Section 7.5 of the Physician Assistant
30 Practice Act of 1987; and
31     (g) the The delegation of limited prescriptive authority by
32 a physician licensed to practice medicine in all its branches
33 to an advanced practice nurse in accordance with a written
34 collaborative agreement under Sections 15-15 and 15-20 of the
35 Nursing and Advanced Practice Nursing Act. This delegated
36 authority may but is not required to include the prescription

 

 

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1 of Schedule III, IV, or V controlled substances as defined in
2 Article II of the Illinois Controlled Substances Act; and .
3     (h) the donation or acceptance, or the packaging,
4 repackaging, or labeling, of prescription drugs to the extent
5 permitted or required under the Drug Repository Program Act.
6 (Source: P.A. 90-116, eff. 7-14-97; 90-253, eff. 7-29-97;
7 90-655, eff. 7-30-98; 90-742, eff. 8-13-98.)
 
8     Section 91. The Wholesale Drug Distribution Licensing Act
9 is amended by changing Section 15 as follows:
 
10     (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
11     (Section scheduled to be repealed on January 1, 2013)
12     Sec. 15. Definitions. As used in this Act:
13     "Blood" means whole blood collected from a single donor and
14 processed either for transfusion or further manufacturing.
15     "Blood component" means that part of blood separated by
16 physical or mechanical means.
17     "Board" means the State Board of Pharmacy of the Department
18 of Professional Regulation.
19     "Department" means the Department of Professional
20 Regulation.
21     "Director" means the Director of Professional Regulation.
22     "Drug sample" means a unit of a prescription drug that is
23 not intended to be sold and is intended to promote the sale of
24 the drug.
25     "Manufacturer" means anyone who is engaged in the
26 manufacturing, preparing, propagating, compounding,
27 processing, packaging, repackaging, or labeling of a
28 prescription drug. "Manufacturer" does not include anyone who
29 is engaged in the packaging, repackaging, or labeling of
30 prescription drugs only to the extent required under the Drug
31 Repository Program Act.
32     "Person" means and includes a natural person, partnership,
33 association or corporation.
34     "Pharmacy distributor" means any pharmacy licensed in this

 

 

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1 State or hospital pharmacy that is engaged in the delivery or
2 distribution of prescription drugs either to any other pharmacy
3 licensed in this State or to any other person or entity
4 including, but not limited to, a wholesale drug distributor
5 engaged in the delivery or distribution of prescription drugs
6 who is involved in the actual, constructive, or attempted
7 transfer of a drug in this State to other than the ultimate
8 consumer except as otherwise provided for by law.
9     "Prescription drug" means any human drug required by
10 federal law or regulation to be dispensed only by a
11 prescription, including finished dosage forms and active
12 ingredients subject to subsection (b) of Section 503 of the
13 Federal Food, Drug and Cosmetic Act.
14     "Wholesale distribution" or "wholesale distributions"
15 means distribution of prescription drugs to persons other than
16 a consumer or patient, but does not include any of the
17 following:
18         (a) Intracompany sales, defined as any transaction or
19     transfer between any division, subsidiary, parent, or
20     affiliated or related company under the common ownership
21     and control of a corporate entity.
22         (b) The purchase or other acquisition by a hospital or
23     other health care entity that is a member of a group
24     purchasing organization of a drug for its own use from the
25     group purchasing organization or from other hospitals or
26     health care entities that are members of a group
27     organization.
28         (c) The sale, purchase, or trade of a drug or an offer
29     to sell, purchase, or trade a drug by a charitable
30     organization described in subsection (c)(3) of Section 501
31     of the U.S. Internal Revenue Code of 1954 to a nonprofit
32     affiliate of the organization to the extent otherwise
33     permitted by law.
34         (d) The sale, purchase, or trade of a drug or an offer
35     to sell, purchase, or trade a drug among hospitals or other
36     health care entities that are under common control. For

 

 

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1     purposes of this Act, "common control" means the power to
2     direct or cause the direction of the management and
3     policies of a person or an organization, whether by
4     ownership of stock, voting rights, contract, or otherwise.
5         (e) The sale, purchase, or trade of a drug or an offer
6     to sell, purchase, or trade a drug for emergency medical
7     reasons. For purposes of this Act, "emergency medical
8     reasons" include transfers of prescription drugs by a
9     retail pharmacy to another retail pharmacy to alleviate a
10     temporary shortage.
11         (f) The sale, purchase, or trade of a drug, an offer to
12     sell, purchase, or trade a drug, or the dispensing of a
13     drug pursuant to a prescription.
14         (g) The distribution of drug samples by manufacturers'
15     representatives or distributors' representatives.
16         (h) The sale, purchase, or trade of blood and blood
17     components intended for transfusion.
18         (i) The donation of prescription drugs to the extent
19     permitted under the Drug Repository Program Act.
20     "Wholesale drug distributor" means any person or entity
21 engaged in wholesale distribution of prescription drugs,
22 including, but not limited to, manufacturers; repackers; own
23 label distributors; jobbers; private label distributors;
24 brokers; warehouses, including manufacturers' and
25 distributors' warehouses, chain drug warehouses, and wholesale
26 drug warehouses; independent wholesale drug traders; and
27 retail pharmacies that conduct wholesale distributions,
28 including, but not limited to, any pharmacy distributor as
29 defined in this Section. A wholesale drug distributor shall not
30 include any for hire carrier or person or entity hired solely
31 to transport prescription drugs.
32 (Source: P.A. 87-594.)
 
33     Section 92. The Senior Pharmaceutical Assistance Act is
34 amended by changing Section 10 as follows:
 

 

 

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1     (320 ILCS 50/10)
2     Sec. 10. Definitions. In this Act:
3     "Manufacturer" includes:
4         (1) An entity that is engaged in (a) the production,
5     preparation, propagation, compounding, conversion, or
6     processing of prescription drug products (i) directly or
7     indirectly by extraction from substances of natural
8     origin, (ii) independently by means of chemical synthesis,
9     or (iii) by combination of extraction and chemical
10     synthesis; or (b) the packaging, repackaging, labeling or
11     re-labeling, or distribution of prescription drug
12     products.
13         (2) The entity holding legal title to or possession of
14     the national drug code number for the covered prescription
15     drug.
16     The term does not include a wholesale distributor of drugs,
17 drugstore chain organization, or retail pharmacy licensed by
18 the State. The term also does not include anyone who is engaged
19 in the packaging, repackaging, or labeling of prescription
20 drugs only to the extent required under the Drug Repository
21 Program Act.
22     "Prescription drug" means a drug that may be dispensed only
23 upon prescription by an authorized prescriber and that is
24 approved for safety and effectiveness as a prescription drug
25 under Section 505 or 507 of the Federal Food, Drug and Cosmetic
26 Act.
27     "Senior citizen" or "senior" means a person 65 years of age
28 or older.
29 (Source: P.A. 92-594, eff. 6-27-02.)
 
30     Section 93. The Illinois Food, Drug and Cosmetic Act is
31 amended by changing Section 16 as follows:
 
32     (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)
33     Sec. 16. (a) The Director is hereby authorized to
34 promulgate regulations exempting from any labeling or

 

 

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1 packaging requirement of this Act drugs and devices which are
2 (i) , in accordance with the practice of the trade, to be
3 processed, labeled or repacked in substantial quantities at
4 establishments other than those where originally processed or
5 packaged on condition that such drugs and devices are not
6 adulterated or misbranded under the provisions of this Act upon
7 removal from such processing, labeling or repacking
8 establishment or (ii) packaged, repackaged, or labeled to the
9 extent required under the Drug Repository Program Act.
10     (b) Drugs and device labeling or packaging exemptions
11 adopted under the Federal Act and supplements thereto or
12 revisions thereof shall apply to drugs and devices in Illinois
13 except insofar as modified or rejected by regulations
14 promulgated by the Director.
15     (c) A drug intended for use by man which (A) is a
16 habit-forming drug to which Section 15 (d) applies; or (B)
17 because of its toxicity or other potentiality for harmful
18 effect or the method of its use or the collateral measures
19 necessary to its use is not safe for use except under the
20 supervision of a practitioner licensed by law to administer
21 such drug; or (C) is limited by an approved application under
22 Section 505 of the Federal Act or Section 17 of this Act to use
23 under the professional supervision of a practitioner licensed
24 by law to administer such drug, shall be dispensed only in
25 accordance with the provisions of the "Illinois Controlled
26 Substances Act". The act of dispensing a drug contrary to the
27 provisions of this paragraph shall be deemed to be an act which
28 results in a drug being misbranded while held for sale.
29     (d) Any drug dispensed by filling or refilling a written or
30 oral prescription of a practitioner licensed by law to
31 administer such drug shall be exempt from the requirements of
32 Section 15, except subsections (a), (k) and (l) and clauses (2)
33 and (3) of subsection (i), and the packaging requirements of
34 subsections (g), (h) and (q), if the drug bears a label
35 containing the proprietary name or names, or if there is none,
36 the established name or names of the drugs, the dosage and

 

 

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1 quantity, unless the prescribing practitioner, in the interest
2 of the health of the patient, directs otherwise in writing, the
3 name and address of the dispenser, the serial number and date
4 of the prescription or of its filling, the name of the
5 prescriber and, if stated in the prescription, the name of the
6 patient, and the directions for use and the cautionary
7 statements, if any, contained in such prescription. This
8 exemption shall not apply to any drug dispensed in the course
9 of the conduct of business of dispensing drugs pursuant to
10 diagnosis by mail, or to a drug dispensed in violation of
11 subsection (a) of this Section.
12     (e) The Director may by regulation remove drugs subject to
13 Section 15 (d) and Section 17 from the requirements of
14 subsection (c) of this Section when such requirements are not
15 necessary for the protection of the public health.
16     (f) A drug which is subject to subsection (c) of this
17 Section shall be deemed to be misbranded if at any time before
18 dispensing its label fails to bear the statement "Caution:
19 Federal Law Prohibits Dispensing Without Prescription" or
20 "Caution: State Law Prohibits Dispensing Without
21 Prescription". A drug to which subsection (c) of this Section
22 does not apply shall be deemed to be misbranded if at any time
23 prior to dispensing its label bears the caution statement
24 quoted in the preceding sentence.
25     (g) Nothing in this Section shall be construed to relieve
26 any person from any requirement prescribed by or under
27 authority of law with respect to controlled substances now
28 included or which may hereafter be included within the
29 classifications of controlled substances cannabis as defined
30 in applicable Federal laws relating to controlled substances or
31 cannabis or the Cannabis Control Act.
32 (Source: P.A. 84-1308.)
 
33     Section 94. The Illinois Controlled Substances Act is
34 amended by changing Section 102 as follows:
 

 

 

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1     (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
2     Sec. 102. Definitions. As used in this Act, unless the
3 context otherwise requires:
4     (a) "Addict" means any person who habitually uses any drug,
5 chemical, substance or dangerous drug other than alcohol so as
6 to endanger the public morals, health, safety or welfare or who
7 is so far addicted to the use of a dangerous drug or controlled
8 substance other than alcohol as to have lost the power of self
9 control with reference to his addiction.
10     (b) "Administer" means the direct application of a
11 controlled substance, whether by injection, inhalation,
12 ingestion, or any other means, to the body of a patient,
13 research subject, or animal (as defined by the Humane
14 Euthanasia in Animal Shelters Act) by:
15         (1) a practitioner (or, in his presence, by his
16     authorized agent),
17         (2) the patient or research subject at the lawful
18     direction of the practitioner, or
19         (3) a euthanasia technician as defined by the Humane
20     Euthanasia in Animal Shelters Act.
21     (c) "Agent" means an authorized person who acts on behalf
22 of or at the direction of a manufacturer, distributor, or
23 dispenser. It does not include a common or contract carrier,
24 public warehouseman or employee of the carrier or warehouseman.
25     (c-1) "Anabolic Steroids" means any drug or hormonal
26 substance, chemically and pharmacologically related to
27 testosterone (other than estrogens, progestins, and
28 corticosteroids) that promotes muscle growth, and includes:
29             (i) boldenone,
30             (ii) chlorotestosterone,
31             (iii) chostebol,
32             (iv) dehydrochlormethyltestosterone,
33             (v) dihydrotestosterone,
34             (vi) drostanolone,
35             (vii) ethylestrenol,
36             (viii) fluoxymesterone,

 

 

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1             (ix) formebulone,
2             (x) mesterolone,
3             (xi) methandienone,
4             (xii) methandranone,
5             (xiii) methandriol,
6             (xiv) methandrostenolone,
7             (xv) methenolone,
8             (xvi) methyltestosterone,
9             (xvii) mibolerone,
10             (xviii) nandrolone,
11             (xix) norethandrolone,
12             (xx) oxandrolone,
13             (xxi) oxymesterone,
14             (xxii) oxymetholone,
15             (xxiii) stanolone,
16             (xxiv) stanozolol,
17             (xxv) testolactone,
18             (xxvi) testosterone,
19             (xxvii) trenbolone, and
20             (xxviii) any salt, ester, or isomer of a drug or
21         substance described or listed in this paragraph, if
22         that salt, ester, or isomer promotes muscle growth.
23     Any person who is otherwise lawfully in possession of an
24 anabolic steroid, or who otherwise lawfully manufactures,
25 distributes, dispenses, delivers, or possesses with intent to
26 deliver an anabolic steroid, which anabolic steroid is
27 expressly intended for and lawfully allowed to be administered
28 through implants to livestock or other nonhuman species, and
29 which is approved by the Secretary of Health and Human Services
30 for such administration, and which the person intends to
31 administer or have administered through such implants, shall
32 not be considered to be in unauthorized possession or to
33 unlawfully manufacture, distribute, dispense, deliver, or
34 possess with intent to deliver such anabolic steroid for
35 purposes of this Act.
36     (d) "Administration" means the Drug Enforcement

 

 

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1 Administration, United States Department of Justice, or its
2 successor agency.
3     (e) "Control" means to add a drug or other substance, or
4 immediate precursor, to a Schedule under Article II of this Act
5 whether by transfer from another Schedule or otherwise.
6     (f) "Controlled Substance" means a drug, substance, or
7 immediate precursor in the Schedules of Article II of this Act.
8     (g) "Counterfeit substance" means a controlled substance,
9 which, or the container or labeling of which, without
10 authorization bears the trademark, trade name, or other
11 identifying mark, imprint, number or device, or any likeness
12 thereof, of a manufacturer, distributor, or dispenser other
13 than the person who in fact manufactured, distributed, or
14 dispensed the substance.
15     (h) "Deliver" or "delivery" means the actual, constructive
16 or attempted transfer of possession of a controlled substance,
17 with or without consideration, whether or not there is an
18 agency relationship. The term does not include the donation of
19 prescription drugs to the extent permitted under the Drug
20 Repository Program Act.
21     (i) "Department" means the Illinois Department of Human
22 Services (as successor to the Department of Alcoholism and
23 Substance Abuse) or its successor agency.
24     (j) "Department of State Police" means the Department of
25 State Police of the State of Illinois or its successor agency.
26     (k) "Department of Corrections" means the Department of
27 Corrections of the State of Illinois or its successor agency.
28     (l) "Department of Professional Regulation" means the
29 Department of Professional Regulation of the State of Illinois
30 or its successor agency.
31     (m) "Depressant" or "stimulant substance" means:
32         (1) a drug which contains any quantity of (i)
33     barbituric acid or any of the salts of barbituric acid
34     which has been designated as habit forming under section
35     502 (d) of the Federal Food, Drug, and Cosmetic Act (21
36     U.S.C. 352 (d)); or

 

 

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1         (2) a drug which contains any quantity of (i)
2     amphetamine or methamphetamine and any of their optical
3     isomers; (ii) any salt of amphetamine or methamphetamine or
4     any salt of an optical isomer of amphetamine; or (iii) any
5     substance which the Department, after investigation, has
6     found to be, and by rule designated as, habit forming
7     because of its depressant or stimulant effect on the
8     central nervous system; or
9         (3) lysergic acid diethylamide; or
10         (4) any drug which contains any quantity of a substance
11     which the Department, after investigation, has found to
12     have, and by rule designated as having, a potential for
13     abuse because of its depressant or stimulant effect on the
14     central nervous system or its hallucinogenic effect.
15     (n) (Blank).
16     (o) "Director" means the Director of the Department of
17 State Police or the Department of Professional Regulation or
18 his designated agents.
19     (p) "Dispense" means to deliver a controlled substance to
20 an ultimate user or research subject by or pursuant to the
21 lawful order of a prescriber, including the prescribing,
22 administering, packaging, labeling, or compounding necessary
23 to prepare the substance for that delivery.
24     (q) "Dispenser" means a practitioner who dispenses.
25     (r) "Distribute" means to deliver, other than by
26 administering or dispensing, a controlled substance.
27     (s) "Distributor" means a person who distributes.
28     (t) "Drug" means (1) substances recognized as drugs in the
29 official United States Pharmacopoeia, Official Homeopathic
30 Pharmacopoeia of the United States, or official National
31 Formulary, or any supplement to any of them; (2) substances
32 intended for use in diagnosis, cure, mitigation, treatment, or
33 prevention of disease in man or animals; (3) substances (other
34 than food) intended to affect the structure of any function of
35 the body of man or animals and (4) substances intended for use
36 as a component of any article specified in clause (1), (2), or

 

 

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1 (3) of this subsection. It does not include devices or their
2 components, parts, or accessories.
3     (t-5) "Euthanasia agency" means an entity certified by the
4 Department of Professional Regulation for the purpose of animal
5 euthanasia that holds an animal control facility license or
6 animal shelter license under the Animal Welfare Act. A
7 euthanasia agency is authorized to purchase, store, possess,
8 and utilize Schedule II nonnarcotic and Schedule III
9 nonnarcotic drugs for the sole purpose of animal euthanasia.
10     (t-10) "Euthanasia drugs" means Schedule II or Schedule III
11 substances (nonnarcotic controlled substances) that are used
12 by a euthanasia agency for the purpose of animal euthanasia.
13     (u) "Good faith" means the prescribing or dispensing of a
14 controlled substance by a practitioner in the regular course of
15 professional treatment to or for any person who is under his
16 treatment for a pathology or condition other than that
17 individual's physical or psychological dependence upon or
18 addiction to a controlled substance, except as provided herein:
19 and application of the term to a pharmacist shall mean the
20 dispensing of a controlled substance pursuant to the
21 prescriber's order which in the professional judgment of the
22 pharmacist is lawful. The pharmacist shall be guided by
23 accepted professional standards including, but not limited to
24 the following, in making the judgment:
25         (1) lack of consistency of doctor-patient
26     relationship,
27         (2) frequency of prescriptions for same drug by one
28     prescriber for large numbers of patients,
29         (3) quantities beyond those normally prescribed,
30         (4) unusual dosages,
31         (5) unusual geographic distances between patient,
32     pharmacist and prescriber,
33         (6) consistent prescribing of habit-forming drugs.
34     (u-1) "Home infusion services" means services provided by a
35 pharmacy in compounding solutions for direct administration to
36 a patient in a private residence, long-term care facility, or

 

 

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1 hospice setting by means of parenteral, intravenous,
2 intramuscular, subcutaneous, or intraspinal infusion.
3     (v) "Immediate precursor" means a substance:
4         (1) which the Department has found to be and by rule
5     designated as being a principal compound used, or produced
6     primarily for use, in the manufacture of a controlled
7     substance;
8         (2) which is an immediate chemical intermediary used or
9     likely to be used in the manufacture of such controlled
10     substance; and
11         (3) the control of which is necessary to prevent,
12     curtail or limit the manufacture of such controlled
13     substance.
14     (w) "Instructional activities" means the acts of teaching,
15 educating or instructing by practitioners using controlled
16 substances within educational facilities approved by the State
17 Board of Education or its successor agency.
18     (x) "Local authorities" means a duly organized State,
19 County or Municipal peace unit or police force.
20     (y) "Look-alike substance" means a substance, other than a
21 controlled substance which (1) by overall dosage unit
22 appearance, including shape, color, size, markings or lack
23 thereof, taste, consistency, or any other identifying physical
24 characteristic of the substance, would lead a reasonable person
25 to believe that the substance is a controlled substance, or (2)
26 is expressly or impliedly represented to be a controlled
27 substance or is distributed under circumstances which would
28 lead a reasonable person to believe that the substance is a
29 controlled substance. For the purpose of determining whether
30 the representations made or the circumstances of the
31 distribution would lead a reasonable person to believe the
32 substance to be a controlled substance under this clause (2) of
33 subsection (y), the court or other authority may consider the
34 following factors in addition to any other factor that may be
35 relevant:
36         (a) statements made by the owner or person in control

 

 

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1     of the substance concerning its nature, use or effect;
2         (b) statements made to the buyer or recipient that the
3     substance may be resold for profit;
4         (c) whether the substance is packaged in a manner
5     normally used for the illegal distribution of controlled
6     substances;
7         (d) whether the distribution or attempted distribution
8     included an exchange of or demand for money or other
9     property as consideration, and whether the amount of the
10     consideration was substantially greater than the
11     reasonable retail market value of the substance.
12     Clause (1) of this subsection (y) shall not apply to a
13 noncontrolled substance in its finished dosage form that was
14 initially introduced into commerce prior to the initial
15 introduction into commerce of a controlled substance in its
16 finished dosage form which it may substantially resemble.
17     Nothing in this subsection (y) prohibits the dispensing or
18 distributing of noncontrolled substances by persons authorized
19 to dispense and distribute controlled substances under this
20 Act, provided that such action would be deemed to be carried
21 out in good faith under subsection (u) if the substances
22 involved were controlled substances.
23     Nothing in this subsection (y) or in this Act prohibits the
24 manufacture, preparation, propagation, compounding,
25 processing, packaging, advertising or distribution of a drug or
26 drugs by any person registered pursuant to Section 510 of the
27 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
28     (y-1) "Mail-order pharmacy" means a pharmacy that is
29 located in a state of the United States, other than Illinois,
30 that delivers, dispenses or distributes, through the United
31 States Postal Service or other common carrier, to Illinois
32 residents, any substance which requires a prescription.
33     (z) "Manufacture" means the production, preparation,
34 propagation, compounding, conversion or processing of a
35 controlled substance, either directly or indirectly, by
36 extraction from substances of natural origin, or independently

 

 

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1 by means of chemical synthesis, or by a combination of
2 extraction and chemical synthesis, and includes any packaging
3 or repackaging of the substance or labeling of its container,
4 except that this term does not include:
5         (1) by an ultimate user, the preparation or compounding
6     of a controlled substance for his own use; or
7         (2) by a practitioner, or his authorized agent under
8     his supervision, the preparation, compounding, packaging,
9     or labeling of a controlled substance:
10             (a) as an incident to his administering or
11         dispensing of a controlled substance in the course of
12         his professional practice; or
13             (b) as an incident to lawful research, teaching or
14         chemical analysis and not for sale; or .
15         (3) the packaging, repackaging, or labeling of
16     prescription drugs only to the extent required under the
17     Drug Repository Program Act.
18     (z-1) "Methamphetamine manufacturing chemical" means any
19 of the following chemicals or substances containing any of the
20 following chemicals: benzyl methyl ketone, ephedrine, methyl
21 benzyl ketone, phenylacetone, phenyl-2-propanone,
22 pseudoephedrine, or red phosphorous or any of the salts,
23 optical isomers, or salts of optical isomers of the
24 above-listed chemicals.
25     (aa) "Narcotic drug" means any of the following, whether
26 produced directly or indirectly by extraction from substances
27 of natural origin, or independently by means of chemical
28 synthesis, or by a combination of extraction and chemical
29 synthesis:
30         (1) opium and opiate, and any salt, compound,
31     derivative, or preparation of opium or opiate;
32         (2) any salt, compound, isomer, derivative, or
33     preparation thereof which is chemically equivalent or
34     identical with any of the substances referred to in clause
35     (1), but not including the isoquinoline alkaloids of opium;
36         (3) opium poppy and poppy straw;

 

 

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1         (4) coca leaves and any salts, compound, isomer, salt
2     of an isomer, derivative, or preparation of coca leaves
3     including cocaine or ecgonine, and any salt, compound,
4     isomer, derivative, or preparation thereof which is
5     chemically equivalent or identical with any of these
6     substances, but not including decocainized coca leaves or
7     extractions of coca leaves which do not contain cocaine or
8     ecgonine (for the purpose of this paragraph, the term
9     "isomer" includes optical, positional and geometric
10     isomers).
11     (bb) "Nurse" means a registered nurse licensed under the
12 Nursing and Advanced Practice Nursing Act.
13     (cc) (Blank).
14     (dd) "Opiate" means any substance having an addiction
15 forming or addiction sustaining liability similar to morphine
16 or being capable of conversion into a drug having addiction
17 forming or addiction sustaining liability.
18     (ee) "Opium poppy" means the plant of the species Papaver
19 somniferum L., except its seeds.
20     (ff) "Parole and Pardon Board" means the Parole and Pardon
21 Board of the State of Illinois or its successor agency.
22     (gg) "Person" means any individual, corporation,
23 mail-order pharmacy, government or governmental subdivision or
24 agency, business trust, estate, trust, partnership or
25 association, or any other entity.
26     (hh) "Pharmacist" means any person who holds a certificate
27 of registration as a registered pharmacist, a local registered
28 pharmacist or a registered assistant pharmacist under the
29 Pharmacy Practice Act of 1987.
30     (ii) "Pharmacy" means any store, ship or other place in
31 which pharmacy is authorized to be practiced under the Pharmacy
32 Practice Act of 1987.
33     (jj) "Poppy straw" means all parts, except the seeds, of
34 the opium poppy, after mowing.
35     (kk) "Practitioner" means a physician licensed to practice
36 medicine in all its branches, dentist, podiatrist,

 

 

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1 veterinarian, scientific investigator, pharmacist, physician
2 assistant, advanced practice nurse, licensed practical nurse,
3 registered nurse, hospital, laboratory, or pharmacy, or other
4 person licensed, registered, or otherwise lawfully permitted
5 by the United States or this State to distribute, dispense,
6 conduct research with respect to, administer or use in teaching
7 or chemical analysis, a controlled substance in the course of
8 professional practice or research.
9     (ll) "Pre-printed prescription" means a written
10 prescription upon which the designated drug has been indicated
11 prior to the time of issuance.
12     (mm) "Prescriber" means a physician licensed to practice
13 medicine in all its branches, dentist, podiatrist or
14 veterinarian who issues a prescription, a physician assistant
15 who issues a prescription for a Schedule III, IV, or V
16 controlled substance in accordance with Section 303.05 and the
17 written guidelines required under Section 7.5 of the Physician
18 Assistant Practice Act of 1987, or an advanced practice nurse
19 with prescriptive authority in accordance with Section 303.05
20 and a written collaborative agreement under Sections 15-15 and
21 15-20 of the Nursing and Advanced Practice Nursing Act.
22     (nn) "Prescription" means a lawful written, facsimile, or
23 verbal order of a physician licensed to practice medicine in
24 all its branches, dentist, podiatrist or veterinarian for any
25 controlled substance, of a physician assistant for a Schedule
26 III, IV, or V controlled substance in accordance with Section
27 303.05 and the written guidelines required under Section 7.5 of
28 the Physician Assistant Practice Act of 1987, or of an advanced
29 practice nurse who issues a prescription for a Schedule III,
30 IV, or V controlled substance in accordance with Section 303.05
31 and a written collaborative agreement under Sections 15-15 and
32 15-20 of the Nursing and Advanced Practice Nursing Act.
33     (oo) "Production" or "produce" means manufacture,
34 planting, cultivating, growing, or harvesting of a controlled
35 substance.
36     (pp) "Registrant" means every person who is required to

 

 

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1 register under Section 302 of this Act.
2     (qq) "Registry number" means the number assigned to each
3 person authorized to handle controlled substances under the
4 laws of the United States and of this State.
5     (rr) "State" includes the State of Illinois and any state,
6 district, commonwealth, territory, insular possession thereof,
7 and any area subject to the legal authority of the United
8 States of America.
9     (ss) "Ultimate user" means a person who lawfully possesses
10 a controlled substance for his own use or for the use of a
11 member of his household or for administering to an animal owned
12 by him or by a member of his household.
13 (Source: P.A. 92-449, eff. 1-1-02; 93-596, eff. 8-26-03;
14 93-626, eff. 12-23-03.)
 
15     Section 95. The Cannabis and Controlled Substances Tort
16 Claims Act is amended by changing Section 3 as follows:
 
17     (740 ILCS 20/3)  (from Ch. 70, par. 903)
18     Sec. 3. Definitions. As used in this Act, unless the
19 context otherwise requires:
20     "Cannabis" includes marihuana, hashish, and other
21 substances that are identified as including any parts of the
22 plant Cannabis Sativa, whether growing or not, the seeds of
23 that plant, the resin extracted from any part of that plant,
24 and any compound, manufacture, salt, derivative, mixture, or
25 preparation of that plant, its seeds, or resin, including
26 tetrahydrocannabinol (THC) and all other cannabinol
27 derivatives, including its naturally occurring or
28 synthetically produced ingredients, whether produced directly
29 or indirectly by extraction, independently by means of chemical
30 synthesis, or by a combination of extraction and chemical
31 synthesis. "Cannabis" does not include the mature stalks of
32 that plant, fiber produced from those stalks, oil or cake made
33 from the seeds of that plant, any other compound, manufacture,
34 salt, derivative, mixture, or preparation of mature stalks

 

 

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1 (except the extracted resin), fiber, oil or cake, or the
2 sterilized seeds of that plant that are incapable of
3 germination.
4     "Controlled substance" means a drug, substance, or
5 immediate precursor in the Schedules of Article II of the
6 Illinois Controlled Substances Act.
7     "Counterfeit substance" means a controlled substance or
8 the container or labeling of a controlled substance that,
9 without authorization, bears the trademark, trade name, or
10 other identifying mark, imprint, number, device, or any
11 likeness thereof of a manufacturer, distributor, or dispenser
12 other than the person who in fact manufactured, distributed, or
13 dispensed the substance.
14     "Deliver" or "delivery" means the actual, constructive, or
15 attempted transfer of possession of a controlled substance or
16 cannabis, with or without consideration, whether or not there
17 is an agency relationship. The term does not include the
18 donation of prescription drugs to the extent permitted under
19 the Drug Repository Program Act.
20     "Manufacture" means the production, preparation,
21 propagation, compounding, conversion, or processing of a
22 controlled substance, either directly or indirectly, by
23 extraction from substances of natural origin, independently by
24 means of chemical synthesis, or by a combination of extraction
25 and chemical synthesis, and includes any packaging or
26 repackaging of the substance or labeling of its container,
27 except that the term does not include:
28         (1) by an ultimate user, the preparation or compounding
29     of a controlled substance for his own use;
30         (2) by a practitioner or his authorized agent under his
31     supervision, the preparation, compounding, packaging, or
32     labeling of a controlled substance: ;
33             (A) as an incident to his administering or
34         dispensing of a controlled substance in the course of
35         his professional practice; or
36             (B) as an incident to lawful research, teaching or

 

 

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1         chemical analysis and not for sale; or
2         (3) the preparation, compounding, packaging, or
3     labeling of cannabis as an incident to lawful research,
4     teaching, or chemical analysis and not for sale; or .
5         (4) the packaging, repackaging, or labeling of
6     prescription drugs only to the extent required under the
7     Drug Repository Program Act.
8     "Owner" means a person who has possession of or any
9 interest whatsoever in the property involved.
10     "Person" means an individual, a corporation, a government,
11 a governmental subdivision or agency, a business trust, an
12 estate, a trust, a partnership or association, or any other
13 entity.
14     "Production" means planting, cultivating, tending, or
15 harvesting.
16     "Property" means real property, including things growing
17 on, affixed to, and found in land, and tangible or intangible
18 personal property, including rights, services, privileges,
19 interests, claims, and securities.
20 (Source: P.A. 87-544.)