94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006
HB3868

 

Introduced 2/25/2005, by Rep. Kathleen A. Ryg

 

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

 

HB3868 LRB094 08461 DRJ 38666 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     Section 10. Drug repository program. The Department shall
23 establish a drug repository program to accept and dispense
24 prescription drugs donated for the purpose of being dispensed
25 to individuals who are residents of this State and meet
26 eligibility standards established in rules adopted by the
27 Department under Section 30. Only drugs in their original
28 sealed and tamper-evident unit dose packaging may be accepted
29 and dispensed. The packaging must be unopened, except that
30 drugs packaged in single unit doses may be accepted and
31 dispensed when the outside packaging is opened if the single
32 unit dose packaging is undisturbed. Drugs donated by
33 individuals bearing an expiration date that is less than 6
34 months from the date the drug is donated shall not be accepted
35 or dispensed. A drug shall not be accepted or dispensed if

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1     direct or cause the direction of the management and
2     policies of a person or an organization, whether by
3     ownership of stock, voting rights, contract, or otherwise.
4         (e) The sale, purchase, or trade of a drug or an offer
5     to sell, purchase, or trade a drug for emergency medical
6     reasons. For purposes of this Act, "emergency medical
7     reasons" include transfers of prescription drugs by a
8     retail pharmacy to another retail pharmacy to alleviate a
9     temporary shortage.
10         (f) The sale, purchase, or trade of a drug, an offer to
11     sell, purchase, or trade a drug, or the dispensing of a
12     drug pursuant to a prescription.
13         (g) The distribution of drug samples by manufacturers'
14     representatives or distributors' representatives.
15         (h) The sale, purchase, or trade of blood and blood
16     components intended for transfusion.
17         (i) The donation of prescription drugs to the extent
18     permitted under the Drug Repository Program Act.
19     "Wholesale drug distributor" means any person or entity
20 engaged in wholesale distribution of prescription drugs,
21 including, but not limited to, manufacturers; repackers; own
22 label distributors; jobbers; private label distributors;
23 brokers; warehouses, including manufacturers' and
24 distributors' warehouses, chain drug warehouses, and wholesale
25 drug warehouses; independent wholesale drug traders; and
26 retail pharmacies that conduct wholesale distributions,
27 including, but not limited to, any pharmacy distributor as
28 defined in this Section. A wholesale drug distributor shall not
29 include any for hire carrier or person or entity hired solely
30 to transport prescription drugs.
31 (Source: P.A. 87-594.)
 
32     Section 92. The Senior Pharmaceutical Assistance Act is
33 amended by changing Section 10 as follows:
 
34     (320 ILCS 50/10)

 

 

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

 

 

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

 

 

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1 of the health of the patient, directs otherwise in writing, the
2 name and address of the dispenser, the serial number and date
3 of the prescription or of its filling, the name of the
4 prescriber and, if stated in the prescription, the name of the
5 patient, and the directions for use and the cautionary
6 statements, if any, contained in such prescription. This
7 exemption shall not apply to any drug dispensed in the course
8 of the conduct of business of dispensing drugs pursuant to
9 diagnosis by mail, or to a drug dispensed in violation of
10 subsection (a) of this Section.
11     (e) The Director may by regulation remove drugs subject to
12 Section 15 (d) and Section 17 from the requirements of
13 subsection (c) of this Section when such requirements are not
14 necessary for the protection of the public health.
15     (f) A drug which is subject to subsection (c) of this
16 Section shall be deemed to be misbranded if at any time before
17 dispensing its label fails to bear the statement "Caution:
18 Federal Law Prohibits Dispensing Without Prescription" or
19 "Caution: State Law Prohibits Dispensing Without
20 Prescription". A drug to which subsection (c) of this Section
21 does not apply shall be deemed to be misbranded if at any time
22 prior to dispensing its label bears the caution statement
23 quoted in the preceding sentence.
24     (g) Nothing in this Section shall be construed to relieve
25 any person from any requirement prescribed by or under
26 authority of law with respect to controlled substances now
27 included or which may hereafter be included within the
28 classifications of controlled substances cannabis as defined
29 in applicable Federal laws relating to controlled substances or
30 cannabis or the Cannabis Control Act.
31 (Source: P.A. 84-1308.)
 
32     Section 94. The Illinois Controlled Substances Act is
33 amended by changing Section 102 as follows:
 
34     (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)

 

 

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

 

 

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

 

 

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

 

 

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1     amphetamine or methamphetamine and any of their optical
2     isomers; (ii) any salt of amphetamine or methamphetamine or
3     any salt of an optical isomer of amphetamine; or (iii) any
4     substance which the Department, after investigation, has
5     found to be, and by rule designated as, habit forming
6     because of its depressant or stimulant effect on the
7     central nervous system; or
8         (3) lysergic acid diethylamide; or
9         (4) any drug which contains any quantity of a substance
10     which the Department, after investigation, has found to
11     have, and by rule designated as having, a potential for
12     abuse because of its depressant or stimulant effect on the
13     central nervous system or its hallucinogenic effect.
14     (n) (Blank).
15     (o) "Director" means the Director of the Department of
16 State Police or the Department of Professional Regulation or
17 his designated agents.
18     (p) "Dispense" means to deliver a controlled substance to
19 an ultimate user or research subject by or pursuant to the
20 lawful order of a prescriber, including the prescribing,
21 administering, packaging, labeling, or compounding necessary
22 to prepare the substance for that delivery.
23     (q) "Dispenser" means a practitioner who dispenses.
24     (r) "Distribute" means to deliver, other than by
25 administering or dispensing, a controlled substance.
26     (s) "Distributor" means a person who distributes.
27     (t) "Drug" means (1) substances recognized as drugs in the
28 official United States Pharmacopoeia, Official Homeopathic
29 Pharmacopoeia of the United States, or official National
30 Formulary, or any supplement to any of them; (2) substances
31 intended for use in diagnosis, cure, mitigation, treatment, or
32 prevention of disease in man or animals; (3) substances (other
33 than food) intended to affect the structure of any function of
34 the body of man or animals and (4) substances intended for use
35 as a component of any article specified in clause (1), (2), or
36 (3) of this subsection. It does not include devices or their

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1 assistant, advanced practice nurse, licensed practical nurse,
2 registered nurse, hospital, laboratory, or pharmacy, or other
3 person licensed, registered, or otherwise lawfully permitted
4 by the United States or this State to distribute, dispense,
5 conduct research with respect to, administer or use in teaching
6 or chemical analysis, a controlled substance in the course of
7 professional practice or research.
8     (ll) "Pre-printed prescription" means a written
9 prescription upon which the designated drug has been indicated
10 prior to the time of issuance.
11     (mm) "Prescriber" means a physician licensed to practice
12 medicine in all its branches, dentist, podiatrist or
13 veterinarian who issues a prescription, a physician assistant
14 who issues a prescription for a Schedule III, IV, or V
15 controlled substance in accordance with Section 303.05 and the
16 written guidelines required under Section 7.5 of the Physician
17 Assistant Practice Act of 1987, or an advanced practice nurse
18 with prescriptive authority in accordance with Section 303.05
19 and a written collaborative agreement under Sections 15-15 and
20 15-20 of the Nursing and Advanced Practice Nursing Act.
21     (nn) "Prescription" means a lawful written, facsimile, or
22 verbal order of a physician licensed to practice medicine in
23 all its branches, dentist, podiatrist or veterinarian for any
24 controlled substance, of a physician assistant for a Schedule
25 III, IV, or V controlled substance in accordance with Section
26 303.05 and the written guidelines required under Section 7.5 of
27 the Physician Assistant Practice Act of 1987, or of an advanced
28 practice nurse who issues a prescription for a Schedule III,
29 IV, or V controlled substance in accordance with Section 303.05
30 and a written collaborative agreement under Sections 15-15 and
31 15-20 of the Nursing and Advanced Practice Nursing Act.
32     (oo) "Production" or "produce" means manufacture,
33 planting, cultivating, growing, or harvesting of a controlled
34 substance.
35     (pp) "Registrant" means every person who is required to
36 register under Section 302 of this Act.

 

 

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

 

 

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

 

 

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