95TH GENERAL ASSEMBLY
State of Illinois
2007 and 2008
HB0813

 

Introduced 2/7/2007, by Rep. Karen May

 

SYNOPSIS AS INTRODUCED:
 
See Index

    Creates the Cancer Drug Repository Program Act. Requires the Department of Public Health to establish a cancer drug repository program, under which any person may donate a cancer drug or supplies needed to administer a cancer drug for use by an individual who meets eligibility criteria specified by the Department. Sets forth requirements that cancer drugs or supplies must meet in order to be accepted and dispensed under the program. Provides that no drugs or supplies donated under the cancer drug repository program may be resold. Provides that nothing in the Act requires that a medical facility, pharmacy, pharmacist, or practitioner participate in the cancer drug repository program. Provides for civil and criminal immunity for drug and supply manufacturers and individuals in relation to the donation, acceptance, or dispensing of cancer drugs or supplies under the cancer drug repository program. Requires the Department to adopt certain rules to implement the cancer drug repository 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 Cancer 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

 

HB0813 LRB095 09713 DRJ 29917 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 Cancer
5 Drug Repository Program Act.
 
6     Section 5. Definitions. In this Act:
7     "Cancer drug" means a prescription drug that is used to
8 treat any of the following:
9         (1) Cancer or side effects of cancer.
10         (2) The side effects of any prescription drug that is
11     used to treat cancer or side effects of cancer.
12     "Department" means the Department of Public Health.
13     "Dispense" has the meaning given to that term in the
14 Pharmacy Practice Act of 1987.
15     "Medical facility" means any of the following:
16         (1) A hospital licensed under the Hospital Licensing
17     Act or subject to the University of Illinois Hospital Act.
18         (2) A clinic or office where a physician licensed to
19     practice medicine in all its branches conducts the practice
20     of medicine.
21     "Pharmacist" means an individual licensed to engage in the
22 practice of pharmacy under the Pharmacy Practice Act of 1987.
23     "Pharmacy" means a pharmacy registered in this State under

 

 

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1 the Pharmacy Practice Act of 1987.
2     "Practitioner" means a person licensed in this State to
3 prescribe and administer drugs or licensed in another state and
4 recognized by this State as a person authorized to prescribe
5 and administer drugs.
6     "Prescription drug" means any prescribed drug that may be
7 legally dispensed by a pharmacy.
8     "Program" means the cancer drug repository program
9 established under this Act.
 
10     Section 10. Cancer drug repository program. The Department
11 shall establish and maintain a cancer drug repository program,
12 under which any person may donate a cancer drug or supplies
13 needed to administer a cancer drug for use by an individual who
14 meets eligibility criteria specified by the Department in
15 rules. Donations may be made on the premises of a medical
16 facility or pharmacy that elects to participate in the program
17 and meets requirements specified by the Department in rules.
18 The medical facility or pharmacy may charge an individual who
19 receives a cancer drug or supplies needed to administer a
20 cancer drug under this Act a handling fee that may not exceed
21 the amount specified by the Department in rules. A medical
22 facility or pharmacy that receives a donated cancer drug or
23 supplies needed to administer a cancer drug under this Act may
24 distribute the cancer drug or supplies to another eligible
25 medical facility or pharmacy for use under the program.
 

 

 

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1     Section 15. Requirements for accepting and dispensing
2 cancer drugs and supplies. A cancer drug or supplies needed to
3 administer a cancer drug may be accepted and dispensed under
4 the program only if all of the following requirements are met:
5         (1) The cancer drug or supplies needed to administer a
6     cancer drug are in their original, unopened, sealed, and
7     tamper-evident unit-dose packaging or, if packaged in
8     single-unit doses, the single-unit-dose packaging is
9     unopened.
10         (2) The cancer drug bears an expiration date that is
11     later than 6 months after the date that the drug was
12     donated.
13         (3) The cancer drug or supplies needed to administer a
14     cancer drug are not adulterated or misbranded, as
15     determined by a pharmacist employed by, or under contract
16     with, the medical facility or pharmacy where the drug or
17     supplies are accepted or dispensed. The pharmacist must
18     inspect the drug or supplies before the drug or supplies
19     are dispensed.
20         (4) The cancer drug or supplies needed to administer a
21     cancer drug are prescribed by a practitioner for use by an
22     eligible individual and are dispensed by a pharmacist.
 
23     Section 20. Resale of donated drugs or supplies prohibited.
24 No cancer drug or supplies needed to administer a cancer drug

 

 

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1 that are donated for use under this Act may be resold.
 
2     Section 25. Participation in program not required. Nothing
3 in this Act requires that a medical facility, pharmacy,
4 pharmacist, or practitioner participate in the cancer drug
5 repository program.
 
6     Section 30. Immunity.
7     (a) Unless the manufacturer of a drug or supply exercises
8 bad faith, the manufacturer is not subject to criminal or civil
9 liability for injury, death, or loss to a person or property
10 for matters related to the donation, acceptance, or dispensing
11 of a cancer drug or supply manufactured by the manufacturer
12 that is donated by any person under this Act, including
13 liability for failure to transfer or communicate product or
14 consumer information or the expiration date of the donated
15 cancer drug or supply.
16     (b) Except as provided in subsection (c), a person other
17 than the manufacturer of a drug or supply is immune from civil
18 liability for injury to or the death of the individual to whom
19 the cancer drug or supply is dispensed and may not be found
20 guilty of unprofessional conduct for his or her acts or
21 omissions related to donating, accepting, distributing, or
22 dispensing a cancer drug or supply under this Act.
23     (c) The immunity or the prohibition on a finding of guilty
24 of unprofessional conduct under subsection (b) does not extend

 

 

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1 to the donation, acceptance, distribution, or dispensation of a
2 cancer drug or supply by a person whose act or omission
3 involved reckless, wanton, or intentional misconduct.
 
4     Section 35. Rules. The Department shall adopt all of the
5 following as rules:
6         (1) Requirements for medical facilities and pharmacies
7     to accept and dispense donated cancer drugs or supplies
8     needed to administer cancer drugs under this Act, including
9     all of the following:
10             (A) Eligibility criteria.
11             (B) Standards and procedures for accepting, safely
12         storing, and dispensing donated cancer drugs or
13         supplies needed to administer cancer drugs.
14             (C) Standards and procedures for inspecting
15         donated cancer drugs or supplies needed to administer
16         cancer drugs to determine whether the drugs or supplies
17         are in their original, unopened, sealed, and
18         tamper-evident unit-dose packaging or, if packaged in
19         single-unit doses, the single-unit-dose packaging is
20         unopened.
21             (D) Standards and procedures for inspecting
22         donated cancer drugs or supplies needed to administer
23         cancer drugs to determine that the drugs or supplies
24         needed to administer cancer drugs are not adulterated
25         or misbranded.

 

 

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1         (2) Eligibility criteria for individuals to receive
2     donated cancer drugs or supplies needed to administer
3     cancer drugs dispensed under the cancer drug repository
4     program. The standards shall prioritize dispensation to
5     individuals who are uninsured or indigent but must permit
6     dispensation to others if an uninsured or indigent
7     individual is unavailable.
8         (3) A means, such as an identification card, by which
9     an individual who is eligible to receive a donated cancer
10     drug or supplies needed to administer a cancer drug may
11     indicate that eligibility.
12         (4) Necessary forms for administration of the cancer
13     drug repository program, including forms for use by persons
14     that donate, accept, distribute, or dispense cancer drugs
15     or supplies needed to administer cancer drugs under the
16     program.
17         (5) The maximum handling fee that a medical facility or
18     pharmacy may charge for accepting, distributing, or
19     dispensing donated cancer drugs or supplies needed to
20     administer cancer drugs.
21         (6) A list of cancer drugs and supplies needed to
22     administer cancer drugs, arranged by category or by
23     individual cancer drug or supply, that the cancer drug
24     repository program will accept for dispensing.
25         (7) A list of cancer drugs and supplies needed to
26     administer cancer drugs, arranged by category or by

 

 

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1     individual cancer drug or supply, that the cancer drug
2     repository program will not accept for dispensing. The list
3     must include a statement that specifies the reason that the
4     drug or supplies are ineligible for donation.
5     The Department may also adopt any other rules deemed
6 necessary to implement this Act.
 
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

 

 

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1 nonpoisonous when used according to the directions on the
2 label, and also do not contain opium or coca leaves, or any
3 compound, salt or derivative thereof, or any drug which,
4 according to the latest editions of the following authoritative
5 pharmaceutical treatises and standards, namely, The United
6 States Pharmacopoeia/National Formulary (USP/NF), the United
7 States Dispensatory, and the Accepted Dental Remedies of the
8 Council of Dental Therapeutics of the American Dental
9 Association or any or either of them, in use on the effective
10 date of this Act, or according to the existing provisions of
11 the Federal Food, Drug, and Cosmetic Act and Regulations of the
12 Department of Health and Human Services, Food and Drug
13 Administration, promulgated thereunder now in effect, is
14 designated, described or considered as a narcotic, hypnotic,
15 habit forming, dangerous, or poisonous drug;
16     (d) the sale of poultry and livestock remedies in original
17 and unbroken packages only, labeled for poultry and livestock
18 medication;
19     (e) the sale of poisonous substances or mixture of
20 poisonous substances, in unbroken packages, for nonmedicinal
21 use in the arts or industries or for insecticide purposes;
22 provided, they are properly and adequately labeled as to
23 content and such nonmedicinal usage, in conformity with the
24 provisions of all applicable federal, state and local laws and
25 regulations promulgated thereunder now in effect relating
26 thereto and governing the same, and those which are required

 

 

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1 under such applicable laws and regulations to be labeled with
2 the word "Poison", are also labeled with the word "Poison"
3 printed thereon in prominent type and the name of a readily
4 obtainable antidote with directions for its administration;
5     (f) the delegation of limited prescriptive authority by a
6 physician licensed to practice medicine in all its branches to
7 a physician assistant under Section 7.5 of the Physician
8 Assistant Practice Act of 1987. This delegated authority may
9 but is not required to include prescription of Schedule III,
10 IV, or V controlled substances, as defined in Article II of the
11 Illinois Controlled Substances Act, in accordance with written
12 guidelines under Section 7.5 of the Physician Assistant
13 Practice Act of 1987; and
14     (g) the The delegation of limited prescriptive authority by
15 a physician licensed to practice medicine in all its branches
16 to an advanced practice nurse in accordance with a written
17 collaborative agreement under Sections 15-15 and 15-20 of the
18 Nursing and Advanced Practice Nursing Act. This delegated
19 authority may but is not required to include the prescription
20 of Schedule III, IV, or V controlled substances as defined in
21 Article II of the Illinois Controlled Substances Act; and .
22     (h) the donation or acceptance, or the packaging,
23 repackaging, or labeling, of prescription drugs to the extent
24 permitted or required under the Cancer Drug Repository Program
25 Act.
26 (Source: P.A. 90-116, eff. 7-14-97; 90-253, eff. 7-29-97;

 

 

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1 90-655, eff. 7-30-98; 90-742, eff. 8-13-98.)
 
2     Section 91. The Wholesale Drug Distribution Licensing Act
3 is amended by changing Section 15 as follows:
 
4     (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
5     (Section scheduled to be repealed on January 1, 2013)
6     Sec. 15. Definitions. As used in this Act:
7     "Blood" means whole blood collected from a single donor and
8 processed either for transfusion or further manufacturing.
9     "Blood component" means that part of blood separated by
10 physical or mechanical means.
11     "Board" means the State Board of Pharmacy of the Department
12 of Professional Regulation.
13     "Department" means the Department of Professional
14 Regulation.
15     "Director" means the Director of Professional Regulation.
16     "Drug sample" means a unit of a prescription drug that is
17 not intended to be sold and is intended to promote the sale of
18 the drug.
19     "Manufacturer" means anyone who is engaged in the
20 manufacturing, preparing, propagating, compounding,
21 processing, packaging, repackaging, or labeling of a
22 prescription drug. "Manufacturer" does not include anyone who
23 is engaged in the packaging, repackaging, or labeling of
24 prescription drugs only to the extent required under the Cancer

 

 

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1 Drug Repository Program Act.
2     "Person" means and includes a natural person, partnership,
3 association or corporation.
4     "Pharmacy distributor" means any pharmacy licensed in this
5 State or hospital pharmacy that is engaged in the delivery or
6 distribution of prescription drugs either to any other pharmacy
7 licensed in this State or to any other person or entity
8 including, but not limited to, a wholesale drug distributor
9 engaged in the delivery or distribution of prescription drugs
10 who is involved in the actual, constructive, or attempted
11 transfer of a drug in this State to other than the ultimate
12 consumer except as otherwise provided for by law.
13     "Prescription drug" means any human drug required by
14 federal law or regulation to be dispensed only by a
15 prescription, including finished dosage forms and active
16 ingredients subject to subsection (b) of Section 503 of the
17 Federal Food, Drug and Cosmetic Act.
18     "Wholesale distribution" or "wholesale distributions"
19 means distribution of prescription drugs to persons other than
20 a consumer or patient, but does not include any of the
21 following:
22         (a) Intracompany sales, defined as any transaction or
23     transfer between any division, subsidiary, parent, or
24     affiliated or related company under the common ownership
25     and control of a corporate entity.
26         (b) The purchase or other acquisition by a hospital or

 

 

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1     other health care entity that is a member of a group
2     purchasing organization of a drug for its own use from the
3     group purchasing organization or from other hospitals or
4     health care entities that are members of a group
5     organization.
6         (c) The sale, purchase, or trade of a drug or an offer
7     to sell, purchase, or trade a drug by a charitable
8     organization described in subsection (c)(3) of Section 501
9     of the U.S. Internal Revenue Code of 1954 to a nonprofit
10     affiliate of the organization to the extent otherwise
11     permitted by law.
12         (d) The sale, purchase, or trade of a drug or an offer
13     to sell, purchase, or trade a drug among hospitals or other
14     health care entities that are under common control. For
15     purposes of this Act, "common control" means the power to
16     direct or cause the direction of the management and
17     policies of a person or an organization, whether by
18     ownership of stock, voting rights, contract, or otherwise.
19         (e) The sale, purchase, or trade of a drug or an offer
20     to sell, purchase, or trade a drug for emergency medical
21     reasons. For purposes of this Act, "emergency medical
22     reasons" include transfers of prescription drugs by a
23     retail pharmacy to another retail pharmacy to alleviate a
24     temporary shortage.
25         (f) The sale, purchase, or trade of a drug, an offer to
26     sell, purchase, or trade a drug, or the dispensing of a

 

 

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1     drug pursuant to a prescription.
2         (g) The distribution of drug samples by manufacturers'
3     representatives or distributors' representatives.
4         (h) The sale, purchase, or trade of blood and blood
5     components intended for transfusion.
6         (i) The donation of prescription drugs to the extent
7     permitted under the Cancer Drug Repository Program Act.
8     "Wholesale drug distributor" means any person or entity
9 engaged in wholesale distribution of prescription drugs,
10 including, but not limited to, manufacturers; repackers; own
11 label distributors; jobbers; private label distributors;
12 brokers; warehouses, including manufacturers' and
13 distributors' warehouses, chain drug warehouses, and wholesale
14 drug warehouses; independent wholesale drug traders; and
15 retail pharmacies that conduct wholesale distributions,
16 including, but not limited to, any pharmacy distributor as
17 defined in this Section. A wholesale drug distributor shall not
18 include any for hire carrier or person or entity hired solely
19 to transport prescription drugs.
20 (Source: P.A. 87-594.)
 
21     Section 92. The Senior Pharmaceutical Assistance Act is
22 amended by changing Section 10 as follows:
 
23     (320 ILCS 50/10)
24     Sec. 10. Definitions. In this Act:

 

 

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1     "Manufacturer" includes:
2         (1) An entity that is engaged in (a) the production,
3     preparation, propagation, compounding, conversion, or
4     processing of prescription drug products (i) directly or
5     indirectly by extraction from substances of natural
6     origin, (ii) independently by means of chemical synthesis,
7     or (iii) by combination of extraction and chemical
8     synthesis; or (b) the packaging, repackaging, labeling or
9     re-labeling, or distribution of prescription drug
10     products.
11         (2) The entity holding legal title to or possession of
12     the national drug code number for the covered prescription
13     drug.
14     The term does not include a wholesale distributor of drugs,
15 drugstore chain organization, or retail pharmacy licensed by
16 the State. The term also does not include anyone who is engaged
17 in the packaging, repackaging, or labeling of prescription
18 drugs only to the extent required under the Cancer Drug
19 Repository Program Act.
20     "Prescription drug" means a drug that may be dispensed only
21 upon prescription by an authorized prescriber and that is
22 approved for safety and effectiveness as a prescription drug
23 under Section 505 or 507 of the Federal Food, Drug and Cosmetic
24 Act.
25     "Senior citizen" or "senior" means a person 65 years of age
26 or older.

 

 

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1 (Source: P.A. 92-594, eff. 6-27-02.)
 
2     Section 93. The Illinois Food, Drug and Cosmetic Act is
3 amended by changing Section 16 as follows:
 
4     (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)
5     Sec. 16. (a) The Director is hereby authorized to
6 promulgate regulations exempting from any labeling or
7 packaging requirement of this Act drugs and devices which are
8 (i) , in accordance with the practice of the trade, to be
9 processed, labeled or repacked in substantial quantities at
10 establishments other than those where originally processed or
11 packaged on condition that such drugs and devices are not
12 adulterated or misbranded under the provisions of this Act upon
13 removal from such processing, labeling or repacking
14 establishment or (ii) packaged, repackaged, or labeled to the
15 extent required under the Cancer Drug Repository Program Act.
16     (b) Drugs and device labeling or packaging exemptions
17 adopted under the Federal Act and supplements thereto or
18 revisions thereof shall apply to drugs and devices in Illinois
19 except insofar as modified or rejected by regulations
20 promulgated by the Director.
21     (c) A drug intended for use by man which (A) is a
22 habit-forming drug to which Section 15 (d) applies; or (B)
23 because of its toxicity or other potentiality for harmful
24 effect or the method of its use or the collateral measures

 

 

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1 necessary to its use is not safe for use except under the
2 supervision of a practitioner licensed by law to administer
3 such drug; or (C) is limited by an approved application under
4 Section 505 of the Federal Act or Section 17 of this Act to use
5 under the professional supervision of a practitioner licensed
6 by law to administer such drug, shall be dispensed only in
7 accordance with the provisions of the "Illinois Controlled
8 Substances Act". The act of dispensing a drug contrary to the
9 provisions of this paragraph shall be deemed to be an act which
10 results in a drug being misbranded while held for sale.
11     (d) Any drug dispensed by filling or refilling a written or
12 oral prescription of a practitioner licensed by law to
13 administer such drug shall be exempt from the requirements of
14 Section 15, except subsections (a), (k) and (l) and clauses (2)
15 and (3) of subsection (i), and the packaging requirements of
16 subsections (g), (h) and (q), if the drug bears a label
17 containing the proprietary name or names, or if there is none,
18 the established name or names of the drugs, the dosage and
19 quantity, unless the prescribing practitioner, in the interest
20 of the health of the patient, directs otherwise in writing, the
21 name and address of the dispenser, the serial number and date
22 of the prescription or of its filling, the name of the
23 prescriber and, if stated in the prescription, the name of the
24 patient, and the directions for use and the cautionary
25 statements, if any, contained in such prescription. This
26 exemption shall not apply to any drug dispensed in the course

 

 

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1 of the conduct of business of dispensing drugs pursuant to
2 diagnosis by mail, or to a drug dispensed in violation of
3 subsection (a) of this Section.
4     (e) The Director may by regulation remove drugs subject to
5 Section 15 (d) and Section 17 from the requirements of
6 subsection (c) of this Section when such requirements are not
7 necessary for the protection of the public health.
8     (f) A drug which is subject to subsection (c) of this
9 Section shall be deemed to be misbranded if at any time before
10 dispensing its label fails to bear the statement "Caution:
11 Federal Law Prohibits Dispensing Without Prescription" or
12 "Caution: State Law Prohibits Dispensing Without
13 Prescription". A drug to which subsection (c) of this Section
14 does not apply shall be deemed to be misbranded if at any time
15 prior to dispensing its label bears the caution statement
16 quoted in the preceding sentence.
17     (g) Nothing in this Section shall be construed to relieve
18 any person from any requirement prescribed by or under
19 authority of law with respect to controlled substances now
20 included or which may hereafter be included within the
21 classifications of controlled substances cannabis as defined
22 in applicable Federal laws relating to controlled substances or
23 cannabis or the Cannabis Control Act.
24 (Source: P.A. 84-1308.)
 
25     Section 94. The Illinois Controlled Substances Act is

 

 

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1 amended by changing Section 102 as follows:
 
2     (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
3     Sec. 102. Definitions. As used in this Act, unless the
4 context otherwise requires:
5     (a) "Addict" means any person who habitually uses any drug,
6 chemical, substance or dangerous drug other than alcohol so as
7 to endanger the public morals, health, safety or welfare or who
8 is so far addicted to the use of a dangerous drug or controlled
9 substance other than alcohol as to have lost the power of self
10 control with reference to his addiction.
11     (b) "Administer" means the direct application of a
12 controlled substance, whether by injection, inhalation,
13 ingestion, or any other means, to the body of a patient,
14 research subject, or animal (as defined by the Humane
15 Euthanasia in Animal Shelters Act) by:
16         (1) a practitioner (or, in his presence, by his
17     authorized agent),
18         (2) the patient or research subject at the lawful
19     direction of the practitioner, or
20         (3) a euthanasia technician as defined by the Humane
21     Euthanasia in Animal Shelters Act.
22     (c) "Agent" means an authorized person who acts on behalf
23 of or at the direction of a manufacturer, distributor, or
24 dispenser. It does not include a common or contract carrier,
25 public warehouseman or employee of the carrier or warehouseman.

 

 

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1     (c-1) "Anabolic Steroids" means any drug or hormonal
2 substance, chemically and pharmacologically related to
3 testosterone (other than estrogens, progestins, and
4 corticosteroids) that promotes muscle growth, and includes:
5             (i) boldenone,
6             (ii) chlorotestosterone,
7             (iii) chostebol,
8             (iv) dehydrochlormethyltestosterone,
9             (v) dihydrotestosterone,
10             (vi) drostanolone,
11             (vii) ethylestrenol,
12             (viii) fluoxymesterone,
13             (ix) formebulone,
14             (x) mesterolone,
15             (xi) methandienone,
16             (xii) methandranone,
17             (xiii) methandriol,
18             (xiv) methandrostenolone,
19             (xv) methenolone,
20             (xvi) methyltestosterone,
21             (xvii) mibolerone,
22             (xviii) nandrolone,
23             (xix) norethandrolone,
24             (xx) oxandrolone,
25             (xxi) oxymesterone,
26             (xxii) oxymetholone,

 

 

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1             (xxiii) stanolone,
2             (xxiv) stanozolol,
3             (xxv) testolactone,
4             (xxvi) testosterone,
5             (xxvii) trenbolone, and
6             (xxviii) any salt, ester, or isomer of a drug or
7         substance described or listed in this paragraph, if
8         that salt, ester, or isomer promotes muscle growth.
9     Any person who is otherwise lawfully in possession of an
10 anabolic steroid, or who otherwise lawfully manufactures,
11 distributes, dispenses, delivers, or possesses with intent to
12 deliver an anabolic steroid, which anabolic steroid is
13 expressly intended for and lawfully allowed to be administered
14 through implants to livestock or other nonhuman species, and
15 which is approved by the Secretary of Health and Human Services
16 for such administration, and which the person intends to
17 administer or have administered through such implants, shall
18 not be considered to be in unauthorized possession or to
19 unlawfully manufacture, distribute, dispense, deliver, or
20 possess with intent to deliver such anabolic steroid for
21 purposes of this Act.
22     (d) "Administration" means the Drug Enforcement
23 Administration, United States Department of Justice, or its
24 successor agency.
25     (e) "Control" means to add a drug or other substance, or
26 immediate precursor, to a Schedule under Article II of this Act

 

 

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1 whether by transfer from another Schedule or otherwise.
2     (f) "Controlled Substance" means a drug, substance, or
3 immediate precursor in the Schedules of Article II of this Act.
4     (g) "Counterfeit substance" means a controlled substance,
5 which, or the container or labeling of which, without
6 authorization bears the trademark, trade name, or other
7 identifying mark, imprint, number or device, or any likeness
8 thereof, of a manufacturer, distributor, or dispenser other
9 than the person who in fact manufactured, distributed, or
10 dispensed the substance.
11     (h) "Deliver" or "delivery" means the actual, constructive
12 or attempted transfer of possession of a controlled substance,
13 with or without consideration, whether or not there is an
14 agency relationship. The term does not include the donation of
15 prescription drugs to the extent permitted under the Cancer
16 Drug Repository Program Act.
17     (i) "Department" means the Illinois Department of Human
18 Services (as successor to the Department of Alcoholism and
19 Substance Abuse) or its successor agency.
20     (j) "Department of State Police" means the Department of
21 State Police of the State of Illinois or its successor agency.
22     (k) "Department of Corrections" means the Department of
23 Corrections of the State of Illinois or its successor agency.
24     (l) "Department of Professional Regulation" means the
25 Department of Professional Regulation of the State of Illinois
26 or its successor agency.

 

 

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1     (m) "Depressant" or "stimulant substance" means:
2         (1) a drug which contains any quantity of (i)
3     barbituric acid or any of the salts of barbituric acid
4     which has been designated as habit forming under section
5     502 (d) of the Federal Food, Drug, and Cosmetic Act (21
6     U.S.C. 352 (d)); or
7         (2) a drug which contains any quantity of (i)
8     amphetamine or methamphetamine and any of their optical
9     isomers; (ii) any salt of amphetamine or methamphetamine or
10     any salt of an optical isomer of amphetamine; or (iii) any
11     substance which the Department, after investigation, has
12     found to be, and by rule designated as, habit forming
13     because of its depressant or stimulant effect on the
14     central nervous system; or
15         (3) lysergic acid diethylamide; or
16         (4) any drug which contains any quantity of a substance
17     which the Department, after investigation, has found to
18     have, and by rule designated as having, a potential for
19     abuse because of its depressant or stimulant effect on the
20     central nervous system or its hallucinogenic effect.
21     (n) (Blank).
22     (o) "Director" means the Director of the Department of
23 State Police or the Department of Professional Regulation or
24 his designated agents.
25     (p) "Dispense" means to deliver a controlled substance to
26 an ultimate user or research subject by or pursuant to the

 

 

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1 lawful order of a prescriber, including the prescribing,
2 administering, packaging, labeling, or compounding necessary
3 to prepare the substance for that delivery.
4     (q) "Dispenser" means a practitioner who dispenses.
5     (r) "Distribute" means to deliver, other than by
6 administering or dispensing, a controlled substance.
7     (s) "Distributor" means a person who distributes.
8     (t) "Drug" means (1) substances recognized as drugs in the
9 official United States Pharmacopoeia, Official Homeopathic
10 Pharmacopoeia of the United States, or official National
11 Formulary, or any supplement to any of them; (2) substances
12 intended for use in diagnosis, cure, mitigation, treatment, or
13 prevention of disease in man or animals; (3) substances (other
14 than food) intended to affect the structure of any function of
15 the body of man or animals and (4) substances intended for use
16 as a component of any article specified in clause (1), (2), or
17 (3) of this subsection. It does not include devices or their
18 components, parts, or accessories.
19     (t-5) "Euthanasia agency" means an entity certified by the
20 Department of Professional Regulation for the purpose of animal
21 euthanasia that holds an animal control facility license or
22 animal shelter license under the Animal Welfare Act. A
23 euthanasia agency is authorized to purchase, store, possess,
24 and utilize Schedule II nonnarcotic and Schedule III
25 nonnarcotic drugs for the sole purpose of animal euthanasia.
26     (t-10) "Euthanasia drugs" means Schedule II or Schedule III

 

 

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1 substances (nonnarcotic controlled substances) that are used
2 by a euthanasia agency for the purpose of animal euthanasia.
3     (u) "Good faith" means the prescribing or dispensing of a
4 controlled substance by a practitioner in the regular course of
5 professional treatment to or for any person who is under his
6 treatment for a pathology or condition other than that
7 individual's physical or psychological dependence upon or
8 addiction to a controlled substance, except as provided herein:
9 and application of the term to a pharmacist shall mean the
10 dispensing of a controlled substance pursuant to the
11 prescriber's order which in the professional judgment of the
12 pharmacist is lawful. The pharmacist shall be guided by
13 accepted professional standards including, but not limited to
14 the following, in making the judgment:
15         (1) lack of consistency of doctor-patient
16     relationship,
17         (2) frequency of prescriptions for same drug by one
18     prescriber for large numbers of patients,
19         (3) quantities beyond those normally prescribed,
20         (4) unusual dosages,
21         (5) unusual geographic distances between patient,
22     pharmacist and prescriber,
23         (6) consistent prescribing of habit-forming drugs.
24     (u-1) "Home infusion services" means services provided by a
25 pharmacy in compounding solutions for direct administration to
26 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

 

 

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1 substance or is distributed under circumstances which would
2 lead a reasonable person to believe that the substance is a
3 controlled substance. For the purpose of determining whether
4 the representations made or the circumstances of the
5 distribution would lead a reasonable person to believe the
6 substance to be a controlled substance under this clause (2) of
7 subsection (y), the court or other authority may consider the
8 following factors in addition to any other factor that may be
9 relevant:
10         (a) statements made by the owner or person in control
11     of the substance concerning its nature, use or effect;
12         (b) statements made to the buyer or recipient that the
13     substance may be resold for profit;
14         (c) whether the substance is packaged in a manner
15     normally used for the illegal distribution of controlled
16     substances;
17         (d) whether the distribution or attempted distribution
18     included an exchange of or demand for money or other
19     property as consideration, and whether the amount of the
20     consideration was substantially greater than the
21     reasonable retail market value of the substance.
22     Clause (1) of this subsection (y) shall not apply to a
23 noncontrolled substance in its finished dosage form that was
24 initially introduced into commerce prior to the initial
25 introduction into commerce of a controlled substance in its
26 finished dosage form which it may substantially resemble.

 

 

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1     Nothing in this subsection (y) prohibits the dispensing or
2 distributing of noncontrolled substances by persons authorized
3 to dispense and distribute controlled substances under this
4 Act, provided that such action would be deemed to be carried
5 out in good faith under subsection (u) if the substances
6 involved were controlled substances.
7     Nothing in this subsection (y) or in this Act prohibits the
8 manufacture, preparation, propagation, compounding,
9 processing, packaging, advertising or distribution of a drug or
10 drugs by any person registered pursuant to Section 510 of the
11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
12     (y-1) "Mail-order pharmacy" means a pharmacy that is
13 located in a state of the United States, other than Illinois,
14 that delivers, dispenses or distributes, through the United
15 States Postal Service or other common carrier, to Illinois
16 residents, any substance which requires a prescription.
17     (z) "Manufacture" means the production, preparation,
18 propagation, compounding, conversion or processing of a
19 controlled substance other than methamphetamine, either
20 directly or indirectly, by extraction from substances of
21 natural origin, or independently by means of chemical
22 synthesis, or by a combination of extraction and chemical
23 synthesis, and includes any packaging or repackaging of the
24 substance or labeling of its container, except that this term
25 does not include:
26         (1) by an ultimate user, the preparation or compounding

 

 

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1     of a controlled substance for his own use; or
2         (2) by a practitioner, or his authorized agent under
3     his supervision, the preparation, compounding, packaging,
4     or labeling of a controlled substance:
5             (a) as an incident to his administering or
6         dispensing of a controlled substance in the course of
7         his professional practice; or
8             (b) as an incident to lawful research, teaching or
9         chemical analysis and not for sale; or .
10         (3) the packaging, repackaging, or labeling of
11     prescription drugs only to the extent required under the
12     Cancer Drug Repository Program Act.
13     (z-1) (Blank).
14     (aa) "Narcotic drug" means any of the following, whether
15 produced directly or indirectly by extraction from substances
16 of natural origin, or independently by means of chemical
17 synthesis, or by a combination of extraction and chemical
18 synthesis:
19         (1) opium and opiate, and any salt, compound,
20     derivative, or preparation of opium or opiate;
21         (2) any salt, compound, isomer, derivative, or
22     preparation thereof which is chemically equivalent or
23     identical with any of the substances referred to in clause
24     (1), but not including the isoquinoline alkaloids of opium;
25         (3) opium poppy and poppy straw;
26         (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

 

 

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1 pharmacist or a registered assistant pharmacist under the
2 Pharmacy Practice Act of 1987.
3     (ii) "Pharmacy" means any store, ship or other place in
4 which pharmacy is authorized to be practiced under the Pharmacy
5 Practice Act of 1987.
6     (jj) "Poppy straw" means all parts, except the seeds, of
7 the opium poppy, after mowing.
8     (kk) "Practitioner" means a physician licensed to practice
9 medicine in all its branches, dentist, podiatrist,
10 veterinarian, scientific investigator, pharmacist, physician
11 assistant, advanced practice nurse, licensed practical nurse,
12 registered nurse, hospital, laboratory, or pharmacy, or other
13 person licensed, registered, or otherwise lawfully permitted
14 by the United States or this State to distribute, dispense,
15 conduct research with respect to, administer or use in teaching
16 or chemical analysis, a controlled substance in the course of
17 professional practice or research.
18     (ll) "Pre-printed prescription" means a written
19 prescription upon which the designated drug has been indicated
20 prior to the time of issuance.
21     (mm) "Prescriber" means a physician licensed to practice
22 medicine in all its branches, dentist, podiatrist or
23 veterinarian who issues a prescription, a physician assistant
24 who issues a prescription for a Schedule III, IV, or V
25 controlled substance in accordance with Section 303.05 and the
26 written guidelines required under Section 7.5 of the Physician

 

 

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1 Assistant Practice Act of 1987, or an advanced practice nurse
2 with prescriptive authority in accordance with Section 303.05
3 and a written collaborative agreement under Sections 15-15 and
4 15-20 of the Nursing and Advanced Practice Nursing Act.
5     (nn) "Prescription" means a lawful written, facsimile, or
6 verbal order of a physician licensed to practice medicine in
7 all its branches, dentist, podiatrist or veterinarian for any
8 controlled substance, of a physician assistant for a Schedule
9 III, IV, or V controlled substance in accordance with Section
10 303.05 and the written guidelines required under Section 7.5 of
11 the Physician Assistant Practice Act of 1987, or of an advanced
12 practice nurse who issues a prescription for a Schedule III,
13 IV, or V controlled substance in accordance with Section 303.05
14 and a written collaborative agreement under Sections 15-15 and
15 15-20 of the Nursing and Advanced Practice Nursing Act.
16     (oo) "Production" or "produce" means manufacture,
17 planting, cultivating, growing, or harvesting of a controlled
18 substance other than methamphetamine.
19     (pp) "Registrant" means every person who is required to
20 register under Section 302 of this Act.
21     (qq) "Registry number" means the number assigned to each
22 person authorized to handle controlled substances under the
23 laws of the United States and of this State.
24     (rr) "State" includes the State of Illinois and any state,
25 district, commonwealth, territory, insular possession thereof,
26 and any area subject to the legal authority of the United

 

 

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1 States of America.
2     (ss) "Ultimate user" means a person who lawfully possesses
3 a controlled substance for his own use or for the use of a
4 member of his household or for administering to an animal owned
5 by him or by a member of his household.
6 (Source: P.A. 93-596, eff. 8-26-03; 93-626, eff. 12-23-03;
7 94-556, eff. 9-11-05.)
 
8     Section 95. The Cannabis and Controlled Substances Tort
9 Claims Act is amended by changing Section 3 as follows:
 
10     (740 ILCS 20/3)  (from Ch. 70, par. 903)
11     Sec. 3. Definitions. As used in this Act, unless the
12 context otherwise requires:
13     "Cannabis" includes marihuana, hashish, and other
14 substances that are identified as including any parts of the
15 plant Cannabis Sativa, whether growing or not, the seeds of
16 that plant, the resin extracted from any part of that plant,
17 and any compound, manufacture, salt, derivative, mixture, or
18 preparation of that plant, its seeds, or resin, including
19 tetrahydrocannabinol (THC) and all other cannabinol
20 derivatives, including its naturally occurring or
21 synthetically produced ingredients, whether produced directly
22 or indirectly by extraction, independently by means of chemical
23 synthesis, or by a combination of extraction and chemical
24 synthesis. "Cannabis" does not include the mature stalks of

 

 

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1 that plant, fiber produced from those stalks, oil or cake made
2 from the seeds of that plant, any other compound, manufacture,
3 salt, derivative, mixture, or preparation of mature stalks
4 (except the extracted resin), fiber, oil or cake, or the
5 sterilized seeds of that plant that are incapable of
6 germination.
7     "Controlled substance" means a drug, substance, or
8 immediate precursor in the Schedules of Article II of the
9 Illinois Controlled Substances Act.
10     "Counterfeit substance" means a controlled substance or
11 the container or labeling of a controlled substance that,
12 without authorization, bears the trademark, trade name, or
13 other identifying mark, imprint, number, device, or any
14 likeness thereof of a manufacturer, distributor, or dispenser
15 other than the person who in fact manufactured, distributed, or
16 dispensed the substance.
17     "Deliver" or "delivery" means the actual, constructive, or
18 attempted transfer of possession of a controlled substance or
19 cannabis, with or without consideration, whether or not there
20 is an agency relationship. The term does not include the
21 donation of prescription drugs to the extent permitted under
22 the Cancer Drug Repository Program Act.
23     "Manufacture" means the production, preparation,
24 propagation, compounding, conversion, or processing of a
25 controlled substance, either directly or indirectly, by
26 extraction from substances of natural origin, independently by

 

 

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1 means of chemical synthesis, or by a combination of extraction
2 and chemical synthesis, and includes any packaging or
3 repackaging of the substance or labeling of its container,
4 except that the term does not include:
5         (1) by an ultimate user, the preparation or compounding
6     of a controlled substance for his own use;
7         (2) by a practitioner or his authorized agent under his
8     supervision, the preparation, compounding, packaging, or
9     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 preparation, compounding, packaging, or
16     labeling of cannabis as an incident to lawful research,
17     teaching, or chemical analysis and not for sale; or .
18         (4) the packaging, repackaging, or labeling of
19     prescription drugs only to the extent required under the
20     Cancer Drug Repository Program Act.
21     "Owner" means a person who has possession of or any
22 interest whatsoever in the property involved.
23     "Person" means an individual, a corporation, a government,
24 a governmental subdivision or agency, a business trust, an
25 estate, a trust, a partnership or association, or any other
26 entity.

 

 

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1     "Production" means planting, cultivating, tending, or
2 harvesting.
3     "Property" means real property, including things growing
4 on, affixed to, and found in land, and tangible or intangible
5 personal property, including rights, services, privileges,
6 interests, claims, and securities.
7 (Source: P.A. 87-544.)

 

 

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1 INDEX
2 Statutes amended in order of appearance
3     New Act
4     225 ILCS 85/4 from Ch. 111, par. 4124
5     225 ILCS 120/15 from Ch. 111, par. 8301-15
6     320 ILCS 50/10
7     410 ILCS 620/16 from Ch. 56 1/2, par. 516
8     720 ILCS 570/102 from Ch. 56 1/2, par. 1102
9     740 ILCS 20/3 from Ch. 70, par. 903